1 j global clinical engineering vol.2 issue 1, 2019 welcome to the initiation of a new column in our global clinical engineering journal that will serve the readership as additional information source of international health technology interest, as opportunity to exchange comment and collect your feedback, and promote stronger engagement with who representative members. this new added feature will be directed under the expertise of adriana velazquez berumen, senior advisor on medical devices, department of essential medicines and health products, at the world health organization in geneva, switzerland (url: www.who.int/medical_devices/en/ and e-mail: velazquezberumena@who.int). your feedback and promotion and sharing of the information posted in this column are welcome. at a press conference at the united nations in geneva, on july 9, 2019, who launched the 2nd who model list of essential in vitro diagnostics (edl) and the application for the 3rd edl list has opened. (https://www.who.int/medical_devices/publications/second_who_model_list_of_essential_in_vitro_diagnostics/en/). the objective of the edl is to increase access, affordability, availability of these tests globally, to support universal health coverage and better health for all. it includes laboratory tests as well as point of care and the objective is that countries will refer to who lists and updated their national reference lists for public procurement or reimbursement. the process to select these diagnostics included: assess the tests submitted for the 2nd edl, ,series of consultations, including public comments and final review, analysis and discussion by members of strategic advisory group of experts on in vitro diagnostics (sage ivd) and who staff . the full report of the process will present a description of the methodologies, reviews, evidence, references and recommendations of the sage ivd members and will be published in september 2019 as part of who technical report series. and will be found at: https://www.who.int/medical_devices/ diagnostics/selection_in-vitro/en/. you may find of interest the exciting update about health product profile directory https://www. who.int/tdr/diseases-topics/product-directory/en/ a free-to-use online resource created and developed by tdr (special programme for research and training in tropical diseases) on behalf of who as a global public good to improve the efficiency of efforts to develop new products for neglected diseases and populations as well as threats to global health. it provides a searchable database of the 8-10 key characteristics used to describe desired health products, including medicines, vaccines, diagnostics and medical equipment. links are provided to access the full product profile document where this is publicly available. the directory was launched in may 2019 and will be continuously updated. you are encouraged to visit the website provided. who update column http://www.globalce.org http://www.globalce.org www.who.int/medical_devices/en mailto:velazquezberumena%40who.int?subject= https://www.who.int/medical_devices/publications/second_who_model_list_of_essential_in_vitro_diagnostics/en https://www.who.int/medical_devices/publications/second_who_model_list_of_essential_in_vitro_diagnostics/en https://www.who.int/medical_devices/diagnostics/selection_in-vitro/en https://www.who.int/medical_devices/diagnostics/selection_in-vitro/en https://www.who.int/tdr/diseases-topics/product-directory/en https://www.who.int/tdr/diseases-topics/product-directory/en https://www.who.int/tdr/about/en/ j global clinical engineering vol.2 issue 1, 2019 2 finally, i would also like to share with you additional highlights from the july 2019 who medical devices newsletter that describe career opportunities at who. in particular, a full time technical officer position is open (position 1902257) where you can find additional information about it such as job description and how to apply as well as about more opportunities at https://careers.who.int/careersection/ex/jobdetail.ftl?job=1902257&tz=gmt%2b02%3a00&tzname=europe%2fberlin. i am delighted with this opportunity to connected with you and to create a new platform for increasing knowledge about and communication between stake holders with interest in health technologies. respectfully, adriana copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://careers.who.int/careersection/ex/jobdetail.ftl?job=1902257&tz=gmt%2b02%3a00&tzname=europe%2fberlin. https://careers.who.int/careersection/ex/jobdetail.ftl?job=1902257&tz=gmt%2b02%3a00&tzname=europe%2fberlin. 1 j global clinical engineering vol.2 issue 1, 2019 editor’s corner often do i hear at meetings debates about how many clinical engineers and technicians are needed per some quantifying unit. quantifying unit like the volume or quantity of assets managed, the replacement or acquisition value of the assets managed, or number of patients’ beds, and even per volume of patients discharged. however, seldom the debate reaches the level of how many such qualified personnel a system such as city or country or even the world may need. recent surveys attempted to identify the volume of clinical engineering professionals practicing around the world. they resulted either in very low response rate (calil 2017) reflecting therefore estimate of very small community of ces practitioners, or as designed by another survey organizers included variety of other than ce engineering professionals such as biomedical engineering other engineering practitioners and technology managers (who 2018) that resulted in high volume count of about 800,000 practitioners but could not clearly identified the share of ces in that count. knowledge about the gap, if one exists, between the volume of practicing qualified ces and the volume of the needed ces can help guide national and global policies, priorities, and program support that are needed to narrow and even eliminate the gap (if one exists) over time. following the publication in 1999 of its landmark manuscript about reducing preventable medical errors committed during provisioning of health care (http:// www.nationalacademies.org/hmd/reports/1999/toerr-is-human-building-a-safer-health-system.aspx), the national academy of medicine (formerly the institute of medicine), published in 2001 their report crossing the quality chasm; a new health system for the 21st century (http://www.nationalacademies.org/hmd/reports/2001/ crossing-the-quality-chasm-a-new-health-system-forthe-21st-century.aspx), and followed up in 2015 with another landmark book about the criticality of getting the correct diagnosis in managing patient conditions and the underappreciated occurrence of diagnostic errors (http://www.nationalacademies.org/hmd/reports/2015/improving-diagnosis-in-healthcare.aspx). these reports call for urgent and fundamental change to healthcare system design, policies, processes, and the direction for the professionals who have stake in its outcomes. these reports state that patients should be able to count on receiving care that meets their needs and is based on the best scientific knowledge – however that is too frequently is not the case. it furthermore points that health care harms patients and routinely fails to deliver its potential benefits. the 2001 report specifically states that “faced with medical and technology rapid changes, the nation’s health care delivery system has fallen far short in its ability to translate knowledge into practice and to apply new technology safely and appropriately. and if the system cannot consistently deliver today’s science and technology, it is even less prepared to respond to the extraordinary advances that surely will emerge during the coming decades.” clinical engineers, according to acce definition i participated in its creation in 1992, are “professionals who supports and advances patient care by applying engineering and managerial skills to healthcare technology.” (https:// accenet.org/about/pages/clinicalengineer.aspx). while there are differences in some of the clinical engineers scope of practice between countries their focus is the same – deliver competent technology life cycle skills that support improvement in patient outcomes and wellness. this calls for clinical engineers to adopt professional guidance about the minimum requirements for education, training, and professional credentialing that will lead to building of competent practitioners’ capacity. capacity that can deliver on the recommendations for plans to correct the above noted deficiencies. http://www.globalce.org http://www.globalce.org http://www.nationalacademies.org/hmd/reports/1999/to-err-is-human-building-a-safer-health-system.aspx http://www.nationalacademies.org/hmd/reports/1999/to-err-is-human-building-a-safer-health-system.aspx http://www.nationalacademies.org/hmd/reports/1999/to-err-is-human-building-a-safer-health-system.aspx http://www.nationalacademies.org/hmd/reports/2001/crossing-the-quality-chasm-a-new-health-system-for-the-21st-century.aspx http://www.nationalacademies.org/hmd/reports/2001/crossing-the-quality-chasm-a-new-health-system-for-the-21st-century.aspx http://www.nationalacademies.org/hmd/reports/2001/crossing-the-quality-chasm-a-new-health-system-for-the-21st-century.aspx http://www.nationalacademies.org/hmd/reports/2015/improving-diagnosis-in-healthcare.aspx http://www.nationalacademies.org/hmd/reports/2015/improving-diagnosis-in-healthcare.aspx https://accenet.org/about/pages/clinicalengineer.aspx https://accenet.org/about/pages/clinicalengineer.aspx j global clinical engineering vol.2 issue 1, 2019 2 so, while we still debating how many ces a technology life-cycle program should optimally has or how many ces the world needs i believe that it is unanimously clear that in order to deliver the value of our profession to improve global health systems outcomes these professionals must be well prepared, ethically committed, competent and professionally credentialed. i look forward to your comments. together we can lead the move from health to wealth! dr. yadin david copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org j global clinical engineering issue 1, 2018 editor’s corner the inaugural issue! if you have ever had the good fortune to experience the moment a child is born, then you know that it transforms life as you know it. if you have not experienced this magnificent moment yet, i do hope that one day soon, you will. it is hard to put such a feeling into words, but it is a glorious moment, especially when the newborn is part of your own family. our journal has arrived! in a way, you can think of the global clinical engineering journal as the child that will foster a sense of pride for clinical engineers all over the world – producing the magnificent aura that new parents delight in as they nurture and rear their beautiful baby. this baby (the journal) has older siblings – all members of the profession’s family that are working together to be successful. among the slew of important, recent achievements that makes our family proud, are: • the ushering of the only congress dedicated to the clinical engineering field – the international clinical engineering and health technology management congress – the third congress slated to take place in rome, italy, in october 2019 (www.icehtmc.com). • the world-wide celebration of the global clinical engineering day (http://global.icehtmc.com/), this year on october 21st will be initiated from chengdu, china, recognizing the contributions of ces to improving healthcare outcomes. • the initiation of the clinical engineering awards program (http://cedglobal.org/awards/). • the free-access posting of human factors for health technology safety book (http://cedglobal.org/ human-factors-for-health-technology-safety/) on the clinical engineering division web site (www. globalced.org); and now • the arrival of our own publication – the global clinical engineering journal (www.globalce.org). it is critically important that you feel as though the journal is your child, since this is going to be your creation, and the outcome will be directly correlated to the level of your personal engagement and investment. we all know that raising a child “takes a village.” it is no exception that global ce journal needs a village, and that with the proper amount of tender loving care, it will grow and turn into a mature, impactful publication. it will only thrive when and if you (the village) will feed, care for, encourage, and share your knowledge with it. we do have a few advantages that should make you all proud. for instance, i am so proud of the amazing members of the editorial board of our journal who make up a wide range of disciplinary fields, including clinical engineers, medical doctors, surgeons, anesthesiologist researchers, health informatics, technology evaluation experts, medical device incubator leaders, forensic engineers, academicians, researchers, adult and pediatric hospital engineers, industry, government, world health organization (who), federation, associations, non-government organizations, and patient care. they are all established leaders in their areas of expertise, with well-published manuscripts. in addition, they represent expertise from the four corners of the world, ranging from africa and the americas, to europe and asia. who can ask for more? another advantage we have is the selection and deployment of an open-access platform that facilitates a timely, systematic, and consistent double-blind review process of submissions, online archiving, and secure access to high-quality manuscripts anywhere in the world. the journal is fortunate to have a dedicated manager, ms. stavrianou, who holds a doctorate degree in biomedical engineering. what a suitable expert for our high-quality journal. our volunteer-based reviewers represent a wide scope of knowledge in many related topics. these reviewers offer their time and expertise to facilitate and promote http://www.globalce.org http://www.globalce.org www.icehtmc.com http://global.icehtmc.com http://cedglobal.org/awards http://cedglobal.org/human http://cedglobal.org/human www.globalced.org www.globalced.org www.globalce.org 3 j global clinical engineering issue 1, 2018 together we will make it the best it can be! dr. yadin david fair, high quality, and a scientifically constructive review process of the submissions, thus supporting the editors’ objectives. as you probably know, raising a child requires resources, and we have an advantage there as well. through the clinical engineering division (ced) early support, the first few baby steps were taken successfully. now thanks to the generous support of china medical device (cmd) enterprise, these steps have turned into a march. this is a momentous occasion, where your submissions and scholarly contributions will turn our dream into a reality. the journal aims to also encourage submissions from young engineers, as well as from senior scientists. to join as a reviewer, or to submit your manuscript, go the web site: www.globalce.org and log in. once you register, you can select the actions you would like to follow – either to become a reader, a reviewer, or to submit your work. i invite you to act and be part of the family. this journal is for you and your colleagues. you have a unique opportunity to participate in “raising” our profession. prepare your submission now! http://www.globalce.org http://www.globalce.org www.globalce.org j global clinical engineering vol.5 issue 2, 2022 2 editor’s corner as if hollywood film stars don’t already get enough attention, once a year even more adulation is heaped upon them with the annual oscars awards: a glamourous events where the good and the great of showbiz world reflect on their achievements and the lucky winners gain awards and recognition for their work. we clinical engineering don’t generally get this level of public recognition. our teams can sometimes feel undervalued – no red carpets and flashing cameras for us. often hidden away in the bowels of the hospital, we dedicated professionals ensure medical equipment is appropriate, legal, safe, properly maintained, used correctly by clinical colleagues and available in the right places and in the right amounts; but we do so in quite a non-showy way. as a breed, we don’t tend to seek the limelight, being content in the knowledge that high-quality patient care is dependent on our skills and hard work. well actually i was lucky enough to have my own little bit of limelight just the other week when received an obe from the princess royal in windsor castle. for those of you not familiar with the uk honours system (and why would you be!) this is a very prestigious award with only a few made each year recognising outstanding service across any field: military, community, charity, sport or professional. my award was for services to clinical engineering, and whilst i was the one receiving the medal, this award was very much for the team of clinical engineers around me and indeed for clinical engineers everywhere. it was a very proud moment for me and my family and i received a many, many messages from well wishes all over the world so thank you for all of that. in all honesty, and believe me when i say that this is not false modesty, i also felt a wee bit embarrassed. yes, embarrassed. because although i know that i have had some degree of success throughout my career and have achieved many successes locally and nationally, perhaps most notably during the covid-19 pandemic when we all faced such pressures, i also know i have been very privileged. when i reflect on my career i realise just how lucky i have been and how much support i have received from colleagues, from professional bodies, from family and friends. my international experience has put my personal fortunes into even starker contrast: so many clinical engineering colleagues from around the world achieve great things in the face of daunting challenges and with none of the support i’ve been so fortunate to receive. so initially, i did feel a little embarrassed that i was being so recognised for my achievements when others were not. however, i realise that despite our natural inclination to stay in the background, we clinical engineers do need to celebrate our successes and broadcast them to help raise our profile. because only when we raise our profile can we gain the recognition we deserve for the work that we do; only when we gain recognition can our value be acknowledged; only when our value is acknowledged will we see investment in our resources, training and capacity building for our profession; and only through this investment can we build our profession, strengthen our teams and develop the services we deliver. and, ultimately, only through developing our services, can we continue to maximise the potential of technology for the benefit of patients – and that, after all is what clinical engineering is all about. so, i got over my natural reluctance and promoted my personal success through news articles, webpages, twitter and the rest and used my award to showcase the work of all clinical engineers everywhere. and my plea now is for you to do the same – the time for modesty is passed. we need to show off our achievements, celebrate our successes and use these opportunities to raise the profile of our profession which in turn will help us to grow. and there are so many ways to lend your weight to this effort. why not write an article about a success you and your team have had and get that published in your http://www.globalce.org http://www.globalce.org 3 j global clinical engineering vol.5 issue 2, 2022 local journals or indeed submit it for consideration here, we’re always looking for good news stories. why not offer to review manuscripts, and we’re always looking for volunteers, or become a mentor for junior staff. organise an open day of your department and invite your senior clinical colleagues and hospital directors to come along. gcea and ifmbe both have awards every year1,2 – not yet matching the glitz and glamour of the oscars but every bit as prestigious in our own way so why not put your team or your colleagues forward for one of those. utilise social media, tweet pictures of your work and short notes about your achievements. if you’re into such things, why not make a video of tik-tok or similar. there are so many ways to promote our profession, so don’t be embarrassed, be proud! the world needs well trained clinical engineers; it just doesn’t always know it. as we struggle to emerge from under the cloud of the covid-19 pandemic, healthcare systems all over the globe are struggling to find sustainable business models. it feels like the challenges before us are dauntingly large. populations in the richer nations are getting older, fatter and more prone to long-term diseases like diabetes, coronary heart disease, and dementia. our life expectancies have risen sharply over the last couple of decades and our demands on the healthcare system have risen even more so. we now expect to be treated for, indeed cured of, conditions and diseases that a generation ago we were prepared to live with and indeed die from. and this is of course a really good news story. as an industry, healthcare has been incredible successful but we are now, in many ways, the victims of our own success: there are more and more people, expecting more and more healthcare and the cost of meeting this expectation is increasing faster much, much faster than the resources we have at our disposal. whilst in the poorer nations, access to healthcare facilities, medicines and technology can continue to be a challenge. a daunting challenge indeed; but a challenge we clinical engineers can play a huge part in solving. technology is already a part of the solution and will increasingly become ever more important to the wellbeing of the patients globally. it will enable new diagnosis and new treatments; it will increase access to healthcare to remote environments and make healthcare provision more affordable for all. but to maximise the potential of this technology for the benefit of patients requires clinical engineers – both developing and adopting new technology and managing and supporting existing technology. so we need a strong, vibrant and connected community of clinical engineers. we need a confident and growing profession. we need resources, training and capacity building. and we need to have a shared platform to promote all that we need to best serve population expectations. so let’s be proud of the work we do. let’s celebrate our successes and shout about them as often as possible. let’s grab the recognition we so richly deserve. let’s stake our claim to those red carpets and camera flashes. and let’s make sure the world sees us, clinical engineers, as the film stars of the future. references: 1. gcea awards (https://www.globalcea.org/clinical-engineering-awards) 2. ifmbe ced awards (https://ced.ifmbe.org/about-us/awards.html) together we are making it better! prof. dan clark (obe) copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://www.globalcea.org/clinical-engineering-awards https://ced.ifmbe.org/about-us/awards.html 35 j global clinical engineering, special issue 3, 2020 received april 20, 2020, accepted april 21, 2020, date of publication april 22, 2020 the chinese experience fighting against covid-19, shanxi medical engineers by jin zhang,，jiansheng li,，zhiyong wu， 1 shanxi bethune hospital, china. 2 shanxi, taiyuan, shanxi provincial people's hospital, china. abstract the world has witnessed as the covid-19 pandemic has been raging wildly across china and the world. although it is a war without gunpowder smoke, it is nevertheless extremely fierce. countless medical and other front-line staff are fighting under grave conditions while facing the death of their patients and the need to protect themselves against the virus. however, against these gigantic challenges, the healthcare team stays firm in their beliefs and with the long-term vision of winning the war for their patients and families. in order to win this battle faster, in addition to the doctors, there are also a large number of clinical/medical engineers fighting on the front line! this group of unsung heroes wrote application letters asking to join the battle and take on assignments at the front line early on. they have kept working at their assignments 7 × 24. these clinical engineers appreciate the urgency of racing against time to expedite the commissioning and installation of new and relocated medical equipment at their hospitals. in the face of the epidemic, as always, they have remained at their stations in hospitals and have become the "patron saints" of medical equipment. although there is a risk of infection, they do not hesitate. it is their commitment in the face of exhaustion that ensures the normal and safe operation of the equipment. it is their untiring belief that together we will wipe out this disease, unite as one, and overcome any challenges. in the end, victory will belong to us all! copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. shanxi bethune hospital faced with the severe situation of a pneumonia epidemic from the novel coronavirus, it has become very important to triage tasks and employ workarounds to deal with the limited supply of protective gear with priority given to medical personnel and ensure that rescue and resuscitation equipment is in place and ready when critically needed. all the staff of the medical equipment and materials management (ce) program of bethune hospital in shanxi province held fast to their posts and mobilized to search for resources and solutions day and night. “we have only one idea, no matter how great the pressure, we must do our best to ensure that protective and disinfection materials are kept in stock and all diagnosis and treatment equipment operates normally,” said their manager. http://www.globalce.org http://globalce.org http://globalce.org zhang,，li, wu: the chinese experience fighting against covid-19, shanxi medical engineers j global clinical engineering, special issue 3, 2020 36 in order to prevent the spread of the epidemic and ensure the safe use of available and much needed medical equipment, relevant resources were consulted and new protocols were organized. this included the "guidelines for disinfection of medical equipment (i) and (ii)" links that were developed to guide clinical and medical departments (ce personnel) on how to clean and disinfect medical equipment scientifically and reasonably. this epidemic knows no boundaries, is merciless, and everyone is impacted to some degree. the hubei medical aid team from bethune hospital in shanxi has continuously rushed to help meet the ce needs at the front lines in hubei. members play a vanguard and exemplary role. our chinese ces, like jin yue actively practice at the front line of this war. on february 4, he went with the shanxi provincial emergency medical rescue team to the epicenter of the virus in wuhan. this is an example of a dedicated medical worker and a model for all healthcare workers. our office has prepared a travel inventory for the team members going to hubei many times. this includes protective clothing, head covers, various masks, goggles, and other decontamination products, to ensure the safety of the medical team members as they work. shanxi provincial people's hospital to establish an isolation ward as soon as possible, it was vital to speed up the progress and shorten construction time. this required the general staff of the engineering department of shanxi people's hospital to work overtime dismantling the old dr and install the new computed tomography (ct) scanner for testing for novel coronavirus. this is shown in the following photos. in order to cope with the new coronavirus pneumonia epidemic, shanxi provincial people's hospital used a ge 16-slice ct for the examination of patients showing symptoms such as fever. however, the ct had to be set up and operated by trained personnel who must enter the computer room. this led to close contact between 37 j global clinical engineering, special issue 3, 2020 zhang,，li, wu: the chinese experience fighting against covid-19, shanxi medical engineers the operator and the patient and increased the possibility of operator infection. to solve this problem, the engineers of shanxi people's hospital carefully studied the environment and equipment structure, reviewed the operating circuits, jointly brainstormed ideas, designed the required additional interconnecting circuits, searched for and purchased the materials needed, and came up with a custom-built built it in-house solution. with the aim of not affecting the function of the ct equipment, the rack control panel was moved to the external operation room so that the operators could safely position themselves outside the ct room and avoid close contact with patients. this greatly reduced the risk of infection. shanxi children's hospital with the continuous spread of the virus, the demand for disinfection equipment in hospitals has increased greatly. in order to meet this demand, the medical engineering (ce) team of shanxi children's hospital designed and manufactured 60 sets of ultraviolet disinfection lamps of differing specifications using existing materials in combination with professional characteristics and first-line operation specifications. this will better meet the needs of clinical departments during the epidemic and is shown in the photos below. at present, the first batch of disinfection lamps have been distributed to dozens of key prevention and control departments such as emergency and respiration departments and comprehensive and clinical examination areas. after they are built and installed, the hospital will be better prepared to carry out disinfection work in a 3000㎡ medical area space while simultaneously providing strong assurance against possible coronavirus infection and strengthening the fight against the epidemic. ultraviolet lamps can effectively disinfect the surface of objects by exposing them to light radiation. they can be reused and can be mobilized and moved between rooms and patient consultation areas. this is the disinfection method recommended by the prevention and control guidelines issued by the national health and safety commission. engineers carried out ultraviolet intensity testing in strict accordance with medical ultraviolet disinfection requirements and formulated usage specifications to more comprehensively ensure the protection and safety of patients, family members, and medical personnel. shanxi coal central hospital the epidemic situation is merciless, people everywhere are impacted, and sadly some succumb to the disease. in the face of this grave situation, shanxi coal central hospital, as the protection department during the epidemic, has volunteered to safeguard the hospital's protection gear and materials. for many years ces have been making continuous and silent contributions to improve patient care. in order to ensure that temporarily assigned onthe-job front-line medical personnel are protected in place, the material support department checked inventory and issued protective gear and materials in a fixed amount every day. it also allocated the necessary equipment for the fever clinic and emergency department in the hospital. in addition to moving needed equipment zhang,，li, wu: the chinese experience fighting against covid-19, shanxi medical engineers j global clinical engineering, special issue 3, 2020 38 between locations, the medical maintenance department also serves as the competent on-site technical service support staff as shown in the photos below. they are at the dangerous forefront of transportation, installation, commissioning, and training of air purification disinfectors that are urgently needed in fever clinics, respiratory medicine departments, emergency departments, clinical departments, and ct rooms. the clinical/medical engineering committee of shanxi medical association issued a "proposal for donations to fight novel coronavirus pneumonia together" which received a positive response from shanxi medical workers. everyone actively participated in the charity fundraising activities and have made a modest contribution to the final victory in the fight against this disease. medical equipment plays an important role in the diagnosis and treatment processes. in order to strengthen the prevention and control work of medical institutions throughout the province, the management and the use of medical equipment must be more efficient during the prevention and control of a pneumonia epidemic from the novel coronavirus. this especially applies to the safe use, cleaning, and disinfection and control of large medical, first aid, and life support equipment. the medical engineering branch of shanxi medical association referred to the cleaning and disinfection plans of philips, ge, and murray for medical equipment during the epidemic. the organization of shanxi province medical equipment management quality control center, shanxi medical association medical engineering professional committee and hospital infection experts conducted research, formulated, and demonstrated various cleaning and disinfection work plans (trial runs) to guide medical facilities in the diagnosis and treatment safety of medical equipment throughout the province and ensure the safety of medical personnel, patients and their families. examples of protocols are attached below. at present, director zhang jin leads all clinical/medical engineers in shanxi in collaboration to help concentrate manpower, perform their extraordinary duties, provide solid backing for front-line clinical medical personnel, build up the cornerstone of epidemic prevention, and improve the required logistics support during these abnormal times. under the guidance of medical engineers, we firmly believe that in the face of the epidemic, we will be able to overcome this difficulty through concerted and collaborative efforts. come on, wuhan! come on, shanxi! come on, china! 17 j global clinical engineering issue 2:17-21; 2019 received march 13, 2019, accepted march 26, 2019, date of publication march 30, 2019 identification of health technology management departments in mexico’s state health services by r. ayala, e. orencio cenetec-salud, méxico abstract due to a lack of verifiable, reliable, and up-to-date official information, the national center for health technology excellence (cenetec) carried out a survey of information to identify the organizational areas in charge of the verification and the development of health technology management (htm) that the state health services in mexico are obliged to perform within each of the 32 states. it was determined that not all states had a department with a specific designation for htm. also, it seems the vast majority of existing areas are led by a biomedical engineering professional who responds to infrastructure planning area directives. these findings seek to promote a discussion on the need to standardize this type of service from state health services across the country. keywords – biomedical engineering, health technology management, public health services. introduction the mexican health system is composed of public and private sectors. the public sector includes social security institutions such as instituto mexicano del seguro social (imss), institute of security and social services of state workers (issste), the health services of federal agencies petróleos mexicanos (pemex), the secretary of national defense (sedena), and the secretary of navy (semar). on the other hand, there are health services for people who are not insured by any of the institutions previously mentioned. these people are cared for by health organizations under the control of the federal health ministry and the 32 state health services. this is done with financial support from the health social protection system known as seguro popular.1 any organization that offers health services must carry out health technology management (htm) which is defined as the “set of systematic procedures to provide and evaluate the appropriate, safe, effective, and costeffective technology in health care establishments, with the aim of ensuring the care and good use of the medical equipment by verifying its functionality, security, and availability to ensure effective access to health services.”2 these processes fall into various operational, medical, or administrative departments but biomedical engineering ayala, orencio: identification of health technology management departments in mexico’s state health services j global clinical engineering issue 2:17-21; 2019 18 (bme) services are considered to be the most appropriate for coordinating these tasks. in mexico, there is no formal or updated census of bme departments in hospitals. according to the information base of health establishments (clues3, a government information system), there is a register of 85 bme departments in hospitals from the state health ministries which represents only 12% of total coverage. given this circumstance, the strategy has been to encourage the creation of central areas in the offices of each state to meet the needs of the htm for all hospitals under its jurisprudence. however, there has been no formal register for those either. therefore, in 2018, the national center for health technology excellence (cenetec), a ministry of health agency, through its bme department, undertook the task of running a situational diagnosis of the areas responsible for htm in the 32 state health services. the goal was to identify the existing areas of opportunity related to the execution of the processes and the corresponding activities of the personnel in charge. as this was the first time that an exercise of this nature had been carried out at the state health services, it was important to be able to have updated data to make an analysis of the situation and determine which areas were the responsibility of the htms. this would allow the further development of strategies to improve these processes in an efficient and responsible way. methods a questionnaire was prepared to identify the existence of areas or departments where htm processes are involved in the state health services, their position within the organizational structure, as well as the human resources and materials they have available to them to carry out their tasks. the general items requested were as follows: 1. the state they are located 2. the data from their bme department 3. the information regarding the person in charge of their bme department 4. the area of the htm processes they are part of 5. the infrastructure they have available to carry out their htm processes the questionnaire was given to personnel identified as possibly responsible for one or more htm processes within the 32 state health services and the following relevant data obtained is outlined below. the answers revealed: • the organizational structure of the areas responsible for htm. • the name designation for each area responsible for htm by state. • the number of areas falling under the term “biomedical engineering.” • the profession of the person identified as being responsible for htm and their duties. • the identification of the areas that carry out htm processes. results organizational structure the 32 states responded with the information requested and it was possible to carry out the analysis to obtain the following results outlined below. twenty-four state health services (sesa) had an area using the term bme or something similar. in 8 sesas an area with a similar designation could not be identified (figure 1). figure 1. states with a department or area responsible for health technology management. 19 j global clinical engineering issue 2:17-21; 2019 ayala, orencio: identification of health technology management departments in mexico’s state health services it was found that 20 different groups or departments had incorporated variations of the title “biomedical engineering.” these included director of biomedical engineering, deputy director of biomedical engineering, department of biomedical engineering, biomedical engineering coordination, biomedical services coordination, and biomedical area. other similar names used were department of technological support to hospitals, department of electromechanics, department of maintenance to medical and electromechanical equipment, department of recovery of medical equipment, department of maintenance to medical and electromechanical equipment, and technology and supplies coordination. these designations suggest these people/departments have one or more htm processes as part of their responsibilities. ten of these departments were found within a formal organizational structure while 14 were not, and as shown in figure 1, 8 did not have an area responsible for htm. figure 2 shows the states where the areas responsible for the htm in the formal organizational structure existed within the state health services. data regarding which area (administrative, medical or planning) provided direction to the htm are outlined below. in 12 states, the htm area depended on direction from a planning or infrastructure group; 6 states depended on direction from a medical department; 4 states depended on direction from an administrative branch; and 2 states have 2 htms being directed by 2 different groups (figure 3). human resources the results shown in the graphs below include data from states that have the area responsible for htm. graph 1 shows the professions of those responsible for the areas reported. please note the prevalence of the bme profession. graph 2 illustrates the type of job contract held by the person responsible for htm. “trust staff” are those who have a formal contract, “base staff” are those who have a permanent contract, and “eventual staff” are those who have a short-period contract that may or may not be renewable. graph 3 presents the monthly salary for those responsible for htm according to the level of position where the prevalence is higher than $20.000 mexican pesos. figure 2. state health services that have an area that is responsible for htm within their formal structure. figure 3. health technology departments line of command. graph 1. profession of those responsible for health technology management in state health services. ayala, orencio: identification of health technology management departments in mexico’s state health services j global clinical engineering issue 2:17-21; 2019 20 htm processes attended graph 4 outlines the prevelence of tasks involving the the htm processes and the execution of these processes and which areas in state health services carry them out. in 17 states the bme-related areas were the groups who executed most of the htm processes, while in 10 other states this work was carried out by administrative areas. conclusion in accordance with the results obtained it can be observed that even when 24 of 32 states have an area related to bme to carry out htm functions, only 42% are positioned within the formal structure of the sesa and also their department name is often not consistent with other similar groups which can cause confusion. taking into consideration the reported areas, 57% have a professionally educated bme as the person in charge. this indicates that this profession should be at the forefront for coordination of the htm processes. in the same way, according to the data provided, (53% of the cases), there is a high likelihood that the bme area has been designated as the group that should be responsible for carrying out the htm processes. this was followed by the administrative area that had been designated in 31% of cases. it could be said that the numbers are promising, but challenges still exist towards achieving effective coordination of the htm processes in the public health sector. the next step could be an analysis of the efficiency and effectiveness in the htm processes when they are carried out by the specific areas chosen. meanwhile, the material presented in this paper will allow a focused effort to continue formulating strategies associated with htm that can promote safe, quality, efficient, and cost-effective access to health services. acknowledgments the authors wish to thank the personnel in the 32 sesa that kindly responded to the questionnaire and to the personnel in the bme area at cenetec for their input and support. thanks also to sonia tena for providing help in graphics design. references 1. gómez-dantés o, sesma s, becerril vm, knaul fm, arreola h, frenk j. sistema health system in mexico. public health mex 2011;53 supl 2:s220-s232. available at: http://www.scielo.org.mx/scielo.php?script=sci_ar ttext&pid=s0036-36342011000800017 graph 2. the type of job contract held by the person responsible for health technology management. graph 3. salary level of the person responsible for health technology management in state health services. graph 4. prevalence in the execution of the health technology management process in state health services. 21 j global clinical engineering issue 2:17-21; 2019 ayala, orencio: identification of health technology management departments in mexico’s state health services 2. national center for health technology excellence. medical equipment management glossary. méxico: cenetec; 2016;107 first edition. available at: http:// www.cenetec.salud.gob.mx/descargas/equipomedico/ ib_publicacion_glosario_8_27jun16.pdf 3. general directorate of health information; classification clues. available at: http://www.dgis.salud.gob. mx/contenidos/intercambio/clues_gobmx.html j global clinical engineering vol.2 issue 2, 2019 4 2020 is now here, i wish you all a healthy, prosperous and joyful new year! i am very interested to continue the recurring who updates and communications with you in this volume of the global clinical engineering journal. the last half of 2019 proved to be very productive for the medical device team, particularly with respect to health technology management issues. in my last update, i talked about the national reference lists of medical devices, which are used in countries as a reference to procurement, reimbursement, which includes two components: first the who essential in vitro diagnostic list (edl), describes the laboratory and point of care tests and related technologies that need to be available to screen, diagnose or monitor priority diseases or health conditions. the strategic advisory group of experts on in vitro diagnostics (sage ivd) is meeting 23rd to 27th of march to review the submissions to update the who model list of essential in vitro diagnostics list (edl, as well as related policies and strategies on laboratories. updates on this work can be found here: https://www.who.int/medical_devices/diagnostics/selection_in-vitro/en/. on the 23rd of march the session will be open in webex format for those that are interested. secondly, with the increase of non-communicable diseases, who has been developing lists for priority medical devices for cardiovascular, stroke and diabetes. this work is ongoing and hope to list all that are needed from diagnostics, to treatment , rehabilitation and palliative care for the 3 levels of care, from prehospital to specialized care. this work is expected to be finalized by march 2020. last october, the global clinical engineering community celebrated global ce day on october 21st. with china hosting the in-person event, the celebration of clinical engineers’ impact on patient outcomes hit a new level. a link to the global ce day video commemorating this event and the importance of the work of clinical engineers in 2019 can be found here: https://www.youtube.com/ watch?time_continue=16&v=yq1duslsfvq&feature=emb_logo. co-aligned with the global ce day, was the 3rd international clinical engineering healthcare technology management congress (icehtmc) held in rome, italy. with over 1,000 attendees from all six who regions, this event showcased what clinical engineers and healthcare technology managers are doing globally to support patient outcomes and typified the global exchange of ideas for the betterment of global standards and outcomes. i was very honored to be invited to share the work that is being done in who and to look forward to address countries needs on medical devices including their selection, management and safe use https://ced. ifmbe.org/blog/icehtmc3-presentations.html. at the end of 2019, who published the decommissioning medical devices book as a continuation of the who medical device technical series. decommissioning is an important part of healthcare technology management in lifecycle management and safe removal and disposal is important to health who update column by adriana velazquez berumen http://www.globalce.org http://www.globalce.org https://www.who.int/medical_devices/diagnostics/selection_in-vitro/en https://www.youtube.com/watch?time_continue=16&v=yq1duslsfvq&feature=emb_logo. https://www.youtube.com/watch?time_continue=16&v=yq1duslsfvq&feature=emb_logo. https://ced.ifmbe.org/blog/icehtmc3-presentations.html https://ced.ifmbe.org/blog/icehtmc3-presentations.html 5 j global clinical engineering vol.2 issue 2, 2019 for all. the publication can be found here: https://apps.who.int/iris/bitstream/handle/10665/33009 5/9789241517041-eng.pdf . while 2019 was a productive year, 2020 already appears to be shaping up to be very fruitful as well. throughout 2019, you heard me discuss a standard nomenclature and its importance for stronger harmonizing reasons on many occasions. in may of 2019, the 145th who executive board included a thorough discussion of the standard nomenclature project which can be found here: https://www.who.int/ about/governance/executive-board/executive-board-145 (statements from member states is covered from 1:03 to 2:04 in video). in 2020, our work continues to focus on the standard who international nomenclature system and its implementation. the next steps include a concept note being published to the executive board as an update and response to the member state comments in the coming months. your input into the survey https://extranet.who.int/dataform/614614?newtest=y will be most welcome. the deadline has been moved to 10th february. on the horizon in 2020 is also the publication of the who technical specifications for automated non-invasive blood pressure measuring devices, technical specifications for cervical cancer and for the procurement of the essential in vitro technologies to allow the edl tests. finally, we are working on response to coronavirus, continue with support for ebola and many other requests from member states. please find technical information for coronavirus here https://www.who. int/emergencies/diseases/novel-coronavirus-2019/technical-guidance. as clinical engineers, you play an important role in supporting medical devices and i look forward to the continued work in 2020. respectfully, adriana http://www.globalce.org http://www.globalce.org https://apps.who.int/iris/bitstream/handle/10665/330095/9789241517041-eng.pdf https://apps.who.int/iris/bitstream/handle/10665/330095/9789241517041-eng.pdf https://www.who.int/about/governance/executive-board/executive https://www.who.int/about/governance/executive-board/executive https://extranet.who.int/dataform/614614?newtest=y https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical j global clinical engineering vol.2 issue 2, 2019 6 in october of 2019, i had the privilege of serving as a short-term technical advisor at the who headquarters in geneva, switzerland. while i had known previously about the who initiatives in the clinical engineering arena, particularly those interfacing with the ifmbe-ced group, i was awestruck at the shear amount of initiatives and breadth of their impact on medical devices globally that are ongoing. in the halls of who headquarters, there are global experts on every healthcare specialty you can imagine. just as in a hospital, clinical engineers work collaboratively with other groups to advance healthcare priorities globally for the betterment of health for all. in a healthcare organization, a clinical engineer works daily to understand the intent and overarching goals of the organization in support of patient access, outcomes, safety and experience. additionally, for decades, clinical engineering has been talking about how the profession can cohesively bring our individual efforts in our spheres of influence to strengthen the clinical engineering profession, regulations and standards globally. daily, adriana velazquez, the senior advisor for medical devices at the who, works tirelessly to bring medical devices to the forefront of global health policy and initiatives. in her role, she interfaces with professionals globally on medical device regulations, health technology assessment and health technology management. in this way, you can see that building capacity and clinical engineers in this space are essential to proper health technology management. as the professionals responsible for the longest portion of a medical device’s life – commissioning, sustainment, maintenance and decommissioningthe clinical engineering community is essential to ensure safe and clinically appropriate medical devices are being used across the world to prevent and treat acute and chronic illnesses. it is further important for clinical engineers to understand not only the emerging trends in health technology management, but those in medical device regulations and health technology assessment as well. expanding this to the global community, one of the key ways a clinical engineer can understand the who’s global health objectives is to familiarize themselves with the who sustainable development goals (sdgs), particularly sdg3 “good health and well-being,” and the triple billion targets of “1 billion people enjoying better health and well-being, 1 billion people benefiting from universal health coverage and 1 billion more people better protected from health emergencies.” in this way, clinical engineers can leverage the strategic framework outlined by the who to align priorities and efforts globally. ifmbe and its clinical engineering division work tirelessly to align their work with the overarching global priorities set forth by the who. as we kickoff 2020, i can’t think of a more exciting time for the global ethos of clinical engineering. on the heels of the 3rd icehtmc in rome, italy, over 1,000 clinical engineering professionals from 6 continents got together to share information, vision and passion for building capacity in clinical engineering to improve patient safety, support access and spur innovation for medical devices and health technology management globally; clinical engineering professionals are well-positioned to use 2020 as a springboard that will bring a new depth of international standards, information sharing an addendum http://www.globalce.org http://www.globalce.org 7 j global clinical engineering vol.2 issue 2, 2019 and understanding of our profession to the world. additionally, we are being led by courageous and passionate leaders in adriana velazquez at the who and tom judd the ifmbe ced chair who have an in-depth understanding of the healthcare landscape and how clinical engineering plays a role in bringing healthcare to all. so what can you do next to stay tapped into the who and ifmbe efforts? check out the ifmbe ced “news and blog” at https://ced.ifmbe.org/blog.html where adriana posts the most up-to-date and agile information about who initiatives, and happenings as it relates to medical devices and health technology management. also, ensure you visit the main who medical devices website at https://www.who.int/ medical_devices/en/. within this site, you will find information and resources on regulations, health technology assessment (hta) and health technology management (htm). additionally, ifmbe/ced is working on several exciting projects and initiatives that will be bringing even more resources to the global clinical engineering landscape. pertinent information on these can be found on the ifmbe ced site at https://ced.ifmbe.org/projects.html. cheers to a 2020 filled with advances in clinical engineering and health and well-being globally. jennifer defrancesco, dha, ms, chtm ifmbe ced collaborator copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://ced.ifmbe.org/blog.html https://www.who.int/medical_devices/en https://www.who.int/medical_devices/en https://ced.ifmbe.org/projects.html 33 j global clinical engineering special issue 1: 33-36; 2018 received march 1, 2018, accepted march 19, 2018, date of publication march 25, 2018 regional nodes of colombian clinical engineers by a garcia-ibarra1, p berrio2, m trujillo-toro3, f salazar4, l garcia5 1external consultan, ministerio de salud y protección social, bogotá, colombia 2hospital pablo tobón uribe, medellín, colombia 3,4hospital san vicente fundación, medellín, colombia 5fundación valle del lili, cali, colombia abstract the health technology management (htm) staff in small or remote hospitals can have difficulty accessing good practice information, so we have created a simple, convenient, and accessible networking model for clinical engineers in colombia, called regionals nodes. these nodes break radically with tradition because they do not have a static structure that limits access to meetings or information. these nodes are dynamic which allows them to reach more people in less time and at a lower cost. the nodes use social media to be in contact, coordinate regular meetings with leaders and topics of interest, and disseminate large amounts of information quickly. thus, new open spaces are created, they are adaptable to each region, and can easily evolve over time. currently the ministry of health and social protection (mohsp), with regional support of engineers from hospitals with national or joint commission accreditation (jci) lead the nodes. today, there are 240 engineers from 140 hospitals and 13 universities and a regulatory agency that recently joined. this initiative began in 2015 with minimal coverage and we have now reached 40% of the country. the members of the nodes meet every 2 months in order to prepare projects on medical equipment management (mem) and share information and experiences. some of the accomplishments and outcomes of these meetings are: continuous training in colombian regulations, positioning biomedical engineers as key stakeholders in mem, institutional strengthening of the mohsp in the health technology field, and htm regional benchmarking. the interaction among the members of the participant institutions has facilitated a successful knowledge and best practices transfer in mem from the 8 high-complexity university hospitals to almost 140 regional and local hospitals. these regional and local hospitals have limited access to resources and the operation of the nodes has contributed in improving the efficiency in the equipment managing process and outcomes that better service the population. one of the priority projects of the nodes is collaboration with the mohsp in the validation of the equipment maintenance and obsolescence assessment manual. the next steps are strengthening of the nodes, increasing membership and motivating members and institutions, and interacting with professional engineering societies and health technology organizations worldwide. these steps will involve seeking support and improving communication with health authorities, hospital directors, and administrators looking for the expansion of the nodes. keywords – medical equipment management, regionals nodes, networking, clinical engineer. http://www.globalce.org http://www.globalce.org garcia-ibarra, berrio, trujillo-toro, salazar and garcia: regional nodes of colombian clinical engineers j global clinical engineering special issue 1: 33-36; 2018 34 introduction in the past few years colombia has made important efforts with legislation development in biomedical equipment. in this context and in terms of formulating public policies that establish goals to strengthen biomedical equipment management practices by the country's health care services providers, the ministry of health and social protection (mohsp) has taken the lead, together with hospitals who have national or joint commission accreditation (jci), and established a working group called the “national board,” with the objective to structure and recommend proposals and guidelines in this field. with the proposals achieved as a product of a national and international reference process and review and dissemination of successful experiences, the context and the realities analysis of the country in the field of medical equipment management (mem), we have been seeking to inform health care service providers about their responsibilities and actions in the use, operation, and maintenance of technology. furthermore, we hope to advance the positioning and empowerment of the leaders of mem in hospitals and clinics of at all levels. in order to promote accessibility to information, guidelines, and tools for mem, the regional nodes were established as a result of the work of the central government and the national board. thus, a collaborative network of clinical engineering was formed to socialize, disseminate, and validate mem proposals in a large area of colombia. as additional objectives, these nodes will contribute collectively to the solution of common needs, to generate collaboration and alliances which will materialize in mutual projects, and the exchange of specialized knowledge, initiatives, innovations as well as experiences and best practices among mem professionals. this paper presents the set-up and implementation of this work initiative called regional nodes, as well as the methodology adopted for its operation, the results obtained, and the next steps. methodology in order to achieve the proposed objectives from the development and work of clinical engineering regional nodes in colombia, initially the participation of the mohsp as the project leader was guaranteed. moreover, the person from mohsp would represent this institution and be responsible for the coordination of the nodes, and consequently, the entire network. from these providers from different regions of the country, clinical engineers were invited to be part of the national board together with the mohsp. this was done to manage and maintain the regional nodes of clinical engineering, which are working groups or technical meetings held in the different regions. the meetings were based on debates and knowledge generated by the national board. afterward, the information flowed to the regional nodes with support from the mohsp. after every debate, meetings were held at the regional nodes for unification, consolidation, and validation of the mem information. this was followed by the identification of needs, feedback to the node leaders, and finally feedback to the mohsp at the meetings of the national board. in order to accomplish the described methodology, it was established that there should be a schedule of the regional meetings in which mem topics were previously defined and discussed. in addition, the results of the work done by the members of the regional nodes could be presented. figure 1. best hospitals and clinics in latin america. ranking 2016. garcia-ibarra, berrio, trujillo-toro, salazar and garcia: regional nodes of colombian clinical engineers 35 j global clinical engineering special issue 1: 33-36; 2018 results currently we have work leaders composed of 12 clinical engineers from 8 high-complexity hospitals, which are recognized because they have national accreditation and jci accreditation, as well as successful experiences in mem. these 12 engineers are leading and maintaining 6 regional nodes of colombian clinical engineering (figure 2): center node: bogotá, cundinamarca and departments of the center of the country; south west node: valle del cauca, cauca, nariño; antioquia node; santanderes node: santander and north of santander; caribean coast node: atlántico, bolívar, cesar, córdoba, la guajira, magdalena, sucre; and coffee triangle area node. networking has proven to be an effective method to optimize resources, create and strengthen communication channels, share mem experiences, and facilitate knowledge transference. as a result, every day, clinical engineers are looking to be part of the network on behalf of their institutions and universities that provide academic and methodological support to the network. table 1 shows the current composition of the regional nodes in relation to the number of clinical engineers, health care institutions, and universities which are part of the network. strengthening of the regional nodes has resulted in a positive impact on the mem around the country, such as: • continuous training in colombian regulations. • cooperation relationships among participants. • institutional referencing to improve processes. • positioning of clinical engineers as the main stakeholders in mem. • institutional strengthening of the mohsp in health care technologies field. • better health care for patients. • accessibility of mem information. • improving efficiency of the mem process in regional and local hospitals. • collaboration with the mohsp in the validation of the equipment evaluation, maintenance and obsolescence manual. • contribution on the development of a proposal for “mandatory requirements for the medical equipment management” for public and private hospitals and clinics, blood banks, and public health laboratories. figure 2. colombian nodes map. table 1. current composition of the regional nodes region clinical engineers hospitals universities bogotá 60 40 2 antioquia 40 20 5 southwest colombia 55 35 2 santanderes 25 10 2 coffee triangle area 30 20 1 caribbean coast 30 15 1 garcia-ibarra, berrio, trujillo-toro, salazar and garcia: regional nodes of colombian clinical engineers j global clinical engineering special issue 1: 33-36; 2018 36 discussion every day the strategy of the regional nodes gathering and disseminating information is strengthened in colombia. by may 2017 there were 200 clinical engineers, and by july 2017 there were 40 more. this shows that the regional nodes are responding to the needs of the clinical engineers. the challenges we face as members and leaders of these regional nodes are to consolidate a networking culture, overcome communication barriers, approve criteria about clinical engineering, ensure credibility in the results that have been obtained, and engage the members to achieve results in the short term. furthermore, as leaders we must look for ways to vitalize the national board and regional nodes to ensure their operation in the long term. currently we are working on network consolidation, information flow improvement, referencing among the members, communication with the mohsp, and promotion of the integration of different stakeholders in clinical engineering management, including the formation of new regional nodes across the country. we identified strengths of the regional nodes as the ability to keep creatively holding meetings and integrating more participants, maintaining activities that facilitate the network of clinical engineers, and developing solutions to common challenges, the management of knowledge, and the development of human capital. the main opportunities for improvement are the consolidation and recognition of the regional nodes, keeping members motivated, and including new members. finally, there will soon be the delivery of tangible products designed and validated by the regional nodes which may be applicable to our country. future work proposed includes: • formation of the association or college of colombian clinical engineering. • increasing the number of members and institutions. • supporting the institute of health technology assessment (iets) in mem projects. • working on joint projects with the american college of clinical engineering’s international committee in colombia. • strengthening interaction with professional engineering societies and health technology organizations around the world. • improving communication with health care regulation authorities, hospital managers, and administrators. • overcoming communication barriers supported by the use of webex platforms necessary to strengthen virtual work. • construction of a website to share experiences, knowledge and documents. conclusions currently, the network has a coverage of 40% in colombian territory, with leadership from the mohsp and 8 hospitals who have national or jci accreditations. as well there is the participation of 240 clinical engineers who work in 140 hospitals. additionally, we have the support of the academy represented in 13 universities. to be part of the regional nodes, there should be no cost for registration or support fees. the members should only demonstrate an interest in meeting colleagues, sharing their experiences and knowledge, and working to improve practices in biomedical equipment management. colombia is a diverse country with large cities and dispersed rural areas. regional meetings make it easier for areas far away from capitals, and clinical engineers with limited resources, to have access to information and tools of the best practices in biomedical equipment management. conflict of interest the authors declare that they have no conflict of interest. 5 j global clinical engineering vol.3 issue 1: 2020 received april 2, 2019, accepted may 4, 2020, date of publication june 25, 2020 maternal-fetal simulator by l.r. rodrigo1, a.m. marcelo2 and a.s. anderson1 1 moinhos de vento hospital/ clinical engineering, porto alegre, brazil. 2 moinhos de vento hospital/ clinical and hospital engineering, porto alegre, brazil. abstract this study presents the implementation of a low-cost automated prototype, in an open code platform, that simulates the maternalfetal signal using the arduino platform. several options exist for providing a basic evaluation of the maternal-fetal monitors, but the need to simulate the medical environment with a man-machine interface is needed in this age of simulation-based medicine. another possible application of this simulator is as a teaching tool. using data generated by the simulator the man-machine interface can measure fetal movement, uterine activity, and fetal heart rate. the data from the interface can then be compared with those presented by the fetal monitor. this comparison makes it possible to check the correct functioning of the equipment tested. keywords – fetal monitor, quality control, biomedical simulator, arduino. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction the concern over fetal cardiac arrhythmia has increased over the last few years, creating a bigger demand in the use of fetal monitoring methods.1 the function of the electronic fetal monitor is to detect and record both the heart rate of the fetus and the uterine activity of the mother in labor.2 to verify the electronic functioning of the fetal monitor there is a need for performance testing. the tests are divided into two parts – quality evaluation (that consists of visual inspection of the structural conditions of the equipment, parts, modules, and accessories) and quantity tests (that consists of the measurement or simulation of biomedical parameters of the equipment).3 an alternative to the test is to use simulators. simulators aim to present practical situations from everyday life.4 the use of simulators also allow new approaches in education and medical practices such as simulation-based medicine. for example, the students can use anatomical and physiological simulations to predict the results of procedures and, therefore, keep up with the results of treatments in virtual patients.5 the improvement of simulators in the health field is largely due to the use and sophistication of artificial intelligence-based on microprocessors using algorithms that can change concepts and mechanisms are used.6 the arduino platform is an easy to use micro-processing tool that allows the utilization of medicine-based simulation. arduino is based on a very versatile system microcontroller that potentate its functions beyond a simple passive interface of data acquisition and can operate independently while controlling many devices.7 due to the need for testing of maternal-fetal monitors, developing a strict quality process allows for the appraisal http://www.globalce.org http://globalce.org http://globalce.org rodrigo, marcelo and anderson: maternal-fetal simulator 7 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 6 rodrigo, marcelo and anderson: maternal-fetal simulator installing the peripherals the system used a selective on/off key. the power to the board and peripherals was through a computer source. for the electromechanical components (the speakerwhich is responsible for the sound wave emission that will stimulate the ultrasonic transducer o the fetal monitor), a tip122 was used that received power of 12v from the switching power supply. control of simulation of the fetal movement was via the use of a 12v relay with a na contact. the pressure sensor used was an mpx5700dp, which controlled the pressure inside the neonatal pni and was connected directly in the arduino platform. the sensor was powered by the 12v source. the pressure bomb was connected with the component tip22 and powered by 12v from the switching power supply. the valve connected to the tip122 received control of the main board and was also powered by the 12v power supply. the display was connected to the processor board. in this prototype, the arduino mega microcontroller was used. the coding platform and free hardware that has its own compiler was developed for use by people with little programming knowledge. the microcontroller used in the arduino mega 2560 was the atmel atmega2560, an 8-bit microcontroller of advanced risc architecture. it has 256 kb of flash (8 kb more are used for the boot-loader), 8 kb of ram and 4 kb of eeprom. it has 16 mips, operating in 16 mhz. arduino based in atmel atmega, among which can highlight 4 communication serial channels, 16 analog inputs, and 15 pwm outings. it has spi communication, 12c and 6 pins of external interruption. the mega 2560 board has 54 input pins and digital outputs that can be used as inputs or outputs. the pins operate with a tension of 5v and can provide or drain up to 40 ma. each pin has a “pull-up” intern resistor that can be enabled by software. it has 16 analog inputs (a0 to a15 pins), where the conversion can be made with a resolution of 10 bits, that is, the value will be converted between 0 and 1023. ihm the ihm of the arduino platform was chosen so the simulator could have mobility and easily interface between the operator and the device. driver the tip122 was used to control the electromechanical devices. power source standard 12v, 2.3a, real potency of 500 watts, efficiency >70%, mtbf of 100.000 hours, 25°c, intern protection against short circuit ovp/ocp/scp, ac input with manual switching 110/220v, low acoustic noise, cables with protection covering, cooling temperature controller system, silent ventilator of 120 mm, iec60950 technical norms (electrical safety), iec 61000 (electromagnetic safety), on/off switch. diaphragm pump a diaphragm pump was used to inject pressure on a plastic membrane controlled by the pressure sensor which generated pressures to the touch. figure 3 shows the system functions of the circuit. relay – with a na/nf of 12v. speaker – 4ω/66w. neonatal cuff – cuff of neonatal pni with a tube. valve – valve with solenoid of 12v. pressure sensor – mpx5700dp. tip122 – 5a, power transducers, 60 volts, 65 watts. of the level of equipment deterioration. this provides information about deficient components and verifies the quality of repairs made.8 in the continuous processes of improvement, the implementation of quality control aims to guarantee the safety and reliability of the results of the diagnostic testing.9 another point to consider is the need to involve the assistant medical team in the performance of a hospital’s medical technology. besides understanding the technology used, the assistant team (doctors, nurses etc.) will need to get involved increasingly in the life cycle of the equipment. to help with cost reduction and maximize the clinical benefits, interaction with the clinical engineers guarantees the effectiveness of preventive maintenance through the use of simulator-based tests and allow participation in the evaluation of potentially outdated or unsafe technology.10 to address this need we developed a low-cost automated system prototype to simulate uterine contractions and fetal heartbeats. the aim was to make it easy to use in universities and hospitals that are looking for quality in fetal monitors testing. method with the specified, calculated, modeled, and simulated data, a prototype was designed, developed, and tested according to the flow-gram demonstrated in figure 1.1 initially, the project was organized as a study group for evaluating the possible solutions for a low-cost prototype of a maternal-fetal simulator. many follow-ups were made with the nursing team in the obstetric center to measure a real antenatal exam. the other steps outlined in the flowgram in figure 1 are described below in equation 1 and equation 2 as a two-step conversion calculation that was within the limits of the processor and the requirements of the maternal-fetal monitor. through these calculations table 1 was created within the parameters of the development of the program. time periods with whole numbers were used to facilitate the programming. program in this step we dealt with programming for the arduino platform (figure 2), with the principle of language c. based on table 1, the periods of each heartbeat were defined causing each one to stay for a minute. after this step, the signal of fetal movement was programmed with the stimulus of five pulses at intervals of one minute. after that, the lines of programming were implemented for the sensor responsible for controlling the pressure bomb causing a variation of pressure of 0–100 mmhg. after getting to maximum pressure, to stabilize the circuit for a minute at a 50 mmhg, the valve must open to reset the pressure of the system. lastly, the display was programmed to show the pulses of fetal movement, uterine pressure, and heart rate/frequency of the fetus. figure 1. method flow-gram. table 1. conversion – relation between heart rate (bpm), frequency (hz) and period (ms) (bpm) (hz) period (ms) 30,0 0,5 2000,0 60,0 1,0 1000,0 90,0 1,5 666,7 120,0 2,0 500,0 180,0 3,0 333,3 240,0 4,0 250,0 figure 2. arduino platform circuit diagram. rodrigo, marcelo and anderson: maternal-fetal simulator 9 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 8 rodrigo, marcelo and anderson: maternal-fetal simulator pni, ecg, and electrical tests, in an integrated way by adding modules to this simulator. this would be made easier due to the simplicity of the program structure and that the arduino platform has many tutorials available on the internet. conclusion the goal of simulating uterine contractions and fetal heart rate with a low-cost automated system was accomplished using quality standards in the tests of the maternalfetal monitors and executed by the clinical engineering services. additional improvements, developments, and new validations are also achievable. conflict of interest the authors declare that they have no conflict of interest. references 1. lindsey ad, robert ha, sullivan id, et al. evaluation of fetal arrhythmias by echocardiography. br heart j 1983. 2. zielinsky p. arritmias cardíacas fetais: papel da ecocardiografiapré-natal no diagnóstico e na terapêutica intrauterina. in: cruz fes, maia ig. eletrofisiologia clínica e intervencionista das arritmias cardíacas. rio de janeiro: ed. rev. interna 1997;31723. results after connecting all peripherals, the program was run to verify if the simulator was within the minimum of uncertainty. to determine the reliability of the prototype a digital oscilloscope was connected (figure 4) in the pressure circuit. the cycle of the program was monitored through this oscilloscope and calibrated with traceability. to obtain the final results, the fetal monitor’s transducers were connected in the simulator and five tests were executed with satisfactory results as shown in the ihm, with the visualization of the measurement of the fetal movement (figure 5), uterine activity (figure 6), and fetal heart rate (figure 7). as a complement to the results, figure 8 shows the system during the testing of the prototype including the number identification for the components of the system. this is also shown in figure 8. discussion it wasn’t simple to reproduce the bpm with an electromechanical system and develop a structure that accommodates the sensors of many models, to execute a low-cost prototype. one of the difficulties was transforming the “electronic garbage” (useless components) available into the appropriate components needed in the simulator. one of the improvements to the project could be a wifi-connected system to allow cloud storage of data and information collected by the fetal detectors. the data could be identified as patrimony or by an identification code. proposed future improvement requiring further study include the development of similar devices to analyze 3. lucatelli mv, batista mb, silva hp, garcia r. metrologia para a vida sociedade brasileira de metrologia (sbm) setembro 2003;01-05. 4. dias cf, rosecler mb, mussoi rb. revista brasileira de informática na educação 2014;22(2). 5. villamil mb. modelagem e simulação da articulação temporomandibular. universidade federal do rio grande do sul. instituto de informática. programa de pós-graduaçãoemcomputação; 2009. 6. almeida mc, tavolaro cr, molisani e. rev. bras. ensino fís.vol.3n.4.são paulo 2011;oct./dec. 7. souza ar, paixão ac, uzêda dd, et al. a placa arduino: uma opção de baixo custo para experiências de física assistidas pelo pc. revista brasileira de ensino de física 2011;33(1)1702. 8. oliveira lm, maia jm, gamba hr, et al. avaliação da qualidade de imagens de equipamentos de ultrassom modo-b. revista brasileira de engenharia biomédica 2010;26(1):11–24. 9. severo ls, lammoglia rs, saito rh, et al. aplicação dos testes de verificação dos indicadores da qualidade de equipamentos de ultra-sonografia. instituto de eletrotécnica e energia da usp 2001. 10. ministério da saúde. avaliação tecnológica em saúde: subsidiando a melhoria da qualidade e eficiência do sus (reforsus). brasília (df): ministério da saúde; 1998. figure 3. circuit flow-gram. figure 4. frequency generated by arduino. figure 5. ihm fetal movement. figure 6. ihm uterine activity. figure 7. ihm fetal heart rate. figure 8. prototype test. traceability.to traceability.to fís.vol.3n.4.são 27 j global clinical engineering vol.3 issue 1: 2020 received may 21, 2020, accepted june 25, 2020, date of publication july 6, 2020 redesigning protective gear for health workers during the covid-19 pandemic: leveling up the “aerosol box” by r. moreno1, e. pedraza2, f. morales, r. mijares2, r. boccardo2 and m.a. garcía2 1 hospital de clinicas caracas (hcc) / clinica santa paula (csp), caracas-venezuela. 2 universidad simon bolivar (usb), caracas-venezuela. abstract background and objective: during the last decade, venezuela has suffered several crises concerning its health, socio-economic, and political institutions. while having a minimum wage of roughly $2.32 us dollars per month, and a precarious quality and coverage of public services (such as water, public transportation, electricity, and internet services), the covid-19 virus struck the nation. this pathology became a pandemic quickly since its transmission occurs mainly through contact with the secretions of infected patients or with contaminated surfaces. health workers face a higher risk of infection than the rest of the population. for this reason, the objective of this work is to reduce the threat that medical personnel face while working with covid-19 patients and redesigning the original "spray box,” to avoid further deterioration of the health institutions. the cooperation and support of the universidad simon bolivar (usb) and the hospital de clinicas caracas (hcc), as well as the job of the manufacturer companies, was exceptional for accomplishing this work. materials and methods: to develop the prototype, the following phases were carried out: (a) a sketch was created; (b) a 3-d cd model was created; (c) the prototype was manufactured; (d) the prototype was improved; and (e) the effectiveness and safety tests were carried out. results: the research team produced protective gear for the safety and health of medical personnel when attending patients with covid-19 to help limit the spread of the virus. this instrument was called "cube de vie" (cubedv). conclusions: the work demonstrates that disregarding the struggling circumstances venezuela faces daily, it was possible to solve a problem that threatened public health globally, to fight the serious covid-19 pandemic. cubedv was a result in a time of crisis and added another tool in the fight against the virus. this gear is just one example of our longing to win this fight and we hope it will represent significant help for people involved in fighting against this crisis. keywords – sars-cov-2, covid-19, protection, personnel, health, cubedv, box, aerosol, workers, protective gear, pandemic, infection risk. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction the united nations (un) and international health agencies have indicated that venezuela's health crisis is causing an increase in infectious diseases, and the resurgence of others that were once considered eradicated, such as malaria or tuberculosis. the world health organization (who) considers that the political and socio-economic situations in venezuela are responsible for the collapse of the healthcare system since those conditions have caused a severe scarcity of medical supplies, the closure of many clinics and hospitals, and a significant decrease of medical personnel who have emigrated from the country. since february 23, 2020, the closure of wuhan in china alarmed the world population with the presence http://www.globalce.org http://globalce.org http://globalce.org moreno, pedraza, morales, mijares, boccardo and garcía: redesigning protective gear for health workers during the covid-19 pandemic: leveling up the “aerosol box” 29 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 28 moreno, pedraza, morales, mijares, boccardo and garcía: redesigning protective gear for health workers during the covid-19 pandemic: leveling up the “aerosol box” • more length to cover the patient, since the redesigned box measures approximately 60 cm (23.6 inches) from the patient's head to the upper chest (figure 1). • the incorporation of a distal flange that reduces the possibility of particle expansion outside the box (figure 2). • the addition of two lateral closing holes to reduce the risk of infection of the auxiliary personnel in the following procedures: intubation, sellick’s maneuvers, burp, cuff inflation, or endotracheal tube fixation. a 3-d model was created the sketch is represented in a three-dimensional shape and was analyzed by specialists. this new gear was named "cube de vie" (cubedv). after some corrections, we moved on to the next step. the prototype was manufactured cubedv is made entirely of 3-mm polymethylmethacrylate (pmma). in order to keep costs as low as possible, the team aimed for the use of the smallest possible caliber of sheets that could provide stability. to shape the box, the surface on which it is supported was heated. afterwards, gutters were drilled at the joint points of the three main pieces of the box, this allowed the sheets to fit into a channel that also added support and stability to the entire system. additionally, at these joint points, chloroform was used as a chemical weld, since it dissolves a small layer of the plastic, to allow the pieces to combine and harden. the prototype was improved after some stability tests, it was decided to make a thicker prototype, using 5-mm pmma. the material used on the cubedv, pmma, is probably the most transparent plastic material and is also resistant to degradation by uv radiation. pmma is not heavy due to its low density (1190 kg/m), which is less than half that of glass making it is easy to transport. it is also 15 times more resistant than ordinary non-tempered glass of the same thickness. as well, pmma is washable and not affected by detergents and commercial solutions commonly used in hospitals for cleaning and disinfecting potentially infected medical equipment. the cubedv is an economical, reusable, easy to transport tool, with the ideal dimensions to carry out procedures with great comfort and protection. to comply with venezuelan national regulations, quality certification of the medical device was necessary, to demonstrate its effectiveness and safety. the effectiveness and safety tests were carried out to simulate the dispersion of the virus, a test was performed in the operating room area of the hospital de clinicas caracas (hcc) with a volunteer as a patient, who simulated sneezing with a fluorescent liquid aerosol device (figure 3), which he squeezed at mouth level at of a new coronavirus (sars-cov-2), which causes the covid-19 disease. this virus managed to spread globally in a considerably short time becoming a pandemic. globally, public health has been facing significant challenges in consequence of this situation,1 to this date (04-30-2020), the who has confirmed 3,090,445 cases and 217,769 deaths worldwide.2 the transmission of covid-19 occurs mainly through droplets which are responsible for spreading the virus when they come in contact with healthy individuals, whether directly or indirectly through contaminated surfaces. coughs, sneezes, and some medical airway management procedures can also produce aerosols made up of smaller airborne particles (droplets), which may contain this virus. these airborne particles can travel long distances and be inhaled, increasing the risk of transmission of covid-19.1–5 during the sars-cov outbreak in canada (2002), half of all sars-cov cases were nosocomially transmitted to healthcare workers. during these high-demand times, the available human resources to attend to patients may decrease significantly, especially in countries with struggling healthcare institutions as considerable personnel have been subjected to quarantine and isolation measures to try to prevent further transmission of the virus. in healthcare institutions, the virus is widely distributed in the air and on the surfaces of objects (for example floors, garbage cans, handrails for sickbeds, and computer mouse devices). this can include general rooms, intensive care units,6 and cardiac laboratory rooms.7 in this regard, healthcare workers are threatened with an increased risk of infection, while managing covid-19 positive patients or by performing procedures that may generate aerosolized saliva particles, such as mechanical ventilation, misting medication, non-invasive ventilation, manual ventilation, tracheal intubation and aspiration, secretion aspiration, bronchoscopy, endoscopy, bronchoalveolar lavage, surgical tracheostomy, or cardiopulmonary resuscitation. several guidelines and recommendations have been published and introduced to reduce these risks; however, the cases of infections and deaths in health professionals due to covid-19 are still increasing in institutions with patients with serious complications.8 recently, robert canelli et al9, published a study in which they tested the effectiveness of a barrier that they called an "aerosol box", which consisted of a transparent plastic that could cover the head of a patient, and incorporated two circular ports to perform medical airway procedures. to demonstrate the effectiveness of the box, they simulated a “strong cough” with a small latex balloon containing 10 ml of fluorescent dye in the hypopharynx of an anatomical model. the explosion of this balloon produced an expansion of dyed particles in the area. they repeated the experiment with and without the aerosol box and illuminated the scene with ultraviolet light to visualize the spread of the dye. with the use of the aerosol box, the simulated cough was only able to “contaminate” the internal surface of the box, and the covered arms and gloves of the worker performing the laryngoscopy. however, with further examination, they concluded that the simulation method was not valid enough to prove an accurate direction of the liquid, its speed, turbulence, or particle size distribution, as it would happen with real coughs. taking this background into account, this “aerosol box” was redesigned to increase the protection of healthcare workers performing high-risk procedures on covid-19 patients.9 material and methods the following phases were carried out: (a) a sketch was created; (b) a 3-d cd model was created; (c) the prototype was manufactured; (d) the prototype was improved; and (e) the effectiveness and safety tests were carried out. results a sketch was created analyzing the original design of the aerosol box, with the experience of medical anesthesiologists, and with the support of the multidisciplinary team, the medical device was redesigned with two specific criteria: safety and effectiveness. to achieve those criteria, the following improvements were made: • an inclined front panel that limits the particles to the distal plane of the patient, and that allows a complete visualization of the procedure to be performed on the patient (figure 1 in annexes). figure 1. inclined front panel and cubedv extension. figure 2. cubedv sketches of the design. moreno, pedraza, morales, mijares, boccardo and garcía: redesigning protective gear for health workers during the covid-19 pandemic: leveling up the “aerosol box” 31 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 30 moreno, pedraza, morales, mijares, boccardo and garcía: redesigning protective gear for health workers during the covid-19 pandemic: leveling up the “aerosol box” the time of intubation. the test was carried out in two stages, with and without the cubedv. in both cases, the expansion of the aerosol particles was recorded with the addition of ultraviolet light through photographs, filming, and testimony of the medical team in the operating room. in the first step of the investigation (without cubedv) the results showed that the distribution of the fluorescent aerosol particles from the position of the patient (where the spray was triggered), was: 1.2 meters (47.2 inches) away in both right and left sides, 1 meter (39.4 inches) in the air, the superior plane of the patient (figure 4), 1.1 meters (43.3 inches) in the coronal plane and 1 meter (39.4 inches) in the distal plane. moreover, there was an evident presence of particles in the facial protection masks of the operator (figure 5). subsequently, the second step of the investigation was carried out with the cubedv, reporting the distribution of the aerosol particles only on the internal part of the box (figure 6) and on the covered hands and forearms of the operator (figure 7). the use of cubedv was also tested in other medical procedures such as: bronchoscopy, upper digestive endoscopy, and induction of inhalation anesthesia in pediatric patients. the use of the cubedv from the tests carried out on the cubedv to prove its effectiveness, the following results were obtained: (a) the sloped front panel allows an important improvement of the visibility of the patient; (b) the cubedv’s improved length played an important role in protecting health workers during procedures with high risk of infection; (c) the distal flange decreases the possibility of particle expansion outside the box. the tests showed that the cubedv contained both the droplets and the large diameter drops, thus avoiding dispersion and contamination of the area; (d) the lateral closing holes reduced the risk of exposure of assisting personnel during different procedures. conclusions this work demonstrates that in spite of the the struggling circumstances venezuela faces daily, it is possible to solve a problem that threatens global public health and to fight the serious covid-19 pandemic. taking into consideration the length of the box, the improved panel, and its material, it is possible to conclude that the team of hcc and usb obtained an effective result when redesigning the aerosol box. our analysis and tests suggested that the cubedv may play an exceptional job protecting the health workers while attending to infected patients. cubedv is a result in a time of crisis and another tool in our fight against the covid-19. this protective gear is just one materialized example of our efforts to win this fight, and we hope, and to provide significant help in this crisis. acknowledgments to the group of anesthesiologists of the hospital de clinicas caracas, who supported the financing of the prototype and facilitated their working hours to carry the tests out. references 1. huang c, wang y, li x, et al. clinical features of patients infected with 2019 novel coronavirus in wuhan, china. lancet 2020 feb 15;395(10223):497–506. figure 3. inclined front panel and cubedv extension. figure 4. upper extension of the fluorescent ink to the surgical lamp. figure 5. ifluorescent ink spread to operator and assistant facial protection. figure 6. containment of the fluorescent ink inside the cubedv. figure 7. fluorescent ink spread limited to operator's forearms with use of cubedv. moreno, pedraza, morales, mijares, boccardo and garcía: redesigning protective gear for health workers during the covid-19 pandemic: leveling up the “aerosol box” j global clinical engineering vol.3 issue 1: 2020 32 2. oms. coronavirus disease 2019 (covid-19) situation report – 72. oms. april 2020. available at:: https:// www.who.int/es/home 3. li q, guan x, wu p, et al. early transmission dynamics in wuhan, china, of novel coronavirus-infected pneumonia. n engl j med 2020 mar 26;382(13):1199–207. 4. chan jf, yuan s, kok kh, et al. a familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. lancet 2020 feb 15;395(10223):514–23. 5. brewster dj, chrimes nc, thy bt do, et al. consensus statement: safe airway society principles of airway management and tracheal intubation specific to the covid-19 adult patient group. med j austr march 2020. available at: https://www.mja.com.au/journal/2020/ consensus-statement-safe-airway-society-principlesairway-management-and-tracheal 6. guo zd, wang zy, zhang sf, et al. aerosol and surface distribution of severe acute respiratory syndrome coronavirus 2 in hospital wards, wuhan, china, 2020. emerg infect dis 2020 apr 10;26. 7. romaguera r, et al. consideraciones sobre el abordaje invasivo de la cardiopatía isquémica y estructural durante el brote de coronavirus covid-19. rec interv cardiol. 2020. https://doi.org/10.24875/recic.m20000119. 8. globerno de espana. manejo clínico de pacientes con enfermedad por el nuevo coronavirus (covid-19) available at: https://www.sedar.es/images/site/noticias/ coronavirus/protocolo-manejo-clinico-covid-19.pdf 9. canelli r, connor c, gonzález m, et al. barrier enclosure during endotracheal intubation. n engl j med 2020; 382:1957–58. 10. mijares r, utrera n, sierra z, et al. quality certification of medical devices in venezuela: process developed by simón bolívar university, caracas-venezuela. global clin https://www.who.int/es/home https://www.who.int/es/home https://www.mja.com.au/journal/2020/consensus https://www.mja.com.au/journal/2020/consensus https://doi.org/10.24875/recic.m20000119 https://www.sedar.es/images/site/noticias/coronavirus/protocolo-manejo-clinico-covid-19.pdf https://www.sedar.es/images/site/noticias/coronavirus/protocolo-manejo-clinico-covid-19.pdf j global clinical engineering issue 1:4-8; 2018 4 received august 19, 2018, accepted september 17, 2018, date of publication october 13, 2018 applying human factors methods in a clinical engineering setting to reduce medical device risks by a easty university of toronto abstract this paper describes the ways in which human factors methods can help to enhance the work of established clinical engineering teams by placing a new emphasis on error reduction and patient safety. this approach in many ways represents a natural evolution for departments that are looking to enhance their usefulness and relevance to healthcare. several examples are given of points at which the introduction of human factors methods can reveal issues related to the safe use of medical devices that are not easily accessible by other means. adoption and implementation of these methods offers the potential for clinical engineering departments to enhance their role in ensuring optimal patient safety. keywords – human factors, medical devices, error investigation, patient safety. introduction for clinical engineering teams, managing risks associated with medical devices is at the core of their work. great attention is rightly paid to the effective maintenance of medical devices, to ensure that they are operating within specification and are inspected as required to support continued good performance. an ideal approach to this considers all phases of the medical device lifecycle, from acquisition planning to eventual decommissioning. the objective is that properly selected and maintained devices will help to ensure good patient outcomes during treatment. in 1999, the institute of medicine (iom) in the united states issued a landmark report titled: to err is human: building a safer healthcare system,1 which provided a harsh wakeup call to the healthcare community with an extrapolated estimate that at least 44,000 to 98,000 deaths were occurring each year in the us healthcare system as a result of generally preventable medical errors. this explosive statistic caused much debate and analysis within the healthcare community, both in the us and in other countries, and subsequent studies in other jurisdictions revealed remarkably similar rates of error when normalized for population size.2 one of the results of this information was to place new emphasis on patient safety, and organizations began to search for methods that would allow them to study their current levels of safety, capture errors, and make improvements that would have a lasting effect on patient safety outcomes. in the search for methods and approaches that might prove beneficial in healthcare, attention turned to the aviation and nuclear power industries, both of which had experienced significant catastrophic events that led to a clear demand for action. the discipline of human factors http://www.globalce.org http://globalce.org http://globalce.org easty: applying human factors methods in a clinical engineering setting to reduce medical device risks 5 j global clinical engineering issue 1:4-8; 2018 combines principles and methods from psychology and engineering to understand how humans interact with the world around them, examining issues of cognition and the interaction between people and the environment that surrounds them. leaders in the field, such as james reason and jens rasmussen, have developed models that help to determine whether a system is well designed for safe human use by posing questions such as; is it clear and logical to operate? does it behave in a manner that is similar to other systems that the operator encounters? does it reveal its operating state in a clear and concise manner? these methods have proved remarkably effective at increasing the safety both in aviation and at nuclear power plants. commercial aviation has become far safer in the past 40 years as a result of the standardization of various procedures and the use of tools such as checklists and safety interlocks.3 these methods offer great potential for improving the safety of healthcare as well, but to date, the results have been mixed4 and it is useful at this point to consider why it is proving so difficult to achieve truly significant reductions in error rates in healthcare. healthcare providers spend many years of training to deliver the best possible care to their patients and are understandably distressed when errors occur during diagnosis or treatment. effective improvements in aviation and nuclear power safety have come about because of the standardization and codification of safe practices, and at first glance it appears that it might be possible to have a similar effect in healthcare, but there are some important differences that come into play which are making it much more difficult to have an impact on error rates. (1) healthcare processes are far more varied than the processes followed in an airplane cockpit prior to take off, for example (j ruiter-ligeti, md, personal communication). they cannot necessarily be standardized to the same extent, and many healthcare providers have become expert at improvising in complex situations. the term “workaround” is one that is commonly heard in patient care environments as front-line care providers modify well-intentioned but restrictive protocols to try to provide optimal care for each patient. (2) in an effort to improve safety, system planners in healthcare often seek to impose a level of standardization which restricts the ability of front-line staff to provide optimal care, leading to frustration and a sense that one must “go it alone” to provide optimal care. this often comes about when systems are imposed on users without a thorough understanding of the specifics of the work being done at the bedside. as an example, it is easier for an administrator to write a policy in response to an earlier error forbidding a particular practice, than to spend time in the care environment understanding why that practice is being used. everyone wants to do what is best for the patient, but understanding what that looks like requires a very detailed knowledge of the actual environment of care. (3) healthcare is not a static entity. indeed, big changes have occurred in the past 19 years since the iom report, including the widespread adoption of computerization and the introduction of new types of medical devices. both of these useful forces add complexity to an already complex environment, making safety an increasing challenge. further, these systems and devices are often introduced in ways that fail to take into account the environment of care and the skills, abilities, and training levels of the users, leading to new possibilities for error. human factors methods can be brought to bear on all of these issues, and there are some early encouraging signs that these are taking hold. interestingly, the application of human factors methods is not new in healthcare. a remarkable early example is the work of dr. jeff cooper and colleagues in boston with regard to anesthesia safety.5 this work was way ahead of its time compared with other areas of healthcare and it had a profoundly positive impact on patient safety during anesthesia. sadly, this approach did not gain a significant foothold in many other areas of care, and so we are now presented with the challenge of how to accomplish widespread adoption in the complex health environment of today, where devices are often networked together and information is aggregated in complex it systems. clinical engineers and technologists are well-placed to champion the application of human factors methods in healthcare, at least regarding the role that medical devices play in errors. jim keller of ecri institute has easty: applying human factors methods in a clinical engineering setting to reduce medical device risks j global clinical engineering issue 1:4-8; 2018 6 stated that their data reveal that 75% of errors that occur with medical devices are not due to device failure per se but are as a result of use error.6 in the next section, a series of ways in which the clinical engineering team can participate in the application of human factors methods in the healthcare process are explained, and it is hoped that we as a profession will seize the opportunities that these tools provide to do our bit to try to ensure that medical devices are used as safely and effectively as possible. human factors roles for clinical engineering while it is unreasonable to assume that clinical engineering can solve all of the systemic error problems in healthcare, it is clear that a number of these relate in one way or another to the use of medical devices and it systems. medical device support has been the traditional domain of clinical engineering, and in recent years there has been a strong emphasis on clinical engineering becoming much more involved in the deployment of it-based systems as well, since in many ways the issues posed by these mimic the ones posed by medical devices themselves; issues such as technical specifications, network connectivity, interfaceability, and overall user satisfaction. it systems are often an extension of patient data collection, much of it initiated by medical devices at the front end, so this extension of activities is logical and sensible. clinical engineering is well-placed to bring a systems engineering approach to helping to reduce error, and this has the advantage of moving the approach away from opinion and conjecture and towards measurable parameters and outcomes; the classic tools of quality improvement. a full review of the various ways in which clinical engineering can engage in bringing a human factors approach to healthcare is beyond the scope of this paper, but a comprehensive treatment of this subject can be found online.7 the following is a brief summary of the key areas where contributions are possible, and further reading is encouraged. there are a small but growing number of teams specializing in these methods in healthcare around the world, and it is hoped that in time, these methods will become widespread and routine, since they offer great potential to improve the level of safety associated with the use of medical devices and it systems. use in assessment and procurement the assessment and procurement of medical devices has long been recognized as a critical task for clinical engineering since decisions that are taken then have an impact of many years. a poor choice of technology can result in devices that are unreliable or difficult to operate. in most jurisdictions, the demand for new technology outstrips the available funding, so decisions need to be made carefully. once made, the selected devices are long-term commitments that ideally should satisfy the needs of the healthcare system. very often, medical device decisions do not involve many, or even any, of the end users who will ultimately have the task of trying to extract good performance from the chosen system. traditional user assessments in clinical areas are often subjective and haphazard, and subject to bias. using the human factors methods of work flow analysis and usability testing in a controlled simulated or real environment allows a high measure of objectivity to be brought to an evaluation of competing products from several vendors. representative end users are initially observed interacting with comparable technologies if present, to gain a thorough understanding of the ways in which the technology fits within the environment and associated work flows. users are then recruited into a series of controlled interactions with competing technologies using scenarios that are scripted to represent typical tasks in the observed clinical work flows. the human factors team members passively observe the performance of each participant, paying special attention to areas where users experience confusion interacting with a device, or make errors during use. if multiple participants experience problems at a particular stage of use, that is a strong indication that some aspect of the device being tested is proving problematic for the entire user population, and an assessment should be made of the potential severity of the problem. could it lead to an incorrect treatment or diagnosis, for example? can it be bypassed or modified in some fashion? mounting tests of this kind requires some effort and knowledge of the evaluation methods used, but the investment of time for a major device acquisition is well worth easty: applying human factors methods in a clinical engineering setting to reduce medical device risks 7 j global clinical engineering issue 1:4-8; 2018 this effort. institutions have to choose which device areas to subject to this rigorous evaluation, and as a general guide, the following filters can be applied; is the device one which has been associated with past incidents and errors? is the device widely distributed in the organization and thus used by a variety of different people? is there a major financial investment being made? if the answer to one or more of these questions is yes, then the upfront cost and effort associated with a human factors-based pre-purchase evaluation may well reap dividends over the lifetime of the equipment. one other important issue to consider is that when end users participate directly in this type of evaluation, they come to a better understanding of the capabilities and limitations of the device, and are more vested in the selected product, assuming that their experiences are used to help inform an optimal purchasing decision. use in predicting and investigating errors even with careful device selections, errors will still periodically occur, and so the next area in which the human factors approach can play an assistive role is in the prediction and investigation of adverse events. tools such as failure mode and effects analysis (fmea) can be used proactively to assess the likelihood of certain events occurring during the use of device or a system. each potential failure mode is identified and the associated effects from each are categorized, asking what the probability of occurrence is and what the impact will be should it occur. once these are drawn up, a list of mitigating strategies can be identified and decisions can be made about which of these are realistically implementable. note that all of this work is prospective. it is done ahead of implementing a particular device or system, and if the analysis is thorough, it offers the potential to significantly reduce the overall error rates associated with a particular system. clinical engineering teams are often very well-placed to lead this analysis since they are aware of the details of implementation of a technology and also have a good grasp of the potential problem areas associated with its use. assuming that an incident has now occurred and that the institution has initiated an investigation, the root cause analysis (rca) method is a powerful tool grounded in human factors theory that can be used to try to understand the root causes behind the incident. with very rare exceptions, healthcare workers are deeply committed to the welfare of their patients and are traumatized when adverse events occur that compromise their patients’ care. sometimes the initial reaction to an adverse event is to criticize the people involved and ascribe it to poor judgment. this has the double effect of quickly identifying the “culprits” and reassuring the system that this was a one-off event, leading to a false sense of security that the underlying issues have been effectively addressed. the human factors approach helps us to look behind these assumptions to try to understand the root causes involved. perhaps the healthcare provider was interrupted during a very critical task. perhaps the system itself is so complicated that many users do not know how to properly operate it. perhaps a user was presented with information that appeared to confirm that the system was performing as intended and failed to notice that the potential for an adverse event was evolving as a result of their actions. an rca helps to uncover these issues, and once they are revealed, helps to guide those responsible for the system regarding the changes that are required to the system to try to minimize the likelihood of a recurrence. again, clinical engineering is well-placed to take a lead role in aspects of this analysis, working with colleagues from other disciplines to uncover these root causes. by identifying and mitigating these issues, systems truly become safer in the long term. looking for no fault found repair reports as mentioned at the beginning of this paper, clinical engineering departments are rightly charged with the effective maintenance of the medical devices used in their institution. ask any hands-on service person in clinical engineering whether they have ever received a piece of equipment from a clinical area with a label on it saying “broken” only to find that when they test it on the bench, it is performing to specification. these are often referred to as “no fault found,” since no fault was detected by the service team. a recent study8 pulled data related to no fault found service events and then identified a range of devices that showed higher incidence levels of no fault found reports. when these devices were assessed for usability, a correlation was found between user difficulties and the likelihood of a no fault found event occurring. in easty: applying human factors methods in a clinical engineering setting to reduce medical device risks j global clinical engineering issue 1:4-8; 2018 8 other words, users were experiencing difficulties using a device and some of them were giving up in frustration on the assumption that something must be wrong with the device itself, or simply taking the approach that if i can’t get this unit to work, maybe i should get another one and send this one in for “repair.” from this it can be seen that no fault found reports in clinical engineering departments are to some degree a proxy for devices that are difficult to operate. further investigation can reveal whether interventions such as further user training can be effective at helping to reduce operating problems, or are the issues built into the design of the device such that the only effective remediation is replacement of the device altogether. conclusion while not all of the approaches described above can be performed solely by the clinical engineering team in an institution, the application of these human factors methods can easily be developed and championed by it. with their technical background, the team is ideally placed to adopt and promote these methods, and will often find allies among clinical staff, administrators and risk managers, all of whom have a strong interest in reducing errors during care as much as possible. as clinical engineering adapts and grows, this area represents a high-impact extension to the work that they currently do, and it can be argued that promoting human factors methods is a challenge not unlike the one faced by clinical engineering 10 years ago regarding their involvement in information technology systems. that debate is largely resolved, and it is hoped that the next 10 years will see a similar outcome regarding the adoption of human factors methods by clinical engineering. to gain this knowledge, users are encouraged to learn more about this topic through reading and through contact with colleagues who have already worked in this area. industrial engineering and psychology departments of nearby universities may have faculty with strong human factors knowledge who are interested in collaborating with people who are working in a live clinical environment. also, there are an increasing number of labs whose work is focused specifically on the application of human factors methods to healthcare, and these represent expert sources of information and, potentially, collaboration. in sum, clinical engineering departments have an excellent opportunity to play an important role in helping to make the provision of healthcare safer through the adoption and application of human factors methods in their work. clinical engineering professionals are encouraged to seize this opportunity and make a contribution. development of this area of expertise in healthcare will help to elevate clinical engineering from a technical support role to important players in ensuring optimal safety for patients. conflict of interest the author declares that there is no conflict of interest regarding the publication of this paper. references 1. kohn lt, corrigan jm, donaldson ms. to err is human: building a safer healthcare system. washington, dc: institute of medicine, national academies press (us); 2000. 2. baker gr, norton pg, flintoft v et al. the canadian adverse events study: the incidence of adverse events among hospital patients in canada. can med assoc j 2004; 170 (11):1678–86. 3. vicente k the human factor: revolutionizing the way people live with technology. toronto: random house canada; 2004. 4. federico f. 15 years after to err is human: the status of patient safety in the us and the uk (december 6, 2015) [internet]. institute for healthcare improvement blogpost. available at: http://www.ihi. org/communities/blogs/_layouts/15/ihi/community/blog/itemview. aspx?list=7d1126ec-8f63-4a3b-9926-c44ea3036813&id=180 5. cooper jb, newbower rs et al. preventable anesthesia mishaps: a study of human factors. anesthesiology 1078;49(6):399–406 6. keller jp. instructions included? make safety training part of the medical device procurement process. mater manag health care 2010;19(4):26–9 7. cassano-piche a, trbovic p, griffin m, et al. human factors for health technology safety: evaluating and improving the use of health technology in the real world. [internet] ifmbe; 2015. available at: https://www.dropbox.com/s/t9vpg8kkvoxmvp7/ ced%20hf%20health%20technology%20safety.pdf?dl=0 8. flewwelling c, easty a, vicente k and cafazzo c. the use of fault reporting of medical equipment to identify latent design flaws. j biomed informat 2014;51:80–85. http://www.ihi.org/communities/blogs/_layouts/15/ihi/community/blog/itemview.aspx?list=7d1126ec-8f63-4a3b-9926-c44ea3036813&id=180 http://www.ihi.org/communities/blogs/_layouts/15/ihi/community/blog/itemview.aspx?list=7d1126ec-8f63-4a3b-9926-c44ea3036813&id=180 http://www.ihi.org/communities/blogs/_layouts/15/ihi/community/blog/itemview.aspx?list=7d1126ec-8f63-4a3b-9926-c44ea3036813&id=180 https://www.dropbox.com/s/t9vpg8kkvoxmvp7/ced%20hf%20health%20technology%20safety.pdf?dl=0 https://www.dropbox.com/s/t9vpg8kkvoxmvp7/ced%20hf%20health%20technology%20safety.pdf?dl=0 33 j global clinical engineering vol.3 issue 2: 2020 marciano: discarding flow proposition for hospital electric and electronic equipment j global clinical engineering vol.3 issue 2: 2020 32 received april 2, 2019, accepted august 13, 2020, date of publication december 1, 2020 discarding flow proposition for hospital electric and electronic equipment by m. a. marciano moinhos de vento hospital/hospital and clinical engineering, porto alegre, brazil abstract this work proposes a project establishing a staged workflow to ensure any electric or electronic equipment used in a hospital environment that is being discarded would be subject to all possible reuse of its equipment and components through to the manufacturing of new equipment. the workflow would apply to all the electronic equipment used in the hospital (i.e., biomedical, electro-mechanical, computer, refrigeration, air conditioning). this appropriate discarding workflow would address socioenvironmental as well as economic/financial concerns. keywords – discarding, electronic equipment, hospital, socio-environmental. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction technological progress has brought benefits to society but has also resulted in increasing levels of waste which has worried organizations and environmentalists. the environmental damage involved in the disposal of electronic waste is very relevant. the production process to make these components involves the expenditure of natural resources, burning of fossil fuels and increased solid, liquid, and gas pollution emission (including greenhouse gas emissions – gee).1 in the assembly of electronic equipment various component are used that have other constituent heavy metals, such as mercury (used in thermostats, sensors, relays, and switches); lead (used in printed circuit board welding); cadmium (used in printed circuit boards, smd resistor chips, semi-conductors, and infra-red detectors), and pvc stabilizers (such as the silicon used in the manufacturing of microprocessors and halogenated substances like polyvinyl chloride [pvc] etc.).2 other materials often used are iron and steel, used in cabinets and frames; glass, used in screens and counters; plastics, used in cabinets, cable coatings, and printed circuit as well as rubber. these substances when disposed of inadequately can cause ground, water, and air contamination in addition to having an accumulative effect in all trophic levels that can bring harm to human health.1 research shows that the residue from electronics manufacturing has a direct relation to 22 types of diseases. physical and chemical effects observed include headache, nausea, impaired vision, respiratory and pulmonary problems, hearing loss, nervous tension, and hypertension. chronic conditions as allergies, bronchitis, teratogenic effects, cancers, organ damage, central nervous system issues are affected by heavy metal exposure and have cumulative effects.2 table 1 outlines some relevant toxic substances and notes their uses in electric and electronic equipment (eee) and their effects on health.3 the residue from the disposal of eee becomes a technological, social, and environmental problem and its proportions are growing larger. that is why it is necessary to develop environmental management planning to reduce their negative effects. only in 2010, was a law approved regulating the solid residue national policy (law 12.305) defining, among other issues, reverse logistics and the manufacturer’s responsibilities for the lifecycle of products. still, in said law, there was, for the first time, the incentive to develop recycling sectors, the select and providing technical training to staff that work in recycling, as well as encouraging environmental and business management systems including programs like the 3rs (reduce, reuse, and recycle), aimed at the improvement of productive processes, a reduction in residue exploitation, and recovery and energy reuse.1 the federal law n. 12.305 of 02/08/2010, establishing the solid residue national policy defined in article 33 that: “are required to structure and implement reverse logistics systems, by returning products after use by the consumer, independently of the public service of urban cleaning and solid waste management, manufacturers, importers, distributors and traders of: ... vi electro-electronic products and their components.”4 “the electro-electronic equipment is small and large and includes all the computing, sound, video, telephony, ventilators, exhaust fans, and other devices equipped, in general, with electronic controls or using electric activation.”4 for the residue from eee (reee) it can be considered the is an annual generation rate of 2.6 kg per capita, based on academic works and trace estimates.1,4 reee comes from outdated electric and electronic equipment that is selected for disposal, including all the consumable components, table 1. relevant toxic substances, its uses in electric and electronic equipment and its effects in health substance uses health effects arsenic semi-conductors, alloys, and transistors carcinogenic and gene-altering beryllium copper alloys, mechanical arts, connectors and springs skin sensitization, emphysema and fibrosis in the lungs, carcinogenic cadmium printed circuit boards, chip resistors, semi-conductors and infra-red detectors, batteries, switches, fluorescent materials damage to kidneys, liver, pancreas, increased blood pressure, carcinogenic and gene-altering lead printed circuit boards welding, glass, cathode ray tubes, welding, and lamp glass damage to the nervous, endocrine, circulatory, urinary, digestive and skeletal systems (it is the most toxic of the elements) copper present in several components liver damage hexavalent chromium and chromium vi decorative surfaces, pigments and covers, stainless steel irritations in the nose, throat, lungs (cancer), muscles, eye, skin, and liver damage mercury thermostats, switch sensors, data transmission systems, telecommunications, cellphones, flourescent lamps and batteries damage to the brain, central nervous system and kidneys, reproductive problems pbb and pbde printed circuit boards, components like connectors, plastic covers and tv cables and home appliances damage to the endocrine system aluminum computer structures and connections one of the factors for alzheimer's disease nickel computer docking structures genetic mutation pbb = polybrominated biphenyl; pbde = polybrominated diphenyl ether http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ marciano: discarding flow proposition for hospital electric and electronic equipment 35 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 34 marciano: discarding flow proposition for hospital electric and electronic equipment subcategories and materials needed to function. in general terms, the composition of the present materials in reees is characterized by the high presence of metal (ferrous and non-ferrous), glass, and plastic. televisions, computers, and monitors present, on average, 49% in metal weight, 33% in plastic weight, 12% in cathode ray tubes, and 6% other material. in studies performed it was found that printed circuit boards – pci must be considered as dangerous residue and be disposed of in appropriate places mainly due to the presence of lead and cadmium. therefore, recycling those materials present in the reee through the shared socio-environmental responsibility in which manufacturers, importers, public power, and consumers are responsible can aid in environmental protection and demonstrate to present and future generations that is the most viable option. eee is made of a variety of high commercial value material that can be recycled.5 with the right action on the appropriate environmental management of this residue, value can be added to what, until then, was considered “waste.” to attenuate this issue there are several residue disposal avenues such as landfills and incineration although recycling is the best and most efficient. as the toxic substances can be found in bigger concentration than they were in nature, the recycling of this residue provides the recovery of toxic substances as well as reducing the exploitation of natural resources. the environmental management of solid waste is a set of activities aiming to reduce or eliminate the damage that these can cause in the environment. also, as well as being a source of material for other technology manufacturing and generating jobs, material recycling offers great savings to organizations and shows a positive corporate image to the consumer market (an example of “green marketing”). the separation and destination of unwanted electronics promote residue reduction, the reuse and recycling of raw material, generate income, and promote social inclusion and the reduction of waste in landfills and helps mitigate environmental degradation from incorrect disposal.1 for eee, the suggested control approaches are: general data and description, generation, collection and transport, destination and final disposal, costs, competence, and responsibilities, needs and deficiencies, relevant initiatives, applicable legislation and applicable standards. there is also the suggestion about the unity of residue processing, such as guidelines, the strategies, the quantitative goals and the programs and actions.4 table 2 highlights the categories of the reees, by the european parliament, through the directive 2002/96/ce.6 considering that the resolution, rcd 16, in 2013, manufacturing good practices, defines the responsibilities of the manufacturer to installation stages, according to the item 6.4.1: “each manufacturer must establish and maintain procedures to the components identification, manufacturing material, intermediate products and finished products during all the storage, production, distribution and installation stages to avoid confusion and to guarantee the correct order fulfilments,”7 considering that the draft conama resolution, which regulates the management of waste electrical and electronic equipment in brazil, suggests “the need to discipline correct table 2. categories of electric and electronic equipment residue category examples 1. large home appliances refrigerators, washing machines, dishwashers, stoves, microwaves, vacuums 2. small house home appliances toasters, electric knives, hairdryers 3. computing and telecommunications equipment desktop computer, laptop computer, printer 4. consumer equipment cellphone and telephone, television equipment, dvd devices 5. lighting equipment fluorescent lamps 6. electronic tools (except consumer equipment) saws, sewing machines, lawnmowers 7. toys, sports and leisure equipment video games, slot machines, sports equipment 8. medical equipment (except the implanted and infected products) nuclear medicine equipment, radiology, cardiology, dialysis 9. control and monitoring instruments thermostats, smoke detectors 10. automatic distributors dispensers of money, beverages, and solid products environmental management and disposal of electrical and electronic equipment residue, concerning the collection, reuse, recycling, treatment or final disposal.”8 this work proposes a project establishing a staged workflow that would make sure any electric/electronic equipment used in a hospital environment that is being discarded would be subject to any and all possible reuse of its equipment and components through to the manufacturing of new equipment. method with the reference to the proposition of the disposal flow of hospital eees were used the researched references, according to what is described below. art. 7 of the resolution, rcd 16, of 2013, about manufacturing good practices states: “are obligations: i – from the manufacturers and importers of eee and its components: (a) adopt technologies or processes of acquisition that take into consideration the “ecodesign,” that allows reducing, reusing or recycling the reee; (b) the reee management (collect, transport, handling, storage, processing and environmentally appropriate disposal). the manufacturers and importers should be able to choose to fulfil this management either individually, adhering to a collective regime or through a third part; (c) collect the reee, creating accredited collection points and/or in articulation with its commercialization network, technical assistance and with the public power as the implementation of the necessary structure to guarantee the reverse logistics of this waste and to give them environmentally appropriate destination; (d) to recover, when possible, the reee in form of new raw material or new products, in its cycle or in other productive cycles; (e) the management of reee applies to current products and historical passages; (f) to establish collection points for the reee that are accessible to consumers / users and to provide environmentally adequate disposal for tailings; (g) to articulate the reverse logistics of reee with its commercialization network and technical assistance; (h) to disclose information on the location and operation of reee collection points and to promote environmental awareness campaigns to combat inadequate disposal; (i) to ensure that the products and electric and electronic components commercialized in brazil indicate with emphasis, the following to the consumer, at least in the equipment manual and in the producer’s official site or importer on the internet.”8 and item iii of the same draft suggests: “iii – of consumers: (a) to adopt practices that make it possible the reduction of its generation; (b) after the use of the product, condition adequately and to deliver of reee to the dealers/distributors or to destine them to the collection points, according to the information provided by the producer/importer.”8 the recycling stages of reees are similar for and include the steps outlined below. disassembly done at a sorting center, this stage involves the removal of parts that contain dangerous substances (chlorofluorocarbons, mercury, polychlorinated biphenyl, etc.), parts that contain valuable substances (copper cables, steel, iron, and precious metals). the environmental risk in this stage is from ground contamination by improper storage of reees or oil or cfcs leaking from removed parts. separation of ferrous and non-ferrous metals, and plastics this step is normally performed manually in a sorting center. recycling/recovery of valuable material items containing ferrous and non-ferrous metals, plastics, and precious metals are sent to specific recycling companies for recovery. processing/disposal of dangerous material and residue any remaining non-recovered/recycled material is sent to landfills or industrial landfills for further disposal following the appropriate legislation.5 figure 1 illustrates the sorting scheme for materials present in eee.4 also described are possible process indicators: • the number of producers, importers, and dealers for used eee. • the number of establishments receiving reees. • the number of agents involved in the waste collection program. marciano: discarding flow proposition for hospital electric and electronic equipment 37 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 36 marciano: discarding flow proposition for hospital electric and electronic equipment • the percentage of employment and income generated. • the quantity of generated residue and the estimate of the amount of waste that is no longer being sent to landfills.5 the implementation of a plan for the disposal of eee makes it possible to improve environmental conditions, encourages future generations to continue the process of environmental education, and generates the potential for increased employment and income. establishing an evaluation and monitoring program is of great importance to help identify the stages that need correction and to continuously improve the process. the monitoring must evaluate all the stages from environmental education to final disposal. the results found by monitoring must be available to those involved in the work. the implementation of monitoring activities also needs a preestablished selection of indicators to simply illustrate the functioning of the plan.5 results based on our results and shown in figure 2 we have a proposed flow for discarding hospital eee. discussion there are some points worth taking into consideration to clarify the process of defining and executing the management plan for disposal of hospital eees: figure 1. sorting scheme for material present in electric and electronic equipment. figure 2. proposed flow for discarding hospital electric and electronic equipment. adapted from meta-recycling.1 • local issues • use of dedicated personnel (own or outsourced) • partners to conduct the external stages • internal policies as well as any relevant municipal, state, or federal guidelines this project should be continuously evolving in the hospital and include the involvement of various departments such as environmental management, patrimony management, and accounting in addition to hospital and clinical engineering. this is important so that after well-defined and detailed stages are in place the results can be taken to the hospital’s directors for analysis and validation. conclusion the reality demonstrates the need for definition by standardization, detailing, and validation of the eees flow disposal. the proper disposal management of the components of eees can eliminate potential environmental damage and be a source of material for other applications. there is also the possibility to generate new jobs and create potential saving for health organizations. hospitals can contribute considerably in this issue by instituting the right processes in handling and disposal of eees. conflict of interest the authors declare that they have no conflict of interest. references 1. del grossi ac. ii brazilian congress of environmental management. unopar. disposal of waste electrical and electronic equipment (reee). londrina; 2011. 2. pallone s. electronic waste: reduction, reuse, recycling and recovery. available at: http://www.comciencia. br/comciencia/handler.php?section=8&edicao= 32&id=379. accessed: 26 april 2017. 3. del grosi a. electronic waste task force. back of flyer. londrina, paraná, brasil; 2010. 4. federal government ministry of the environment. local governments for sustainability. iclei. solid waste management plans: guidance manual supporting the implementation of the national solid waste policy: from national to local. brasília – df, brasil; 2012. 5. belo horizonte: state environment foundation: foundation israel pinheiro integrated management plan for waste electrical and electronic equipmentpgireee / eualdo lima pinheiro; 2009. 6. european parliament directive 2002/96 / ec of the european parliament and of the council of 27 january 2003. concerning waste electrical and electronic equipment – reees. available at: https://eur-lex.europa.eu/ legal-content/en/txt/?uri=celex%3a32002l0096 7. anvisa. good manufacturing practices rdc 16, 2013. 8. conama resolution draft. regulates the management of waste electrical and electronic equipment in brazil. access in: 28 april 2017. http://www.comciencia.br/comciencia/handler.php?section=8&edicao= http://www.comciencia.br/comciencia/handler.php?section=8&edicao= https://eur-lex.europa.eu/legal-content/en/txt/?uri=celex%3a32002l0096 https://eur-lex.europa.eu/legal-content/en/txt/?uri=celex%3a32002l0096 j global clinical engineering special issue 1: 42-49; 2018 42 publicly available march 12, 2014, revised march 22, 2018. building a reliable wireless medical device network by d hoglund,1 and v varga2 1integra systems, inc. 2global technology resources, inc. abstract how to design and test the most effective and secure wireless medical device connectivity applications that will provide the true mobility experience that is needed in the 2018 healthcare marketplace. today’s medical devices will need to be connected to provide the data to the electronic medical record. this connectivity will be either real time or on a non real time basis. in either case; the majority of this data transfer will move toward a wireless medium from a legacy wired connection. the following will discuss best practices for wireless network design based upon application requirements; but also the protection of any data regarding cybersecurity requirements. the author has over three decades of medical device knowledge sense but also two decades of wireless and security integration knowledge sense. the take away is to understand the best practices and how to apply this to product design and the overall enterprise implementation into the healthcare ecosystem of connected devices. keywords – wireless, wlan, network, acute care, patient monitoring, ieee802.11, wmts, telemetry. introduction a brief history of the wlan-enabled medical device. historically, patient-wearable monitoring – commonly referred to as telemetry – required its own custom designed and proprietary radio system and coaxial cable infrastructure for unidirectional communication. this infrastructure was built around regulatory domain-controlled technologies, such as wireless medical telemetry service (wmts) in the united states. while these designs proved to be reliable, they were often expensive, unique to each manufacturer, and lacked enterprise management and/ or troubleshooting capabilities. these telemetry systems were generally confined to individual care units within the healthcare facility and utilized several to 100 or more dedicated telemetry patient channels. for the past several decades networked bedside (or acute care) patient monitoring was confined to proprietary, standalone networks for communication from the bedside monitor to the central station. this was, and is even today, often the de-facto standard methodology in the majority of critical care units on a global basis. over the past decade, many medical device manufacturers have incorporated wlan in their devices for a multitude of use requirements. this has included the next generation of smart infusion pumps, portable patient monitoring, and within the past five years, telemetry. modern enterprise networks, both wired and wireless ethernet systems, have progressed to the point where they, if designed and installed correctly, have proven to be cost effective and reliable – as demonstrated by hundreds of thousands of mission-critical wlan networks deployed on https://www.globalce.org https://www.globalce.org hoglund and varga: building a reliable wireless medical device network 43 j global clinical engineering special issue 1: 42-49; 2018 a global basis in many industries. as a result, both medical equipment manufacturers and healthcare institutions are looking to leverage their nearly ubiquitous wlans by utilizing them for network-enabled medical devices. clinical benefits of having a wlan throughout the healthcare institution the healthcare industry was an early adopter of wlans because they enabled more timely and accurate bedside medical statistics recording, voice-over-ip-over-wi-fi, asset location, and guest internet access – which benefitted clinicians, it and biomedical groups, as well as patients and their families. this new methodology of networked patient monitoring has many clinical benefits. specific to telemetry and patient monitoring, an omnipresent wlan can now enable the following: • expansion of telemetry area coverage: the telemetry system can operate across the entire facility, and not be limited to specific care areas. the trend is to increase telemetry usage across a common enterprise network, versus managing hundreds of standalone monitors. • increased reliability: patient monitoring can leverage proven networking technology that is consistent in design and deployment. this networking infrastructure can provide true bi-directional communication for increased overall system reliability. • increased space utilization and patient safety: having all monitors networked through the wlan gives the hospital the flexibility to monitor patients anywhere in the hospital. for example, if the emergency department is at capacity, they can add extra monitored beds in another unit, thereby keeping the patient in the delivery network, versus having to divert the patient to another facility because of the lack of monitored beds. having additional monitored beds also enables hospitals get patients out of higher acuity, and higher cost, settings. • reduced risk of undetected events: for example, if a prior cardiac patient comes in for an orthopedic procedure, the orthopedic nurse could easily have a cardiac trained nurse observe that patient using wlan monitoring while the patient is being treated for that orthopedic procedure. suitability of wlan for patient monitoring overview any wireless network is dependent upon proper planning, design, and implementation, taking into consideration the internal and external variables that may impact the network’s performance and reliability. such internal and external factors include high availability (ha) network infrastructure, radio frequency (rf) interference, quality of service (qos) requirements, and cost budgets. in terms of suitability of the wlan for patient monitoring, the healthcare institution must consider the requirements of the specific applications that will run over the wlan. any patient monitoring network has to be 100% reliable around-the-clock, 365 days a year, while communicating alarms, events, and recordings in real time. suitability factors the following factors influence the suitability of a wlan to support a patient monitoring system: • design of the wlan: over the last 15 years, wlan design has migrated from a simplistic paper-based approach to a very scientific methodology utilizing computer-based predictive modeling tools and onsite rf spectrum analysis to identify the sources of any potential rf interference. this methodology takes into account building materials, client device density, wireless access point (wap) placement, antenna patterns, rf link speeds, and rf channelization/ power and then creates a predictive model with 98% to 100% accuracy of design. in addition, a proper logical design must be created to define ip addressing, vlans, multicast, dhcp, qos, and other network-layer settings that affect wlan quality and reliability. when using these tools, the hospital can have confidence that the network they install will need little to no modification after installation. • installation and troubleshooting: a well planned and designed lan and wlan is the foundation for a well performing patient monitoring system. as mentioned above, predictive wlan modeling tools ensure a design with over 98% accuracy before implementation. for the few instances where the hoglund and varga: building a reliable wireless medical device network j global clinical engineering special issue 1: 42-49; 2018 44 wlan design may incorrectly place wireless access points (waps), wap location modifications can easily be made in the field at the time of deployment. when installing a wlan, all operational settings are configured in a central wlan controller that interfaces with the facility’s core network and allows for efficient network communication. in addition, depending on the size of the wlan, a separate wlan management system may also be implemented to provide a single “pane of glass” for the management, monitoring, alarming, troubleshooting, reporting, and assurance of consistent configurations across multiple wlan controllers. all of these improvements make the implementation of a reliable lan and wlan scientific and predictable. • interference: while rf interference is always a possibility, the modern wlan generally has spectrum analysis functions built into the network as a whole. this allows for constant monitoring of the network for any interference and acts to either issue an alarm to the network administrator or automatically mitigate those specific interferers. as good design practice, an onsite spectrum analysis should be performed to determine any rf interferers present in the facility in the 2.4ghz and 5ghz bands and their potential impact. • reliability: today’s wlan is an intelligent network. although waps have a mean time between failure (mtbf) of over ten years, this network can automatically sense and alarm if a wap fails or is not performing as expected. good wlan design practices dictate overlapping adjacent wap cells to ensure seamless client device roaming across the network. even if an individual wap fails, radio output power in adjacent waps can be set to automatically increase/ decrease to ensure adequate coverage. in addition, high availability (ha) designs feature redundant wlan controllers that will failover in a seamless fashion in the event of a network controller failure. • scalability: in the past, understanding how the wlan client density may increase was a challenge. wlan designs must anticipate the potential number of client devices such as patient monitors that will be used over the life of the wlan. today there are tools from such companies as ixia (www.ixiacom. com) that allow end users and wlan device manufacturers to assess the scalability of a wlan. given the new higher-speed wlan standards, it is common to build and scale networks to thousands of users to support data, voice, video, and wlan-enabled medical devices. • two-way communication: previous generations of proprietary wireless communication for telemetry was unidirectional; wlans offer two-way or bidirectional communication. two-way communication supports the latest generation of patient-worn monitoring devices. these devices send patient vital signs data to the central monitoring station for display and alarming, as did yesterday’s telemetry transmitters, but they also display and alarm locally. so, if the patient accidentally walks outside of the wi-fi network coverage area, the patient will continued to be monitored locally. the caregiver is therefore able to monitor the patient without compromising the mobility of ambulatory patients. • cost issues: healthcare systems are under tremendous cost pressures, so the more value that they can realize from a technology investment, the better. in the case of patient monitoring, this is yet another application across which to allocate the fixed wlan cost. more than likely, the investment in the wlan was made for bar code medication administration (bcma), wireless voice-over-ip (voip), real-time location services (rtls), and/or “smart” infusion pumps. adding wlan-based patient monitoring may add some small incremental costs, but this application can be amortized over a number years with the other applications to improve the return on investment (roi). wi-fi vs. wmts cost comparison the costs of implementing patient monitoring on wi-fi are significantly less than on a wmts network. the following cost comparison tool provides a general indication of costs involved. www.ixiacom.com www.ixiacom.com hoglund and varga: building a reliable wireless medical device network 45 j global clinical engineering special issue 1: 42-49; 2018 best practices the following are best practices for maximizing reliability and uptime when implementing patient monitors on an existing wireless lan: start with the right “wireless radio design” within the medical device one popular misconception that frequently compromises performance is that “all ieee802.11a/b/g radios are created equal.” on the contrary, the quality of radio devices varies, and if a medical device manufacturer selects a sub-par, low-cost radio, it can undermine the performance of a life-critical medical device that costs thousands of dollars. device testing is the key to protecting table 1. wlan vs. wmts cost comparison tool hoglund and varga: building a reliable wireless medical device network j global clinical engineering special issue 1: 42-49; 2018 46 yourself from buying a device with a sub-par radio. more on that in the next section. another costly misconception is that a radio obtaining a stamp of approval from the wi-fi alliance means everything will work fine; but there’s more to it than that. the wi-fi alliance was founded in 1999, the same year that the ieee approved the extended version of 802.11 (802.11b) standard for the specific purpose of ensuring interoperability between client radios and wireless access points. the interoperability testing conducted does not include modeling the specific characteristics of a data, voice, video, or medical device client or the simulation of different mixed client traffic load environments; nor does it measure application performance. obtaining the wi-fi alliance’s stamp of approval is a great start, but it’s far from the end. the fact that a radio is wi-fi approved, or subscribes to 802.11i and 802.11e, does not demonstrate how well the roaming algorithms will work, or assess the passing of security supplicants. many healthcare institutions employ wpa2 or other enterprise-level wlan security methods but differ in how they implement security methodologies, which in turn impacts device and application performance. in selecting the optimal wlan-embedded radio, device manufacturers must assess the ability of the components to meet their intended use for quality of service, roaming, and varying security implementations. as the mobile healthcare ecosystem grows ever more complex, embedded radio strategies must be able to accommodate all enterprise-grade security strategies and effectively roam amidst a myriad of traffic types throughout a highly mobile environment. it behooves the hospital to choose devices that contain radios that meet their current requirements in order to provide a foundation for future requirements. device testing: what it is and why it’s important the device manufacturer is responsible for testing medical client devices during validation and verification. a comprehensive methodology for testing the device proceeds from highly controlled lab testing to assessing performance in the field via open air. testing should include validating components such as radios, chipsets, and driver firmware and, once that is completed, progress to assessing the real-world performance of the medical device itself. hospitals have the right to ask manufacturers if their devices have been tested or installed successfully in a similar configuration to what they are considering. the proven methodologies should include: 1. base-lining network performance using “golden” clients to obtain a “best-case” use model 2. base-lining device performance under ideal network conditions where it’s the only client communicating with waps under optimal conditions 3. assessing range and roaming capabilities by varying rf signal attenuation to prompt devices under test (duts) to move away from and between specific waps. this includes: • determining device association to the wlan at various ranges • measuring the accuracy of device throughput, latency, and packet loss characteristics • assessing performance as devices travel across multiple waps to emulate patient mobility. testing should progress from simple setups using only two waps at a time to complex scenarios where the device sees multiple available access points broadcasting at different signal strengths. 4. assessing real-world performance and security by simulating live network conditions. generating high traffic loads and interference allows the resilience, coexistence, and security capabilities of devices to be realistically and thoroughly assessed. user-configured clients should be generated to populate a realistic network ecosystem containing device traffic typically found in healthcare environments – voice over ip, data from wireless infusion pumps, wireless laptop transactions, video, etc. – all generating simultaneous network traffic. 5. measuring interoperability with multiple waps and mobile clients and major customers’ preferred wlan equipment vendors 6. quantifying application performance and quality of experience (qoe) from the user perspective hoglund and varga: building a reliable wireless medical device network 47 j global clinical engineering special issue 1: 42-49; 2018 7. reproducing field conditions and modeling “what if ” scenarios in the lab to simulate individual hospital environments 8. onsite assessment to ensure successful deployments out of the gate 9. ongoing lab and site testing of network firmware changes and devices software upgrades the wlan patient monitoring deployment: what and why in the area of patient monitoring, the actual patient-use model is critical to a successful monitoring selection and implementation. before the technical requirements can be solved, the clinical requirements need to be addressed and understood, including: • where are the patients going to be monitored? a good starting point is to sit down with cad drawings of the hospital floor plan and have clinical staff highlight all the areas where patients need to be monitored. for example, would a patient need to be transported from the icu down the elevators to radiology and/or therapy areas? if so, then adequate wireless coverage would be needed to ensure real-time connectivity. • how many patients are going to be monitored simultaneously, at maximum patient census? • where will the staff monitoring these patients be located? once the clinical requirements are vetted out and agreed to, then the technical requirements can be addressed. the following questions should also be discussed: • what are the anticipated growth requirements (scale)? • what is the current network infrastructure in place to support the new patient monitoring system requirements? • what, if any, network remediation needs to be completed? based upon an understanding of the medical device’s network characteristics and the existing network infrastructure, an accurate wlan design can be initiated. the figure 1. wireless patient monitoring integration process figure 2. example of marked up hospital floor plan, highlighting all places where patients will be monitored hoglund and varga: building a reliable wireless medical device network j global clinical engineering special issue 1: 42-49; 2018 48 design tasks may include creating a completely new design or modifying the existing wlan. this design can be then handed off to the hospital’s integrator for any potential remediation and/or additional infrastructure. frequently asked questions why is it common for hospitals to use wi-fi for bedside and transport monitoring, but not for telemetry? it has been easier for medical equipment manufacturers to design wi-fi into a bedside and transport monitor due to the looser constraints around wi-fi power consumption and associated battery life. portable monitors tend to be powered by battery and ac line power and tend to be used for shorter periods of time. until most recently, wi-fi radios tended to be relatively power hungry. telemetry monitoring is wearable, requiring smaller batteries to conserve weight and space, and has a requirement for the devices to be worn for days. when i look for wi-fi based patient monitoring, is the particular wlan technology important – such as 802.11a, b, g, n, or ac? the evolution of wi-fi has been driven by the radio manufacturers and ieee standards seeking increasingly higher performance networks with increased radio spectrum efficiency. here is the history of ieee 802.11. what is important is to focus on the application and use model. patient monitoring data throughput requirements are extremely low and do not need the high speed capabilities of 802.11n and 802.11ac chipsets. the choice of radio is really dictated by chipset availability (for example, one would be hard pressed to find an 802.11b radio in 2014), power consumption, and feature set required by the patient monitor. wi-fi clients built on earlier 802.11 standards will communicate with the same qos (quality of service) and security but simply may not be able to take advantage of capabilities inherent in 802.11n and 802.11ac. these include but are not limited to channel binding at 40/80mhz, mimo spatial streams and multi-use mimo, high modulation 64 qam and 256 qam, beam-forming and co-existence mechanisms for 20/40/80/160mhz. when the healthcare enterprise desires to move forward with 802.11n and then 802.11c, adding the low bandwidth requirements of patient monitoring will have little to no impact on the overall wireless infrastructure. how do i know that wi-fi will be reliable for a lifecritical medical application when the spectrum is already crowded with data, voice, etc.? the evolution of wi-fi has been to primarily increase networking speed, quality of service, and security. wi-fi has evolved to a level of performance capability whereby it is now displacing the wired ethernet network at the access layer. those applications with low bandwidth requirements, such as infusion pumps and patient monitoring, will reliably function in the 802.11g (2.4ghz) and/or 802.11a (5ghz) spectrums. since 802.11n is backward-compatible with both ‘g’ and ‘a’, those same monitors will work well in a 802.11n wlan infrastructure. applications such as high-end video will tend to migrate to 802.11ac operating in the 5ghz band. therefore, all applications can co-exist successfully on a modern wlan network. modern wlan systems increase overall system reliability using: • persistent spectrum analysis to identify rf interferers and proactively reconfigure rf channelization to work around the interference • applying best practices for networking design and deployment for quality of service (qos) to prioritize patient monitor system traffic over other traffic types • applying best practices for networking design and deployment for network segmentation via vlans that address scalability, security, and network management table 2. history of ieee 802.11 hoglund and varga: building a reliable wireless medical device network 49 j global clinical engineering special issue 1: 42-49; 2018 i’m adding wi-fi patient monitoring to my hospital network. how can i design wired and wireless redundancy into the network? the practices for designing redundancy into a network do not change by adding patient monitoring. standard networking practices which can be planned in conjunction with hospital networking staff and/or third-party providers will meet your needs. most wlan vendors have capabilities for high availability (ha) for their wlan controllers (wlc) and offer near zero failover time to a secondary or tertiary wlc. in addition, modern wlans can automatically modify the waps output power to increase the surrounding waps cell coverage in the event of wap malfunction. although the network access-layer is typically not configured for redundancy, the access layer switches generally will, in healthcare facilities, have redundant ethernet connections to the core network. are there differences in the way redundancy works with wi-fi wireless monitoring compared to monitoring suppliers that utilize wmts? the principal difference is that redundancy can be cost-effectively built into an 802.11 wireless network. due to the proprietary nature of wmts telemetry antenna systems, it is either technically impossible or too costly to design redundancy into the system. wmts, or realistically all “telemetry” antenna and receiver designs, use antenna diversity: if there were a null (lack of signal) from one antenna, the other adjacent antenna may likely receive the signal. however, this is highly dependent upon the quality of design which is more of an art, versus a proven, scientific wlan enterprise design. several things need to be taken into consideration for a wmts implementation. upon installation of a wmts antenna system, it must be balanced. these coaxial antenna designs consist of splitters, power supplies (to supply power to the specific legs of the antenna system), attenuators, exact cable lengths, and connections. in large designs this could amount to thousands of connections and hundreds of antennas, which have be at the exact right place and with the right connections made with the ultimate two home runs to the receiver sections. multiple points of failure potentially exist to either cause dropout of the signal or the introduction of noise into the system as whole. this could result from a bad connection, removing an antenna, adding an antenna, relocating an antenna, or a receiver section failing. this coaxial wmts antenna design is what is considered to be “non-intelligent”. it is simply an active powered coaxial tv based diversity antenna infrastructure that is connected to powered telemetry receivers. unlike with wlan, no software exists in a wmts design to actively monitor the air space for interferers or adjust power for changes in wlan signal coverage. nor are there provisions for redundant failover of receivers (in case a receiver fails). in addition, the network management for a patient monitoring system operating on a wlan will be absorbed into the overall network management costs as the patient monitoring system is operating on a common network infrastructure versus a proprietary wmts-based system. conclusions 1. wi-fi is safe and reliable for patient monitoring. 2. the key to success is in the design, implementation and management of the network. 3. wi-fi opens the door to unprecedented benefits to the hospital, such as the ability to monitor a virtually unlimited number of patients house-wide, improved patient mobility, significant cost savings and more. 4. wireless monitoring gives hospitals the ability to provide continuity of patient care across the enterprise for the entire patient stay, which is only financially feasible with wi-fi. about the authors david hoglund, president and ceo of integra systems, inc., has more than 30 years of experience in patient monitoring networking and has authored over 20 white papers and publications. (www.integrasystems.org) vince varga, business development manager for mobility at global technology resources, inc. has over 13 years of experience in wireless networking technology, worked with clients across multiple vertical markets, and has managed more than 40 wireless lan patient monitor deployments at healthcare facilities across the us since 2004. (www.gtri.com) www.integrasystems.org www.gtri.com 15 j global clinical engineering special issue 1: 15-22; 2018 received march 8, 2018, accepted march 8, 2018, date of publication march 25, 2018. certification in the united states, canada and asia by james o. wear certified biomedical equipment technicians the first certification in the us in the clinical engineering field was for biomedical equipment technicians (bmets).1–4 as biomedical equipment maintenance was developing in us hospitals in the late 1960s, there were no training programs for bmets. a few 2-year technical schools initiated training programs based on their electronics curriculum, but there was no standardized curriculum. even the electronic programs in these schools were not accredited nor had a standard electronic curriculum. there were also bmets that had been trained in the military. the association for the advancement of medical instrumentation (aami) had a task force to look at the bmet field and the maintenance of medical equipment in hospitals. the task force decided that something needed to be done to allow bmets to demonstrate that they had a minimum level of expertise. certification of bmets became the tool to demonstrate this minimum level of expertise. a board of examiners was established by aami and the first exam was given in 1970. individuals who passed the written exam became certified biomedical equipment technicians (cbets). certification was not readily accepted by bmets or by the institutions hiring them. there also was an issue of testing sites and dates to allow bmets to readily be tested without considerable travel expenses. the department of veterans affairs (va) wanted to have its bmets certified, but funds were not available to provide travel for them to go to the aami meeting for testing. in 1973, the va developed its own bmet certification program from its engineering training center.5 the requirements to take the exam were the same as the aami and the exam was similar since the director of the va training center was on the aami board of examiners. the va used the human resources department at each hospital as a testing site since they were approved for giving other exams. the va exam was developed by the va training center faculty. in the va, the technicians are called biomedical engineering technicians which is still bmet. aami found a need to develop specialist exams for bmets who worked on laboratory and radiological equipment. these bmets might not be able to pass the general exam since they only worked on special equipment, but they need certification to demonstrate a minimum level of expertise in their specialty. aami developed specialty exams in these two areas and individuals that passed these exams became certified radiological equipment specialists (cress) and clinical laboratory equipment specialists (cless). these three certification programs still exist today. the va also found the need to establish the radiological specialty certification program and cres. in 1984-5, the va merged its certification program with the aami program. all va certifications were accepted by the aami program and the va allowed its human resources offices to be used to give aami certification exams. individuals must meet the following qualifications to take the aami bmet certification exam: • associate’s degree in biomedical equipment technology program and two years’ full-time • bmet work experience; or • completion of a u.s. military biomedical equipment technology program and two years’ full-time bmet work experience; or http://www.globalce.org http://www.globalce.org james o. wear: certification in the united states, canada and asia j global clinical engineering special issue 1: 15-22; 2018 16 • associate’s degree in electronics technology and three years’ full-time bmet work experience; or • four years’ full-time bmet work experience the exam can be taken if a person has an associate degree in bmet or two-years’ experience full time as a bmet. if they pass the exam, they have five years to complete the additional 2 years of full-time experience as a bmet to be certified. to take the cres or cles exam, a person must have worked at least 40% of the time in the past two years or 25% of the time in the past five years in the designated specialty area. each of the aami exams is 165 multiple-choice questions and is administered by a professional testing organization. the board of examiners creates questions for the exam bank and reviews new exams before they are used. the professional testing organization has responsibility for the exam security. in the aami certification program over 3000 are cbets, about 600 cress and around 100 cless. every three years, individuals must renew their certification by demonstrating a certain amount of continuing education to be maintained as a cbet, cres or cles. most of the cbets are in the united states, but bmets in several other countries have taken the exam and become cbets. aami has placed all of their certification programs in their aami credentials institute (aci). in 2016 the cbet, cles and cres became ansi accredited under iso/iec 17024 personnel certification. electronics technicians association international (eta) also certifies bmet as both general medical equipment and radiological equipment technicians. they must be certified as certified electronics technicians (cet) before they can take the journeyman certification exams. with six or more years of training and work experience in the field, the cet can take the journeyman exam. they must score 85% on the journeyman exam to be certified.6 if they pass the journeyman certification exam for medical equipment, they become cet-bmd. by passing the journeyman certification exam for radiological equipment, they become cet-biet.7 their programs are aligned with the iso/iec 17024 standards “conformity assessment – general requirements for bodies operating certification of persons” certified healthcare technology manager (chtm) in 2015, the aami credentials institute (aci) initiated the certified healthcare technology manager (chtm) program.8 aci defines a chtm as “the healthcare technology manager is a person responsible for planning and directing activities of other healthcare technology management professionals, monitoring their work, and taking corrective actions when necessary. this htm certification covers two major areas in healthcare technology management: the management of healthcare technology operations; and, the management of personnel. the functions of the manager are to include the participation in the “leadership” of the business enterprise. the manager is also expected to have the skills and understanding needed to perform strategic, business, and change management as well as employee relation.” this certification is not currently ansi accredited. individuals interested in pursuing the chtm designation must meet one of the following paths to be eligible for the program. path 1: a current certification as a clinical engineer (cce), biomedical equipment technician (cbet), radiology equipment specialist (cres), or a laboratory equipment specialist (cles) with at least three (3) years of work experience as a supervisor or manager in the last five (5) years. path 2: successful completion of the department of defense’s biomedical equipment maintenance technician (dod bmet) training program with at least three years of work experience, military or civilian, as an htm supervisor or manager in the last five years path 3: an associate degree in biomedical technology, related health care discipline, information technology or business with at least three years of work experience as an htm supervisor or manager in the last five years. path 4: a bachelor’s degree or higher in biomedical technology, engineering, related health care discipline, information technology or business with at least two years as a manager within the last five years. james o. wear: certification in the united states, canada and asia 17 j global clinical engineering special issue 1: 15-22; 2018 path 5: work experience with or without a degree not related to biomedical technology, related health care discipline, information technology, or business management. seven years of work experience in the htm field with three years of management experience in the last five years in any of the paths, if the individual does not have the title of supervisor or manager, he/she would have to confirm that he/she performs management duties either through self or third-party attestation. recertification requirements for this certification are a combination of work experience and continuing education to demonstrate sustained competency and knowledge in the healthcare technology management field. certified in clinical engineering (cce) dr. caesar caceres, md coined the term “clinical engineer” in 1967 for engineers working with physicians in the clinical setting. at that time, various types of engineers, physical scientists, and physiologists were performing engineering type work in the clinical setting in hospitals. as more medical instrumentation came into the hospital, more of this type of personnel came into the field as well. also, as bmets were hired to maintain the medical instrumentation, engineers and physical scientists were hired to manage clinical/biomedical engineering departments in hospitals. aami thought that engineers should be certified in clinical engineering since there were no academic programs that trained clinical engineers. some of the major people working in the field of clinical engineering were not engineers but held degrees in some other scientific field. it was decided that a program should be developed to certify people in the clinical engineering field and not as clinical engineers. an initial board of examiners was established with prominent people in the clinical engineering field. it was decided that for one year, individuals working in clinical engineering could be certified based on credentials. they had to have at least a bs degree in engineering or a physical science and at least three years experience working in the field of clinical engineering. these credentials were evaluated by the board of examiners. the aami certification program for clinical engineering was established in 1975 and within a year about 200 individuals were certified in clinical engineering (cce). after this first group of cces, the board of examiner developed a written exam and an oral exam to test future individuals for certification. at this same time, another group of prominent individuals in the field decided that certification on credentials was the wrong approach to certifying people. they decided that people should take an exam to become certified in clinical engineering. as a result, five people self-certified themselves and developed an exam for certification in clinical engineering. this group became the american board of clinical engineering (abce) and also started their certification program in 1975. most of the initial individuals in this program were academic clinical engineers. aami and the abce continued to certify individuals in clinical engineering until 1984. in 1983 the two groups began discussions on a possible merger of their programs. the merger was finalized in 1984 with all the abce cces being accepted into the aami certification program. as part of the merger the international certification commission for clinical engineering and biomedical technology (icc) was established. fifty individuals had been certified by the abce. in 1979, aami started requiring cces to renew their certification every three years by demonstrating continuing education. in 1992, the renewal policy was that anyone certified after 1992 and not renewed would have their certification revoked. anyone certified before 1992 that did not renew would become delisted. as of 2002, there were about 100 listed cces on the aami website. in 1999 aami discontinued accepting applications for certification because there were not enough applicants to support the program financially. however, they did continue to accept renewals. at the time aami discontinued accepting applications for certification, 474 had become a cce by credentials or exam including 50 certified by the canadian board of examiners for clinical engineering. this also included several individuals in other countries certified by the us board of examiners. however only about 200 had kept their renewal up-to-date. in 2002, the healthcare technology certification commission (htcc) was created under the healthcare james o. wear: certification in the united states, canada and asia j global clinical engineering special issue 1: 15-22; 2018 18 technology foundation (htf) to reestablish a cce program. a us board of examiners was created to develop a written and oral exam. the written exam was based on the american college of clinical engineering (acce) body of knowledge (bok) determined by an acce survey of practicing clinical engineers. this survey asked the clinical engineers about the work that they were doing and the knowledge requirements. the new certification program accepted anyone from a previous certification program who demonstrated that they were current in the field by continuing education for a one-year period. there were 112 individuals that were accepted in the new program from the previous program. the first exam was given in 2004 with three individuals taking the exam. in 2013 the htcc begin looking for a new sponsoring body since new us tax policies were such that a non-profit foundation such as htf could not have an income producing unit like the htcc. they looked at various organizations as sponsors as well as considering becoming a stand-alone organization without a sponsor. finally, aami and acce indicated an interest in becoming a sponsor and each presented their proposal. the acce was accepted as a sponsor since they guaranteed the exam process could continue to have the oral exam. aami was not sure they could continue to sponsor with the oral exam since they were trying to obtain ansi recognition of their exam program. thus, acce became the administrative sponsor for htcc in 2014. at that time there were a little over 200 individuals certified by the htcc from the us and the canadian board of examiners. individuals must meet the following qualifications to take the cce exam: • three years of clinical engineering experience plus • profession engineer license or • ms eng or • bs eng plus 4 years total engineering experience or • bset in engineering technology plus 8 years total engineering experience. they also must provide three professional references. the written exam is 150 multiple choice questions administered by a professional testing company. the questions are developed by the board of examiners and are based on the bok developed by the acce. the oral exam is about 2 hours and given by two members of the board of examiners and is based on practical knowledge needed to function on the job. canada certification canada uses the icc for certifying bmets and they add the requirement that an individual must have a bs in biomedical technology to take the exam.9 the exam is developed by the canadian board of examiners under the icc under the laws of the canadian provinces and territories, the use of the title “engineer” in a job description requires that the incumbent be licensed as a professional engineer in that jurisdiction. canada has always taken the position that to be eligible to seek certification in clinical engineering; an applicant must first obtain licensure as a professional engineer. once a person is licensed as a professional engineer and is working in the field of clinical engineering, then he or she can apply to the canadian board of examiners for clinical engineering certification. by 1980, it was recognized that engineers working in the clinical engineering role required a distinct but unrecognized bok to perform their tasks competently. since there was no licensing process in place specifically for clinical engineering, leaders in canada decided to establish a certification process that would be administered by competent members of the profession. in order to begin such an effort, discussions were held with colleagues in the united states who had undertaken a similar approach under the leadership of the (aami). canadians with established track records working in the profession were grandfathered as certified and established the first canadian board of examiners for clinical engineering certification. they developed a written exam and an oral exam. this process of certification continued for several years. however, the initial rush of applicants dwindled, and it remained a voluntary activity with limited visibility amongst the health care community. by the late 1990s, the work of the board had effectively ceased with very few applicants coming forward. james o. wear: certification in the united states, canada and asia 19 j global clinical engineering special issue 1: 15-22; 2018 around 2008, there was a growing interest in certification in canada as younger engineers entered the profession and the need for skilled staff continued to grow. members of the former canadian board were asked by the canadian medical and biological engineering society (cmbes) to restart a canadian certification process and bring it up-to-date. it was apparent that with the small number of certification applicants, it would be difficult to launch and sustain a self-supporting certification process. since there are many similarities in the practice of clinical engineering between canada and the united states, they decided to approach the us board about the possibility of sharing aspects of the enhanced us exam process. adding further credibility to the process, the us board of examiners is accountable to the health technology certification commission, which oversees the work of the board and ultimately decides on recommendations from the board to certify individuals. discussions between the canadian and us boards went well with good support and encouragement from us colleagues. the main issue of divergence of practice between canadian and us clinical engineers relates to the country specific codes, regulations and standards, an important but relatively small part of the written exam. in discussion, it was agreed that members of the canadian board would review the us written exam, to identify those questions requiring specific knowledge of us codes, standards and regulations. out of a full exam of 150 multiple-choice questions, the total number of exempted questions is typically no more than 30. these questions are not counted for canadian examinees and the same percentage pass mark is used. to compensate for the lack of written exam questions on canadian codes, standards and regulations, it was decided to put an additional (fourth) question into the canadian oral exam process, specifically on these topics. the canadian board agreed to develop such a question using the same process as the us board. in this way, canadian candidates are examined through a slightly different but parallel process to their us counterparts. it was agreed that canadian applicants would register and be administered by the secretariat to the us board, to avoid setting up a parallel office in canada. sites are available in canada to sit for the written exam, which is made available in both countries on a single date and time each year, early in november. all policies and procedures are harmonized, and the canadian board assists the us board in the generation of new written and oral exam questions. members of the two boards discuss their work on a regular basis, and the chairs of each board sit on the htcc. the harmonized process was established in 2010 and remains in place. there has been good communication between each board, and a generally high level of support for this harmonized process. commission for the advancement of healthcare technology management in asia (cahtma) cahtma was initiated in 2005 with the endorsement of the asian hospital federation.10 the asian hospital federation (ahf) is an international non-governmental organization, supported by members from 14 countries in the asia pacific region. cahtma is a member of the international federation of medical and biological engineering (ifmbe) and initially had who advisers. it was established to provide a platform for health care professionals to discuss and exchange ideas on health care technologies and practices. central to these objectives are the promotion of best technology management practices, the certification of clinical engineering practitioners and healthcare professionals and the dissemination of appropriate management tools through seminars and workshops. cahtma has certified a few clinical practitioners, but there has been no major need for certification in malaysia since it has not been required. when cahtma started certification, the government was planning legislation to require certification for maintenance of medical equipment. technicians are certified as a level one clinical practitioner with a written exam and experience which is like the icc bmet. engineers are certified as level two clinical practitioners with a written exam and an oral exam and experience which is similar to the htcc cce. in order to encourage more engineers to become certified, cahtma is going to use the process of certifying individuals based on credentials similar to what has been with the initial program in the us and taiwan. james o. wear: certification in the united states, canada and asia j global clinical engineering special issue 1: 15-22; 2018 20 cahtma is also certifying faculty for biomedical engineering technology programs which are developing with the increased need for technologist to maintain the medical equipment. the government is looking at requiring these technologists to be certified for certain work. in 2012, lecturers at one school were tested as assessors and certified by cathma with certification for clinical engineering assessors. lecturers who completed five weeks of training and passed the exams were certified by cathma with certification for clinical engineering trainers. certification in taiwan certification in clinical engineering in taiwan is performed by the taiwan society for biomedical engineering (tsbme).11 in 2000, tsbme established the certification executive committee for ce certification. during 2001, they certified clinical engineers by application. in 2003, they initiated a recertification program for cce. the first testing for certification of clinical engineering and technologists of medical equipment was in 2007. the tsbme provides certification for clinical engineers, medical equipment technicians and biomedical engineers. in 2010 they had certified 93 clinical engineers, 132 medical equipment technicians and 224 biomedical engineers. the clinical engineers and medical equipment technicians are for working in the hospitals and the biomedical engineers are for working in the medical device industry. this is the only certification that has separate certification for hospital and industry engineers. to become certified an individual must be a member of tsbme. the requirements to take the certification exam are as follows: • clinical engineer: ms degree in biomedical or related field plus at least one year of ce experience plus working in a hospital for more than 10 years. • medical equipment technician: bs degree in biomedical or related field plus at least one year of ce experience plus working in a hospital for more than 4 years. • biomedical engineer: bs degree in engineering plus at least two years of bme experience plus working in bme field for more than 4 years. the content of the assessment exams by the tsbme for each of their certifications is as follows: clinical engineer (core exam plus oral exam) • anatomy (24%) • medical instrumentation (16%) • clinical engineering (16%) • medical imaging system (16%) • major area: (biomechanical or biomaterial or medical electronics or medical information (28%) medical equipment technician (core exam) • anatomy (20%) • electronics & electrical safety (40%) • medical instrumentation (40%) biomedical engineer (core exam) • anatomy (20%) • medical devices, safety regulation & gmp (10%) • major/minor (biomechanics plus biomaterial or medical electronics plus medical instrumentation) major 45% and minor 25% (70%) certification in japan clinical engineering in japan is different from other parts of the world.12,13 it is the only country that the government certifies clinical engineering technologists (cets). the cets must graduate from a clinical engineering training school which can be a university, junior college or training school and pass a national exam to be certified. the cets are also called clinical engineers. the cets are paramedical staff and specialize in the medical equipment essentials in medical care. about 35% work in hemodialysis and about 20% in maintenance. others work in respiratory, operating room, icu, heart related, hyperbaric and other areas. the clinical engineer system was established in 1987 by the clinical engineers act. this act created the cet as a professional medical position responsible for the operation and maintenance of life-support systems under the direction of doctors. this act established a national qualification including passage of the 180-question exam in medicine, engineering and medical technology. in 2010 there were about 28,000 certified cets and about 18,000 james o. wear: certification in the united states, canada and asia 21 j global clinical engineering special issue 1: 15-22; 2018 current working in the field. the certification of the cets is most equivalent to the cbet in the icc system in the us. in addition to the cet certification by the government, the japan society for medical and biological engineering (jsmbe) has a biomedical engineering certificate program.14 the jsmbe has two classes of certification for biomedical engineers. the 1st class certification is for experienced clinical engineers and in 2008 the pass rate was 22.2% for 433 applicants. the 1st class exam covers basic aspects on medical engineering and medical device related subjects. the 2nd class exam is for students or recent graduates of clinical engineering and many take it as preparation for the national cet exam. in 2008 the pass rate on the 2nd class exam was 29.3% for 1398 applicants. certification in china in 2005, the international clinical engineer certification was introduced in china.15 the medical engineering division of the chinese medical association hosted the first international clinical engineering certification training courses and certification examination. from 2005 to 2016, eight sessions of lectures by international senior specialists and exams were done. a written exam based on the acce bok with some adjustment for the practice of clinical engineering in china. the written exam is in english and is prepared by international senior specialists. individuals that pass this 100-question multiple choice exam have to pass an oral exam in english to become certified. the oral exam is given by the international senior specialists. in the eight training sessions, there have been 700 clinical engineering personnel from hospitals and universities. there have been 219 individuals that have passed the two exams and been certified as international clinical engineers. in the past 7 years, china has been working to establish its own certification program. in 2012, the medical engineering division of the chinese medical association carried out chinese registered clinical engineer certification (rcec) training and examination. the candidates were junior engineers in large hospitals or new graduates with majors in medical engineering. this exam is the basic admission exam to the occupational qualification of clinical engineering. the rcec exam consists of a theoretical exam and practical test. there is a chinese exam question bank from which the theoretical questions are randomly selected. candidates then take a practical test including repair, measurement and maintenance of medical devices. a committee of chinese clinical engineering experts evaluates the ability of the candidates and determines if they are qualified to receive the rcec. in 2012, there were 176 people who took the exam and 56 passed to become certified as rcec. in the future, the candidates for international clinical engineering certification will be mostly senior clinical engineers with more than 10 years experience. they are establishing a continuing education for both certification to maintain and improve the quality of the clinical engineers. the medical engineering division plans to recommend to the government to officially authorize clinical engineer training and certification. references 1. wear jo. global perspectives on competency certification of medical electronic graduates in the fast-changing healthcare engineering field. international keynote, symposium on innovation and commercialization for medical electronic technology, bandor enstek, nilai, malaysia; 2012. 2. croswell dw. the evolution of biomedical equipment technology. j clin engineer 1995;20(3):230–4 3. wear jo. certification of biomedical engineering technicians and clinical engineers: important or not. 7th asian-pacific conference on medical and biological engineering ifmbe proceedings, 19, 558-61; 2008. 4. nicoud t and kermit e. clinical engineering certification in the united states. in: jf dyro (ed.), clinical engineering handbook. burlington, ma: elsevier; 2004. 5. wear jo and van noy fe. veterans administration bmet certification exam. j clin engineer 1979;4 (4)311–3. 6. eta international. eta senior and master certifications [internet]. 2013. available at: http://www.eta-i.org/senior_master.html. 7. eta international. eta journeyman certifications [internet]. 2013. available at: http://www.eta-i.org/electronics.html 8. association for the advancement of medical instrumentation. aami credentials institute (aci) certification handbook. arlington, va: author; 2018. http://www.eta-i.org/senior_master.html http://www.eta-i.org/senior_master.html http://www.eta-i.org/electronics.html james o. wear: certification in the united states, canada and asia j global clinical engineering special issue 1: 15-22; 2018 22 9. easty ac. the evolution of clinical engineering certification in canada, ifmbe proceedings 2015;45:950–3. 10. wear jo. global perspectives on competency certification of medical electronic graduates in the fast-changing healthcare engineering field. international keynote, symposium on innovation and commercialization for medical electronic technology, bandor enstek, nilai, malaysia; 2012. 11. chang wh and lin k-p. development and progress of biomedical engineering certification programs in taiwan. in workshop on clinical engineering education and training. workshop conducted at the 3rd international conference on the development of biomedical engineering, ho chi minh city. vietnam; 2010. 12. umimoto k. development of clinical engineering in japan. short paper no. 0309 at the 35th annual conference ieee engineering in medicine and biology society, osaka, japan; 2013. 13. kanai h. clinical engineering in japan. in j. f. dyro (ed.), clinical engineering handbook. burlington, ma: elsevier; 2004. 14. sakuma i and ishihara k. jsmbe (japan society for medical and biological engineering) activities in clinical engineering education. in workshop on clinical engineering education and training. workshop conducted at the 3rd international conference on the development of biomedical engineering, ho chi minh city. vietnam; 2010. 15. zhou d and ying j. development of clinical engineer certification in china. ifnbe news 2013;93:25–7. _hlk508615019 35 j global clinical engineering vol.1 issue 2:35-42; 2019 received april 24, 2019, accepted june 6, 2019, date of publication june 29, 2019 barriers to availability of surgical equipment in kenya: a surgical equipment journey approach by r.m. oosting1, l.s.g.l wauben2, s.w. mwaura3, j.k. madete4, r.s. groen5, j. dankelman1 1dept. biomechanical engineering, delft university of technology, the netherlands 2research centre innovations in care, rotterdam university of applied sciences, rotterdam, the netherlands 3association of medical engineering of kenya, nairobi , kenya 4dept. of electrical and electronic engineering, school of engineering and technology, kenyatta university, nairobi, kenya 5dept. gynecology and obstetrics, johns hopkins university, baltimore, usa abstract background and objective the need for surgery is currently not being met in sub-saharan africa, requiring both extra workers and surgical equipment. currently, there is a gap in the availability of surgical equipment which limits the provision of safe surgery. to design strategies to increase availability the use of surgical equipment in this context needs to be understood. this study aims to: (1) identify the different phases surgical equipment goes through during its lifespan (i.e., the surgical equipment journey) in kenya, and to (2) identify barriers that are perceived by biomedical equipment technicians (bmets). material and methods seven semi-structured in-depth interview sessions were conducted with a total of 17 bmets working in kenya. participants worked in 6 different hospitals (4 public, one private and one mission). interviews were conducted between december 2016 and december 2018. participants were asked to describe or draw the surgical equipment journey and describe the perceived barriers during this journey. results the surgical equipment journey consists of 3 phases: procurement, usage, and disposal. stakeholders involved in the surgical equipment journey are users, bmets, procurement officers, local distributors, and in case of donations, donation agencies. bureaucracy during procurement, difficulties to obtain consumables and spare parts (especially for donated equipment), cleaning with heavy chemicals, and usage in challenging environments were identified as barriers during the surgical equipment journey. conclusion sustainable interventions at multiple organizational levels are required to optimize the surgical equipment journey in hospitals in kenya. different strategies that can be applied in parallel to increase availability of surgical equipment in kenya were identified by the participants in this study: policies on donations, procurement of durable equipment, more well-trained bmets and university-trained biomedical engineers, and designs and business models that fit the local use in kenya and presumably other countries in sub-saharan africa. keywords – surgery, surgical equipment, sub-saharan africa, kenya, biomedical equipment technicians (bmets), maintenance. http://www.globalce.org http://globalce.org http://globalce.org oosting, wauben, mwaura, madete, groen, dankelman: barriers to availability of surgical equipment in kenya: a surgical equipment journey approach j global clinical engineering vol.1 issue 2:35-42; 2019 36 introduction surgery requires human resources, equipment, medicines, and organized infrastructure. several authors have already indicated gaps in the availability of surgical equipment in lowand middle-income countries (lmics) such as malawi, sierra leone, nigeria, cameroon, somalia, and ethiopia.1–6 the gap in the availability of surgical equipment is a large contributor to the unmet needs of surgical care in these countries.7 a large evidence-based study performed by duke university estimated that for example up to 40% of equipment available in hospitals in lmics is not usable.8 a report of the world health organization, “managing the mismatch,” identified that consumables, spare parts, and other support systems are often limited in lmics, resulting in equipment being unavailable.9 local use is not always considered during the donation of equipment. for example, howie et al. described a case study in gambia where the lifespan of donated oxygen concentrators did not exceed 30 minutes (as opposed to 5–7 years in highand middle-income countries [hics]) because of the wrong voltage and frequency to match the electricity network in gambia, leading to overheating.10 limited access to maintenance, spare parts, and inappropriate donations have been documented before as barriers to functioning equipment in lmics.10–13 however, to design successful strategies for increasing the availability of surgical equipment, the root causes of these problems need to be understood. installation and maintenance of equipment are often provided by biomedical equipment technicians (bmets), which makes their perspective on surgical equipment very valuable. to understand the barriers to availability and functioning surgical equipment in lmics, the situation in kenya is used as a case study. this study aims firstly, to identify the surgical equipment journey (the different phases surgical equipment goes through during its lifespan), and secondly, to identify the barriers that are perceived by bmets during the different phases. methods semi-structured in-depth interview sessions were conducted during hospital visits in kenya with bmets. interviews were conducted from december 2016 to december 2018. participants selection was done by snowball sampling. participants were instructed that equipment, such as electrosurgical units, monitors, operating theatre lights, sterilizers, and anesthesia machines were identified as surgical equipment in this study. all interviews were done in english. each session consisted of 2 parts in which participants were asked to describe: 1. the different phases surgical equipment goes through during its lifespan within their hospital and which stakeholders are involved in each phase, and 2. how the following concepts are related to the surgical equipment journey within their hospital: the supply chain, procurement, sterilization/cleaning, donation, policies, disposal, design, maintenance, costs, misuse, hidden costs, lack of infrastructure, spare parts, usage, management of equipment, training, and disposables. this study was approved by the human research ethics committee of the delft university of technology and informed consent was obtained from all participants. data analysis the interviews were recorded and transcribed. data were analyzed with masdaq 2018. the concepts discussed during the interviews were used for coding the transcripts. results in total, 17 bmets participated from 6 different hospitals (table 1). after 7 sessions data saturation was reached. session 4 and 6 were in the same hospital. table footnote: bmets = biomedical equipment technicians. # surgical care in kenya is provided by public, mission (nonprofit) and private hospitals. the public care system consists of 4 national hospitals (level 6) that fall under the responsibility of the national government, the county (level 5) and sub-county hospitals (level 4) fall under the responsibility of the 47 county governments.14 *certificate includes 1 year of training, diploma 3 years of training, and higher-level diploma 5 years of training at a technical college in kenya 37 j global clinical engineering vol.1 issue 2:35-42; 2019 oosting, wauben, mwaura, madete, groen, dankelman: barriers to availability of surgical equipment in kenya: a surgical equipment journey approach equipment journey participants within this study identified 3 phases within the surgical equipment journey: procurement, use and maintenance, and disposal (figure 1). stakeholders that were identified in the equipment journey were: the user, the bmet, the procurement officer, local distributors of the medical device company, and in the case of donations, the donation agency. the user refers to the healthcare worker (nurse, surgeon, etc.) who operates the equipment. bmets are responsible for maintenance and the procurement officer is responsible for procurement. donation of equipment to a hospital can be organized by either a foreign hospital, non-governmental organizations (ngos [e.g. amref]), or a foreign government. procurement phase all participants indicated the following procurement process: when a healthcare worker (a user in the equipment journey) requires new equipment, a need assessment is done by the user and the procurement officer. when the need is defined, the bmets are consulted to define the equipment specifications. thereafter, a tender request is placed in the local newspaper and on the hospital’s website for local distributors or medical device companies to respond. all public hospitals are obliged to procure by tenders. the highest referral level hospitals (level 6) can figure 1. the surgical equipment journey according to bmets in kenyan hospitals. user = healthcare worker (e.g., nurse, surgeon) using the equipment. biomedical equipment technician (bmet) = person responsible for maintaining the equipment. procurement officer = person responsible for procuring the equipment. local distributor = local agent of the medical device company. table 3. participants’ characteristics during each interview session session number bmets during session type of hospital# gender education level* 1 1 public hospital female higher level diploma 2 1 mission hospital male diploma 3 1 private hospital male diploma 4 1 public hospital male diploma 5 3 public hospital all male 1× diploma 5 3 public hospital all male 1× diploma, 1× higher-level diploma, 1× certificate 6 7 public hospital 1× female, 6×male 3× diploma, 3× higher level diploma 7 3 public hospital all male all diploma oosting, wauben, mwaura, madete, groen, dankelman: barriers to availability of surgical equipment in kenya: a surgical equipment journey approach j global clinical engineering vol.1 issue 2:35-42; 2019 38 organize their own tender process, all other public hospitals organize this process via the county government. private and mission hospitals use tenders too, but they can also procure directly from the local distributor or the medical device company. the bureaucracy within the procurement phase, which makes it a very time-consuming process, was mentioned in all 7 interview sessions. the procurement committee comes together to analyze the bidders and will often award the lowest bidder that meets all the specifications. ‘to get a new electrosurgical unit took up to 4 months. we have to make a request, set up specifications, this is taken to the supply department who puts it in the local newspaper. the bidders get 2 weeks to respond. after 2 weeks we sit down for an evaluation, after which we write a report to the ceo advising which company to award. then the award letter is made and then we have to wait for the supplier. then the problems around importing it into the country start, delays often happen at customs.’ session 7 ‘it is often a challenge to know what the market value of equipment is. sometimes we budgeted for 1000 dollars, but the good equipment is 2000 dollars, that is also why we end up with cheaper inappropriate equipment. the procurement law states that the lowest price that suits the specifications wins. european equipment is often too expensive to win.’ session 6 ‘we also check what the hospital’s history with a company is. if the company did good training and has good support they are rated higher during the tendering process.’ session 7 ‘some equipment is really cheap, but when it breaks it is difficult to repair and then we have to buy new ones’ session 2 although the system for procurement is in place, a lot of surgical equipment is often received by donations. donations can either be organized via the county government or are directly sent to the receiving hospital. the private hospital visited during this study did not receive any donations, whereas one of the mission hospitals obtained equipment mostly by donation, often arranged by expat surgeons working in the hospital. the public hospitals’ equipment was received by both donation and procurement. before the new equipment can be used and maintained (next phase), training is needed. the difficulty to receive appropriate usage and maintenance training by the medical device company was identified as a large barrier too and was mentioned during 4 of the 7 interview sessions. one participant stated: ‘we have received on-site training given by the medical device company. however, information is often quite limited. often, we cannot open a machine to do troubleshooting because they come in with a new machine. we would recommend that we can train on models that can be opened up and where we can troubleshoot to learn what to do in case of an error.’ session 7 use and maintenance phase equipment is used by various healthcare workers (e.g., surgeons, nurses or medical officers) in the operating theatre (ot). many types of surgical equipment require accessories to perform surgery; these can either be consumables (one-time use) or reusable parts. accessories need to be cleaned and sterilized after usage, which is most often done by the sterilization department. however, participants within this study explained that some parts (for example, accessories of the electrosurgical unit) are cleaned in the ot complex with heavy chemicals (e.g., cidex). equipment, such as electrosurgical units and anesthesia devices are often stored in the ot or in the corridors between the ots. these devices are cleaned by the cleaning staff, often also with heavy chemicals. surgical equipment can either be out of service because of a breakdown or because of planned preventative maintenance (ppm). repairs and ppms are done by the bmet department within all hospitals in this study. spare parts, tools, and manuals are required to keep equipment functioning. spare parts can refer to power boards or displays that need to be replaced when they are broken, but also to filters that need replacement every other month. all hospitals reported their repair orders in hardcopy books, except for 2 hospitals (1 mission and 1 private) that additionally store a digital copy in a software program. 39 j global clinical engineering vol.1 issue 2:35-42; 2019 oosting, wauben, mwaura, madete, groen, dankelman: barriers to availability of surgical equipment in kenya: a surgical equipment journey approach the difficulty to get spare parts in kenya was mentioned during all 7 interview sessions. the 5 hospitals that receive donations all have difficulties to obtain both consumables and spare parts required for the equipment. ‘the challenge with donated equipment comes when it breaks, the spare parts are often not available. for example, for the electrosurgical unit, a different patient plate is available within the country than the ones that came with the device, so we have to find a way to work around this.’ session 2 however, also for procured equipment, the supply chain of consumables and spare parts remains a challenge. this is either due to the long bureaucratic procurement process that needs to be followed for each new order, the high costs of spare parts and consumables, or delays because parts have to come from outside kenya or the african continent. only a small portion of the equipment available in the hospitals is supported by a maintenance service contract, which means that maintenance, spare parts, and consumables are provided by the medical device company. ‘if we have imported a machine from overseas, we also have to import the spare parts. getting the spare parts becomes tricky and takes a lot of time.’ session 3 one participant mentioned that they do not always get permission to order a spare part required for ppm, that has the potential to increase the lifespan of the equipment. ‘sometimes bmets only get permission to fix when it the equipment is broken. when it is still functioning but needs to be serviced to keep functioning, this is not understood. at the moment it is obsolete, everyone starts looking for a spare part’. session 1 participants in 2 hospitals also mentioned the breakdown of equipment due to the challenging environment in which equipment is used. modern sensitive equipment is often not designed to withstand power interruptions, unstable electricity networks, dust, and high temperatures. additionally, participants working in 2 hospitals described how the use of heavy chemicals for cleaning shortens the lifespan of the equipment. ‘power in kenya is different, also temperatures, altitudes, pressure, and the users are trained differently than in europe and asia where equipment comes from’. session 4 disposal phase when equipment is obsolete, it needs to be disposed of either by the hospital or via the government. all participants were involved in the disposal process, but approval often has to be obtained from the disposal committee or from the procurement department. this is a time-consuming procedure and often results in piles of unused equipment on the hospital grounds, as one of the participants from session 5 described: ‘you find we even get used machines and they are most of the time obsolete. then we only have to worry about the disposal, and that means extra work for us.’ session 5 discussion surgical equipment is not always available in lmics, which results in delays of surgeries that are urgently needed by the population.. other studies have identified synergies in the barriers to medical equipment between different lmics.10–13 this study offers insights from frontline bmets providing maintenance on a daily basis on why these barriers exist, by identifying the journey during the life span of surgical equipment. participants worked in 6 different hospitals in kenya. in other to ensure theoretical saturation 5 additional hospitals (1 private hospital, 3 public hospitals, and 1 mission hospital) were visited. the identified surgical equipment journey within this study revealed that equipment undergoes 3 different phases during its lifespan: procurement, use and maintenance, and disposal. within the procurement phase, a difference between public and private hospitals was found that results in a different procurement route: public hospitals are obliged to procure via tenders, whereas mission and private hospitals can also buy directly from the medical device company. procurement of equipment was identified as a timely process by all the participants. besides the tender process being very time-consuming, it does not always result in the most appropriate type of equipment when the lowest bidder wins. diaconu et al. oosting, wauben, mwaura, madete, groen, dankelman: barriers to availability of surgical equipment in kenya: a surgical equipment journey approach j global clinical engineering vol.1 issue 2:35-42; 2019 40 identified that equipment costs are often leading in procurement planning in many lmics, underestimating the true costs of maintenance, servicing and user training.15 public hospitals can only buy equipment from respondents to the tender, and those respondents need to provide equipmentthat fits the specifications of the tender. according to the participants in the public hospitals, this means they can often not buy from large international brands, because they do not respond to the tenders, or are out of scope because of the budgets that are set in the tender specifications. however, training opportunities and companies’ track records on spare part delivery and support are becoming more and more important during the tender awarding process according to some of the participants in this study. diaconu et al. also identified that careful consideration of the context of use results in the most successful uptake of medical technology in lmics.15 procurement of appropriate equipment is the first step in a good functioning surgical equipment journey, secondly, the use phase should be properly organized. this starts with providing training for both the user and the bmets.15 the participants in this study have experience with on-site training and overseas factory training at the medical device companies. participants indicated that some of the on-site training is very short and superficial, especially when the training is done with functioning equipment without the possibility to open up or troubleshoot. by the time maintenance is required, the company has to be consulted for advice again, because it was not covered during the training. maintenance is now often recorded offline in repair books, which is difficult to consult during the procurement of new devices. computer software for inventory, repair, and maintenance record could increase the amount of information about previous procured or donated equipment and their lifespan within the hospital, which can be helpful information during the procurement process.15 previous studies mentioned the lack of consumables and spare parts as a barrier to the availability of surgical equipment in lmics.11,16 our study confirmed these barriers within the surgical equipment journey. however, within this study, we also have researched the underlying process to these barriers. we identified that the procurement of consumables and spare parts can be a timely and costly process. firstly, spare parts can become very expensive when they have to be imported from overseas. secondly, parts for donated equipment are often not manufactured anymore which leads to disposal of equipment. lastly, participants indicated that they do not always get permission to order a spare part for ppms because the equipment is still working. when the delivery of consumables is delayed, this results in equipment that is out of use. this is one of the reasons why consumables are often reused. the costs of consumables are often paid by the patient, so reuse of these parts will reduce the costs of surgery for the patients. participants within this study indicated that although problems arise with donated equipment when maintenance or consumables are required, they still welcome donations because a lot of newer technology will otherwise stay out of their reach due to its high costs. some medical device companies are starting to lease high-end equipment to hospitals in kenya. these hospitals have a contract with the medical device company for the consumables and servicing of the equipment. additionally, the kenyan government has recently equipped 98 public national and county hospitals with brand new equipment for intensive care units, diagnostic imaging, and surgical equipment. within this program training and servicing is provided for at least 7 years.17 kenya aims to increase the quality of its healthcare system, alongside the who and the global health community aim to increase access to safe surgery worldwide. availability of medical equipment is vital for the realization of these goals. the possibility to lease high-end equipment and the implementation of high-end equipment by the kenyan government are all attempts to increase the availability of equipment in kenya. however, sustainable interventions at multiple organizational levels are required to optimize the surgical equipment journey in the future. a list of potential interventions to increase availability that were identified by participants is provided in table 2. table footnote: bmets = biomedical equipment technicians. lmic = lowand middle-income countries; r&d = research and development. 41 j global clinical engineering vol.1 issue 2:35-42; 2019 oosting, wauben, mwaura, madete, groen, dankelman: barriers to availability of surgical equipment in kenya: a surgical equipment journey approach this study only included bmets working in kenya and the quality of the healthcare system in kenya (number 73 on the gdp list of the world bank) is expected to be higher than in other countries, such as uganda or mozambique (number 106 and number 132, respectively).18 kenya has 6 colleges for bmet training and 2 university programs for biomedical engineers which equip bmet departments with well-trained bmets. in contrast, other countries have no bmet departments within their hospitals or bmet training available in the country. they have to hire employees with a technical background, but without specific training on medical equipment. barriers identified in this study could be even larger in these countries. commonalities and best practices of both medical providers and bmets in other countries may, therefore, provide also other root causes to limited availability of surgical equipment in lmics. despite these limitations, we believe that this study can be used as a starting point to design strategies to increase the availability of surgical equipment in the future either by academia, medical device companies or policy makers. it also highlights the importance of including local stakeholders’ input in the design and the development of plans for the provision of surgical care. acknowledgments this research was funded by the delft global initiative of the delft university of technology, delft, the netherlands (p70357). conflict of interest the authors declare that there is no conflict of interest regarding the publication of this paper. ethical statement all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 helsinki declaration and its later amendments or comparable ethical standards. ethical approval was obtained from the human research ethics committee of the delft university of technology. references 1. henry ja, frenkel e, borgstein e, mkandawire n, goddia c. surgical and anaesthetic capacity of hospitals in malawi: key insights. health pol plan 2015;30(8):985–94. 2. henry ja, windapo o, kushner al, groen rs, nwomeh bc. a survey of surgical capacity in rural southern nigeria: opportunities for change. world j surgery 2012;36(12):2811–8. 3. kouo-ngamby m, dissak-delon fn, feldhaus i, et al. j a cross-sectional survey of emergency and essential surgical care capacity among hospitals with high trauma burden in a central african country. bmc health serv res 2015;15(1):478. 4. wong eg, gupta s, deckelbaum dl, et al. the international assessment of capacity for trauma (intact): an index for trauma capacity in low-income countries. j surg res 2014;190(2):522–7. table 2. potential interventions to increase availability of surgical equipment as stated by the participant in this study theme potential intervention donations policies on donations procurement procurement of durable equipment, including training, access to spare parts and consumables training more university-trained biomedical engineers, more on-site training for users and bmets training by the medical device company on models that can be opened to troubleshoot equipment demonstrations before equipment is procured robust designs and suitable for the context (able to withstand: eruptive power supply, dust, high temperatures, cleaning detergents etc.) medical device companies and manufacturing medical device companies within the country/or continent. users and bmets in contact with r&d departments to give feedback adapted strategies for lmics based hospitals (placement of equipment or leasing equipment) oosting, wauben, mwaura, madete, groen, dankelman: barriers to availability of surgical equipment in kenya: a surgical equipment journey approach j global clinical engineering vol.1 issue 2:35-42; 2019 42 5. elkheir n, sharma a, cherian m, et al. a cross-sectional survey of essential surgical capacity in somalia. bmj open 2014;4(5):e004360. 6. chao te, burdic m, ganjawalla k, et al. survey of surgery and anesthesia infrastructure in ethiopia. world j surg 2012;36(11):2545–53. 7. meara jg, leather aj, hagander l, et al. global surgery 2030: evidence and solutions for achieving health, welfare, and economic development. lancet 2015;386(9993):569–24. 8. perry l, malkin r. effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? med biolog engineer comput 2011;49(7):719–22. 9. world health organization. medical devices: managing the mismatch: an outcome of the priority medical devices project: geneva: author; 2010. 10. howie sr, hill se, peel d, et al. beyond good intentions: lessons on equipment donation from an african hospital. bull world health org 2008;86(1):52–6. 11. malkin ra. design of health care technologies for the developing world. annu rev biomed eng 2007;9:567–87. 12. emmerling d, dahinten a, malkin ra. problems with systems of medical equipment provision: an evaluation in honduras, rwanda and cambodia identifies opportunities to strengthen healthcare systems. health technol 2017:1–7. 13. neighbour r, eltringham r. the design of medical equipment for low income countries: dual standards or common sense. 7th international conference on appropriate healthcare technologies for developing countries; 2012. 14. republic of kenya. ministry of health. kenya health policy 2014-2030 2014. available at: https://www. afidep.org/?wpfb_dl=80. accessed on april 1st, 2019 15. diaconu k, chen y-f, cummins c, et al. methods for medical device and equipment procurement and prioritization within low-and middle-income countries: findings of a systematic literature review. globaliz health 2017;13(1):59. 16. ogembo-kachieng'a m, ogara w. strategic management of technology in public health sector in kenya and south africa. east african med j 2004;81(6):279-86. 17. republic of kenya. ministry of health. demystifying the managed equipment services (mes) project in kenya. available at: http://publications.universalhealth2030. org/uploads/mes-brochure.pdf. accessed on april 1st, 2019 18. the world bank. world development indicators. washington, dc: author. accessed on april 1st, 2019 https://www.afidep.org/?wpfb_dl=80. https://www.afidep.org/?wpfb_dl=80. http://publications.universalhealth2030.org/uploads/mes-brochure.pdf http://publications.universalhealth2030.org/uploads/mes-brochure.pdf 5 j global clinical engineering, special issue 3, 2020 in the midst of the novel coronavirus (covid-19) pandemic, today, more than ever, medical devices are indispensable to save lives. furthermore, clinical engineers, healthcare technology managers and biomedical engineering technicians are important in the resourcing, equipping and sustainment of medical devices supporting life sustaining treatments. the who has published a wide range of covid-19 information and resources which are consolidated in the technical guidance page https://www.who.int/emergencies/diseases/novel-coronavirus-2019/ technical-guidance. the priority medical devices for covid-19, as well as the respective catalogue and technical specifications and a surge calculator to assist in planning for care provisions including the priority medical devices for covid-19 which can be found at https://www.who.int/emergencies/diseases/ novel-coronavirus-2019/technical-guidance/covid-19-critical-items. as we continue to learn more and our global understanding of the virology of covid-19 continues to evolve, in vitro diagnostics and medical equipment facilitating laboratory testing will be essential to identifying cases, taking proactive measures and reducing the impact of the disease until further measures can be achieved. the who has created an emergency use listing that is updated each week to expand capability which can be found at https://www.who.int/diagnostics_laboratory/eul/en/. additionally, the who is leading an effort to facilitate a functioning global supply chain during the pandemic via a public-private collaboration. further information can be found at https://www.weforum.org/projects/pandemic-supply-chain-network-pscn regarding this effort. the international federation of medical and biological engineers’ clinical engineering division (ifmbe-ced) has also worked to consolidate covid-19 guidance from clinical engineers and healthcare technology management professionals globally via their covid-19 resource center that can be found at https://ced.ifmbe.org/blog/covid19-resources.html. additionally, i was honored to work with healthcare technology management professionals globally and partake in the global ce covid-19 day hosted by ifmbe-ced on april 9, 2020. the link to the recording of the presentation can be found at https://youtu.be/ovi4xfcjlbe. i will continue to provide additional information regarding covid-19 in the who medical devices newsletter and blogs for ifmbe-ced which can be found at https://ced.ifmbe.org/blog.html. who update column by adriana velazquez berumen http://www.globalce.org http://www.globalce.org https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/covid https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/covid https://www.who.int/diagnostics_laboratory/eul/en https://www.weforum.org/projects/pandemic https://ced.ifmbe.org/blog/covid19-resources.html https://youtu.be/ovi4xfcjlbe https://ced.ifmbe.org/blog.html j global clinical engineering, special issue 3, 2020 6 thank you for all you are doing on the front line to implement, innovate and maintain medical devices and technology during this dynamic time. the world, more than ever, needs clinical engineer’s technical knowledge, entrepreneurial and innovative spirit, know-how and empathy to ensure the wellbeing of patients around the globe. please stay safe, remember your ppe and wash your hands! regards, adriana velazquez copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org j global clinical engineering special issue 1, 2018 editor’s corner o ver the past three-plus decades, my work as a clinical engineer has brought me to close to 50 countries where i have had the good fortune to meet and collaborate with many dedicated practitioners in our field. the professionals i have had an opportunity to work with are passionate about our shared endeavor--sometimes in the face of adversity, minimal institutional support, or an outright lack of resources. but the universal concern of the clinical engineer remains laser-like focus on making sure that patients are cared for with safe, appropriate and effective technology. over the years, many have told me that while their passion and efforts have never diminished, the recognition of their contributions has yet to be expressed. some have argued that this is at least partially the result of insufficiently publicity about the good work performed by clinical engineers, that we do not publish enough, and that we do not participate in the exchange of evidence-based publications that promote awareness of our many achievements in the field. therefore, the argument continues, our profession’s critical contributions to the improvement of world population health, wellness, and rehabilitation for the most part goes unrecognized. at the same time, the healthcare system has never been more dependent on technology than today. that may seem axiomatic. but the integration of technology into patient care has become routinized, accepted by, and more visible to patients than even before. in a study published in 2016 the estimated volume of medical devices sale for 2015 was 371$ us billion and projected to reach 530$ billion us in 2022. so, it seems only appropriate that the management of healthcare technology will increasingly be led by the professionals who create, curate, and manage this critical tool. however, academic opportunities to enter the field as well as to sustain life-long professional development seem to fall short compared with other professions in healthcare. if clinical engineering is to have a future, it must capture and retain the imaginations of educating the talent pool. the projected need of educated manpower capacity is growing while level of competent clinical engineers’ stays leveled around the world. for these reasons, i am very enthusiastic about the creation of this new on-line, open-access free journal. the global clinical engineering journal (globalce) is intended to focus on the intersection of technology and patient care and to promote the exchange of scientific knowledge to better patients’ care outcomes and promote safe, appropriate and effective instrumentation as well as optimally trained users. globalce will promote and publicize innovative work while encouraging new practitioners to research and publish. our objective for this publication is to create a public forum to share observations and insights about technological tools improving healthcare delivery outcomes. our hope is that this interaction will create a forum for our community of professionals. globalce is your publication and will reflect your efforts. we issue a call for papers and encourage you to consider publishing your work with us and ask you to share this call for papers with colleagues even if they have never previously published. we are proud of the editorial board we have assembled for our publication. the team represents the best and brightest in our profession across multiple disciplines. their acceptance of the editorials duties is evidence of their commitment to the journal mission. we are looking to add quality reviewers. please visit our website and register as reviewer if you have expertise in subject of the field that is identified in the call for papers. our aspiration for this unique journal is to rapidly connect the far corners of the globe and bring clinical engineers from every laboratory, university, and industry closer together than ever before. please join me in celebrating this long-awaited new beginning. together we can make it better! dr. yadin david http://www.globalce.org http://www.globalce.org http://info.evaluategroup.com/rs/607-ygs-364/images/mt-wp16.pdf j global clinical engineering vol.2 issue 3: 2020 24 received february 20, 2020, accepted may 8, 2020, date of publication may 19, 2020 a model for priority setting in health technology innovation policy by j. sharma1,2; j. bunders2; t. zuiderent-jerak2; b. regeer2 1 ceo, ap med tech zone & executive director, kalam institute of health technology, visakhapatnam, india. 2 athena institute, vrije universiteit amsterdam. abstract health technology assessment focuses on the equal appraisal of health technologies introduced into the market. this has made regulators and the governance of innovation reactive and dependent on the initiatives that innovators take for technology development, thus making it supply-driven. the policy-makers’ role has become one of appraising technologies that are already developed rather than guiding the development agenda. this severely limits the possibility to ensure that health technologies sufficiently address major issues such as the burden of disease, trade deficit, and health inequalities. it places governments outside of the actor arena that co-shapes technologies in the early stages, restricting the involvement in facilitating whether to scale up or not. it makes it hard to achieve health technology governance practices that maximally contribute to ensuring technological developments that address public concerns. what is the potential of the framework for changing this dynamic and how can evidence shape technology development agendas without falling into the traps of regulator lock-in or social engineering? the methodology presented in this study takes the first important steps toward an evidence-based framework for priority setting to guide innovations, particularly in the health and social sectors. keywords – assessment, health technology, medical technology, regulation, innovation, development, priority setting. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction the appraisal of health technologies introduced in the market is of utmost relevance for healthcare governance. one of the greatest challenges that governments face is aligning the agenda of technology development with social indicators like the burden of disease and macro-economic indicators like trade. however, the role of evidence-based policy restructuring in guiding medical device development has remained an overlooked possibility. understanding the necessities and gaps in medical device development could have major consequences for sectoral advancement and its benefits to the society instead of being locked in a supply-driven mode. as the current covid-19 pandemic painfully shows, it is also necessary to take into account a country’s capacity for self-sufficiency in terms of manufacturing the devices used in their territories and becoming more independent from importing medical devices and the economic impacts of such import. the pandemic shows that countries across the world, lower-middle-income countries (lmics) as well as high-income countries (hics), have all become largely dependent on the import of medical devices and that self-sufficiency by no means is a concern for emerging economies alone. this study aims to provide an evidence-based framework for priority setting in guiding innovations by developing a practical http://www.globalce.org http://globalce.org http://globalce.org 25 j global clinical engineering vol.2 issue 3: 2020 sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy model that can be implemented using country-specific data that reflects the actual territorial needs and can be related to the countries’ economic capabilities. a set of composite indicators have been identified and used for the priority setting exercise. firstly, the quality of human life is a major indication of national economic progress and human development index.1 the corollary of gross domestic productivity as a human health welfare index is an indication of national health,2 both economic and contextual. one major parameter for the identification of wellness of populace is public health data records.3 all countries have their specific manner of maintaining public health records4 and analysis methodologies5 to use evidence from such records. while minor variations in the analytical tools might be present, one common consensus among all government structured health analytics is the importance of mortality records.6 of the common parameters of assessing disease-affected livelihood, the quality-adjusted life-year is a generic measure of disease burden, including both the quality and the quantity of life lived. the institute of health metrics and evaluation (ihme) at the university of washington published a report titled who global burden of disease (gbd) which considered disabilityadjusted-life-year (daly) as the point of consideration for disease-affected livelihood.7,8 to consolidate the data of the major disease burden for india, this study focused on interpolating the diseases that are of immense concern. each disease has a large number of diagnostic, therapeutic, rehabilitative, and palliative procedures meant for combating the condition. while the diseases are classified under the international classification of disease (icd-11) by who, the interventions to tackle such diseases are listed under the international classification of health interventions also by who. the interventions are thereafter dependent on various health technologies, and while pharmaceutical products often come with varied alternatives, most medical devices do not have an alternative for the patient nor operationally for the care provider. for example, while several lines of drug therapy exist for non-communicable diseases such as renal failure or diabetes, there are no alternatives to a dialysis machine, a dialyzer, a glucometer, or an insulin pump. there lies an important distinction between medical devices, with both devices and drugs being health technologies. furthermore, by conceptually combining the evidence from the burden of disease estimates for a country to the export-import trade data on medical devices, a model list could be enumerated to estimate which medical devices could be developed in a country, which would be reflective of its health as well as economic impact. this reasoning was applied in this study to india’s context. as a country, india currently imports >80% of its medical device needs.9 this ranges across all healthcare paradigms as well as all domains of devices.10 it greatly affects the healthcare cost attributed primarily to capital expenditure on commodities as essential as health technologies.11 the overall medical devices market in india is estimated to be usd 7 billion,12 however the country imports over 80% of its needs, making medical technology acquisition costlier which negatively impacts the healthcare costs. the medical device market in india is growing at a 15.8% cagr (compound annual growth rate) and is postulated as the fourth largest potential globally. the methodology described in this paper, using a model that could cross-pollinate information from both disease burden and trade deficit has several advantages. firstly, avoidable death or disabilities from disease or ailments that could be possibly cured by medical technology is an effective indicator of meaningful technological and scientific progress. secondly, the import dependency on such devices including life-saving ones has a direct impact on the country’s trade deficit impacting its macro-economic growth and therefore societal progress. needless to say, united nations in its 17 sustainable development goals has given equal importance to these by keeping poverty elimination as goal 1; good health and well-being as goal 3; and industry, innovation, and infrastructure as goal 9. aligning these goals for priority setting in medical technology innovation could, therefore, result in health improvement and economic sustainability. this would also help realign the trade and export-import decision-making processes to encourage domestic manufacturing, which is increasingly important in light of world-wide outbreaks of infectious diseases. to the best of our knowledge, this study presents the first-ever attempt in correlating these sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy j global clinical engineering vol.2 issue 3: 2020 26 essential principles to establish a pathway for medical technology development and drive innovation policy to improve healthcare access, economic sustainability, and societal impact. methods and results in this section, the creation of a model or methodology to enumerate the priority list of medical devices that need to be developed is explained. the methodology is also a part of the results themselves, given that this study focuses, first, on the creation of a model and then application of the model to do the priority listing. for this reason, the authors opted to merge the methods and the results in the same section. to estimate disease burden, the main causes of mortality compared over a decade for india, estimated by the ihme was used and are tabulated below (see table 1). trends from 2005 to 2015 signify that while there has been a substantial decline in mortality due to neonatal complications, mortality due to metabolic disease and/ or lifestyle diseases has overtaken the mortality due to communicable diseases – a classic trend across developing economies. table 2 signifies similar parameters in the disability or morbidity estimates since mortality can be indicative but does not singularly affect gdp or macro-economic progress in a population. the aspects under study were disease models which required significant medical device intervention, hospitalization, or otherwise. to outline the relevant causative factors and disease conditions, the major disease burdens were classified as communicable and non-communicable. the top five from both were enlisted and relevant treatment procedures that required technological interventions were detailed. concomitantly each of the medical devices used for diagnosis and treatment were mapped for each of the therapies corresponding to the diseases. further, the segmentation of medical devices was charted by bringing in common devices used for these diseases. this had a relationship of one-to-many (e.g., cardiac and pulmonary diseases require more than one medical device) but also of many-to-one (hollow fiber membrane finding application in dialysis, oxygenator, ecmo and the like) (figure 1). table 3 entails the communicable diseases list and technological interventions required to tackle such disease conditions. table 4 enlists the non-communicable diseases and their diagnostic methods involving technological table 1. top 10 causes of death in 2015 and percent change from 2005 (data from institute of health metrics and evaluation, india) cause of death 2015 (rank) 2005 (rank) % change ischemic heart diseaseheart disease 1 1 (+) 16.7% chronic obstructive pulmonary disorder 2 2 (+) 4.3% cerebrovascular diseasedisease 3 3 (+) 7.3% lower respiratory infection 4 5 (−)(-) 22.6% diarrheal diseasedisease 5 4 (−)(-) 31.7% tuberculosis 6 6 (−)(-) 30.7% diabetes 7 11 (+) 34.8% chronic kidney disease 8 10 (+) 20.6% neonatal prepre-term birthbirth 9 7 (−)(-) 39.5% road injuriesinjuries 10 9 (−)(-) 2.7% neonatal encephalopathy 11 8 (−)(-) 31.0% table 2. top 10 causes of disability in 2015 (data from institute of health metrics and evaluation, india) 2015 rank disability causes 1 iron deficiency anemia 2 low back and neck pain 3 sense organ diseases 4 depressive sdisorders 5 musculoskeletal disorders 6 migraine 7 skin diseases 8 diabetes 9 anxiety disorders 10 chronic obstructive pulmonary disorders 27 j global clinical engineering vol.2 issue 3: 2020 sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy interventions that are critical to disease treatment or mitigation. figure 1. model flow diagram of burden of disease to categories of interventions to medical devices involved. starting from the left: (1) make a list of non-communicable and communicable diseases in order of highest burden (see tables 1 and 2). (2) identify diagnosis methods and device-related interventions for the top 5 diseases (see tables 3 and 4). (3) create a consolidated list of essential medical technologies (see table 7) by combining the priority lists of medical and diagnostic devices for communicable and non-communicable diseases (tables 5 and 6). next, starting from the right: (4) tabulate export and import data of categorized medical devices (see table 8). (5) consolidate high import and low export-dependent devices (see table 9) as they require the increase or improvement in internal manufacturing capability to create self-dependency, higher affordability, and greater access. table 3. classification of communicable diseases and their corresponding technological dependencies rank communicable disease or infectious disease diagnosis methods and device-related interventionsdevice related interventions and uses 1 malaria, dengue, parasitic infections like filariasis, and hookworm infestation microscopic examination rapid diagnostic tests molecular testing antibody testing (igg and igm) fecal matter testing with pcr assays endoscopy of intestinal tracts dna testing surgery serological techniques 2 diarrheal diseases along with amoebiasis and cholera, and similar gastroenteritis, and typhoid microscopic examination cyst search in fecal matter serological techniques dna testing rapid dipstick urine testing swab samples laboratory examinations endoscopy and colonoscopy blood culture stool culture bone marrow culture widal testing typhidot medical testing (for detection of igg and igm antibodies) 3 tuberculosis, and fever-associated complications like influenza and leptospirosis led microscopic examination commercial culture and dst testing tb and drug resistance using xpert mtb/rif assay diagnosis and screening of active tuberculosis in people living with hiv, using lateral flow urine lipoarabinomannan assay detection of resistance to second-line antituberculosis drugs using molecular line probe assays diagnosis of pulmonary tb using loopmediated isothermal amplification detection of resistance to isoniazid and rifampicin using molecular line probe assays latent tb infection testing (tst or igra) ultrasound imaging sputum cultures mantoux tuberculin skin tests nucleic acid amplification tests adenosine deaminase tests serology, virus isolation and culture, antigen detection, rna detection by pcr endoscopy examination using flashlight x-ray examination using tongue depressors serum tests blood tests kidney function tests liver function tests elisa tests pcr tests microscopic agglutination tests sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy j global clinical engineering vol.2 issue 3: 2020 28 data were collected by taking into account the top five communicable and top five non-communicable diseases which account for the most lives lost as per the latest data available. with the perspectives of disease paradigm enlisted on priority, our methodology brought in the next component of these diseases and their possible intervention to prevent prevalence or provide treatment. matching was done between diseases and relevant medical devices of the relevant intervention procedure from the prior lists removing overlapping entities if any. table 5 lists the priority medical and diagnostic devices in communicable diseases subset, while table 6 details the priority medical and diagnostic devices list for non-communicable ones. by merging the two previously referred lists and removing overlapping entities, a common list of essential medical technologies was created as shown in table 7, consolidating this entire dataset. this list is referred to as the “priority list of medical and diagnostic devices on the rank communicable disease or infectious disease diagnosis methods and device-related interventionsdevice related interventions and uses 4 jaundice and hepatitis, and similar diseases which affects the liver blood tests urine tests fecal tests lft ultrasound imaging computerized tomography scan magnetic resonance imaging scan endoscopic retrograde cholangiopancreatography with the help of x-ray liver biopsy lft hepatitis a, b, d, and c marker tests 5 venereal diseases like stds (gonorrhea, syphilis, hiv, etc.,) blood tests urine samples fluid samples diaphragm or cervical cap male condom female condoms cervical cap dst = drug susceptibility testing; hiv = human immunodeficiency virus; led = light-emitting diode; pcr = polymerase chain reaction; stds = sexually transmitted diseases; tb = tuberculosis. table 4. classification of non-communicable diseases and their corresponding technological dependencies rank noncommunicable disease diagnosis methods and device-related interventionsdevice related interventions and uses 1 cad or ihd and their abnormalities cad and ihd diagnosis and monitoring using ecg holter monitoring event monitoring cardiac stress testing ultrasonic imaging of the heart using echocardiography nuclear stress testing (radioisotopes injected into the bloodstream) heart ct scan (ct coronary angiogram), which requires high-speed ct scanner coronary catheterization (diagnosis and interventional purpose, invasive) intravascular ultrasound intracoronary optical coherence tomography fluoroscopy 2 copd, lower respiratory tract infection, and asthma spirometry chest radiography ct scan complete blood count arterial blood gas analysis other pulmonary function tests 3 cerebrovascular disease and strokes carotid angiogram ct scan magnetic resonance imaging scan ecg cerebral angiogram vertebral angiogram 4 diabetes and obesity-associated disorders like hypertension glycated hemoglobin (a1c) test random blood sugar test fasting blood sugar test oral glucose tolerance test 5 iron deficiency and protein malnutrition complete blood count (using microscope or analyzers) endoscopy (to check for internal bleeding in the upper gastrointestinal tract) colonoscopy (to check for internal bleeding in the lower gastrointestinal tract) ultrasound imaging cad = coronary artery disease; ct = computed tomography; copd = chronic obstructive pulmonary disease; ecg = electrocardiogram; ihd = ischemic heart disease. 29 j global clinical engineering vol.2 issue 3: 2020 sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy disease burden context.” this formed half of our dataset for this study. a second dataset was also created, referred to as the priority list in medical devices from the perspective of trade using export-import data as available in the public table 5. priority list of medical and diagnostic devices communicable diseases communicable disease priority list of medical devices • malaria, dengue, parasitic infections like filariasis, and hookworm infestation • diarrheal diseases along with amoebiasis and cholera, and similar gastroenteritis, and typhoid • tuberculosis, and feverassociated complications like influenza and leptospirosis • jaundice and hepatitis, and similar diseases which affect the liver • sexually transmitted diseases (gonorrhea, syphilis, human immunodeficiency virus, etc.) • microscopes • rapid diagnostic test kits • antibody testing (igg and igm) kits • fecal matter examination kits • complete blood testing kits (viz. kidney function test, liver function test) • dna and protein-based test assays • devices for serological techniques and widal tests • kits for biopsy including fluid and tissue • endoscope, colonoscope, duodenoscope, and sigmoidoscope • ultrasound imaging devices • x-ray imaging devices • computed tomography scanner • magnetic resonance imaging scanner • female condom and cervical cap table 6. priority list of medical and diagnostic devices non-communicable diseases communicable disease priority list of medical devices • malaria, dengue, parasitic infections like filariasis, and hookworm infestation • diarrheal diseases along with amoebiasis and cholera, and similar gastroenteritis, and typhoid • microscopes • rapid diagnostic test kits • antibody testing (igg and igm) kits • fecal matter examination kits • complete blood testing kits (viz. kidney function test, liver function test) • dna and protein-based test assays communicable disease priority list of medical devices • tuberculosis, and feverassociated complications like influenza and leptospirosis • jaundice and hepatitis, and similar diseases which affect the liver • sexually transmitted diseases (gonorrhea, syphilis, human immunodeficiency virus, etc.) • devices for serological techniques and widal tests • kits for biopsy including fluid and tissue • endoscope, colonoscope, duodenoscope, and sigmoidoscope • ultrasound imaging devices • x-ray imaging devices • computed tomography scanner • magnetic resonance imaging scanner • female condom and cervical cap cad = coronary artery disease; ct = computed tomography; copd = chronic obstructive pulmonary disease; ecg = electrocardiogram; ihd = ischemic heart disease. table 7. priority list of medical and diagnostic devices on the disease burden context for both communicable and non-communicable diseases priority common medical and diagnostic devices • microscopes • rapid diagnostic test kits • antibody testing kits (igg and igm) • examination kits for fecal matter • complete blood tests (viz. kidney function tests, liver function tests) • dna and protein-based test assays • serological techniques and widal tests • kits for biopsy including fluid and tissue • endoscope, colonoscope, duodenoscope, and sigmoidoscope • ultrasound imaging devices and probes (including intravascular ultrasound) • x-ray imaging device • ct scanner (including heart ct scanner) • magnetic resonance imaging scanner sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy j global clinical engineering vol.2 issue 3: 2020 30 domain. this list looked at medical devices apropos their hs codes. the harmonized commodity description and coding system, also known as the harmonized system (hs) of tariff nomenclature is an internationally standardized system of names and numbers to classify traded products. the entire export and import data of categorized medical devices were tabulated as per recent import figures compared against the past few years of export (table 8). it was postulated that threshold or higher exports indicated self-dependency, higher affordability, and greater access. by opposition, the extreme or high import dependency denoted greater costs and lower accessibility. figure 2 illustrates the two types of scenarios mentioned, a and b, respectively. the consolidated high import and low export-dependent devices (driven from the illustrative scenario b) were then highlighted and tabulated into segments that required an increase or improvement in internal manufacturing capability. table 9 forms the other half of the dataset of the study from the trade perspective. further, two of the aforesaid priority lists (table 5 and table 9) were overlapped in a venn diagram format, creating an intersection area of the priority list. the outcome of this entire exercise (figure 3) was then subjected to expert discussion. the expert group included public health experts, epidemiologists, academia, research scientists, and user specialists. using the listed medical devices in the priority list that qualified expert group approval, these medical devices were mapped to their current domestic manufacturing priority common medical and diagnostic devices • female condom and cervical cap • heart monitoring devices (ecg, holter monitor, and event monitor) • echocardiogram device • nuclear stress test (radioisotope) • c-arm (for cerebral angiogram, vertebral angiogram, carotid angiogram) • stents (drug eluting for angioplasty, cerebroangioplasty) • balloon catheters (angioplasty, cerebroangioplasty) • spirometer • mechanical ventilators and accessories • nebulizers and accessories • disposable resuscitators • portable oxygen units • automatic insulin pumps • syringes with needles • sutures and surgical instruments • blood bags and accessories • portable oxygen concentrators ct = computed tomography; ecg = electrocardiogram. figure 2. diagram of the import and export data relationship in a country. scenarios a and b are depicted, as resulting in a lower medical device (md) cost and higher accessibility (scenario a) and greater md device cost and lower affordability. illustrative scenario b is the focus model of the trade data in this study. burden of disease import dependency national priority list figure 3. consolidated modeling of the priority lists from the burden of disease and trade dataset to arrive at the national priority list. 31 j global clinical engineering vol.2 issue 3: 2020 sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy capability. this was named as the priority list of health technology and was used as a key approval criterion by a public agency for providing financial support for further research. as some devices in the list could have domestic production viability for some of its components but would be completely dependent on exports for other components, it was also critical to understand which critical parts of components needed additional or focused research. to understand the key components of these technologies, two-day technology consultation was organized. this was named as “first” (formative industry leaders research institutes start-up partners technology meet) to identify essential components for focused research. the technology consultation included innovators, researchers, academia and industry, in which the shortcomings were highlighted and the technology development pathway discussed. as part of the consultative process, a list of 108 core technology components was identified. the list was then submitted to the concerned agencies within the government that provide funding for technology research. requests for proposal for these were subsequently released by the table 8. high import category of medical devices (year 2014 – 2015, reference directorate general of foreign trade, government of india) s no. hs code commodity export year 2013-14 (million usd) export year 2014-15 (million usd) import year 2013-14 (million usd) import year 2014-15 (million usd) 1 90189099 other surgical instruments and appliances (including veterinary) 59.50 56.08 235.32 246.98 2 90185090 ophthalmic surgical instrument and appliances 11.09 12.57 117.76 139.15 3 90272000 chromatographs and electrophoresis instruments 5.03 5.04 104.34 132.97 4 90181990 other electro diagnostic apparatus 83.52 68.01 89.84 93.36 5 90181300 magnetic resonance imaging apparatus 3.23 5.37 74.23 84.48 6 90181290 other electro diagnostic apparatus 30.10 83.65 68.31 80.02 7 90213100 artificial joints 0.68 1.97 63.21 78.50 8 90221200 computed tomography apparatus 0.52 0.67 70.84 65.03 9 90273010 spectrometers 1.84 2.52 71.74 59.43 10 90271000 gas analysis apparatus 4.27 11.00 46.96 58.10 11 90221490 other xray machines for medical uses 84.13 40.14 53.77 52.71 12 90189019 other diagnostic instruments 17.34 43.94 55.27 51.34 13 90223000 x-ray tubes 20.83 32.78 31.88 43.36 14 90189044 endoscopes 4.32 6.17 31.14 40.09 15 90184900 other instruments and appliances, usd in dental science 5.26 5.14 32.80 36.76 16 90189029 other surgical tools 15.86 12.94 39.35 36.31 17 90221900 apparatus based on use of x-rays, for other use including radiography/ radiotherapy apparatus 0.86 1.39 32.68 35.70 18 90183100 syringes, w/n with needles 27.02 30.06 32.92 34.06 19 90183920 cardiac catheters 1.66 4.22 33.75 32.24 20 30063000 preparation material for x-ray exams; diagnostic reagents designed to be administered to patient 8.55 7.96 23.07 23.62 sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy j global clinical engineering vol.2 issue 3: 2020 32 public funding agency under the categories established as part of priority list of medical devices for research. the categories include: (1) biochemistry, (2) immunology (3) hematology, (4) histopathology, (5) molecular biology, (6) genetics, (7) imaging, (8) catheters, (9) ultrasound, (10) neonatal equipment, (11) ventilators, (12) renal care, (13) sutures and scaffolds, (14) non-cardiac implants, (15) endoscopy, and (16) muscular dystrophy treatment. the list elaborates three distinct categories of research priorities. 1. health technologies that are not domestically engineered and add to substantial import, high economic costs, and extremely relevant clinical utility. 2. health technologies that forms solutions for diseases that have not had solutions globally, such as muscular dystrophy and their research would be of both national as well as global significance. 3. health technologies that focus on disease/clinical conditions reflective of lmics/specific geographies and whose research would not be priorities in any other geography – such as snake bites. discussion this study aimed to provide an evidence-based framework for priority setting to guide innovation in the healthcare sector. by analyzing a combined dataset of the top ten diseases that account for the most lives lost and trade impact in india, this study specifically developed a method to determine a priority list of medical devices to address both the rising burden of diseases and growing trade deficit in the medical technology sector. traditionally, the role of policy-makers has been to focus mainly on appraising technologies that are already selected by the innovators for research due to knowledge or engineering capabilities available with the innovators. therefore, the policy maker’s role has been reactive and necessarily not reflective of actual healthcare needs. this methodology allows the policy maker’s approach to shifting from being merely reactive to actively driving the agenda of technology development. to do this, it is necessary to find, based on data, what the sectoral needs for development are. to the best of our knowledge, this study is the first to develop a transparent and intuitive method to establish the national priority list of medical devices research. the results of this study are twofold. firstly, the formulation of the model can be considered a result in itself. secondly, the medical device list that resulted from the application of the model/method developed for india is another result. for the first set of findings, such as the method/model creation, it is important to consider that given its intuitive steps it can easily be adapted to other national settings, for lmic or even hics. similar models could also be applied in other contexts besides the medical device sector, after further testing, like for instance, in agriculture. in this study, a group of 10 diseases (top five communicable and top five non-communicable diseases) was selected. for other broader studies, this number can also be higher, thus resulting in different scale of results. table 9. priority list of medical and diagnostic devices from a trade deficit perspective s. no. hs code medical and diagnostic device category 1. 90272000 chromatographs and electrophoresis instruments 2. 90221200 computed tomography apparatus 3. 90221900 apparatus based on use of x-rays, for other use including radiography/ radiotherapy apparatus 4. 90273020 spectrophotometers 5. 90189011 instrument and apparatus for measuring blood pressure 6. 90183220 hollow needles for injection, aspiration, biopsy and transfusion 7. 90192010 oxygen therapy apparatus 8. 90278010 viscometers 9. 90278030 instruments and apparatus for measuring the surface or interfacial tension of liquids 10. 30062000 blood-grouping reagents 11. 90275010 photometers 12. 90275030 polarimeters 13. 90189024 surgical tools, chisels, gauges, elevators, osteotome, craniotomy, bone cutters, etc. 14. 90229020 radiation generation units 15. 90189033 hemofiltration instruments 16. 90189097 nephrostomy/lithotripsy instruments 33 j global clinical engineering vol.2 issue 3: 2020 sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy despite the high incidence of communicable diseases, non-communicable diseases account for more than half of the health crisis and are more life-threatening in nature in india.13 the comparative weight of the type of diseases (communicable versus non-communicable) could also be taken into account when developing national priorities for research. to the best of the author’s knowledge, the only comprehensive study to estimate summary measures of population health for the world, by cause, is the global burden of diseases, injuries, and risk factors (gbd) enterprise, which was updated by who for the years 2000 and who estimates were subsequently updated for the year 2004.7 later, who developed a comprehensive and consistent set of daly estimates for years 2000–2012 for population, births, all-cause deaths and specific causes of death as well as who estimates for some specific diseases and analyses carried out for the global burden of disease 2010 study. thus, using data on causes of premature death, loss of health and disability in different populations’ mortality and disability, other than a disease, would be valuable to enrich the model itself and the resulting list of priority medical devices. thus, this methodology could be further improved depending upon the contexts and breadth of the application intended. conclusion the findings of this study outline extrapolative projections for the future for population health,14 based on certain demographic and trade assumptions. we use the word assumption with measured responsibility because irrespective of the plausible uncertainty, this is only an application of epidemiological data and its convergence with macro-economic indicators. this is expected to impact a generation of indigenous manufacturing and innovation that are need-driven, market-driven, as well as highly relevant for self-reliance in the context of pandemics. in turn, such innovation policy could guide the government to make strategic resource allocation, positively impact healthcare indicators besides improving manufacturing and employment. similar models for other sectors/programs that require to be fueled by innovations is suggested for further research. governance of innovation has been influenced by very few methods and decision making is reactive to the understanding of technology at the point of product submission. such proactive methods, one described through this study, could initiate a wider dialogue on resilient innovation policy which has become so much more pressing in times where all nations simultaneously experience enormous dependencies on the import of crucial medical devices. references 1. eißel d, rokicka e, and leaman j. welfare state at risk: rising inequality in europe: springer international publishing; 2013. 2. amiri a and ventelou b. 2012 granger causality between total expenditure on health and gdp in oecd: evidence from the toda–yamamoto approach. econom lett 2012;116(3):541–44. 3. kelman cw, bass aj, holman cdj. research use of linked health data — a best practice protocol. aust n z j pub health 2007;26(3):251–55. 4. kim jy. data for better health—and to help end poverty. lancet 2012;380(9859):2055. 5. pope c and mays n. qualitative research: reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. bmj 1995;311(6996):42. 6. murray cjl and lopez ad. alternative projections of mortality and disability by cause 1990–2020: global burden of disease study. lancet 1997;349(9064):1498–504. 7. murray cjl, et al. disability-adjusted life years (dalys) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the global burden of disease study 2010. lancet 2012;380(9859):2197–23. 8. lim ss, et al. a comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990–2010: a systematic analysis for the global burden of disease study 2010. lancet 2012;380(9859):2224–60. 9. mahal a and karan ak. diffusion of medical technology: medical devices in india. exp rev med dev 2009;6(2):197–205. sharma, bunders, zuiderent-jerak, regeer: a model for priority setting in health technology innovation policy j global clinical engineering vol.2 issue 3: 2020 34 10. mahal a, varshney a and taman s. diffusion of diagnostic medical devices and policy implications for india. int j technol assess health care 2006;22(2):184–90. 11. thatte u, et al. evidence-based decision on medical technologies in asia pacific: experiences from india, malaysia, philippines, and pakistan. value health 2009;12(s3):s18–s25. 12. chakravarthi i. medical equipment industry in india: production, procurement and utilization. indian j pub health 2013;57(4):203–207. 13. kinra s, et al. sociodemographic patterning of noncommunicable disease risk factors in rural india: a cross sectional study. bmj 2010;341:c4974. 14. chan m. from new estimates to better data. lancet 2012;380(9859):2054. 39 j global clinical engineering, special issue 3, 2020 received february 2, 2020, accepted march 27, 2020, date of publication april 17, 2020 emergency relocation of a cardio-surgical health facility due to war by t. l. djankou and v. albonico st. elizabeth catholic general hospital cardiac centre, shisong, cameroon. abstract this article seeks to share our experience on the consequences of a poorly managed conflict and its impact on a healthcare institution. we further try to talk about what it takes to relocate, especially such a vital sector like cardiac surgery amid the socio-economic and socio-political context in which the hospital happens to be situated. bearing in mind that the promptness of a patient’s recovery in a healthcare facility depends immensely on how accurate the engineers were during the design and construction phase how precise international standards are implemented in the various engineering sectors of the hospital is of capital importance. following the cameroonian mindset, wherein division of labor and meritocracy are usually far fetch realities, it is therefore of prime importance to choose experienced and qualified contractors, architects, project managers to take part in the implementation of healthcare projects. the process of relocating either temporarily or permanently some health services from a crisis-stricken zone to a safer environment also demands a lot of tactfulness in decision making as well as personnel involvement. all personnel from the various sectors being relocated must work closely with the team leader such that all necessary equipment, consumables, surgical materials are put together to simplify logistics and even safeguard the logistical process. keywords – healthcare, outreach, crisis, international standards, facilities, emergency copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction the st. elizabeth catholic general hospital cardiac center shisong is a hospital founded in 1936 as a dispensary by the tertiary sisters of st. francis. the tertiary sisters of saint francis are a roman catholic religious congregation of pontifical right with motherhouse in brixen, south tyrol – italy and general administration in rome – italy. the hospital was recognized by the cameroon government in 1952. the hospital has several departments amongst which the cardiac center is our point of interest in this article. the cardiac center shisong is a state-of-the-art hospital constructed on a surface area of 12,500 m2 in a remote area of kumbo, bui division, north west region – cameroon between 2005 and 2009. it was officially inaugurated on november 19th, 2009 by the cameroon minister of public health. this was done in the presence of the italian ambassador to cameroon amongst other top-ranking personalities. following this inaugural ceremony, the cardiac center was recognized http://www.globalce.org http://globalce.org http://globalce.org djankou, albonico: emergency relocation of a cardio-surgical health facility due to war j global clinical engineering, special issue 3, 2020 40 as a national referral center for cardiovascular diseases in cameroon. on november 4th, 2015, following presidential decree № 2015/493, the cardiac center shisong was recognized as a “public utility.” this hospital is the end product of a fruitful collaboration between 3 main partners (non-governmental organization) which are: “tertiary sister of st francis” (cameroon), “bambini cardiopatici nel mondo” onlus (italy), “cuore fratello” onlus (italy). these 3 partners signed an mou in june 2010 to define management, responsibilities, and ownership of the cardiac center. responsibilities before inauguration table 1 summarizes some responsibilities of the 3 partners before inauguration. table 2 summarizes some responsibilities of the 3 partners after inauguration. the following day after the inauguration ceremony, the first cardiac surgery was performed in the new infrastructure which was very successful. presentation of cardiac center shisong health facility 1. total bed capacity is 86 with 13 intensive care unit (icu) beds included 2. an outpatient department 3. well-equipped icu 4. electrophysiology and hemodynamic (angiograph) 5. two well-equipped operating theaters in which heart surgeries can go on simultaneously 6. blood bank service 7. pharmacy and procurement 8. technical department table 1. responsibilities of the various partners before inauguration tertiary sisters of st. francis cuore fratello onlus bambini cardiopartici nel mondo onlus selection of patients to be operated upon in milan accommodation of patients and staff who travel to milan training of chosen staff staff recruitment before sending to milan for training technical assistance to site engineers carry out surgical interventions construction of new infrastructure to accommodate the new hospital provision of medical, electrical and mechanical equipment provision of some medical equipment and surgical materials management sponsorship of surgical procedures for underprivileged patients table 2. responsibilities of the various partners after inauguration tertiary sisters of st. francis cuore fratello onlus bambini cardiopartici nel mondo onlus selection of patients who cannot be operated upon in shisong due to the complexity of the surgical intervention accommodation of patients and staff who travel to milan training of chosen staff staff recruitment and management, selection of those needing supplementary training in their respective fields. organization with foreign partners for possible training technical assistance to site engineers and help desk function. connection with potential suppliers of spare parts. follow up purchase and dispatch to shisong. carry out surgical interventions in shisong. collaboration with other foreign healthcare practitioners for possible organization of pediatric surgical missions in shisong facility management of the infrastructure donation of medical, electrical and mechanical equipment donation of some medical equipment and surgical materials management of hospital activities sponsorship of surgical procedures for underprivileged patients 41 j global clinical engineering, special issue 3, 2020 djankou, albonico: emergency relocation of a cardio-surgical health facility due to war methods in november 2016, social unrest broke up in the 2 english speaking regions of cameroon (north west and south west regions). the cardiac center shisong happens to be situated in one of these regions that is the north west region. the crisis which initially started as a non-violent protest in which teachers and lawyers were demanding reforms of the educational and judicial sector, and were molested and chased from the streets. some youths took upon themselves to retaliate and fight for their rights, a situation which transformed into violent and deadly confrontations. from thence, an extremist part of the population became radicalized and transformed the protest into a fight for independence (cessation). the number of extremists grew and we started to observe a wide proliferation of arms of all sorts. there was chaos all over the anglophone regions as the confrontation between separatist fighters and the military became deadlier, leading to the massive internal displacement of citizens. it was after the october 7th, 2018 presidential election that the confrontations gained grounds generally speaking (although some localities had already experienced severe and deadly confrontations). people fled from their homes into bushes with the hope of returning after a few days. they then fled from their hideouts into neighboring villages until some found themselves in neighboring countries while others settled in the french-speaking regions of the country. this situation forced many companies and hospitals to shut down. some were even reduced to ashes. the cardiac center shisong, fortunately, was not reduced to ashes but suffered from a long period of inactivity. some patients who were hospitalized just before the situation aggravated were stranded and couldn’t return to their homes and some patients who had been booked for cardiac surgeries ended up dying. due to the low patient turnouts, the hospital administration was forced to send about 75% of staff on technical leave. activities performed by the center before october 7th, 2018 table 3 shows medical activities performed between november 2009 and october 2018. some technical facilities found at the cardiac center shisong table 4 groups some of the biomedical, electrical and mechanical equipment found in the hospital. table 3. various activities performed over 10 years activity number consultations 74,655 echocardiograms 24,000 diagnostic and interventional catheterization 515 cardiac pacemaker 185 open-heart surgeries 769 table 4. various activities performed over 10 years designation quantity electricity generators (700 kva, 900 a, 3 phases) 2 voltage stabilizer (650kva, 3phases, regulates between −35% and +15% of nominal voltage) 1 voltage transformers 10kv–400v (630 kva 3 phases) 2 vacuum pumps for centralized suctioning (7 kw) 3 medical oxygen production plant (6m3/h) 1 syringe pumps 30 infusion pumps 25 patient ventilators 8 multi-parameter patient monitors 18 anesthetic machines 4 coagulation analyzers 3 blood gas analyzers 4 chemistry analyzer 1 portable ultrasound machines 3 mobile ultrasound machines 2 defibrillators 5 surgeon’s headlamp 1 auto-transfusion pumps 2 intra-aortic balloon pump 1 heating/cooling machines 5 air compressors (11 kw, 3 phase, 108 m3/h) 3 djankou, albonico: emergency relocation of a cardio-surgical health facility due to war j global clinical engineering, special issue 3, 2020 42 some impacts of the crisis on the cardiac center 1. the growing cost of preventive maintenance due to prolonged shutdown of equipment. 2. worries about the state of equipment containing internal batteries which had not been charged. 3. a long blackout period or lack of electricity leading to the possible deterioration of rechargeable batteries in equipment. in the event of a fault on the grid, workers from the electricity supply company would not be able to intervene unless a period of ceasefire was announced. 4. increased expenditure on fuel for the electricity generators. 5. travelling for distances of about 100 km during violent confrontations in search of fuel for electricity generators. this led to the rationing of the electricity supply. in a bid to economize fuel, the electricity generator would work for only 4 hours a day. 6. a growing number of patients on the waiting list needing prompt surgical interventions. 7. expiration of drugs, surgical materials, valves, patches, and other consumables. 8. loss of manual dexterity of the personnel due to the long period of technical leave. it was following some of these points that studies were made to create an outreach program for the cardio-surgical unit of the hospital in a safer city. the challenges were numerous for this project to go operational and we had to keep in mind that not all pieces of machinery were to be transferred out from the cardiac center as surgical activities could resume in the cardiac center whenever the crisis was resolved. there was a lot of discussion mostly between the surgeon and the technical coordinator seeking the most appropriate model of implantation to be adopted. our first worry was the city in which we were to settle in. we had to choose between yaounde, douala, and bafoussam. the criteria which guided our choice of city were: 1. the climatic condition of the city (temperature and humidity). 2. level of pollution. 3. population density. 4. security and safety in association with urban disorder. after carefully deliberating on these points, we realized that yaounde, the capital of cameroon, was the most suitable. we were convinced that our proximity to decision-makers (ministries, insurance companies, and non-governmental organizations) could increase our chances of integration and reaffirming our place in the healthcare sector. the next challenging task was to find either an appropriate piece of land to construct new facilities to accommodate the services or to collaborate with an existing hospital or clinic. due to the unavailability of enough funds, the second option was chosen to raise another problem of which hospital to work with. this was very challenging knowing that we were to choose among close to 20 renowned government, private, and confessional hospitals. 1. criteria for choosing a partnering hospital 2. the close proximity to the center of the city. 3. an institution with lesser administrative latency. 4. an institution with similar religious perspectives. 5. an institution who puts patients’ recovery as the main priority. 6. an institution with similar hygienic standards. designation quantity sternum saws 2 electrosurgical units 4 weighing scales 3 measuring tapes 3 blood warmers 3 drug refrigerators 6 extracorporeal circulation machines siii 2 mobile suction machine 1 infusion stands 20 drug trolleys 15 electrocardiograph machines 2 transesophageal probe 1 oxygen flow meters 45 negatoscopes 15 patient’s bedside tables 48 43 j global clinical engineering, special issue 3, 2020 djankou, albonico: emergency relocation of a cardio-surgical health facility due to war 7. an institution in which workers and administrators are completely apolitical. after visiting several health institutions both state and privately owned, our choice was made on a private clinic considering the above-mentioned criteria. it should be noted that cardiac center shisong is the only center in central african sub-region where routine open-heart surgeries are performed. we have in cameroon, the douala general hospital who also does open-heart surgeries, but patients are grouped and wait for foreign specialists to come once or twice a year for surgeries. we had several challenges to kick-start activities in the chosen healthcare institution and we expected to meet these challenges knowing that hospitals not performing such levels of surgical interventions would not invest in upgrading facilities. challenges encountered hindering the smooth take off of surgeries in the chosen clinic 1. there were 2 split-type air conditioners in the operating theater. contrary to the conventional air-handling units with high-level filter management of air pressure in the rooms, we had a completely closed operating theater with no possibility of renewing the air. among the 2 air conditioners, none was cooling to our satisfaction. 2. there was only 2 outlets for oxygen in the theater. the operating theater had no anesthetic pendant nor enough outlets for medical oxygen. we needed at least 3 outlets for our machines. 3. piping for medical air in the operating theater was absent. medical air (air containing 21% oxygen) is needed by the anesthetic machine and heart-lung machine. 4. there was an absence of piping for the anesthetic gas scavenging system in the operating theater. 5. only 3 electrical sockets were present in the operating theater. mindful of the number of appliances connected during heart surgeries and even general surgeries to a lesser extent, it was unworkable to have only 3 electrical sockets. we also noticed electricity distributors were being used with little knowledge about their electrical rating. 6. there was the presence of a very tight and poorly ventilated 2-bed icu. we also had a slit-type air conditioner with no possibility of air renewal. 7. there was a poor disposition of oxygen cylinders and supply networks. the health facility was supplied with medical oxygen from a two-cylinder ramp. knowing very well the role and importance of oxygen in heart surgery and hospitals with emergency units, we wondered how the patients survive during the process of replacing empty cylinders. furthermore, the distribution network was composed of only one pressure reducer situated beside the ramp. it was reducing the pressure from 145 bar to 4.5 bar. meaning that there wasn’t any second stage reduction. 8. a centralized vacuum system was absent. we found only 3 mobile suction machines available in the hospital. 9. a medical gas alarm system was absent. we witnessed instances where oxygen ran out and no one knew about it. with all these challenges in mind, discussions were scheduled with the ceo of the clinic. the aim is to present all the listed challenges hindering a smooth take-off and to propose recommendations according to international standards which would be taken into consideration while upgrading the facility. bearing in mind the complexity of the task and huge financial constraints involved and the fact that all investments were to be borne by the ceo of the clinic alone, we were obliged to reshape or soften our recommendations while still trying to align with international standards. recommendations to be implemented while upgrading the healthcare facility to accommodate the cardio-surgical service 1. due to financial constraints, we asked that the air conditioners in the operating theater be repaired and cleaned rather than purchasing an air-handling unit. this issue was to be reviewed after the first year of collaboration. 2. more oxygen sockets were to be added to the operating theater. 3. installation of new pipeline for medical air in the operating theater. 4. installation of piping and scavenging system for anesthetic gas from the machine in the operating theater. 5. to foster a continuous supply of oxygen to the hospital, we recommended the installation of at least 2 ramps with 2 cylinders each, having an automatic switchover djankou, albonico: emergency relocation of a cardio-surgical health facility due to war j global clinical engineering, special issue 3, 2020 44 between both ramps. this new system should be linked to a medical gas alarm system to indicate ramp discharge, low, and high pressures. we also asked that a second stage pressure reducer be installed. 6. the purchase of more mobile suction machines to serve in the operating theater as well as in the icu. 7. owing to the very limited space in the existing icu, we asked for a new location to be provided. the ceo instead promised to construct a new building to accommodate the icu as he was about to embark on an extension project of his clinic. 8. increase the number of electrical sockets in the operating theater and reevaluate the power rating of the ups to make sure that it matches our demand of 15 kva. 9. review of the earthing system. recommendations for the implementation during the construction of the new icu the icu was to be constructed on a 35-square meter piece of land (7 m length and 5 m width). after careful analyses, we decided to design the room such that it could contain 3 adult patients’ beds and 2 infants’ or neonates’ beds with warmers for a total of 5 head beds altogether. 1. each bed should have 12 electrical sockets. all sockets including those in the operating theater were to be protected following the nfc 15 – 100. more specifically, the earthing system was to be the it system. 2. the installation of 2 oxygen sockets per bed and one socket of medical air per bed. 3. the installation of rails on the wall for hanging medical fixtures and equipment. 4. the installation of an air-handling unit comprising recommended levels of air filtration (f5, f6, f9, and absolute filter) including the management of room pressure, temperature, and humidity. 5. the provision of a sluice room. 6. the installation of 2 small drawers on the wall for each bed. 7. the installation of a washbasin with a tap that has a lever mechanism or pir sensor. limitation observed in the construction of the icu after handing over the recommendations for the construction of the icu to the hospital’s ceo and project coordinator, we were told that the entrepreneur was up to the task and would deliver the goods based on the recommendations. one month after the kick-off of the project, a site visit was scheduled to understand the level of progress and to validate the implementation of our recommendations. to our greatest dismay, we had the following lapses which were immediately corrected while some other lapses were discovered in the course of using the facility. 1. there was a small number of electrical sockets (4) installed per patient bed contrary to the recommendations. 2. there was no provision for a sluice room. nurses were asked to move completely out of the zone housing the icu to empty waste. 3. there was a poor installation of water collectors on the roof. during rainfall, some walls were completely soaked leading to the proliferation of fungal growth. 4. there was poor anchorage of bedside cupboard/ drawer on the wall which broke when syringe pumps or patient monitors were placed on them. 5. there was the poor demarcation of sterile zones, hence communication of construction site with the icu. 6. there was the poor implementation of the oxygen distribution system which lead to frequent ruptures in the oxygen supply to the various services. 7. contrary to requests, a split-type air conditioner was installed in the icu. challenges or limitations to a smooth take off for the cardiac center while working closely with the partnering clinic, we faced many challenges that could equally delay if not addressed, the smooth take-off of surgical activities. they were: 1. the means of transporting required equipment, medications and consumables from shisong to yaounde amid the prevailing crisis. many truck drivers were reluctant to travel to the area for fear of being killed or seeing their vehicle burned. 2. regrouping all displaced workers who were to take part in the outreach activity. 45 j global clinical engineering, special issue 3, 2020 djankou, albonico: emergency relocation of a cardio-surgical health facility due to war 3. compilation of a list of needs (consumables, materials, and equipment) from the various sectors involved in heart surgery. 4. negotiating and obtaining a balanced mou between both institutions. 5. discussion by the cardiac center administrator with staff to arrive at an optimum working condition in yaounde. 6. the main technical coordinator, not being in shisong, found a lot of difficulties in selecting medical equipment, spare parts, packaging, labelling, and transporting out of the hospital for onward transmission to yaounde. 7. establishing a list of medications and surgical consumables based on a predefined list of pathologies to be handled. infrastructure available for the outreach activity 1. bed capacity: • icu = 3 adult and 2 infant beds. • pre-surgical ward = 2 beds. • post-surgical ward = 2 beds. 2. an operating theater. 3. an office for pre-surgical consultation and post-surgical follow up. 4. due to limited space in the hospital, the room for magnetic resonance imaging was used as an extended storage facility. 5. the point of care was performed in the icu. 6. the blood bank hosted by the clinic. the clinic’s laboratory was responsible for all tests.list of different personnel chosen to take part in the outreach program some of the personnel chosen to take part in the outreach program are detailed in table 5. table 5. personnel chosen to take part in the outreach program designation number administrator 1 cardiac surgeon 1 list of medical equipment, fixtures, and other appliances successfully transferred from shisong to yaounde table 6 lists some of the equipment taken for the outreach program. anesthesiologist 2 cardiologist 1 pharmacist 1 biomedical engineer 1 icu nurse 6 perfusionist 2 table 6. equipment taken for the outreach program designation quantity syringe pumps 16 infusion pumps 15 patient ventilator 3 multi-parameter patient monitor 9 anesthetic machine 1 coagulation analyzer 1 blood gas analyzer 1 chemistry analyzer 1 portable ultrasound machine 2 defibrillator 2 surgeon’s headlamp 1 auto-transfusion machine 1 heating/cooling machine 1 air compressor 1 sternum saw 2 electrosurgical unit 2 weighing scale 1 measuring tape 1 blood warmer 1 drug fridge 2 extracorporeal circulation machine siii 1 extracorporeal circulation machine s5 1 djankou, albonico: emergency relocation of a cardio-surgical health facility due to war j global clinical engineering, special issue 3, 2020 46 timeline of activities table 7 presents a visual timeline of activities leading to relocation or creation of outreach. designation quantity mobile suction machine 4 infusion stand 6 drug trolley 4 electrocardiograph 2 transesophageal probe 1 oxygen flow meter 5 negatoscope 1 patient’s bedside table 3 table 7. timeline date activities october november 21st, 2016 anglophone lawyers and teachers began protesting. gradual transformation of peaceful protest into violent confrontations after this date. september 20th, – october 14th, 2018 separatists groups ordered the complete lockdown of both north west and south west region in view of upcoming campaigns for the presidential election, including the day of elections and postelectoral activities. october – november 7th, 2018 discussions and underground works between the cardiac surgeon and technical coordinator concerning the possibilities of reviving surgical activities in a safer location. november 17th, 2018 after sharing our thoughts with the hospital administrator, we performed the first site visit to the health facility which was our first choice. november 20th, 2018 sharing of an elaborated report of the visit with the cardiac center administration and cardiac surgeon. this report brought forward the state of the partnering healthcare facility, improvements to be made in the facility, how long it would take to upgrade before the kick-off of cardiac surgeries and the list of equipment not available within the healthcare facility but needed to be transported from shisong. the target is begin surgeries within the second week of january 2019. november 20th, – december 12th, 2018 review of upgrading tasks to be accomplished at the jordan medical services, review of the hospital’s layout to understand and reorganize work flow. proposal of a second healthcare facility as second choice. sharing of idea to relocate with the several partners of the cardiac center shisong including the cameroon ministry of public health. december 12th, 2018 second visit to our first choice partnering institution to see the level of work progress, organized meetings with the contractors responsible for executing the recommendations given the constructing a new icu block. equally paid a first and second site visits to a healthcare institution which was our second choice and was equally under renovation and restructuring. november 2018 – january 2019 sharing of an idea to relocate with the several partners of the cardiac center shisong including the cameroon ministry of public health. december 29th, 2018 discussions after sharing reports of the last interventions. a decision was taken to collaborate with the jordan medical services. upgrading work was to last for 5 months. january – february 2019 prepared the list of various equipment, accessories, spare parts, and consumables to be transported from cardiac center shisong to yaounde. march 2019 third site visit to the clinic to follow up on the work progress and implementation of recommendations. in the course of the evaluation meeting, there was a change of location for the icu. a new building was being erected to serve this purpose, more recommendations were given for this icu block. commissioning scheduled for mid-may. preparation of storage space to safely pack all materials and equipment from shisong. investigations to understand the best moment to transport materials safely out of the hospital in shisong. march 2019 holding of technical committee meeting (hospital’s board of directors) to designate management and to elaborate a model/ draft of the mou between both healthcare facilities. march – april 2019 dismounting, packaging, and transportation of listed equipment, accessories, spare parts, medical as well as technical consumables, drugs, and surgical materials to bamenda using an ambulance before onward transmission to yaounde given that there were more security threats on the stretch of road kumbo – bamenda than bamenda – yaounde. mid april 2019 after grouping close to 95% of the materials in bamenda, we organized and transported them to the clinic in yaounde. received them in yaounde and packed in the already previewed storage space. april 27th, – may 8th, 2019 commissioning of the new icu and upgraded operating theater amid some adjustments and finishing touches to be made. reception of remaining materials required to complete the list of items used to perform cardio-surgical activities. unpacking, assembling, cleaning and testing of all equipment before sending them to their various locations. may 18th, – june 6th, 2019 signing of an mou and the kick-off of first surgical mission with a total of 9 patients with cardiomyopathies operated upon. 47 j global clinical engineering, special issue 3, 2020 djankou, albonico: emergency relocation of a cardio-surgical health facility due to war recommendations 1. diversification of production units is of key importance. this means that for a given healthcare institution performing open-heart surgeries, it won’t be good to concentrate all investments in one city or town. they should divide the investment and implant of another healthcare unit in another town. also recommended in bilingual countries like cameroon or countries with 2 distinct groups of people or races, not locating both structures in the towns belonging to the same group of people or race. 2. when the relocating health facility is discussing with the partnering hospital, it will be good to take part in sharing the cost of renovation or upgrading work if any. this is because the partnering hospital may not have enough funds to put in place all the facilities necessary to carry out safe surgical interventions according to international standards or may simply be ignorant about international standards and by so doing not see the need to invest and implement all recommendations. to this effect, the relocating hospital once made aware of the importance of having all recommendations implemented, may decide to assist financially and later include in the mou the terms to recover the investment. 3. the neutrality of the hospital trying to relocate must be made known to all conflicting parties or the different groups of activists engaged in the war. this neutral position is very important to the safety of materials when transporting them out of the war zone. 4. before organizing any transport activity in the war zone, a good investigation must be carried out to understand the safest periods. this is to avoid being caught up in a cross fire during transportation leading to death or destruction of goods. 5. the implementation of the heads all of units involved in heart surgery for instance will go a long way to avoid forgetting important materials needed during the process knowing that transportation within the crisis hit zone becomes risky. 6. while planning and organizing the workflow in a chosen healthcare facility, emphasis must equally be paid on the reduction to near zero the transmission of nosocomial infections. this is because, a surgical procedure can be performed perfectly with the required instruments, equipment, and consumables, but because attention was not paid to the sterility of instruments and air, the patient, later on, develops severe complications or bacterial infections. this situation may couple with the patient’s long stay in the icu to produce bed sores aggravating the condition and even leading to death. 7. for those who want to relocate to a city where stable electrical supply is still a farfetched reality, care must be taken so that uninterruptible power supplies are installed, stand-by electricity generators installed, and a proper grounding system implemented. 8. the availability of enough medical oxygen for continuous activities is also very important knowing that the life of a cardiac patient in the operating theater and icu depends primarily on it. 9. when both institutions meet to discuss the model of partnership, it is advisable to strive at maintaining autonomy in management. that is, personnel management, medical supplies, and billing must remain under the control and supervision of the visiting hospital or relocated healthcare institution. 10. for none profit-making healthcare institutions, a frank and sincere discussion should be held with all potential benefactors including the government for possible sponsorship. this assistance can go a long way to even acquire new or refurbished machines which cannot be easily displaced from the crisis-hit zone like an angiograph or computed tomography scanner. these are vital and supportive equipment used for pre-surgical diagnosis of the coronaries for instance, (in most aging patients above 45 years or younger patients presenting a higher risk factor of having coronary stenosis). also, the angiograph can also be used in correcting some cardiopathies within the scope of minimally invasive procedures. if these discussions held before starting upgrading or renovating works, the problem of limited space can be handled by transforming the operating theater into a hybrid operating room. results a glance through the results obtained after the creation of the outreach program may not be very encouraging vis-à-vis our capacity, but for those patients who survived through the period during which we were inactive, it is a success (table 8). irrespective of the several limitations encountered along the line with the construction of an icu djankou, albonico: emergency relocation of a cardio-surgical health facility due to war j global clinical engineering, special issue 3, 2020 48 within a short time, the threats to burn down equipment and consumables during their transportation out of the crisis-hit zone, we were able to perform successful open surgeries. the creating of this outreach program has given hope to some cameroonians and beyond for a better life and health condition. table 8. achievement over 10 months surgical missions periods number of surgeries first surgical mission may 18th – june 2nd 2019 9 second surgical mission july 16th – 28th 2019 8 third surgical mission september 23rd – october 8th 2019 8 fourth surgical mission november 12th – 18th 2019 5 fifth surgical mission december 6th – 15th 2019 7 sixth surgical mission january 17th – february 4th 2020 7 total 44 figure 1 & 2. the staff at work in the operating theater during open-heart surgery. figure 3 & 4. staff at work in the icu. discussion after the kick-off of surgical activities, notwithstanding the successes recorded, the technical department continued working hand-in-glove with the different sectors involved trying to know their level of satisfaction. we also sought to know those areas which needed improvement either by adding equipment to ameliorate working conditions or speeding up patients’ recovery. in this line we were able to change the noisier and space-consuming mobile vacuum/suction pumps to a miniature less noisy, wall-mounted vacuum regulator using compressed air to generate a negative pressure (venturi effect). although while implementing this solution we created another problem (that of increase in the demand of compressed air), we have been working on possible fundraising to purchase a bigger air compressor to cover the entire needs during surgical missions. 49 j global clinical engineering, special issue 3, 2020 djankou, albonico: emergency relocation of a cardio-surgical health facility due to war the absence of an air-handling unit in both the operating theater and icu has been one of our major setbacks in patient recovery and infection control. to that effect, while seeking funds to handle this issue, we intensified the use of an antiseptic spray for in-depth sterilization and antiseptic solution for cleaning of surfaces. conclusion the prompt and speedy recovery of patients after heart surgery are the driving forces that keep energizing medical and paramedical personnel to continue working harder to attain better results. these driving forces are also responsible for the quest to brainstorm and come up with lasting solutions which when implemented per international standards would step up the level of healthcare offered in the outreach setting. mindful of the fact that the term outreach here does not mean working at the minimum level prescribed by standards, we are determined to put more efforts such that surgeries shall be performed under safer conditions and that the right health technologies are utilized. the hospital administration is working closely with some benefactors who have opted to offer some equipment in a bit to meet up with the standard working conditions and patients’ safety. we are also determined to work closely with all parties concerned if asked to do so, towards the resolution of the pending conflict which has dispersed a majority of patients who were already living in a precarious situation before the escalation of peaceful protest into armed conflict. bibliography 1. cardiac center management team. cardiac center shisong development plan 2018 – 2022, november 2017. 2. shikder s and price a. design and decision making to improve healthcare infrastructure. longborough, uk: school of civil and building engineering loughborough university; 2011. 3. o’neill t (editor). technical design requirements for health care facilities, “the blue book” second edition. edmonton, canada: infrastructure alberta; september 2005. available at: http://www.infrastructure.alberta.ca/ content/doctype486/production/bluebook-2005.pdf j global clinical engineering issue 2, 2019 editor’s corner in today’s digital communications, institutions and individuals alike are taking extra efforts to protect the confidentiality and privacy of their records. this behavior, however, is not restricted to the digital era. well before the arrival of what we now know as digital communications, existed the era of analog communications. the desire to conceal or to cipher records became globally notorious from the electro-mechanical enigma cipher machine. its unique code system is illustrated on the cover page of this issue. developed at the end of world war i, and commercialized in the early 1920s, it was adopted by military and government services – most notably, those of nazi germany before and during world war ii (https:// www.cryptomuseum.com/crypto/enigma/hist.htm). upon the release of the 2014 oscar-nominated film, the imitation game, our society became familiar with the name and work of the brilliant mathematician, alan turing. alan cracked the enigma code at the beginning of world war ii (https://www.iwm.org.uk/history/ how-alan-turing-cracked-the-enigma-code) and helped decipher the military codes used by germany and its allies. his impact on computer science has been widely acknowledged and revered. throughout the ages, our society has gone to great lengths to protect certain records. on the contrary, here at the global clinical engineering journal, we aim to collect and share records and information by publishing them, and broadcasting this knowledge to all four corners of the healthcare world. for a long time now, i have heard clinical engineers express that they feel underrepresented. in some way we countered that, by establishing the american college of clinical engineering association (https://accenet. org); and by reviving the ifmbe/ced (http://cedglobal. org). after that, several people mentioned the need for a clinical engineering recognition/awards program… and now we have a program to do it (http://cedglobal. org/awards). following that, others voiced their opinion about our field lacking focused general conference…and now we have a very successful international clinical engineering and health technology management congress (http://www.icehtmc.com). last but not least, we have now also the newly created global ce journal https:// www.globalce.org. it is the duty of clinical engineers all over the world to improve patient care, and one effective way to move toward that goal is by publishing quality manuscripts that teach, increase the visibility, and contributions of our professional practice. a recent international survey by who suggests that there are more than 800,000 practitioners in our field. but where are the submissions? contrary to the enigma machine, the global clinical engineering editorial board and myself intend to initiate workshops and training to teach clinical engineers how to write papers that will be successfully reviewed and published – hopefully in our global clinical engineering journal. let’s open up pathways to information, encourage authors to submit, and dissolve one of clinical engineering’s disreputable attributes: being fearful of publishing. help me to break that cycle by deciphering and sharing the knowledge our clinical engineers have to offer! together we will make it the best it can be! dr. yadin david 1 j global clinical engineering vol.2 issue 2, 2019 editor’s corner would you like to know the health state of your brain? have you ever assessed your intelligence quotient (iq)? soon, in addition to measuring your iq we will also be able to determine your brain’s health with quantification just like those used in the assignment of iq levels. this depends to a large extent on how many resources, including clinical engineers, will focus on the research about the intricacies of the human brain. in the book “the tell-tale brain,” a new york times bestseller, ramachandran, director of the center for brain and cognition at the university of california in san diego investigates the working of the mind through malfunctions of the brain. he states that in the 50s we were able to decipher the human genetic code, but by comparison, the science of the mind languishes and that, for most of the 20th-century neuroscience, was still young upstart. “as heady as our progress has been, …we have only discovered a tiny fraction of what there is to know about the human brain.” to help initiate, last october, the celebration of the 2019 global clinical engineering day, i invited distinguished faculty members to share with me in the program hosted in china. recognized experts such as tobey clark from the university of vermont, ilir kullolli from stanford/children’s hospital and currently acce president, dr. kallirroi stavrianou from warwick university in the uk, and dr. howard derman, a neurologist chief of the concussion center at the methodist hospital in houston, texas. each member of the faculty shared their unique expertise, and all were received with roaring success https://www.youtube.com/watch?time_continue=16&v=yq1duslsfvq&feature=emb_logo. it was a perfect set-up for the initiation of the global celebration recognizing all that clinical engineers do every day around the world to better patient care outcomes! specifically, i wanted to include physician/neurologist to our global clinical engineering program because not too many clinical engineers know of the specific neurology based challenges healthcare practitioners face in the management of brain conditions. dr. derman did an excellent job of connecting a wide spectrum of clinical needs with expectation that future technological tools will meet. over years of working with neurology based researchers, i personally observed how much they struggled to overcome the inability to quantify changes in the health state of the brain when they were faced with the challenge of managing or diagnosing brain injury, trauma, or diseases. in several studies, where i joined as a clinical engineer with a team that included pediatric neurologists and other scientists, we all experienced firsthand the difficulty of developing and applying experimental technological tools to diagnose and quantify brain functions. not only such instrumentation was rare but more often the interpretation of the results produced by these tools set a new frontier for wide interpretation of new brain mapping data. these studies included instruments such as near-infrared spectroscopy to measure cerebral blood flow (“correlation of near infrared spectroscopy cerebral blood flow estimations and microsphere quantitations in newborn piglets” https://www.karger. com/article/abstract/14056), and scalp temperature sensors that measured and correlated with predicted brain decay (“rectal-scalp temperature difference predicts brain death in children, pediatric neurology april 1999; 20(4);267–9) https://www.academia. edu/6751649/rectal-scalp_temperature_difference_predicts_brain_death_in_children, and cortical electrodes in “computer-controlled electrical stimulation for quantitative mapping of human cortical function,” https:// www.ncbi.nlm.nih.gov/pubmed/19061348. http://www.globalce.org http://www.globalce.org https://www.youtube.com/watch?time_continue=16&v=yq1duslsfvq&feature=emb_logo. https://www.youtube.com/watch?time_continue=16&v=yq1duslsfvq&feature=emb_logo. https://www.karger.com/article/abstract/14056 https://www.karger.com/article/abstract/14056 https://www.academia.edu/6751649/rectal https://www.academia.edu/6751649/rectal https://www.ncbi.nlm.nih.gov/pubmed/19061348 https://www.ncbi.nlm.nih.gov/pubmed/19061348 j global clinical engineering vol.2 issue 2, 2019 2 the pharmaceutical field is in a similar situation. the cover story in the scientist, december 2019, “markers of alzheimer’s,” michelle mielke, a neurologist at the mayo clinic in rochester, minnesota, who studies cognitive decline states, “at this point, i do not think we have the best idea in term of what biomarker is exactly going to be used for what”. essentially suggesting that pharmaceutical industry and the technological solutions are at the same situation. however, dr. derman’s presentation directed at clinical engineers described the physiology of injured brain following with observed symptoms from such injuries suffered in combat, motorbike accident, or during contact sport. his message was that engineers need to focus on solving how to equip healthcare providers with tools that help form a quantified diagnosis so that they can know how to better manage the patient condition/progress. as reported in a study by geriatrician sharon inouye at hebrew seniorlife and harvard medical school “20–30% of patients over the age of 70 who have a major surgery will experience delirium that is associated with longterm cognitive decline and increased risk for developing alzheimer’s disease.” again, still a non-quantified condition. (wall street journal, december 10, 2019, page a12). improving the arrival at the correct diagnosis is a key aspect of good health care. it provides an explanation of a patient’s health problem and informs proper subsequent health care decisions, states the institute of medicine’s report, september 2015, on “improving diagnosis in health care.” one way to achieve that is through closer collaboration between clinical engineers, physicians and researchers to guide and enable the focusing of technological innovation on addressing challenges not only in neurology but in every medical/surgical and rehabilitation discipline. it is important to insert scientific exchanges such as dr. derman’s presentation within clinical engineering meetings and this journal will continue to facilitate that as reflected by the membership of the global clinical engineering journal editorial board. having neurologist, orthopedic surgeon and anesthesiologist reviewing submissions together with clinical engineers. what do you think can increase clinical engineers’ participation in finding and evaluating tools to quantify the health status of our brains? together we can do it better and i amlooking forward to your feedback! dr. yadin david copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org j global clinical engineering vol.2 issue 3: 2020 4 received april 2, 2019, accepted april 14, 2020, date of publication may 2, 2020 proposed calibration of apheresis equipment by a. a. dos santos1, m. a. marciano2 and r. l. rezer1 1 hospital moinhos de vento/clinical engineering, porto alegre, brazil 2 hospital moinhos de vento/ clinical and hospital engineering, porto alegre, brazil abstract the health establishment is currently developing quality control through the calibration of biomedical equipment, systematically and comprehensively throughout the wide range of available hospital technology. thus, this work aims to propose and demonstrate a method of qualifying apheresis equipment through equipment calibration before releasing it for first-time use. results show the values obtained in calibration of apheresis equipment, relating to the mnc protocol (removal of mononuclear cells), the pressure of access, and return pressure. keywords – qualification of incorporation, biomedical equipment, calibration of apheresis machines. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction among the human pathologies are hematological diseases, immunodeficiency, genetic diseases and some tumors such as from breast cancer. one of the available treatments is donor (autologous) and donor (allogeneic) donor transplantation of peripheral blood progenitor cells. these cells, classified as cd34 +, have a high capacity for self-renewal and proliferative potential, which makes it possible to differentiate them into progenitor cells from all blood strains and to reconstitute the population from a single cell hematopoietic. also called a blood stem cell. they comprise 0.05% to 0.1% of circulating human bone marrow hematopoietic cells.1,2 for collection and treatment in this invasive and safe procedure, a cell separator, called the apheresis machine, is used, which in greek means separation. apheresis therapy is the removal of one or more components of a person's whole blood. one of the most important steps in the process is the introduction of a sufficient amount of anticoagulant sufficient to prevent blood components from clotting or clumping together when they are processed through the apheresis device. the anticoagulant flow rate cannot be high, to avoid adverse reactions in the donor/patient. depending on the amount of anticoagulant returned, you can generate physical symptoms such as tingling in the extremities until the potential damage to the donor/ patient.3 the apheresis equipment can be used to remove plasma (plasmapheresis), leukocytes (leukapheresis/ lymphocyteapheresis), platelets (thrombocyte-apheresis centre) or the red cells (erythrocyte apheresis).4 the apheresis machine performs the separation of peripheral blood and blood products through a technology that utilizes centrifugal effect forces. cells with higher densities are targeted at specific layers, where they can be identified and collected by a cardiopulmonary bypass induced by the equipment itself. the basic steps of apheresis, are the removal of whole blood from a donor http://www.globalce.org http://globalce.org http://globalce.org 5 j global clinical engineering vol.2 issue3: 2020 santos, marciano and rezer: proposed calibration of apheresis equipment or patient, separating blood components, plasma retention, or one of its cellular components and returning the remaining elements to the donor or patient.5 the principle of operation of this equipment is shown in figures 1a and 1b.6 these centrifugal forces act on only a small portion of the blood, causing the separation of blood elements, called apheresis. after the end of the cycle, which takes around three to five hours, the desired component is directed into a collection bag. the apheresis machine procedure is initiated by a physician who performs the programming of the parameters based on the mononuclear cells removalmnc protocol. (the protocol's calculation is based on the amount of hematocrit collected from autologous or allogeneic donator, on the day of the procedure.7) the physician keeps up with the process and monitors the physical state of the patient. the physician inputs the age, sex, and weight of the patient or donor and also assesses the need to change the length time or flow rate. at the end of processing, it is possible to collect the plasma cells, platelets, lymphocytes, granulocyte, and erythrocyte as needed. figure 2 demonstrates the specific blood cell densities.8 considering the given relevance, criticality, and care necessary in the method of separation of cells by apheresis, we need to understand how testing with this equipment is performed. when evaluating the methods of certification effectiveness of operating and the results of the procedure performed by the apheresis machine, it was verified that an item of brazilian resolution number 57,9 called calibration is not necessarily being performed in a systematized way. this evaluation was done with the manufacturer of the equipment, specialists, and general research. it is critical to confirm the proper functioning of apheresis equipment using calibration, before releasing use throughout the course of its lifecycle. this paper aims to propose and demonstrate a method of accomplishing the qualification of apheresis equipment through calibration, in addition to the usual quantitative testing, before it is released for use. method search during this process, we checked for quality control regulations for this equipment and standards relevant to its use. it was requested for the equipment manufacturer to provide the operating limits and tolerances of pressure and volume measured parameters as well as procedures to confirm conformity of post-factory output specification. it was verified in article 11 of the brazilian resolution 57/2010 that "the hematology services must have compatible equipment activities and establish a program that includes initial validation, qualification, calibration, preventive and corrective maintenance of equipment and instruments, keeping their schedules and records." when evaluating the methods of certification effectiveness for operation and results of the machine, it was found that the method used is often a six-month check to compare technical specifications to actual physical parameters. the parameters evaluated are those relating to access pressure, back pressure, pressure leaks, pressure sensors, rotation of centrifugal, circulation pumps, red sensor, and the digital conversion of these parameters. according to information from the medical care specialists in the subject, normally the form of verification of the performance of the machine is the analysis of figure 1. apheresis circuit. figure 2. demonstration of specific cell densities. santos, marciano and rezer: proposed calibration of apheresis equipment j global clinical engineering vol.2 issue 3: 2020 6 the count of the blood products and blood products of patients, post-procedure. in this case, when the quality of processing is not adequate, there is a need to inform the patient of the need to perform a new procedure and consequently expose themselves again. figure 3 has the flow method, with job steps. figure 3 shows the proposed inclusion of equipment calibration step as a way to raise the level of confidence of apheresis. results calibration planning a qualified company was hired to perform the calibration which evaluated the uncertainties involved and the standard deviations. this was done in conjunction with hospital technicians who assisted in this activity by providing access to the service equipment. the following parameters were evaluated: pressure (mmhg), back pressure (mmhg), and protocol mnc in volume (ml). the calibration method for measuring the volume was to measure the volume by weighing the liquid by time. for pressure measurement was performed compared to the default. the materials used for calibration were: digital scale, digital timer and pressure analyzer. the calibration results were presented according to the following table 1. table 1. presentation of the measured data for the equipment: a) mnc protocol collection bag, b) access pressure and c) back pressure a) apheresis mnc protocol collection bag set. volume (ml) value measured average error uncertainty total error tolerance limits 175 179,10 4,10 ±0,01 | 4,11| 6% b) apheresis mnc protocol access pressure set. pressure (mmhg) value measured average error uncertainty total error tolerance limits − 265 −270,00 −5,00 ±0,01 | 5,01| 12% − 150 −147,10 3,00 ±0,01 | 3,01| 12% − 50 −54,00 −4,00 ±0,01 | 4,01| 12% c) apheresis mnc protocol return pressure set. pressure (mmhg) value measured average error uncertainty total error tolerance limits 52 50,00 −2,00 ±0,01 | 2,01| 12% 254 256,00 2,00 ±0,01 | 2,01| 12% 403 408,00 5,00 ±0,01 | 5,01| 12% in this way, the calibration procedure was added to the quantitative tests that were conducted for this type of equipment and complemented the proposed qualifying procedure apheresis equipment before release technique to use. performing verification technician among the quantitative tests also performed are: checking the battery voltage of master boards; endurance tests figure 3. the flow method, with job steps. 7 j global clinical engineering vol.2 issue3: 2020 santos, marciano and rezer: proposed calibration of apheresis equipment of the protection earth leakage current; verification of ac and dc voltages; verification and calibration of pressure sensors; functional check of the rbc detector; verification of pump rotation; and simulation with saline. conclusions evidence shows that the parameters compared were calibrated within the tolerances stated by the manufacturer. it was noted also that all measurements fell between the variations set and measured (even if within the range of tolerance). in this way, there may be situations where the parameters are very close to the tolerance allowed or even outside of it. also, we can apply techniques of probability (considering the uncertainties of measurement) to evaluate whether the value measured is within the maximum allowable limit. another point to assess is the type of protocols and tests that must be performed in this equipment so that they can reflect, in the most appropriate way, the effectiveness of the process of blood cell separation carried out by the machine. considering the details above, there is a need to consolidate criteria and do a greater scope of tests and calibrations on apheresis equipment to avoid initial or routine use of equipment that has not been calibrated. this may help ensure that the equipment performs properly and thus avoid the risk of errors. conflict of interest the authors declare that they have no conflict of interest. references 1. quesenberry pj, colvin ga, beutler e, et al. williams hematology, north america 2001;6:153–74. 2. zerlotti hwg, noronha jfa. identification of hematopoietic stem cells: conventional flow cytometry versus automated hematology counter view. braz hematol hemother 2003;169–72. 3. grimm dj. apheresis system with anticoagulant flow. us: baxter; 2005. 4. marikar a, tatsui nh. therapeutic aféreses. cap 2001;21:257–71. 5. hlavinka dj, felt tj. centrifugal separation method for separating fluid components us, google patents, gambro; 1999. 6. gambro. model cobe spectra. introduction to user manual. rev. e; 2001. 7. schmaldienst s, goldammer a, derfler k, et al. location of the extracorporeal circuit anticoagulation with heparin neutralization with protamine by the company and during immune ergatterte. division of hematology and blood coagulation, university of vienna, 2000;september 36:490–97. 8. octavian cj. serological evaluation for infectious diseases transmitted through blood transfusion in blood recipients, general hospital of palmas, brazil dissertation; 2015. 9. anvisa. the national health surveillance agency of the brazilian. resolution rdc 57 collegiate board of directors of the brazilian, no. 57. 2010. available at https://portal.anvisa.gov.br. https://portal.anvisa.gov.br 17 j global clinical engineering vol.2 issue 2: 17-21 ; 2020 received april 2, 2019, accepted february 11, 2020, date of publication february 24, 2020 application of multiparameter method as an assistance to the evaluation of the need for replacement of medical equipment by m. a. marciano1 and e. k. souza2 1moinhos de vento hospital/clinical and hospital engineering, porto alegre, brasil 2moinhos de vento hospital/clinical engineering, porto alegre, brasil abstract medical equipment is an increasingly important element in modern medicine and medical and hospital care. for medical equipment to contribute effectively and productively to health organizations, it is necessary to carry out the management of their life cycle. a decisive factor in this life cycle is to know when a piece of equipment must be replaced. it is observed that defined and clear methods must be in place to assist the clinical engineering and hospital management in deciding and prioritizing which medical equipment needs to be replaced and when. this work has a practical application in the management of the medical equipment inventory. as a result, the classification of medical equipment and the prioritization of substitution is obtained concerning variety, quantity, and cost of the equipment to be replaced. the application of this method may contribute to the increased quality of the installed equipment and effective budget planning for hospital investments. keywords – prioritization replacement, multiparameter method, biomedical equipment. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction medical equipment is increasingly important in modern medicine to aid in research, diagnosis, monitoring, therapy, and life support of human beings in need of medical and hospital care. hospitals, in turn, have become sophisticated centers of technology.1 the inappropriate use of technology may put users and the effectiveness of health organizations at risk. for medical equipment to contribute effectively and for health organizations to use them more productively, there is a need to manage their life cycle. the equipment’s life cycle is divided into phases, in the following sequence: innovation, initial diffusion, incorporation, large-scale use, and renouncement/ substitution.2 a key factor in this life cycle is knowing when any medical equipment should be replaced (to avoid inefficiency, unavailability, risks to patients, etc.). other reasons for replacement need may be high operation cost, obsolescence, or inadequacy in meeting demand.3 the equipment can be classified into two groups, those with decreasing efficiency and a predictable useful life (with low equity options without replacement, low with replacement by same type equipment, and low with replacement by more efficient equipment), and those with constant efficiency and unpredictable useful life.3 as there is a historical scarcity of financial resources in healthcare an increasing, rational allocation of this resource is vital. therefore http://www.globalce.org http://globalce.org http://globalce.org marciano, souza: application of multiparameter method as an assistance to the evaluation of the need for replacement of medical equipment j global clinical engineering vol.2 issue 2: 17-21 ; 2020 18 studies, methodologies development, and tools to define the cost of a technology’s useful life are increasingly valued to avoid those subjective criteria being used in the decision-making process.4 for some factors, such as which technologies tend to be cumulative rather than substitutive, it is complex to define obsolescence criteria for medical technology.5 in view of such complexity, it is observed there is an absence of clear and defined methods in the literature, as well as the application of methods and criteria to assist clinical engineering and hospital management in deciding which medical equipment needs to be replaced. this study presents an alternative method, practical application and has the main objective to present a classification of medical equipment regarding replacement priorization as a consequence of obsolescence, evaluation of the technological medical equipment in use in the hospital, and to assist with direction in the variety, quantity, and costs of medical equipment needing replacement according to obsolescence criteria. the method used in this practical application was the multiparameter developed in 1992 and applied for the first time at st. luke medical center to a range of five different types of equipment, such as intra-aortic balloon, ecg, defibrillator, neonatal incubator, and ergometric treadmill, totaling 146 pieces of equipment.6 the option for this method was to understand that it covers a variety of parameters and attributes, from technical, economic-financial and medical-assistance points of view. in the evaluation of the medical equipment life cycle, the importance of the observation by the prism of manufacturer and medical-care user is relevant.7 this proposed method has a clear and objective formulation and allows applying to a variety and quantity of medical equipment, which is one of the assumptions of this work. because it is composed of quantitative and qualitative attributes, and thus a wide coverage of the evaluation criteria, the application becomes attractive in relating practice and experience with actual data.8 the application of this method can contribute to an increase in the quality of the management of medical equipment installed and with the investment planning of the hospital budget. this demonstrates that the knowledge acquired and developed by frequent research from clinical engineering professionals and the disseminated practical application can contribute to the decisions of health organizations´ management and thus add value in a more meaningful way because well-prepared professionals are essential to guide the decisions of health organizations.5 materials and method the applied method considers four groups of parameters to compose the plots of the equation denominated rpv (replacement priority value), being: technical (contributing with 40% in the equation), criticality (contributing 20%), financial-economic (contributing 20%), and clinical parameters (contributing 20%). one of the prerequisites for this application is to have the information about the medical equipment inventory to be analyzed, as well as the maintenance history of each one. the first group mentioned, shown in table 1, is composed of four attributes related to equipment: the age, maintenance cost (in this study, the maintenance cost [mc] was adapted to 24% according to the brazilian reality, since in the original study the mc reference is 15%, considering the last 3 years regarding the purchase value), stopping time, and end of manufacturer support. in the four attributes, if the analyzed medical equipment has a good classification it receives a zero score, otherwise, it receives 1. limits are described in table 1. table 1. technical parameters criteria scoring rule technical criteria man = age + mc + st + ms age (age) age ≥ 7 years = 1 age < 7 years = 0 maintenance cost (mc) mc ≥ 24% new equipment = 1 cm < 24% new equipment = 0 stopping time (st) st ≥ average group break time=1 st < average group break time = 0 end of manufacturer support (ms) ms = 1, when spare parts are available on the market ms = 0, when spare parts are not 19 j global clinical engineering vol.2 issue 2: 17-21 ; 2020 marciano, souza: application of multiparameter method as an assistance to the evaluation of the need for replacement of medical equipment the age of the equipment was considered using data provided by the accounting sector of the institution. the mc and stopping time of the equipment were acquired through the asset management software. for the end of manufacturer support criteria, the formal communication issued by manufacturers was used as a reference. the second group mentioned, as shown in table 2, is composed of a single attribute, which is the function of the equipment. in this attribute, the medical equipment is framed in one of four classifications, according to the function, as shown in table 2. in relation to criticality, the equipment was classified according to its application/ function. the third group, shown in table 3, is composed of two attributes, one is the increase of billing and the other is the reduction of cost. in the two attributes, if the replacement of the medical equipment analyzed results in increased billing or cost reduction, it receives a score of 1. to classify or score the equipment in the financialeconomic parameter, it was necessary to know by which technology the equipment under analysis could be replaced. and, also be aware whether the replacement could bring cost reduction or increased billing. if positive, the score of each of the two mentioned attributes would be 1 (table 4). in this parameter group, it was necessary to know if the equipment replacement in the evaluation could be more efficient, to increase the standardization, or to have increased user preference. this classification was conducted with the support of care managers and doctors from the areas in which the analyzed equipment were allocated. table 2. em criticality criteria scoring rule medical equipment criticality (fun) fun life support fun = 4 therapy fun = 3 diagnosis/ monitoring fun = 2 analysis / support / assistant fun = 1 table 3. financial-economic parameters criteria scoring rule financial-economic parameters cost benefit (cb) = ib + cr increased billing (ib) ib = 1, if the replacement equipment provides a higher billing ib = 0, if the replacement equipment does not provide a higher billing cost reduction (cr) cr=1, if the replacement equipment provides a reduction in the cost of operation and/or maintenance cr = 0, if the replacement equipment does not provide a reduction in the cost of operation and/or maintenance table 4. clinical-safety parameters criteria scoring rule clinical parameters and safety clinical efficacy and preference (cep) cep = it + up + is improvement in treatment (it) it = 1, if em offers improvement in the treatment mt = 0, if em doesn´t offer improvement in the treatment user preference (up) up = 2, if the user preference for exchanging equipment is large up = 1, if the user preference is medium up = 0, if there is no preference for exchange increased standardization (is) is = 1, if the replacement equipment provides increased standardization among medical equipment is = 0, if the replacement equipment doesn´t increase standardization among medical equipment marciano, souza: application of multiparameter method as an assistance to the evaluation of the need for replacement of medical equipment j global clinical engineering vol.2 issue 2: 17-21 ; 2020 20 after completing all the parameters listed, the following formula was applied to obtain a final score, called replacement priority value (rpv). this formula considers a weight or percentage for each group of parameters evaluated. rpv = 0,4. + 0,2. + 0,2. + 0,2. (1) to support the classification of replacement prioritization there is a decision scale in this method, as shown in table 5. a spreadsheet was used as a tool to apply this method in a private, non-profit hospital with approximately 400 beds and an installed base of approximately 4,500 medical equipment. results through the application of the multiparametric method, it was possible to know and visualize an overview of the replacement, which equipment should be kept in operation without any restriction, and how many should be kept in operation but with a reevaluation in the next 12 months (81 pieces of equipment) and 24 months (164 pieces of equipment), as shown in figure 1. it was also possible to identify which types and quantities of equipment should be prioritized, visualize the diversity prioritized by cost center, and provide management with an estimate of the financial resources needed to invest in replacements. another possible analysis was the verification of the partial classification referring to the groups of clinical, financial, economic, and technical parameters that determined if it was graduated with a partial result. this prism of analysis assists in the understanding of under which parameters certain equipment is worse qualified. discussion health organizations, through clinical engineering services, need to have effective control of the medical equipment they own. the use of medical equipment life-cycle management software allows us to record all maintenance history. knowledge of this data and information are a prerequisite for using technology evaluation methods. the multiparametric method, with the range of criteria demonstrated, may be a practical alternative when evaluating the replacement prioritization of a wide range of medical equipment types. the continuity of application of this method, adaptations of attributes, and way of applying (mainly subjective ones) are subject to refinement and adjustment. there is also a need to implement the results after modeling, simulation, and resolution of the equations and types of computational tools being used. both the methods and results of this practical application were fully accepted by senior management, by the managers, coordinators, and the multi-professional team responsible for the evaluation of hospital investments. the list of medical equipment with a priority of replacement, as a result of the evaluation of obsolescence of the table 5. classification of replacement priorization criteria scoring rule keep in operation rpv < 1 reevaluate the condition of the equipment in the next 12 months 1 ≤ rpv ≤ 1,2 replace in the next 24 months 1,3 ≤ rpv ≤ 1,6 replace in the next 12 months rpv ≥ 1,7 figure 1. overview of the replacement. 21 j global clinical engineering vol.2 issue 2: 17-21 ; 2020 marciano, souza: application of multiparameter method as an assistance to the evaluation of the need for replacement of medical equipment inventory of the technology was the basis of the biomedical equipment investment sheet. other medical equipment made the list but came from other hospital needs. conclusion clinical engineering services can increase the performance of this evaluation and propose plausible alternatives (appropriate, comprehensive, practical, etc.) to hospitals regarding the use of methods and criteria that allow indicating the appropriate timing and prioritization of equipment replacement. the use of these methods can contribute to the quality, availability, security, and performance of the technologies as well as aid in accounting for the costs related to the life cycle of the hospital medical equipment inventory which would help in the planning of the health institution investment. other types of methods also need to be developed, studied, analyzed, and applied in a larger variety of medical equipment (to evaluate which method is best applied to a certain class of equipment) and more widely in the health organizations, to contribute substantially to managing the life cycle of the medical equipment installed. conflict of interest the authors declare that they have no conflict of interest. references 1. bronzino jd the biomedical engineering handbook. 2nd ed. usa: crc press, inc; 2000. 2. krauss-silva l. avaliação tecnológica em saúde: questões metodológicas e operacionais. caderno de saúde pública; 2006. 3. brehm do. ponto 2: metodologia e princípios da análise de investimentos; análise de projetos industriais e substituição de equipamentos; prática instrumental, tabelas, planilhas e calculadoras financeiras; 2012. 4. stiefel r and riskalla e. the elements of a complete product evaluation, biomed instrum technol 1995 nov-dec;29(6):482–8. 5. novaes hmd. produções e avaliações de tecnologias dos sistemas de saúde: desafios do século xxi. são paulo 2006;40:133–40. 6. fennigkoh l. medical equipment replacement model. j clin eng 1992 jan/feb; 17(1): 43–47. 7. santos f, garcia r. contribuição de metodologia para definição de substituição e incorporação de novas tecnologias na área da saúde. ii xii jornadas internationales de inginieria clínica y tecnologia médica (entre rios-argentina). anais. argentina 2006;27–31. 8. katz z. estudo de metodologias econômicas e multiparamétricas aplicadas à decisão de substituição de equipamentos médicos. dissertação mestrado em engenharia elétrica. fee unicamp; 1998. 5 j global clinical engineering vol.4 issue 1: 2021 received january 17, 2020, accepted december 1, 2020, date of publication january 25, 2021 a multi-platform information management system of the total life cycle for medical equipment by huang. erliang1,2, chen. xiaoyi, xie. pengcheng1,2, xie. weihua1,2 1 logistics department of guangzhou women & children’s medical center, guangzhou, china 2 medical devices management branch of guangdong association of primary medicine, guangzhou, china abstract objective: to establish a total life cycle information management system for medical equipment based on our hospital’s actual situation. methods: per the definition of the total life cycle for the particular item of medical equipment, the function modules were designed and distributed according to different staff postings and then implemented on the wechat public account-a series of api and services to develop custom features, a mobile app, and a computer web browser. results: after implementation, the system can cover a series of management stages of the entire life cycle for medical equipment and the information exchanged among various stages. the relevant staff in different posts can operate the medical equipment management information on any of the three platforms. conclusion: the improvement and efficiency aid staff in various settings in managing medical equipment and medical behaviors and patient safety is increased.. keywords – medical equipment, information system, multi-platform. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction large-scale hospitals have a wide variety of scientific and medical equipment which requires efficient information management systems. traditional management methods cannot cover and connect the devices at various stages effectively while they are in hospital circulation. traditional medical device management methods have the following drawbacks: • data are not interconnected. there is an information island between the functional modules of medical device information management because each function module has different application sequences, different software vendor solutions, and different technical levels in different periods. there is also a failure of unification in planning and construction leading to differences in system architecture, data formats, protocol standards, and network environment among functional modules. the system function modules are independent of each other, making it impossible to implement or partially implement data sharing. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ erliang, xiaoyi, pengcheng, weihua: a multi-platform information management system of the total life cycle for medical equipment j global clinical engineering vol.4 issue 1: 2021 6 • data management is not integrated. traditional management methods focus on bidding procurement, contract management, installation and acceptance, fixed asset files, maintenance and measurement, and scrapping. therefore, traditional management systems are generally established in these areas. however, for planning and budgeting, market research and inquiry, usage evaluation, routine maintenance, inspections and preventive maintenance, adverse event monitoring and recalls are usually underestimated leading to a relative lack of management information modules for the devices. • the data processing error rate is high. as data in device management modules cannot share or partially share information, and if the device management information among the modules is inconsistent, data will not be accurately provided. for example, a device in a chinese hospital management system has four ledgers: (1) financial management department general ledger; (2) fixed assets management department ledger; (3) procurement ledger; and (4) medical equipment maintenance unit account. since the four ledgers' management information is not entirely interconnected, it may cause data discrepancies if login is on different systems and may also cause management information inconsistency with the physical object. the management information of the equipment may be lost due to poor management, mostly when recorded in paper format. • data processing is not timely. for traditional equipment, information management at various stages is stored in different system modules and storage media, such as client/server architecture mode database, excel spreadsheet, or paper files. accessing and updating real-time information on devices requires operating on different systems at different times. also, equipment maintenance, inspections, measurements, etc., need to be executed regularly, but traditional management methods cannot achieve dynamic setting plans and automatic expiration reminders effectively. • data statistics and reporting functions are imperfect. the statistical data of various devices are fuzzy, and muti-latitude measurement and comparison data are scarce. monitoring of the running status of equipment is not clear or intuitive. with the needs of modernization and the intelligent refinement development of hospitals and the need to review china's 3a grade and healthcare information and management systems society (himms), medical equipment management urgently needs an integrated information management system to break the barriers among the original modules and realize information interconnection among modules and systems. the total product life cycle (tplc) method is a holistic approach that considers all of the steps and processes in the evolution of a device from conception to obsolescence and integrates information and knowledge across pre-market and post-market activities. david w. feigal proposed that tplc of a medical product included phases such as concept, prototype, preclinical, clinical, manufacturing, marketing, commercial use, and obsolescence. combining the perspectives from different science disciplines was widely accepted in the medical devices field.1 according to the characteristics of equipment management in china's medical institutions and the medical technology management of our hospital, we divided the total life cycle information management system for medical equipment (tlcimsme) in the hospital into the following stages: (1) equipment demand, planning, and budget as the starting point; (2) market research, bidding procurement, and contract management as the initial stage of equipment life; (3) receiving, installation, and acceptance, personnel training, fixed asset file management, use management, application evaluation, daily maintenance, inspection and preventive maintenance, metering maintenance, and monitoring and analysis of adverse events are used as application stages; and (4) recalls, scraps, and updates as the later stages. according to the four stages, the medical equipment life cycle information management system should be fully covered and all stages can be interconnected. each user of the system can log in to the system to manage medical equipment information at any time or place and get statistics and report information intuitively. methods the tlcimsme had to be designed to interconnect functional modules and other relevant information 7 j global clinical engineering vol.4 issue 1: 2021 erliang, xiaoyi, pengcheng, weihua: a multi-platform information management system of the total life cycle for medical equipment systems in the hospital. the tlcimsme was designed and implemented from multiple perspectives, including logical general view, hierarchical system structure, life cycle timing diagram, functional module diagram, and three-platform operation diagram. connecting medical equipment management systems and other related information systems in the hospital the information systems related with medical equipment management system in our hospital have are office automation (oa) system, medical equipment preliminary marketing research system, third-party tender evaluation system, intensive care system, laboratory information system (lis, picture archiving and communication systems [pacs]), outpatient and inpatient electronic medical record system, fixed asset management system and finance system. the medical equipment information management system should interconnect with these related systems (figure 1). medical equipment management system layered structure 1. user interface layer. this layer, containing all user pages, is responsible for interacting with the outside world, receives business requests from the application programming interface (api), forwards the request to the business logic layer for processing, and returns the final result. 2. business logic layer. this layer is responsible for processing requests submitted by users. the requests are submitted to the data access layer and the results are passed back to the user interface layer. windows communication foundation (wcf) is used to pass messages between the user interface layer and the business logic layer. 3. data access layer. this is a bridge between the business logic layer and the database. pass the request to the database and return the results to the business logic layer2 (figure 2). functional organization structure 1. the starting point of the lifeline. when the medical equipment demand departments fill in the application form and submit the demands, a serial number figure 1. connecting medical equipment management systems and other related information systems in the hospital. figure 2. medical equipment management system layered structure. erliang, xiaoyi, pengcheng, weihua: a multi-platform information management system of the total life cycle for medical equipment j global clinical engineering vol.4 issue 1: 2021 8 is generated to track the equipment. information such as the application department, equipment name, quantity, budget, and basic equipment configuration and functional requirements are transmitted to the tendering stage. 2. initial stage of equipment. the hospital generally entrusts a third-party bidding company to tender according to a hospital’s needs (refer to the provisions of the national bidding documents) and determines the bid supplier, equipment brand, model, quantity, and price. this information is transmitted to the hospital procurement stage. our hospital and the winning supplier sign the purchase and sale contract following the winning bid information. 3. equipment application stage. then the clinical medical engineer, the manufacturer engineer, department staff, and the fixed asset manager install, test, and accept the medical equipment together according to the contract. after acceptance, the fixed asset administrator will file the equipment information into the assets system. after training medical engineers and equipment operators, the equipment can be used. clinical medical engineers then conduct risk assessment of the equipment in the system, develop preventive maintenance measures and content and cycle, inspection plans and daily maintenance plans and later execution, additional measurement plans and a measurement equipment file are prepared for the metering equipment and executed later. if the equipment fails, the equipment user can initiate application by two-dimensional code of the fixed assets which is created during the acceptance. medical engineers also receive the repair information through the system to execute and fill in the maintenance report form. when an adverse event occurs, both the equipment users and the clinical engineers can report through the system, and the fixed asset administrator also counts the medical device by scanning the two-dimensional code. 4. late stage of the equipment. when a medical device recall occurs, all the models and batch numbers of the equipment involved are queried in the system, and the recall procedure is executed. when the medical device is scrapped, the device user, the fixed asset administrator, and the clinical medical engineer operate and record the event together in the system. when updating the equipment, the system can be used to check and analyze the medical equipment repair, inspection, and maintenance data records and determine whether the equipment needs to be updated. in this way, a medical device completes the closed-loop management of the entire life cycle3 (figure 3). personnel positions for medical equipment management medical equipment personnel positions are divided into equipment section chiefs, equipment operators, purchasers, fixed asset administrators, gaugers, and clinical medical engineers4 (figure 4). the medical equipment department chief mainly obtains statistics and reports on various types of equipment management information from a macroscopic perspective. the requirements include statistics on the hospital’s entire assets, statistics on the asset distribution in various hospital departments, the proportion of risk levels and another 16 asset statistical analysis charts such as usage rate and asset brand statistics. the equipment operators use the system for routine maintenance and inquiry to repair. the purchaser mainly uses the procurement management module, including summary demanding application and approvals, procurement demonstration and plan, entrusting the third-party tendering company, signing purchase and sales contracts and conducting contract management and invoice management. figure 3. equipment lifeline sequence diagram. 9 j global clinical engineering vol.4 issue 1: 2021 erliang, xiaoyi, pengcheng, weihua: a multi-platform information management system of the total life cycle for medical equipment the fixed asset manager is responsible for equipment acceptance, documentation, asset label printing, asset allocation, borrowing, inventory, and scrapping. the gauger is responsible for the metering of medical equipment in the hospital according to annual plans, including compiling the inventory of the metering instruments, drawing up the annual metering plan for the instruments, recording the metering files, and ensuring consistency between accounting books and physical inventory. clinical medical engineers utilize three modules: repair, maintenance, and quality control management.5 functions of the repair module include online receipt of repair orders, online dispatch, repair stations, online work orders, online approval, warranty management, equipment faults library, spare parts inventory management, and maintenance invoice management. the maintenance module includes inspection and preventive maintenance, as well as daily maintenance. the quality control management module includes medical device risk assessment, medical device performance testing and planning, measurement management, and adverse event management. after logging on to the system, personnel in different positions can set the corresponding function modules' operation rights, and the information between each function module can be interconnected. three platform terminals the system makes full use of the popular mobile app technology and computer network technology to provide three kinds of platform for user interaction: a public wechat account, a mobile app, and pc web pages.6 the underlying data of the three platforms are interactive and interoperable. public wechat account wechat is a multi-purpose messaging and social networking app developed by tencent. it has been called china's "app for everything" and a "super app" because of a wide range of functions and platforms. almost every chinese person has a wechat account.7 wechat supports developers registering a public account, which can interact with users and provide them with services. this system has developed a public account named "gzfezx" as the interaction ports and equipment operators can register user account through the public account and then scan two-dimensional code on the assets to record daily maintenance information and submit a repair application of medical equipment. mobile app a mobile app is a computer program designed to run on a mobile device such as a phone/tablet or watch. the figure 4. the personnel positions for medical equipment management. erliang, xiaoyi, pengcheng, weihua: a multi-platform information management system of the total life cycle for medical equipment j global clinical engineering vol.4 issue 1: 2021 10 system is specially developed named medical equipment information system（meis（app. equipment operators, fixed asset managers, gaugers, clinical medical engineers, and equipment chiefs can log in on the meis app to implement the modules in their rights distributed. it will not be detailed here. pc web pages the pc web pages adopt the traditional browser/ server（b/s（based architecture mode, and the equipment asset manager, metering staff, equipment chief, and clinical medical engineer can login through uniform resource locator（url（to access the web server for medical device management information interaction. after login on the url, modules can be found based on their right, and it will not be expanded. the configuration environment for the pc web pages is as follows: • database: mysql database: simple operation, friendly interface, multi-user database management system; • development language: php language: cross-platform, efficient execution, supports almost all popular databases and operating systems; • server operating system: linux operating system: occupying small resources, safe and stable. implementation results medical device life cycle line selecting either device and clicking allows the user to display the events of the device by time axis. the events include the installation date, the date of repair, routine maintenance, inspections, preventive maintenance date, metering date, and transfer cases. clicking on each item expands the details of each item. double-clicking the device name queries the fixed asset details, device pictures and graphically displaying the medical device overview, including normal usage, number of repairs, maintenance costs, and maintenance hours. the users can also analyze maintenance, quality control analysis, and benefits analysis for the device selected. equipment repair process the clinical department’s equipment manager scans the quick response（qr（code of asset management using figure 5. equipment repair process. 11 j global clinical engineering vol.4 issue 1: 2021 erliang, xiaoyi, pengcheng, weihua: a multi-platform information management system of the total life cycle for medical equipment the smartphone app to apply for repair which is transmitted to the server. the team leader who is responsible for repair dispatches engineers according assigned jobs. the engineers will judge the equipment fault type and then carry out an independent repair or inform the manufacturer or a third-party company to repair as needed. after the maintenance is completed, the engineers fill in the maintenance report, the related clinical department scores the maintenance situation, and then finally, the process ends (figure 5). purchasing module this management module includes purchase application, purchase review, procurement plan, equipment selection demonstration, procurement announcement, negotiation record, contract management, acceptance, installation, and invoice management. clicking on each item to allows access specific information. other modules include maintenance, quality control, maintenance, adverse event management, metering management and equipment benefit analysis. the system also has a distribution map for life support devices that can monitor status such as the amount, type, distribution, fault condition, and intact rate of equipment in the hospital. three interfacing platforms public wechat account this port is mainly provided for clinical departments. after clinical department equipment managers log in, the system automatically matches all the department's devices to their accounts. the equipment administrator can perform daily maintenance or submit repair applications for all department equipment by scanning a code. for equipment with a borrowing time of 3 days or less, the borrower can operate through the temporary maintenance menu. for equipment that is not in the department when scanning the code, instructions are given for borrowing or asset transfer procedures before maintenance. under this interface the system can remind the user of the number of daily maintenance orders. after clicking the reminder, the user can check the detailed information and carry out maintenance. the equipment administrator can also check the number of equipment items in the department that are under repair. also, the equipment administrator can also perform asset transfer and repair applications after logging in and can perform daily inspections and view inspection records and statistical analysis. mobile phone app this app supports both android and apple operating systems. this port is intended for use by clinical engineers, fixed asset managers, gaugers, and equipment management chiefs. after the clinical engineers log in, they can check the maintenance status of all clinical departments. they can inspect the equipment according to departments. they can also perform preventive maintenance and produce reports in the system for the equipment according to the plan. the clinical engineers can process the repair applications initiated by the clinical departments and record at this interface; the metering staff can perform metering and performance testing management after logging in; the common items can be statistically graphed. asset administrators can also perform inventory management on the devices with this app. pc web pages pc web pages allow clinical engineers, fixed assets administrators, metering staff, and medical equipment departments to operate and achieve detailed statistics and graphical reports. the computer maintenance and management module has three menus: routine maintenance, inspection, and preventive maintenance. the routine maintenance menu can be queried according to the device name, type of care, the use of the department and templates of routine maintenance can also be set up. the inspection menu can set the inspection task and remind the inspection time. after an inspection, an electronic report form is generated and archived. the preventive maintenance menu can alert devices that are due for expiration, set up preventive maintenance plans, and execute and set up a personalized template and match. the system can also provide abundant graphical reporting features such as the distribution of equipment failure types,8 statistics of value of equipment assets over time, and the total number of repairs according to the department. erliang, xiaoyi, pengcheng, weihua: a multi-platform information management system of the total life cycle for medical equipment j global clinical engineering vol.4 issue 1: 2021 12 conclusion the meis system comprehensively utilizes the public wechat public account the mobile phone app and web pages based on the b/s structure to modularize the design of the medical device life cycle, and the work-flow moves through various staff positions in the equipment department to realize optimal equipment management and interconnect information resources in multiple modules allowing users to share and break the information resources "island" situation. interconnection between various management modules mutual authentication information ensures accurate information is extracted. the management data also updates to the cloud server, the security of device management information is guaranteed, and the risk of information loss is greatly reduced. the system uses the two-dimensional code-fixed asset tag as the interactive medium between the staff and the medical devices. all the three platforms can scan the fixed asset two-dimensional code to read and write the device management information in real time. the system can output a variety of equipment management information statistical charts, including statistical analysis functions of assets from 16 different angles, including value, use department, equipment risk level, normal usage rate, and statistical analysis by asset brand. also, 23 different statistical analysis functions are available, including maintenance and maintenance costs, fault type, the type of maintenance, repair application departments distribution, top 20 clinical departments by the number of malfunction statistics, graphical daily maintenance, inspection and preventive maintenance profiles by department, and by type of equipment. the system also enables cost analysis of large medical devices and provides analytical reports and statistical analysis of medical device adverse events and metrology. discussion the meis system's promotion and use standardize the workflow in the daily maintenance, inspection, and preventive maintenance of medical equipment. the system platforms can be planned in advance and then implemented according to the plan to ensure the workflow's smooth progress. simultaneously, the devices can be effectively monitored in real-time on three different platforms to ensure the quantity of maintenance. the promotion of the meis systems has improved user interaction and experience. the combination of the qr code and smartphones enables the user to operate through the scan code login platforms under the 4g mobile network and the wifi network, which greatly assists the users of each role. the traditional medical equipment management system is based on a fixed asset management system and a medical equipment maintenance system, paper processing, and excel form management for the initial stage, application stage, and final medical equipment stage. the meis system realizes electronic management of data at each stage of the life cycle, which aligns with the hospital's paperless development process and himms review requirements. of course, there are still some issues at present. for example, if the manufacturer does not provide a standardized, unified data interface such as a digital imaging and communications in medicine (dicom) protocol port, it will make the device dynamic data collection difficult. thus, the user cannot analyze the benefit of a single medical device effectively. the hospital environment is complex, equipment is scattered, the network communication conditions can be poor, and the hospital networking infrastructure can be weak. also, the overall program cost can be high which could delay the use of the meis system. however, with the hospital's intelligent development needs, these problems can be solved gradually. references 1. feigal dw. total product life cycle, center for devices and radiological health. fda [internet] available at: www.fda.gov. 2. songcheng, xie, jing, yan. medical device management and technical norms. zhejiang university press; 2016. 3. fiedler ba, david y. reframing product life cycle for medical devices. in: managing medical devices within a regulatory framework. elsevier; 2017. 4. hui, cao, jian, zhang, yang, liu. exploration of medical equipment management development in public 13 j global clinical engineering vol.4 issue 1: 2021 erliang, xiaoyi, pengcheng, weihua: a multi-platform information management system of the total life cycle for medical equipment hospitals. zhongguo yi liao qi xie za zhi = chinese j med instrument 2019;43(1):65–68. 5. jamkrajang p, daochai s, sroykham, et al. the survey on medical equipment maintenance system in general hospitals of thailand; 2011. 10.1109/ bmeicon.2012.6172048. 6. geng xiang-nan. development and application of medical equipment management system based on wechat public platform. china medical devices; 2016. 7. rui, zhu, xianglong, et al. decreasing the use of edible oils in china using wechat and theories of behavior change: study protocol for a randomized controlled trial. trials 2018. 8. morrison tm, dreher ml, nagaraja s, et al. the role of computational modeling and simulation in the total product life cycle of peripheral vascular devices. j med device june 2017;11(2):024503. 7 j global clinical engineering vol.2 issue 1: 7-14; 2019 received april 2, 2019, accepted september 15, 2019, date of publication november 3, 2019 assistant multi-parametric method to the selection in the process of incorporation of hospital equipment by a. m. marciano1, l. s. schneider2, j. pedroni2 1moinhos de vento hospital/ clinical and hospital engineering, porto alegre, brazil 2moinhos de vento hospital/ hospital engineering, porto alegre, brazil abstract this project aims to demonstrate a multi-parametric method of hospital technology comparison. the main goal was to develop a method to assist the clinical and hospital engineering team, in the process of acquisition and incorporation of medical-hospital equipment, to be used as a tool in the comparison stage of brand options and models of available equipment in the market. the method is composed by groups of criteria or characteristics that can be evaluate referring to the technologies to be compared. this method was applied to compare autoclaves and disinfecting machines that would be purchased to install in a material central and sterilization in a hospital in the south of brazil. as a result, it was obtained the classifications with the final scoring referring to each brand and model of technology. it also contributed significantly to assist the choice definition of the equipment, considering the hospital and technology profile, as well as the requirements and expectations of the multi-professional technical group of evaluators and users. keywords – multi-parametric method, hospital equipment comparison, selection assistance, incorporation process. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction where technologies are evolving with great speed, new priorities in the medical device incorporation process are emerging. medical equipment must correspond to local clinical needs, as well as be accurate and reliable in the environment for which they are used, in order to generate safety and effectiveness for health care.1 medical device incorporation as defined by wang “is the entire process of absorbing technology into a health system or organization through planning, selection, and acquisition, with emphasis on its dependence on technology policies and continuous feedback from technology management.”2 the acquisition process of hospital equipment requires a defined criteria to make the comparison possible between different equipment from different brands and models and to the ensure ease of incorporation in the hospital for a specific application. a few items that must compose the technical specifications list of the equipment to be purchased, are the characteristics of use, functioning principle, nominal capacity, physical dimensions, indication mode and parameter record, outputs and inputs, accessories, construction characteristics, safety, etc.3 most hospitals (75%) do not have any decision-making tools such as multiple criteria decision analysis. table 1 represent the categorization of different criteria used by hospitals to select a medical device by the degree of importance or the applied weight.4 http://www.globalce.org http://globalce.org http://globalce.org marciano, schneider, pedroni: assistant multi-parametric method to the selection in the process of incorporation of hospital equipment j global clinical engineering vol.2 issue 1: 7-14; 2019 8 an alternative to comparison of hospital equipment is to use a matrix composed by the models of the equipment and its technical characteristics with the possibility of defining the weights of each characteristic and grade. after finding the results of each characteristic and multiplying the weight by of grade given by the specialists in the evaluation, it is possible to obtain the final scoring for each brand and model of the evaluated equipment. the characteristics suggested in this method are reliability, precision, repeatability, safety, maintainability, interchangeability, performance, and cost.5 another options of characteristics that could be included in the comparison are the estimated price of parts, the existence of the part in national market, the stock list of the provider, the ease of importing parts, the proximity of the provider, stocking costs, reliability of the provider, and stoppage cost of the equipment by lack of parts.6 in the process of the comparison matrix development it was observed that a model should grade, weight, and categorize the features. this comparative matrix has three categories. the technical evaluation is composed of: precision, repeatability, maintainability, safety, performance, reliability and ergonomics. the clinical evaluation category includes the operation features, alarms, and display. and the third category, the financial evaluation accounts for the cost of the equipment, accessories, contract, and cost of the test instruments.7 in this line of categorization, there is also a spreadsheet that proposes additional categories that can be evaluated, them being: safety (by mechanical and electric features), human engineering (design evaluation criteria, ease of maintenance, maintenance instructions, etc.), users experience (clinical engineering, doctors, nurses, and reports from other hospitals that have the referred equipment already evaluated, as a way of benchmarking) and other factors (such as standardization, familiarity). in this method, besides grouping criteria, scoring, and weighing, it is also suggests the weights of categories (0 to 1) and the grades for each criteria (0 to 10).8 health care decisions are complex and involve confronting trade-offs between multiple, often conflicting, objectives. using structured, explicit approaches to decisions involving multiple criteria can improve the quality of decision making. a set of techniques known under the collective heading, multiple criteria decision analysis (mcda), are useful for this purpose. mcda methods are widely used in other sectors, and recently there has been an increase in health care applications.9 the technology assessment domain corresponds to the choice and applying of multi-criteria methods in supporting the decision, such as: analytic hierarchy process (ahp), multi-attribute failure mode analysis (mafma), elimination and choice translating reality (electre) among others.10 multi-criteria decision analysis (mcda) concepts, models, and tools have been used increasingly in health technology assessment (hta), with several studies pointing out practical and theoretical issues related to its use.11 the goal of this project was to develop a multi-parameter method to assist the process of acquisition and incorporation of hospital technologies which can be used as a tool in the comparison stage of brands and models of equipment available. also, this project would contribute methodically and standardized a more assertive definition of the choice of equipment while considering the hospital profile, technologies evaluated, users, and applications. table 1. categorization of different criteria used by hospitals to select a medical device by the degrees of importance 9 j global clinical engineering vol.2 issue 1: 7-14; 2019 marciano, schneider, pedroni: assistant multi-parametric method to the selection in the process of incorporation of hospital equipment methods a. development of the multi-parametric method of evaluation the method was developed from the bibliographical research, by reading the technical specifications provided in the technical commercial propositions through the notes from hospital and clinical engineering professionals and is demonstrated in flow-gram in figure 1. the stages demonstrated in figure 1 were followed to develop the multi-parametric evaluation method of hospital equipment at the moment of acquisition to help determine the choice of model and equipment settings. b. presentation of the criteria (or attributes) and groups (or categories) examples of criteria and groups used to evaluate the technologies are demonstrated in table 2. the information from table 2 generated the following model, disposed in an excel spreadsheet and presented in table 3. the proposed method, was used to compare the hospital equipment used in material central and sterilization (cme) as support in the choice of autoclaves and washing disinfecting machines. a multi-professional group was created of specialists, composed by the areas of hospital engineering (clinical engineering, production and electric-mechanic) of cme (nursing and administration) and ccih (nursing), to validate the weights and grades to each criterion, in agreement, considering the types of technology that would be evaluated. meetings were organized to validate the scores. figure 1. project development flow-gram table 2. evaluation groupings and criteria group/category examples of evaluated criteria cost installation, life cycle, parts, accessories, inputs... performance productivity related factors provider structure, profile, team, after sales… infrastructure infrastructure needs, utilities, electric, water... maintenance mtbf, tx. failures, parts stocked… operation/usability operation, functions, facility, audiovisual indicators... safety applied technology, criteria, standards, redundancies... technology constructive material, applied technology, evolution, component types... marciano, schneider, pedroni: assistant multi-parametric method to the selection in the process of incorporation of hospital equipment j global clinical engineering vol.2 issue 1: 7-14; 2019 10 the spreadsheet with the criteria was sent to the three providers that took part in competition. they only had access to the criterion list, not to the groups weights. excel was used to generate the results with suggested calculations. table 4 shows some examples of the criteria and categories used to compare the washing disinfecting machines. table 3. comparative spreadsheet configuration criteria/ attributes group/ category weight option 1 grade total grade of option 1 total grade of option 2,3, ... 1 2 3 ... table 4. examples of criteria and evaluation categories what is the annual cost of non-contract preventive maintenance and no mp kit in porto alegre? cost what is the annual cost of non-contract preventivemaintenance and mp kit in porto alegre? cost what is the cost of infrastructure adequacy? cost what is the cost of replacing the gate trim? cost what is the replacement cost of the resistors? cost what is the cost of the controller for the disinfecting machine? cost what is the cost of the water reuse system for the disinfecting machine? performance/efficiency what is the water consumption per tray (in l)? performance/efficiency what is the water consumption per complete cycle (in l)? performance/efficiency what is the average time of the flash cycle including drying? performance/efficiency what is the average time of the instrumental cycle including drying? performance/efficiency what is the average cycle time for ventilator material including drying? performance/efficiency what is the time for daily water heating when the machine is cold? performance/efficiency what is the size of the inner chamber (height x width x depth)? performance/efficiency what is the capacity of loading in number of din baskets? performance/efficiency what is the load capacity in number of iso baskets? provider does the company have any quality certification? (e.g. iso 9001, bpf, bpad) provider does the company have its own or outsourced technical assistance (representative) in poa? provider does the warranty cover the door resistances and fittings? provider do you provide operation manuals in portuguese? provider do you provide technical reference manuals? provider is there another differential related to the technical assistance structure not addressed? if so, please comment provider will the engineers and technicians attending the hmv have an nr-32 or nr-10 training certificate? infrastructure what is the weight of the equipment? (net weight + charge) infrastructure what is the electric peak power? infrastructure what is the nominal electric power? infrastructure is there a need for exhaustion? infrastructure is there a need for a water treatment system? infrastructure is there a need for an energy stabilization system? infrastructure is there a need for a compressed air point? infrastructure does the passageway have the necessary floor dimensions/resistance required for this equipment? maintenance what is the maximum period for delivery of the pieces in porto alegre? inform in numbers of days maintenance what is the maximum time in hours for call after call on hmv poa? (state whether there is difference with and without contract) does the manufacturer recommend preventive maintenance at what intervals? maintenance what will be the technical assistance telephone service? maintenance does the company have stock for immediate supply of parts for the maintenance of the products offered? is there any part that you do not keep in stock? (please attach list) maintenance allows remote access to services? what infrastructure is needed? maintenance in short, what preventive care will be required for this equipment? maintenance what are the types of maintenance contracts available? maintenance can the equipment be connected to a material traceability system? operational/usability is the control display colourful? operational/usability does it have a printer / registration system? operational/usability does it send data for external printing? operational/usability how is the door locking system? operational/usability how are notifications and alerts displayed /viewed? operational/usability 11 j global clinical engineering vol.2 issue 1: 7-14; 2019 marciano, schneider, pedroni: assistant multi-parametric method to the selection in the process of incorporation of hospital equipment the criteria were listed according to the number of specifications and technical descriptions that these types of equipment present. this was done through the initial proposals received from both the suppliers and the technical knowledge of the multiprofessional team from the hospital (which listed which criteria would be important to evaluate for the technical comparison of these types of equipment). the information or data in tables 4 and 5 were initially obtained by sending the complete spreadsheets (some criteria were exemplified in table 4) to the representatives / suppliers of the three equipment brands that participated in the comparison. the spreadsheets were received, filled in, and returned us with the information or data of the equipment. after receiving the answers from the suppliers, they were evaluated by the multiprofessional group from the hospital according to the information received. these scores were equivalent to the levels of information provided by the manufacturers for each criterion (according to the consensus of this multiprofessional group). c. weighing coefficients the goal of the replacement of sterilization and thermodynamic equipment was to optimize flow, increase productivity, and thus qualify the service of material and sterilization center, due to the demand in elevation and restricted physical area. for this, the multiprofessional group defined that the criteria / category of performance, and consequently technological characteristics / category (which allows increased productivity with decreasing process times, for example), as well as usability criteria / category (to facilitate the use, avoiding unavailability of the equipment due to doubts of use, difficulty of use and even misuse, were avoided). it was also defined that the post-sale / technical assistance category would have relevance (so that preventive maintenance and corrective maintenance routines were the most assertive and performed by a technical team capable of reducing downtime). we use ahp method to validate the consistency of the weights uses for each criterion. d. how to transform qualitative criteria to quantitative criteria. the multidisciplinary group defined analogy to transform criteria with qualitative to quantitative answers. for example, score from 0 to 5, where 0 (equals not shown, non-existent). score 1 (equals little, or bad, weak, ... up to 5 (equals a lot, good, strong, ...) results with the scores inserted a spreadsheet summarizing the final results was generated (table 5). the weight for the cost-related criteria group was 15%. and as explained earlier, the initial goal was to increase productivity, and from this, given relevance to the criteria and groups, that would impact on productivity. the groups with the highest weights (with 15%) were the cost criteria; performance / efficiency; maintenance; operation / usability and technical / technology. it was also observed that the acquisition and lifecycle prices were similar, varying in a small range, between the three options of models and brands. thus, incorporation and lifecycle costs would not have a major impact on the what notifications appear on the display and are easyto see? operational/usability what is the layout of the command? operational/usability what is the layout of the display? operational/usability what is the construction material of the inner chamber? safety is the control display touchscreen? safety are the measuring instruments calibrated? safety does it have the option of two independent control systems (one for control and one for recording) as well as temperature sensors? safety how is the door security system? safety what is the guarantee of the chamber? safety what is the construction material of the generator safety valve? safety what is the door type? safety what is the spray cover of the spray arms? technology what is the thermal dissipation? (wall thickness and insulation type) technology what is the construction material of the control panel? technology what is the construction material of the water pump? technology what is the electrical resistance construction material? technology what is the printer type? technology marciano, schneider, pedroni: assistant multi-parametric method to the selection in the process of incorporation of hospital equipment j global clinical engineering vol.2 issue 1: 7-14; 2019 12 organization, if one or the other brand (among those compared) was chosen. after generating the results an opinion was issued to the purchases/supplies sector of the hospital who performed the final scores for each brand/model of participating equipment. the acquisitions were made considering the best scores resulting from this method. the deal was closed in the third trimester of 2016. the equipment arrived in the first trimester of 2017 and the installing was finalized in may of 2017. the machines are in initial process of use after going through installation, validation, performance, calibration, and operational training of the users and technical team. the technical trainings are scheduled for june/july of 2017. discussion not only was the method model creation and definition laborious, so too was assigning the criteria (which were very extensive) and receiving the information from the providers/representatives. the companies, in general, don’t know all their products’ information. all companies needed to request information from their respective industries. these factors took a long time and delayed the comparison process. it also required a lot of attention, time, and dedication to include the definition of weight average and scores to the criteria. depending on the weight averages and scores, scales the differences in final scores became very tenuous. it was also necessary to define qualitative scales to support the quantitative scales. however, criteria don’t always have data (quantitative) and there are criteria that are qualitative. therefore, it is necessary to transform them into quantitative data. in some cases it was noticed that some characteristics interface/relate each other with others or that can be associated with more than one group/category. table 6 demonstrates the quantity of criteria defined, by group/category to be evaluated in the process of comparison. table 5. final results of option comparison by category option 1 option 2 option 3 cost characteristics (installation, life cycle, etc.) 5,8 4,7 5,0 performance/efficiency characteristics (productivity related factors...) 16,2 11,9 12,2 provider characteristics (structure, profile, team, after sales...) 8,9 8,4 9,6 infrastructure characteristics (structure needs, utilities, electric, water…) 6,0 6,5 4,1 maintenance characteristics (access, mtbf, tx., failures, stock parts...) 4,7 4,4 5,1 operational characteristics (operation, functions, access, facility, audiovisual indicators...) 7,5 6,4 6,6 safety characteristics (applied technology, redundancies, criteria, standards...) 8,4 7,1 6,5 technical characteristics (constructive material, applied technology, evolution, component types...) 16,1 14,6 18,9 total 73,5 63,8 67,9 table 6. criteria quantity defined by category group/category criteria quantity to autoclave criteria quantity to disinfecting washing machine cost 22 22 performance 21 27 provider 24 25 structure 18 19 maintenance 11 9 operation/ usability 19 18 safety 14 14 technology 29 32 total 158 164 13 j global clinical engineering vol.2 issue 1: 7-14; 2019 marciano, schneider, pedroni: assistant multi-parametric method to the selection in the process of incorporation of hospital equipment the impacts of the technology sterilization substitutions, washing, and disinfection, will be measured concerning performance, productivity, maintainability, costs and other pre-evaluated criteria and can be certified in practice. other comparative-method developments, including criteria inspection, groupings, weights, calculations, can be done. additionally, the influence analysis on the types of technologies to be compared, in criteria and weights that work as a base to the comparison. to make validations and adjustments possible you must have adhesion according to the technology to be compared. for example, this method was applied in other acquisition processes, as an assistant to the comparison of medical-hospital equipment. it was applied by both the hospital engineering team, to evaluate other technologies like air central and medicinal vacuum, and by the clinical engineering team, evaluating the multi-parametric monitor options and in other cases in which the results can be demonstrated in further projects. conclusion the acquisition process of hospital equipment requires defined criteria to make comparison possible between different brands and models, and to point to the selection and consequent definition of which item will be more fit to incorporate in a certain hospital in a certain application. this project proposed the development of a multicriterion method to support the acquisition process and incorporation of hospital technologies, to be used as a tool in the comparison stage of brand options and equipment models available in the market. the project contributed significantly in the assistance of more assertive definitions of the steam autoclave and disinfecting washing machine, while considering the hospital profile, requirements, and expectations from the multi-professional technical group of evaluators and users. it is believed that methods like this must be developed and replicated according to the technology profiles of hospitals as well as their needs and acquisition goals. conflict of interest the author declares not having conflict of interest. references 1. margotti a, santos f, and garcia r. decision making process to incorporate medical equipment in hospital: clinical engineering perception. in world congress on medical physics and biomedical engineering, china: world congress on medical physics and biomedical engineering may 26-31, 2012. 2. wang b. strategic health technology incorporation (1st ed.). connecticut: morgan and claypool; 2009. 3. calil sj. fatores para a aquisição de equipamentos médico-hospitalares. anais xvii congresso brasileiro de engenharia biomédica, florianópolis, brasil, p.3845.11-13 setembro, 2000. 4. european scientific journal. february 2018 edition. vol. 14. nº. 6. issn: 1857 – 788 (print e – issn 1857 -743. <au: is this reference for the whole issue? if not, please add author and title> 5. bronzino jd. management of medical technology: primer for clinical engineers. stoneham: butterworthheinemann; 1992. 6. müller jr., el, pedroso jcl. aquisição de equipamentos médicos in: s.j. calil; e.t. gomide (orgs.), equipamento médico-hospitalares e o gerenciamento da manutenção: capacitação a distância/ministério da saúde, secretaria de gestão de investimentos em saúde, projeto reforsus – brasília, df: ministério da saúde. 2002; 153–180, 720. 7. vergara galeano jc. procedimentos de aquisição de equipamentos médicoassistenciais: uma ferramenta computadorizada de apoio. dissertação (mestrado em engenharia elétrica) – programa de pós graduação em engenharia elétrica da universidade federal de santa catarina (ufsc), florianópolis: 1999; 166. 8. stiefel r, riskalla e. the elements of a complete product evaluation. biomed instrument technol 1995;29(6):482–88. 9. thokala p, devlin n, marsh k, et al multiple criteria decision analysis for health care decision making – an introduction: report 1 of the ispor mcda emerging good practices task force. value health 2016;19:1–13. 10. santos fa and garcia r. decision process model to the health technology incorporation. conf proc ieee marciano, schneider, pedroni: assistant multi-parametric method to the selection in the process of incorporation of hospital equipment j global clinical engineering vol.2 issue 1: 7-14; 2019 14 eng med biol soc. 2010;2010:414–7. doi: 10.1109/ iembs.2010.5627344. 11. oliviera md, mataloto i, kanavos p. multi-criteria decision analysis for health technology assessment: addressing methodological challenges to improve the state of the art. eur j health econom 2019;20:891–918. https:// doi.org/10.1007/s10198-019-01052-3 j global clinical engineering vol.2 issue 2: 8-16 ; 2020 8 received august 1, 2019, accepted december 11, 2019, date of publication february 9, 2020 is there sufficient evidence to support the use of temporal artery and non-contact infrared thermometers in clinical practice? a literature review by s. bolton, e. latimer, d. clark cheata, clinical engineering, nottingham university hospitals nhs trust abstract background and objective accurate measurement of body temperature is a key part of patient observations and can influence important decisions regarding tests, diagnosis, and treatment. for routine measurements in hospitals, non-invasive thermometers such as tympanic infrared ear thermometers are very widely used even though non-invasive thermometers are not as accurate as core thermometry. however, there are known issues regarding the accuracy of these thermometers due to user errors including dirty probe covers and not straightening the ear canal. we were therefore keen to understand if there was evidence to support the use of alternative non-tympanic, non-invasive thermometer that could be easily and widely deployed across nottingham university hospitals nhs trust. material and methods a search of the published literature via the nice hdas was undertaken to identify the evidence on the use of temporal artery (tat) or non-contact infrared forehead (ncit) thermometers compared to a core body temperature thermometer in a clinical setting. the relevant literature was identified, appraised and summarized. results fifteen papers described the use of tat but only 5 reported results that were considered within clinically acceptable limits of which 2 included febrile patients. nine of the 10 studies where tat was considered not to be within acceptable limits included febrile patients. for the ncit, 3 studies were identified but only 1 reported results within acceptable limits and this did not include febrile patients. conclusion a review of the literature for both tat and ncit has indicated that in their current form neither is suitable as a replacement for oral or tympanic thermometers in clinical practice. in particular, the evidence suggests that they are not acceptable methods for detecting temperatures outside the normothermic range and do not detect fever accurately. known user errors with both tat and tympanic infrared ear thermometers (iret) could be detracting from the usefulness of the technology. keywords – thermometer, infrared, temporal artery, non-contact, forehead, tympanic, oral, core, virus. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org 9 j global clinical engineering vol.2 issue 2: 8-16 ; 2020 bolton, latimer, clark: is there sufficient evidence to support the use of temporal artery and non-contact infrared thermometers in clinical practice? a literature review introduction body temperature measurement is a key part of routine patient observations in all healthcare settings including secondary care and it is one of the 6 components of the national early warning score (news) system developed by the royal college of physicians (https://www.rcplondon. ac.uk/projects/outputs/national-early-warning-scorenews-2) to standardize the assessment and response to acute illness. temperature monitoring can influence important decisions regarding tests, diagnosis, and treatment. it is therefore crucial that thermometers are accurate, reliable and easy to use since inaccurate results may lead to a failure in identifying patient deterioration and compromise patient safety. the most accurate measure of body temperature comes from invasive “core” thermometry options such as pulmonary artery (considered gold standard1) but also bladder, nasopharynx or esophageal thermistors.2 however, these methods are invasive, potentially high risk and restricted to patients undergoing specific procedures and not suitable for everyday use in all care settings. there is a range of non-invasive thermometers for obtaining temperatures from peripheral body sites including the tympanic membrane, the mouth or the axilla. electronic contact non-disposable thermometers that incorporate probes specific for use in either the oral cavity (sublingual), axilla or rectum, are commonly used in many different healthcare settings, particularly the oral cavity. infrared sensing thermometers such as iret or tympanic, which measure the temperature at the tympanic membrane, are also very commonly used across all healthcare settings as well as in a domestic setting. other infrared thermometers include the non-contact infrared forehead thermometers (ncit) and the temporal artery thermometers (tat). there are several chemical thermometry options such as chemical dots or phase change strips though these are generally not as widely used as the electronic thermometry options. while peripheral body sites are convenient for rapid and easy temperature monitoring, not all thermometers have clinically acceptable accuracy and published studies comparing them to core or oral electronic temperature measurements show substantial variability in the methodologies, outcomes and patient populations. in particular, the use of peripheral thermometers to detect temperatures outside of the normal range (36–38°c) is crucial to identify patients who are either hyperor hypothermic and to make the necessary treatment decisions. the wide range of often conflicting data has made drawing firm conclusions from these studies difficult but there have been various systematic reviews and metaanalysis2–5 which overall conclude that not all peripheral thermometry options are clinically acceptable. of all the thermometry options, non-disposable electronic oral thermometers are considered by many to be the most accurate reflection of core body temperature3 and can be considered as the “gold standard” of non-invasive temperature monitoring.6 the royal marsden manual of clinical nursing procedures (ninth edition, chapter 11: observations7) includes recommendations on the use of different thermometry devices to determine patient temperature including the use of tympanic thermometers as an acceptable method to measure body temperature. within the nhs, tympanic thermometers are widely used non-invasive thermometry devices. however, there are issues associated with tympanic thermometers which have been previously described8 and by the marsden guidelines7, such as dirty probe covers and user error (not straightening the ear canal) as factors that could contribute to inaccurate readings being recorded by these devices. in addition, the mhra also published a medical device alert in may 20039 that highlighted these 2 issues as contributing to low-temperature readings. measuring body temperature at peripheral sites, therefore, represents a compromise between patient acceptance, ease, and speed of recording over temperature accuracy. the clinical engineering department at nottingham university hospitals nhs trust (nuh) are responsible for the medical equipment that is used across the trust including tympanic ear thermometers for patient monitoring. many of the devices are returned to the department for cleaning and maintenance due to the issues described above. we were therefore keen to understand if there was evidence to support the use of alternative non-tympanic, non-invasive thermometer that could be easily and widely deployed across the trust to measure https://www.rcplondon.ac.uk/projects/outputs/national https://www.rcplondon.ac.uk/projects/outputs/national bolton, latimer, clark: is there sufficient evidence to support the use of temporal artery and non-contact infrared thermometers in clinical practice? a literature review j global clinical engineering vol.2 issue 2: 8-16 ; 2020 10 body temperature in patients. there have been 2 horizon scanning/technical scoping articles published covering infrared thermometer use in both children (ncit10) and adults (tat11). the overall conclusions of these 2 reports were that the evidence is somewhat equivocal but that ncit could be useful in clinical practice but more research is needed. the 2 types of thermometer considered here were the tat and the ncit. materials and method literature search strategy all searches were performed using the nice hdas (healthcare databases advanced search) and included pubmed (including cochrane database), medline, embase and cinahl. searches were restricted to the english language and in the last 10 years (2008 onwards). search terms were as follows: thermometer; forehead; non-contact; temporal artery; thermometer and noncontact; thermometer and temporal artery; non-contact infrared thermometer. the output was downloaded to excel and the output reviewed with references being selected according to the inclusion/exclusion criteria and availability (see table 1). data review each paper that was considered to be in scope according to the criteria in table 1 was reviewed and summarized in terms of populations, setting, devices used, outcomes and detection of hypo/hyperthermia (febrile) patients. the conclusion of the authors regarding whether the device was clinically acceptable or not was also recorded where it was explicitly stated. funding no funding was sought for this study. results literature search for the literature search and review, no age groups apart from neonates were excluded to review the widest range of literature. the literature search identified 161 references of which only 16 were considered to be in scope. the 16 original clinical research papers were very varied in their populations, interventions, comparator (or standard reference thermometer), study design, primary outcomes, how the data was analyzed and how the results were reported. however, all papers compared the test devices to a standard reference method (which was presumed to be the most accurate) and most (though not all) concluded whether the test devices returned results within defined clinically acceptable limits. most papers discussed the limitation of the study which included whether febrile patients were included, whether the study included any device-specific training and whether user technique was considered. reference methods included invasive core measurements such as pulmonary artery, esophageal and bladder thermometers as well as non-invasive thermometers such as oral or rectal electronic thermometers. as anticipated, no test devices were found to be superior to the standard reference device. some studies included a range of devices, not just infrared non-contact devices and these were included in the analysis for completeness. the key question we asked of the papers was whether the evidence supported the use of infrared non-contact thermometers in the population being studied and this is summarized in table 2. table 1. inclusion/exclusion criteria for infrared non-contact thermometer search inclusion exclusion non-contact infrared forehead thermometer (ncit) measurement of temperature in other body locations e.g., skin, corneal, umbilicus temporal artery thermometer (tat) no comparison to other thermometers clinical or professional use in humans non-clinical studies i.e., animals or scientific studies, exercise studies any age group large population scanning studies e.g., traveller studies comparison to core or oral thermometers use of mercury-in-glass thermometers original research published since 2008 11 j global clinical engineering vol.2 issue 2: 8-16 ; 2020 bolton, latimer, clark: is there sufficient evidence to support the use of temporal artery and non-contact infrared thermometers in clinical practice? a literature review table 2. literature review of infrared non-contact thermometry authors population febrile patients thermometer type and devices used in study conclusions allegaert 12 pediatric, n=294 y rectal filac 3000, covidien tympanic genius 2 tat exergen ncit thermoflash yes tat agreed with rectal but still not optimal barringer 13 adult patients undergoing elective surgery, n=86 n oral welchalleyn suretempplus model 690 axilla welchalleyn suretempplus model 690 tat exergen tat5000 yes tat provided temperature readings closer in agreement with oral readings bodkin14 adult patients, n=100 y oral dinamap procare 400, oral electronic non-disposable tat exergen tat5000 no tat gave significantly different readings to oral electronic thermometer brosinski 15 pediatric <3yrs, n=126 geriatric >65 yrs, n=125 unable to use oral thermometer y tat exergen tat5000 rectal welchalleyn suretempplus no tat device not accurate enough compared to rectal to be used in the ed calonder 16 patients undergoing colorectal or gynecology surgery, n=23 n esophageal es400-18 level 1 acoustascope esophageal stethoscope oral welchalleyn suretempplus model 678 tat exergen tat5000 yes tat were accurate for temperature assessment but tended to over-estimate temperature compared to esophageal counts 17 acutely ill patients aged > 18 years old, n=48 y oral welchalleyn suretempplus model 690 oral disposable digital oral electronic thermometer: medichoice (mesure technology co, tat exergen tat5000 no tat was judged to exceed clinically acceptable limits forrest 18 febrile and afebrile pediatric patients, 36 months and under, n=85 y rectal welchalleyn suretempplus model 690 axilla welchalleyn suretempplus model 690 tat exergen tat5000 no tat cannot be recommended to detect fever in pediatric populations gates 19 adults, multiple myeloma, inpatient unit bone marrow transplantation. y oral welchalleyn suretempplus model 690 tympanic genius 2 tat exergen tat5000 no – tat over-estimates temperature hamilton 20 adult febrile (n=11) and afebrile (n=8) pediatric febrile (n=53) and afebrile (n=99) y oral welchalleyn suretempplus model 692 tympanic braun thermoscan 4520 ncit visiomed sas thermoflash lx-26 forehead beurer ft 60 infrared contact forehead thermometer tat exergen tat-2000c forehead chicco thermo touch plus contact forehead thermometer no tat or ncit (or other forehead thermometers) not considered acceptable bolton, latimer, clark: is there sufficient evidence to support the use of temporal artery and non-contact infrared thermometers in clinical practice? a literature review j global clinical engineering vol.2 issue 2: 8-16 ; 2020 12 authors population febrile patients thermometer type and devices used in study conclusions hamilton 21 febrile (n=94) and afebrile (n=111) children y oral welchalleyn suretempplus tympanic thermoscan® pro 4000 prewarmed tip ear thermometer tat exergen tat5000 no tat not acceptable. compared to reference, tat gave statistically significantly different readings langham 22 patients undergoing laparoscopic surgery. aged 18-80 yrs, n=50 n bladder foley catheter (mon-a-therm foley-temp) esophageal – esophageal stethoscope with thermistor (mon-atherm est) tatexergen tat-5000 tympanic firsttemp genius 3000a skin-surface thermocouple (monatherm 6130) skin liquid-crystal display strip (crystaline moving line) oral and axilla electronic thermometer (ivac tempplus ii 2080a) deep thermometer (coretemp ctm-205 with a pd-51 probe) no – tat only had reasonable correlation to core. electronic oral thermometry was the most accurate and reliable device compared to the reference lunney 23 hemodialysis patients y thermometer in fresenius 5008 hemodialysis machine, tat exergen tat5000 no tat method exceeds the clinically acceptable reference method marable 24 adult male patients, critical care unit, n=69 y oral welchalleyn suretempplus model 692 axilla welchalleyn suretempplus model 692 tat exergen tat5000, forehead and ear tat exergen tat5000, forehead only tat exergen tat5000, ear only no – the results do not favour temporal artery scanning in adult critical care patients opersteny 25 pediatric patients aged 0–17 years, inpatient surgical units, n=298 y oral welchalleyn suretempplus model 692 axilla welchalleyn suretempplus model 692 tat exergen tat5000 yes tat is an acceptable temperature measure that could substitute oral or axillary thermometers sollai 26 healthy term (n=119) and preterm newborns (n=70) nursed in incubators n axilla – sanitas digital thermometer tympanic thermoscan pro 4000 ncit thermofocus 800 yes ncit is a promising, quick non-invasive and accurate method to measure temperature in newborn and preterm babies stelfox 27 18 years or more, expected to stay in icu for 24hr or more. n=736 readings from 14 patients y bladder level 1® foley catheter temperature sensor, smiths group plc tat exergen tat5000 yes tat closely agreed with the bladder thermometer for normothermic measurements but less agreement for temperatures < 36°c or >38.3°c bold indicates study reference devices. 13 j global clinical engineering vol.2 issue 2: 8-16 ; 2020 bolton, latimer, clark: is there sufficient evidence to support the use of temporal artery and non-contact infrared thermometers in clinical practice? a literature review the results from all 16 papers were collated and summarized by device including which thermometer was used as a reference standard, whether the tat or ncit were considered as the next best compared to the standard (a frequently reported outcome) and whether it was considered to be within clinically accepted limits (which was considered to be +/0.5°c [1°f]) unless otherwise stated, though it was not always explicitly stated. of the 15 papers that included the tat, only 5 of these studies12,13,16,25,27 reported results that were considered to be within clinically acceptable limits or were not statistically significantly different from the reference device and would support the use of tat in clinical practice. of these 5 studies, only 2 reported that the tat could accurately detect fever.12,25 of the remaining 3 papers, stelfox et al.27 included febrile patients but reported that the tat was only acceptable for patients within the normal range (36–38°c) as there was less agreement for temperatures below 36°c and temperatures greater than or equal to 38°c. the other 2 papers13,16 concluded that tat was acceptable but they did not include febrile patients in their study. in the 10 studies where tat was judged to be not acceptable, 9 of the studies included patients with fever indicating that tat did not perform accurately to identify fever in a wide range of patient populations. there were only 3 studies that compared ncit to a reference thermometry measurement. the study by sollai26 using the thermofocus device reported results that were considered acceptable compared to the reference standard. however, the reference standard was digital axillary in neonates and the study did not include febrile babies. both studies 13,20 where ncit devices were not considered acceptable included febrile patients indicating that the ncit is not acceptable for detecting temperatures outside the normothermic range. discussion a search and review of the published literature was undertaken to determine if there is sufficient evidence to support the use of non-tympanic non-invasive thermometers in a hospital setting (table 3). two types of thermometer were considered: tats and non-contact infrared forehead thermometers. the literature reviewed focused on the studies comparing tat and ncit with either invasive core thermometry or standard oral electronic thermometry. table 3. literature review summary by device thermometer type: device manufacturer no . of studies used as reference standard next best to ref device outside accepted limits oral: suretempplus welchalleyn 8 7 1 axilla: suretempplus welchalleyn 4 1 2 1 rectal: suretempplus welchalleyn 3 2 esophageal: stethoscope with temperature sensor mon-a-therm smiths medical 2 2 bladder: foley catheter mon-a-therm smiths medical 2 2 axilla: sanitas dx sanitas 1 1 oral: dinamap procare 400 dinamap 1 1 rectal: filac 3000 covidien 1 1 dialysis machine, 5008 fresenius 1 1 tat: tat5000/2000 exergen 15 5 10 tympanic:genius 2 covidien 3 1 2 tympanic: thermoscan pwt braun 2 2 bolton, latimer, clark: is there sufficient evidence to support the use of temporal artery and non-contact infrared thermometers in clinical practice? a literature review j global clinical engineering vol.2 issue 2: 8-16 ; 2020 14 despite a decent sized body of evidence, including clinical studies for the tat, the results do not support their use in a clinical setting with many studies reporting that they were inaccurate outside of the normal body temperature range. this conclusion is in agreement with meta-analyses conducted by geijer28 and niven.2 the evidence for the ncit was more limited with very few papers meeting the inclusion criteria and also did not support their use in a clinical setting for the same reasons. one of the key issues was the relatively small number of papers meeting the inclusion/exclusion criteria used in our study which then described a wide range of settings, populations, devices, comparator (standard reference) devices, outcomes including detection of fever and how the results were analyzed and reported. this wide variation in reporting and outcomes was also identified and discussed as a drawback in the meta-analysis.2–5 there was some variability in standard reference methods in the papers reviewed and none of the studies used an intravascular measure of temperature (gold standard) although one study23 did use the thermometer incorporated in the dialysis machine. typical invasive thermometry options included in these studies were either bladder or esophageal thermometers. however, the most common reference method was an electronic non-disposable oral thermometer such as the welchalleyn suretempplus. the outcomes, analysis, and reporting also differed between the studies and varied from reporting the mean differences to calculated limits of acceptability. where febrile patients were included, the reporting varied from false negative or positive rates to misclassification percentages. due to this variability, we chose to record whether the authors would recommend either the tat or the ncit device being studied for use in clinical practice. overall, from the 15 papers the described the use of tat devices, the device was in general considered to be outside the clinically acceptable limits. this is also highlighted and discussed in the recently published meta-analysis and reviews published.2,4,5 the majority of studies that found tat to be acceptable did not include patients outside the normal range and it was shown that there was less agreement for temperatures below 36°c and temperatures greater than or equal to 38°c. these studies indicate that tat is acceptable for normothermic patients only as has already been highlighted by the metaanalyses. however, several studies found tat devices to be more acceptable to patients, especially children, and more likely to record a reading at the first attempt.13,25 there were fewer papers involving the ncit and these devices were specifically excluded from the meta-analysis of niven.2 similar to the tat, these thermometers performed reasonably well in normothermic ranges but not outside this range and the study where the results were within acceptable limits did not contain any febrile patients. a study by fletcher29 looked at 9 ncits (all unnamed, 3 groups according to specification) which were calibrated using 2 npl standard blackbody sources with emissivities >0.999. ncits from 2 of the groups were shown to give large measurement errors with readings falling far outside both the manufacturer’s stated uncertainties. a third group of ncit performed well, with all the results falling within the stated uncertainties. overall, more evidence needs to be gathered as to the clinical acceptability of the ncit devices in all settings but there is potential for ncits to provide a rapid, hygienic and non-invasive means of measuring temperature, particularly in children. the evidence indicates that the tat and ncit in their current form are not well suited to detecting temperatures outside the normal range. failure to detect fever has significant consequences for patient care if the fever is missed and the patient is not treated accordingly or if fever is falsely detected, it may result in unnecessary clinical interventions. this is more critical in patients with cancer where detection of fever can be an indication of a potentially life-threatening infection.19 for both types of thermometer, both calibration and training to reduce user error was discussed as being a key factor in obtaining accurate and consistent readings. three of the studies13,19,24 specifically mentioned device training and 7 of the studies16–20,26,27 documented that the devices were calibrated by the clinical engineering department. while there was no specific literature on the usability or training for ncit, there has been a publication detailing the training and use of tat in clinical practice. barry et al.30 undertook an observational study to look at the impact of user technique on the accuracy of tat measurements. despite documented training on the 15 j global clinical engineering vol.2 issue 2: 8-16 ; 2020 bolton, latimer, clark: is there sufficient evidence to support the use of temporal artery and non-contact infrared thermometers in clinical practice? a literature review correct technique, only 39% of users demonstrated the correct technique and returned acceptable temperature measurements. the remaining 61% failed to demonstrate correct technique and recorded statistically significantly lower temperatures. the most common mistake was to scan only the forehead and to miss either the temple or under the ear. similar user mistakes have also been documented with tympanic thermometers where users fail to straighten the ear canal to direct the ir beam to the correct quadrant of the tympanic membrane.8,9,31 it is interesting to speculate how the manufacturers could use this information to redesign their products to eliminate the user error issues and thereby improve the intuitive use of the device which would in turn reduce the need for regular training to make sure the device is used appropriately. this would then enable a more accurate evaluation to determine whether, when used easily and correctly, the thermometers can measure body temperature within clinically acceptable limits and could be considered as a long-term option for thermometry. conclusions a review of the literature for both tat and ncit has indicated that in their current form neither is suitable as a replacement for oral or tympanic thermometers in clinical practice. in particular, the evidence suggests that they are not acceptable methods for detecting temperatures outside the normothermic range and do not detect fever accurately. known user errors with both tat and tympanic iret could be detracting from the usefulness of the technology. acknowledgement the authors would like to thank rob furby and david williams for their expert input and advice during this project. grant support no grant funding was obtained for this study. references 1. akata t, setoguchi h, shirozu k and yoshino j. 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26. sollai s, dani c, berti e, et al. performance of a noncontact infrared thermometer in healthy newborns. bmj open 2016;6(3);e008695. 27. stelfox ht, straus se, ghali wa, et al. temporal artery versus bladder thermometry during adult medicalsurgical intensive care monitoring: an observational study. bmc anesthesiol 2010;10:13. 28. geijer h, udumyan r, lohse g, et al. temperature measurements with a temporal scanner: systematic review and meta-analysis. bmj open 2016;6(3):e009509. 29. fletcher t, whittam a, simpson r, et al. comparison of non-contact infrared skin thermometers. j med engineer technol 2018;42(2);65–71. 30. barry l, branco j, kargbo n, et al. the impact of user technique on temporal artery thermometer measurements. nurs crit care 201611(5):12–14. 31. yeoh wk, lee jkw, lim hy, et al. re-visiting the tympanic membrane vicinity as core body temperature measurement site. plos one 2017;12(4):e1074120. https://www.community.healthcare.mic.nihr.ac.uk/reports-and-resources/horizon-scanning-reports/hs https://www.community.healthcare.mic.nihr.ac.uk/reports-and-resources/horizon-scanning-reports/hs http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/earlier_scoping_reports/technologies_scoping_report_11.aspx http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/earlier_scoping_reports/technologies_scoping_report_11.aspx http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/earlier_scoping_reports/technologies_scoping_report_11.aspx http://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/earlier_scoping_reports/technologies_scoping_report_11.aspx 5 j global clinical engineering vol.3 issue 2: 2020 received september 16, 2020, accepted october 16, 2020, date of publication october 21, 2020 international survey of clinical engineering professionals by y. david1, s. calil2, n. pallikarakis3, m. poluta4, k. stavrianou5, s. bergamasco6, d. clark7, t. judd8, j. wear9, t. easty10 1 global clinical engineering summit chairman, usa 2 clinical engineering professor, brazil 3 chairman of the institute of biomedical technology, greece 4 clinical engineer, south africa 5 ifmbe/clinical engineering division secretariat, uk 6 italian clinical engineers association (aiic), italy 7 clinical engineering, nottingham university hospitals nhs trust, uk 8 ifmbe/clinical engineering division chairman, usa 9 clinical engineering consultant, usa 10 clinical engineering professor, canada abstract to determine the maturity of a profession one must have knowledge of the individual attributes of the practitioners of that profession and the universal strength of unique skills among them. we have conducted an international survey of clinical engineering (ce) professionals associated with the management of technological tools developed for and deployed within the healthcare delivery system. the survey targeted participants who are practicing engineering tasks related to the safe and efficient management of technology used in the delivery of healthcare services. the participants, consisted of cohort of individuals whose contact information was collected from attendees at previous clinical and biomedical engineering events including: (1) presentation at congresses/regional meetings, (2) serving on international technical committees or task forces, (3) attending virtual clinical engineering events, or (4) subscribing to the global clinical engineering journal. the purpose of the survey was to identify the state of organization of ce professionals and the potential gaps, if any exists, in meeting their professional development needs. the survey was developed and conducted using on-line internet apps and links that provided access to a questionnaire in six different languages to facilitate optimal participation and response accuracy in as many geographical regions as possible. the survey was conducted in the early part of 2020 over period of 6 weeks. the overall response rate1 was over 5% (total of 14,400 individual contacts less estimated 1,750 contacts who did not open/bounced back). a total of 667 responses from 89 countries were received. this survey is considered an improvement, over previously reported international surveys,2,3 with regard to response volume and rate. the strength of this survey, having larger response volume and geographical representation, when compared with previously documented ce surveys has improved even with narrower time window of data collection. the current survey consisted of twelve questions, beginning with information request about the respondent professional affiliation and moves on to request the ranking of the criticality of c.e. specific issues, while another question provided for comments in free formatting text style. the responses received were in all of the seven languages posted and included representation from all the continents. the analysis of the survey responses shows that about 60% of the responders identified themselves as clinical engineers, 16% as other type of engineers, 13% as technicians, and 12% as health professionals. responses to particular questions demonstrate highest ratio of number of affirmative to negative responses. they were related to the perceived value responders placed on stronger international collaboration and on their willingness to engage in it. a conclusion, based on the analysis of the responses to this international survey, that the ce profession is awaiting the consolidation of the momentum generated by growing healthcare needs and present global conditions. the identified gap is lack of a dedicated international representation that is clearly identifiable within the ce field. analysis of the survey data suggests the need of an international framework focusing on the various ce professional groups/associations and their members to face present challenges. the establishment of a global alliance to clearly identify the field of clinical engineering; to promote public awareness; to form liaison with government agencies and other healthcare decision makers, will improve global cooperation and inter ce societal relations that will serve patients as well. keywords – clinical engineering, survey, questionnaire, global, association, professional, technicians, health, international, alliance, collaboration. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ david et all: international survey of clinical engineering professionals 7 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 6 david et all: international survey of clinical engineering professionals the optimal survey format to be used is based on literature of systematic survey and analysis of the use of international population surveying methods in various other fields. our survey used a questionnaire template style following an introductory statement about its purpose and identifying its administrators and timetable for response acceptance. clear and simple questions’ language, together with a small number of questions and the use of multiple-choice questions style were all intended to help increase survey response rate.11 since the total size of the international community of practicing c.e. is unknown at present and the response rate of previous survey was low9 the sampling methods for this research study was probability sampling12 where members of the community are chosen randomly. the survey questions were translated into six different languages, in addition to english, to facilitate better response rate from the different continents and countries. the languages used included: english, spanish, french, arabic, chinese, french, and russian. a short introductory that preceded the questionnaire explained for the community who received it the survey’s purpose and the importance of completing the questionnaire. it is presented in figure 1 below. the questionnaire consisted of twelve questions, eight of them (shown in table 1 below) having multiple choice answers, three asking for additional information and one provides space for free text format at the end of the questionnaire to collect un-prescribed comments. the last question asks the responders for ranking of professional challenges faced by the clinical engineer practitioners. the main questions are shown in the following table 1 below and the full questionnaire in its original form is found in the appendix. table 1. questionnaire format question response are you a member of one of the following professional groups: engineer a clinical/biomedical engineer engineer (other) clinical engineering technician (bmet) scientist healthcare scientists healthcare professional professional (other) do you have a representative clinical engineering association/society in your country? yes no i do not know are you a member of the association/ society and do you participate in their meetings or programs? yes i am a member, and participate in its meetings/activities yes i am a member, but do not participate in its meetings/activities not yet, but plan to do so in the future no are there any higher education-based programs in the area of clinical engineering offered in your country? yes no i do not know would you volunteer a few hours a month to help advance clinical engineering and its application and impact locally and globally? yes no i am not sure do you see value in an international organization focusing the needs of clinical engineering? yes no i am not surefigure 1. introduction explaining the purpose of the questionnaire. introduction the dependency of healthcare systems on technology for the delivery of their services is at an all-time high and projected to continuously grow.4,5 in addition, costs associated with the provisioning of healthcare programs are showing an increasing trend to consuming a large portion of total national gross product.6 to maximize patient care outcomes and to achieve optimal return on the investment in healthcare technology, it is important to manage the healthcare technology life cycle. this is the main area that clinical engineers, and related technologists and technicians are trained to apply their respective competencies to cost effectively manage and service healthcare technology. to meet the need to determine how well optimal management of healthcare technology is improving the ability of care providers to practice their profession, fundamental data must be collected relating to how well the needs of the professionals who manage and service this industry are being met.7 the authors intended to gain new knowledge about the needs of ce practitioners. specifically, how to overcome lack of opportunities for sustaining sharing of knowledge between international clinical engineering practitioners due to limited clinical engineering professional associations knowledge sharing and exchanging. other researchers attempted, in previous work, to determine availability and the extent of ces responsibilities were deployed by using survey methodology and concluded that lack of harmonization and wide variation are evident in the management of hospitals biomedical technology around the world.8 reported results of one of the early surveys looked at ce effectiveness at hospitals in developing countries included 163 responses from 43 countries mostly from africa, latin america and asia.9 this survey states “this is the first study to collect and analyze data on the complexity and state of hospital equipment across the developing world; additionally, it is the first to collect significant responses from africa. prior to this study, only 10 developing countries had been profiled in international studies.” to increase knowledge of a field of practice and to identify attributes of practitioners in that field can be accomplished through a survey. however, limited response volume and the only few published surveys recorded in the international ce field highlight the challenge that this work is addressing in an attempt to gain understanding of current state of the ce profession needs. a survey that directly seeks answers from the involved community according to industry norms suggests that “wherever possible, researchers should use existing data, and not bother people again with questions they have already answered in other surveys or can be found in registers.”10 the international handbook of survey methodology7 identifies a survey as “a study that collects planned information from a sample of individuals in order to estimate particular population characteristics.” it further concludes that “although sample surveys are costly and time-consuming, it may turn out that they are in many situations simply the best instrument for collecting high quality, relevant data.” we designed the optimal survey format to be used. it is characterized by short content without open ended style, and yet providing for free text format area at the end of the survey to collect additional information not included within the formal set of questions. methodology one specific form of data collection method was an online survey consisting of a set of structured questions that can be clearly understood by the expected respondents. the online survey delivers advantages of being easy to respond to and efficient to analyze, having a low margin of errors as respondents select buttons and can easily change or correct their choices prior to submission. available on-line tools can be used to analyze the data in variety of determinants. in addition, the survey was offered online with applications that could be easily be read and responded to on a working station, tablet, as well as other mobile devices. most surveys have a goal of being able to make inferences about points of interest in the target population. in general, one is faced with the need to make assumptions that the persons in the data collection sample are similar on the characteristics of interest to persons not in the sample to be able to make inferences about the population. as such, the design of a survey is critical to its success, and therefore special attention should be given to fit the survey design and structure the questions to clearly preventing possible errors that responders may commit. david et all: international survey of clinical engineering professionals 9 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 8 david et all: international survey of clinical engineering professionals the fourth question asked if the respondent is a member of such an organization and do you participate in its meeting or activities; 48% responded that yes, they are members and participate. while 17% wrote that they are members but do not participate, while 20% said that they are not but planned to join in the future, and 15% replied with no, as shown in figure 4 below. the fifth question asked about higher education-based programs being offered in the field of ce in your country? responses were 74% yes, 17% no, 9% i am not sure. the sixth question asked: would you volunteer a few hours a month to help advance clinical engineering and its application and impact locally and globally? the answers show distribution of 86% yes, 4% no, and 10% not sure. the two questions that received the highest ratio of positive to negative responses were question number 7 and question 8, shown in table 3 below. question number 7: do you see value in an international organization focusing the needs of clinical engineering? this question registered the highest positive responses with 93% yes, 2% no, and 5% not sure. question seven is important for the understanding of the responders’ level of perceived value and need for global organization to unite the ce field. to the question eight: “would you participate in the activities of such an organization?”, 84% replied with yes, 4% with no, and 12% were not sure. next, responders were asked to rank in order of importance eight topics, shown in table below. these topics were discussed at the global ce summits13 that show continuous growing attendance over the last five years as during the 2019 third international ce and htm figure 3. graphical representation of the results of question #1: are you a member of one of the following professional groups?. figure 4. graphical representation of the results of question #4: are you a member of the association/society and do you participate in their meetings or programs? table 3. responses to survey questions # 7 & #8 question response do you see value in an international organization focusing the needs of clinical engineering? yes 612 93% no 13 2% i am not sure 32 5% would you participate in the activities of such an organization? yes 553 84% no 28 4% i am not sure 76 12% table 1. questionnaire format (continue) results the volume of responses to the survey that were collected over relatively short time ( six weeks) suggests that the survey was clear to understand and that subject matter was of interest to responders. as a matter of fact, the average time to complete the survey was measured to be 11:27 minutes for desktops, over 3 minutes for tablets, and over 8 minutes for mobile devices all respectfully for users of the english language. it is also interesting that although the number of responses from english speaking countries like usa, uk, ireland, canada, and australia accounted for 121 participants, the number of survey responses in the english language was 282; suggesting that individuals found the survey questions to be sufficiently clear even as a second language. responses were received from all the continents and are shown in figure 2 below. the blue color indicates location from where responses were received, and the color intensity indicates volume of responses with darker blue means larger volume. the first question was about the professional standing of the respondent. of the total of 669 responses received: 59% of the respondents identified themselves as clinical or biomedical engineer, 16% identified themselves as other type of engineer, 13% identified themselves as clinical engineering technician, healthcare scientists were checked at 5%, healthcare professional at 4%, and other professional were marked 3%. a graphical presentation of the results of question number # 1 is shown in figure 3 below. the second question addressed information about the prevalence of ce national societies, where 73% answered that they have such an association or society, 20% did not, and 7% were not sure. question response would you participate in the activities of such an organization? yes no i am not sure what are the top challenges we should address? (you can add your own at the end of the list) education-training recognition professional standing-credentialing engagement with leaders networking career progression publication opportunity other figure 2. world map showing in levels of color intensity origin of the responses received. table 2. questionnaire participation by continent continent participation australia 23 africa (rwanda, nigeria, ghana, ethiopia, uganda, egypt, kenya, bhutan, zambia, somalia, zimbabwe, south africa, senegal, benin, cameroon, niger, tanzania, botswana) 76 north america (usa, canada, mexico, el salvador, costa rica) 101 south america (brazil, peru, colombia, venezuela, argentina, ecuador, bolivia, chile, cuba, puerto rico, uruguay) 200 asia (china, india, lebanon, bangladesh, bhutan, bahrain, japan, jordan, nepal, pakistan, philippines, qatar, saudi arabia, singapore, turkey, united arab emirates, yemen, syria) 142 europe (italy, france, uk, ireland, spain, portugal, greece, germany, latvia, netherlands, sweden, bosnia and herzegovina, czech republic, russia) 86 david et all: international survey of clinical engineering professionals 11 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 10 david et all: international survey of clinical engineering professionals collaborations across areas and on issues better resolved on an international level. as such, the establishment of a global structure clearly identifying unified field of clinical engineering that will: promote public awareness; form liaison with government agencies and other healthcare decision makers; and improve international cooperation and inter societies relations and will ultimately support better patients care and wellness everywhere. acknowledgements the authors would like to thank all of the translators who helped convert the questionnaire from english into additional total of six languages. german giles (spanish), saide calil (portuguese), farid riad (arabic), zheng kun (chinese), andrei issakov (russian), nicolas pallikarakis (french). references 1. m. clark, m. rogers, a. foster, f. dvorchak, f. saadeh, j. weaver, v. mor: a randomized trial of the impact of survey design characteristics on response rates among nursing home providers eval health prof. 2011;34(4):464-486. doi:10.1177/0163278710397791. 2. l. nascimento, s. calil, t. judd, y. david: analysis of ifmbe-ced 2017 worldwide clinical engineering survey, global clinical engineering journal, vol. 2, issue 1, december 2019 https://doi.org/10.31354/ globalce.v2i1.70 3. m. frize, x. cao, i. roy: survey of clinical engineering in developing countries and model for technology acquisition and diffusion, proceedings of ieee, 2005 embs 27th annual conference, shanghai, china, sept. 1-4, 2005. https://ieeexplore.ieee.org/abstract/ document/1616369 4. j. dyro: clinical engineering: evolution of a discipline, clinical engineering handbook, chapter 1, elsevier academic press series in biomedical engineering, usa, 2004. 5. clinical engineering handbook, e. iadanza (ed.), chapter 1, second edition, academic press, elsevier 2020. https://www.elsevier.com/books/ clinical-engineering-handbook/iadanza/978-012-813467-2?countrycode=us&format=print& utm_source=google_ads&utm_medium=paid_search&utm_ campaign=usashopping&gclid=cjwkcajw4rf6braveiwan2q76u0eu1bxj0asb7pyrsprovmzqwmpljh6bfxjq2k9b1xkm0rlqmbygxoceiyqavd_bwe 6. american institute for medical and biological engineering, wiley encyclopedia of biomedical engineering, april 2006. https://www.wiley.com/en-us/wiley+e ncyclopedia+of+biomedical+engineering%2c+6+v olume+set-p-9780471249672 7. de leeuw, e. d., hox, j. j., & dillman, d. a. (eds.). international handbook of survey methodology. taylor & francis group/lawrence erlbaum associates. (2008). https://psycnet.apa.org/record/2008-04187-000 8. m. glouhova, n. pallikarakis: world clinical engineering survey, clinical engineering handbook, chapter 15, elsevier academic press series in biomedical engineering, usa, 2004. 9. s. mullaly, m. frize: survey of clinical engineering effectiveness in developing world hospitals: equipment resources, procurement and donations, conference proceedings ieee/embs 2008, doi: 10.1109/ iembs.2008.4650212. 10. d. korniewicz, t. clark, y. david: a national online survey on the effectiveness of clinical alarms, american journal of critical care 17 (1):36-41, january 2008. https://aacnjournals.org/ajcconline/articleabstract/17/1/36/643/a-national-online-survey-onthe-effectiveness-of?redirectedfrom=fulltext 11. part iv culture, cognition and response in survey methods in multinational, multiregional, and multicultural contexts, edited by harkness et al. 2010, john wiley & sons, inc. https://www.researchgate.net/profile/ daphna_oyserman/publication/230015384_cognition_ communication_and_culture_implications_for_the_survey_ response_process/links/59eccf864585151983ccd415/ cognition-communication-and-culture-implicationsfor-the-survey-response-process.pdf 12. b. schouten, f. cobben, j. bethlehem: indicators for the representativeness of survey response, survey methodology, june 2009, vol. 35, no. 1, pp. 101-113 canada. https://www.researchgate.net/profile/ jelke_bethlehem/publication/267836796_indicators_for_the_representativeness_of_survey_response/ congress, rome, italy, having record number of accepted abstracts and of international participation.14 the top challenges that needed to be addressed were listed. the analysis of the survey results shows the following order for the challenges as were ranked by responders: discussion and conclusions most of previously reported surveys conducted in the clinical engineering field resulted in relatively small response volume and rate. these surveys were discussed in the introduction segment of this manuscript. the present survey was distributed and available for response for shorter time duration than the previous surveys and yet the volume of the responses was higher. the results of this clinical engineering international survey provide representative data that suggest gaps in building sustainable global exchange of knowledge and professional networking between groups/associations of clinical engineering practitioners. the survey essentially composes of two parts. the multiple-choice questionnaire (part i) and the ranking of challenges and free text (part ii). the results from part i, deem to suggest that a positive change taking place in the ce field reflected by growth in the volume of the number of national ce associations around the world as reflected by the relatively high confirmation response rate to question two “do you have ce association in your country?” (73%) and to question four about participation in such association (48%). in yet another demonstration, for same phenomenon observed by the data, is the high positive response to the question about availability of higher education-based program in your area (74%). however, this stands in contrast to the results analyzed for part ii the ranking of the top challenges the responders are facing. the data clearly reveals that the most important challenges responders face are limited availability of education and training (446 responses), follow by lack of professional recognition (361 responses), and by absence of professional credentialing programs (337 responses). all other listed challenges recorded less than 200 responses each, placing higher significant on the top three. the data also sufficiently demonstrate a clear and overwhelming positive response for the value seen in having international organization that will focus on ce needs (612 responses) as well as for responders’ intention to participate in such an organization (553 responses). it is also revealing to see that only 2% of the responders (13 responses) do not perceive of such a value. the combination of the results of (part i ) of this questionnaire with the ranking of top challenges the ce field is facing (pat ii), with also the growing attendance at international ce congresses, and the recent increase volume of ce publications15 – reveals a ce field in the midst of a professional evolution in need of leadership to further facilitate its important impact on healthcare programs. the survey highlighted the state of ce associations, networking, professional challenges, and the desire for more international cooperation that leads needed professional development programs. programs that support expansion of skills, job responsibilities and equal participation in healthcare teams. patient care outcomes stand to improve when healthcare technology is optimally managed. identifying the global challenges faced by international community of ces is the first step towards overcoming them and the shared goal of better healthcare outcomes can then be better guided. establishment of global collaboration and structure to achieve partnerships will help to overcome barriers, support professional development, and increase recognition, as well as addressing other challenges facing the ce profession. based on the analysis of the survey data, one such initiative can be to unify the global ce field and provide a framework for the various professional groups/associations and their members with continuous opportunity for table 4. questionnaire results show order ranking of top challenges in current ce field challenges in ce field answers education-training 446 recognition 361 professional standing-credentialing 337 engagement with leaders 270 networking 230 career progression 299 publication opportunity 184 other 31 https://doi.org/10.31354/globalce.v2i1.70 https://doi.org/10.31354/globalce.v2i1.70 https://ieeexplore.ieee.org/abstract/document/1616369 https://ieeexplore.ieee.org/abstract/document/1616369 https://www.elsevier.com/books/clinical-engineering-handbook/iadanza/978 https://www.elsevier.com/books/clinical-engineering-handbook/iadanza/978 https://www.wiley.com/en-us/wiley https://psycnet.apa.org/record/2008 10.1109/iembs 10.1109/iembs https://aacnjournals.org/ajcconline/article-abstract/17/1/36/643 https://aacnjournals.org/ajcconline/article-abstract/17/1/36/643 https://www.researchgate.net/profile/daphna_oyserman/publication/230015384_cognition_communication_and_culture_implications_for_the_survey_response_process/links/59eccf864585151983ccd415/cognition-communication-and-culture-implications-for-the-survey-response-process.pdf https://www.researchgate.net/profile/daphna_oyserman/publication/230015384_cognition_communication_and_culture_implications_for_the_survey_response_process/links/59eccf864585151983ccd415/cognition-communication-and-culture-implications-for-the-survey-response-process.pdf https://www.researchgate.net/profile/daphna_oyserman/publication/230015384_cognition_communication_and_culture_implications_for_the_survey_response_process/links/59eccf864585151983ccd415/cognition-communication-and-culture-implications-for-the-survey-response-process.pdf https://www.researchgate.net/profile/daphna_oyserman/publication/230015384_cognition_communication_and_culture_implications_for_the_survey_response_process/links/59eccf864585151983ccd415/cognition-communication-and-culture-implications-for-the-survey-response-process.pdf https://www.researchgate.net/profile/daphna_oyserman/publication/230015384_cognition_communication_and_culture_implications_for_the_survey_response_process/links/59eccf864585151983ccd415/cognition-communication-and-culture-implications-for-the-survey-response-process.pdf https://www.researchgate.net/profile/daphna_oyserman/publication/230015384_cognition_communication_and_culture_implications_for_the_survey_response_process/links/59eccf864585151983ccd415/cognition-communication-and-culture-implications-for-the-survey-response-process.pdf https://www.researchgate.net/profile/jelke_bethlehem/publication/267836796_indicators_for_the_representativeness_of_survey_response/links/547458fc0cf245eb436dd8ae/indicators-for-the-representativeness-of-survey-response.pdf https://www.researchgate.net/profile/jelke_bethlehem/publication/267836796_indicators_for_the_representativeness_of_survey_response/links/547458fc0cf245eb436dd8ae/indicators-for-the-representativeness-of-survey-response.pdf https://www.researchgate.net/profile/jelke_bethlehem/publication/267836796_indicators_for_the_representativeness_of_survey_response/links/547458fc0cf245eb436dd8ae/indicators-for-the-representativeness-of-survey-response.pdf david et all: international survey of clinical engineering professionals 13 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 12 david et all: international survey of clinical engineering professionals appendix ii full questionnaire in english. links/547458fc0cf245eb436dd8ae/indicators-for-therepresentativeness-of-survey-response.pdf 13. the global clinical engineering summit, 3rd icehtmc congress, rome, italy, 2019. https://ced.ifmbe.org/ blog/ifmbe-ced-cestatus-cesummit2019.html 14. international clinical engineering and health technology management congress, rome, italy, october 21-22, 2019. http://www.icehtmc2019.com/papersubmission.html 15. making a difference – global health technology success stories: overview of over 400 submissions from 125 countries. global journal of clinical engineering, vol.1, no. 1, 2018. https://www.globalce.org/index. php/globalce/article/view/43 appendix i the following question was selected as an example for the use of multilanguage translation (english, portuguese, arabic, chinese, french, russian and spanish) and are shown in their original posting in the figures below. https://www.researchgate.net/profile/jelke_bethlehem/publication/267836796_indicators_for_the_representativeness_of_survey_response/links/547458fc0cf245eb436dd8ae/indicators-for-the-representativeness-of-survey-response.pdf https://www.researchgate.net/profile/jelke_bethlehem/publication/267836796_indicators_for_the_representativeness_of_survey_response/links/547458fc0cf245eb436dd8ae/indicators-for-the-representativeness-of-survey-response.pdf https://ced.ifmbe.org/blog/ifmbe-ced-cestatus-cesummit2019.html https://ced.ifmbe.org/blog/ifmbe-ced-cestatus-cesummit2019.html http://www.icehtmc2019.com/papersubmission.html http://www.icehtmc2019.com/papersubmission.html https://www.globalce.org/index.php/globalce/article/view/43 https://www.globalce.org/index.php/globalce/article/view/43 david et all: international survey of clinical engineering professionals j global clinical engineering vol.3 issue 2: 2020 14 35 j global clinical engineering vol.2 issue 3: 2020 received march 6, 2020, accepted april 17, 2020, date of publication may 21, 2020 development of a biomechatronic device for motion analysis through a rgb-d camera by f. pristerà1,3, a. gallo2,3, s. fregola2,3, a. merola1 1 department of experimental and clinical medicine, università magna graecia di catanzaro 2 ethoslab s.r.l 3 ianuslab. abstract this work investigates the validity and reliability of a novel biomechatronic device providing an interactive environment in augmented reality (ar) for neuromotor rehabilitation. an rgb-depth camera and telemonitoring/remote alert module are the main components of the device, together with a pc-based interface. the interactive environment, which implements some optimized algorithms of body motion capture and novel methodologies for human body motion analysis, enables neuromotor rehabilitation treatments that are adaptable to the performance and individual characteristics of the patient. the rgb-depth camera module is implemented through microsoft kinect, orbbec zed2k devices; the telemonitoring module for teleassistance and therapy supervision is implemented as a cloud service. within the module of body motion tracking, the abduction and adduction movements of the limbs of the full-body structure are tracked and the joints angles are measured in real-time; the most distinctive feature of the tracking module is the control of the trunk and shoulder posture during the exercises performed by the patient. indeed, the device recognizes an incorrect position of the patient's body that could affect the objective of the exercise being performed. the recognition of an incorrect exercise is associated with the generation of an alert to both the patient and the physician to maximize the effectiveness of the treatment based on the user's potential and to increase the chances of getting better biofeedback. the experimental tests, which have been carried out by reproducing several neuromotor exercises within the interactive ar environment, show that the feature recognition and extraction, both of joints and segments of the musculoskeletal structure and wrong postures of the patient can achieve good performance in several experimental conditions. the developed device is a valid tool for patients affected by chronic disability, but it could be extended to neurodegenerative diseases in the early stages. thanks to the enhanced interactivity in augmented reality (ar), the patient can overcome some difficulties during the interaction with the most common it tools and technologies; also she/he can perform rehabilitation at home. the physician can also check the therapeutic results while customizing the care pathway in real-time. the enhanced interactivity, provided by the device during rehabilitation sessions, increases the patient’s motivation and the continuity of care, as well as supporting low-cost remote assistance and telemedicine which optimizes therapy costs. the key points of the developed devices are: 1. making rehabilitation motivating the patient to become an active “player.” 2. optimization of therapy effectiveness and costs. 3. the possibility of low-cost remote assistance and telemedicine. keywords – body motion analysis, smart rehabilitation, home rehabilitation, biomechatronic device. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org pristerà, gallo, fregola, merola: development of a biomechatronic device for motion analysis through a rgb-d camera j global clinical engineering vol.2 issue 3: 2020 36 introduction gesture recognition refers to the recognition of significant expressions of a motion made by a person using hands, arms, head, or other parts of the body.1 this gesture recognition provides a wide range of applications such as: • development of aids for the hearing impaired. • support for children interacting with computers. • monitoring of emotional states or stress levels of patients. • navigation and/or interaction in virtual environments. • communication in video conferencing. • support for patients with specific physical interaction difficulties with machines and computers. in the last few years, to make more natural and intuitive the environmental interactions with computers new research topics are exploring the direct use of hand gestures, without the use of mouse or joystick, to communicate with machines. the use of controllable interfaces through hand gestures can provide: • a more natural interaction with the machine since the gestures are a natural form of communication and easy learning; • a more powerful and effective interaction mediated by the device that acquires both hand position and the trajectories of the extremities of the upper limbs. a single gesture can be acquired by the interface to identify both a target object and the action to perform on it; and • direct interaction from a cognitive point of view where the hand becomes the input device, without needing to intermediate transducers. some studies on the use of gestures for human communication have detected that 70– 80% of verbal messages during a dialog may be expressed exclusively through gestures that involve all parts of the body.2 systems that exploit interactions mediated by gesturerecognition technologies can also provide a valuable tool for people with limited motor skills by allowing an efficient human-machine interaction based on a limited set of gestures or body movements. ar could also return to prominence by becoming a promising form of investment in military, entertainment and medical industries. especially in clinical rehabilitation, ar can improve the experience of patients by increasing the effectiveness of treatment.3 the main feature of ar systems is the ability to adapt the experience of a patient to his real physical ability.4 furthermore, the arrangement of the joints and the measured value of joint angles must be taken into account. this allows the patient to objectively assess the effectiveness of treatment with the possibility of increasing the biofeedback.5 the real-time monitoring and measurement of the user's performance can provide biofeedback and, consequently, also aid in the evaluation of improvements or deterioration of the patient’s performance. the evaluation of the performance can be achieved based on of some performance indices and clinical protocols see.4 there is evidence that most patients can benefit from virtual reality rehabilitation. this includes patients who have had strokes,5 patients who need to recover limb motor skills in general,6 patients who need to perform neurorehabilitation in the early stages of recovery,7 as well as the elderly, children, and anyone who needs to work on posture or balance.4 this study aims to develop and test a rehabilitation device that motivates the patient to become a "player," by optimizing both the effectiveness and costs and provides the possibility of implementing, in a clinical and/ or domestic context, low-cost and remote assistance and telemedicine services. the current study is part of a more complex project that takes into account the following main steps: step-1: identification and preliminary testing of different commercial devices using the rgb-d camera for rehabilitation purposes and analyzing different rehabilitation scenarios to conceptually represent the entire rehabilitation process. step-2: building the first prototype using commercial hardware and implementation of dedicated software for image acquisition and processing. step-3: testing of the prototype and the software in a simulated but real context. at this point, all the components of the device are globally tested and compared to standard clinical practice (process and tools). 37 j global clinical engineering vol.2 issue 3: 2020 pristerà, gallo, fregola, merola: development of a biomechatronic device for motion analysis through a rgb-d camera step-4: the rehabilitation protocol implemented is extended into the prototype. step-5: the system moved to the experimental stage and was tested on large scale involving different clinical partners to produce data for assessment of the device performance, not just on hardware but considers the whole process of rehabilitation mediated by the biomechatronic device. currently, we are working on the step-3 of the project and this paper describes the experimental results obtained on the performance during the interaction of the patientbiomechatronic device within the ar environment. materials and methods body motion capture and motion analysis in an environment for interaction in ar is based on the use of a rgbdepth camera (microsoft kinect) and video output devices (pc monitor or projector); the interaction environment is conceived to support adaptive and customized neuromotor rehabilitation during some exercises that promote the interaction between the patient and the device. the system, as shown in figure 1, can be divided into 3 distinct macrophases: (1) a phase of pre-processing carried out on each captured frame, which allows to segment one or more human figures; (2) a conversion phase that allows converting the obtained image into a segmented model, functional to the next step and achieved at low computational burden required for the extraction of the points in order to track the different parts of the body (arms, legs, and head); (3) a post-processing phase that allows the extraction of the movement. the flow diagram shown in figure 2 summarizes the steps point by point. steps 1, 2, 3, and 4 are made by recalling the microsoft's kinect for windows sdk functions, while the following steps (5, 6, and 7) have been developed specifically for the functions made available in processing, a real open-source programming language that has enabled the acquisition and the elaboration of the data stream from microsoft kinect and other compatible devices. the presentation and the discussion of the results obtained for the rehabilitation of the upper limb are discussed in the next sections. the main features of the device are (1) tracking of the body, (2) calculation of detected angles; (3) posture control, and (4) performance acquisition. figure 1. main phases of the system. figure 2. flow diagram of the algorithm used to process the patient data during the rehabilitation session. pristerà, gallo, fregola, merola: development of a biomechatronic device for motion analysis through a rgb-d camera j global clinical engineering vol.2 issue 3: 2020 38 1. the basic algorithm can able to identify the body joints and to track their position. the tracked movements of abduction and adduction of the upper limbs are visualized in real-time and in ar and the visual support to the patient improves the execution of movements and the patient’s performance. 2. the calculation of the joint angle detected on the tracked limbs during in the different opening and closing positions and the visualization of the values of the angular displacements are carried out in real-time. in this step, the variables and constants are initialized for the right and left upper limbs. 3. posture control during the exercise execution is determined by 2 methods “shoulder check” and “body check.” 4. the device starts to acquire the patient’s performance and then checks the correct posture at a constant acquisition rate during the rehabilitation session. finally, the output is stored and transferred to the cloud service. to develop our rehabilitation prototype, we used a microsoft kinect. it consists of an rgb camera with a resolution of 640 × 480 pixels to 1280 × 1080 at 30 hz that can be increased at the expense of a drop in frame-rate. the same device is equipped with a depth camera consisting of an infrared projector and a monochrome cmos camera with a resolution of 320 × 240 pixels. finally, an array of 4 microphones for listening to voice commands is integrated into the microsoft kinect. for both cameras, the viewing angle is 57.5 degrees in horizontal line and 43.5 degrees vertically, with the possibility of extending the last one by 54 degrees thanks to the inclination platform that is equipped with a motor that rotates the sensor to automatically center the user. other features are 3 optical devices for visual recognition of the moving body, 2 video cameras and an additional infrared sensor, and a kionix kxsd9 three-axis accelerometer.8 each patient is analyzed separately. this choice allows the focus to be on the blob of each patient that can be extracted from the background. in the developed model, the main steps of the proposed system have been identified as solutions to the following problems listed below. • what technique is adopted for segmenting the human figure? • which parts of the body are recognized and the related movements to be tracked, with low computation burden, by optimizing the precision/performance ratio of the recognition and tracking algorithm implemented into the device? once the above problems are solved, the selection and the development of the algorithms for detection and tracking of the target movements of the body have been performed. the identification of the points of the body segments as target features, which are important to describe an action and to track body motion, takes into account all the points of the image and provides an estimate of all points in the form of a "line" according to the following 5 variables below. 1. the expected position of the patient (for example standup). 2. what point is detected and its anatomical name. 3. the environmental characteristics of the scene such as the illumination level of the room. 4. the patient’s position is centered into the scene. 5. the cartesian coordinates of the joints of the tracked musculoskeletal structure. for the study of movement, the approach used is based on an algorithm that calculates the opening angle of the upper limb. after the identification of the skeletal segments and joints, the next step is to calculate the joint angles of the musculoskeletal structure from the cartesian coordinates extracted from the segmentation image data. after presenting the principles functional features of the rehabilitation system and before evaluating the motion tracking performance, the approach taken for implementing the overall system, made by the user interface and body motion analysis module, is presented here. since the software is intended for a target group of patients with motor problems but also for a target group that is halfway between rehabilitation and neurodegenerative diseases, the model developed was designed to be as intuitive and easily manageable as possible. the 39 j global clinical engineering vol.2 issue 3: 2020 pristerà, gallo, fregola, merola: development of a biomechatronic device for motion analysis through a rgb-d camera font size of the text was chosen according to the reading from a certain distance and red was the color chosen to make it immediately visible to the patient. first of all, we note the division of the rehabilitation interface into 2 areas regarding the exercises to be performed with the right arm (top right), with the left arm (top left). also, for each limb, the visual output of the detected angle is given. in the middle of the window, the mirror image of the patient detecting depth is displayed on the screen in real-time. the mirror image allows the patient to better coordinate body movement and also to identify the target joints and segments of the skeletal structure on which the therapy is focused. once the recognition by the kinect has been performed, a sequence of segments and a series of ellipses in a yellow, red, green, or blue color is used to highlight the joint junctions. the procedure that allows us to understand where the joints inside the human skeleton are located is called pose recognition in parts, and it is realized starting from the depth image. the approach used refers to modern and robust techniques in object recognition based on the principle of subdivision of objects into parts. the kinect obtains 3-d information from the analyzed scene by creating a depth map within it. this map is normally obtained through a stereovision system but the kinect is not such a system as it is equipped only with a color camera, a depth camera, and an infrared emitter.9–10 the solution adopted was that the infrared emitter projects a large number of light spots into the environment whose distribution, at first sight, seems random. the emitted pattern is visible by turning off the lights and framing the environment with a digital camera. the optical sensors contribute by providing the primesense ps1080-a2 chip with the necessary data to create an image containing depth information related to the observed scene. this image also contains a certain amount of information related to the distortion of the spots with respect to their ideal position. in this way, the kinect determines the distance of the objects in the scene and their conformation. after recording a depth image of the observed scene, the next step of the process involves the software execution of the tracking algorithm that identifies the number, the position, and the skeletal joints of the human skeletal structure that are to be tracked. microsoft's tracking algorithm11 is the result of 500,000 samples of recorded data concerning different human behaviors (dancing, moving, greeting, etc.). the tracking data is processed in real-time and provided to the computer where the microsoft kinect is interfaced. a result of this tracking is the skeleton data will be available as a skeleton object, obtained by calling the getskeleton() function. the position and orientation of each articulation are stored into the skeletonjoint object, which can also be obtained by using the skeleton.getjoint() function. to obtain information about the various joints, such as position and speed, to measuring user attention, or to draw the skeletal model (joints), is it possible to use the function jointtype joint = user.getskeleton().getjoint(jointtype. (anatomical part of interest)) which will return an object of jointtype type giving information about the target joint. this provides a general method for the representation of open kinematic chains, and the attachment of reference systems to the joints to determine their characteristic parameters as shown in figure 3. figure 3. arm joints used for the kinematic model. skeleton.getjoint user.getskeleton pristerà, gallo, fregola, merola: development of a biomechatronic device for motion analysis through a rgb-d camera j global clinical engineering vol.2 issue 3: 2020 40 once defined the reference systems and assigns constants representing the lengths of the various links: a) the length of the shoulder b) the length of the arm c) the length of the forearm detection of the position of the arm joints while previous problems are more theoretical, the first practical problem concerns the angles measuring the arm joints and then the data output for the display device and remote monitoring. to solve this problem, we reference the joints j1 and j2 as shown in figure 4. to calculate the angles of the arm joints, the position in the cartesian space of the joint are taken from the image data stream. we consider 3 basic elements of the arm (shoulder, elbow, and wrist) to obtain the tracked angles. the calculation of these 2 angles of the shoulder and elbow is based on trigonometric transformations (atan and asin functions) from the position in the cartesian space of the joints identified by the tracking module. to calculate the angles of the various arm joints, a count_step method has been developed that uses the kinect libraries to detect the position in cartesian space of the 3 fundamental elements of the arm (shoulder, elbow, and wrist) and then algebraically obtain the angles. from the trigonometric projection of figure 6, the angles are derived from the position in cartesian space of the points identified by microsoft kinect device. float m1=0; float m2=0; float p1x = joints[jointtype1].getx(); float p2x = joints[jointtype2].getx(); float p1y = joints[jointtype1].gety(); float p2y = joints[jointtype2].gety(); m1 = (p1x-p2x); m2 = (p1y-p2y); int a1= (int) math.abs(((math.atan(m2/m1))*100 / math.pi)); figure 4. variation of the angle in the abduction–adduction movements. figure 5. the image shows the initial values of the patient. figure 6. projection and angle calculation. math.abs math.atan math.pi 41 j global clinical engineering vol.2 issue 3: 2020 pristerà, gallo, fregola, merola: development of a biomechatronic device for motion analysis through a rgb-d camera the algorithm involves the calculation of the arguments of the atan function in terms of the increments m1 and m2 along x-axis and y-axis respectively. the values of the cartesian coordinates of the 2 joints on the same musculoskeletal segments are used to calculate the angle. the results show the device can measure a joint angle with a margin of error of +/1°. the margin error has been estimated by comparison with a set of repeated measurements performed on the shoulder through a set of protractors commonly used by physiotherapists. the experimental tests have shown that the system is also capable of checking the patient's correct posture. an alert is generated if the patient's shoulders or body are in an incorrect position, by taking also into account a threshold interval such as around a reference angle of 0° achieved by the shoulder during the horizontal position of the upper arm. the device displays a warning on the ar interface by giving the patient information about the type and side of the wrong position. the same information is transmitted by email to the therapist at the end of the session by the telemonitoring module through a report collecting the number and types of the patient’s errors. if the subject's position is incorrect, performance will be paused until the subject resumes the correct posture to perform the exercise. examples of wrong positions detected are shown in figure 7 and figure 8. results the device performance has been tested in: • a controlled environment with only people who want to interact with the system present in the field of view of the webcam; • a heterogeneous background for each test performed where the background has heterogeneous characteristics (shades, shadows); and • short distances where the distance between the patient and the location of the webcam (and screen) does not exceed 3 meters. during the tests performed during rehabilitation sessions on the upper limbs, the points that identify the joint junctions are almost always detected correctly, obtaining good accuracy. the device uses a detection algorithm of a wrong posture during rehabilitation sessions. the algorithm has taken into account 2 reference points for the body and the shoulder, and calculate a gradient. if the slope is greater than a threshold, the device does not consider the wrong exercise. table 1 shows the values measured in a patient session. abduction–adduction of the right and left arms the movement starts with the arm in the rest position and the counter is increased only when the arm is at 90° relevant to the bust and returns to the initial position. if the patient performs the movement "by half," meaning it reaches an opening lower than the established ones, the counter is not increased. the actual repetition count only occurs if the patient completes the movement such as if he starts from a rest position, performs abduction, until he reaches 90° position, and then it returns to the rest position through the adduction of the arm (figure 9). since the system has figure 7. wrong position detection for right shoulder. figure 8. wrong position detection for body. table 1. values measured in a patient session starting angle end angle right arm 76° 2 ° left arm 80 ° 5 ° pristerà, gallo, fregola, merola: development of a biomechatronic device for motion analysis through a rgb-d camera j global clinical engineering vol.2 issue 3: 2020 42 tolerance thresholds of +/-1%, the count is considered valid if the measured value falls within this threshold. shoulder rehabilitation results the proposed isotonic exercises aim to recover joint mobility and optimize joint function. the goal of the execution of the exercise, from 0° to 60°, is to restore a normal joint function with an opening angle up to 180°. after this first evaluation, related to the movements of the trunk (and therefore the pelvis), the patient’s hands were placed along the axis of the trunk. the patient was then asked to tilt their torso. the test was successful and just as expected, when the tilting exceeded the permitted tolerance limit, the patient was notified of the incorrect position of the trunk. the results obtained and the sequence of exercises used in the rehabilitation path, with reference to the rehabilitation standards taken as a reference,12 show that the values obtained compared to those measured in normal clinical practice and are more than satisfactory. the device is also equipped with a telemonitoring module that is connected to the cloud and can send the patient's performance to the physician (or physiotherapist) in real-time. thanks to the telemonitoring system, the physician can optimize the rehabilitation path according to the patient's performance. discussion from the experimental findings it possible to conclude that the exercises mediated by the ar interface can effectively support the main rehabilitation protocols both for the recovery of mobility following trauma and for the case of surgery. in shoulder rehabilitation protocols, in the case of surgery involving the rotator cuff, or even in the case of surgery for proximal fractures (near the shoulder) of the humerus, isotonic exercises (including abduction and adduction of the arm), must be performed standing in front of a mirror, taking care not to contract the upper beam of the trapezius muscle, that is, avoiding the elevation of the shoulder. the objective is to recover joint mobility and to optimize joint function; the exercise is performed from 0° to 60°, until the joint function is reached that allows an opening up to 180°. it is emphasized that the movement during the exercise should be performed slowly and should not be painful and the exercises should be avoided if the joint is sore or swollen, since the rehabilitation session not only aims to strengthen the muscles but also increase the amplitude of the joint movement, while improving the precision and safety of the movement. it is also useful to perform the exercises with the joint that not affected. as shown by the results obtained, the system can be easily integrated into standard clinical practice and, at the same time, the device easily customizable to guarantee, personalized rehabilitation-functional path. conclusions in this study, the microsoft kinect v2 has been tested by assessing the performance of the motion tracking of a patient in rehabilitation. the experimental tests show that the tracking algorithm implemented is very robust and the system performance has been characterized over several operating conditions. the estimated accuracy during tracking is a few millimeters in most cases. the tracking algorithm follows the full-body figure of the individual as long as they remain within the field of vision of the rgb-d camera. the tracking performance is strongly affected by the following circumstances: a limb covering another one, an object placed into the scene, and a camera point of view not perpendicular to the frontal plane of the body. in these cases, the visualization of the tracked trajectories and body elements into the virtual reality scene was affected by some drift between the 3-d figure 9. counter increase. movement begins with the arm in the rest position, the counter is increased only when the arm is j1/j2. 43 j global clinical engineering vol.2 issue 3: 2020 pristerà, gallo, fregola, merola: development of a biomechatronic device for motion analysis through a rgb-d camera visualization and the real points on the patient’s musculoskeletal system. accuracy is the main requirement needed evaluate the sensor performance as objective as possible after considering all the performance constraints involved in the rehabilitation tasks used for testing the device. in this respect, the achieved maximum accuracy of 1° is satisfactory. at the current development stage, the estimation of system performance has been carried out by evaluating the tracking accuracy of the joint angles from 0–90°. the accuracy is measured as the angle of error between the output of the mechatronic device and the protractor measurements carried out manually on the patient during abduction–adduction exercises. in conclusion, the strong points of the device and resulting rehabilitation model are its accessibility and usability. following the preliminary phase of definition of the design constraints based on the needs of standard rehabilitation protocol, the obtained results are the design, testing of a device, and the assessment of its therapeutic applicability that support an intuitive interaction together with the adaptation to the specific performance and individual characteristics of the "target" user. the device provides a valid tool for people with chronic disabilities but also for the treatment of neurodegenerative diseases, especially in the early stages. thanks to the conceived interactive model, patients can improve their quality of life by overcoming difficulties in interacting with the most common digital tools and new technologies (information technology) that can be introduced in healthcare facilities as well as in everyday environments, to improve therapeutic performance and optimize cost. therefore, patients can carry out the rehabilitation exercise sessions independently but at the same time they can be supported and encouraged and, above all, the physiotherapist can "control" the results in real-time, allowing a better evaluation of the evolution of the treatment path together with greater personalization and higher frequency of treated patients over time providing the advantages of low-cost teleassistance and telemedicine in the context of "at-home rehabilitation," as a further development of the device, a voice recognition module will be implemented, as the voice signal can be used to start the rehabilitation session or to interrupt and then resume the exercise later. another important development concerns facial recognition. the ability to customize the "list" of exercises that the patient has to perform and the extension of the dataset of exercises made available to the patient would be most useful. this could expand the possibility of therapy and to make the rehabilitation model more complete and effective. at the current stage of the development, we are testing the use of hardware platforms, like the kinect (azure, orbec 3d), that support the processing software. by exploiting the enormous progress in the field of machine learning, further tests are being addressed through the use of a normal web camera for tracking movements that at present; however, it still guarantees a suboptimal accuracy compared to those obtained in this study. references 1. du w and li h. vision based gesture recognition system with single camera. cad laboratory institute of computing technology, chinese academy of sciences, 100080, beijing, china; 2000. 2. mcneill, d. & levy e. t.speech, gesture, and discourse, in discourse processes,15, (1992) 277-301. 3. rose fd, brooks bm, rizzo aa. virtual reality in brain damage rehabilitation, cyber psychol behav 2005;8:241−262. 4. 4. paraskevopoulos it, tsekleves e, craig c, et al. design guidelines for developing customised serious games for parkinson’s disease rehabilitation using bespoke game sensors, entertain comput 2014;5:413–24. 5. abate af, acampora g, ricciardi s. augmented tour of archaeological site by means of adaptive virtual guide. dms; 2008. 6. steven b, feiner k. augmented reality: a new way of seeing. sci amer 2002. 7. larsona eb, feigonb m, gagliardod p, dvorkina ay. virtual reality and cognitive rehabilitation: a review of current outcome research. neurorehabil 2014;34. 8. rahman m. beginning microsoft kinect for windows sdk 2.0: motion and depth sensing for natural user interfaces, apress; 2017 t.speech pristerà, gallo, fregola, merola: development of a biomechatronic device for motion analysis through a rgb-d camera j global clinical engineering vol.2 issue 3: 2020 44 9. roccetti m, marfia g. recognizing intuitive pre-defined gestures for cultural specific interactions: an imagebased approach”, proc. 3rd ieee international workshop on digital entertainment, networked virtual environments, and creative technology (denvect’11) 8th ieee communications and networking conference (ccnc 2011), las vegas (usa), ieee communications society, january 2011. 10. wren c, azarbayejani a, darrell t, and pentland a. pfinder: realtime tracking of the human body.” ieee trans. on patt. anal. and machine intell 1997;19. 11. kinect. microsoft corporation, 2014. accessed: 201410-01. available at: http://www.kinect.com/. 12. linee guida per le attività di riabilitazione. conf. statoregioni, gazzetta ufficiale n. 146 del 24 giugno; 2002. http://www.kinect.com j global clinical engineering vol.2 issue 1: 28-35 ; 2019 28 received november 11, 2019, accepted november 21, 2019, date of publication december 1, 2019 distribution and utilization of radiotherapy units in greece by a. dermitzakis1, s. domente2, n. pallikarakis1 1 institute of biomedical technology, greece 2 regional office for europe, world health organisation abstract biomedical engineering is playing a leading role in the development of medical technology which is one of the pillars of modern medicine, or as differently expressed at the european economic and social committee (eesc) opinion paper: “biomedical engineering is not simply a subset of modern medicine. modern medicine predominantly secures important advances through the use of the products of biomedical engineering.”1 health technology, according to the world health organization (who), refers to the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of life. therefore, medical devices (mds) belong to health technologies, and radiotherapy (rt) is an important subgroup. rt refers to high-tech mds that are of high capital value both in terms of initial investment and operation, requiring specially trained personnel for its use and needs regular quality control, preventive maintenance and management procedures, to function properly and safely. clinical engineering plays a major role in facing of the aforementioned challenges. the present paper provides an overview of the results of an assessment report under the who action on strengthening capacity for universal coverage greece/phase 2 (scuc2)2 aiming to: • assess the sufficiency and equity in the distribution of rt and its use in greece • identify eventual inequalities in terms of geographical coverage, specific needs and lack of rt • assess the current status of staffing in rt units • estimate the costs for the use of high-value capital medical equipment (hvcme) since a country-wide medical equipment inventory for greece does not exist, various sources were used to obtain a clear picture of the installed units in public greek hospitals, and private clinics. as a result, it came out that, in terms of the number of units per million population the number of rt units rose by 23% from 4.3 in 2009 to 5.3 in 2017. in terms of the number of acts, a general increasing trend is noticed, resulting in a total cost increase of 25% from 2013 to 2016. the analysis revealed that in greece, there are quite pronounced inequalities in terms of availability of rt technologies in different regions. long term strategic planning is needed based on evidence, such as updated inventory of mds, acts performed, associated costs etc., which are unfortunately lacking in greece. additionally, the role of clinical engineers in effective management and safe use of this technology should be widely recognized and regulated. keywords – radiotherapy units, inventory, clinical engineering, distribution, greece. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org 29 j global clinical engineering vol.2 issue 1: 28-35 ; 2019 dermitzakis, domente, pallikarakis: distribution and utilization of radiotherapy units in greece introduction advances in biomedical research are leading to a storm of innovation and the development of new diagnostic and therapeutic devices has led to a radical change in current healthcare delivery. modern medicine is strongly dependent on technology. who has published a general approach for performing a needs assessment based on existing and available equipment in a region or country, comparing it with what should be available, considering particular demands and needs, and taking account of epidemiological data, recognized standards, and clinical practice guidelines. by considering this alongside with possible financial restrictions and the human resources available, the actual technological gap can be identified. the whole approach is depicted in the general needs assessment diagram shown in figure1. it is important to note that reliable baseline data on the existing situation and evidence-based assessment of needs are prerequisites for effective use of such a model. in addition to the international scientific and technical literature, the standards and best practices in use and the current trends on these technologies, the general information sources for this report are data available from international organizations such as who; organisation for economic co-operation and development (oecd), european union (eu), national institute for health and care excellence (nice), ecri institute (ecri), and other reliable web sources. in greece, there is no centralized national inventory for installed hvcme, so the relevant information and data collected and used in this report are based on cross-referenced sources which creates several problems associated with data integrity, reliability, and (in some cases) compatibility. there are also no available data related to the actual use of these technologies, except for indirect information on those procedures that are reimbursed by the national organization for healthcare provision (eopyy). however, these data do not present the whole picture of actual use and the associated expenditures since the numbers of diagnostic or treatment procedures not reimbursed by eopyy are not known. furthermore, the rebate and clawback procedures applied in greece due to the economic crisis, are resulting to partial cost estimation. finally, several interviews/discussions with medical specialists in the fields of radiology, rt and nuclear medicine; medical physicists; biomedical engineers; technologists and other specialists provided valuable input. radiotherapy planning and acts, require the collaboration of mainly medical doctors and medical physicists, which both have a recognized, distinguished, and established role in the field. although rt unit’s state and quality of maintenance, play a crucial rule for the overall effectiveness, safety and quality of the provided health service, the intervention of clinical engineers which is of utmost importance to achieve these goals, is not yet regulated. the present assessment report aims to assess the sufficiency and equity in the distribution of rt and its use in greece, to identify eventual inequalities in terms of geographical coverage, specific needs and lack of rt, estimate the associated costs of use and assess the current status of staffing in rt units. materials and method in the present assessment report, due to the lack of a concrete set of reliable data, a great number of different sources had to be used. since there is no centralized national inventory for installed hvcme in greece, the relevant source: who, 2011 figure 1. who needs assessment diagram. dermitzakis, domente, pallikarakis: distribution and utilization of radiotherapy units in greece j global clinical engineering vol.2 issue 1: 28-35 ; 2019 30 information and data collected and used in this report are based on cross-referenced sources from the greek atomic energy commission (eeae), national evaluation center of quality and technology in health (ekapty), hellenic association of medical physicists (hamp), federation of technologists radiologists of greece (otae) and the inventory for medical devices (mds) performed in 2015 by the biomedical technology unit of the university of patras under an espa [in english nsrf (national strategic reference framework)] project. this creates some problems associated with data integrity, reliability, and (in some cases) compatibility. the data available from international organizations (e.g., oecd, who) rely also on sources providing the information (e.g., ekapty, eeae, professional societies) and therefore also present discrepancies in the numbers of equipment installed in greece. these various sources were not set up to provide a continuously updated and reliable mds inventory, but for other more specific reasons. for instance, the eeae database (considered as the most reliable) focuses on licensing and radiation safety issues and does not gather information on the year of manufacture or of entry into service. as a result, the database does not reflect the actual situation of the installed base (i.e., number of units actually in use) of these technologies at any moment. additionally, there are no available data related to the actual use of these technologies except for indirect information on those procedures that are reimbursed by eopyy. however, these data do not provide the whole picture of actual use and the associated expenditures since the numbers of diagnostic or treatment procedures not reimbursed by eopyy are not known. furthermore, the rebate and claw-back procedures applied mean that eopyy’s data are also partial. taking into account the various sources of information, this analysis focuses on the existing rt installed technology as of november 2017. existing online information available at the eeae website was cross-checked against that obtained from the other sources mentioned previously, duplicate entries were deleted and any new data identified were added. data are organized and presented per administrative region in which each unit is installed. the administrative regions and their populations are shown in table 1. all data are based on the 2011 census. results the distribution of rt units is very sparse in comparison with other modalities and only a few regional sectors have these facilities. the distribution of rt units in the different administrative regions is shown in figure 2. five of the 13 regions have no rt units – central greece, north aegean, peloponnese, south aegean, west macedonia and ionian islands. of the 7 regions that have rt units available, only 3 have units in the private sector. this is expected since rt facilities are very expensive, need both dedicated infrastructures and specialized human resources, and should be linked to cancer diagnosis and treatment facilities. conversely, rt units in public hospitals are available table 1. populations of greek administrative regions, 2011 census regions population attica 3.833 central greece 547 central macedonia 1.882 crete 623 east macedonia and thrace 608 epirus 336 ionian islands 207 north aegean 199 peloponnese 577 south aegean 306 thessaly 732 west greece 679 west macedonia 283 31 j global clinical engineering vol.2 issue 1: 28-35 ; 2019 dermitzakis, domente, pallikarakis: distribution and utilization of radiotherapy units in greece in all the other 7 regions. athens (in the region of attica) has the greatest number of rt units. with a total of 57 rt units available, resulting in a ratio of 0.53 units per 100 000 inhabitants, greece meets eu recommendations.3 of these 57 units, 39 are in the public sector and 18 in the private. the exact number and technologies installed in each region are shown in table 2. it is important to point out that technologies other than linac (linear accelerator) and co-60 are available only in athens. figure 2. radiotherapy units: distribution per 100 000 inhabitants in each administrative region, 2017. source for fig.2 and table 2: data from eeae table 2. radiotherapy units: absolute number and number of units per 100 000 inhabitants in each health region, 2017 health region total radiotherapy units private sector public sector absolute no. per 100k inhabitants absolute no. per 100k inhabitants absolute no. per 100k inhabitants attica (athens) 34 0.89 15 0.39 19 0.50 cyberknife 1 0.03 1 0.03 0.00 linac 22 0.57 11 0.29 11 0.29 co-60 8 0.21 8 0.21 tomotherapy 2 0.05 2 0.05 γ knife 1 0.03 1 0.03 central macedonia (thessaloniki) 11 0.58 2 0.11 9 0.48 linac 9 0.48 2 0.11 7 0.37 co-60 2 0.11 2 0.11 crete (heraklion) 2 0.32 0.00 2 0.32 linac 2 0.32 0.00 2 0.32 east macedonia and thrace (alexandropolis) 2 0.33 0.00 2 0.33 linac 1 0.16 0.00 1 0.16 co-60 1 0.16 0.00 1 0.16 epirus (ioannina) 2 0.59 0.00 2 0.59 linac 2 0.59 0.00 2 0.59 thessaly (larissa) 3 0.41 1 0.14 2 0.27 linac 3 0.41 1 0.14 2 0.27 west greece (patras) 3 0.44 0.00 3 0.44 linac 3 0.44 0.00 3 0.44 total 57 0.53 18 0.17 39 0.36 dermitzakis, domente, pallikarakis: distribution and utilization of radiotherapy units in greece j global clinical engineering vol.2 issue 1: 28-35 ; 2019 32 a comparison between greece and other eu countries of similar population is shown in figure 3. as can be seen, northern eu countries, such as finland and denmark, have twice as high a ratio of units per 100 000 inhabitants. while portugal and austria have similar ratios to greece. concerning use and cost, the evolution of the number of reimbursed rt acts and the associated reimbursement costs from 2013 to 2016 are presented in table 3, based on data provided by eopyy. despite a few fluctuations, the number of rt acts remains more or less steady between 2013 and 2016. the market share also appears to be almost evenly distributed between the public and the private sector, with a 57/43 ratio. the relative distribution of rt acts per 1000 inhabitants per administrative region in 2016 is shown in figure 4. this graph shows only the regions where rt units are available. central macedonia and attica have the highest percentages of acts because they compensate for the lack of rt facilities in surrounding regions. some technologies (e.g., γ-knife, cyberknife, tomotherapy) are available only in athens. the time evolution of the number of rt acts per 1000 inhabitants per region between 2013 and 2016 is shown in figure 5. the number of acts shows an increasing trend in all regions where rt units are available, except for attica (athens) and central macedonia (thessaloniki). these 2 regions show a steady increase from 2013 to 2015 but a slight drop in the number of acts during 2016. this may indicate that fewer patients are moving to these cities from other regions. figure 3. evolution of the number of radiotherapy units per million inhabitants: comparison with 4 eu countries, 2009–2016. source: data from oecd (other eu countries) and eeae (greece) figure 4. relative distribution of radiotherapy acts per 1000 inhabitants in each administrative region, 2016. note: regions without radiotherapy facilities are not shown. source: data from eopyy table 3. radiotherapy acts: analytical data, evolution and comparison of number of acts, installed units and costs reimbursed by eopyy, 2013–2016. year number of reimbursed rt acts per year no of unitspublic private total 2013 232 574 64% 132 986 36% 365 560 49 2014 248 409 61% 160 617 39% 409 026 50 2015 245 393 58% 174 443 42% 419 836 51 2016 233 892 57% 176 549 43% 410 441 53 year total eopyy expenditure per year (€) public private total 2013 18 564 495 50% 18 630 985 50% 37 195 480 2014 19 373 735 47% 21 625 454 53% 40 999 189 2015 19 416 459 44% 24 896 716 56% 44 313 175 2016 18 616 010 40% 27 935 467 60% 46 551 477 rt = radiotherapy; eopyy = national organization for healthcare provision source: data from eopyy 33 j global clinical engineering vol.2 issue 1: 28-35 ; 2019 dermitzakis, domente, pallikarakis: distribution and utilization of radiotherapy units in greece discussion in both private and public health sectors, all rt departments in greece are licensed according to the national law on radiation protection.4 in addition, the eeae closely supervises the terms of radiation protection and compliance with quality and safety regulations for rt treatments. a common practice for the lifetime of rt treatment machines (8–15 years) does not appear to have changed over the last decade. however, in greece until 2016, the vast majority of rt equipment (mainly linacs and co-60 units) in the public sector was more than 15 years old. in 2017, this situation changed radically as a result of the stavros niarchos foundation donating 10 new linacs to replace old equipment in 7 public hospitals. european directive guidance on the important issues of accessibility and availability of rt equipment5 is based on the corresponding european society for radiotherapy & oncology (estro) and european federation of organizations for medical physics (efomp) guidelines. these guidelines, recommend a ratio of at least one rt equipment available for every 200 000 to 250 000 inhabitants. given the population of 11.4 million, greece should have at least 45 to 50 rt machines and therefore it can be concluded that it meets the guidelines on the number of units. staff levels in both private and public health sectors fall far below european standards and guidelines. the hellenic association of medical physicists (hamp) reported that the new european directive 2013/59/euratom on basic safety standards for protection against the dangers arising from exposure to ionizing radiation, includes several articles related to the medical physics profession and competency requirements (articles 14 and 18). it also details the tasks required of experts in medical exposures and radiation protection that are pertinent to the roles and responsibilities of the medical physicist – namely the medical physics expert and the radiation protection expert (rpe)6. on the contrary, no regulation and guidelines are existing concerning the role of clinical engineers inside the rt departments. it is well known that maintenance is assigned to private companies under maintenance contracts. although maintenance is crucial for the quality of provided health service, unfortunately, no data are available on the quality of repair or preventive maintenance acts, safety checks etc. as for the case of medical physicists, which have a clearly stated role with well-defined rules and guidelines, the same should apply for clinical engineers, which should be responsible to closely inspect and supervise the maintenance procedure and the safety status of the rt units. as reported by hamp, under-staffing is one reason why rt, as the primary treatment for more than 60% of cancer patients in europe and the united states, is used to only 30% of cancer patients in greece.7 as a result, health system in greece is forced to pay for less effective and more expensive treatments such as surgery and extensive chemotherapy. a structural problem should also be mentioned. the fact that most centers have only one or 2 rt units results in high overhead costs for the accompanying equipment and eventually staff. at the same time, the widespread of equipment critically affects a patient’s treatment. currently, 28 linacs are installed in 15 public-sector rt departments in 7 large greek cities. of these, 4 have only one unit, 10 have two units and only one has 3 units. in cities with other public rt departments, single-unit rt departments are ineffective in both organization and service provided. reorganization into bigger rt centers could produce serious resource savings and improvements in the treatment provided. figure 5. time evolution of number of radiotherapy acts per 1000 inhabitants in each administrative region, 2013–2016. note: regions without rt facilities are not shown. source: data from eopyy dermitzakis, domente, pallikarakis: distribution and utilization of radiotherapy units in greece j global clinical engineering vol.2 issue 1: 28-35 ; 2019 34 whether used for diagnosis or therapy, a healthcare facility should ensure that the equipment is performing as intended by the manufacturer. uncontrolled use of technology in medicine can result in increased costs for the delivery of healthcare services. hence, it has become evident that there is a need to develop proper infrastructure for evaluating, supporting and managing biomedical technology. greece lacks reliable information related to mds, including the rt technologies addressed in this assessment. data on the purchase price, annual maintenance costs, downtime, and actual use of devices are lacking. evidence-based decisions are impossible without adequate data and information and it is impossible to calculate the median age of the installed bases, their value, annual service costs and annual use; or to estimate potential underuse of the machines or calculate incremental costs of corrective actions. during the last 3 decades, computerized maintenance management systems (cmmss) for medical equipment have been used worldwide, providing all necessary data for cost-effective management and evidence-based decisions. such systems these have been available since the late 1980s but installed in just a few greek hospitals till today. cmmss have multiple advantages, providing a complete and updated inventory at any time, with at least the following essential information for each machine – make and model, value, annual maintenance costs, weekly operating hours and number of uses. such a system would have made the data collected within this assessment report available instantly to the ministry of health, avoiding a great deal of effort and enabling verification. additionally, such systems are essential for vigilance purposes, evidence-based decisions on replacement, and control of service providers (i.e., response time, cost, respect of service contract rules) amongst many others, which are under the responsibility of the clinical engineering departments. aggregated data on maintenance costs of rt units in the public sector are not available. most hospitals have maintenance contracts with equipment providers but these are negotiated on a case-by-case basis and the actual costs are not known. as a general rough estimate, the assumption of an annual cost of 8–10% of the initial equipment purchase price could be used. maintenance and repair issues are becoming more critical as the equipment ages. after the initial few years period during which maintenance is usually well-defined in the procurement agreement, in many cases price negotiations are under the control of manufacturers. additionally, rapid technological developments lead to the high-paced introduction of new or improved devices and require lifelong learning and continuous training for all healthcare professionals. therefore, necessary means and facilitating conditions should be provided to guarantee the level of knowledge and skills of staff involved. professional associations should play an important role in such procedures, and assessment should become a priority for all. conclusions lack of a continuously updated inventory means that there are no centrally available data concerning medical equipment information on maintenance, age and actual use of devices. the availability of such data is necessary for correct decisions on technology procurement, management, and replacement. this information is generally needed to estimate potential underuse, identify unjustifiably high management costs or calculate incremental costs of corrective actions. evidence-based decisions are impossible without adequate data and information. personnel issues are considered to be a problem in rt departments and there is a discrepancy between the actual number of staff employed (especially non-medical) and the number recommended by (already approved) eu guidelines. staffing of rt departments should be regulated in line with best practices and guidelines, and in accordance with eu regulations and directives. the application of these regulations should become a priority. adequate staffing could allow the available infrastructure to be fully exploited, resulting in economy of resources and better patient treatment, the presence of clinical engineers should be regulated. continuing professional development should also be organized in collaboration with professional societies to assist personnel in keeping pace with recent technological developments. improvement of rt investment planning is a critical factor for ensuring that healthcare systems are more 35 j global clinical engineering vol.2 issue 1: 28-35 ; 2019 dermitzakis, domente, pallikarakis: distribution and utilization of radiotherapy units in greece cost-effective and able to respond to patient needs in a most efficient way. therefore, rt should be installed and used according to well-defined criteria, needs assessment analysis and priority settings. greece should develop its health technology assessment (hta) capacity, as suggested by a 2016 who mission on hta in greece7. the absence of biomedical/clinical engineering departments in most greek hospitals, is a great obstacle to effective and safe management of medical technology, resulting in incomplete records and no quality and cost control. maintenance of rt and the relevant costs should be followed using modern computerized systems in all public-sector hospitals. acknowledgement this work was performed under the world health organization action on “strengthening capacity for universal coverage greece/phase 2” (scuc2), carried out with funding from the european union through a grant agreement between the european commission and who. references 1. european economic and social committee. promoting the european single market combining biomedical engineering with the medical and care services industry. ον: 2014. available at: https://www.eesc.europa.eu/ en/our-work/opinions-information-reports/opinions/ biomedical-engineering-and-care-services 2. world health organization, w.h.o. rationalizing distribution and utilization of high value capital medical equipment in greece. on: 2018. available at: http:// www.euro.who.int/en/countries/greece/publications/ rationalizing-distribution-and-utilization-of-high-valuecapital-medical-equipment-in-greece-2018 3. dunscombe p, grau c, defourny n et al. guidelines for equipment and staffing of radiotherapy facilities in the european countries: final results of the estro-hero survey. radiother oncol 2014;112(2):165–77. available at: https://doi.org/10.1016/j.radonc.2014.08.032 4. greek atomic energy commission, eeae. approval of greek radiation protection regulations, ministerial decision 216/β/06.03.2001 (unofficial translation). athens 2001. available at: https://eeae.gr/en/legislation 5. directorate-general for energy. european guidelines on medical physics expert. luxembourg: publications office of the european union; 2014. available at: https:// publications. europa.eu/en/publication-detail/-/publication/b82ed768-4c50-4c9a-a789-98a3b0 df5391 6. greek government. article 32, law 4486/2017 φεκ 115/α/7-8-2017. reform of primary health care, urgent regulations of the ministry of health and other provisions (in greek). τράπεζα πληροφοριών νομοθεσίας e-nomothesiagr [legislation information bank]; 2017. available at: https://www.e-nomothesia.gr/kat-ygeia/ nomos-4486-2017-fek-115a-7-8-2017.html 7. health technology assessment in greece, mission report, world health organization, 2016 https://www.eesc.europa.eu/en/our-work/opinions-information-reports/opinions/biomedical https://www.eesc.europa.eu/en/our-work/opinions-information-reports/opinions/biomedical https://www.eesc.europa.eu/en/our-work/opinions-information-reports/opinions/biomedical http://www.euro.who.int/en/countries/greece/publications/rationalizing http://www.euro.who.int/en/countries/greece/publications/rationalizing http://www.euro.who.int/en/countries/greece/publications/rationalizing https://doi.org/10.1016/j.radonc.2014.08.032 https://eeae.gr/en/legislation europa.eu/en/publication-detail/-/publication europa.eu/en/publication-detail/-/publication https://www.e-nomothesia.gr/kat-ygeia/nomos-4486-2017-fek-115a-7-8-2017.html https://www.e-nomothesia.gr/kat-ygeia/nomos-4486-2017-fek-115a-7-8-2017.html 45 j global clinical engineering vol.2 issue 3: 2020 received february 23, 2020, accepted may 19, 2020, date of publication may 29, 2020 bedside communication and management of vital parameters and alarms in care-intensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology by i. de rosa1, a. pepino2, g. giaconia3, m. guarino4 1 biomedical engineer – università degli studi di napoli federico ii 2 professor of bioengineering – università degli studi di napoli federico ii 3 director of economato and clinical engineering – azienda ospedaliera dei colli di napoli 4 director of emergency department – azienda ospedaliera dei colli di napoli. abstract background and objective: the deliberation n.7301 of 31/12/2001 provides for the inclusion of a call system with acoustic and luminous signaling within the minimum equipment of the recovery ward. however, traditional call systems are inefficient since they are based on the following incorrect assumptions: patients and staff are unmoving, information sources are static, and assistance is unidirectional. taking care of a patient involves different personnel who should be dynamic and should be able to exchange information. furthermore, the high number of clinical calls and alarms might be an issue, as they are essential to fulfill patients’ needs, but could cause stress and additional workload for medical staff. indeed, they sometimes ignore some calls or waste time on non-urgent requests. also, the identification of an alarm and prompt intervention seems to be more difficult during travel. an ideal alarm system should have 100% sensitivity and specificity. however, the alarms are designed to be extremely sensitive, at the expense of specificity. the alarm fatigue, that is the work overload due to an excessive alarms number exposition, is a critical problem in terms of safety in the current clinical practice because it involves desensitization and alarm loss, and occasionally a patient's death. material and methods: appropriate approaches to notifications should be evaluated, including the effectiveness of mobile wireless technologies that are key to linking patients, staff, data, services, and medical devices which simplifies communications and workflows. several issues related to the communication among staff members, between patient and caregiver, and regarding the alarms and vital parameters distribution in care-intensive environments have been analyzed. the focus was on the clinical effectiveness analysis of innovative technology to support the activities in the emergency department of the azienda ospedaliera dei colli. afterward, we created a simulation model with simul8, so that a digital twin reproduces direct and indirect activities in two cases: with and without (what if and as is model) the aid of the technology. results and conclusions: the model provides a set of key performance indicators (number of performing activities, average alarm resolution time, wait time) on which the compensatory aggregation method is applied to obtain a single final score in both cases. this score is 52.5 in the as is model and 80 in the what if model. so, clinical effectiveness has been demonstrated. keywords – alarm fatigue, safety, communication, clinical effectiveness, simulation model, workflow, vitalsigns. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology j global clinical engineering vol.2 issue 3: 2020 46 introduction different people are involved in the patient care process. all of them have to share and discuss information about patient management. these people are not stationary but move around the hospital while engaging in multiple activities at the same time. this can include the manual recording of clinical data and filing medical records which increases the possibility of error and can impact the assistance response times. furthermore, hearing and correctly identifying an alarm signal and promptly intervening can be more difficult due to the movement of caregivers. as a result, both the interest and the use of information and communication technologies to support health services has increased. information and communication technologies offer powerful tools to restructure health service processes. nowadays, there is a growing range of communication channels, media, and devices, which makes it possible to provide these services. a growing literature on the value of communication in the healthcare sector has already been developed. although there has been advanced research in highly specific areas (i.e., telemedicine), the clinical adoption of simpler services, such as voice mail or email, are still not common in many health services. this situation would change if we realized that the biggest information repository in healthcare is the heads of the people who work in it, and the biggest information network is the complex network of conversations that connects the actions of these individuals.1 even small clinical teams can generate large and complex communication spaces. the clinical communication space is also characterized by numerous interruptions, poor communication systems, and inadequate practices. the participants are often separated by time and space. we have synchronous communication in case the attendees exchange messages simultaneously, asynchronous if not (table 1). therefore, care devices and hospital information systems should be integrated to encourage the exchange of information among caregivers and to provide structured data for improving the timely and effective coordination of care. the goal is to provide an easy way to acquire and insert clinical data into the hospital registration system, through the use of mobile, lightweight, portable devices. linking patients, staff, data, services and medical devices simplifies communications and workflows. appropriate approaches to notifications should be evaluated, including the effectiveness of mobile wireless technologies to reduce alarm fatigue. the analysis is focused on the current structure and organization of the emergency department of hospital cto of napoli (azienda ospedaliera dei colli of napoli). this work aims to propose and test a new organizational, technological, and managerial network which is capable of optimizing the hospital's response to the individual's need for health and guarantee caregivers the ability to carry out their clinical activities within the system the study involves the analysis of the clinical effectiveness (one of the nine domains defined by the eunethta core model) of a technology that supports the department activities. for this analysis, a digital twin of the healthcare process was developed using simul8, to which a set of indicators was calculated. finally, the compensatory aggregation method was applied to the selected indicators, to obtain a single value that allowed the evaluation of the clinical effectiveness of this technology. state of art in this work, studies and solutions in literature that face these problems have been analyzed. one of the most representative is hendrich’s study.2 after equipping each nurse with a personal digital assistant (pda) for recording activities and a bracelet capable of measuring skin temperature and displacements to assess energy expenditure and distances traveled, this study showed that a table 1. values measured in a patient session sound images data synchronous telephone video conferencing electronic cards, documents asynchronous voice mail letters, notes, image archive fax, email 47 j global clinical engineering vol.2 issue 3: 2020 de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology nurse spends 37% of her time in the patient's room and 43% in the nursing station (figure 1). the main nurse activities are the documentation (i.e., the compilation of medical records, acceptance, and discharge documents) and the coordination of the treatment process (i.e., the communication with other team members to establish the best approach for the patient). a total of 19% of their time (less than 1/5 of the time) was dedicated to direct patient care activities and only 7% was dedicated to the monitoring of vital signs (figure 2). the manhattan medical research adoption study of june 2012 found that the use of mobile devices in healthcare is pervasive (figure 3). the majority of the interviewed clinicians (87%) confirmed the adoption of smartphones and tablets in the workplace to improve resources and information at the point of care.3 company policies for the use of mobile devices can be byod (bring your own device) or cope (corporate owned, personally enabled). in the first case, the company’s initial investment is less, but there are lots of hidden costs and risks, such as distractions, which can lead to clinical risk situations, cybersecurity issues, and data loss problems. in the hospital, it would be appropriate to provide caregivers with dedicated devices. the main features of these devices should be that they are high quality, lightweight to support mobility; robust and resistant to the action of aggressive detergents or disinfection solvents to reduce infections; impermeable, have a longer battery life, and good network coverage. another important problem is alarm fatigue. sendelbach’s research showed that from 72–99% of clinical alarms are false alarms.4 the high number of false alarms has led to the alarm fatigue problem. alarm fatigue an overload of work that occurs when caregivers are exposed to an excessive number of alarms it may lead to desensitization and loss of the alarms. the research should evaluate various approaches to alarm notification, including the effectiveness of wireless technology and to increase the specificity of the alarms without a significant loss of sensitivity. this research aims to figure out these problems by focusing on the analysis of the clinical effectiveness of innovative technology in support of the ward activities. the technology is modular and includes patient receivers, bed modules, conversation modules (to allow patients to quickly communicate with caregivers and control the figure 1. nurse activities: location. figure 2. nurse activities: subcategory. figure 3. smartphone and tablet use in hospital. de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology j global clinical engineering vol.2 issue 3: 2020 48 environment), modules with inputs to connect medical devices for monitoring remotely and for the alarm notification, door modules, peripheral modules, corridor lights and displays, personnel consoles, signalers, gateways, and passive bus concentrators (figure 4).5 methods clinical effectiveness is one of the nine domains defined in the eunethta core model; a multidisciplinary evaluation model born from the eunethta project funded by the european union since 2006. the nine domains are developed by a multidisciplinary and multi-professional team. this work involves the analysis of the fourth domain: the evaluation of the clinical effectiveness of the technology. effectiveness represents the benefit obtained by using technology in a real work context, whereas the efficacy represents the benefit in ideal conditions. simulation can be seen as a valid method for assessing effectiveness, especially in situations where there is a lack of data in the literature and there is no possibility of directly observing the use of technology. simulating consists of reproducing as accurately as possible the functioning of a system to study its responses to the change of the external environment, even before putting the change into action, through the analysis of suitably chosen performance indicators, called key performance indicators (kpi). for this analysis, a digital twin of the healthcare process is developed using simul8. a digital twin is a digital replica of physical systems, devices, processes, people, places. simul8 is a simulation software product by simul8 corporation, used for the simulation of systems that involve the processing of discrete entities in discrete time. through a model developed with simul8, it is possible to test real scenarios in a virtual environment. simul8 allows simulation of the process, defining activities, times, resources, work shifts, to obtain a model representing the entire workflow with reasonable reliability. a simul8 simulation revolves around the processing of work items. they enter the system through the work entry points, pass through the work centers, can temporarily reside in the queues (storage areas), and terminate their path in the process through the work exit points. the work centers may need specific resources to process the represented activity. simul8 outputs can be graphs, statistics, numeric values. for this analysis, the analyzed kpis are: • number of performing direct activities compared to the total number of required direct activities; • average alarm resolution time; • waiting time. it is possible to apply the compensatory aggregative method on them, to obtain a single decision support score. p = priority score w_(i )= i-th weight v_i = i-th indicator value contest of application mobile handheld devices show greater benefits in high care-intensive environments where time is critical and rapid response is crucial. the application context of the technology is the emergency department of hospital cto (napoli). this consists of a first aid located on the ground floor, equipped with 4 beds in the observation area, 2 beds in the red code room and 2 beds in the yellow code room (figure 5). the ward is located on the fourth floor and has 18 beds divided into 7 rooms (4 with 3 beds and 3 with 2 beds). there is also a nurse station (figure 6). figure 4. ascom telligence technology. 49 j global clinical engineering vol.2 issue 3: 2020 de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology considering the number of beds, it was determined that 26 devices should be installed (table 2). regarding the organization of the emergency-urgency team, in the worst case (the one with the highest number of caregivers) there were: • 3 doctors, 8 nurses (2 of them are always in the triage area) and 1 social and health professional in the first aid (ground floor), for a total of 12 units; and • 2 doctors, 5 nurses and 1 social and health professional in the ward (fourth floor), for a total of 8 units. the number of caregivers present at the same time was 20. it was determined that 20 smartphones should be given to caregivers (table 3). elaboration of simulation model the development of the simulation model foresaw a first phase, in collaboration with the emergency medicine staff, in which all possible activities carried out in the ward were identified. during this analysis, several direct activities (completed at the bedside) and indirect activities were selected, in three different periods of the day figure 5. first aid – ground floor. figure 6. emergency department fourth floor. table 2. bed locations beds first aid 4 2 red code room 2 yellow code room observation area 4 ward 18 table 3. values measured in a patient session first aid observation area ward doctors 2 (7:00 – 15:00) 2 (15:00 – 23:00) 2 (23:00 – 7:00) 1 (7:00 – 15:00) 1 (15:00 – 23:00) 1 (23:00 – 7:00) 2 (7:00 – 15:00) 1 (15:00 – 23:00) 1 (23:00 – 7:00) nurses 7 (7:00 – 15:00) 7 (15:00 – 23:00) 6 (23:00 – 7:00) 1 (7:00 – 15:00) 1 (15:00 – 23:00) 1 (23:00 – 7:00) 5 (7:00 – 15:00) 3 (15:00 – 23:00) 3 (23:00 – 7:00) auxiliary staff 1 (7:00 – 15:00) 1 (15:00 – 23:00) 1 (23:00 – 7:00) 1 (7:00 – 15:00) 1 (15:00 – 23:00) 1 (23:00 – 7:00) de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology j global clinical engineering vol.2 issue 3: 2020 50 (morning, afternoon, and night) which reflect the different work shifts and staff availability. all staff members filled out a questionnaire. their answers and the direct observation of the process allow the definition of the frequency and duration of their activities. the direct activities identified were: • therapy administration; • vital parameters control; • patient hygiene; • withdrawal, catheterization, medications; • tours; • alarm management; • bed calls; and • health status updates. the indirect activities identified were: • emergency in the first aid department; • medical record filling; • drug preparation and therapy; • medication warehouse management; • instrument management; • briefing with colleagues; • patient disposal activities; • patient acceptance activity; • conducting diagnostic tests; • transfers to other facilities; and • exam requests. for direct activities, the work item corresponded to every care need at the bed. every work item was processed in a work center and for each of them an operating time may be defined, depending on three different levels of patient complexity. every activity was made by one or more people (nurses, doctors, and auxiliary staff) recruited on predefined shifts. these activities involve the movements of caregivers into the department and the operation time reflects the distance between the nurse station and the room from which the assistance need originated. regarding indirect activities, the work items no longer represent patient needs but the repetitions of the individual activities and their duration was independent of the patient complexity level. after having entered all the required data, the simulation model could run on different time frames and at different speeds through a dedicated cursor. it was also possible to obtain indications regarding the trend of the variables that characterize the functioning of the model through a series of graphs selected by the user. during execution, the icons and animations facilitate understanding of the workflow. before using the model, it was necessary to verify whether the model could represent a reasonable approximation of reality. an approach divided into two successive steps was adopted for its validation outlined below. • formal validation: evaluation of the code correctness. • structural validation: comparison between the behavior of the simulation model and the real system, to assess whether and how much the model can be considered a good approximation of reality. the structural validation consists of two successive moments: • open-box validation: the staff evaluate the model: • black-box validation: the results are compared with the data obtained from the real system.6 according to these validations, it was possible to find that the simulation model implemented constituted a good approximation reality. the as is model the as is model consists of the evaluation of the workflow characteristics and performance in the current configuration. the as is model created is described in figure 7. to define the model, 5 steps needed to be implemented. 1. identification of direct and indirect activities. 2. identification of the frequency and duration of all activities through direct observation and questionnaire. 3. identification of the resources that complete the activities, taking into account the work shifts. 4. validation of the model. 5. analysis of kpis. 51 j global clinical engineering vol.2 issue 3: 2020 de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology each work item generated by the start point related to direct activities represented a care needs at the patient's bedside. considering that there were 18 beds in the ward, it was estimated that these needs occurred every 5 minutes. a label was associated with each work item and set on a distribution that represents the frequency of each patient’s bedside care needs (figure 8). each care need may come from a different bed, so each generated work item was associated with an additional label, set on a different distribution which defined the distance from the nurse station and takes into account that rooms 1, 2, 3 and 4 have 3 beds and rooms 5, 6 and 7 have 2 beds (figure 9). figure 7. as is model. figure 8. distribution of patient bedside care needs. de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology j global clinical engineering vol.2 issue 3: 2020 52 the movements were modeled through an activity whose operation time was defined by the time taken to reach the room the call comes from. the 7 possible paths defining the movements from the nurse station to the patient’s room have the following lengths (measured by autocad): 15.64 m; 23.82 m; 30.62 m; 35.53 m; 41.76 m; 44.47 m; 42.37 m. considering that the operator average speed is 5 km/h, the travel times are calculated. operation time is defined for the movement activities and depends on the distances (figure 10). operation times of the other activities, on the other hand, take into account the level of complexity of the patient (figure 11). the model determined that only 50% of cases did the bedside activities end directly at the bedside: the caregiver was often forced to make multiple movements to satisfy the patient’s needs. the model took into account the alarm acknowledgment times (due to the lack of a centralized monitoring system) and the possibility of losing the alarms (due to the alarm fatigue problem). moreover, each activity was associated with one or more resources (figure 12). three shifts were identified. 1. shift from 07.00 to 15.00, in which 5 nurses and 3 doctors are available. figure 9. distribution of nurse station-bed distances. figure 10. routes on the emergency department map. figure 11. visual logic code for defining the movement activities operation times. figure 12. visual logic code for defining shifts. 53 j global clinical engineering vol.2 issue 3: 2020 de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology 2. shift from 15.00 to 23.00, in which 5 nurses and 2 doctors are available. 3. shift from 23.00 to 07.00, in which 3 nurses and 2 doctors are available. one social and health professional was always available. regarding indirect activities, the work item no longer represented a patient’s bedside needs but the single repetitions of the individual activities. resources, frequency, and duration were also appropriately associated with the indirect activities and were independent of the patient complexity level. the simulation time was 24 hours, every day for one month. according to the validation, the simulation model implemented constituted a reasonable approximation of the real system. it might, therefore, be suitably modified to study the response to the introduction of technology. improvements to the workflow were introduced in the what if model to check the introduction of the technology’s impact on kpis. the what if model the what if model created is shown in figure 13. figure 13. what if model. this model was created by properly modifying the as is model, taking into account the activities on which the technology operates. the main differences with the as is model are: 1. the calls end directly to the bed, without making further movements. it may happen because the caregivers already know the patient’s need even before going there. 2. the vital signs can be remotely checked. 3. the patient’s health status can be updated via devices. de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology j global clinical engineering vol.2 issue 3: 2020 54 4. there is no longer an alarm acknowledgment time since the technology reports the bed from which the alarm goes off. furthermore, there are no more lost alarms. indirect activities remain unchanged. results the kpis are: 1. the number of completed direct activities compared to the required activities. the ratio between the two numbers ranges from 0 to 1: it is 1 when the number of completed activities is equal to the required ones (ideal case), 0 if none of the required activities is completed (worst case). 2. average time to resolve an alarm. 3. waiting time for direct activities. the weights for the application of the compensatory aggregation method, chosen in collaboration with the staff, are: 50 for v1, 20 for v2, 30 for v3. the sum of the weights is 100 and the ideal values of v1, v2 and v3 is 1. at the end of the simulation, the data related to the identified kpis are presented. the as is model showed the results below 1. a total of 70% of bedside care needs are fulfilled. 2. the average resolution time for an alarm was 28.57 minutes. 3. the waiting time to complete direct activities was 9.23 minutes. kpis for the as is model are outlined in figure 14 and the compensatory aggregation method of the as is model is presented in table 4. the what if model shows the following results: 1. a total of 90% of bedside care needs are fulfilled. 2. the average resolution time for an alarm is 15.86 minutes. 3. the waiting time to complete direct activities is 5.16 minutes. kpis for the what if model are outlined in figure 15 and the compensatory aggregation method of the as is model is presented in table 5. table 4. bed locations vi 0.7 0.065 0.54 wi 50 20 30 0,7*50 + 0,065*20+0.54*30 = 52.5 figure 14. compensatory aggregation method – as is model figure 15. kpis – what if model. table 5. compensatory aggregation method – what if model vi 0.9 0.64 0.74 wi 50 20 30 0,9*50 + 0,64*20+0,74*30 = 80 55 j global clinical engineering vol.2 issue 3: 2020 de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology considering that in the ideal case the final score is 100, from the compensatory aggregation method it results that this is 52.5 in the current model, 80 in the model that simulates the introduction of technology. the clinical effectiveness of the innovative technology for the communication and distribution of alarms and vital signs is therefore demonstrated. discussion the analysis of the clinical effectiveness of the technology studied in this work was based on the compensatory aggregation method applied on the kpis obtained by the simulation models created with simul8 (see table 4 and table 5). the above-mentioned approach allows for: • estimation of the organizational changes, which are generally complex to analyses in other ways; • assessment of the operating conditions of the department; • determination if, and how much, the resources operate in compliant conditions; • determination of which resources intervene to improve the workflow; and • determination of which activities should be modified. this methodology was also very educative for the caregivers who had the opportunity to systematically analyzes their work organization both during the analysis phase and the discussion of the simulation results. having more precise measurement results of the real system behavior would be desirable: unfortunately, it is very complicated to obtain in an operating environment such as a hospital ward, even more in a high-intensity care environment like an emergency department. to obtain precise estimates, it would be necessary to measure the completed activities at the bedside in daily life with precise tools and for a longer time. the main limitation of this work, like most of the works based on simulation models, is the difficulty to compare the results of the simulations with the results of the real world, despite the effort of the formal and structural validations. the analysis began from a real-world measurement of the process: it was empirical and based on subjective assessments of the caregivers and on the observation of ward activities. the reliability of the model and results depended on the reliability of the indications given by the caregivers and also the observations made internally in the ward. however, the model and methodology used can be considered a sufficient basis for further customizations in many case studies. conclusions the clinical effectiveness of the technology supporting the ward activities was demonstrated with the simulation method, in situations in which validated scientific literature was not yet developed. the as is model has a good adherence to reality – both formal and structural validation were used. according to the caregivers, the as is model represented a good approximation of reality, but the comparison should be made on indicators that can be accurately measured. it is not always possible, especially in emergency medicine departments. the what if model could be improved with the analysis of some data from realities where the technology is already in use. the simulation model offers the possibility to find out the resources and activities that need to be modified for improving the workflow. the simulation model has increased the awareness of hospital employees regarding the complexity of the processes. references 1. coiera e. communication systems in healthcare. clin biochem rev 2006;27(2):89–98. 2. hendrich a, chow mp, skierczynski ba, et al. a 36-hospital time and motion study: how do medical-surgical nurses spend their time? permanente j 2008;12(3):25–34. 3. pepino a, torri a, tamburis o. implementing simulationbased approaches for healthcare workflow analysis: the case of a department of laboratory medicine in south italy. proc. of the third intl. conf. advances in computing, communication and information technologyccit 2015; institute of research engineers and doctors, usa. isbn: 978-1-63248-061-3 doi: 10.15224/ 978-1-63248-061-3-11 de rosa, pepino, giaconia, guarino: bedside communication and management of vital parameters and alarms in careintensive environments: simulation model development for the clinical effectiveness analysis of an innovative technology j global clinical engineering vol.2 issue 3: 2020 56 4. sendelbach s, funk m. alarm fatigue: a patient safety concern. aacn adv crit care 2013;24(4):378–86. 5. ventola cl. mobile devices and apps for health care professionals: uses and benefits. p t 2014;39(5):356–64. 6. ascom holding ag. website. available at: www.ascom. com. www.ascom.com www.ascom.com 37 j global clinical engineering special issue 1: 37-41; 2018 received february 8, 2018, accepted march 12, 2018, date of publication march 25, 2018. survey and analysis of current state of ventilator alarms in the intensive care unit by zk lin, k. zheng, ym shen, cx zheng, and yy wu the children’s hospital zhejiang university school of medicine, hangzhou, zhejiang province, china correspondence may be directed to zk lin: 291567468@qq.com. abstract this article reports on a survey and analysis of ventilator alarm state in a children hospital. based on the evaluation of the alarm effectiveness, we designed a survey statistical table for ventilator alarm investigation. we evaluated the alarm situation synthetically through investigation and statistical methods. result shows that the current ventilator alarms are not sufficiently effective, 26.84% of them are meaningless alarms and those leading to clinician’s intervention make up only 2.26% of all the alarms generated. the reliability of statistical data was also analyzed. according to the survey results, we identified and analyzed the causes of the problem and proposed the corresponding alarm management methods. keywords – ventilator alarm information, alarm effectiveness, alarm management, survey statistics introduction the intensive care unit (icu) is one of the most critical clinical departments for patients in a tertiary hospital. yet, the volume of medical equipment equipped in this clinical area also presents great challenges in terms of alarm fatigue due to overwhelming alarm information generated during daily operation. there are simply too many alarms that do not result in medical intervention in the icu.1 it was reported that an alarm sounded every 92 seconds in the icu in 2006.2 this was shortened to every 66 seconds by 2010,3 and shortened further to every 42 seconds by 2014.4 too many alarms bring about auditory and visual confusion for medical staff.1 they can’t identify the sources of the alarms effectively,5 which is a serious threat to the safety of patient care.6 according to one report from the ecri institute, the number of adverse events related to alarm management is increasing yearly.7 a hospital may experience tens of thousands of alarm messages every day, but 85–99% of them are nuisance alarms or do not need clinical intervention.8 the presence of these alarms leads medical staff a to state of alarm fatigue and can cause alarm ignorance or even the turning off of the alarm function.9 however, above reports mainly focus on alarm issues for adult patients, there are few reports based on the same issue for pediatric patients. children, especially newborns, with their language, awareness, and behavioral abilities not yet fully developed, bring more challenges to a health care team. based on the above background, this paper presents an analysis method that integrates the statistical design of the survey, the investigation experiment, and the statistical analysis of the data, and analyzes the state of ventilator alarms in the neonatal icu in a children hospital. http://www.globalce.org http://www.globalce.org mailto:291567468@qq.com lin, zheng, shen, zheng, and wu: survey and analysis of current state of ventilator alarms in the intensive care unit j global clinical engineering special issue 1: 37-41; 2018 38 materials and method based on the literature review and our experience, alarms can be categorized into meaningful alarms and meaningless alarms. meaningful alarms are those alarms that require a clinician’s quick attendance due to changes in patient condition or those technical alarms originating from equipment malfunctions that require timely correction. meaningless alarms are those that don’t reflect the true changes of a patient’s condition, do not improve patient management, and may be caused by false alarm, improper alarm settings, or recoverable transient artifacts. in order to carry out an assessment of the common ventilator alarms, we first consulted with clinicians to categorize the three main alarm interventions for ventilators in their routine practice: (1) clinician’s medical intervention, (2) clinical engineering and nurse’s equipment correction; and (3) alarm elimination by silencing. clinician’s medical intervention means patients with clinically changed conditions requiring timely intervention of medical staff; clinical engineering and nurse’s equipment correction means a technical problems with the ventilator occurred requiring clinical engineering or nurse’s action such as immediate repair; while alarm elimination by silencing means that both the patient and instrument were ok and the alarm did not recur after silencing. we also collected and analyzed common alarm contents, common alarm intervention measures, and alarm causes. since alarm limit settings are highly relevant with alarm occurrence, it is also important to record common alarm limit values accurately. based on the key elements mentioned above, we design the statistics of clinical meaningful alarms, as shown in table 1. in this study, we selected the sle5000 ventilator as an example, where this paper applies the designed survey table to the collection and observation of the sle5000 ventilator alarms generated in daily use in the neonatal intensive care unit (nicu) over a period of 10 days. result the results of the survey this survey is based on 120 total questionnaires, with 486 events of recorded alarm information from 112 valid questionnaires, and 12 kinds of common alarms generated. the specific number of alarms shown in figure 1. among them, the high-pressure alarm, low pressure alarm, and cycle failure occur with higher frequency. the results of intervention are shown in table 2. according to the effectiveness of the alarm and the definition of meaningful alarms described earlier, we classify 354 alarms events as meaningful alarms, and the calculation of meaningful alarms rate per day is shown in table 3. table 1. statistics of clinical meaningful alarms ventilator model: patient hospital number: date: set value peep h: l: amplitude hz frequency h: l: tidal volume h: l: minute ventilation h: l: alarm content intervention measures and their causes (multiple choice) the result of the intervention event hints:  mute endotracheal secretions are much, should suck them out  abnormal machine and accessories the patient is restless  there is water in the tube replacement of the sensor  adjust the position of the endotracheal intubation  pipeline discount, off other  alarm elimination by silencing  clinician’s medical intervention  clinical engineering and nurse’s equipment correction …… …… …… lin, zheng, shen, zheng, and wu: survey and analysis of current state of ventilator alarms in the intensive care unit 39 j global clinical engineering special issue 1: 37-41; 2018 figure 1. alarm name and number of alarms. table 2. the result of the intervention clinician’s medical intervention clinical engineering and nurse’s equipment correction alarm elimination by silencing number of alarms 11 343 132 proportion 2.26% 70.58% 27.16% table 3. overview of alarm data time total meaningful alarm meaningless alarm rate of meaningful alarm 1st day 50 43 7 86.00% 2nd day 46 31 15 67.39% 3rd day 36 28 8 77.78% 4th day 45 39 6 86.36% 5th day 59 46 13 77.97% 6th day 69 44 25 63.77% 7th day 48 31 17 64.58% 8th day 48 34 14 70.83% 9th day 45 29 16 64.44% 10th day 40 29 11 72.50% total 486 354 132 —— average 46.8 35.4 13.2 73.16% lin, zheng, shen, zheng, and wu: survey and analysis of current state of ventilator alarms in the intensive care unit j global clinical engineering special issue 1: 37-41; 2018 40 the rate of meaningful alarms was 73.16% of all alarms generated. this included those alarms that really reflect the changes of patient condition which need the clinician’s quick attendance or those technical alarms for equipment malfunction that require correction immediately or soon. yet, the alarms that required clinician medical intervention reached only 2.26%. there is quite a large proportion of meaningless alarms, which consists of 26.84% of all alarms generated. this indicates that the alarm conditions should and could be improved greatly. reliability test reliability refers to the degree of questionnaire results repeatability. the coefficient of cronbach’s alpha is between 0 and 1, and the larger the value, the better the relevance of the items in the questionnaire and the higher the degree of internal consistency.10 in general, the internal consistency is considered excellent, good, or poor accordingly if the coefficient of cronbach’s alpha is greater than 0.8, within 0.6~0.8, and less than 0.6 respectively . using the spss19.0 software to analyze the experimental data, the results show that the cronbach’s alpha coefficient of our survey is 0.915, which indicates that the statistical experiment is credible and statistically significant. discussion the survey uses the designed form to collect and analyze the state of the sle5000 ventilator alarms management. there were 486 recorded alarm events collected over a time period of 10 days. though we believe the survey only collect the most common relevant alarms occurring, the actual alarms generated by a ventilator may be higher than this survey collected. yet, the internal consistency reliability of the 10 days’ survey data is analyzed by spss19.0 software and it shows overall survey data are solid and strong. survey results show that 26.84% of the alarm data is meaningless alarms, which means that those alarms did not contribute to better patient management and could have been avoided in the first place. even some of those classified as meaningful alarms, in particular some technical alarms, there is still room to reduce their occurrence. alarm management is teamwork. all stakeholders including hospital leadership, medical staff, clinical engineers, manufacturers, and independent service organizations should participate. we suggest the following strategies: • first, urge manufacturers to improve the quality and reliability of equipment and improve the design of alarm system. • second, assure clinical engineering staff to perform service and preventive maintenance of relevant medical equipment timely and appropriately. • third, strengthen user training in terms of medical equipment operation as well as alarm management including setting alarm limits appropriately. • fourth, develop and apply alarm integration and management systems based on it technology. conclusions the article aims are a survey and analysis of the current state of ventilator alarms in an icu. the results show that the current ventilator alarm management in the icu needs to be improved. as well. collaboration among clinicians, clinical engineering staff, and ventilator manufacturer is important and necessary in terms of providing a better solution based on training, smart alarm design, and alarm integration management. we believe the methodology mentioned in this paper is not only suitable for sle5000 ventilator alarms information survey and assessment, but also could be used as reference for other types of ventilators or medical equipment such as monitors, infusion pumps, etc. nevertheless, the systematic management of all instruments’ alarm is a complex project. further research is needed to learn best practices of other facilities currently and into the future. acknowledgement we would like to extend our sincere gratitude to dr. yadin david, director of health technology task group iupesm, for his comments and suggestions. we are also deeply indebted to our other clinical engineering staff and nicu physicians and nurses who helped us to complete this survey. lin, zheng, shen, zheng, and wu: survey and analysis of current state of ventilator alarms in the intensive care unit 41 j global clinical engineering special issue 1: 37-41; 2018 conflict of interest the authors declare that there is no conflict of interest involved this paper. references 1. lacherez p, donaldson l, burt js. do learned alarm sounds interfere with working memory. j hum fact ergonom soc 2016;58(7):1044–51. 2. graham k c, cvach m. monitor alarm fatigue: standardizing use of physiological monitors and decreasing nuisance alarms. am j crit care 2010;19(1):28–34. 3. hooper j. unpublished data. washington, dc: children’s national medical center; 2009. 4. drew bj, harris p, zègre-hemsey jk, et al. insights into the problem of alarm fatigue with physiologic monitor devices: a comprehensive observational study of consecutive intensive care unit patients. plos one 2014;9(10):e110274. 5. jacques s. breaking barriers to patient-centric alarm management. biomed instrument technol 2016;50(3):181–83. 6. paine cw, goel vv, ely e, et al. systematic review of physiologic monitor alarm characteristics and pragmatic interventions to reduce alarm frequency. j hospit med 2016;11(2):136–44. 7. ecri institute. top 10 technology health hazards for 2016. [internet]. 2015. www.ecri.org/2016hazards. 8. joint commission. medical device alarm safety in hospitals. sentinel event alert 2013. 9. criscitelli t. alarm management: promoting safety and establishing guidelines. association of operating room nurses. aorn j 2016;103(5):518. 10. wu m, wu j, liu q, et al. reliability and validity analysis of the practical application of the drug information service. comp syst appl 2013;(10):198–202. www.ecri.org _ref461114133 _ref461114141 _ref461112075 _ref461110075 _ref461114197 _ref461114685 23 j global clinical engineering special issue 1: 23-32; 2018 received april 4, 2015, accepted may 8, 2015, date of publication june 1, 2015, revised march 21, 2018. planning medical technology management in a hospital by y david1 and eg jahnke2 1biomedical engineering consultants, llc, houston, tx 2baylor college of medicine, houston, tx abstract appropriate deployment of technological innovation contributes to improvement in the quality of health care delivered, the containment of cost, and access to health care services. hospitals have been allocating a significant portion of their resources to procuring and managing capital assets; they are continuously faced with demands for newer medical technology and are challenged to interoperate and manage legacy and newer generation of inventory simultaneously. to objectively manage this investment over it life cycle, hospitals are adopting medical technology management programs that need pertinent information and planning methodology for integrating new equipment into existing operations as well as for optimizing costs of ownership of all equipment. clinical engineers can identify technological solutions based on the matching of new medical equipment with the hospital’s objectives. they can review their institution’s overall technological position, determine strengths and weaknesses, develop equipmentselection criteria, supervise installations, train users and monitor post procurement performance to assure meeting of goals. this program, together with cost accounting analysis, will objectively guide the capital assets decision-making process. cost accounting analysis is a multivariate function that includes determining the amount, based upon a strategic plan and financial resources, of funding to be allocated periodically for medical equipment acquisition and replacement. often this function works closely with clinical engineering to establish equipment’s useful lifespan, prioritization of acquisition, upgrade, and replacement of inventory within budget confines and without conducting time-consuming, individual financial capital project evaluations. the clinical engineer’s skills and expertise are needed to facilitate the adoption of an objective methodology for implementing the program, thus improving the match between the hospital’s needs and budget projections, equipment performance and cost of ownership. systematic planning and execution will result in a program that assures appropriate inventory level at the lowest life-cycle costs at optimal performance. keywords – clinical engineering, equipment assessment, technology management, equipment planning, technology evaluation, program methodology, cost accounting, life cycle, capital asset, budget. introduction the appropriate deployment of technology contributes to improvement in the quality of health care delivered, the containment of cost and to increased access to services offered by the health care system. over the past one hundred years, the dependence of the health care system on medical technology for the delivery of its services has continuously grown. in this system, the technology facilitates the delivery of the “human http://www.globalce.org http://www.globalce.org david and jahnke: planning medical technology management in a hospital j global clinical engineering special issue 1: 23-32; 2018 24 touch.” all medical specialties depend to varying extent on technology for achieving their goals. some specialties more than others, use medical technology, be it in the fields of preventive medicine, diagnosis, therapeutic care, rehabilitation, administration or health-related education and training. medical technology enables practitioners to collaboratively and timely intervene together with other caregivers with patients in a cost-effective and efficient manner. technology also enables integration and continuum care in a way that improves the level of overall health indicators. hospital and clinical administrators are faced with the expectation for return-on-investment that meets accounting guidelines and financial pressures. society’s expectations for quality care and for the containment of the cost of care, as expressed in relationship to the gross national product brought the need for even better integration and control into the public debate arena. the u.s. government, in 1983, attempted to contain runaway health care costs through federal regulation. these regulations established a new method of reimbursement, called the prospective payment system, which encouraged hospitals to manage their resources more effectively. reimbursement methodology continues to influence innovation, development, and adoption of medical technologies. as a result, routine methods for delivering care are being replaced with alternatives, such as the growth of outpatient clinics, ambulatory surgery and telemedicine. conventional as well as alternative, sites of health care services are expected to meet a specific set of goals and objectives. these goals and objectives include administrative, clinical, financial, and regulatory parameters that influence how the integration of medical technological tools are planned for, funded, and executed. it also guides how these tools are selected, installed, trained for, integrated, safely operated, serviced, upgraded, and retired or replaced. these are essentially the phases of all technology, including medical technology. the application of knowledge about the optimal management of various life cycle phases of capital assets will maximize system utilization during each one of the phases. capital assets management, one life cycle phase, the process of selecting and acquiring medical technology, has not been well coordinated in most hospitals until recently.1 in addition, financial evaluations, which rely upon net present value (npv) and internal rate of return would consume an enormous amount of a manager’s or director’s time and may in fact be questionable when put in their proper context.2 npv is an important evaluation tool that needs to be integrated with a clinical engineering assessment when evaluating new rather than existing demand-based service lines of business or large program comparisons of alternatives based on cost efficiencies. examples include, the proposed addition of a diagnostic imaging center or the comparison of major system software packages. examples of equipment not needing npv analysis, existing assets include: defibrillators, infusion pumps, and anesthesia machines. in this case, a typical health care organization may have an inventory encompassing thousands of individual pieces of equipment. however, in their attempt to improve allocation of resources to medical equipment, the majority of health care executives have been making significant capital expenditure decisions with growing involvement of clinical engineering expertise and costof-ownership information.3 the concept of management of capital assets is a far-reaching one that goes beyond merely acquiring or maintaining medical equipment and generally includes market-based demand forecasting as a method of estimating future demand for a health care organization’s services.4 changing payment methodology and existing inventory operations and maintenance costs are important factors in planning the deployment of new equipment; these are management issues that merge together in the clinical environment.5 this paper describes the emerging process for managing medical technology in the hospital and the role that clinical engineers are fulfilling. the technology management program – achieving goals the health care delivery system is going through a transition that is led by three major driving forces: cost, technology, and social expectations. the impact of these forces may change from time to time, as does their relative significance. in addition, the human factor that interacts with these forces is not constant either, thus submitting an important subject for public debate. nevertheless, the david and jahnke: planning medical technology management in a hospital 25 j global clinical engineering special issue 1: 23-32; 2018 system is being subjected to mounting pressures from the needs to first identify its goals, secondly select and define priorities, and finally allocate the limited resources. hospitals’ rising investment demonstrates their belief in the importance of and the benefit from the deployment of technology. health care organizations have been using a variety of evaluation methodologies to provide alternatives in the delivery of care. they are driven by medical innovation, prospective reimbursement, and societal expectations. in this environment, evaluation methodologies only work if an organization is truly prepared to cancel a project after the initial investment. the flaw in the theory is not its complexity, as some have said, but in the fact that it ignores the psychological and political realities of capital investments.6 it becomes imperative for providers to make good resource allocations decisions at the outset of their capital budgeting process and often those decisions are biased towards equipment that has a positive impact on reimbursement. health care providers spent $8.25 billion on capital equipment in 1988, compared with $8.21 billion in 1987.7 a survey of hospitals’ spending plans for capital budgets, one that includes equipment and construction, indicates that spending rose during 1992 by 15%, reaching $23.6 billion.8 however, the increasing scarcity of available resources within the hospital community on the one hand and the demand for quality health care on the other, promoted a public debate and awareness of such a paradoxical economic perspective. new tools for cost and outcomes management include disease management and patient safety initiatives.9 it is in such an environment that hospitals have begun to manage their fixed assets (i.e. capital investments) and equipment-related operation expenditures better than ever before. as the deployment of medical equipment continuously evolves, its impact on the hospital operations and on the consumption rate of its financial resources increases. the ability to forecast and manage this continual evolution and its subsequent implications has become a major component in all health care decisions. in a survey of three large hospitals in houston, texas, with a combined licensed capacity of about 1400 beds, the average number of medical devices being used per licensed bed has increased between 1982 and 2002 from four devices per bed to over 17 devices per bed.10 this illustrates that hospitals are experiencing a continual increase in the number of medical devices used on a per bed basis. it is therefore imperative that in an industry where the only constant is change, there is a program that: a. provides for a guiding strategy for allocation of limited resources b. maximizes the value provided by resources invested in medical technology c. identifies and evaluates technological opportunities or threats d. optimizes priorities in systems integration, facility preparation and staff planning e. meets or exceeds standards of care f. reduces operating costs g. reduces risk exposurecreates h. better care environment. whereas both knowledge and practice patterns of management in general are well organized in today’s literature, the management of the health care delivery system and that of medical technology in the clinical environment is more fragmented and has not yet reached that level of integration. however, we are beginning to understand the relationship between the methods and information that guide the decisions regarding the management of the medical technology that is being deployed in the highly complex environment of the health care delivery system, including the variances among users, applications and cultures from one hospital to another. the health care delivery system presents a very complex environment where strategy, facilities, equipment, drugs, information and the full range of human interventions are interacting. it is in this clinical environment that patients in various conditions, staff, temporary skilled labor and the wide variety of technology converge. the technology that has been developed for and is deployed in the health care delivery system ranges from the “smart” facilities within which care is being provided to the products that are used around the provision of healthcare services, and to its regulation and management. “technology means merely the use of tools, that is, the involvement of any agent which assists in the performance of a task.”11 such tools have been introduced at an increasing rate during the past 100 years and include the use of techniques, david and jahnke: planning medical technology management in a hospital j global clinical engineering special issue 1: 23-32; 2018 26 instruments, materials, systems, and facilities. of all the factors and resources that will shape the future of the health of mankind, the one that most often stretches the imagination is medical technology.10 but yet, it is also blamed for contributing to the escalation of health care costs without receiving recognition for improving access to and quality and efficiency of the system. it is, therefore, expected that the only winners are those who use superior strategy and execution. generally, a superior strategy is the result of the use of market-based demand forecasting. market-based demand forecasting is a method of estimating future demand for a health care organization’s services by using a broad range of data that describe the nature of demand within the organization’s service area. this provides a fundamental link between strategic planning and financial planning and thereby provides a rational basis for assessing how many patients may be expected to use services and what level of capital resources is needed to provide those services.12 this would define the types and volume of equipment needed to meet demand. equipment is categorized by its function and owner department requirements in an assets list developed by the user and equipment planner as part of biomedical engineering validation of meeting appropriate clinical standards and institution integration prior to purchase recommendation. the plan must be layered with present organizational capital asset requirements for replacing and upgrading existing inventory to maximize effective use of the existing capital equipment matrix and for appropriate systemization of medical processes. at this point, it is the managers who have to link technical capabilities to clinical requirements. too often planning is the result of a crisis, a situation that does not permit thorough analysis and usually it is a time when it is too late to begin a plan. managers are expected to understand why their institution’s values and mission are set as they are, to pursue their institution’s strategy and business plan through that knowledge and to act in a way that effectively allocates resources for which they are responsible. one may not necessarily be a part of the organizational level that develops the institution’s strategic plan; however, one must be familiar with it, one must understand and believe in it, to be able to develop an action plan at that level that supports the institution’s mission. to implement an effective plan, one will be expected to know how the present state of technological deployment should be assessed, and to have a good rapport with the research and development industry to be able to provide a forecast and review of emerging technological innovations, the impact that they may have on the particular institution, plus have the ability to articulate justifications and provisions for adoption of new technology or of the needs to enhance or replace existing ones. because tomorrow’s clinical devices are in the research laboratories today, a medical equipment manager should be considering visits to such sites as well as to the exhibits areas of the major medical scientific meetings. to facilitate the process, the current state of the health care organization’s inventory should be assessed and quantified by the clinical engineer based upon numerous criteria. this process is aided by the existence of both biomedical engineering equipment and finance capital equipment databases. the technology management process would include an assessment using a multi-year template of when and if equipment will need upgrading, replacement, and when new acquisitions are to be added. clinical engineering should then calculate a life-cycle for each asset. using cost accounting analysis that includes a review of the impact equipment has on reimbursement methodologies such as cost based or case based, and in conjunction with a market-based forecasting model, each prospective piece of equipment should be priced and an overall annual cost of maintaining the organizational inventory assessed as well as new additions supporting the strategic plan. given the limits of an organization’s resources, an overall prioritization can then be developed so that the most important medical technology related to the strategic plan are procured, thereby enabling the organization to satisfactorily meet its service obligations, maximize financial returns, and attain goals. the past decade has shown a trend of increased legislation that supports more federal regulations in health care. these and other pressures will require that deployment of, and justification for, additional or replacement medical technology is well planned. if you subscribe to the saying that you cannot manage what you do not measure, and you cannot measure what you do not define, then the need for the development and the maintenance of a systematic david and jahnke: planning medical technology management in a hospital 27 j global clinical engineering special issue 1: 23-32; 2018 and comprehensive planning process for the adoption of medical technology in hospitals is obvious. a mixture of literature review and experience demonstrates that the rationale for technology adoption is derived from the following reasons: clinical necessity • meet or exceed medical standards of care • impact care quality or level • effect on life quality • improve accuracy, specificity, reliability, timing and/ or safety of interventions • change in service volume or focus • response to community needs • reduce errors or improve predictability of outcomes management support • better or more effective decision-making protocol for interventions • improve operational and maintenance efficiency and effectiveness • facilitate development of or current offering of service • reduce liability exposure • increase compliance with standards or regulations • decrease dependence on staffing and/or the skill level of personnel, improve staff retention • effect on supporting departments • improve return on investment or cash flow • enhances integration and knowledge sharing • improve patient throughput market preference • improve access to quality care • increase customers’ convenience and/or satisfaction • enhance organization or service image • improve financial or value impact • reduce cost of adoption and ownership • effect on market share • improves community conditions • facilitate continuum of care strategic planning assets management equipment procurement and integration technology assessment equipment planning figure 1. the technology management process at the texas children's hospital. many hospitals are reformulating their technology management process, which starts with the strategic planning process, thus demonstrating clearer support for the prescribed management of medical technology. it is a process in which the understanding of the key issues and the critical success factors are followed by a more defined task of resource allocation, and assignment of the responsibility for sustained improvement in technology’s performance through attainment or progression toward measurable technology utilization rate goals. this is a planned process that may be unique for each organization and is essentially a prescription for the way to look ahead. although it may be different for every organization, all are faced with the following five similar questions: what are we? what do we want to be? where are we going? what will be our role? and, how will we do it? planning and monitoring the deployment of medical technology as we developed our medical technology management program model (figure 1), adoption of the strategically prescribed norms took place, as well as the monitoring in accordance with a well-thought-out plan, equipped with know-how from a multidisciplinary team of users, and the implementation of an agreed-upon policy. the david and jahnke: planning medical technology management in a hospital j global clinical engineering special issue 1: 23-32; 2018 28 multidisciplinary team has a similar approach toward the creation of definition of needs, scope and objectives for a specific type of technology, such as the equipment. the question is no longer whether a medical technology management plan is worth the effort, but rather can we afford not to implement it, and do we have the adequate tools to execute it? if we do then the hospital will be able to make informed decisions regarding deployment of new technology as well as monitor its utilization.3 the need for clinical engineering involvement in such a team became evident when the following problems were repeatedly encountered: • recently purchased equipment not sufficiently used • ongoing user problems with equipment • excessive downtime and ownership cost • lack of compliance with accreditation agencies and regulations • high percentage of equipment failing and awaiting repair • maintenance costs emerging as a large single expense • medical equipment upgrading, replacement, and planning are not intertwined • use errors and near-miss events a further analysis of these symptoms using a system performance analysis technique would likely reveal.13: • a lack of a central clearing house to collect, index and monitor medical technology performance for resolving current issues and for future planning purposes • the absence of strategy for identifying emerging technologies for potential integration • the lack of a systematic plan for conducting technology assessment, thereby not being able to maximize the benefits from prioritization of the deployment of available technology • an inability to benefit from the organization’s experience with a particular type of technology or supplier • the random replacement of medical technologies, rather than a systematic protocol based on a set of well-developed criteria • the lack of integration of technology forecasting into the strategic planning of the hospital • limited opportunities for interdisciplinary exchange between engineering-related and clinically-related professionals to address these issues a technology assessment plan was initiated with the following six objectives: (1) accumulate pertinent information regarding decisions about medical equipment. (2) develop a multi-year plan for technology replacement and associated costs. (3) communicate replacement selection criteria that is supported by users. (4) create an ongoing assessment methodology with outcomes measurements. (5) improve the capital budget process by integrating the status of current technology with long-term needs relative to surgical-medical services goals. (6) integrate the competency of clinical engineering into patient safety goals. because the program provides for both the management of the existing inventory of medical equipment aiming at the lowest reasonable life-cycle cost, and for the recommendations relating to procurement, it is mandatory to integrate trended operational and utilization information with the projected budget strategy into the technology management plan. at the texas children’s hospital, the biomedical engineering department has been accumulating pertinent information and has developed indicators for measuring medical equipment performance.14 a medical technology evaluation committee (mtec), which is chaired by the director of biomedical engineering, began developing analytical selection criteria and life-cycle costs information. the membership of the committee includes representatives of the medical and nursing staff, high-tech users, administration, equipment planning, risk management, safety, and materials management departments. another clinical engineer from the same department with nursing training experience serves as the committee’s designated coordinator for all evaluation tasks. once the committee accepts a request for review (rr), it identifies other users who may have an interest in it and authorizes the coordinator to assemble a task force of users specified by the committee. this task force then serves as an ad hoc committee responsible for the evaluation of the david and jahnke: planning medical technology management in a hospital 29 j global clinical engineering special issue 1: 23-32; 2018 equipment described on the rr form. during any specific period, there may be multiple task forces, each focusing on a specific equipment protocol. the task force coordinator cooperates with the materials management department in conducting a market survey, in obtaining equipment for evaluation purposes, and in scheduling of vendor-provided demonstration and in-service training. after establishment of a task force, the coordinator analyses the evaluation objectives and together with input from the task force devises appropriate tests, and the associated evaluation feedback form. there are two stages to this phase: an engineering test to validate safety and performance issues, and a clinical trial to evaluate user interface issues and efficacy. only equipment that has successfully passed engineering tests may proceed to a clinical trial. a clinical coordinator collects and reports the summary of experiences gained during the clinical trials to the task force. the committee coordinator then combines the results from the engineering tests and the clinical trials into a summary report and prepares recommendations for mtec approval. in this role, the coordinator serves as a multidisciplinary professional, bridging the gap between the clinical, technical, and administrative needs of the hospital. the technology assessment process actually begins as soon as a department or individual fills out a budget request and then the rr form already mentioned. the form is submitted to the hospital’s product utilization and review committee, which determines if a previously established standard for this equipment already exists. on the rr form, the originator delineates the rationale for acquiring the medical device. for example, how the item will improve patient care, generate cost savings, support the quality of service or improve ease of use, and who will be the primary user. the form is sent to the mtec if the item requested is not currently used by the hospital, or if it does not conform to previously adopted hospital standards. the committee has the authority to recommend either acceptance or rejection of any request based on a consensus of its members. if the request is approved by the mtec, then the requested technology or equipment will be evaluated using technical and performance standards. the role of the medical technology evaluation program in the purchase of medical equipment is threefold: (1) assuring that biomedical equipment facilitates the delivery of quality patient care, (2) assuring that the equipment purchased meets the needs of all users, and (3) establishing hospital standards for biomedical equipment. medical technology evaluation occurs in two phases. phase 1 is in the submission of recommendations for the purchase of new equipment. phase 2 is the technical and clinical evaluation. this allows the hospital to validate equipment specifications, to obtain superior equipment at a competitive price and, in turn, consistently improve the quality of patient care. the evaluation process addresses pertinent issues regarding the medical equipment safety, user friendliness, and equipment performance history. based on satisfactory evaluation results and feedback from the technical and clinical staff, a recommendation is made to purchase a specific equipment item. following these product evaluation steps facilitates the standardization of the equipment selection process and, therefore, the standardization of biomedical equipment. this will allow the hospital to obtain superior equipment at a competitive price and, in turn, provide consistent, high-quality patient care.15 upon completion of the review, a recommendation is returned to the hospital’s product standards committee, which reviews the results of the technology evaluation, determines whether the particular product is suitable as a hospital standard, and decides if it should be purchased. if approved, the request to purchase will be reviewed by the capital planning committee (cpc) to determine if the required expenditure meets with available financial resources of the institution, and if or when it may be feasible to make the purchase. to ensure coordination of the technology evaluation program, the chairman of the mtec also serves as a permanent member of the hospital’s cpc. in this way, technology evaluation is integrated with and impact budget decisions. the role of a clinical engineer advances in technology accelerated multidisciplinary approaches to healthcare management.16 clinical engineering, a profession based on both engineering and the life sciences, developed in response. the recently created american college of clinical engineering provides a better david and jahnke: planning medical technology management in a hospital j global clinical engineering special issue 1: 23-32; 2018 30 understanding of the profession, and defines a clinical engineer as “a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology.”17 the role of a clinical engineer is shared between planning for new equipment and optimizing the utilization of the existing inventory.18 the clinical engineer must be completely familiar with the procurement phase of medical equipment and with the synthesizing of clinical needs into a bid request document. this further includes bid specifications, vendor negotiations, installation preparation, acceptance criteria, user training and servicing of the installed base. the clinical engineer is also familiar with methods for assuring that medical equipment performance and risks are monitored, reported and managed. the process includes the assigning of criteria, i.e. values reflecting the evaluator or user preference, and measuring the degree to which those criteria are met in the daily routine of the clinical environment.19 criteria could be the format and quality of information displayed at the client goals and strategy people, structure and management assets management design and interface outcomes performance budget allocation technology life cycle technological environment figure 2. medical technology management environment at texas children’s hospital. bedside physiological monitor, the set-up of minimum infused volume of an infusion pump, or the amount of work of breathing associated with one particular brand of mechanical ventilator compared with another. medical technology policy supported by an organized program of planning, implementing, monitoring and evaluation results in effective use of resources and reduction in operational risks. medical technology management environment at texas children’s hospital, outlines such a program (figure 2). positive outcomes affect allocation of capital and are dependent on the success of the assets management program, the impact of changes in the technology life cycle, the inherent design and quality of the technology as well as the environment within which the assets are deployed and serviced. the methodology for the development and sustainment of medical technology management program must include properties that demonstrate the impact from each of these parameters on outcomes. outcomes performance indicators include: cost effectiveness, compliance level, and client satisfaction and service leadership.20 performance indicators can include safety-related events such as the elimination or reduction in medical errors. cost effectiveness can include return-on-investment analysis, reduction in cost per procedure, or improvement in uptime. other indicators can represent the result of life cycle technology planning and the integration of technologies at the point-of-care measured by utilization rate and the level of satisfaction the caregivers team has with the environment of care. the program needs to encompass all involved parties. this may at times extend the evaluation and provide for participation of professionals with different interests, which will require mediation between parties. the acceptance of the process is based on respect for their participation and at times will require a sequence of steps taken to pre-empt escalation of antagonistic attitudes among the parties participating in the evaluation. often, one party seems to prefer an equipment feature that presents unacceptable conditions to another. the clinical engineer should provide the technical and cultural leadership needed to maintain the progress of the evaluation process in a participatory mode. the individuals participating should david and jahnke: planning medical technology management in a hospital 31 j global clinical engineering special issue 1: 23-32; 2018 be representatives of the user groups, support groups, medical staff, nursing, engineering risk management, finance and administration. factors by which the equipment will be evaluated are selected, agreed upon, and a relative importance weight is assigned to them. devices that pass the engineering bench test are forwarded to the clinical evaluation stage, which must be preceded by user training that is provided to all shifts by the clinical engineering staff and/or the vendor. during the clinical evaluation, the clinical engineer serves as a focal point for collecting users’ problems as an indication for a possible mismatch between the equipment’s real-life performance and user or system requirements. following the evaluation, the clinical engineer collects the users’ report documenting their experiences and presents it to the committee for a recommendation, while the cost accounting representative reviews the financial alternatives. generally, to review financial alternatives, information is accumulated and developed into a capital equipment matrix that includes replacement cost, projected retirement, replacement, upgrade, and associated life-cycle dates. based upon input from clinical engineering, equipment is prioritized regarding their role in the organization. this data is then compiled and provides a useful determination of expected capital costs for future capital budgets and can aid in the development of future strategic planning by providing specific costs by service component. clinical planning thereby provides options for management in future years despite limited financial resources. a period of time after equipment has been installed, for example between six and twelve months, a follow-up study of actual operational costs, service problems and utilization indicators relative to projections is performed. this activity supports and becomes part of the equipment planning and continuous quality improvement program. many good lessons are learned this way. it is also important to review the implementation state and determine if it can be further optimized the next time. the clinical engineer, from that point on, continues with managing the other phases of the equipment life-cycle with proper attention to the planning for equipment upgrades, enhancements and replacement. the skills of the clinical engineer are needed now, more than ever, to manage this new responsibility: a responsibility for managing the medical technology program within guidelines that range from a strategic technology planning phase to the planning for systems replacement. conflict of interest the authors declare that there is no conflict of interest regarding the publication of this paper. references 1. sprague gr. managing technology assessment and acquisition. healthc exec 1988;3(6):26–29. 2. johnson re. forum: scrap capital project evaluations. cfo mag 1988;1:may 1. 3. david y, maltzahn ww, neuman mr, and bronzino jd. clinical engineering. boca raton, fl: crc press; 2003. 4. beech aj. market-based demand forecasting promotes informed strategic financial planning. hfma 2001;1-2. available at: http://www.findarticles.com/cf_dls/m3257/11_55/82394650/ p1/article.jhtml 5. pelnik tm. improving product introduction through effective design reviews. biomed instrument technol 2003;37(2):131–33. 6. fink r. reality check for real options. cfo mag 2001;1. 7. wagner m. promoting hospitals’ high-tech equipment. mod healthc 1989;19(46):39–46.8. 8. for the record. mod healthc 1991;21(44):14. 9. agency for healthcare research and quality. health care costs? why do they increase? what can we do? ahrq workshop. los angeles, ca; 2001. available at: http://www.ahrq.gov/ news/ulp/costs/ulpcosts.htm 10. david y. advanced clinical engineering workshop proceedings, havana, cuba; june 2001. 11. berkowitz da and solomon rp. providers may be missing opportunities to improve patient outcomes, costs. outcomes measure manage 1991;may/june:7–8. 12. beech a. market-based demand forecasting promotes informed strategic financial planning. hfma 2001;1–2. 13. stalhandske e. how to make the most of failure mode and effect analysis. biomed instrument technol 2003;37(2):96–102. 14. bronzino jd. management of medical technology: a primer for clinical engineers. stoneham, ma: butterworth/heinemann; 1992. 15. blair c. hospital’s medical technology evaluation process. second joint embs-bmes conference. houston, tx; 2002. http://www.findarticles.com/cf_dls/m3257/11_55/82394650/p1/article.jhtml http://www.findarticles.com/cf_dls/m3257/11_55/82394650/p1/article.jhtml http://www.ahrq.gov/news/ulp/costs/ulpcosts.htm http://www.ahrq.gov/news/ulp/costs/ulpcosts.htm david and jahnke: planning medical technology management in a hospital j global clinical engineering special issue 1: 23-32; 2018 32 16. david y. practical implementation: tools, policies, and best practices. mobile health care conference & exhibition. las vegas, nv; oct. 16-18, 2002. 17. bauld tj. the definition of a clinical engineer. j clin engineer 1991;16:403–405. 18. zhou d, david y, zhu xw. medical equipment risk management and preventive maintenance. international medical devices, hong kong, china, technology exchange; sept. 2000. 19. porter a, roper ar, mason tw, and banks j. forecasting and management of technology. new york: john wiley & sons; 1991. 20. david y. technology evaluation in a us hospital: the role of clinical engineering. health technology assessment issue. med biol engineer comput 1993;31:28–32. authors' biography yadin david is principal at biomedical engineering consultants, llc and previously has been the director of the biomedical engineering department at texas children’s and st. luke’s episcopal hospitals since 1982. he received his master and doctorate degrees from west virginia university, is affiliated with the university of texas school of public health, and previously also with the department of pediatrics, baylor college of medicine. he is registered professional engineer and certified clinical engineer. he is a member of the fda advisory and nfpa technical committees, and chairman of iupesm httg group and member of the ifmbe clinical engineering division. ernest gus jahnke is manager of hematology/oncology section at baylor college of medicine and holds mba degree in business informatics and bachelor’s degrees from the college of charleston, is a certified public accountant licensed in the state of texas, and is a certified forensic accountant. previously was the manager of finance at texas children’s hospital where he was the 23 j global clinical engineering vol.2 issue 1: 23-27; 2019 received april 2, 2019, accepted september 15, 2019, date of publication november 3, 2019 integration of the trans-operative information with the patient's electronic record by e. k. souza1, a. m. marciano2 1moinhos de vento hospital/ clinical engineering, porto alegre, brazil 2moinhos de vento hospital/ clinical and hospital engineering, porto alegre, brazil abstract this article presents an integration project between the anesthetic station used in the step of trans-operative (life signals multiparameter monitor, anesthesia device and controlled-target infusion pump) and the system of hospital information. the main goal of this project is to automatically capture the vital signals from the medical equipment and the records trans-operatives and provide an anesthesia record to be stored in the patient’s electronic medical record. the integration mode is through a gateway that executes the conversion of the machinespecific language into data/information of the hl7 standard. this interaction will allow integrating data and information from multiparametric monitors, anesthesia devices, controlled-target infusion pumps, and the intra-operative anesthesiologist inputs. keywords – medical equipment, anesthesia station, step of the trans-operative, patient data integration, electronic records. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction the patient’s record is a mandatory document in health assistance establishment and is considered an extremely important tool that requires a mechanism of follow up of the data inserted in it. the electronic medical record can be quoted as one of the mechanisms that present many advantages to the institution such as paper use reduction, digital certification, more reliability and safety for the data inserted in the records and, to the information derived from it.1 it has been claimed that a combination of information technology (it) devices such as computers, communication networks, medical information, and online electronic data can improve the quality and decisions concerning health care. therefore, the automation of the patient’s records (even incomplete) contributes significantly to the quality improvement of the treatment beyond the effective control of costs involved.2 a medical record system is represented by a series of components that form mechanisms so the records can be created, used, stored, and accessed as part of a hospital information system (his).3 in the surgical environment, there are examples of software development that consists of the data integration of monitoring parameters during anesthesia and a group of rules configured by the anesthesiologist. alerts generated by the software provide important information about the patient’s condition and eventual risk situations which wouldn't be highlighted if only the individual alarms of the parameters coming from the monitors were considered.4 http://www.globalce.org http://globalce.org http://globalce.org souza, marciano: integration of the trans-operative information with the patient's electronic record j global clinical engineering vol.2 issue 1: 23-27; 2019 24 this project presents an integration proposition between the anesthesia station equipment used in the trans-operative stage (multiparametric monitors, anesthesia devices, controlled-target infusion pumps) and the patient’s medical electronic records (pemr). the goal is to automatically capture the vital signals from the medical equipment and the records of the trans-operative data to create anesthesia file that integrate the pemr with the his. the specific goals of this project are: (a) increase the safety and reliability of data and information from the trans-operative stage; (b) qualify this data and information via automatic inputs with no further manipulation; (c) improve the medical document and protocol pattern; (d) diminish the probability of failures and increase clarity; (e) facilitate the data research and information for studies, benefiting doctors, hospitals, and patients. methods described below are the development phases of the project, the integration alternatives, the integration method option used, and the information that will be integrated into the implementation stage. a. project development the stages of development flow-gram of the project are described below in figure 1. as demonstrated in figure 1, risk evaluations were executed as well as the vulnerability/fragility of the anesthetic procedure related to the absence of automated records and data integration and information from the medical technology used in this stage of the surgical process. next, we surveyed the hospital’s equipment that can already transmit data for then plan and the sub-stages of the implementation. the next stage consisted of the processes/operations/activities detailing the peculiarities that determine which data and information would be registered and integrated, the technologies available in the market for this type of record integration as well as the costs. b. architecture/topology of the integration system the definition of interoperability, according to the institute of electric and electronic engineers (ieee) deals with the capacity of two or more systems to exchange information and being able to use the information exchanged.5 the communication health level 7 (hl7) is a communication structure with determined standards to the exchange execution, integration and sharing of communication information between devices or clinical data system devices.6 the architectures or topologies of communication can be divided into two suggested formats, “without gateway” and “with gateway.” in the topology format without gateway, the data are transmitted from equipment in hl7 and are processed before storage in his. the format with gateway requires an intermediary device that physically separates the his and the biomedical equipment. this device performs the machine-specific language conversion of hl7 standard to be consequently processed and stored. concerning the integration method of monitoring data and trans-operative stage information, the topologies and/or architectures are demonstrated in figures 2 and 3. figure 1. project development flow-gram. figure 2. “direct” topology without gateway. 25 j global clinical engineering vol.2 issue 1: 23-27; 2019 souza, marciano: integration of the trans-operative information with the patient's electronic record in the architecture model of figure 2, the equipment provides the information directly in the hl7 language allowing the storage of clinical data in the his database. in figure 3 below, it is demonstrated the topology using the intermediary device, named gateway. in this type of topology, the information from the equipment needs a data converter named gateway responsible for trans-coding the information from the equipment to clinical storage data in pemr. in this last model evaluated it is observed the need of more devices to integrate and intercommunicate data treatment and information storage appliance so the information generates an electronic anesthesia file with further storage in pemr. considering the evaluated options of integration methods and equipment profiles installed in hospitals it was necessary to use the topology demonstrated in figure 4. results the suggested method was applied in a private, nonprofit hospital that has around 400 hospital beds and is located in the capital of rio grande do sul (a brazilian state). the hospital has around 4500 pieces of biomedical equipment. among the various areas that execute assistance health care treatment, using technologies, was defined the automatic capture of information from the trans-operative process from the equipment that was able to transmit data referring to the patients’ monitoring and therapy, in 5 specific surgical rooms to store in pemr and his. the topology to be used in this project is illustrated in figure 4. the data to be captured and information inserted in this integration are related in table 1. in the architecture of figure 4, the data of the anesthesia station provided by the equipment (multiparametric monitors, anesthesia devices, controlled target infusion pumps) and the information and events manual input in the trans-operative (executed by the anesthesiologist) are integrated and converted in hl7 by an all in one computer (aoc) attached to the anesthesia activities medical-assistance device, providing the institution the information to improve its procedures. as described in table 1, this integration allows to automatically register data from the patient’s vital signals in surgery, ventilator mechanics, anesthetic gases, drugs table 1. integration parameters origin information multi parameter monitor vital signals (ecg, spo2, pni, pi, co2) anesthesia equipment ventilator data and anaesthetic gases (vmin, aereal vias pressure, frequency, peep, ventilator mode) controlled target infusion pumps drugs volume and administered concentrations anaesthesiologist input events and information transoperative elapsed figure 3. “indirect” topology with gateway. figure 4. topology used in the project (without gateway). souza, marciano: integration of the trans-operative information with the patient's electronic record j global clinical engineering vol.2 issue 1: 23-27; 2019 26 infused, as well as the events and information trans-operatively executed and informed by the anesthesiologist. it was also possible to identify which types and quantities of equipment are integrated with further stages so the solution can be implemented in all surgical rooms in the hospital, and thus allow the estimation of the financial resources needed to invest in future implementation to include budget planning in the institution’s posterior year. discussion this project is a consequence of the maturing associated with the continuous improvement of the storage processes of the patient information from the service promoted by a large hospital in the south region of brazil. it’s worth pointing out that the success of this project is directly tied to the active participation of the medical, technology information, clinical engineering teams beyond investing in needed hospital equipment that can export data, besides in technology information infrastructure including processing and storage servers, cabling, enabled network points, etc. attention is needed concerning issues including concept alignment with the board of directors and scenario evaluation referring to opening the service suggested (because this project will change the modus operandi). another important factor is in the previous capacity of all the teams involved. the data safety has worried various sectors in many areas in the world, therefore, it is recommended that the product selection and technologies have the recognition of the national health surveillance agency (anvisa) or similar group in the application country and are in compliance with the information safety rules. the continuity of application of this integration, the way the data and information are transferred, stored and further accessed, and the safety protocols, are susceptible to further analysis, developments, adjustments, and validations. conclusion the health organizations using electronic systems tend to have more effective control over data and patients’ clinical information. this more efficient way of information collection can provide safety, transparency, and better service to the patient, allowing the audit of activities such as medical-assistance, providing the institution data to improve its procedures. in more advanced centers and some brazilian hospitals this form of more efficient collection, storage, and information integration begins to develop, mainly in the application of intense therapy unities.7 the clinical engineering teams with their multidisciplinary knowledge can contribute to the medical teams, assistance, and information technology and become increasingly applied to the integrated possible technologies. the expectation is that the project will automatically capture the vital signals from the medical equipment and the records from the trans-operative and to provide an anesthesia file to be stored in the pemr and in his, which can effectively contribute to the safety and reliability of data and information from the trans-operative stage. the project will also qualify the data and information via the automatic inputs and with no further manipulation. this will contribute to improving the standardization of documents and medical protocols, decrease failures, and provide more clarity in adverse events via the ease of data search and information for studies which benefits doctors, assistants, hospitals, and patients. conflict of interest the authors declare that they have no conflict of interest. references 1. enade, tecnologia em gestão hospitalar, 2016. 2. lindberg dab and humphreys bl. computers in medicine. j am med assoc 1995;272(231)1667–68. 3. rodrigues f, xavier j, jefferson colombo b, and adriano al. a tecnologia da informação na área hospitalar: um caso de implementação de um sistema de registro de pacientes.rev. adm. contemp.[online]. 2001;5(1)105– 20. issn 1982-7849. http://dx.doi.org/10.1590/ s1415-65552001000100007. pacientes.rev http://dx.doi.org/10.1590/s1415 http://dx.doi.org/10.1590/s1415 27 j global clinical engineering vol.2 issue 1: 23-27; 2019 souza, marciano: integration of the trans-operative information with the patient's electronic record 4. dherte pm et al. alertas inteligentes: desenvolvimento de software para otimização dos dados de monitorização. revista brasileira de anestesiologia 2011;61(1). 5. moreno ra. interoperabilidade de sistemas de informação em saúde. j health informati 2016;8(3). 6. stiefel r and riskalla e. the elements of a complete product evaluation. 1995. available at http://www. hl7.org/about/index.cfm?ref=common. 7. rebelo m, et al. vmon-mobile: experiência na integração de monitores de sinais vitais ao pep utilizando tecnologia de redes sem fio. serviço de informática, instituto do coração (incor) hcfmusp, brasil. http://www.hl7.org/about/index.cfm?ref=common. http://www.hl7.org/about/index.cfm?ref=common. j global clinical engineering vol.6 issue 2: 2024 30 received may 17, 2023, accepted march 12, 2024, date of publication march 25, 2024 healthcare providers’ readiness to address medical device cybersecurity within the irish healthcare system by dara keeley biomedical & clinical engineering association of ireland abstract medical devices that can diagnose and treat critically ill patients have become sophisticated and complex. device manufacturers have been developing these systems to meet market requirements as technology evolves. combining medical devices and ict into a distributed medical device it system can be a solution to incorporating continuous monitoring from the patient bedside to interoperability with a clinical information system. these technology innovations aim to manage patient data and configure medical devices into networked systems that can provide functionality and safety. the implementation of a medical device network solution allows a healthcare provider to take advantage of managing the flow of information to improve clinical work practices and implement a system that can be interoperable with other clinical information systems. international electrotechnical commission (iec) 80001-1 was developed to assist healthcare providers in identifying and managing the risks associated with medical devices sharing the same it network with other systems and software. this standard defines roles, responsibilities, and activities in relation to the management of risk with medical devices on an it network. this study aims to determine if the standard international electrotechnical commission (iec) 80001-1 is being implemented and determine familiarity with regulations and appropriate standards and guidance for an effective medical device security risk-management program with irish healthcare providers. a literature review highlighted the restrictions healthcare providers face in adopting and implementing iec 80001-1 and the security threats and risks present when integrating medical devices and it networks. the study research was conducted with clinical engineering members of the biomedical and clinical engineering association of ireland (beai). this survey targeted beai members due to their wealth of experience, knowledge, and skill level in supporting complex medical device systems. an online anonymous survey was created to determine knowledge, awareness, and familiarity with iec 80001-1 and other medical device security risk-management guidelines. the study research results revealed low knowledge, awareness, and familiarity among research participants with iec 80001-1 and guidelines on medical device security risk management. these results were consistent with the literature review that a key to the success of standard adoption is collaboration between stakeholders and a multidisciplinary approach to compliance. keywords – vital signs, physiological monitor, medical device, news, vital signs automation, medical it network, patient safety, cybersecurity risks, iec 80001:1 standard, nist, aami tir57, nis directive, enisa. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 31 j global clinical engineering vol.6 issue 2: 2024 keeley: healthcare providers’ readiness to address medical device cybersecurity within the irish healthcare system introduction physiological monitoring technology has advanced in the last few years, enabling these devices to be incorporated into healthcare providers’ networks. this system can provide real-time centralized management of patient monitors, with patients’ vital signs being supervised by clinicians, allowing them to recognize and immediately react to clinical conditions through alarm notifications.1 this clinical information system can be integrated with other hospital information systems, including a laboratory information system (lis), patient administration system (pas), and radiology information system (ris). the greater automation of a provider’s information system can be associated with reductions in patient mortality, complications and costs.2 the international electrotechnical commission (iec) developed and released a standard to address risks associated with medical devices that share the same it network with other peripheral devices and software applications. the standard iec 80001-1, “application of risk management for it networks incorporating medical devices – part:1 safety, effectiveness and security in the implementation and use of connected medical devices or connected health software”, defines roles, responsibilities, and activities that are necessary for risk management, before during and after connecting medical devices to it infrastructure.3 the objective of this standard is to prevent adverse incidents and patient harm in three areas safety, effectiveness, and security, and requires that a comprehensive risk management program be implemented. study aims this research study aimed to determine knowledge and awareness of the following within irish healthcare: • iec 80001-1 standard – application of risk management for it networks • incorporating medical devices, defining roles, responsibilities, and activities. • the restrictions prohibit the adoption of iec 80001-1 standard and a medical device security risk-management program. • national institute of standards and technology (nist) guidelines to secure network-connected medical devices. • association for the advancement of medical instrumentation (aami) guidance for effectively implementing a medical device security risk-management program. • a medical device security risk management program. • responsibility for implementing and managing a risk management program relating to medical devices incorporated into medical it networks. • the national early warning score (news) and the criteria included to calculate the score. • a digital initiative called vital signs automation (vsa) to capture physiological parameters and automatically calculates the news. literature review medical devices have developed over time to become sophisticated and complex systems that can be incorporated into medical it networks. this digital transformation can provide benefits to a healthcare provider but can also have the potential to be open to cybersecurity threats that can compromise patient safety.4 in the european union, medical devices are strictly regulated by safety protocols; however, when a medical device is integrated into an it network, it becomes a medical it network.5 the standard iec 80001-1 was developed in 2010 to identify and address inherent risks and to assist with managing these risks. it received several iterations to reduce understanding complexity and enable healthcare providers to engage with implementation. the most recent release is iec 80001-1:2021, which includes significant technical changes to the application of risk management. search strategy a literature review was undertaken to inform the subject matter and develop a substance review for this thesis. the search criteria are outlined in table 1. keeley: healthcare providers’ readiness to address medical device cybersecurity within the irish healthcare system j global clinical engineering vol.6 issue 2: 2024 32 physiological monitor the world health organisation (who) defines a medical device as, “any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose,”6 for prevention and screening, diagnose illness, monitor treatments, assist disabled people and to intervene and treat illness, both acute and chronic. the european medicines agency (ema) defines medical devices as “products or equipment intended for a medical purpose. in the european union (eu) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended.”7 two new eu laws were enacted in april 2017 relating to medical device regulations (mdr) 2017/745 and in vitro diagnostic medical devices (ivdr) to replace the previous medical device directives. these new regulations aim to address the weaknesses of the previous directives and provide a secure, consistent regulatory framework across all medical devices in the eu market. clearly defined requirements and specific obligations on stakeholders throughout the supply chain are the main points that stand out with the new regulations.8 patient physiological data from a bedside monitor can be routed to a central station monitor for display, printing, and alarm monitoring. the importance of this workstation cannot be underestimated in allowing clinicians to respond to adverse patient events, reviewing alarm history, and analyzing trend data for research.9 the increasing complexity of medical devices, mainly physiological monitors, comes with the ability to monitor multiple vital sign parameters simultaneously with each parameter having the ability to have individual alarms and complex software that can include sub-screens for the clinician to navigate to other devices10 and systems that include a ris and lis. clinicians can perform tasks and manage admitting, transferring, and discharging patients, changing alarm limits, storing and retrieving parameter values and trends, and monitoring remote patients.11 these systems are interoperable with modern electronic health records, enabling patient data to be transferred and populated in real-time. iec 80001-1 standard the standard iec 80001-1:2021, “application of risk management for it networks incorporating medical devices – part:1 safety, effectiveness and security in the implementation and use of connected medical devices or connected health software”, defines roles, responsibilities, and activities that are necessary for risk management, before during and after connecting medical devices to it infrastructure.3 the standard applies to responsible organizations, medical device manufacturers, and information technology providers. first published in 2010, with the latest revision released in 2021, the standard was considered too complex and complicated to implement and was revised as a process-based approach to overcome reported barriers, such as a lack of alignment between it and clinical engineering departments within hospitals and a lack of motivation from management to implement the standard.12 iso/iec/tr 80001, under the general title application of risk management for it networks incorporating medical devices are outlined in table 2. the role of clinical engineering (ce) / health technology management (htm) departments will have to evolve to meet the needs of healthcare technology risks and needs, in line with objectives and policies. alwi et al, found that one of the key elements for successfully implementing this standard was the collaboration between ce / htm and it departments.13 table 1. electronic search criteria criteria english language databases ucd library onesearch, pubmed, science direct, google, and google scholar. type journals, books, websites, standards, reports, white papers, government publications and academic papers. key words and “terms” searched vital signs, physiological monitor, medical device, news, vital signs automation, medical it network, patient safety, cybersecurity risks, iec 80001:1 standard, nist, aami tir57, nis directive and enisa. 33 j global clinical engineering vol.6 issue 2: 2024 keeley: healthcare providers’ readiness to address medical device cybersecurity within the irish healthcare system the risk management process has three main phases (table 3). with the implementation of this standard’s risk management framework, there is a reliance on it best practices and increasing ce / htm and it department convergence. this collaboration is key to ensuring the safe management of medical device it networks to benefit staff and patients.13 iso published a technical report in 2015, iso/tr 80001-2-7:2015, guidance for healthcare providers to self-assess conformance to the standard. this includes a process reference model (prm) and process assessment model (pam) with assessment questions to assist with identifying strengths and weaknesses of the risk management process.14 in 2016, a technical report, iec tr 8001-2-8:2016, was developed to guide healthcare providers and medical device manufacturers in identifying security controls and addressing each security capability for the risk management process.15 standards and risk management the nist developed a cybersecurity framework (csf) to enable organizations to protect themselves and continue business operations during an attack. the csf allows organizations to manage and mitigate cybersecurity risk based on existing standards, guidelines, and practices.16 as seen in table 4, csf is organized into five core functions. the nist csf guides healthcare organizations in managing assets, defining their vulnerabilities, and assisting with fending off a growing number of malicious attacks as new digital transformation projects are incorporated.17 in 2016, the aami published technical information report 57 (tir57) to provide guidance and assist medical device engineers in integrating cybersecurity risk management into the development of the device so potential threats can be identified and mitigated before placing on the market. tir focuses on cyber risks and provides steps for identifying and evaluating threats and vulnerabilities, as well as security risk controls and monitoring the ease of use of these controls. the fda have recognized and approved this standard, reflecting on the requirement for the protection of medical devices as we move toward the transition to digital healthcare.18 table 2. application of risk management part 1 roles, responsibilities, and activities part 2-1 step-by step risk management of medical it networks, practical applications, and examples. part 2-2 guidance for the communication of medical device security needs, risks, and controls. part 2-3 guidance for wireless networks. part 2-4 general implementation guidance for healthcare delivery organisations. part 2-5 application guidance for distributed alarm systems. part 2-6 application guidance for responsibility agreements. part 2-7 guidance for healthcare delivery organisations (hdos) on how to self-assess their conformance with iec 80001-1. part 2-8 application guidance on standards for establishing the security capabilities identified in iec 80001-2-2. table 3. risk management process phase 1 risk assessment to identify application hazards and assess risk for each. phase 2 risk evaluation and control to mitigate identified risk and re-evaluate and develop a report. phase 3 post project and operation to continuously monitor and reassess risk. table 4. nist cybersecurity framework 1. identify physical assets and information to establish a risk management strategy that is tailored to an organisations business function. 2. protect the assets and data from malicious attacks or unintentional compromise. 3. detect and monitor the environment for security incidents and events. 4. respond to attempted or successful attacks. 5. recover from the attack and adjust security policies in retrospect. keeley: healthcare providers’ readiness to address medical device cybersecurity within the irish healthcare system j global clinical engineering vol.6 issue 2: 2024 34 in 2016, the eu enacted cybersecurity legislation in the form of the network and information systems (nis) directive 2016/1148 to enhance cybersecurity across member states. as shown in table 5, nis has three parts. the european network and information security agency (enisa) is responsible for cybersecurity and implementing the nis directive to assist member states in identifying good practices, supporting the eu-wide cybersecurity incident reporting process, guidance with common approaches and procedures, and assisting member states in addressing common cybersecurity issues.19 enisa has developed good practice guidelines to manage cybersecurity threats with medical devices. the national electrical manufacturers association (nema) developed a voluntary standard in 2008, the manufacturer disclosure statement for medical device security (mds2), to assist appropriate and responsible persons in assessing security risks in managing medical device security issues. this form allows medical device manufacturers to answer a series of questions covering relevant security capabilities about a medical device and is shared with a healthcare provider.20 iec 27001:2022 was developed for information security management systems (isms) and provided a systematic and comprehensive approach to managing and protecting sensitive information. the standard outlines several requirements that organizations must meet that including developing security policies, performing risk assessments, defining information security roles, managing and maintaining an inventory of assets, training staff to be security aware, developing a business continuity plan, ensuring compliance with gdpr, developing an incident response plan, monitoring the performance of isms and restricting access to information to authorized personnel only.21 the eu medical device coordination group developed guidance on cybersecurity for medical devices in 2019 to guide manufacturers on fulfilling all annex i mdr 745/2017 requirements and ivdr 746/2017 about cybersecurity. manufacturers must develop products that consider riskmanagement information security principles and set out minimum requirements concerning it security measures, including protection against unauthorized access.22 argaw et al. found that building and improving the cyber resilience of a healthcare provider is vital and a shared responsibility. clinicians and administration staff should be provided with training and practice digital hygiene, while decision-makers should enforce policies that include cybersecurity when making purchasing decisions. information security teams in hospitals should upkeep security tools to safeguard the provider and patients.23 results and analysis method the purpose of this project is to conduct research and determine if the standard iec 80001-1 “application of risk management for it networks incorporating medical devices” is being implemented and determine familiarity with regulations as well as appropriate standards and guidance for an effective medical device security riskmanagement program with irish healthcare providers. the online questionnaire was hosted by qualtrics, which could generate a report based on individual feedback on each question posed. question 1, position participants were asked to provide an outline of this current position within clinical engineering, whether working within a hospital setting or working for private enterprise. table 5. nis directive phase 1 risk assessment to identify application hazards and assess risk for each. phase 2 risk evaluation and control to mitigate identified risk and re-evaluate and develop a report. phase 3 post project and operation to continuously monitor and reassess risk. response count percentage working within a healthcare provider 31 79 working for a private company 8 21 total 39 100 35 j global clinical engineering vol.6 issue 2: 2024 keeley: healthcare providers’ readiness to address medical device cybersecurity within the irish healthcare system question 2, experience participants were asked if they had any prior experience integrating medical devices with medical it networks. question 3, support this question asked participants whether they support medical devices integrated with medical it networks. question 4, clinical engineers clinical engineers’ skills, abilities, and knowledge have expanded to support medical systems that have become more complex with hardware and software technology. question 5, responsibility who maintains and supports your organization’s medical device systems and it networks? question 6, standards the importance of standards cannot be underestimated, particularly as they relate to healthcare and patient safety. question 7, iec 80001-1 participants were asked to indicate knowledge and awareness of iec 80001-1 standard – “application of risk management for it networks incorporating medical devices, defining roles, responsibilities and activities.” question 8, nist guidelines participants were asked to indicate familiarity with nist guidelines to secure network-connected medical devices. response count percentage yes 35 92 no 3 8 total 38 100 response count percentage strongly disagree 3 8 somewhat disagree 1 3 neither agree nor disagree 4 10 somewhat agree 7 18 strongly agree 24 61 total 39 100 response count percentage yes 36 95 no 2 5 total 38 100 response count percentage clinical engineering 3 8 it department 4 11 both clinical engineering and it 29 81 total 36 100 response count percentage strongly disagree 5 14 somewhat disagree 0 0 neither agree nor disagree 2 6 somewhat agree 4 11 strongly agree 25 69 total 36 100 response count percentage not at all aware 7 19 slightly aware 9 25 moderately aware 17 47 very aware 1 3 extremely aware 2 6 total 36 100 keeley: healthcare providers’ readiness to address medical device cybersecurity within the irish healthcare system j global clinical engineering vol.6 issue 2: 2024 36 question 9, aami guidelines participants were asked to indicate their level of knowledge and awareness of the aami guidance for implementing an effective medical device security riskmanagement program. question 10, security participants were asked whether a medical device security risk-management program concerning a medical it network was implemented within your organization. question 11, implementation participants were asked if iec 80001-1 standard – “application of risk management for it networks incorporating medical devices” was implemented within your organization. question 12, responsibility participants were asked who is responsible for implementing and managing a risk management program for medical devices incorporated into medical it networks. question 13, restrictions participants were asked what they feel are the restrictions prohibiting the adoption of iec 80001-1 standard and a medical device security risk-management program. three responses were categorized from research as the main barriers and restrictions to adopting this standard. response count percentage not at all familiar 13 36 slightly familiar 5 14 moderately familiar 13 36 very familiar 2 6 extremely familiar 3 8 total 36 100 response count percentage not at all aware 8 22 slightly aware 12 33 moderately aware 11 31 very aware 2 6 extremely aware 3 8 total 36 100 response count percentage yes 8 22 no 13 36 don’t know 15 42 total 36 100 response count percentage yes 4 11 no 10 28 don’t know 22 61 total 36 100 response count percentage clinical engineering 1 3 it department 3 10 both clinical engineering and it 12 39 multidisciplinary team 15 48 total 31 100 total 36 100 37 j global clinical engineering vol.6 issue 2: 2024 keeley: healthcare providers’ readiness to address medical device cybersecurity within the irish healthcare system question 14, news participants were asked to indicate their level of knowledge and awareness of the news and the criteria included to calculate the score. question 15, digital news & vsa participants were asked to indicate knowledge and awareness of a digital initiative called vsa to capture physiological parameters such as oxygen saturation, blood pressure, pulse rate, heart rate and temperature by automatically calculating the news used to track whether a patient’s condition is deteriorating. conclusion strengths a benefit of the survey would be generating a greater awareness among the participants that standards are available for cybersecurity risk management of medical devices and a national initiative, digital news – vsa, being implemented across acute hospital settings—confirmation of the barriers to adopting iec 80001-1 correlated with the study results. implications of the research study highlighted by the research findings were the barriers to implementing this standard, with participants surveyed agreeing that the lack of management support to provide resources and a lack of alignment of the clinical engineering and it departments were the main restrictions to adoption. the literature review highlighted the inherent cybersecurity threats when integrating a medical device into a medical it network. healthcare providers and appropriate stakeholders must adopt and implement a cybersecurity risk management program, mainly iec 80001-1, and ensure compliance to minimize an adverse event or incident. recommendations and future research the research study results highlight the lack of knowledge, awareness, and adoption of standard iec 80001-1 “application of risk management for it networks incorporating medical devices” and a low level of familiarity with regulations as well as appropriate standards and guidance for an effective medical device security riskmanagement program with irish healthcare providers. the following recommendations are required at the local response strongly disagree somewhat disagree neither agree nor disagree somewhat agree strongly agree total standard is complicated to understand 0 5 13 11 2 31 lack of management support to provide resources 1 2 4 16 8 31 clinical engineering and it department are not aligned 1 1 0 16 14 32 response count percentage not at all aware 6 19 slightly aware 6 19 moderately aware 7 24 very aware 6 19 extremely aware 6 19 total 31 100 response count percentage not at all aware 10 32 slightly aware 5 16 moderately aware 8 26 very aware 2 7 extremely aware 6 19 total 31 100 keeley: healthcare providers’ readiness to address medical device cybersecurity within the irish healthcare system j global clinical engineering vol.6 issue 2: 2024 38 healthcare provider, regional hospital group, and national level for adoption and implementation to be successful: • education with the appropriate internal and external stakeholders on the importance of standards and their adoption, focusing on iec 80001-1. the development of a training resource and identifying with the health service executive (hse) and healthcare providers management to provide resources in the development of expertise and coordinate the availability of personnel to provide education. • enable adoption and implementation of iec 80001-1 more easily by removing the historical barriers to adoption. hse management provides guidance and governance to healthcare providers, enabling a simple pathway to compliance. increased and close collaboration between all stakeholders is essential for standard adoption and implementation success. conclusion medical devices integrated into healthcare providers’ it networks have become more prevalent over the last few years, specifically physiological monitoring. this integration and converging of medical systems with traditional it networks have transformed the it architecture and introduced additional risks that may have a bearing on the safety and security of this medical it network. this was highlighted recently in the hse with wannacry ransomware attack in may 2017, and the major ransomware cyberattack suffered in may 2021, causing all the it systems nationwide to be shut down. iec 80001-1 standard was developed to assist healthcare providers in applying risk management and system security to minimize patient safety and infrastructure threats by defining roles, responsibilities, and activities. the nist provides guidelines to secure network-connected medical devices. the aami guides healthcare providers in implementing an effective medical device security riskmanagement program. this study research highlights the barriers to adoption of iec 80001-1. it makes recommendations to ensure compliance with the implementation of this standard, particularly with the increasing number of digital transformation projects being realized across acute hospital settings in ireland. references 1. kniubó i and cartaya m. implementation of the multiprocessing in a central monitoring station with 16 patient monitors'. world congress on medical physics and biomedical engineering, september 7 12, 2009, munich, germany, berlin, heidelberg, 2009: springer berlin heidelberg, 100-103. 2. amarasingham r, et al. 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https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en 7 j global clinical engineering, special issue 3, 2020 date of publication april 13, 2020 patient safety recommendations for covid-19 epidemic outbreak lessons from the italian experience by micaela la regina, michela tanzini, francesco venneri, giulio toccafondi, vittorio fineschi, peter lachman, luca arnoldo, ilaria bacci, alessandra de palma, mariarosaria di tommaso, andrea fagiolini, marco feri, raffaele la regina, antonino morabito, stefano parmigiani, mario plebani, elisa romano, chiara seghieri, pierfrancesco tricarico, giorgio tulli, riccardo tartaglia. international society for quality in health care version – 1.1 (30 march 2020) summary introduction 8 1. general recommendations for the work system 8 2. recommendations for diagnosis 9 3. recommendations for hospital treatment 11 4. the ethics of treatment decisions 12 5. recommendations related to surgery 12 6. recommendations related to pregnant women 13 7. recommendations related to pediatric patients 14 8. recommendations related to hospital discharge 14 9. recommendation related to home isolation 15 10. recommendations related to persons in quarantine (39) 15 11. recommendations related to oncologic and immunosuppressed patients 15 12. mortuary/morgue operating procedures 15 13. psychological safety of staff and mental wellbeing of patients 17 14. measures (51,52,53) 19 15. references 19 16. appendix medications 23 this document is re-posted with permission from riccardo tartaglia (president of italian network for safety in health care) copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 8 introduction on the basis of reports and questions forwarded to the clinical risk managers of the italian network for health safety (insh) from physicians working on the front line, a series of recommendations have been developed referring to documents and papers published by national institutions (iss) and italian and international scientific societies and journals. we have arranged the process to describe organising the work system according to the seips human factors approach (1). 1. assess the work system: a. team and organisational culture and communication b. environment c. tasks required and skills to complete tasks d. equipment for patient care and to protect staff e. the people needed to provide care f. the patients who will receive care 2. develop reliable pathways of care. 3. measure the outcomes of care. isqua is honoured to publish these recommendations with our partners in italy. the document is work in progress and will be subject to updates by all professionals on a continuing basis. we appreciate and welcome the contribution of all those involved in covid19, both providers of care and patients who have received care: (e-mail info@insafetyhealthcare.it). 1. general recommendations for the work system building the team including communication and team culture 1. emergency taskforce should be promptly activated with a clear chain of command, roles and responsibilities, reliable information sharing tools and proactive approach. 2. check frequently every day the communications sent by your institutions. read carefully and respect them. alternatively, print and make such communication available in the ward and share such information during handovers. 3. clinical risk management units can support dissemination of documents, guidelines issued by the national institutions for supporting the emergency management, relatively for measures of prevention to be taken. knowledge about coronavirus transmission and spreading and clinical characteristics of related disease (covid-19) are constantly evolving, so that indications for clinical practice change frequently, i.e. case or suspicion definition, criteria for making swabs, etc. 4. the clinical risk management units must keep contact with front line workers and provide support. the reporting of adverse events must occur within the task-force activity and be primarily related to the core activities in time of the pandemic. secondly, the reporting of adverse events should be encouraged in order to maintain the underpinning safety climate in order to prompt corrective and improvement actions. consider quick reporting tools such as confidential im or audio-messages (e.g. whatsapp, wechat, telegram, line etc.) 5. the clinical risk management units should also receive evidence of good practice so this can be disseminated. tasks to be undertaken and skills required 1. organise brief educational training on the correct use of medical and protective devices targeted to all healthcare workers and develop video tutorials to be available on the healthcare trust website. 2. hold refresher courses on hand-hygiene, the prevention of vap (ventilator associated pneumonia) and clabsi (central line associated bacterial infection) bundles and the sepsis bundle for early sepsis recognition and management to all healthcare workers (2), but in particular to the staff not in the frontline of the emergency who could be called as replacements. 3. organise early support of expert doctors/nurses with young or colleagues from other specialties who may be called upon to replace them to properly educate them 4. do not forget appropriate instructions for environment disinfection (detergents, contact time, frequency) to cleaners (3). mailto:info@insafetyhealthcare.it 9 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience equipment needed to protect staff 1. contact and droplet precautions can be used in routine patient care of patients with suspected or confirmed covid-19 (4). 2. contact and airborne precautions are recommended when performing aerosol generating procedures (agps), including intubation and bronchoscopy (4). 3. prevent biosafety precautions shortage by extended use and limited re-use of full-face shields and disposable facial filtering masks (5), by identifying a priority order to the different wards and by supply of reusable tyvek suits. store such devices in a locked or secured area and distribute to staff appropriately (5). the infection spreads so quickly that a depletion of reserve medical supplies is almost unavoidable. equipment needed to treat patients 1. give suspected or confirmed patients a surgical mask to put on, at their first contact with healthcare services (6). 2. in the dedicated care areas for patients with covid-19, ensure that: a. haemo-gas analyzers b. pulse oximeters c. oxygen therapy d. ventilator therapy equipment e. e. suction pumps. are available and well-functioning (7). environment 1. strictly apply, without exceptions, the indications for disinfection of environments and tools (sodium hypochlorite at 0.5% or 70% ethyl alcohol solution) (8). it is not yet well known how long the virus resists in the environment, but it is inactivated by solutions based on hypochlorite and alcohol. 2. prevent germicide deficiency by using galenic preparations. 3. keep in mind that the creation of dedicated hospitals may divert from the emergencies /emergencies network. evaluate carefully the fallout of the timing of treatment decisions for time-dependent diseases. consider the use of underused or quiescent equipped hospitals to meet this need.4. unless activity is suspended, in the outpatient (public or private) clinics: a. avoid gatherings in waiting rooms (recommend people wait outside, respecting the distance of at least 1m between seats); b. inform symptomatic subjects with fever and / or cough and / or dyspnea (shortness of breath) not to go to clinics; c. disseminate hygiene and health standards recommendations in the waiting room. patients 1. reduce hospital admissions, routine outpatient clinic appointments and routine surgical procedures and regulate hospital visits. even in absence of strong evidence, it would be a good practice for authorized family members to enter the wards wearing medical masks, due to patients’ frailty. in the full-blown epidemic phase: a. consider all patients with flu-like symptoms who access hospitals as potentially affected until proven otherwise (2 negative swabs at least 48-72h apart); b. create separate unclean/clean paths, even with the help of external mobile structures (i.e. tents). 2. contacts of positive patients must follow the instructions provided by those who carry out epidemiological investigation and be clinically evaluated in the locally designated sites, only if symptomatic. 3. use a screening interview to identify suspected cases before admission to the examination room in case of infection symptoms or to healthcare services for other reasons (i.e. surgery, coronary angioplasty, labour and delivery, etc.) a. if the criteria of case or suspicion are met, refer the patient for evaluation, according to local procedures. b. general practitioners will provide their patients with useful information by social networks, email or other tools and keep them updated. 2. recommendations for diagnosis 1. the adequate specimen for real time-polymerase chain reaction (rt-pcr) testing is nasopharyngeal patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 10 and oropharyngeal sampling. prefer lower respiratory tract (lrt; expectorated sputum, endotracheal aspirate, or bronchoalveolar lavage) when readily available (for example, in mechanically ventilated patients). quality of rt-pcr testing is a crucial issue. both pre-analytical and analytical variables should be carefully considered, and a validation process should be performed according to iso 15189 (3 protocols). (9) 2. many of the most common symptoms of novel coronavirus disease (covid-19) are like those of common flu or cold. so, it is also suggested knowing which common symptoms of flu or cold are not symptoms of covid-19. covid-19 infection seems to rarely cause a runny nose. rhinorrhea ("runny nose") is not a symptom of covid-19 and nasal congestion ("stuffy nose) is reported only by 4.8% of patients (10). 3. the most common covid-19 symptoms are: fever (88%), dry-cough (68%), fatigue (38%), thick sputum production (34%), shortness of breath (19%), arthromyalgia (15%), sore throat (14%), headache (13.6%), chills (11%), nausea/vomiting (5%), nasal congestion (4.8%), diarrhoea (3.7%). data from a series of 55,924 laboratory confirmed cases of covid-19 in china in the period up to february 2020 (11). 4. beware of patients with gastrointestinal symptoms. nausea / vomiting and / or diarrhea can be present in about 9% of cases. these symptoms have so far been one of the most frequent causes of omission or diagnostic delays (11). 5. unexplained hyposmia, anosmia and dysgeusia could be other symptoms of covid-19. this issue is currently under investigation (12). 6. vital signs measurements (do not forget respiratory rate, please) and blood gas analysis in room air, if spo2 <94%, at triage or as soon as possible, are essential to correctly assess patients coming to the emergency room (13, 14). 7. do not rely only on po2 <60 for the diagnosis of respiratory failure, always calculate the pao2/ fio2 ratio (p/f ratio), especially in young subjects. 8. define a “covid-19 profile” for the rapid order entry of blood tests, including the following tests: blood count, c-rp, creatinine, electrolytes, blood glucose, albumin, ast alt, ldh, bilirubin, pneumococcal and legionella urinary agents, pt-inr, troponin and procalcitonin. 9. chest x-rays have limited sensitivity in early stages of covid-19 pneumonia. ct scan is more sensitive but raises logistical problems. if ultrasounds competencies are available, use chest us, but disinfect us probes after contact with every covid-19 suspected patient (15). 10. monolateral lung infiltrates do not exclude covid-19. they have been described in 25% of cases (15). 11. the most common reported laboratory abnormalities in covid-19 patients are: lymphopenia (35-75%), increased c-rp (75-93%), ldh (27-92%), esr (up to 85% of cases), hypoalbuminemia (50-98%) and anemia (41-50%). data from a systematic revision of literature (16). 12. the following negative prognostic factors have been reported: leukocytosis, neutrophilia, increased procalcitonin, ldh, ast, alt, total bilirubin, creatinine, troponin, d-dimer, pt and hypoalbuminemia, lymphopenia. even thrombocytopenia is associated with severe disease (16, 17). severe lymphopenia and lymphocytes count fall during the first 4 days since hospital admissions have been associated with a higher mortality. increased white blood cell count, neutrophil count and procalcitonin could reflect bacterial superinfection, while increased d-dimer and pt a diffuse intravascular coagulation (dic), reported in up to 75% of patients who died (16). 13. history of smoking, respiratory failure, maximum body temperature on admission 37.3°c, albuminemia<4 mg/dl would be risk factors for disease progression (severe or critical disease/death). esults from a multivariate analysis on a small sample (or ranging from 7 to 15) (18). 14. do not forget other respiratory infections (legionella, pneumococcus, mycoplasma, chlamydia, other respiratory viruses) even if during epidemics, so look for other pathogens and consider antibiotics. during epidemics it is important to avoid availability bias that means diagnose all infections due to epidemic agents. 11 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience who recommends investigating other pathogens, as co-infections have been reported (2). 15. use disease severity stratification for the choice of the treatment setting (home, ordinary, sub-intensive or intensive care unit). who distinguishes 6 clinical syndromes associated with covid-19: uncomplicated disease, mild pneumonia, severe pneumonia, ards, sepsis and septic shock. patients with uncomplicated upper respiratory tract viral infection, may have nonspecific symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache, muscle pain or malaise. these patients do not have any signs of dehydration, sepsis or shortness of breath and can be treated at home (2). 16. pay attention to elderly people and immunocompromised subjects as they can present vague and/or atypical symptoms (2). 17. immediately notify the public health officials of covid-19 positive patients (use infectious disease notification forms) (19). 3. recommendations for hospital treatment 1. before prescribing antiviral drugs, verify drug-drug and drug-disease interactions, pay particular attention to oral anticoagulants that could be substituted by low molecular weight heparin. current antiviral therapy schemes include drugs such as lopinavir / ritonavir, chloroquine or hydroxychloroquine, darunavir, cobicistat, tocilizumab, remdesivir (14,20) which present interactions with antibiotics, antiarrhythmics, statins, anti-angina, etc. (table 1, 2, 3, 4). 2. angiotensin-converting enzyme (ace) inhibitors and angiotensin ii receptor blockers (arbs) are safe and should not be discontinued during coronavirus epidemics (21). 3. there is no proof that ibuprofen can aggravate covid-19 clinical picture and the european medicines agency is monitoring this issue (22). 4. start oxygen therapy at 5 l/min and titrate flow rates to reach spo2 ≥90% in non-pregnant adults and spo2 ≥92-95 % in pregnant patients (2). 5. high-flow nasal oxygen (hfno) or non-invasive ventilation (niv, mainly c-pap) should only be used in selected patients with hypoxemia, respiratory failure (p/f next to 300 for hfno and 250-300 for niv), but with alerts and with preserved ventilator dynamics. monitor closely for clinical deterioration (7, 23). 6. do not prolong hfno or niv for over 2 hours in the case of failure to improve (hfno: respiratory rate ≥24/ min, niv: respiratory rate ≥28/min and/or worsening p/f for both) (7, 23). high flow nasal cannulas and non-invasive ventilation are not recommended in viral pandemics, based on studies conducted in influenza and mers (2). 7. avoid nebulisation therapies for the potential spread of bacteria. nebulisers generate aerosol particles that can carry bacteria and viruses deep into the lung. the risk of infection transmission may increase with nebulisers as they can generate a high volume of respiratory aerosols that may be propelled over a longer distance than in natural dispersion pattern. nevertheless, the larger particles may cause cough in both patients' and bystanders' and increase the risk of spreading the disease. nebulisers in patients with pandemic covid-19 infection have the potential to transmit potentially viable covid-19 to susceptible bystander hosts (24). 8. administer intravenous fluids only if needed and avoid steroids, unless for other indications. excessive fluid administration could aggravate oxygenation and be dangerous, especially in settings where mechanical ventilation is not readily available. steroids were not associated with benefits, but rather with damage in the 2003 sars epidemic and a delay in virus clearance in middle-eastern respiratory syndrome (mers) of 2012 (2). 9. assess thromboembolism and bleeding risk of every patient and provide appropriate thromboprophylaxis. consider that recovery times and therefore hypo mobility of a subject with covid-19 are long (at least 15 days in mild forms and up to 6 weeks in severe / critical ones) and diffuse intravascular coagulation (dic) can complicate the course (2,15). thromboprophylaxis.consider thromboprophylaxis.consider patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 12 10. the respiratory rate, peripheral oxygen saturation (spo2) and arterial blood gas analysis results must be monitored closely during hospital stay due to insidious presentation of severe hypoxemia in this disease. intra-arterial radial catheters insertion is to be considered to reduce arterial punctures, even outside icu. 11. also monitor white blood cells, lymphocytes and platelets count, ldh, procalcitonin and d-dimer are considered alarm flags (13, 15, 17). 12. be aware of an eventual development of severe form +/7 days after symptom onset (13). 13. if a patient reports a spo2 ≤90% in free air or ≤92% in conventional oxygen therapy and/or presents ≥30 acts/min and/or severe respiratory distress, intensive care therapist consultation must be required (25). 14. use biosafety precautions when handling oxygen therapy devices (23); cover the patient's face with a surgical mask during hfno or c-pap (23); to reduce the risk of aerosolization, possibly use a dual or single circuit non-invasive ventilator with an integrated expiratory valve and a helmet that allows to insert a filter as interface (7). 4. the ethics of treatment decisions this is a complex issue which will be decided upon in the local setting as per previous ethical frameworks. we recommend that the ethical decision-making process be developed in anticipation of making complex decisions, rather than in reaction to the need to decide. with regard to management of the patient affected by covid-19 in intensive care, we offer a number of references which will assist in developing the local ethical guidelines. (19, 25, 26, 27). other important publications (not included among references): these provide recommendations that can assist in developing local, though may be context specific. giacomo grasselli, antonio pesenti, maurizio cecconi. critical care utilization for the covid19 outbreak in lombardy, italy early experience and forecast during an emergency response. jama published online march 2020 https://jamanetwork.com/journals/jama/ fullarticle/2763188 robert d. truog, christine mitchell and george q. daley, robert d. truog., christine mitchell, george q. daley. the toughest triage — allocating ventilators in a pandemic this article was published on march 23, 2020, at nejm.org. https://www.nejm.org/doi/pdf/10.1056/ nejmp2005689?listpdf=true ethical framework for health care institutions responding to novel coronavirus sars-cov2 (covid-19) guidelines for institutional ethics services responding to covid-19 managing uncertainty, safeguarding communities, guiding practice hastings institute https:// www.thehastingscenter.org/wpcontent/uploads/hastingscentercovidframework20 20.pdf 5. recommendations for surgery these recommendations apply to the medical staff of the operating blocks in case covid-19. patients with covid-19 may need to undergo emergency and/or emergency surgery. the following recommendations should be observed (29, 30, 31): covid-19 patient positive asymptomatic 1. surgical team wearing disposable masks, caps and gloves correctly. anesthesiologist and assistant nurse: ffp2 masks. 2. patients must wear a medical mask until i.o.t. (orotracheal intubation). 3. airway protection of the patient also intubated with tnt drapes compatible with anesthesiologist assistance. symptomatic or having few or minor symptoms positive covid-19 patient 1. surgical team wears personal protective equipment (ppe) and ffp2 or ffp3 masks. 2. anesthesiologist and nurses assigned to direct assistance: ffp2 / ffp3 masks and ppe. 3. patients must wear a medical mask for the entire time of surgery and / or after the iot procedure for airway protection with compatible tnt drapes. https://jamanetwork.com/journals/jama/fullarticle/2763188 https://jamanetwork.com/journals/jama/fullarticle/2763188 nejm.org https://www.nejm.org/doi/pdf/10.1056/nejmp2005689?listpdf=true https://www.nejm.org/doi/pdf/10.1056/nejmp2005689?listpdf=true https://www.thehastingscenter.org/wpcontent/uploads/hastingscentercovidframework20 https://www.thehastingscenter.org/wpcontent/uploads/hastingscentercovidframework20 https://www.thehastingscenter.org/wpcontent/uploads/hastingscentercovidframework20 20.pdf 13 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience patient covid-19 sick and in invasive airway management. 1. all professionals must wear ppe and ffp2 / ffp3. while staying in the operating room it is recommended to utilise laminar flow according to current legislation and post-intervention sanitisation for at least 1 hour. team working and organisation surgical teams in order to stay healthy and maintain continuity of care should divide into teams of senior and junior doctors and work for a 2-week period. after the 2 weeks, teams will come in to release the other. this will allow easier replacement of team members should they fall ill and potential containment of the virus to smaller staff numbers and an ability to maintain some service provision and clinical care. 6. recommendations related to pregnant women 1. reduce access of pregnant women to prenatal care, limiting only to high-risk cases (32). there is no evidence of an increased risk of unfavourable maternal or foetal outcomes in the case of covid-19. however, evidence relating to influenza and sars-cov1 must induce to consider the pregnant woman as a high-risk patient. 2. infants born to mothers with confirmed covid-19 should be considered as suspects. as such, these infants should be isolated from others (33). 3. separation (i.e. in an individual room) of the infant from the mother with covid-19 confirmed or suspected, until the precautions based on the transmission risk of the mother are suspended. the decision should be discussed carefully between the caring team and the mother, evaluating risk and benefits of this choice, including the protective potential of colostrum, breast milk and feeding time. (32,33). 4. the discharge of mothers after childbirth must follow the recommendations for discharge of covid-19 or suspected patients (32). 5. in the case of a woman with suspected sars-cov-2 infection or with covid-19, according to her clinical conditions and desire, breastfeeding should be started and / or maintained directly on the breast or with expressed breast milk (33). if mother and child must be temporarily separated because of mother clinical conditions, one should help the mother to maintain milk production through manual or mechanical/ electric expressing (33). in a limited series reported to date, the presence of the virus in the breast milk of infected women has not been reported, but antisars-cov2 antibodies have been found (31). so breast milk would be protective. 6. a mother with confirmed covid-19 or ongoing swab samples because symptomatic should take all possible precautions to avoid spreading the virus to the baby, including washing hands before touching the baby and wearing a face mask, if possible. during breastfeeding. if using a manual or electric breast pump, the mother must wash her hands before touching the breast pump or parts of the bottle. if possible, have another person administer the milk to the baby (33). it is not yet known whether covid-19 can be transmitted through breast milk. at present, the main concern is not whether the virus can be transmitted through breast milk, but rather whether an infected mother can transmit the virus through respiratory droplets during breastfeeding (32). 7. for assisting the delivery of women with confirmed or suspected covid-19, staff must use the safety precautions provided for non-pregnant patients (33). 8. pregnant women with suspected or confirmed sarscov2 infection should be treated with supportive therapies, however taking into account the physiological characteristics of pregnancy (2). 9. the use of experimental therapeutic agents outside of a research study should be guided by an individual risk-benefit analysis based on the potential benefit to the mother and the safety of the foetus, with the consultation of an obstetrician specialist and an ethics committee (2). 10. the decision to proceed to a pre-term birth is based on many factors: gestational age, maternal conditions and foetal stability and requires a collegial evaluation by obstetric, neonatal and intensive care specialists (depending on the mother's condition) (2). patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 14 11. positivity in itself to coronavirus is not an indication for a caesarean section which in these patients should only be performed based on other obstetric or medical indications (33). 12. in covid-19 pregnant women, it is useful to be very cautious in inducing maturity of the lung by means of corticosteroids, since these drugs seem to worsen the course of the infection. if possible, evaluate each case with a neonatologist. 7. recommendations related to pediatric patients keep in mind that: 1. to date there is a paucity of information regarding covid-19 in children. 2. children and infants are affected and with milder forms (x-ray more often negative; ct more sensitive) (34, 35). 3. a small series of children with covid-19 has shown a greater prevalence of peripheral halo (halo-sign) lung consolidations on ct (35). 4. the criteria for the definition of acute respiratory distress syndrome (ards) and septic shock, the guidelines for the management of sepsis and septic shock and the use of noninvasive ventilation in children are different from those of adults (2). 5. children desaturate more easily during intubation; therefore, it is important to preoxygenate with 100% o2 with a mask with a reservoir before intubating (2). 6. a rectal swab may be useful in children to determine the timing of the termination of quarantine. some authors have used the cycle threshold values of the serial rectal and nasopharyngeal swab tests to indicate viral load. interestingly, the measurements have indicated that viral shedding from the gastrointestinal system could be greater and last longer than the respiratory tract (36, 37). 8. recommendations related to hospital discharge 1. the patient with fever without respiratory failure (normal ega and walking test) and normal chest x-ray, <70 years and without risk factors (lung disease, diabetes mellitus and/ or heart disease) can be discharged from the emergency room (14, 20) with indication of home isolation, waiting to run the swab sampling or its result. the discharge physician: • obtains a telephone number to contact the patient for swab sampling and / or to communicate the result; • provides information on how to access the pad (where and when). if the swab test does not take place in the emergency department, but is performed elsewhere to another area or hospital, it is strictly suggested to use systems to avoid the loss of information. the facility / service running the buffer • must report the result as soon as it is available to the patient and, if positive, to the public health department for establishing active surveillance. 2. at the end of the hospitalisation, write clearly on the discharge letter: • clinically cured patient (patient with clinical symptoms resolution, but still positive for swab) (38) or • cured patient (patient who, in addition to resolving the symptoms, is negative in two consecutive swabs, carried out at least 24 hours apart) (38). or • clinically cured patient: write clearly on the discharge letter the indication to be observed at the home quarantine until the swab is negative on two determinations after 24 hours and the execution methods of the control buffer. although there is no clear supported evidence, it is considered appropriate to suggest patient retesting no earlier than 7 days and, if negative, confirm the negativity after at least 24 hours (38). or disabled patient, roommate of patient with positive swab or whose result is not yet known: • write clearly the indication of home isolation on the discharge letter (up to 14 days from contact with the infected person) and indication to call the appropriate number (in italy 112) if symptoms appear; 15 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience • assure a telephone number to communicate buffer result; • communicate swab results as soon as available to the patient and, if positive, to public health trusts, in order to establish active surveillance (38). 9. recommendation related to home isolation 1. provide prevention measures and explain them to patients in home isolation also by using designs, charts or pictures. 2. give also clear indications on alarm symptoms: a. promote information b. diffusion of telephone numbers to call in case of occurrence of symptoms c. arrangements for support e.g. shopping 3. provide call centres, online chats, faqs and video tutorials to consult when there is doubt. 10. recommendations related to persons in quarantine (39) 1. information represents the key success factor; quarantined persons must be constantly informed and updated on the epidemic progress. 2. it is necessary to provide food and other materials and any necessary drugs without making people feel abandoned or alone. 3. the quarantine period should be short, and the duration should not be modified except in extreme circumstances. 4. most of the side effects derive from the freedom restriction imposition; voluntary quarantine is associated with less stress and fewer long-term complications; therefore, it is necessary to explain clearly the reasons for such suggested behaviours. 5. public health officials should stress the selfless choice of self-isolation. quarantined healthcare workers can be helpful in producing useful documents or other materials while at home for their colleagues. they could contribute by making suggestions and stay in touch with social media. 11. recommendations related to oncologic and immunosuppressed patients 1. do not indiscriminately discontinue antineoplastic or immunosuppressive therapies. (40-42). 2. in cancer patients, consider the possibility of postponing the treatment cycle on a case-by-case basis (40). 3. immunosuppressant withdrawal is indicated if symptoms suggestive of infection appear (41); in this case it is good practice to inform the physician responsible for the treatment promptly. 4. steroids can be continued, but with caution (41). 5. new immunosuppressant prescriptions or dose increases are not recommended during an epidemic (42). 6. consider the switch from parenteral drugs to others that can be administered at home (e.g. subcutaneously) to reduce access to outpatient clinics (41). 7. ensure non-deferred outpatient visits and postpone visits for long-term follow-up, after remote evaluation (telephone, email, etc.) (40, 41). 8. do not allow visitors in therapy rooms and allow the presence of a maximum of one visitor per patient in hospital stays (40). please refer also to general recommendations (section 1) for other indications relating to outpatient clinics. 12. mortuary/morgue operating procedures management of the deceased body with suspect, probable or confirmed covid-19 respiratory infection. the proposed procedure is aimed at the safe management of the phases of acceptance, handling, custody, and discharge of the body with suspected, probable or confirmed diagnosis of covid-19 (43). the objective has been pursued by drawing up the following recommendations: 1. the acceptance and handling of the body must be done by personnel equipped wearing the recommended ppe; 2. the body must be positioned on a sanitised metal stretcher for custody and subsequent investigations. 3. at the end of the investigations, the body must be placed in the coffin with the clothes and wrapped in a sheet soaked in disinfectant solution. patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 16 4. if the corpse is required to remain in the mortuary is necessary, pending or at the conclusion of the investigations, the same must take place inside a special closed body bag and dedicated refrigerated room. 5. at the end of the handling and transport operations, all the equipment used must be subjected to sanitisation. recommendations for autopsy investigation in cases of suspect, probable or confirmed covid-19. for the safe and effective performance of hg3 (hazard group 3) autopsy investigations, is required: • generic risk assessment and adoption of universal standard precautions; • knowledge of possible pathological findings that can be highlighted; • the definition of sop (standard operating procedures) for the management of autopsies with high biological risk. 1. the use of universal precautions effectively protects against most risks related to sarscov-2 infection. professionals have a duty to carry out risk assessment for each case in order to prevent actions that could put operators at risk (44). 2. at the end of the autopsy investigations, the body must be positioned in a body bag and transported in a refrigerated room. 3. disinfect the outside of the body bag with a hospital disinfectant applied according to the manufacturer's recommendations. it is also recommended in this phase the use of suitable ppe by each operator involved in the movement and exit phases of the body. disinfection of autopsy rooms in addition, following an autopsy on a subject with suspect or confirmed covid-19, the following recommendations for disinfection of autopsy rooms should be applied (45): 1. keep ventilation systems active during cleaning; 2. wear disposable gloves when cleaning and handling cleaning or disinfectant solutions; 3. dispose of gloves after cleaning; do not wash or reuse the gloves in any case; 4. use eye protection, such as a visor or goggles, if splashing is expected; 5. if necessary, use respiratory protection based on the type of detergent or disinfectant; 6. wear a long-sleeved waterproof device to protect skin and clothing; 7. use disinfectants with indications of efficacy against human coronaviruses; 8. clean the surfaces and apply the disinfectant ensuring an adequate contact time for effective disinfection; 9. comply with the safety precautions and warnings indicated on the product label (for example, allow adequate ventilation in restricted areas and ensure correct disposal of the unused product or used containers); 10. avoid product application methods that cause the production of splashes or aerosols. regarding environmental disinfection, the available evidence has shown that coronaviruses are effectively inactivated by adequate sanitisation procedures that include the use of common hospital disinfectants, such as sodium hypochlorite (0.1% -0.5%), ethanol (6271%) or hydrogen peroxide (0.5%). there is currently no evidence to support a greater environmental survival or a lower sensitivity of sars-cov-2 to the aforementioned disinfectants. 1. hard and non-porous surfaces can be cleaned and disinfected as previously described. 2. handle with gloves and disinfect properly after use, equipment such as cameras, telephones and keyboards, as well as all objects that remain in the autopsy room. 3. cleaning activities must be supervised and periodically checked to ensure that correct procedures are followed. sanitation personnel must be properly trained and equipped with suitable ppe. 4. after cleaning and removing the ppe, wash the hands immediately. avoid touching the face with gloved or unwashed hands. 5. environmental disinfection must include cleaning with water and detergent soap on all vertical and horizontal surfaces, followed by disinfection with hospital disinfectants effective against sars-cov-2. 17 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience 6. for environmental decontamination, it is necessary to use dedicated or disposable equipment. reusable equipment must be decontaminated after use with a chlorine-based disinfectant. the use of special trolleys is strongly recommended, different from those used for cleaning common areas. 7. the instruments used for autopsies should be autoclaved or treated through chemical sterilisers. 13. psychological safety of staff and mental wellbeing of patients psychological safety of staff (46, 47, 48, 49) 1. create a healthy work, ethos and environment during crises and also to have systems in place to deal with subsequent distress and disorder. 2. organisations which have the foresight to prepare their staff to deal with trauma might consider using interventions such as pfa (psychological first aid is a humane, supportive response to a fellow human being who is suffering and who may need support). 3. consider that factors negatively affecting the psychological well-being of staff are: • concerns over the contracting the illness • concerns for safety of their family • witnessing the death of colleagues • isolation from family and colleagues • sense of being underappreciated • extended length of epidemic 4. reduce mental health stigma. the best ways of reducing stigma were believed to be raising awareness of mental health issues and telling people that it’s quite normal to feel that way and have those feelings; 5. educate healthcare workers who are exposed to trauma about the effects of cumulative stress. the training should be delivered either online ‘because they can do it at their own convenience’ or via educational leaflets ‘rather than finding the time to spend on a day course’. the education about psychological trauma may lead to better understanding, better recognition of symptoms in oneself and in others, less judgement, and therefore reduced stigma, and that positive relationships with others in the workplace can have a positive impact on psychology. 6. maintain teamwork and effective leadership while at the same time providing individuals the opportunity to provide input into the decisions that affect their lives. staff often experience severe emotional stress during viral outbreaks. it is often the nursing staff who feels the greatest level of stress due to their constant contact with sick patients, who may not be improving despite the nursing staff's best efforts. physicians usually cope somewhat better with this situation because they are in a position to make treatment decisions and are less directly involved in implementing patient care. 7. be receptive to suggestions from nursing staff and support personnel. input is empowerment and provides a sense that these critical staff retain some control over their situation. if suggestions are not acted on, clear explanations as to why they were not should be provided and alternatives should be explored. 8. administration needs to be supportive of staff and not be seen as pedantic and overly controlling. in cases where staff and support personnel did not feel appreciated or listened to, there was a high degree of dissatisfaction and an increased occurrence of absenteeism and staff strikes, which further reduced personnel in an already-strained system. 9. take care of yourself and your loved ones. healthcare providers are not invulnerable to experiencing their own emotional distress during outbreaks, and this distress can be compounded by caring for sick and distressed patients. 10. make sure your basic needs are met, including: eating, drinking, and sleeping; take a break when you need one; check in with loved ones; practice the strategies to reduce distress listed above; and monitor yourself for stress reactions too. 11. make efforts to ensure that your office and/or organisation has a viable plan to monitor the course of the outbreak and take rapid and appropriate action if needed. patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 18 mental well-being of patients (50) 1. medical and mental health clinicians are likely to encounter patients who are experiencing various levels of emotional distress about the outbreak and its impact on them, their families, and their communities. we must consider that covid-19 patients have long hospital stays and in the early stages they will experience the anguish of having an aggravation of the disease with the possibility of being intubated. furthermore, the limited staff available will not be able to guarantee them continuous assistance and their relatives as well. 2. providers should acknowledge uncertainty about emerging diseases and help patients understand that there is often an emotional component to potential health concerns. 3. providers should be cognisant that the symptoms might extend beyond classical mental health symptoms to include relational struggles, somatic, academic, or vocational issues. 4. every person, including mental health providers, can either react in fear, anger, or despair and regress, or can choose resilience and play as an active part of the solution. in addition, providers should consider the following recommendations for promoting patients’ mental wellbeing during emerging infectious disease outbreaks: be informed: obtain the latest information about the outbreak from reliable public health resources in order to provide accurate information to your patients. educate: healthcare providers are on the front lines of medical intervention and in a position to influence patient behaviours for protecting individual, family, and public health. psycho-education is of utmost importance in the aftermath of disasters. patient education plays a critical role in both containing the disease and mitigating emotional distress during outbreaks. depending on the nature of the outbreak, this can range from education about basic hygiene such as hand-washing and cough etiquette to more complex medical recommendations for prevention, diagnosis, and treatment. 5. let patients know what you, your office, or your organisation is doing to reduce the risk of exposure. 6. correct misinformation. in this age of social media, misinformation can spread quickly and easily, causing unnecessary alarm. if patients present you with inaccurate information related to the outbreak, correct their misconceptions and direct them to vetted public health resources. 7. limit media exposure. the excess media exposure to coverage of stressful events can result in negative mental health outcomes. use trusted media outlets to gather the information you need, then turn them off— and advise your patients to do the same. 8. anticipate and counsel about stress reactions. emotional distress is a common mental condition in the context of uncertain and potentially lifethreatening situations, such as covid-19 epidemic. a good first step for mitigating your patients’ stress is to acknowledge that it exists and help normalise it (“i see that you’re stressed, and that’s understandable. many people are feeling this way right now.”). 9. teach patients to recognise the signs of distress, including worry, fear, insomnia, difficulty concentrating, interpersonal problems, avoiding certain situations at work or in daily living, unexplained physical symptoms, and increased use of alcohol or tobacco. this will help them become more aware of the state of their mental health and head off distress before it becomes harder to manage. 10. discuss strategies to reduce distress, which can include: • being prepared (developing a personal/ family preparedness plan for the outbreak). • taking everyday preventive measures (e.g., frequent handwashing). • maintaining a healthy diet and exercise regimen. • talking to loved ones about worries and concerns. • engaging in hobbies and activities you enjoy to improve your mood. • if a patient is experiencing severe emotional distress or has a diagnosable mental illness, refer for specialized mental health care. 19 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience 14. measures (51,52,53) it is important that we measure the impact of our actions. we include some measures that may be of use. outcome measures outcome measures should be collected in order to support the monitoring of effective provider (hospital) epidemic/pandemic response including the capacity to adequately treat patients with other common severe conditions like heart attacks, strokes, trauma, copd in order to assure that the health of the public is protected to the fullest extent possible: 1. hospitalisation rate for covid-19 (indirect outcome measure of the territory). 2. in-hospital mortality rate of patients hospitalized for covid-19. 3. average length of stay of covid-19 patients. 4. percentage of covid-19 patients admitted to icu. 5. in-hospital mortality rate of no-covid-19 patients hospitalised for ami. 6. in-hospital mortality rate of no-covid-19 patients hospitalized for stroke. 7. in-hospital mortality rate of no-covid-19 patients hospitalized for copd. 8. percentage of no-covid-19 hospitalized patients that acquired covid during the hospitalisation. 9. covid-19 infection rate among staff / number of tests performed to hospital staff (as process measure) 10. survival rates where possible indicators 1-7 should be stratified by age groups. additionally, the proposed outcome measures should be used and interpreted with great caution if used to benchmarking care quality between providers. in this case, consistent data definitions should be adopted and measures from 1 to 7 should be adjusted for potential confounding factors (i.e. patient case mix) in order to draw meaningful and correct comparisons among providers of mortality rate. length of stay measures 1. length of stay 2. average length of stay in icu of infected 3. average length of stay in hospital process measures (some examples) 1. percentage of infected individuals 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infettivo da coronavirus covid-19 indicazioni per l’oncologia available at: https://www.aiom.it/ wp-content/uploads/2020/03/20200313_covid 19_indicazioni_aiom-cipomo-comu.pdf 41. r. mao et al. implications of covid-19 for patients with pre-existing digestive diseases, the lancet gastroenterology and hepatology, published on march 11th, 2020 doi:https://doi.org/10.1016/s2468-1253(20)30076-5 42. eular guidance for patients covid-19 outbreak published on march 17th, 2020 available online at: https:// www.eular.org/eular_guidance_for_patients_covid 19_outbreak.cfm 43. management of the corpse with suspect, probable or confirmed covid-19 respiratory infection – italian interim recommendations for personnel potentially exposed to material from corpses, including body fluids, in morgue structures and during autopsy practice. vittorio fineschi on behalf of the scientific society of hospital legal medicine of the national health system (comlas) and anna sapino on behalf of the italian society of anatomical pathology and cytology (siapec), pathologica, in press. 44. health and safety executive. managing infection risks when handling the deceased. guidance for the mortuary, post-mortem room and funeral premises, and during exhumation. available at: https://www.hse. gov.uk/pubns/priced/hsg283.pdf 45. the royal college of pathologists. briefing on covid-19. autopsy practice relating to possible cases of covid-19 (2019-ncov, novel coronavirus from china 2019/2020). available at: https://www.rcpath.org/uploads/assets/d5e28baf-5789-4b0facecfe370eee6223/ fe8fa85a-f004-4a0c-81ee4b2b9cd12cbf/briefing-oncovid-19autopsy-feb-2020.pdf 46. samantha k. brooks, rebecca dunn, richard amlôt, g. james rubin and neil greenberg, protecting the psychological wellbeing of staff exposed to disaster or emergency at work: a qualitative study bmc psychology (2019) 7:78 https://doi.org/10.1186/ s40359-019-0360-6 47. samantha k. brooks, rebecca dunn, richard amlôt, g. james rubin & neil greenberg social and occupational factors associated with psychological wellbeing among occupational groups affected by disaster: a systematic review. j ment health, early online (2017): 1–12, doi: 10.1080/09638237.2017.1294732 48. solon r. providing psychological first aid following a disaster. occup health saf. 2016 may;85(5):40, 42, 44. available online at: https://ohsonline.com/ articles/2016/05/01/providing-psychological-firstaidfollowing-a-disaster.asp x 49. who, war trauma foundation and world vision international psychological first aid: guide for field workers available online at: https://apps.who.int/iris/ bitstream/handle/10665/44615/9789241548205 ita.pdf?ua=1 50. center for the study of traumatic stress department of psychiatry. caring for patients’ mental well-being during coronavirus and other emerging infectious diseases: a guide for clinicians (2020) available online at: https://www.cstsonline.org/assets/media/documents/csts_fs_caring_for_patients_ mental_wellbeing_during_coronavirus.pdf.pdf 51. european centre for disease prevention and control. novel coronavirus disease 2019 (covid-19) pandemic: increased transmission in the eu/eea and the uk – sixth update – 12 march 2020. stockholm: ecdc; 2020. available online at: https://www.ecdc.europa.eu/sites/ shedding.nat https://www.nature.com/articles/s41591 https://www.nature.com/articles/s41591 https://www.iss.it/documents/20126/0/rapporto https://www.iss.it/documents/20126/0/rapporto domiciliare.pdf https://doi.org/10.1016/s0140 https://doi.org/10.1016/s0140 https://www.aiom.it/wp-content/uploads/2020/03/20200313_covid https://www.aiom.it/wp-content/uploads/2020/03/20200313_covid 19_indicazioni_aiom-cipomo-comu.pdf https://doi.org/10.1016/s2468 https://www.eular.org/eular_guidance_for_patients_covid https://www.eular.org/eular_guidance_for_patients_covid 19_outbreak.cfm https://www.hse.gov.uk/pubns/priced/hsg283.pdf https://www.hse.gov.uk/pubns/priced/hsg283.pdf https://www.rcpath.org/uploads/assets/d5e28baf https://www.rcpath.org/uploads/assets/d5e28baf autopsy-feb-2020.pdf https://doi.org/10.1186/s40359 https://doi.org/10.1186/s40359 https://ohsonline.com/articles/2016/05/01/providing https://ohsonline.com/articles/2016/05/01/providing following-a-disaster.asp https://apps.who.int/iris/bitstream/handle/10665/44615/9789241548205 https://apps.who.int/iris/bitstream/handle/10665/44615/9789241548205 ita.pdf https://www.cstsonline.org/assets/media/documents/csts_fs_caring_for_patients_ https://www.cstsonline.org/assets/media/documents/csts_fs_caring_for_patients_ mental_wellbeing_during_coronavirus.pdf.pdf mental_wellbeing_during_coronavirus.pdf.pdf https://www.ecdc.europa.eu/sites/default/files/documents/rra 23 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience default/files/documents/rra-sixth-updateoutbreakof-novel-coronavirus-disease-2019-covid-19.pdf 52. world health organization (who). pandemic influenza severity assessment (pisa): a who guide to assess the severity of influenza epidemics and pandemics. geneva 2017. available online at: https://apps.who. int/iris/bitstream/handle/10665/259392/whowhe-ihm-gip2017.2-eng.pdf?sequence=1 53. wang d, hu b, hu c, et al. clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus– infected pneumonia in wuhan, china. jama (2020); 323(11): 1061–1069. available online at: https:// jamanetwork.com/journals/jama/fullarticle/2761044 table 1. chloroquine and hydroxy-chloroquine: main italian drug interactions drugs interactions chloroquine antacids based on aluminum, calcium and magnesium and kaolin can reduce their absorption. in association with: • corticosteroids accentuation of any myopathies or cardiomyopathies • phenylbutazone can induce exfoliative dermatitis • isoniazid, amiodarone, carbamazepine, phenytoin, phenothiazide, ketoconazole and mao inhibitors (mono-amino-oxidase inhibitors) risk of hepatotoxicity • mefloquine and bupropion risk of convulsions • metronidazole possible dystonic reactions • penicillamine serious haematological or renal adverse events • pyrimetamine / sulfadoxineskin reactions effects of chloroquine on other drugs: • ampicillin reduced absorption (administer at least 2 hours after chloroquine) • class ia and iii antiarrhythmics, tricyclic antidepressants, antipsychotics increased risk of ventricular arrhythmia • antiepileptic antagonism on anticonvulsant effects • cyclosporine increase in plasma concentration • digoxin increase in plasma concentration and relative toxicity • methotrexate potentiation of the action • neostigmine and pyridostigmine antagonism of the effects • vaccines antibody response reduction only with rabies vaccine hydroxychloroquine in association with: • phenylbutazone can induce exfoliative dermatitis • isoniazid, amiodarone, carbamazepine, phenytoin, phenothiazide, ketoconazole and mao inhibitors (mono-amino-oxidase inhibitors) can cause hepatoxicity effects of hydroxychloroquine on other drugs • anti-epileptics antagonism on anticonvulsant effects • cyclosporine increased plasma concentrations • digoxin increased plasma concentration and relative toxicity • insulin and antidiabetics potentiation of hypo-glycemic effects 16. appendix medications https://www.ecdc.europa.eu/sites/default/files/documents/rra outbreak-of-novel-coronavirus-disease-2019-covid-19.pdf outbreak-of-novel-coronavirus-disease-2019-covid-19.pdf https://apps.who.int/iris/bitstream/handle/10665/259392/who https://apps.who.int/iris/bitstream/handle/10665/259392/who 2017.2-eng.pdf https://jamanetwork.com/journals/jama/fullarticle/2761044 https://jamanetwork.com/journals/jama/fullarticle/2761044 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 24 table 2. lopinavir/ritonavir: main italian interactions and recommendations co-administered drug mechanism of interaction clinical recommendations retroviral agents: nucleoside reverse transcriptase inhibitors (nrtis), non-nucleoside reverse transcriptase inhibitors (nnrtis), hiv ccr5 antagonist, integrase inhibitor, inhibitors of hiv protease specialist advice, dose adjustment is not required in most cases. coadministration with other hiv protease inhibitors (pis), according to current guidelines, is not recommended. antacids no contraindications alpha antagonists alfuzosin increased concentration (cyp3a inhibition) contraindicated (hypotension) analgesic drugs fentanyl increased concentration (cyp3a inhibition) close monitoring (risk of respiratory antianginal drugs ranolazine increased concentration (cyp3a inhibition) contraindicated co-administered drug mechanism of interaction clinical recommendations antiarrhythmics amiodarone, dronedarone increased concentration (cyp3a inhibition) contraindicated (arrhythmia) digoxin increased concentration (p-gp inhibition) plasma level monitoring bepridil, systemic lidocaine, quinidine increased concentration plasma level monitoring antibiotics clarithromycin moderate increase of under-curve area (cyp3a inhibition) dose reduction in kidney failure (crcl<30 ml/min); attention in patients with impaired liver and kidney function antineoplastics specialist advice anticoagulants warfarin cyp2c9 induction inr monitoring rivaroxaban auc: 153%, cmax: 55% (cyp3a and p-gp inhibition) contraindicated (bleeding) vorapaxar increased concentration (cyp3a inhibition) contraindicated antiepileptic phenytoin concentrazioni diminuite (induzione del cyp2c9 e del cyp2c19) plasma level monitoring carbamazepine, phenobarbital increased carbamazepine concentration (cyp3a inhibition); reduced lopinavir concentration (cyp3a induction) plasma level monitoring → → 25 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience co-administered drug mechanism of interaction clinical recommendations antidepressants and anxiolytics trazodone auc: 2,4 times dose reduction antifungals ketoconazole increased concentration (cyp3a inhibition) dose reduction co-administered drug mechanism of interaction clinical recommendations anti-gout colchicine auc: 3-times; cmax: 1,8-times (cyp3a and/or p-gp inhibition) contraindicated antihistamines astemizole, terfenadine increased concentration (cyp3a inhibition) contraindicated (severe arrhythmias) anti-infectives fusidic acid increased concentration (cyp3a inhibition) contraindicated (rhabdomyolysis) anti-mycobacterial agents specialist advice benzodiazepines midazolam oral administration: auc: 13-times parenteral administration: auc: 4-times (cyp3a inhibition) oral administration contraindicated; close monitoring for parenteral administration beta2 agonists salmeterol increased concentration (cyp3a inhibition) contraindicated (severe cardiovascular event and arrhythmias) calcium channel blockers felodipine, nifedipine, nicardipine steroids dexamethasone reduction of lopinavir concentrations (cyp3a induction) clinical monitoring of antiviral activity phosphodiesterase inhibitors avanafil, sildenafil increased concentration (cyp3a inhibition) contraindicated ergot alkaloids dihydroergotamine and others increased concentration (cyp3a inhibition) contraindicated intestinal prokinetics cisapride increased concentration (cyp3a inhibition) contraindicated direct anti-hcv agents increased plasma concentration (combined mechanisms) contraindicated hcv protease inhibitors contraindicated → → → → → patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 26 co-administered drug mechanism of interaction clinical recommendations immuno-suppressers ciclosporine increased concentration (cyp3a inhibition) plasma level monitoring statins contraindicated; fluvastatin and pravastatin tolerated opioids methadone decrease in concentration plasma level monitoring contraceptives ethinylestradiol decrease in concentration use additional contraceptive methods hormone replacement therapy (hrt) levothyroxine potential interactions not well documented tsh monitoring during the first month from the beginning and / or from the end of the treatment 27 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience table 3. darunavir/cobicistat: main italian interactions and recommendations co-administered drug interaction mechanism clinical recommendations anti-retroviral agents (hiv) inhibitors of the strand transfer of ' integrase, inhibitors nucleoside / nucleotide hiv reverse transcriptase inhibitors (nrtis) specialist advice, no dose adjustment necessary, except for emtricitabine / tenofovir alafenamide nonnucleoside / nucleotide inhibitors of hiv reverse transcriptase (nnrti) specialist advice, nonrecommended co administration rilpivirine, the increase of which is not considered relevant, is an exception ccr5 a ntagonists no dose adjustment necessary mavaviroc increased concentration (cyp3a inhibition) specialist advice for dose adjustment al / m or calcium carbonatebased antacids no dose adjustment alpha antagonists alfuzosin increased concentration (cyp3a inhibition) contraindicated (hypotension) anaesthetic al fentanyl increased concentration (inhibition of cyp3a4) dose reduction and monitoring (respiratory depression risk) antianginal/tymic antiaries amiodarone, dronedarone chinidina, bepridile, ivrabradina, ranolazina increased concentration (inhibition of cyp3a and/or cyp2d6) contraindicated dysopyramid, flecainide, systemic lidocaine, mexiletine, propaphenone increased concentration (inhibition of cyp3a and/or cyp2d6) caution and monitoring digoxin increased concentration (pglycoprotein inhibition) dose titration and accurate monitoring of drug concentration antibiotics clarithromycin increased auc (cyp3a inhibition) caution dose adjustment in patients with renal impairment crcl <30 ml / min anticoagulants warfarin theoretical mechanism of alteration of plasma concentrations inr monitoring apixaban, edoxaban, rivaroxaban increased plasma concentrations (inhibition of cyp3a & p-gp) contraindicated dapigatran; ticagrelor increased plasma concentrations (inhibition of cyp3a & p-gp) contraindicated anticonvulsants clonazepam increased concentration (cyp3a inhibition) clinical monitoring carbamazepina, fenobarbitale, fenitoina reduced concentrations of darunavir and/or cobicistat (cyp3a induction). contraindicated patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 28 co-administered drug interaction mechanism clinical recommendations antidepressants and anxiolytics st. john's grass reduction of darunavir and / or cobicistat concentrations (cyp3a induction). contraindicated paroxetine, sertr alina, amitriptilina, desipramina, imipramina, nortriptilina, trazodone increased plasma concentrations (cyp2d6 and/or inhibition cyp3a) dosage reduction and clinical monitoring antidiabetic metformin increased plasma concentration dosage reduction and clinical monitoring αntiemetics domperidone not studied contraindicated anti-fungals clotrimazolo, fluconazolo, itraconazolo, isavuconazolo, posaconazolo increased concentration (inhibition of cyp3a &/or pgp) caution, clinical monitoring and dosing voriconazole contraindicated anti-gout colchicine increased concentration (inhibition of pgp and/or cyp3a4) dosage reduction, contraindicated in the presence of hepatic or renal impairment h2 receptor antagonists no dose adjustment necessary antimycobacterials specialized evaluation, tendentially contraindicated anti-psychotics / neuroleptics perfenazina, risperidone, tioridazina increased plasma concentrations (inhibition of cyp3a, cyp2d6 and/or pgp) dose reduction and clinical monitoring lurasidone, pimozide, sertindolo, quetiapina contraindicated anti-cancer theoretical mechanism of concentration increase (cyp3a inhibition) specialist evaluation, extreme caution beta2 agonists salmeterol increased concentration (cyp3a inhibition) contraindicated (serious cardiovascular adverse events, arrhythmias) beta blockers carvedilol, metoprolol, timolol plasma concentrations increased (cyp3a inhibition) dose reduction and clinical monitoring calcium antagonists amlodipina, diltiazem, felodipina, nifedipina, nicardipina, verapamil increased concentration (inhibition of cyp3a and / or cyp2d6) dose reduction and clinical monitoring 29 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience co-administered drug interaction mechanism clinical recommendations corticosteroids dexamethasone reduction of darunavir and / or cobicistat concentrations (cyp3a induction) caution proton pump inhibitors no dose adjustment inhibitors of phosphodiesterase tadalafil, sildenafil increased concentration (cyp3a inhibition) contraindicated antivirals direct action against hcv (inhibitors ns3-4a protease) increased plasma concentrations (combination of mechanisms) contraindicated endothelial receptor antagonists (bosentan) increased concentration (theoretical consideration) contraindicated immunosuppressant cyclosporine increased concentration (cyp3a inhibition) monitoring of drug levels everolimus contraindicated narcotics, opioids methadone increased concentration (theoretical consideration) monitoring of drug levels buprenorphine / naloxone increased concentration (theoretical consideration) clinical monitoring fentanyl, oxycodone, tramadol increased concentration (theoretical consideration) clinical monitoring opioid antagonists naloxegol not studied contraindicated sedatives / hypnotics buspirone, clorazepam, diazepam, estazolam, flurazepam, zolpidem increased concentration (cyp3a inhibition) caution, dose reduction and clinical monitoring midazolam (parenteral) only in intensive care. midazolam (oral) contraindicated urological drugs fesoterodina, solifenacina not studied caution, dose reduction and clinical monitoring dapoxetine not studied contraindicated contraceptives alteration of plasma concentrations use additional methods of contraception drospirenone monitoring for possible hypokalaemia statins and other hypo-lipidemic agents (lomitapide) contraindicated patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 30 table 4. serious adverse effects lopinavir / ritonavir darunavir / cobicistat chloroquine hydroxychlor oquine tolicizumab serious adverse effects hypersensitivity reaction, angioedema stevens-johnson syndrome / toxic epidermal necrolysis / erythema multiforme qt prolongation & torsade de pointes av block, pr prolongation hyperglycaemia, hypertriglyceride mia renal failure anemia, leukopenia, neutropenia pancreatitis hepatotoxicity hepatotoxicity anorexia, hypercholesterol aemia hypertriglyceridemia renal failure stevensjohnson syndrome rarely qt prolongation & torsades de pointes reduction in seizure threshold anaphylaxis or anaphylactoid reaction neuromuscula r impairment neuropsychiat ric disorders (potential to increase delirium) pancytopenia, neutropenia, thrombocytop enia, aplastic anemia hepatitis hypoglycemia qt prolongation cardiomyopathy muscle asthenia retinal or visual field alterations skin reactions interstitial pneumonia infections leukopenia, neutropenia hypo fibrinogenaemia upper respiratory infections herpes simplex and zoster oral ulcerations complicated diverticulitis hepatotoxicity common adverse reactions nausea / vomiting, diarrhoea insomnia, anxiety nausea / vomiting, diarrhoea insomnia, anxiety headache rash muscle pain nausea / vomiting, diarrhoea, abdominal pain visual disturbance, headache extrapyramida l symptoms nausea / vomiting, diarrhoea, abdominal pain visual disturbance, headache skin rash, itching extra-pyramidal symptoms hypertension headache skin reactions conjunctivitis hyper cholesterolemia abdominal pain, gastritis cough, dyspnoea contra indicated in: cardiac disease ischemic heart disease, cardiomyopathy, structural heart disease, qt prolongation liver disease liver failure (class c childpugh) haemophilia porphyria g6pd deficiency epilepsy heart failure recent myocardial infarction porphyria retinopathy maculopathies children <6a <31 kg administration of alive or attenuated vaccines monitor transaminases kidney function serial complete blood count qt interval blood count, glycemia, qt interval cholesterol, blood count, transaminases introduction 1. general recommendations for the work system 2. recommendations for diagnosis 3. recommendations for hospital treatment 4. the ethics of treatment decisions 5. recommendations for surgery 6. recommendations for pregnant women 7. recommendations for pediatric patients 8. recommendations for hospital discharge 9. recommendation for home isolation 10. recommendations for persons in quarantine (39) 11. recommendations for oncologic and immunosuppressed patients 12. mortuary/morgue operating procedures 13. psychological safety of staff and mental wellbeing of patients 14. measures (51,52,53) 15. references 16. appendix medications 37 j global clinical engineering vol.2 issue 2, 2019 global clinical engineering journal has been dedicated to encourage the sharing of knowledge and the publication of engineering and scientific work in the clinical engineering field. in our continuous efforts we are initiating a new section of our global clinical engineering journal www.globalce.org we call book review. we hope that you will professionally gain from it and at the same time promote the submission of such reviews for the benefit of all our readers. clinical engineering handbook second edition editor-in-chief: ernesto iadanza isbn 978-0-12-813467-2 academic press, elsevier published 2020 our first book review is about the elsevier academic press newly published clinical engineering handbook second edition with ernesto iadanza as editor-in-chief. mr. iadanza is adjunct professor in the university of florence, italy. he is currently also the ifmbe health technology assessment division chairman. following the reach of the first edition of this handbook, the second edition provides expanded coverage of the wide spectrum of technology-related responsibilities that the modern clinical engineering field is tasked with. this handbook contains over 900 pages of content that, while it may range in its importance level, is all pertinent to every practitioner in the clinical engineering and healthcare technology management field. the handbook consists of 13 sections and 127 chapters. the long list of section editors and chapter contributors made up of academicians and practitioners, that together, represents an authoritative view of the current state of subject matter that each of them covered. as noted in the foreword written by adriana velazquez, senior advisor on medical devices, world health organization (who) “this book is a major contribution to the evolution of the profession itself, and serves as a call to institutional leaders to look to clinical engineering to expand the professional capabilities that healthcare systems need worldwide as they grapple with the often overwhelming complexities, always keeping the enduser perspectives of patients, and healthcare workers’ needs globally.” the purpose of this handbook is noted in the introduction as “to provide a body of knowledge to all clinical engineers who intend to practice their profession.” indeed, the extended coverage of the handbook provides well for the many phases of the technology life cycle and for the professional practice guidelines. these subjects are fundamental for those who already manage the healthcare technology and a ‘must read’ for those who enter the field. for those who are at their mid-career practice, they stand to benefit from reading this handbook in preparation for their next career step. handbook organization that covers such a large scope of many career roles and tasks within the clinical engineering discipline can be structured in different styles. the style selected here could have been improved upon if, for example, section 1 on clinical engineering would have been restructured so that chapters on opensource medical devices and the rfid technology been reassigned into section 7 on medical devices, allowing for more logical grouping of a single subject matter. few other similar restructurings of chapters’ subject location should have been considered. also regarding the style, some of chapters offer the benefit of “further reading” book review by y. david editor-in-chief, globalce journal http://www.globalce.org http://www.globalce.org www.globalce.org j global clinical engineering vol.2 issue 2, 2019 38 segment that is very useful, but unfortunately, it is not uniformly incorporated throughout the book. as one of the authors within the long list of colleagues who contributed material for this handbook, i personally witnessed the great deal of effort and burden that the editor-in-chief lived with over the couple of years that it took to make this second edition a reality. it is significant accomplishment and can easily serves as the main “go to” source about the clinical engineering field and be part of every library and healthcare related academic programs resource. everyone that will examine the list of experts that contributed material for the handbook is surely to be overwhelmed with their knowledge of the subject matter, with their ability to present clear and easy to read content, and of the many locations around the world they represent. the contribution of so many well-known experts is making this handbook unique. it is a challenge to produce a resource that can encompasses the vast volume of information like that which is contained with an encyclopedia and simultaneously keep the depth of each of the individual subjects being addressed at reasonable level. this handbook is successful in its ability to offer expansive coverage of subject matters while at the same time reaching sufficient depth to help educate the reader. in my review i found this characteristic of the handbook to be uniquely and properly done. you can find the handbook at https://www.elsevier.com/books/clinical-engineering-handbook/ iadanza/978-0-12-813467-2 at the current discounted price of us $170.00. it is unfortunate since this cost is considered a far reach by many in the low resources’ regions of the world where such a handbook stands to make the most impact. i hope that the publisher will take this dilemma into consideration. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://www.elsevier.com/books/clinical-engineering-handbook/iadanza/978 https://www.elsevier.com/books/clinical-engineering-handbook/iadanza/978 https://www.elsevier.com/books/clinical-engineering-handbook/iadanza/978 j global clinical engineering vol.4 issue 1: 2021 14 received february 28, 2020, accepted december 9, 2020, date of publication february 3, 2021 evaluation and optimization of ces performances: application of the pareto principle to kpis by alessia cecchini, grazia maria pia masselli, sergio silvestri clinical engineering service, university hospital campus bio-medico, rome, italy abstract in recent times the approach to health care has been mostly influenced by the growing quantity of biomedical equipment used in hospitals, which needs the support of the clinical engineering service (ces). this work aims to suggest a methodology to improve the performance of a ces through the application of pareto principle to the leading key performance indicators (kpis). the methodology is applied by focusing on using kpis that represent a quantifiable measure of achieving goals set by an organization. in this study, five kpis are considered: uptime, mttr (mean time to repair), ppm (percentage preventive maintenance completion), mtbf (mean time between failures), and the cosr (cost of service ratio). the first three indicators express the measure of ces efficiency in ensuring regular maintenance. the first step consists of retrieving data related to work orders for 2015-2016 on 6000 installed devices, carried out by management software. the second step is to get the results by using an environment for numerical calculation and statistical analysis. to identify the main critical issues that may be present, three indicators (uptime, mttr and mtbf) are analyzed by applying the pareto principle (i.e., 20% of the causes produce 80% of the effects). considering the totality of work orders, it is possible to concentrate on only 20% of them to focus on a small group to understand the correlations between them. identifying these characteristics means identifying the main critical issues that are present, on which action must be taken, and which affect 80% of the overall behavior. instead, the cosr and ppm indicators suggest distribution models that focus on the most critical devices. in conclusion, the way to analyze the results is obtained, when possible, by applying pareto principle. therefore, a ces will be able to focus on a few causes of poor performance. the achievement of these results could allow the standardization of the method used, enabling it to be applied to any healthcare system. keywords – ces, kpis, uptime, mttr, mtbf, cosr, ppm, ucbm. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction • key performance indicators (kpis) represent a quantifiable measure of achieving goals set by an organization, both operational and strategic. generally speaking, companies have different kpis depending on their priority criteria. kpis can also be established arbitrarily but, to be useful, they must meet the following requirements1: • quantifiability kpis must be presented in the form of numbers. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 15 j global clinical engineering vol.4 issue 1: 2021 cecchini, masselli, silvestri: evaluation and optimization of ces performances: application of the pareto principle to kpis • practicality they integrate well with current business processes. • directionality they help to determine whether companies are improving. • operations they can be related to the practical context to measure an effective change. the four leading indicator typologies are1: 1. general indicators measure the amount of work in the process. 2. quality indicators evaluate the quality of the process output based on certain standards. 3. cost indicators. 4. service or time indicators they measure the response time from the start of the process until its conclusion. thanks to a set of kpis, it is possible to evaluate the performance of a clinical engineering service (ces). this paper discusses the current status of benchmark indicators within the field of clinical engineering. the paper focuses on the evaluation and optimization of the medical equipment repair and maintenance activities of a ces by applying the pareto principle to kpis to focus on main critical activities. state of the art according to cohen et al., kpis represent the process of comparing business performance levels to identify opportunities to improve. the results provided an idea of what should be changed and how. however, comparisons have met with limited success due to poor and inconsistent definitions of the parameters measured and lack of quality data available. in the first phase, it was necessary to identify basic indicators that are applied to any healthcare facility. they must be uniquely defined and consequently calculated by the same method so that they can be compared. afterward, it was possible to start to build other indicators that will be different depending on the specific needs and the technical-economic information that everyone possesses. for this reason, the primary purpose of this paper was to detail some of the quantitative performance and cost benchmark indicators that have been historically used in medical equipment maintenance and repair and to make recommendations on how the clinical engineering profession can develop good quality, useful and meaningful benchmarks. the general characteristics of a useful benchmark indicator are2: • well defined; • objective; • measurable; • based on current knowledge experience; and • valid. the study by bassem et al. aims to evaluate ces's performance at the university of cairo, egypt, using quantitatively measured parameters to allow comparison and improvement objective.3 in addition to the parameters proposed by cohen et al., considered insufficient, bassem proposed new indicators. data were collected by 10 hospitals, corresponding to different healthcare organizations.2,3 these data were subsequently analyzed by a software tool, providing a score for each ces. the first step was to decide what exactly to evaluate and monitor. some of the studies reported by bassem adopted a survey technique as ces directors were asked to select from a list of proposed performance indicators that could be used for performance measurement benchmarking. their response revealed three mainstream performance indicators. other indicators had to be added and measured to evaluate the performance of the other services. they used additional essential indicators that should be involved to get an increased accurate evaluation. the results indicated an average gap of 67% between the performance of the ces and the reference they have identified, considered the ideal target.3 according to the tiwari study, service performance on medical equipment serviced by external suppliers is assessed.4 the performance indicators of ces are first defined according to the needs and benefits required in the specific hospital structure and are then categorized and finally measured as indicated below. 1. the definition of kpis considering the opinion of experienced staff. 2. the categorization of kpis into four groups. 3. the measurement of kpis. cecchini, masselli, silvestri: evaluation and optimization of ces performances: application of the pareto principle to kpis j global clinical engineering vol.4 issue 1: 2021 16 the tiwari study is an example of an outsourced ces, and the key to success is the measurement of performance to quantify the expected benefits.4 methodology this study, conducted by the university campus biomedico of rome (ucbm), where there are about 6,000 pieces of biomedical equipment for the year 2016. before going into the explanation, and then in the calculation of the kpis, it is vital to understand what type of data have been used. the ces utilizes an equipment management software, in which all the data are collected and related to the inventory number of biomedical equipment: the description, the serial number, the manufacturer, the purchase value, the intervention priority, therefore any information useful to characterize a specific piece of equipment. from the mentioned software, further information can be obtained relating to work orders and the schedule for preventive maintenance. in the first case, the ces takes care of entering all the work orders executed. in the second case, the ces takes care of inserting, within a schedule, all the equipment and the corresponding deadlines for preventive maintenance, in order to record the periodicity with which it is required to carry out maintenance. this approach maximizes effectiveness and efficiency in technical management and ensures economic and technical control of maintenance. it has the objective of providing operational and decision-making support for further optimizing the processes related to registry/inventory management. in this way, from this software, it is possible to obtain categorized data, from which it is possible to calculate the kpis. starting from these data, the results are obtained through the use of "matlab," an environment for numerical calculation and statistical analysis, which also includes the programming language. it allows the calculation of the kpis considered here. the following paragraph will report the explanation, and the subsequent calculation, of the identified and measurable kpis. the following kpis are used and calculated: 1. uptime. this denotes the time the biomedical equipment has been working for over one year; downtime is its complementary statistic and denotes the state of a not operational system. this may be due to failure, preventive maintenance, or other causes. the measurement is carried out in absolute values or percentage. uptime is particularly important for all machines where stability and availability are fundamental. through uptime, efficiency can be deduced: a high uptime indicates that the equipment is well configured, while a low uptime could mean instability of the equipment. to get more evidence on the critical issues, this kpi calculation involves the initial use of data from all the equipment from which one or more work orders have taken place. also, all devices that have not undergone a work order are then considered and has always been functional; a maximum uptime value will appear. the uptime calculation, represented by a percentage, is carried out by first calculating the downtime: the work orders corresponding to each inventory number of the equipment are considered and, consequently, the duration given by the sum of all the work orders for that specific inventory is calculated. it is then divided by the number of days within a year to indicate, the percentage of the number of days that a specific piece of equipment remained inoperative relative to the total period.4 the formulas used are the following: 2. mttr (mean time to repair). this denotes the time to restore (ttr) expected value, where the ttr is the time interval where the equipment is unavailable due to a failure. the mttr includes the time for diagnosis, the arrival of the maintenance technician, the arrival of the component(s) to be replaced, and the actual repair. it is a useful parameter for evaluating the effectiveness of the ces in terms of the logistic organization. the calculation of this coefficient involves data from all equipment on which a work order has occurred involving corrective maintenance or functional verification. the mttr is calculated according to the work orders corresponding to the equipment’s inventory and the duration given by the sum of the times to repair in all the work orders, or that specific item is calculated. this is referred to as ttr and it is then divided by 17 j global clinical engineering vol.4 issue 1: 2021 cecchini, masselli, silvestri: evaluation and optimization of ces performances: application of the pareto principle to kpis the total number of work orders within a year.4 the formula used is: 3. mtbf (mean time between failures). this term corresponds to the average time interval between two successive failures (tbf) and indicates the frequency with which a failure can occur. this is mainly a reliability parameter used to indicate the probability that equipment operating under certain conditions will retain, after a predetermined time, the functional capacities for which it was built. the calculation of this coefficient involves data from all equipment on which a work order has occurred that involved corrective maintenance or functional verification. the work orders correspond to each inventory number of the equipment and consequently the total time that elapses between the start date of one work order and the start date of another. this would be the tbf. the tbfs from all work orders are added together and then divided by the total number of work orders within one year.4 the inverse parameter, defined as “frequency of failure,” indicates the rate at which technicians must carry out maintenance. the formulas used are the following: 4. cosr (cost of service ratio). cosr is an economic parameter that represents the sustainability of costs. it is calculated as the ratio between the overall maintenance cost and the purchase cost, assessed through a percentage measure.4 the calculation of the overall cosr is carried out by proceeding in three phases outlined below. 1. equipment with maintenance contracts, to which maintenance cost (if any) has been added the cost of the pieces of spare parts. 2. equipment with only spare parts and without maintenance contracts. 3. company cost of all the personnel working in the ces. the formula used is the following: 5. ppm (percentage preventive maintenance). this term expresses the overall number of preventive maintenance events or carried out within the deadline, divided by the total planned preventive maintenances within a year expressed as a percentage.4 this calculation is made for each piece of equipment based on the future expiration date of preventive maintenance and the scheduled maintenance frequency. this makes it possible to derive the previous preventive maintenance expiration date, which is compared with the date of the beginning of the maintenance carried out on each piece of equipment, allowing us to understand if the maintenance has been carried out before or after the deadline. the ppm calculation is also necessary in light of the accreditation manual of the hospitals of the joint commission international.5 according to this manual, “all medical equipment and technologies are regularly subjected to inspections, maintenances and calibrations and these activities are documented in the appropriate registers. the staff ensure that all medical equipment and technologies operate at acceptable levels and safely for operators.” when there is a need to manage the maintenance of many pieces of equipment, it is necessary to adopt criteria allowing priority. the equipment is not all critical in the same way, so it is necessary to distinguish the critical equipment on which the patient's life depends from the less critical ones for which the priority level is lower. there is, therefore, an issue to solve: if the technician receives two maintenance requests at the same time, the technician must be able to evaluate what the priority request is. to do this, a risk assessment is carried out, which is done with objective criteria and not left to free interpretation. in our case, the criticality analysis is carried out based on the assignment of five scores, respectively relating to five categories of equipment criticality (equipment management program mayo clinic6 has taken up this method). according to these criteria, equipment that should be excluded from the cecchini, masselli, silvestri: evaluation and optimization of ces performances: application of the pareto principle to kpis j global clinical engineering vol.4 issue 1: 2021 18 plan can still be included if requested by a certification body or if scheduled by the manufacturer for periodic maintenance or calibrations. the formulas of ppm used are the following: results and discussion firstly, the first three indicators are analyzed, where possible, by applying the pareto principle, one of the most used tools in quality management. the pareto principle, also known as the 80/20 rule, took its name from vilfredo pareto, an italian engineer who, in 1906, observed that the distribution of wealth in his country had an unequal distribution: 20% of the population owned 80% of the wealth.7 by expanding this idea to other areas and concepts, an empirical theory has been formulated which is respected in the majority of cases (this means that the distribution referred to it must be a very numerous distribution). the pareto diagram's construction, based on this principle, shows that 20% of the causes produce 80% of the effects. the advantages that derive from the application of the pareto principle and diagrams are: • to help to break down big problems into smaller problems and to establish what are the main factors causing them; • to help to focus on the most important causes in order to establish priorities, using the available time more effectively; • to help to link causes with effects; and • to support in evaluating the improvement based on an analysis of the situation before and after the application of the corrective action. to identify critical issues, the data relating to the first three indicators, namely uptime, mttr and mtbf, are analyzed by applying the pareto diagrams, showing that, where applicable, 20% of the causes produce 80% of the effects. considering all the medical equipment, it is possible to concentrate efforts only on 20% of causes to obtain a significantly better result. however, the analysis of data through the pareto law is not always possible, but to extend its application, it expanded to 30% of causes. however, where the percentage is more than 30%, its application is not considered significant. this analysis makes it possible to focus on a small group of medical devices and understand the correlations between them (type of equipment, manufacturer). identifying these characteristics allows the discovery of the main critical issues present within the health structure and what action is required. this will pertain to 80% of the overall behavior. for the construction of the pareto diagram, a combination of a bar chart can be considered showing the data in order of decreasing kpis (uptime, mttr, mtbf), and of a cumulative curve, constructed by adding the i-th value to the previous values. this allows for immediate identification and effect of the relevant elements. on the other hand, the cosr and ppm indicators help analyze the data and suggest distribution models that enable focus on the most critical equipment. the graph of uptime only considered those devices on which one or more work orders took place, which involved a value of uptime <100%. it is precisely on these parameters that the analysis of pareto is carried out. focusing will be on the downtime rather than on the uptime to immediately highlight any critical issues. overall, we note distribution of data mainly concentrated around 100%, while only a smaller percentage corresponds to a value of uptime less than 100%, mainly distributed between 20% and 30%. figure 1 shows the average value calculated, which is very high and aligned well with similar measurements noted in the bibliography. the mttr graph shows a data distribution mainly concentrated in a range between 0 and 1000 hours (42 days), while only a smaller part, the initial one, shows an increase in the number of hours that goes up to 1800 hours. as shown in figure 2, this reflects the average value calculated. since mtbf is the time between failures, the calculation is performed if there are, for each inventory item, at least two failures, therefore two work orders within a year. 19 j global clinical engineering vol.4 issue 1: 2021 cecchini, masselli, silvestri: evaluation and optimization of ces performances: application of the pareto principle to kpis the data analysis focuses on the frequency of faults, and it is carried out using pareto diagrams. the mtbf graph (figure 3) shows data distribution mainly concentrated in a range between 0 and 832 hours (35 days), while only a smaller part, the initial one, shows an increase in the number of hours that rises to 1354 hours. the cosr is calculated by paying attention to equipment with cosr> 0% to highlight any critical issues more efficiently. a histogram has been constructed (figure 4) from these devices: the cosr trend has been highlighted through 0.5% intervals and the number of devices is then reported, having the corresponding cosr. the cosr trend resembles a poisson distribution, in fact the data are distributed bell-shaped around a value belonging to the cosr range between 1.5 and 2%, corresponding to which we have 115 devices in 2015 and 124 devices in the year 2016. the trend over the two years is, in fact, the same. however, the highest histogram bar remains the one with cosr> 10% and will be analyzed later in detail for the analysis of critical issues. as can be seen, the cosr values are quite low at around 1%, but personnel costs must be added to this value, so overall it is around 4%. the data analysis for the ppm is carried out through the use of histograms (figure 5) that highlight the equipment on which preventive maintenance took place in advance figure 1. pareto diagram for calculating downtime for equipment in 2015. x axis = number of devices; y-axis = percentage of time out of service (downtime). figure 2. pareto diagram for calculating mttr for equipment in 2015. figure 3. pareto diagram for calculating the frequency of failures for equipment in 2015. figure 4. histograms for calculating cosr interspersed by 0.5% in 2016. cecchini, masselli, silvestri: evaluation and optimization of ces performances: application of the pareto principle to kpis j global clinical engineering vol.4 issue 1: 2021 20 (negative numerical value of the days) and late (positive numerical value of the days) concerning the scheduled deadline. if the number of days is 0, the preventive maintenance took place on the same day as the planned date. it should be noted that the maintenance carried out in advance is greater than the delayed since the initial section of the graph is greater than the final one. if we want to summarize in a single value what has just been shown, the value of the uptime, mttr, mtbf, cosr, and ppm is reported expressing the measure according to its mean value and standard deviation. each kpi is calculated for 2015 and 2016, as follows (equipment that does not have work orders is also included in the uptime calculation, resulting in 100% uptime). as shown earlier, the tiwari study, which shows numerical calculations and graphs of identified kpis, assesses the performance of medical equipment serviced by external suppliers; the ces examined in this work, on the other hand, is a predominantly internal ces, so a first difference is immediately apparent. in detail, however, we note that the numerical value of uptime and cosr obtained from the two studies is comparable; the calculation of mttr was carried out individually for each month by tiwari, so it is clear this type of comparison is inconsistent. also, because some work orders last more than one month; finally, in order to be able to compare the ppm, a clarification is needed, that is, it is necessary to take into account that, in the ucbm polyclinic, the system revolves around a risk classification that guides the professionals of the ces to act according to different priorities. it is clear that comparing the two numerical values, they are different, figure 5. histograms of the number of days in advance and delay concerning the scheduled deadline from the next preventive maintenance date. but, taking this into account, it would then have been more significant to take as a reference the value of the calculated ppm for priority equipment, at 93.7%. comparison with the study by tiwari et al is shown in table 1. starting with the results obtained critical issues are analyzed. in the case of the uptime, mttr, and mtbf, this analysis is conducted globally as there is a correlation between them and the level of the numerical calculation performed. they are calculated starting from the durations of the work orders that are carried out during a year. it is therefore important to concentrate on the equipment for which this phenomenon is most evident and this is possible with the analysis carried out using the pareto diagrams, which are found to be applicable only in those cases where 20% or 30% of the causes have produced 80% of the effects. therefore, making a detailed analysis for each of these kpis, a global analysis is deduced, identifying the equipment that more frequently falls into 20% or 30% of the causes. also, in the case of cosr, the critical issues present are analyzed and made possible by focusing on the equipment for which cosr is more than 10%. finally, the same reasoning is carried out for the ppm, which, regarding preventive maintenance, focuses on the type of intervention priority, such as equipment of priorities i, ii, iii. for example, it is reported as an average across the fleet of pressure such as therapy units for that particular manufacturer of equipment, considered from the criticality analysis of the uptime, mttr and mtbf (table 2). table 1. comparison with the study by tiwari and tiwari. 21 j global clinical engineering vol.4 issue 1: 2021 cecchini, masselli, silvestri: evaluation and optimization of ces performances: application of the pareto principle to kpis this paper summarizes medical equipment repair and maintenance benchmark indicators that can be used. therefore, the clinical engineering profession must develop and use indicators that accurately reflect the true costs and quality of medical equipment repair and maintenance. the way to analyze the results obtained is, when possible, using pareto diagrams. they help to break down the big problems into smaller problems and to determine which are the main factors that cause them; to help to focus on the most important causes and to set priorities, using the time available more effectively help to link the causes with the effects. this methodology makes it possible to have precise information on the critical equipment that will then be replaced or repaired correctly, which will be taken through work experience and information. table 2. analysis of critical issues through the pareto diagram for uptime, mttr and mtbf: types of equipment that fall within 20% or 30% of the causes performance measurement of clinical engineering departments in hospitals using these indicators will get more accurate and fairer performance evaluation. we will be able to find the real reasons for failure and improve performance. further analysis may be required to better define creating a standard and substantive performance evaluation benchmarks and solve it. references 1. project management europa. executive dashboards and kpi: to know to decide. available at: http://www. projectmanagementeuropa.com/cruscotti-direzionalie-kpi-conoscere-per decidere/ 2. cohen t, bakuzoinis c, friedman sb, and roa rl. benchmark indicators for medical equipment repair and maintenance. biomed instrument technol 1995;308–21. 3. ouda bk, ayman m. an integrated evalutation for the performance of clinical engineering department. ieee engineering in medicine and biology society 2014;1:3110–3. 4. tiwari a and tiwari a. performance evaluation of outsourced medical equipment maintenance service in a tertiary care hospital. int j sci res pub 2014;4(9):1–9. 5. joint commission international. joint commission international accreditation standards for hospitals; 2017. available at: https://www.jointcommissioninternational.org/-/media/jci/jci-documents/accreditation/ hospital-and-amc/jci-standards-only_6th-ed-hospital.pdf 6. mayo clinic. equipment management program rev 6-08. rochester: au. 7. whatissixsigma.net. pareto chart and analysis. available at: http://www.whatissixsigma.net/ pareto-chart-and-analysis/ http://www.projectmanagementeuropa.com/cruscotti-direzionali-e-kpi-conoscere-per http://www.projectmanagementeuropa.com/cruscotti-direzionali-e-kpi-conoscere-per http://www.projectmanagementeuropa.com/cruscotti-direzionali-e-kpi-conoscere-per https://www.jointcommissioninternational.org/-/media/jci/jci-documents/accreditation/hospital-and-amc/jci-standards-only_6th-ed-hospital.pdf https://www.jointcommissioninternational.org/-/media/jci/jci-documents/accreditation/hospital-and-amc/jci-standards-only_6th-ed-hospital.pdf https://www.jointcommissioninternational.org/-/media/jci/jci-documents/accreditation/hospital-and-amc/jci-standards-only_6th-ed-hospital.pdf http://whatissixsigma.net http://www.whatissixsigma.net/pareto-chart-and-analysis/ http://www.whatissixsigma.net/pareto-chart-and-analysis/ 31 j global clinical engineering, special issue 3, 2020 date of publication april 15, 2020 italian clinical engineer experience during covid-19 transcript of march 24, 2020 webinar (on behalf of aiic & ifmbe/ced) health technology alliance townhall (himss, aami and acce) by umberto nocco, vice-president of aiic and director of the clinical engineering department, in charge of evaluation, acquisition and maintenance of medical equipment. a.s.s.t. dei sette laghi, varese, italy copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. umberto nocco: it's a pleasure to be here and to share with you some of the things we've been dealing with for the past month, actually, because it hasn't been longer than that. lombardy is the region in the northern part of italy where i live in. it's been one of the most struck from the virus inside our state. basically, data shown today shows that we have some 30,000 cases among the 70,000 gross numbers throughout italy. this happened basically in three weeks. patient one, as we call him, was found positive on february 21st. since then, we add an exponential incremental ratio of known patients basically based in kind of a defined area throughout the region. but later on, the outbreak expanded over the entire nation. the point is that the rest of italy aside lombardy seeing cases after two weeks from the start in our region, so that at least they had the time to get ready to some extent before the outbreak reaches them. of course, we all wish it doesn't happen, but it's an option, of course, that this might end up having quite a number of cases. just to give you an idea, the difference between lombardy and rome, for example, although i'm saying they did a great job, they had the time one week, not very much, to remodel a closed hospital to accept covid-19–positive patients only. while in our region due to the birth and the continuous flow of patients to the hospitals, we had to work day by day and try to find out the solution to have them inside our hospitals. from an htm point of view, i would like to outline three major problems: 1. machine availability plus space inside the hospitals (e.g., icu beds). 2. organizational issues. 3. acquisition problems for devices. one of the main problems we had to cope with was that the need for ventilated beds, not only did we use icu beds which were more or less full because of standard patients. we were just running normal routine, and we are normally running at 95% better in lombardy and i think that more or less the same number throughout italy, but we had to define new areas where positive patients were to be placed. the more patients, the more icu beds were needed. those that could create new icu beds out of nowhere this document is posted with permission from italian clinical engineers association (aiic) http://www.globalce.org http://globalce.org http://globalce.org patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 32 did so, while other suffered the way even and they had to figure out a place where to put them, whether it be a normal ward, or some hospitals are starting to put tents outside the hospital at least to do the first screening when a patient comes in with the ambulance or with their car or however they get to the hospital. this means that the major issue about acquiring technology is basically on four to five types of assets. i'm talking about continuous positive airway pressure systems, ventilators, monitors, infusion systems, and beds being the last and the easier to describe and with difficulties to be found on the market and to be acquired. although, in the end, we ended up using normal ward beds even if we are to handle intensive care patients because, in some places throughout our region, we are basically a war zone. it's really whatever you have available, that's fine for the patient.  italy: the most important devices needed umberto nocco: the point is that if you get the continuous positive airway pressure system, they are the first line because patients come in with some sort of breathing problems. you might use noninvasive ventilation but usually requires a mechanical ventilator which is precious because we don't have a lot of them. we immediately swapped to continuous positive airway pressure systems. these can be used outside the icu, especially if you already have training personnel like in lung department or other specialties or medical departments. but you have to be aware that you are risking a lot more aerosol spreading outside the system rather than with the invasive ventilators. we have come to the point where we are making basically our own gas blenders because vendors can't keep up with the need we have. when it comes to ventilators, if you ask an anesthesiologist, he will ask for the top quality of the product. the point is that we had so many patients that we have become greedy rather than specific, if you see what i mean. we had to acquire devices really fast. the typical call we used to make a couple of weeks ago was calling the vendor and saying, "how many ventilators do you have in stock that can you bring me, say, tomorrow?" what we had to consider especially devices that could run without compressed air since we don't usually have that in ward. if you end up installing icu beds in what yesterday used to be normal wards, of course, you don't have all the facility you may have in an icu as usually defined. of course, i don't know how many of you are familiar with the italian way of setting up at hospitals. we usually don't have a room for the patient regardless of his type of treatment that goes from the icu to the general ward before he goes home. we have specific areas of the hospital dedicated to a different level of intensity of care we have to give to the patients. the next kind of asset we need to acquire really fast and in good big numbers were monitors and monitoring systems. they are, of course, important for an icu but also for patients who are taking care in normal wards. general conditions that we want to monitor are oxygen saturation, which is probably the best for a meter to look at, together with co2, to figure out whether the lungs are working correctly. but they asked for monitors rather than simple telemetry systems because they want to be able to view the monitor without going too close to the patient. so they avoid getting dressed up with protection clothes and breathing all the aerosols, which is, of course, one of the major issues. as far as i figured out in this past three weeks, you don't need a high-level monitoring. you don't need a lot of parameters. basically, basic parameters: pressure, of course, invasive pressures because the more the patient becomes bad and more ill, the more you may need to have some invasive pressure, and plus co2 monitoring unless you have it on the ventilator, of course, because you need to be really aware of the condition of the oxygen exchange in the lungs. the point is that we needed a lot. in my hospital, we have in standard conditions, some 50 intensive care beds. we've come up to almost a hundred. we basically doubled the number of icu beds in the hospital to handle this kind of patients and you have to be aware that the hospital i work in, it's not one of the most involved in the outbreak. we have a lot of cases but not as many as in other parts of the region. the last thing is the infusion systems, both syringe and iv lines. the thing is you never know how many you need. at least, that's what happened to me. if you talk to different anesthesiologists, they may ask you for different numbers. i wouldn't be able to say the correct number, 33 j global clinical engineering, special issue 3, 2020 patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience but probably a gross number is something around four pumps per patient, but the problem is always the same. we're talking about 20, 30 beds at the time, so numbers go up real, real fast. in italy, at least, we don't have a sort of organization where we have stocks of medical devices that can be used by hospitals without too much effort. i mean we had to buy all the devices to get them running inside the hospitals. of course, the more you get into it, the more requests come up from clinicians because, then basically, you need to put up a covid-positive, as we call it, patients and a non-covid patients icu. there are really two different icus for different kinds of patients. hopefully, once this empties, the covidpositive, while the other doesn't, but then everything is doubled up. so, you need two more ultrasound machines, more point-of-care diagnostics, and many other devices. for example, the emergency ward requires for extra ultrasound machine to do first screening of the patient's, portable x-rays because they're easy to handle. they give you a good shot at the beginning, and then, they're really easier to assess rather than ct scans. italy: what supplies are running out umberto nocco: one of the problems we are starting to face right now, and we are talking about right now and in the past two or three days, is the problem about spare parts. i don't have data on this, but one thing i must say is that probably ventilators run more steadily, if you see what i mean, because they're running on the same patient for a long time, so they suffer less failure if compared with the time when you have a higher patient turnover in the icus. so basically, technology is more stable, but then you need a lot more oxygen cells because they fail more often, probably it is due to the higher oxygen concentration used. and also one of the other problems is the consumption of oxygen. i don't have calculations handy, but lump figures say that we kind of doubled up, or maybe more than that, the oxygen used in the hospital. and so you need to increase the capability of the tanks, of the oxygen tanks. and also you need to be sure that you give an extra boost to the oxygen in the flow because continuous pressure airways support system use very high flows. and when you have many of them connected to the same pipe, you might end up figuring out that you're not really giving the patient the wanted flow of oxygen because everybody's sucking up from the same reservoir. so basically that's what it is. italy: tackling organizational issues umberto nocco: at the beginning of the outbreak we had to divide production lines, especially in the ers, sorry for my poor english, and i hope you understand what i mean. basically you need to define which wards and which icus, if you have them, you want to put positive patients in and which wards you want to put non-positive patients in. i know it's a stupid point of view, but the thing is that normal patients will show up anyway. so if you have a contagious disease ward, which is usually designed also with regard to air flux and isolation of the rooms, then you're quite ahead. but at least in italy, those are really a few and usually they don't have so many beds as needed in this kind of an outbreak. so you need to use a general ward, which is usually not designed to handle this kind of situation. you need to set it up with monitors, continuous pressure airway support system, point of care diagnostics, personnel, which we're really running short of personnel, and protection devices. these can be set up in advance. of course, if you know where to put patients, where you're really staying there. and this process division has to, at least we experienced, you have to figure it out also in the emergency ward, especially if you need to have basis for clean patients because unfortunately, as i said before, strokes, trauma still happen. although we experienced a significant decrease, especially after lockdown, it seems like patients don't have strokes anymore. we're kind of asking, “why?” but there are fewer cases that have come up to the hospital, luckily. of course, you have to have completely different spaces for known or suspect positive patients and known positive patients. this basically is like having two emergency departments inside the same hospital. also from an asset point of view, so you need to have the space, and you need to have the technology to make it run. another thing is about biomeds and biomedical equipment technicians and as hospital technology management people who kind of walk around the hospital just to have everything set. we need to be alert. of course, this is easy to say, but it's hard to handle. but one thing is that you patient safety recommendations for covid-19 epidemic outbreak: lessons from the italian experience j global clinical engineering, special issue 3, 2020 34 may need to define where to go and especially when it's worth or needed. by this, what i mean, this is mainly to prevent exposure to the virus, to the biomeds, and to your people in your organization, plus, to reduce the use of the protection clothing and devices, which are always short. and so this might not be liked by the personnel, at least it is not liked in italy, they don't like to attach cables, but sometimes some really easy basic line maintenance probably should be given out by nurses and people who can do that inside the ward without biomeds and people from the health technology department going inside a kind of positive area, which has all kind of problems. italy: the challenge of acquiring devices umberto nocco: last, but it's still a major problem, probably it's more local because it's probably it's more related to the way we acquire devices in italy. i won't get into the details related to public tenders, which probably don't apply to the u.s. market, but to some extent we faced a kind of saturation of the capability to produce devices, which is probably typical of medical device market, which is not usually accustomed to producing by the hour in great numbers, if you see what i mean. so, we were the first, and so we were able to use stocks, and we were able to acquire some numbers of devices at the beginning of the outbreak. but after a short time, we started experiencing a longer and longer time to hospital, as they call it, for ordered goods. orders given today are scheduled to be given to the hospital by the mid of april. so that's way too long. we need the devices before that. and we also experience lower quality due to a certain, probably to the speed on the production line, details that are not present on the devices, things that are missing, things that probably are not assembled very well and stuff like that. last thing, is how many devices do i need? basically, it's another way of putting the question i started with. we had hospitals where more was never enough, still today, and hospitals where you had the feeling that you were doing something wrong in acquiring all that kind of technology because it didn't seem like needing more devices and beds and somebody else might have a need rather than you. the problem is that you never know. you never know what's going on tomorrow. also, all these nice curves of patients that we see every day, we're not really sure they're correct. so we don't know what will be happening in the hospital tomorrow, how many cases we have at home, and they're are not even aware that they have covid-19, and they might end up in a hospital in a couple of days. so it's really hard to find the balance when you have to decide how many devices, which type, what you want them to do, and how you want the thing run. 5 j global clinical engineering vol.5 issue 3, 2023 new normal and year reflections as i sat to write this column during the 2022 holiday season between xmas, hanukah, and the new year celebrations, one cannot ignore the changing behavior of humanoids as the year came to a close. the elevated feeling from experiencing ubiquitous kindness shared by and among people, that of caring for one another, of conveying the season’s joy to others around us near and far, and the realization that we all share this planet. this was magnified, and subconsciously visibly appeared, during our serious conversations as well as within the small talks we carried. you could hear it, smell it, see it, and above all you could feel it. it seemed like everyone partakes in forwarding good wishes, joining in the sharing of fellowship, and gift exchange while getting prepared next to engage in making new year’s resolutions. as the world population has surpassed at the end of the year 8 billion persons mark consequently to ongoing innovation, access to energy, food, water, and medical care becoming more reliable and available. yet, the projected expectations for the more rapid growth1 of the human population will contribute to the higher challenges we face together in order to meet our combined future needs as shown in figure 1 below. adopted from https://population.un.org/wpp/graphs/ probabilistic/pop/tot/900. engineering report by yadin david biomedical engineering consultants, llc, houston, tx figure 1. world population surpassed 8 billion persons in 2022. http://www.globalce.org http://www.globalce.org https://population.un.org/wpp/graphs/probabilistic/pop/tot/900 https://population.un.org/wpp/graphs/probabilistic/pop/tot/900 j global clinical engineering vol.5 issue 3, 2023 6 you could easily be confused that this beautiful seasonal period, as short as it may be, is normal compared with years past but in essence, this has been just a masking of the fear of the unknown of uncertainty. following three years of human suffering caused by the most devastating plague in the past 100 years that completely engulfed our globe and turned every normalcy on its head, the normalcy that until then we began to take for granted. today, there are still regions where this disease is not contained. normalcy during this dreadful three-year period was only becoming a dream or a faint memory, with our aspiration not to forget the way we were. the normal world seems no more. families lost loved ones, national economies were forced to shut down, schools were empty of students, social gatherings were curtailed, and travel was not an option. grandparents could not hug their grandkids, and the only entertainment left to enjoy was from balconies or on the electronic display screens we kept becoming glued to at home. science became somewhat of a political pawn, factories were closed, and the supply chain could not stand up to its gigantic challenge (we still are faced in some regions with the infant formula supply crisis) bringing the world to almost a standstill. unfortunately, many difficult and sad lessons are still being debated and shared with the hope of never being faced with isolation and helplessness again. among the industries having a central role and perhaps the biggest impact on our lives is the healthcare delivery system. the system found itself in the middle of distress trying to meet the sudden rise in demand for its services and suffering from being unprepared, understaffed, and uncoordinated regarding its life-critical assets such as space, skilled personnel, drugs & vaccines, medical devices, and medical gases. that compelled healthcare systems to search for alternatives, workarounds, and innovative solutions to quickly produce the needed isolated patient care spaces, and obtain sufficient quality of personal protection equipment for their staff and patients, as well as mechanical ventilators, oxygen concentrators, and oxygen supply. healthcare providers and their support teams became exhausted, and fatigued but could not, for several reasons, be easily replaced by others. as history and global markets showed us, we are not good at predicting our future. we generally look for a brighter future, one that would not teach words like “new variant” or “subvariant”. what was normal before is no more, and in the vacuum, the new normal started to be created and has already begun to spread its roots. as reported by kxan2 and the jama-network open publication “prevalence of and factors associated with nurse burnout in the us”, almost 3% of practicing nurses, in the us, ages 49 and younger left their practice during the 2021 pandemic year. the figure below shows that in a short period between 2020 and 2021 over 100,000 caregivers (about 3%) left the workforce. however, their jobs had to be covered by other staff especially as patient volume has increased due to the pandemic. this condition, as difficult as can be imagined, gave rise to the new normal where potential partial relief can be derived from a new closer training between members of the healthcare team such as nurses and clinical engineering professionals. figure 2. over 100k nurses in the us left their job. http://www.globalce.org http://www.globalce.org 7 j global clinical engineering vol.5 issue 3, 2023 clinical engineering professionals (engineers, technologists, and technicians) are team members of this stressed industry and are deserved to be counted within the silent hero’s community that kept the healthcare delivery systems innovative, functioning, and safe under the extreme once-in-century challenge, brought about by the covid-19 pandemic, and thus sustain the system of patient-ready and operationally safe technologies around the world. the reality of the new normal was one of the reasons that in may 2022, t. judd and i published in the national academy of engineering perspectives an article discussing the growing role of clinical engineering professionals in merging technology at the point of care 3 sharing with nursing staff new responsibilities. to meet the needs of the new normal we included in this article a call for action for clinical engineering practitioners to transition from focusing on strategies addressing the localized point of care to those that meet larger population health needs, taking a bigger role in the healthcare delivery team, achieve certain systems competencies, and have a stronger contribution to national health technology policies. such as: 1. education of the workforce to create greater collaboration and resiliency within and between health team members. collaborative interdisciplinary educational training4 will ensure the availability of systems skills needed to maximize the benefits of health technologies. with demonstrated competencies and internationally coordinated professional credentialing, ces will be prepared to be equal partners with the other members of a healthcare team, participating in new clinical roles and workflows to free physicians and nurses for direct patient care. 2. participate in national health technology policy decisions to address priority national challenges. pandemic-related impacts necessitated the rapid implementation of national health technology policy in many countries.5 this and experiences with other disasters (e.g., floods, wildfires, earthquakes, power outages) clearly show the need for international coordination of new national guidelines to sustain access to, availability of, and the transfer of critical healthcare technology tools. clinical engineers can play an important role in informing and implementing such policies. 3. engage with national and international alliances and partnerships to share expertise and lessons learned. alliances, like the global clinical engineering alliance www.globalcea.org, will coordinate meetings of healthcare stakeholders (e.g., clinicians, administrators, and ministry of health personnel with clinical engineers) to examine areas of concern where ces can make a difference. for example, the global clinical engineering alliance has offered webinars, a virtual international congress, and a global ce summit to identify and rank common global challenges. such alliances can help those in the health sector, industry, academia, and ngos drive cost-effective and high-quality innovations in healthcare delivery and manage the performance of the technology used at both points of care and in regional and global populations. as healthcare delivery systems around the world are increasingly dependent on technology6 for the provisioning of their services, the expertise of clinical engineering professionals in the development, use, and management of this asset is critical for achieving the best outcomes. for both point-of-care and population health, a systems approach can improve the delivery of health services through education, workforce collaboration, inclusion in policy development, and engagement in partnerships. records from the pandemic era show that these professionals have much to be proud of and appreciated as they delivered solutions critical to sustaining the lives of patients all over the world. nevertheless, the new normal is expecting that clinical engineering professionals will continue to raise the bar on their commitment to pursue career-long continued education, credentialing, and active engagement in national associations and international alliances. as a result, credentialed clinical engineering professionals will continue to be indispensable partners http://www.globalce.org http://www.globalce.org http://www.globalcea.org http://www.globalcea.org http://www.globalcea.org https://www.globalcea.org/home https://www.globalcea.org/home https://www.globalcea.org/webinars https://www.globalcea.org/icehtmc j global clinical engineering vol.5 issue 3, 2023 8 in achieving healthcare missions. the approach described here shows a pathway to achieve the outcomes during the new normal era we all desire. references 1. world population to reach 8 billion on 15 november 2022, https://www.un.org/en/desa/ world-population-reach-8-billion-15-november-2022. 2. s. hernandez, this data is alarming: why over a 100k nurses left their job last year, 100k nurses left their jobs last year, the foundation says (kxan.com) 3. judd, t., david, y. https://www.nationalacademies. org/news/2022/05/the-growing-role-of-clinicalengineering-merging-technology-at-the-point-of-care copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. 4. institute of medicine. 2015 measuring the impact of interprofessional education on collaborative practice and patient outcomes (doi.org). washington: national academies press. 5. sharma, j., j. bunders, t. . zuiderent-jerak, and b. regeer. “a model for priority setting in health technology innovation policy”. global clinical engineering journal, vol. 2, no. 3, 2020, pp. 24-34, doi:10.31354/ globalce.v2i3.84.4. 6. judd, t., and y. david. “making a difference – global health technology success stories: overview of over 400 submissions from 125 countries”. global clinical engineering journal, vol. 1, no. 1, 2018, pp. 24-49, doi:10.31354/globalce.v1i1.43. http://www.globalce.org http://www.globalce.org https://www.un.org/en/desa/world-population-reach-8-billion-15-november-2022 https://www.un.org/en/desa/world-population-reach-8-billion-15-november-2022 https://www.kxan.com/news/national-news/this-data-was-alarming-and-disturbing-why-over-a-100k-nurses-left-their-job-last-year/ https://www.kxan.com/news/national-news/this-data-was-alarming-and-disturbing-why-over-a-100k-nurses-left-their-job-last-year/ http://kxan.com https://www.nationalacademies.org/news/2022/05/the-growing-role-of-clinical-engineering-merging-technology-at-the-point-of-care https://www.nationalacademies.org/news/2022/05/the-growing-role-of-clinical-engineering-merging-technology-at-the-point-of-care https://www.nationalacademies.org/news/2022/05/the-growing-role-of-clinical-engineering-merging-technology-at-the-point-of-care https://nap.nationalacademies.org/catalog/21726/measuring-the-impact-of-interprofessional-education-on-collaborative-practice-and-patient-outcomes https://nap.nationalacademies.org/catalog/21726/measuring-the-impact-of-interprofessional-education-on-collaborative-practice-and-patient-outcomes https://nap.nationalacademies.org/catalog/21726/measuring-the-impact-of-interprofessional-education-on-collaborative-practice-and-patient-outcomes http://doi.org j global clinical engineering issue 1:24-49; 2018 24 received september 10, 2018, accepted october 9, 2018, date of publication october 13, 2018 making a difference – global health technology success stories: overview of over 400 submissions from 125 countries by t judd1 and y david2 1ifmbe ced chairman, marietta, ga 30068, usa 2biomedical engineering consultants, llc, houston, tx 77004, usa abstract health technology (ht) is vital to global health care. the dependence of health, rehabilitation, and wellness programs on technology for the delivery of services has never been greater. it is essential therefore, that ht be optimally managed. clinical and biomedical engineers have been recognized by world health organization (who) as essential to providing this critical management. at the 1st international clinical engineering and ht management congress and summit held in china in 2015, a resolution was adopted by the global clinical engineering (ce) country participants to identify and promote ce unique qualifications, and to record the ce contributions to the improvement of world health status. review of published literature and submissions of case studies resulted in the first group of ce success stories. the review captured 150 stories from 90 countries – spanning over a period from the prior 10 years and the results were presented to health leaders at the who world health assembly in 2016. last year, in 2017, additional 250 case studies from a total of 125 countries were added from the 2016-2017 period. this paper describes the evidence identified during the review, their sources and the 6 major categories they represent. keywords – healthcare, clinical engineering, technology management, safety, efficacy, outcomes, innovation, success stories introduction health technology (ht) is vital to health and the dependence of health, rehabilitation and wellness programs on ht for the delivery of their services has never been greater. therefore, it essential that competent and trained professionals manage in an optimal and safe way for better response to the burden of diseases and resources. trained clinical engineers are academically prepared and appropriately responsible for ht life-cycle management, fulfilling a critical role as members of the healthcare team focusing on availability and reliability of safe and effective technologies and outcomes. over the past 50 years growing concerns among clinical engineering (ce) professionals about lack of knowledge of government agencies and key stakeholders, coupled with the mute recognition for their vast contributions to the safe and effective creation and deployment of ht, led to programs that address these concerns. knowledge about ifmbe-ced is the international federation for medical and biological engineering (ifmbe)-clinical engineering division (ced), currently representing clinical engineers (hospital-based biomedical engineers) in these roles in 165 countries. see more information about ced at cedglobal.org/organization-and-teams/ http://globalce.org http://www.globalce.org http://www.globalce.org http://cedglobal.org/organization-and-teams/ judd and david: global health technology success stories 25 j global clinical engineering issue 1:24-49; 2018 and recognition for the professionals of ce community who provide critical services will help recruit students and future practitioners into this needed field. is ce practice important for health, rehabilitation, and wellness programs and are their contributions recognized? this paper shares the methodology and the findings identified following a three-year examination of published evidence. following the international congress on ce and ht management in hangzhou, china in 2015, a global ce summit took place to determine whether regional issues are shared across the world and present common international challenges requiring global strategy for optimal addressing of the critical issues. after order ranking of the issues that identified at the end of the global ce summit, the attending members voted that there were 2 major concerns: (1) a lack of understanding of and recognition for the ce contribution to improvements in healthcare delivery. (2) a lack of sufficient education and training for both those who would like to enter the field and for ongoing professional development. an action plan was devised to address these and other issues raised at the summit. at the second global ce summit in sao paulo, brazil, in 2017, these challenges were reviewed and confirmed with attendees adopting resolutions seeking to continue to address these concerns. the action plans from the summit focused first on data collection identifying if ce contributions qualify as improvement to world health and wellness and can they be substantiated through evidence-based records. addressing the second issue, an international survey of body of practice and body of knowledge was initiated and has been now completed. methods rationale a task force consisting of senior certified clinical engineers from ifmbe/ced issued a global call for submissions of evidence-supported case studies of ce contributions to the improvement of delivery of healthcare services or of patient outcomes. in addition, literature survey was performed in 2016, and of both sources, the literature and the submitted studies, an aggregate volume of 150 responses from 90 countries was examined and qualified as evidence-based contributions, (see http://global. icehtmc.com/publication/healthteachnology). results were rated and tabulated into categories (innovation, improved access, health systems, ht management, safety & quality, and e-technology) and incorporated into document http://global.icehtmc.com/publication/ globalsuccess that was submitted to who’s world health assembly in may 2016. we expanded our review in 2017, as submissions and publications continued to be collected, to include conference-accepted data that was presented and published at ifmbe sponsored events. our examination methodology identified 250 additional stories from 35 more countries – now raising the total volume over 2 years to 400 publications from 125 countries. these ce success stories point to improved outcomes with benefit from ht, and present overall demonstration of complex integrated systems that must be effectively managed for their optimal and safe clinical and business impact to be realized. clinical outcomes included change in human life quality, care management decisions support, improving 365×24×7 readiness, and improving operational efficiency. definitions for the present study, we classified the collected database into 6 categories with definitions: • innovation through provision of new ht solutions, adaptation of existing, or a combination to address several issues. • improved access ease in reaching ht-related health services or facilities in terms of location, time, and ease of approach. • health systems positive impact from more efficient and effective deployment of ht at national or policy level. • safety & quality ht’s positive impact on health services safety or quality outcomes, or through ht human resource development. • healthcare technology management (htm) establishing or improving htm methodology resulting in improved population health or wellness. • e-technology improvements achieved due to deployment of internetbased ht tools. http://global.icehtmc.com/publication/healthteachnology http://global.icehtmc.com/publication/healthteachnology http://global.icehtmc.com/publication/globalsuccess http://global.icehtmc.com/publication/globalsuccess judd and david: global health technology success stories j global clinical engineering issue 1:24-49; 2018 26 measures during the first global clinical engineering summit in 2015 the question was raised whether evidence of successful ht innovation, management, accessibility, e-technology applications, safety, and quality outcomes can be identified. to accomplish this, a successful project (or submission) was defined as satisfying 2 objective measures developed by the sponsors. these measures included timeliness, cost saving, deployment or adoption by care providers, impact on services, and overall projection for success. each success metric was evaluated using 3-point scale against a statement representing the success construct (1= strongly disagree; 3=strongly agree). • timeliness refers to whether the project/submission was implemented in timely manner. this was measure by the statement “the submission will impact outcomes on present time.” • the cost measure was evaluated by whether the submission’s overall costs were within budget constraints and reasonable for the conditions in the region. this was assessed by the statement, “the submission cost objectives can be met in the region.” • the next 2 metrics were combined into the statements “the submission will be deployed by its intended users” and “the submission will have a positive impact on those who will adopt it.” • finally, overall submission success expectations were assessed with the statement “all things considered, the submission will be a success.” innovation is the beginning of the technology life cycle where new ideas offer solutions to current problems faced by healthcare providers or their patients. clinical engineers are well positioned to understand the current problems and guide different or new approaches to resolve them. innovation, in our category, means to demonstrate the team approach to solving problems all the way from the concept and building of a prototype, to continuing with clinical trials, and a demonstration of compliance with standards, regulations, and intended outcomes. improved access to services follows the innovation stage the same as the safety and quality category, e-technology category, and htm. products and applications that are considered in successful deployment were rated high and included in the total count for the evidence-based category. results summaries of the 6 categories of submissions database are described below. they come from the ced’s 2016 health technologies resources1 document provided to the world health assembly, who’s may 2017, 3rd global forum on medical devices2; (3), the ced’s september 2017 sao paulo ii icehtmc3 (s), and others4 from 2016-2017 ifmbe published sources (o): a new resource summary document of the findings – with links below – demonstrates that a benefit was registered in the 6 categories from every region around the world. overall this review identified evidence from 400 case studies received from 125 countries where management of medical devices (main component of health technologies) made a positive difference over the past 12 years. the 2007 who wha resolution 60.29 urges member states to create national ht management plans in collaboration with biomedical engineers. who further clarified the definition of these personnel in 20172018 as part of a global survey5 (http://www.who.int/medical_devices/ support/en/) in coordination with ifmbe ced. “trained and qualified biomedical engineering professionals are required to design, evaluate, regulate, maintain and manage medical devices, and train on their safe use in health systems around the world.5” these occupations have various names in different countries like clinical engineers, medical engineers, … and related professionals and technicians. [who and ifmbe ced surveys have identified over 800,000 of these global professionals in 2018.] the case studies – grouped in 6 categories – aim to formulate national strategies and plans to improve use of health technologies and better manage costs. in several countries, this has best been achieved by developing a ht unit at the ministry of health level with ce leadership. the studies provide clear evidence that ht is beneficial; at times, presenting complex systems that must be effectively guided and managed for optimal impact to be realized. http://www.who.int/medical_devices/resolution_wha60_29-en1.pdf http://www.who.int/medical_devices/support/en http://www.who.int/medical_devices/support/en judd and david: global health technology success stories 27 j global clinical engineering issue 1:24-49; 2018 • innovation • access • management • health systems • e-technology • quality & safety the case studies are actually health technology success stories demonstrating, in a limited resource environment, that it is desirable to include professional ht expertise, such as clinical engineers, in national decision-making in order to maximize health systems’ services. case studies from the links on the following pages demonstrate these benefits: • access: the ministry of health ht unit-led project in albania that doubled access to critical diagnostic services, such as computed tomography scanners, magnetic resonance and angiography imaging, while reducing equipment downtime to zero, and significantly reducing cost. • health systems: improved coordination between multiple stakeholders in the national laboratory and its satellites in colombia, led by the ministry of health and clinical engineers who partner with experts from academia and industry. • quality & safety: a clinical engineer-led 122-hospital program in the shanghai region that cooperates with officials, industry, and academic entities, resulting in improved device user satisfaction, tracking of emerging technologies, and closer partnerships with industry. conclusions ht is vital to health and the dependence of health, rehabilitation, and wellness programs that rely on ht for the delivery of their services has never been greater. beyond the ongoing healthcare burdens of population growth, political and economic instability, disease management, disasters, the refugee crisis, accidents, and terror attacks, world healthcare technological systems are facing enormous challenges to be innovative and optimally managed. the transition into health programs for the 21st century requires the employment of trained competent ce professionals. disease prevention, treatment, and rehabilitation is more efficient and effective when health services are provided with appropriate tools. along with world health organization (who), the international federation for medical and biological engineering (ifmbe) clinical engineering division (ced) recognizes and emphasizes how important the use of appropriate, integrated, and safe health technologies (ht) is to successful outcomes for every healthcare delivery systems. in the may 2016 ht resource document that was prepared for the world health assembly (wha), a recommendation was made: health technologies must be managed to ensure full clinical benefit and expected financial return on investment. it is critical, therefore, that with limited resources, ht must be professionally managed and its deployment over its life cycle be appropriately guided. this paper describes the extensive study of published data on the vast contributions by ce that positively impact patient outcomes. this study shows that every region of the world including low-resource regions face a challenge of improving health services while facing varied levels of infrastructure and human resources capacity challenges. ces play vital roles in all stages of healthcare technology life-cycle management. from creation to planning, and from commissioning to utilization and integration; technology-based systems must and can be managed for optimal performance. in each of the technology life-cycle stages the requirement for trained and competent ce input makes critical difference as shown in the analyzed evidence reviewed here. it is our hope that government agencies and other interested parties will have better understanding of ces role and thus will support their inclusion in the healthcare team of professionals. recommendation to encourage the availability, recognition, and increased participation of clinical engineers as part of the health workforce in your national healthcare delivery programs.2 references 1. ifmbe clinical engineering division (ced). [internet] health technologies resource. available at: http://cedglobal.org/ global-ce-success-stories/ http://cedglobal.org/global http://cedglobal.org/global judd and david: global health technology success stories j global clinical engineering issue 1:24-49; 2018 28 2. world health organization. [internet] third global forum on medical devices, may 2017. available at: http://www.who.int/ medical_devices/global_forum/3rd_gfmd/en/ 3. ifmbe ced. [internet] 2nd international clinical engineering and health technology management congress (ii icehtmc) proceedings, september 2017. available at: http://cedglobal. org/icehtmc2017-proceedings/ 4. ifmbe. [internet]. other related ce papers. available at: cedglobal.org. 5. world health organization. [internet]. medical devices: biomedical engineering resources. available at: http://www.who. int/medical_devices/support/en/ additional links and resources • who hq: http://www.who.int/medical_devices/en/ • who emro: http://www.emro.who.int • who amro: http://www.who.int/about/regions/amro/en/ • who digital health: http://www.who.int/medical_devices/ global_forum/thedigitalhealthaltas.pdf • who assistive devices-gate: https://mednet-communities. net/gate/ • who emergency: www.who.int/medical_devices/global_forum/ essentialresourcesemergencycare.pdf • who ncd kit refugees: http://www.who.int/medical_devices/ global_forum/ncdkitrefugees.pdf • ifmbe, ced, hta: http://ifmbe.org/, http://cedglobal.org/ http://htad.ifmbe.org/ • path: https://www.path.org/ (belgium, china, drc, ethiopia, ghana, india, kenya, malawi, mozambique, myanmar, peru, senegal, rsa, switzerland, tanzania, uganda, ukraine, vietnam, zambia) • awhp: www.ahwp.info; asian harmonization working party 30 countries, 3/17 regulatory authorities • htai: https://www.htai.org/ http://www.who.int/medical_devices/global_forum/3rd_gfmd/en http://www.who.int/medical_devices/global_forum/3rd_gfmd/en http://cedglobal.org/icehtmc2017 http://cedglobal.org/icehtmc2017 cedglobal.org http://www.who.int/medical_devices/support/en http://www.who.int/medical_devices/support/en http://www.who.int/medical_devices/en http://www.emro.who.int http://www.who.int/about/regions/amro/en http://www.who.int/medical_devices/global_forum/thedigitalhealthaltas.pdf http://www.who.int/medical_devices/global_forum/thedigitalhealthaltas.pdf https://mednet-communities.net/gate https://mednet-communities.net/gate www.who.int/medical_devices/global_forum/essentialresourcesemergencycare.pdf www.who.int/medical_devices/global_forum/essentialresourcesemergencycare.pdf http://www.who.int/medical_devices/global_forum/ncdkitrefugees.pdf http://www.who.int/medical_devices/global_forum/ncdkitrefugees.pdf http://ifmbe.org http://cedglobal.org http://htad.ifmbe.org https://www.path.org www.ahwp.info https://www.htai.org judd and david: global health technology success stories: innovation 29 j global clinical engineering issue 1:24-49; 2018 focus area title, authors, with active links afghanistan, iraq, libya, occupied palestinian territory, somalia, sudan, syria, and yemen medical devices for emergency kits (ncd kit), laura alejandra velez, slim slama australia phototherapy to reduce exchange transfusions, luciano moccia, gaston arnolda, daniele trevisanuto australia freo2 oxygen solutions: the low-pressure oxygen storage system and freo2 siphon, roger rassool, jim black australia bme development of non-electric portable blood/fluid warmer for roadside trauma, anne-louise smith, mark mcewen bangladesh health technology enhancing rural primary care and ehealth, ahmed raihan abir brazil dynamical orthostatic chair development of a new method of lifting and locomotion for physically disabled people, walef robert ivo carvalho brazil a multiband reflectance photometric device for reveal gestational age at birth, rodney guimaraes, zilma reis brazil prematurity detection by light, zilma reis, rodney nascimento guimarães, gabriela luíza nogueira vitral, maria albertina santiago rego, ingrid michelle fonseca brazil actions travelling ecg for telemedicine a partnership of academic and public service, kleber teixeira de souza et al brazil flow analyzer for blood pump, l.r. rodrigo, a.m. marcelo and s. anderson brazil principal component analysis usage in biomedical engineering to aid at diagnosing pathologies, e.f. esmanhoto brazil digital storage and system management for video surgery records in a network platform, benedito fernandes de lima et al brazil early stage strategic effectiveness evaluation of high flow nasal therapy (optiflow®) in the treatment of acute pediatric respiratory failure, graziela de araujo costa et al brazil location of electromedical equipment in closed environment using wi-fi technology, william knob de souza brazil remote equipment monitoring system, a. ricardo maranho brazil model fitting and simulation of the respiratory control system under incremental exercise and altitude in healthy subjects, c. a. sarmiento, a. m. hernández, l. y. serna canada provincial respiratory outreach program in the province of british columbia (bc), anthony chan, esther khor chile clinical simulations using actors as a patients as part of a strategic plan to reduce risks associated to a “big bang” opening of a new hospital in santiago, francisco acevedo china a novel automatic method of renal segmentation in grf estimation, xu lei colombia modeling and simulation of ciprofloxacin pharmacokinetics: electric circuits approach, j. d. otálvaro, a. f. zuluaga, a. m. hernández resources reviewed http://www.who.int/medical_devices/global_forum/ncdkitrefugees.pdf http://www.who.int/medical_devices/global_forum/3rd_gfmd/oxgyenstoragesystem.pdf 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italy assessing the impact of a cis/pacs technology for a cardiology department using qfd methodology, alessio luschi, laura caltagirone, claudio mondovecchio, roberto miniati, ernesto iadanza italy model national ce society and impact on legislation, paolo lago, lorenzo leogrande japan roles of clinical engineering in medical device development, hiroki igeta et al japan the business operations of ces, roles and certifications, jun yoshioka kenya using htm to improve moh care delivery, philip anyango amoko, (part2) kyrgyzstan, albania ht characteristics of countries in the who european region, tifenn humbert latin america the status of biomedical engineering (bme) programs in latin america, martha zequera díaz, a. p. koch mexico health technology project value chain, andrade bravo ignacio mexico opportunities of the mexican biomedical engineering society to influence and adopt clinical engineering in mexico, elliot vernet mexico cenetecmoh ht unit creates nation-wide htm capacity, roberto ayala mexico hta, ht regulation, htm to improve care delivery, cardenas, de alba, orencio, moreno, (part2) moldova medical devices management strategy in the republic of moldova, v. sontea, s. morgoci, gh. turcanu, c. pislaru nigeria using ht policy and htm to improve care delivery, bukola esan peru improving emergency preparedness through hybrid interactive training, t. clark, r. rivas, y. david peru a comprehensive system for htm, l. vilcahuaman, m. cordova, j. kalafatovich, r. rivas peru moh & national institute of health ht unit care improvement strategies, rossana rivas, luis vilcahuaman http://www.who.int/medical_devices/global_forum/3rd_gfmd/medicalequipmentmanagement.pdf http://www.who.int/medical_devices/global_forum/3rd_gfmd/medicalequipmentmanagement.pdf https://docs.google.com/viewer?a=v&pid=sites&srcid=zgvmyxvsdgrvbwfpbnxhy2nlywr2b2nhy3l8z3g6ngq1nwm5njhhmduxzdg2mq 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current state of ventilator alarms in icu, lin, zheng kun china shanghai region medical equipment quality and safety, li bin china design of a web-based medical equipment management system for ce, 2015, liu shenglin, zhang qiang, wu hanxi, zhang xutian, wang guohong colombia moh health technology management regulations, andrea garcia-ibarra dominican republic medical – surgical vacuum and anesthetic residue extraction policy in the dominican republic, diogenes hernandez germany technological surveillance and integrity monitoring of infusion systems, d. grossewentrup, u. m. hoelscher global a pneumonia prevention system, peter young; maryanne mariyaselam global global professional credentialing project, yadin david, mario medvedec, jim wear global adoption of medical-technologies in infrastructure-poor environments, gisela abbam, vikram damodaran, sally lee global hospital integrated networks risk management issues and recommendations, yadin david, (part2) 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http://cedglobal.org/wp-content/uploads/2018/08/46.-r.a.m.-s%c3%a1-et-al.-the-clinical-engineering-in-hospital-accreditation-case-study-radiology-clinic-brazil.pdf http://accenet.org/publications/newsletters/accenewsmayjune2015.pdf http://accenet.org/publications/newsletters/accenewsmayjune2015.pdf https://www.linkedin.com/in/murilo-cont%c3%b3-3396b15/ http://cedglobal.org/wp-content/uploads/2018/08/51.-sun-lv-feng.-a-hospital-based-dynamic-warning-system-for-medical-consumables-related-adverse-event-management-china.pdf http://cedglobal.org/wp-content/uploads/2018/08/51.-sun-lv-feng.-a-hospital-based-dynamic-warning-system-for-medical-consumables-related-adverse-event-management-china.pdf http://cedglobal.org/wp-content/uploads/2018/08/53.-jing-ying-gao-lei-wei-and-yin-chun-lu.-case-study-and-management-improvement-of-medical-device-adverse-events-china.pdf http://cedglobal.org/wp-content/uploads/2018/08/53.-jing-ying-gao-lei-wei-and-yin-chun-lu.-case-study-and-management-improvement-of-medical-device-adverse-events-china.pdf http://cedglobal.org/wp-content/uploads/2018/08/55.-zk-lin-zheng-kun-et-al.-survey-and-analysis-of-current-state-of-ventilator-alarms-in-icu-china.pdf https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/11/china-ss2-ht-shanghai-ht-qc.pptx https://link.springer.com/chapter/10.1007/978-3-642-29305-4_208 https://link.springer.com/chapter/10.1007/978-3-642-29305-4_208 https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/11/colombia-moh-htm-regulations-andrea-garcia-ibarra-.pptx http://cedglobal.org/wp-content/uploads/2018/08/86.-diogenes-hernandez-medicinal-gases-medical-%e2%80%93-surgical-vacuum-and-anesthetic-residue-extraction-policy-in-the-dominican-republic.pdf http://cedglobal.org/wp-content/uploads/2018/08/86.-diogenes-hernandez-medicinal-gases-medical-%e2%80%93-surgical-vacuum-and-anesthetic-residue-extraction-policy-in-the-dominican-republic.pdf https://link.springer.com/chapter/10.1007/978-3-319-19387-8_370 https://link.springer.com/chapter/10.1007/978-3-319-19387-8_370 http://www.who.int/medical_devices/global_forum/3rd_gfmd/apneumoniapreventionsystem.pdf http://www.who.int/medical_devices/global_forum/cehtmeducationtrainingcredentialing.pdf http://www.who.int/medical_devices/global_forum/adoptionmedicaltechnologiesinfrastructure.pdf http://www.who.int/medical_devices/global_forum/adoptionmedicaltechnologiesinfrastructure.pdf http://cedglobal.org/wp-content/uploads/2018/08/18.hospital-integrated-networks-yadin-david_part1.pdf http://cedglobal.org/wp-content/uploads/2018/08/18.hospital-integrated-networks-yadin-david_part1.pdf http://cedglobal.org/wp-content/uploads/2018/08/18.part2_.pdf judd and david: global health technology success stories: quality & safety j global clinical engineering issue 1:24-49; 2018 48 focus area title, authors, with active links global skill development for growth in emerging markets, gisela abbam, marut setia global clinical engineering risk management, frank painter global ce certification globally to improve care delivery, jim wear, mario medvedec global human factors engineering book global resource, tony easty et al global global training partnerships, shauna mullally global promoting the image of biomedical engineers and improving safety, michael cheng global managing the medical equipment lifecycle resource, thet, anna worm global medical equipment maintenance book, 2013, binseng wang global profile of biomedical engineering education in latin america, sj calil et al global preventable adverse events: how to? yadin david global medical device risk management from a human factors perspective, tony easty global medical devices vigilance and the european union regulations, nicolas pallikarakis italy a new digital era of clinical and biomedical process, giulia and stefano marchesi italy, egypt a new approach for preventive maintenance prioritization of medical equipment, neven saleh et al japan the role of policymakers for health technologies, dr. masato mugitani jordan implementation of six sigma on case study at the directorate of bme in the jordanian moh, 2012, adnan al-bashir, akram al-tawarah kenya roadmap to validation and verification of intravenous devices in kenya, bintiomar tsala, abdulatif ali, abel onyango kuwait safe care: an initiative for regulations in kuwait, who 2gfmd, 2013, ms. hanan al-awadhi, association for biomedical engineers mexico impact of state ce directorate, ignacio macias, 2016 mozambique, portugal training program in central hospital of maputo (2011-2016), mario forjaz secca papua new guinea improving pediatric and neonatal care in rural district hospitals in the highlands of papua new guinea: a quality improvement approach, m. saavu, trevor duke, sens matai samoa, fiji user care of medical equipment, nehal kapadia, sunema talapusi http://www.who.int/medical_devices/global_forum/3rd_gfmd/skilldevelopmentemergingmarket.pdf https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/11/ce-risk-management-2015-frank-painter-.ppt https://www.researchgate.net/publication/316668780_global_professional_credentialing_project https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/11/ced-hf-health-technology-safety.pdf https://blogs.bmj.com/bmj/2013/02/05/shauna-mullally-on-fixing-the-lack-of-medical-equipment-in-africa/ http://www.who.int/medical_devices/publications/en/md_regulations.pdf https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/11/a-worm-thet-managing-the-medical-equipment-lifecycle-book.pdf https://books.google.gr/books/about/medical_equipment_maintenance.html?id=g4e7qdqvjnmc&amp;redir_esc=y https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/11/profile-of-bme-education-in-latin-america-2012.pdf https://www.researchgate.net/publication/326720456_preventable_adverse_events_how_to http://cedglobal.org/wp-content/uploads/2018/08/30.-easty.-medical-device-risk-management-from-a-human-factors-perspective-canada.pdf http://cedglobal.org/wp-content/uploads/2018/08/47.-medical-devices-vigilance-and-the-eu-regulations-pallikarakis.pdf http://cedglobal.org/wp-content/uploads/2018/08/61.-giulia-and-stefano-marchesi.-a-new-digital-era-of-clinical-and-biomedical-process-italy.pdf https://www.researchgate.net/publication/286184415_a_new_approach_for_preventive_maintenance_prioritization_of_medical_equipment https://www.researchgate.net/publication/286184415_a_new_approach_for_preventive_maintenance_prioritization_of_medical_equipment http://www.who.int/workforcealliance/about/governance/board/mugitani/en/ http://www.iieom.org/ieom2012/pdfs/586.pdf http://www.iieom.org/ieom2012/pdfs/586.pdf http://www.who.int/medical_devices/global_forum/3rd_gfmd/ivdskenya.pdf http://www.who.int/medical_devices/global_forum/3rd_gfmd/ivdskenya.pdf http://www.who.int/medical_devices/sun_am_hr_6_al_awadhi.pdf http://www.who.int/medical_devices/sun_am_hr_6_al_awadhi.pdf https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/11/mexico-impact-of-state-ce-directorate-ignacio-macias.pptx http://marioforjazsecca.com/mario_forjaz_secca/about_me.html https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/11/papua-new-guinea-pediatric-and-neonatal-equipment-qi.pdf https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/11/papua-new-guinea-pediatric-and-neonatal-equipment-qi.pdf https://docs.google.com/viewerng/viewer?url=http://cedglobal.org/wp-content/uploads/2016/05/pacific-htm-success-story-user-care-of-medical-equipment-v2.ppt judd and david: global health technology success stories: quality & safety 49 j global clinical engineering issue 1:24-49; 2018 focus area title, authors, with active links saudi arabia unifying efforts against counterfeiting medical devices, nazeeh alothmany taiwan actions of medical device post-market surveillance, kp lin, y-t hung, shiuhuei yeh usa application of quality, risk & asset management principles to clinical engineering, binseng wang, (part2) cape verde, senegal, the gambia, guinea bissau, guinea, sierra leone, liberia, mali, ivory coast, ghana, togo, benin, burkina faso, nigeria, niger the west african health organization, biomedical engineering curriculum, bobo-dioulasso et al, (part2) http://www.who.int/medical_devices/global_forum/3rd_gfmd/againstcounterfittingforgingdocuments.pdf http://www.who.int/medical_devices/global_forum/3rd_gfmd/postmarketsurveillance.pdf http://cedglobal.org/wp-content/uploads/2018/08/7.application-of-quality-risk-asset-management-principles-to-clinical-engineering-binseng-wang_part1.pdf http://cedglobal.org/wp-content/uploads/2018/08/7.application-of-quality-risk-asset-management-principles-to-clinical-engineering-binseng-wang_part1.pdf http://cedglobal.org/wp-content/uploads/2018/08/7.part_2.pdf http://www.wahooas.org/spip.php?page=rubriques&id_rubrique=24&lang=en http://www.wahooas.org/spip.php?page=rubriques&id_rubrique=24&lang=en http://www.who.int/medical_devices/gfmd_report_final.pdf?ua=1 1 j global clinical engineering vol.3 issue 1, 2019 editor’s corner when was the last time you thought about your next breath? will it happen? do i need to do something to get it going? like you, i do not find myself thinking about it. fortunately, the respiratory center controlling our breathing is in our upper brainstem where the medulla oblongata and the pons send signals to the muscles that control involuntary respiration and cause breathing to occur. unfortunately, before the discovery of a safe and effective vaccine, some children were infected with the poliomyelitis virus that leads to paralysis. there is no cure for the devastating effects of polio but it can be prevented by the vaccine and the volume of global cases since 1988 have been reduced by 99.9% according to rotary club (https://www.endpolio. org/). this becomes much more personal and touching after one of our own editorial board members shared with me the story, from over a generation ago, about the loss of his sister at the age of 12 from polio. in 1927 philip drinker and louis shaw (faculty members at harvard university) invented a mechanical respirator powered by an electric motor that could temporarily maintain artificial respiration in a person. a couple of years later, calling it the tank respirator, inventor john emerson refined the design and adopted cost-cutting engineering enabling this “contraption” to become a staple within medical facilities. the cost of the tank respirator was, at the time, equal to the cost of a house. in the 1930s, drinker and harvard university took john emerson to court, claiming he had infringed on patent rights by altering drinker’s iron lung design. emerson defended himself by making the case that such lifesaving devices should be freely available to all. emerson’s tank respirator was first used in 1931 in rhode island, usa. years later, when jonas salk (inventor of the polio vaccine) was asked whether he would patent his polio vaccine and make a fortune, he replied that the vaccine belonged to everyone, making the comparison, “how could you patent the sun?” the first human use of a mechanical ventilator was recorded in 1909 when george poe, jr. was able to revive moses goodman using the apparatus, he called machine for inducing artificial respiration that he patented two years earlier. (https://en.wikipedia.org/wiki/george_poe#/ media/file:poe_patent.gif). about a century later, due to the coronavirus pandemic, once again the world is becoming concerned over the lack of availability of mechanical ventilators (https://www.weforum.org/agenda/2020/04/ covid-19-ventilator-shortage-manufacturing-solution/). the history of the mechanical ventilator is the story of how an engineering solution addressed critical and urgent medical needs and healthcare’s growing dependence on technology. also highlighted was that the technology lifecycle, from innovation to use, and from upgrades to accessibility, must be professionally managed by competently trained experts like clinical engineers. to be considered competent, clinical engineering education and training must include innovation, disaster preparedness, and assets management strategies. unfortunately, during this covid-19 pandemic, like the previous era of the polio virus, lives that technology could have saved, were lost. yet, the ability to connect challenges with engineering solutions just like john emerson did about 90 years ago is the contribution to better care that clinical engineers do every day. in the profession that creates and ensures that technological tools are patient-ready there no room for error or mistakes. the professional principals that every engineering training program must incorporate into their curriculum. regardless of the era humans live in, they can always find ways to collaborate and disseminate information, and there is no better time than now to appreciate and participate in the global clinical engineering journal. http://www.globalce.org http://www.globalce.org https://www.endpolio.org https://www.endpolio.org https://en.wikipedia.org/wiki/george_poe poe_patent.gif https://www.weforum.org/agenda/2020/04/covid https://www.weforum.org/agenda/2020/04/covid j global clinical engineering vol.3 issue 1, 2019 2 today, there are still few polio-stricken patients like paul alexander from dallas, texas, who are surviving thanks to the engineers and technicians who can keep old iron lung machines going for over six decades (https:// www.youtube.com/watch?v=gpla6pq9cos). like paul alexander says in the linked video “i’m not crippled. i’m a human being.” so, let me ask you again: when was the last time you thought of your next breath? how fortunate we are not having to think about it. i hope you will enjoy reading the rest of this journal and remember to send me your feedback. today, tomorrow, together! dr. yadin david copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://www.youtube.com/watch?v=gpla6pq9cos https://www.youtube.com/watch?v=gpla6pq9cos 11 j global clinical engineering vol.3 issue 1: 2020 hosea: emerging horizons of clinical engineering in disaster preparedness and management j global clinical engineering vol.3 issue 1: 2020 10 received april 21, 2020, accepted june 15, 2020, date of publication june 30, 2020 emerging horizons of clinical engineering in disaster preparedness and management: proposal for an expanded professional identity by f. hosea yachay tech university, ecuador. abstract the covid-19 pandemic of 2020 has exposed a wide range of systemic deficiencies in public health strategy, poor alignment of global health and economic institutions, insufficient budgeting, and the urgent need for real-time management of scientific resources, rapid-cycle clinical innovations, competent political decision-making, and supply chain logistics under disaster conditions. this article proposes that a new model of multi-disciplinary professional skills is needed globally to re-engineer existing public and private healthcare systems for both normal and disaster conditions. clinical engineers are recommended to play a growing role in future global disaster management and systems integration activities, owing in large part to their multifunctional expertise in technology assessment, hospital operations, and as stakeholders in healthcare innovation. twenty-six recommendations are presented as foundational strategies to create a 21st century model of globally aligned healthcare systems, centered on the growing role of clinical engineers as subject matter experts in both normal and disaster conditions. keywords – disaster preparedness, clinical engineering, systems engineering, alternate sites of care, health technology design, dual-use infrastructure. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction global disaster unpreparedness the global covid-19 crisis of 2020 has thrown a global spotlight on the many ways in which healthcare systems,1,2 governments,3,4 medical industries,5 markets,6 and healthcare professions7 have been unprepared, under-resourced, tragically slow and uncoordinated in responding to the most disruptive medical disaster of our times. despite numerous threat-analysis studies,8 detailed pandemic scenarios,9 and simulations by state and federal agencies,10 despite trillions of dollars spent on post-9/11 international disaster preparedness,11 and repeated top-levels warnings by epidemiological and public health experts, the world’s governments, markets, and healthcare systems have failed to prepare and prevent a health disaster from exploding into a multidimensional catastrophe. the fragmentation of plans and competencies across sectors – complicated by political decision-making – clearly demand mission-critical re-organization among the institutional players, with more coordinated, integrated, and systems-oriented professional approaches worldwide, and active cultivation of public health intelligence. for the reasons that follow, clinical and biomedical engineers are among the best-suited health professionals to assume an expanded and more comprehensive leadership role as subject matter experts in this urgently needed transformation, “particularly following the recent adoption of the recommendations of the un high-level commission on health employment and economic growth, the who global strategy on human resources for health, and the establishment of national health workforce accounts.” in particular, the who analysis and recommendations in “human resources for medical devices” provide a transformational vision for biomedical and clinical engineering worldwide that strongly harmonize with the recommendations contained in this article.12 why clinical and biomedical engineers? traditionally, clinical engineers and biomedical engineers are professionally prepared to perform a very broad range of overlapping clinical, technical and operational tasks – working from bench innovations to bedside care, including the design and assessment of medical devices and their internal components,13 to the management of complex hospital infrastructures and supply chains, encompassing possibly hundreds of device families, models, network interfaces and “care-anywhere” services via telehealth and telemedicine. for the purposes of this article, the term “clinical engineer” (ce) will be used to encompass both biomedical and clinical engineers, because clinical engineers (and clinical systems engineers) typically have the widest, multi-systems professional orientations and skillsets that are well-suited to the often improvisational complexities of disaster preparedness and management in healthcare systems.14,15 beyond individual hospital operations, ces may also be involved extramurally in standards development and technology assessment organizations, research and clinical trials, innovation consortia, startups, professional associations, and consultations to ministries of health and the world health organization. as such, they can have wide-ranging, inter-institutional experiences that are directly relevant to the multi-systems challenges of disaster preparedness and management. although they may work with different job titles and tasks different professional education and certifications around the world, ces share a common mission to optimize safety, efficiency, cost controls, and healthcare quality through the application of systems-oriented engineering expertise that encompasses not only devices, but processes, human resources, procurement, risk management, and strategic planning. these integrative skillsets take on even greater importance in disaster circumstances. compared to many other vertically-specialized professions in healthcare, the multi-disciplinary, intersectoral span of professional relationships in ce provides a unique foundation to bring a more coherent, rapid-cycle integration of science, technology, standards, regulation, institutional strategy, planning, and execution. as science and technology have advanced with increasing velocity and scope, these life-saving engineering professions are also evolving and expanding to incorporate new tools and processes into increasingly complex healthcare systems.16 the successful incorporation of existing knowledge and urgent innovations under disaster circumstances requires new categories of professional expertise and institutional alignments. because of their wide-ranging organizational knowledge and technical skills, ces are uniquely prepared to become the next generation of multifunctional experts who can help cultivate the systemic organizational intelligence and planning that is increasingly indispensable for modern healthcare, as well as for disaster preparedness and management. proposal for an expanded professional identity the growing need for systems expertise for both normal and emergent conditions as innovators in the medical device industry, ces may be involved in highly specialized research aimed at designing or improving diagnostic devices,13 monitoring,17 or therapeutic devices that are technically complex,18 multifunctional, networked,16 and designed for “precision medicine” that may disrupt traditional clinical and business practices. as managers of a clinical operations infrastructure, ces may be responsible for the 24 × 7 hospital requirements for maintenance and repairs, for http://www.globalce.org http://globalce.org http://globalce.org hosea: emerging horizons of clinical engineering in disaster preparedness and management 13 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 12 hosea: emerging horizons of clinical engineering in disaster preparedness and management assessing new technologies, managing installations and upgrades, project and team coordination, scheduling maintenance and repairs, coordinating it integration, facility design consultation and new facility provisioning, cross-functional troubleshooting with it, end-user training, vendor and supply chain management, surge capacity planning, replacement planning, service-level agreements, budgeting, technology assessment, risk management,19 hazard alerts and recalls, and emergency preparedness. because ces may span such vast areas of expertise20–23 that are essential to the quality and reliability of day-to-day healthcare services, they are at the same time uniquely positioned to be recognized as systems-oriented, subject matter experts who can help repair and re-engineer the prevailing fragmentation in disaster preparedness and management. an action plan for the future this article provides a very condensed compilation of technological, organizational, and professional recommendations that will enable ces, clinical systems engineers, and biomedical engineers to build upon their existing system lifecycle expertise and assume wider institutional roles in disaster preparedness (dp) and disaster management (dm). although the current global concerns are for pandemic response, the following topics will be equally relevant for all-hazards disaster conditions. as well as for improving normal strategic and operational efficiencies and resilience of clinical systems, ensuring a more robust, integrated infrastructure for future events. because of the inherent complexities of normal healthcare operations, where it is necessary to work in a 3-to-5-year planning window to make significant changes, it is likewise necessary to begin planning now during the 2020 covid-19 pandemic, to deliver the global systemic improvements that will be necessary to prevent, mitigate and better manage future disaster challenges 5 to 10 years from now. these expanded ce competencies will fill critical gaps in the ways that healthcare systems plan and manage their future dp/dm programs, which often suffer from lack of functional integration, staffing, and budgets. while most of the current responses to the covid-19 pandemic are necessarily focused on near-term endpoint devices, therapies and protections, this article will offer a wider, panoramic, long-term systems-of-systems view that will strengthen the organizational, technological and professional underpinnings of both normal operations and dp that should dramatically improve the global response to future threats to public health. these recommendations are organized in a series of highly concentrated topics and specific actions that can be executed incrementally over time to expand the professional competencies and institutional roles of ces for dp/dm. each topic can easily be expanded as a workshop or academic course to provide the necessary technical or operational details needed for full implementation. while some of the recommendations can be enacted at an individual level of persons and organizations, others will require scaling up through new regional, national, and international collaborations. ongoing programs between who,24 the international federation of medical and biological engineering (ifmbe, through its ce division25), the icehtmc (international ce and health technology management congress26), the american college of ce (acce),27 the chinese society of ce, the association for the advancement of medical instrumentation (aami),28 the european alliance for medical and biological engineering & science (eambes),29 and the global ce journal30 are creating new, global frameworks for research,31 professional development, conference coordination, standards development, credentialing, regulatory frameworks, and consultation to establish more coherent, innovative and dynamic capabilities across healthcare systems. in many cases, the ability to ask systemically relevant questions will be more important than the application of known, but overly specialized answers which may risk delivering obsolete or disjointed solutions. the world is clearly in need of professional expertise that can help compress and align the scientific, technological, and operational timelines for life-critical innovations and successful implementation under extraordinary circumstances. we cannot allow these monumental challenges to deter us from the necessity, now being proven worldwide, to forge a radically different, long-term model of public health stewardship and institutional capabilities that are suited simultaneously to both normal and disaster conditions. the world is already fortunate this day to have many gifted ces around the world who are ready for such a noble quest – highly educated, energetic, caring, creative, expert in the complex lifecycles of healthcare systems, and now, tested by the high-velocity change, logistical chaos, global uncertainty, economic disruption and human sufferings imposed in the 2020 pandemic. in the coming years, let there be no doubt how these quiet heroes rose to the occasion. recommendations (note: additional information and links for many of the following recommendations can be found in the resources section at the end of this document, grouped by topic) 1. understand your existing local, national, and international frameworks of dp and management. don’t re-invent the wheel. investigate with your ministry of health and emergency preparedness agencies, public health agencies, and local hospitals to identify existing agreements, processes, and resources. a. united nations, who, ocha, cadri, un clusters (unisdr, unhcr, ifrc, iom, fao, wfp, undp, unicef, save the children), ifrc, icrc, sendai framework, gdacs, osocc, insarag (see resources section) b. your national frameworks: national incident management and emergency operations centers. c. your state/province and local hospital and public health frameworks. d. conduct interviews and document existing gaps at any level of preparedness or response capabilities and discuss proposals to remediate them.33 arrange to attend training and simulations, and become subject matter expert in one or more areas of dp/ dm.32–35 2. in your organizations (hospital, professional association, standards organizations, r&d consortium, government agency, legislative and regulatory bodies), promote clinical and biomedical engineers as subject matter experts for system lifecycle management, with specific applications in dp/dm. develop dp/dm skillsets and experience through the following: a. schedule specialized dp/dm coursework, interdisciplinary and cross-functional workshops, conferences, credentialing and certification. b. re-write job descriptions for ces to include dp/ dm as a required competency; set aside time for dedicated assignments to organizational emergency preparedness teams and practice drills. include readiness research, conferences, and publication in scientific and professional journals36,37 as ce performance evaluation criteria. c. arrange for ces to be permanent delegates to organizational emergency preparedness teams – local, regional, and national. d. delegate ces to serve on standards committees and medical device design consortia to promote inclusion of dp/dm performance factors in design standards for medical devices and systems.38 e. contribute to the design of table-top exercises for dp/dm, with emphasis on functional interdependencies and risk/failure points that other stakeholders might ignore. 3. promote regional and national purchasing cooperatives to maximize cost-savings over the lifecycle of devices and services, including specific disasterrelated terms and conditions. 4. promote health technology design among ces as the front-end of the device lifecycle management process to integrate best disaster practices into future designs. a. formalize device and system design to provide real-time networked performance feedback of device data to manufacturers (as feedforward into nextgeneration device/system design, with all necessary safeguards for patient privacy and confidentiality). formalize consulting relations between ces and manufacturers to conduct regular design consultations as part of the contractual relationship. b. define, design, and enforce universal minimum functionality for medical devices (umf). most medical device manufacturers emphasize product differentiation from their competitors, and this produces highly specialized devices that may be perfect for normal circumstances, but be hosea: emerging horizons of clinical engineering in disaster preparedness and management 15 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 14 hosea: emerging horizons of clinical engineering in disaster preparedness and management sub-optimal or dangerous under disaster conditions, when there may be a transfer of life-support patients to other sites of care, significant rotation of staff across locations, and staff who have to use medical devices that are different from what they are accustomed to. the specialized differences in user interfaces, it connectivity, consumables, and performance characteristics may cause significant risk to patient safety. we need to promote umf requirements for procurement of all medical devices to ensure the lowest common denominator of safety, performance, and user interfaces as a default setting under disaster conditions, to support rapid transport and accurate continuity of patient care across locations, caregivers, and device brands. with the push of a button, the umf functions can be invoked to provide a specific menu of minimum, universally standardized functions, and user interfaces. umf device design and training would support patients with generic functionalities that would assure higher overall population benefits than what would result from overly specialized functions that could put patients at risk due to inappropriate use by untrained staff. include supply chain guarantees and contingency plans to ensure technical support for diverse disaster locations, and plan for universally standardized consumables. c. develop capability maturity roadmaps to identify strategic pathways for medical technologies and services with a 5to 10-year performance horizon. adjust roadmaps for different economic conditions.39,40 d. promote formal collaborations between it and biomedical forecasting institutions such as gartner and ecri, professional and industry associations. produce joint assessments of innovative technologies and plot on biomed/ct/it hype cycles and magic quadrants. e. design to cascade – devices should be designed for extended use and re-use across diverse economic development zones so that umf functions eventually become available to ldcs (less-developed countries) through redeployment, using local refurbishing and production where possible, and strictly-managed donations. this will gradually create a predictable minimum of standardized device functionality globally that will increase the safety and efficiency of clinical efforts by clinicians who at times must work at remote and unfamiliar disaster sites. 5. include smart design requirements for all medical devices with computing capabilities so they have extensive, built-in capabilities for universal time synchronization, self-monitoring, self-reporting, selfupdating, self-diagnosis, and self-healing. real-time location, performance readiness, configuration, and mobility of medical devices will be critical for rapid emergency deployment and redeployment conditions (e.g., patient transfer to an alternate site of care, with infusion pump and ventilator). a. specify multicore device design, which will segregate clinical and device lifecycle operations functions on separate computing cores, with a hypervisor bridge. this will enable highly secure, real-time asset, service, and configuration management to be executed without interfering with clinical performance. this includes device identification, location, configuration history, component provenance, performance and service history, making the device an active partner in managing its asset, and service lifecycle. architect devices to internalize and support external service, security and process controls so that devices themselves become active players in managing routine monitoring, compliance, and reporting activities. b. leverage emerging ipv6 capabilities41 envision devices as intelligent members of the extended iomt (internet of medical things). device components can be independently addressed and managed via ipv6 addressing, to significantly improve security, remote patient monitoring, and cloud management of iomt data which will become increasingly important in “care-anywhere” and behavioral health services. c. build “developmental headroom” into device hardware and software architecture, to extend usable life and afford built-in capacity for new functionality without burdensome replacement costs and inefficiencies. d. coordinate ce tightly with it asset management and service management to develop aligned processes, data dictionaries, configuration management, and roles that will support standardized service and performance analytics for primary, transitional and alternate sites of care, including ambulance services and military locations having other network, security, and compatible consumables standards. e. explore secured, cloud-based product development partnerships for device design and prototyping. promote interdisciplinary, intersectoral alliances, and collaboration frameworks. 6. adopt the itil framework of service strategy and service management. the information technology infrastructure library (itil) is the global standard for business process engineering, based on it lifecycles, for ensuring alignment and coherence of all services provided within an organization and between organizations. it is an indispensable tool to ensure that all organizational services support healthcare activities that are safe, efficient, effective, and expertly managed. careful mapping of service processes and accountabilities during normal operations should be used to create parallel process maps that are adapted to disaster conditions. a. obtain training and certification for ce staff in basic itil concepts and methods (3-day course). b. create end-to-end service process maps for your organization for normal and disaster conditions, working closely with all stakeholders, escalation paths, and decision points. c. where feasible, explore how business process automation can improve workflows during disaster conditions by guiding staff through automated, pre-defined checklists and options so staff doesn’t have to improvise randomly amid stressful circumstances. 7. prepare professionally for alternate sites of care (asocs). certain disaster situations will overwhelm existing hospital facilities and small-scale surge preparation, requiring the setup of emergency hospital capabilities at schools, warehouses, hotels, sports arenas, field tents, military bases, factories, and other sites. ces should play a major role in anticipating, planning, and executing on asoc logistics, deployment, testing, and site readiness certification. a. anticipate the need to prepare to work rapidly and closely with local, national, and international military, national guard, national and local police authorities to manage dynamic disaster conditions and coordinate efforts to plan and deploy asocs. b. clarify in advance the hierarchy of decisionmaking authorities, geographical jurisdictions, and processes. use scenarios to anticipate potential decision crises. c. evaluate facility surge area design, setup, device requirements, disinfection, patient identification, tracking, and medical record continuity, patient transfer processes, patient monitoring, surge capacity limits. conduct periodic drills. establish criteria for transfers from hospital or surge areas to asocs. d. develop technology-mediated patient transfer protocols and process maps to ensure continuity of care: patient transport, infusion pumps, medications, belongings, device tracking, ventilators, vital signs, family contacts, data interfaces with electronic medical records, wireless or cellular connectivity. e. evaluate and acquire early situation awareness software, pre-load critical infrastructure locations, facilities and profiles. update annually. this will enable instantaneous activation of a regional incident tracking utility, enabling emergency operations centers to know exact the gps location of incidents, deployed responder vehicles, and dangerous conditions. f. evaluate facility needs for backup power, space management coordination, utilities, wireless access, medical gasses, waste management, security, maintenance and repair parts, disinfection, it coordination. g. arrange to serve as a multifunctional engineering expert and consultant in disaster resource/ emergency operations center design, simulations, response roles. hosea: emerging horizons of clinical engineering in disaster preparedness and management 17 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 16 hosea: emerging horizons of clinical engineering in disaster preparedness and management h. evaluate the need for additional equipment for decontamination, generators, mobile or field operating rooms, rapid assembly shelters, containerized clinics. i. perform quarterly updates of asoc status to identify any significant changes in readiness, resources, staffing, plans. j. evaluate the role of portable emergency electronic medical records and mobile connectivity to medical devices for vital signs, medications, infusions, treatment plans, etc. k. review supply chain management practices to address specific disaster conditions. i.  use multi-professional scenarios to identify probable stress points, gaps, failures, and decision-making bottlenecks that may impede rapid ramping up of disaster response actions: vendor contracts, preorders, 3-d printing, open-source online design specifications, delivery, receiving, storage, distribution, security, configuration for asocs. ii.  anticipate the need to coordinate with national military logistics agencies and ensure that minimum compatibility standards for devices and consumables are applied in the procurement process. iii.  identify critical trigger points in early disaster awareness that will prepare manufacturers to shift from just-in-time production to large-scale emergency production standards. l. pre-define equipment lists, rapid supply chain strategies, and asoc requirements to manage the possibility of multiple-hazard disasters and resulting health threats (e.g., simultaneous pandemic and earthquake victims). m. identify multiple constituencies/stakeholders who need to be involved in normal and asoc capability planning: building science professionals (air quality, negative pressure, decontamination, medical gasses), contractors and vendors, childcare providers, disaster survivors, emergency managers and personnel, fire services, community safety associations, disabled persons, language translators, time-sensitive treatments (chemotherapies, pregnancy, dialysis, etc.), livestock owners, parents and teachers, pet owners, individuals with physical access and mobility needs, media contacts, tribal representatives, university research partners, volunteer coordinators. n. consult with anthropologists, ethologists, social psychologists and historians to evaluate the impact of cultural, ethnic, religious, and linguistic differences that will significantly affect patient treatment and possible interactions with families, relatives, loved ones, ambulance services, forensic, morgue and funeral services, burial, and grieving practices. 8. establish dual-use infrastructure the dual-use concept in traditional military usage refers to civilian materials or processes that can also be used or altered for terrorist purposes. but in our case, the dual-use-infrastructure concept requires that all medical equipment that may be used under disaster conditions shall be designed for maximum compatibility between civilian and military services, and shall include a least-common-denominator of clinical functionality, data standards and user interfaces that enable instant usability by trained clinical staff anywhere, regardless of brand. a. build on military alliances for large/complex disasters; identify and establish formal liaisons and schedule periodic meetings to keep current of developments. b. for all-hazard risks, identify relevant medical devices needed for each risk category, including multiple disaster situations (e.g., simultaneous earthquake, tsunami, radiation), and ensure cross-compatibility between military and civilian applications. c. align military and civilian procurement processes, inventory synchronization, and decision-making for disaster procurement, especially for national stockpiles. d. ensure interoperability of electronic identity management applications and processes so that military and civilian professionals can interact without obstruction or delay. e. review and establish trusted domain rights on dm networks; update credentials as needed for instant, uncontested sign-on in asocs. f. negotiate with government and commercial network providers to establish dedicated network priority bandwidth during disaster conditions, providing top quality of service for all medical system users and devices, and research partners. g. require universal wireless location of medical devices and high-value, mobile capital equipment by using built-in radio-frequency identification; use this function to support patient and device transfer to asocs and timely return of outgoing devices; formalize control of network credentials, login, and device recovery processes. 9. ensure cross-border credentialing database exists to enable rapid verification of professional skills for asocs. a. volunteers and retirees from other regions/states/ countries may arrive to assist in disaster response activities, and it is important to verify in advance their identities, relevant skills, and credentials, and issue necessary identification badges, vests, or wristbands to enable rapid access to different areas of disaster control 10. research and compose mutual aid agreements at all levels and ensure clear jurisdictional authorities at each level. a. obtain master service agreement templates42 and confer with local public health agencies to identify existing agreements. b. meet with actual and potential partners to review msas and adjust as needed. 11. research and incorporate rapid deployment technologies for dm a. hastily formed networks. b. ushahidi (an online tool for aggregating information from the public for use in crisis response). c. sahana (open-source dm software). d. google crisis response, google public alerts, and fusion tables. e. solar-powered wireless access points. f. failsafe communications: bluetooth walkie talkie; ham radio. g. sms messaging. h. mobile refrigerated morgue trailers. 12. plan for standard tests and point-of-care diagnostics to supplement or replace centralized laboratory use a. evaluate rapid turnaround, automated, and selfadministered covid-19 tests. b. evaluate conformal electronic vital signs monitors and wireless links to nursing station monitors or telemedicine monitoring stations. c. assess telemedicine/telehealth and automated monitoring technologies annually to determine the best combination of onsite clinicians, offsite monitors, and automated alerts to manage patients who may be treated at home, in ambulance, in hospital, at asocs, or post-discharge. d. evaluate: i.  bluetooth proximity monitoring technologies on smartphones as early detection and contact tracking tools. ii.  smartphone diagnostic attachments: microassays, flow cytometry. iii.  miniaturized mass spectrometry. iv.  lab on a chip. v.  electrochemical detection. vi.  saliva test. vii.  antibody test. viii.  antigen test. ix.  molecular/pcr test. x.  elisa, ifa tests. xi.  crispr. 13. identify and track emerging treatment modalities (covid-19 examples) a. blood purification, apheresis, and adsorption. b. convalescent plasma transfusion. hosea: emerging horizons of clinical engineering in disaster preparedness and management 19 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 18 hosea: emerging horizons of clinical engineering in disaster preparedness and management c. antivirals. d. interferon. e. monoclonal antibodies. f. hydroxychloroquine. 14. refine triage and fatality management resources and processes a. isolation tents with diagnostic and sterilization tools. b. wireless patient identification and vital signs monitoring, location monitoring. c. backup plans for wireless infrastructure during disasters that can include cell towers and hastily formed networks. d. refrigerated morgue trailer. 15. test dp routinely to point of failure, to identify weak links in plans and performance. a. large-scale stress testing. b. intersectoral simulations. 16. include failsafe and high-reliability communications to ensure basic communication capabilities if commercial wireless or internet services fail or are overloaded. a. ham radio. b. dedicated medical wi-fi spectrum. 17. acquire early situation awareness platform capabilities and integrate into emergency operations centers.43 a. evaluate software options; acquire and install the application in emergency operations center and dedicated cellphones. b. pre-load regional database with critical infrastructure sites, profiles, contacts. c. establish criteria for distributed use of cellular reporting application by responsible staff and civilians to ensure data reliability. d. conduct training and simulations. 18. negotiate trigger criteria and rapid execution timelines and industry workplans. negotiate specific terms under which early disaster conditions will be officially declared which will trigger initial work plans of academic, professional, government, and industry partners, to prepare for ramping up of pre-defined research activities and production of essential equipment and supplies. 19. evaluate and negotiate manufacturing alliances for dp/dm to establish contractual agreements that obligate manufacturers to prioritize emergency production requirements specific to the disaster type. 20. promote an organizational culture of information sharing and tactical flexibility for dp/dm a. promote professional and organizational norms of informational openness to ensure that decisions are made based on evidence, not rumor or guesswork. b. promote professional and organizational norms that optimize the ability to be tactically flexible and adaptable to changing circumstances and information. build in specific secondary role assignments and responsibilities (role-shifting) in job descriptions for all ces and disaster-related staff. 21. define need for role shifting. during early and mid-disaster conditions, routine clinical roles and responsibilities and reporting relationships may need to change significantly to enable proper execution of disaster protocols. doctors, nurses, ces, facility, and administrative staff may be shifted to other tasks that over-ride normal job descriptions. a. identify most likely disaster scenarios for your location or region, including the possibility of 2 simultaneous disasters. b. based on projected needs for equipment, staffing, and asoc, estimate which types of activity will be de-prioritized (such as elective surgery, non-critical preventive maintenance, training), and which activities will become mission-critical. c. identify secondary roles for each job family to be invoked under disaster conditions and obtain crosstraining as needed. specialists may be re-deployed as hospitalists. hospitalists may be re-deployed as call-center staff for telemedicine screening; ces may be re-deployed to set up field hospitals or other asocs and work closely with it staff to integrate asoc devices into it networks. identify the rescheduling and re-prioritization criteria for corrective and preventive maintenance services. 22. form strategic health intelligence alliances between academic, government, provider, and medical industry partners. a. develop comprehensive models of healthcare ecosystems to complement the increasing clinical specializations and technical granularity that often lack proper integration or rational cost controls. b. coordinate 5-year outlook analyses to identify, assess, and prioritize candidate technologies to provide new efficiencies and dm capabilities. c. establish routine evaluation sessions to review device and system performance data and discuss any strategic implications for next-generation device/system design. d. explore academic and professional channels for joint degree and certificate programs with medical and nursing schools, to build stronger career relationships between ces and other clinicians. 23. establish or link to data fusion and monitoring centers to monitor emergent, multi-hazard conditions that may require rapid changes in disaster response – flooding, landslides, biohazard dispersion, disruption of transport or supply chain plans, power outages, gas leaks, tsunamis, firestorms, etc. establish formal membership for ce liaisons with fusion and monitoring centers. a. establish hourly conference calls to review incidents, discuss options, and coordinate decisions. 24. establish an international ce rapid-response network for rapid-response information sharing in the early stages of any disaster. convene daily online consultation meetings. a. establish a dedicated website and teamwork tools to compile findings, promote problem-solving, and maintain, professional focus under difficult circumstances. b. compile improvised and emerging good practices for ongoing evaluation and validation, using a standardized ontology for technologies, pharmaceuticals, clinical trials, prototyping, dilemmas, and other relevant topics of concern. 25. establish inter-professional innovation partnership networks to coordinate brainstorming, prototyping, troubleshooting, problem-solving, resource-sharing, team formation, standards promotion, process engineering, best-practice identification, and dissemination. a. form a dedicated dp/dm team to sustain multiyear innovation efforts and report results in all relevant professional journals and associations. b. use virtual meetings and conferences to sponsor inter-professional design forums and scenarios to ensure – in advance of disasters – the alignment of cross-functional activities, data exchange, device interoperability, status updates, and prioritization criteria. 26. work with media liaisons to help elevate social expectations that dp is a social priority and that political leadership will be expected to understand and incorporate preparedness recommendations into public policy and budgets. a. invite media and other clinical professionals to ce and dm conferences, simulation exercises, and disseminate proceedings of events to media outlets, including social media. conclusion taken together, these aspirational recommendations offer a comprehensive, but not yet exhaustive set of actions that can improve outcomes and alter the historical trajectory of the ce profession and dm capabilities worldwide. certainly, other topics and recommendations can and must be added to the agenda, but this list does offer a plausible foundation of starting points with sufficient breadth and detail to begin the transformational work with a collective framework of efforts. working individually and in teams and associations, the daunting magnitude of the challenge can be mastered over time, building on the global presence and growing leadership of ces. hosea: emerging horizons of clinical engineering in disaster preparedness and management 21 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 20 hosea: emerging horizons of clinical engineering in disaster preparedness and management references 1. blumenthal d and seervai s. coronavirus is exposing deficiencies in u.s. health care. harvard business review. march 2020. available at: https://hbr.org/2020/03/ coronavirus-is-exposing-deficiencies-in-u-s-health-care 2. grazier d, castle s, and landler m. ignored warnings left the 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mutual_aid_template.pdf 43. danial sn, smith j, khan f. situation awareness modeling for emergency management on offshore platforms. human-centric comput informat sci 2019;(9):37. available at: https://link.springer.com/article/10.1186/ s13673-019-0199-0 resources note: all commercial mentions are for illustrative purposes only and do not imply a recommendation or endorsement. links are active as of april 2020. topic detail url ifmbe/ced clinical engineering division of the international federation of medical and biological engineering https://ced.ifmbe.org/ united nations the united nations https://www.un.org/en/ who world health organization https://www.who.int/ ocha un office for the coordination of humanitarian affairs https://www.unocha.org/ cadri capacity for disaster reduction initiative: global partnership of fao, iom, undp, unicef and unfpa (executive partners), gndr, ifrc, ocha, unesco, unops, wfp, who, wmo (technical partners) and gfdrr, oecd, odi, redr australia, undrr, un women https://www.cadri.net/ un clusters unisdr, unhcr, ifrc, iom, fao, wft, undp, unicef, save the children https://www.who.int/health-cluster/about/ cluster-system/en/ undrr (formerly unisdr) un office for disaster risk reduction https://www.undrr.org/about-undrr unhcr un high commission for refugees https://www.unhcr.org/ ifrc international federation of red cross and red crescent societies https://www.ifrc.org/en/--/ iom international organization for migration https://www.iom.int/ fao food and agriculture organization of the un http://www.fao.org/home/en/ wfp un world food program https://www.wfp.org/ undp un development programme https://www.undp.org/content/undp/en/ home.html unicef un international children’s emergency fund https://www.unicef.org// save the children save the children https://www.savethechildren.org/ ifrc international federation of the red cross https://www.ifrc.org/en/--/ paho/ops pan american health organization/organizacion panamericana de salud https://www.paho.org/en/ health-emergencies/disaster-risk-reduction topic detail url sendai framework the sendai framework https://www.undrr.org/publication/ sendai-framework-disaster-riskreduction-2015-2030 gdacs global disaster alerting coordination system https://www.gdacs.org/ osocc on-site operations coordination center https://www.gdacs.org/ insarag international search and rescue advisory group https://www.insarag.org/ fema emergency planning exercises https://www.fema.gov/ emergency-planning-exercises institute of medicine crisis standards of care: a systems framework for catastrophic disaster response https://www.ncbi.nlm.nih.gov/ pubmed/24830057 ifrc training in disaster management https://www.ifrc.org/en/what-we-do/ disaster-management/preparing-fordisaster/disaster-preparedness-tools/ training-for-response/ purchasing cooperatives us general services administrationstate and local disaster purchasing https://www.gsa.gov/buyingselling/purchasing-programs/ gsa-schedules/schedule-buyers/ state-and-local-governments/ state-and-local-disaster-purchasing multicore processors meet medical device design challenges https://www.embedded.com/processorsmeet-medical-device-design-challenges/ multicore the impact of the introduction of multicore technologies on the computing market and opportunities for europe https://publications.europa.eu/ resource/cellar/d2eeb993-5e7c403d-b0bc-fda57388d211.0001.01/ doc_1 multicore enabling embedded multicore systems with multiple oses and critical goals https://www.techdesignforums.com/ practice/technique/enabling-embeddedmulticore-systems-with-multiple-oses-andcritical-goals/ alternate sites of care infection prevention and control considerations for alternate care sites https://www.cdc.gov/coronavirus/2019ncov/hcp/alternative-care-sites.html?cdc_ aa_refval=https%3a%2f%2fwww. cdc.gov%2fcoronavirus%2f2019ncov%2fhealthcarefacilities%2falternative-care-sites.html alternate sites of care global base camp support services https://www.basecampservices.com/ alternate sites of care standards and guidelines for healthcare surge during emergencies http://www.cidrap.umn.edu/sites/default/ files/public/php/258/258_acstools.pdf alternate sites of care medical surge and the role of health clinics; public health emergency preparedness, and other articles https://asprtracie.hhs.gov/technicalresources/48/alternate-care-sites-includingshelter-medical-care/47 10.1109/iwcmc https://www.cambridgepublichealth.org/services/emergency-preparedness/products/mutual_aid_template.pdf https://www.cambridgepublichealth.org/services/emergency-preparedness/products/mutual_aid_template.pdf https://www.cambridgepublichealth.org/services/emergency-preparedness/products/mutual_aid_template.pdf https://link.springer.com/article/10.1186/s13673 https://link.springer.com/article/10.1186/s13673 https://ced.ifmbe.org https://www.un.org/en https://www.who.int https://www.unocha.org https://www.cadri.net https://www.who.int/health-cluster/about/cluster-system/en https://www.who.int/health-cluster/about/cluster-system/en https://www.undrr.org/about https://www.unhcr.org https://www.ifrc.org/en https://www.iom.int http://www.fao.org/home/en https://www.wfp.org https://www.undp.org/content/undp/en/home.html https://www.undp.org/content/undp/en/home.html https://www.unicef.org https://www.savethechildren.org https://www.ifrc.org/en https://www.paho.org/en/health-emergencies/disaster https://www.paho.org/en/health-emergencies/disaster https://www.undrr.org/publication/sendai https://www.undrr.org/publication/sendai https://www.gdacs.org https://www.gdacs.org https://www.insarag.org https://www.fema.gov/emergency https://www.fema.gov/emergency https://www.ncbi.nlm.nih.gov/pubmed/24830057 https://www.ncbi.nlm.nih.gov/pubmed/24830057 https://www.ifrc.org/en/what-we-do/disaster-management/preparing-for-disaster/disaster-preparedness-tools/training https://www.ifrc.org/en/what-we-do/disaster-management/preparing-for-disaster/disaster-preparedness-tools/training https://www.ifrc.org/en/what-we-do/disaster-management/preparing-for-disaster/disaster-preparedness-tools/training https://www.ifrc.org/en/what-we-do/disaster-management/preparing-for-disaster/disaster-preparedness-tools/training https://www.gsa.gov/buying-selling/purchasing-programs/gsa-schedules/schedule-buyers/state-and-local-governments/state https://www.gsa.gov/buying-selling/purchasing-programs/gsa-schedules/schedule-buyers/state-and-local-governments/state https://www.gsa.gov/buying-selling/purchasing-programs/gsa-schedules/schedule-buyers/state-and-local-governments/state https://www.gsa.gov/buying-selling/purchasing-programs/gsa-schedules/schedule-buyers/state-and-local-governments/state https://www.gsa.gov/buying-selling/purchasing-programs/gsa-schedules/schedule-buyers/state-and-local-governments/state https://www.embedded.com/processors https://publications.europa.eu/resource/cellar/d2eeb993-5e7c-403d-b0bc-fda57388d211.0001.01/doc_1 https://publications.europa.eu/resource/cellar/d2eeb993-5e7c-403d-b0bc-fda57388d211.0001.01/doc_1 https://publications.europa.eu/resource/cellar/d2eeb993-5e7c-403d-b0bc-fda57388d211.0001.01/doc_1 https://publications.europa.eu/resource/cellar/d2eeb993-5e7c-403d-b0bc-fda57388d211.0001.01/doc_1 https://www.techdesignforums.com/practice/technique/enabling https://www.techdesignforums.com/practice/technique/enabling https://www.cdc.gov/coronavirus/2019-ncov/hcp/alternative-care-sites.html?cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2fcoronavirus%2f2019-ncov%2fhealthcare-facilities%2falternative-care-sites.html https://www.cdc.gov/coronavirus/2019-ncov/hcp/alternative-care-sites.html?cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2fcoronavirus%2f2019-ncov%2fhealthcare-facilities%2falternative-care-sites.html https://www.cdc.gov/coronavirus/2019-ncov/hcp/alternative-care-sites.html?cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2fcoronavirus%2f2019-ncov%2fhealthcare-facilities%2falternative-care-sites.html https://www.cdc.gov/coronavirus/2019-ncov/hcp/alternative-care-sites.html?cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2fcoronavirus%2f2019-ncov%2fhealthcare-facilities%2falternative-care-sites.html https://www.cdc.gov/coronavirus/2019-ncov/hcp/alternative-care-sites.html?cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2fcoronavirus%2f2019-ncov%2fhealthcare-facilities%2falternative-care-sites.html https://www.cdc.gov/coronavirus/2019-ncov/hcp/alternative-care-sites.html?cdc_aa_refval=https%3a%2f%2fwww.cdc.gov%2fcoronavirus%2f2019-ncov%2fhealthcare-facilities%2falternative-care-sites.html https://www.basecampservices.com http://www.cidrap.umn.edu/sites/default/files/public/php/258/258_acstools.pdf http://www.cidrap.umn.edu/sites/default/files/public/php/258/258_acstools.pdf https://asprtracie.hhs.gov/technical-resources/48/alternate-care-sites-including-shelter-medical-care/47 https://asprtracie.hhs.gov/technical-resources/48/alternate-care-sites-including-shelter-medical-care/47 https://asprtracie.hhs.gov/technical-resources/48/alternate-care-sites-including-shelter-medical-care/47 hosea: emerging horizons of clinical engineering in disaster preparedness and management 25 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 24 hosea: emerging horizons of clinical engineering in disaster preparedness and management topic detail url mutual aid agreement mutual aid template draft text for customizing to user needs https://emilms.fema.gov/is706/assets/ wyomingtemplate.pdf rapid deployment blockchain technology for emergency response https://scholarspace.manoa.hawaii.edu/ bitstream/10125/63814/0061.pdf rapid deployment the evolution of hastily formed networks for disaster response https://www.researchgate.net/ publication/221567937_ ushahidi the ushahidi platform allows anyone to gather distributed data via sms, email or web and visualize it on a map or timeline. its goal is to create the simplest way of aggregating information from the public for use in crisis response. https://www.ushahidi.com/ sahana open-source disaster management software https://sahanafoundation.org/ google crisis response google.org supports nonprofits working alongside affected communities from the immediate aftermath of a crisis through long-tail recovery. this includes providing nonprofits with funding and connecting them to the right google volunteers—whether they’re a data scientist, a communications expert, or an engineer. https://crisisresponse.google/ google public alerts provides global map with data on floods, earthquakes, fires and other disaster conditions https://google.org/publicalerts solar-powered wi-fi solar-powered wireless access points https://robotechvision.com/ solar-access-point/ ham radio backup radio communication technology in case normal telephone and cell services fail https://www.youtube.com/ watch?v=llqc8cvh_aw point-of-care testing geospatial science and point-of-care testing: creating solutions for population access, emergencies, outbreaks, and disasters https://www.ncbi.nlm.nih.gov/pmc/articles/ pmc6988819/ point-of-care testing path diagnostics for low-income settings https://www.path.org/programs/ diagnostics/ point-of-care testing innovations in point-of-care testing for enhanced united states disaster caches – american journal of disaster medicine https://www.wmpllc.org/ojs/index.php/ ajdm/article/view/2135 point-of-care testing smartphone based medical diagnostics https://www.sciencedirect. com/book/9780128170441/ smartphone-based-medical-diagnostics point-of-care testing lab on a chip https://www.azolifesciences.com/article/ health-applications-of-lab-on-a-chip.aspx advanced diagnostic lab technology mass spectroscopy https://pubs.acs.org/doi/10.1021/ acsomega.9b03764# defense production act enables the government to commandeer national production capabilities in order to meet defense and national emergency needs. https://www.fema.gov/ defense-production-act-program mobile morgue trailer refrigerated body storage https://www.mopec.com/ mortuary-response-solutions/ topic detail url mobile hospital solutions mobile clinics, hospitals, prefabricated hospitals, hyperbaric oxygen chambers http://oxycare.com.tr/ mobile hospital solutions mobile medical, dental, mammography, blood mobiles, laboratories https://lifelinemobile.com/ mobile hospital solutions modular disaster response solar-powered clinics in a mobile container; morgue unit; laboratory; radiology suite; maternal/ infant clinic; primary care exam http://www.clinicinacan.org/#about 3d printing 3d printing solutions for healthcare https://www.dynamism.com/healthcare. shtml 3d printing medical devices produced by 3d printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics https://www.fda.gov/medical-devices/ products-and-medical-procedures/3dprinting-medical-devices supply chain management in disasters prepared by us center for disease control and prevention https://www.cdc.gov/cpr/ readiness/healthcare/ supplychaindisasterpreparednessmanual. htm disaster credentialing sample guidelines for credentialing for volunteer physicians and allied health practitioners; need for credentialing of professionals, call-center staff, and volunteers from other states, countries https://studylib.net/doc/7359857/ guidelines-for-credentialing-and-grantingdisaster-privil... common operating picture online mapping software that combines pre-loaded data about critical infrastructure elements with real-time, location specific (gps) data about disaster incidents and conditions that are submitted via cellphone app. helps track deployment of first responders and visualization of regional response activities in real time. http://comopview.org/sfc/ pandemic planning checklist us dept. of health and human services checklist for pandemic planning https://www.phe.gov/preparedness/ covid19/documents/covid-19%20 healthcare%20planning%20checklist.pdf capability maturity roadmapping paho information systems for health maturity assessment tool https://www.paho.org/ish/images/docs/ about-is4h-mm.pdf?ua=1 capability maturity roadmapping the use of maturity/capability frameworks for healthcare process assessment and improvement https://www.semanticscholar.org/paper/ the-use-of-maturity%2fcapabilityframeworks-for-and-s%c3%b6ylemez-ta rhan/30b0cdbcdb75b8f6a0105b59627d8d5 f2c015284 research coordination the who r&d blueprint is a global strategy and preparedness plan that allows the rapid activation of r&d activities during epidemics. https://www.who.int/blueprint/en/ action research on disaster response a proposal to ifmbe/ced to document best practices, problems and recommendations about management of the covid-19 pandemic, led by clinical engineers. https://www.dropbox.com/ s/9zgq5absdlno9fu/draft%20proposal%20 for%20disaster%20mgt%20research%20 program%20rev3.pdf?dl=0 https://emilms.fema.gov/is706/assets/wyomingtemplate.pdf https://emilms.fema.gov/is706/assets/wyomingtemplate.pdf https://scholarspace.manoa.hawaii.edu/bitstream/10125/63814/0061.pdf https://scholarspace.manoa.hawaii.edu/bitstream/10125/63814/0061.pdf https://www.researchgate.net/publication/221567937_ https://www.researchgate.net/publication/221567937_ https://www.ushahidi.com https://sahanafoundation.org google.org https://crisisresponse.google https://google.org/publicalerts https://robotechvision.com/solar https://robotechvision.com/solar https://www.youtube.com/watch?v=llqc8cvh_aw https://www.youtube.com/watch?v=llqc8cvh_aw https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6988819 https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6988819 https://www.path.org/programs/diagnostics https://www.path.org/programs/diagnostics https://www.wmpllc.org/ojs/index.php/ajdm/article/view/2135 https://www.wmpllc.org/ojs/index.php/ajdm/article/view/2135 https://www.sciencedirect.com/book/9780128170441/smartphone https://www.sciencedirect.com/book/9780128170441/smartphone https://www.sciencedirect.com/book/9780128170441/smartphone https://www.azolifesciences.com/article/health-applications-of-lab-on-a-chip.aspx https://www.azolifesciences.com/article/health-applications-of-lab-on-a-chip.aspx https://pubs.acs.org/doi/10.1021/acsomega.9b03764 https://pubs.acs.org/doi/10.1021/acsomega.9b03764 https://www.fema.gov/defense https://www.fema.gov/defense https://www.mopec.com/mortuary https://www.mopec.com/mortuary http://oxycare.com.tr https://lifelinemobile.com http://www.clinicinacan.org https://www.dynamism.com/healthcare.shtml https://www.dynamism.com/healthcare.shtml https://www.fda.gov/medical-devices/products-and-medical-procedures/3d https://www.fda.gov/medical-devices/products-and-medical-procedures/3d https://www.cdc.gov/cpr/readiness/healthcare/supplychaindisasterpreparednessmanual.htm https://www.cdc.gov/cpr/readiness/healthcare/supplychaindisasterpreparednessmanual.htm https://www.cdc.gov/cpr/readiness/healthcare/supplychaindisasterpreparednessmanual.htm https://www.cdc.gov/cpr/readiness/healthcare/supplychaindisasterpreparednessmanual.htm https://studylib.net/doc/7359857/guidelines https://studylib.net/doc/7359857/guidelines http://comopview.org/sfc https://www.phe.gov/preparedness/covid19/documents/covid https://www.phe.gov/preparedness/covid19/documents/covid 20checklist.pdf https://www.paho.org/ish/images/docs/about-is4h-mm.pdf?ua=1 https://www.paho.org/ish/images/docs/about-is4h-mm.pdf?ua=1 https://www.semanticscholar.org/paper/the https://www.semanticscholar.org/paper/the https://www.who.int/blueprint/en https://www.dropbox.com/s/9zgq5absdlno9fu/draft https://www.dropbox.com/s/9zgq5absdlno9fu/draft 20rev3.pdf hosea: emerging horizons of clinical engineering in disaster preparedness and management j global clinical engineering vol.3 issue 1: 2020 26 author biography fred hosea, phd, has worked in different areas of health care and psychosocial development for over 30 years, conducting research on professional development in philanthropy, conducting fbi research on convicted sex offenders, and working as a mental health worker in adolescent psychiatric wards, community-based residential care for adolescents, school-based counseling, and in a maximum security treatment center for the criminally insane. he has taught graduate-level courses in business and professional ethics, and has taught undergraduate courses in “the art and science of innovation” at yachay tech university. he worked for 17 years with kaiser permanente, the largest non-profit hospital system in the us, responsible for annual clinical technology plans for northern california, implementing a national process re-engineering, asset management and it service management systems, and most recently was director of research and innovation in clinical technology. he has published articles on disaster management and the future of biomedical and clinical engineering professions. he edited human resources for medical devices in 2017 for the world health organization to promote biomedical and clinical engineering as essential professions for modern healthcare systems worldwide. he lives in cotacachi, ecuador and is active in a variety of projects to strengthen indigenous kichwa culture, improve local health services, and promote sustainable models of development. fred is currently a collaborating member of the clinical engineering division of the international federation of medical and biological engineering, and has presented on the future of ce at international conferences in beijing, shenzhen, visakhapatnam, bangkok, rome, geneva, sao paulo, and zagreb. j global clinical engineering vol.2 issue 3: 2020 8 received february 18, 2020, accepted april 14, 2020, date of publication may 4, 2020 quality certification of medical devices in venezuela: process developed by simón bolívar university, caracas-venezuela by r mijares,1 n. utrera,2 z. sierra,1 s. gonzález,2 r. lugo,2 m. rincón,3 r. mijares4 1 simón bolívar university, health technology management unit (ugts), caracas, venezuela 2 simón bolívar university, department of biological and biochemical processes, caracas, venezuela 3 shell venezuela, hiring and procurement, caracas, venezuela 4 shanahan´s, project coordinator, calgary, canadá abstract background and objective: the development of medical technology and advances in biomedical engineering are in constant growth. every year new medical devices are found in the market that seeks to satisfy the demand and requirements of medical services in health institutions. consequently, health systems of the countries generate methodologies to regulate and accredit medical devices that really satisfy the needs of medical services with safety, effectiveness, efficiency, and quality. a third party must guarantee the safety and effectiveness of medical technology and issue a quality certification before its available to use in medical establishments. in venezuela, one of the institutions authorized by the regulatory entity (ministry of health) that grants quality certification to medical devices is the health technology management unit (ugts in spanish), attached to the research and development foundation (funindes) of the simón bolívar university (usb). the objective of this work is to show the protocol for ugts certification to comply with iso 9001 standards and guarantee the quality of the processes of the medical devices certifying unit. material and methods: the process is based on the iso 9001 standard. five activities were determined: (i) prepare the teaching, technical and administrative staff as iso auditors. (ii) carry out an external audit, to make proposals for improvement; (iii) plan changes in our quality management system and processes and qualify as a supplier guided by the iso 9001 philosophy by a prestigious international company; (iv) submit our capabilities and to the ministry of health, and (v) execute the protocol to certify medical devices.medical devices certification includes the analysis not only of the devices itself but the manufacturer, distributor, and post-market services. all these stages and stakeholders are evaluated in the certification process per the guidelines established by the iso 9001 standard. results: the ugts has developed a protocol that guarantees the safety and effectiveness of new medical devices before its use in the venezuelan health care system. the protocol is based on the national and international regulations; it has been evaluated by johnson & johnson medical s.c.s. and the ugts it has been approved as a supplier for the analysis of medical devices by the company in complying with iso 9001 standard. under this new protocol, 550 medical devices have been certified. conclusions: advance on technology allows the breakthrough in medical device development. it is important to acknowledge the need to incorporate less invasive, more accurate and effective devices, in which physicians often rely on to treat a patient, but also developers must be compelled to meet the bioethical principles. the ugts protocol to certify medical devices is had been recognized and the unit is authorized by the ministry of health (mpps) through the sanitary comptroller's office to issue quality certificates to medical teams since 1999. approximately 55 companies that have received service are registered in its database. in the period audited (2012 2014), 25 files were created. its processes comply with iso 9001. keywords – quality, certification, medical devices, processes, and food and drugs administration. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org devices.medical 9 j global clinical engineering vol.2 issue 3: 2020 mijares, utrera, sierra, gonzález, lugo, rincón, mijares: quality certification of medical devices in venezuela: process developed by simón bolívar university, caracas-venezuela introduction medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates; however, the use of medical devices has an associated risk. also, with the advance of technology medical-device complexity had increased over time, representing a challenge to the health system to keep on track.1–3 currently, there is a great diversity of medical devices, due to the increasing technological and biomedical advances and developments which make it possible to improve the diagnosis and treatment of pathologies, and thus improve the quality and efficiency of medical care services.4 governmental health systems seek mechanisms to regulate the acquisition of these medical devices, to ensure that their use effectively complements quality medical service. according to the food and drugs administration (fda), equipment or medical device is instrument, device, implement, machine, implant, or other similar or related article, including a component, part, or accessory, designed for (1) the use in the diagnosis of a disease or other conditions, or the cure, mitigation, treatment, or prevention of disease in humans or animals; (2) affecting the structure or any function of the body of humans or animals, without this being done from chemical processes and without depending on human or animal metabolism to obtain the desired result.5 the definition presented shows the amplitude of the concept since it includes different teams whose functions vary. medical equipment can range from a simple thermometer to complex angiography equipment, and both its manufacturing and the complexity of the technology are increasing. a 17.4% growth in employment related to all areas of health including prevention, diagnosis, monitoring, treatment, and care is expected.6 growth will also thrive in the healthcare manufacturing industry. internationally it is considered that all equipment or material for use in human medicine should be subject to registration and control by the health authorities of the country of origin to ensure that such equipment or material is "safe and effective."7 in venezuela, the registration and control of medical materials and equipment is regulated by resolution no. dm-001 0-99 dated september 21, 1997. article 1 of the resolution establishes that: "every juridical person constituted in venezuela interested in manufacturing, importing, marketing or providing maintenance services of materials and equipment for use at the levels of the health area, must previously register in the national sanitary registry that the directorate of regulation and control of materials, equipment, establishments and health professions carries out, attached to the general directorate of health controllership of the ministry of popular power for health (mpps).8 article 4 states that: "the materials and equipment used in the area of human health must be registered in the corresponding directorate of this ministry contemplated in article 1 of this resolution." among the requirements required to obtain such registration, the interested party must present a quality certification issued by an accredited institution (article 6, paragraph f).8 to satisfy this legality, the venezuelan state has authorized institutions, which have the infrastructure and specialized personnel to guarantee the processes that allow issuing the appropriate certificate, based on the aforementioned principle of "safety and effectiveness." among these institutions is the health technology management unit attached to the research and development foundation of the simón bolívar university, which is also part of the biophysics and bioengineering group and is an active part of the biophysics laboratory.8,9 the safety of medical equipment and material is subject to the criteria of the evaluating specialist and its effectiveness will depend on fulfilling the functions for which it was designed and constructed, according to the manufacturer's technical specifications (that is, that the device does what it says it must do). these two aspects constitute the elements of judgment to issue the quality certificate.7 additionally, any process developed by an organization, to be recognized must have approval of the international organization for standardization (iso). iso creates documents that provide requirements, specifications, guidelines or features that can be used consistently to ensure that the materials, products, processes, and services are suitable for their purpose.10 mijares, utrera, sierra, gonzález, lugo, rincón, mijares: quality certification of medical devices in venezuela: process developed by simón bolívar university, caracas-venezuela j global clinical engineering vol.2 issue 3: 2020 10 one of the families of the iso standards is the one called iso 9001. iso 9001: 2015 establishes the criteria for a quality management system and is the only standard in the family that can be certified (although this is not a requirement). it can be used by any organization, large or small, regardless of its field of activity. there are more than one million companies and organizations in more than 170 countries certified with iso 9001. this standard is based on a series of quality management principles that include a strong focus on the client, the motivation and involvement of top management, the process approach and continuous improvement. the use of iso 9001: 2015 helps ensure that customers obtain consistent, high-quality products and services, which in turn provide many business benefits.11 the general objective of the work was to show how the ugts comply with the requirements of the iso 9001 standard in the quality certification processes for medical devices in venezuela to guarantee the highest possible quality in each evaluation process of the biomedical technologies that are intended to be commercialized in venezuelan territory. the specific objectives were: (a) to prepare the teaching, technical and administrative personnel as internal auditors iso 9001; (b) request the execution of an external audit, to make proposals for improvement; (c) plan changes in our quality management system and processes; and (d) qualify as an iso 9001 approved supplier by a prestigious international company. methodology the research performed was a qualitative study, and was exploratory and descriptive according to its purpose.12,13 according to its source, the work is documentary. information was collected from primary and secondary sources. the design of the research is not experimental and from a temporal point of view is longitudinal. its analysis unit is the process of quality certification of medical equipment implemented by the ugts-usb. within the aforementioned process, a series of requirements were identified that must be met for the process to be effective. results and discussion preparation of staff the ugts met with all staff (teaching, technical and administrative) in january 2014 and assumed the commitment over the quality management system as its work philosophy. that same year, two courses were held on this standard, totaling 112 hours of classes to become "iso 9001 auditors." subsequently, in 2015, the same personnel carried out three courses on iso 13485 with a duration of 60 hours. iso 13485 of medical equipment is an internationally recognized quality management system (qms) for manufacturers of medical equipment and related services. the main objective of the standard is to establish a set of harmonized regulatory requirements for qmss within the sector of medical devices. it is based on iso 9001, especially on the requirements of customer satisfaction and continuous improvement, but with modifications to make them more appropriate to the regulatory objective.14 after staff preparation after the preparation of the ugts staff an external audit of the certification processes that were being used since 1999 was requested. the audit was carried out by an external university (metropolitan university) with a school of production engineering. within this university, an expert professor in processes in health institutions was contacted and the field study became degree work for two students.15 the conclusions of the audit it was found that the ministry of health autonomous health comptroller service does not have specific requirements established for the quality certification of medical equipment so that each accredited institution has freedom regarding the certification process to carry out the evaluation. the requirements recommended by the food and drug administration (fda)16 and the pan american health organization (paho)17 were studied. a review of the literature was carried out at the most important universities in venezuela using the pubmed and lilacs databases and similar works were not obtained. there was no classification of medical equipment according to the level of risk they represent. there was no post-marketing surveillance of medical 11 j global clinical engineering vol.2 issue 3: 2020 mijares, utrera, sierra, gonzález, lugo, rincón, mijares: quality certification of medical devices in venezuela: process developed by simón bolívar university, caracas-venezuela equipment. faults were identified in the requirements related to the technical documentation, specifically related to the capacity of the applicant company to give technical support to the equipment. changes in the qms to plan the changes in the qms and its processes several activities were carried out. once the results of the external audit were known, the ugts adopted the classification of the fda's medical equipment18 and began to request that companies that require the certificate in writing describing their capacity to give technical support for the equipment. the processes were as follows: (i.) company documentation: name of the company; person to contact; address and telephone numbers of the company; technical capacity; list of equipment to be certified with respective technical documentation (catalogs and technical sheets); estimate of the approximate sale price; written evidence of technical personnel that will perform after-sales service; sanitary registry issued by the ministry of popular power for health of venezuela. in cases where the company had never been evaluated, we visited its facilities. (ii.) characteristics of the manufacturing company (of the equipment to be evaluated): name of the company; address and telephone numbers of the company; development areas; technical capacity. (iii.) if the equipment or instruments have a certificate from their country of origin, the most important being those of the fda (usa), european conformity (ce) according to directive 93/68 / eec, iec 60601, iso 13485 and iso 9001, iso 62353, the application must be accompanied by the documentation referring to the international certification. copies of the standards taken as a basis for the issuance of such certificates, as well as of the free sale certificates issued in the country of origin should be included. the required copies must be in spanish or english and duly legalized by the consulate or venezuelan embassy in the country of origin. in addition, the applicant must issue a letter committing to supply the required material and cancel the invoices for expenses generated during the certification process. (iv.) for the issuance of the certificate by the usb, the equipment must be operational in venezuela so it can be verified by the specialists in clinical engineering and medicine. if the equipment is not located in venezuela and the documentation presented meets the requirements, a provisional certificate and a recommendation for its importation will be issued to the respective official body. once the equipment enters the country and is operational, the technical visit will proceed, and the final certificate will be provided. (v.) if the requesting person or company does not have the aforementioned documentation, if the equipment is manufactured locally, or there is a standard for the certification of the equipment and its accessories, the specialists of the usb will proceed with its study to define the protocol or design the set of tests required. the usb will notify the applicant about the materials and equipment that must be supplied to carry out the tests. (vi.) if the documents presented are valid, or if it is feasible to initiate the procedures, after a thorough evaluation of its contents and it contains all the sufficient elements required, the certification process will begin, and all interested parties will be notified. if, on the other hand, the documentation submitted does not meet all the requirements required by the law, or the procedures are not feasible, the pertinent recommendations will be made and all the material will be returned. (vii.) after carrying out these steps we will proceed to the analysis and decision-making regarding whether to guarantee or not the quality certificate to the medical team. (viii.) after having the new qms, a working meeting was requested with the venezuelan association of distributors of medical, dental, laboratory and allied equipment (avedem),19 with the objective convey our impressions to our main clients. after the rigorous explanations, avedem remained in agreement as it follows the guidelines of the main specialized agencies in the field. the process is summarized in figure 1. mijares, utrera, sierra, gonzález, lugo, rincón, mijares: quality certification of medical devices in venezuela: process developed by simón bolívar university, caracas-venezuela j global clinical engineering vol.2 issue 3: 2020 12 qualifying as a supplier under the performance standards according to iso 9001 the prestigious transnational company johnson & johnson medical s.c.s. requested that we in bogotá (colombia)20 conduct a remote audit to qualify them as an approved supplier for the certification service of its products in venezuela. after completion, in january 2017 they were informed that their services were based on the iso 9001 standard. medical device certifications since 1999 more than 80 companies have requested medical device certifications from the ugts, for one or more of the devices they manufacture, distribute, and sell in venezuela. the ugts have issued certification for over 3000 medical devices since that year. after the incorporation of the iso 9001 normative to the certification process in 2017, 550 medical devices were certified. these, more recent, certifications correspond to 4 companies with a greater number of devices grouped in families or series. another aspect that has influenced the certification of figure 1. diagram of medical device certification stages. each stage must be accomplished in order to advance to the next. medical technologies in venezuela is the venezuela-china cooperation agreement,21 signed in 2013 which allows the acquisition, selling, distribution, and commercialization of medical technologies between these countries without the quality certification. due to this agreement, the presence of chinese technology in venezuela, without quality certification, has increased during the past few years. the most recent 1200 medical devices certified by the ugts are shown in a graphic form as classified by medical function (figure 2). it is important to note that this classification is only for this paper as a reference of the certified technological diversity. figure 2 and table 1 present the certified devices according to their main function. some aesthetic devices that use radiofrequency and radiation emission are aimed to preserve or restore the health of the skin, as a consequence, they are also figure 2. certified medical devices classified by function. table 1. certified medical devices classified by function 13 j global clinical engineering vol.2 issue 3: 2020 mijares, utrera, sierra, gonzález, lugo, rincón, mijares: quality certification of medical devices in venezuela: process developed by simón bolívar university, caracas-venezuela considered medical devices. diagnosis and monitoring medical devices include those that provide information directly related to pathology and biological variable registries such as electric signals, anatomical images, or metabolites concentration. treatment and therapy medical devices are those designed to mitigate or eliminate the pathology or condition such as implants, nebulizers, hyperbaric chambers, or infusion pumps. instrumental medical devices are all metallic reusable tools used during surgeries. disposable devices are those designed for single-use such as needles, injectors, and condoms. auxiliaries and furniture are those devices that support a clinical procedure but are not directly in contact with the patient such as centrifuges, plasma extractors, operating room lamps, refrigeration and sterilization equipment, nebulization and oxygen masks, and clinical furniture (tables, clinical beds). life support devices are those such as mechanical ventilators, anesthesia machines, neonatal cribs, defibrillators, and pacemakers. conclusions the ugts is certified by the standard iso 9001:2015, which guarantees the quality operation of the unit that is authorized by the ministry of health through the sanitary comptroller's office to issue quality certificates to medical teams since 1999. the objective of the certifying ugts team was to develop the protocols for action and verification, based on the iso 9001 standard, in the quality certification processes for medical devices in venezuela. to achieve this goal, the teaching, technical, and administrative staff were prepared as internal iso 9001 auditors. an external audit was then requested to make proposals for improvement. based on this audit, changes were made to the qms and its processes and was immediately made known to the clients. the clients were satisfied, as it follows the guidelines of the main specialized agencies in the field. part of the ugts staff was accredited as iso 9001: 2015 auditors enabling this protocol to be incorporated into the process of medical devices certification. this will guarantee the quality of the management systems of the companies involved in the manufacture, distribution, and post-market servicing of the intended technology. the importance of certification, as noted by guberta and badnjevic1 and vukovic et al,22 suggested to the ministry of health there was a need for the existence of a clinical engineering unit in every health institution to continuously monitor the performance of medical devices. finally, the company johnson & johnson medical s.c.s. requested an audit to qualify them as an approved supplier for the certification service of its products in venezuela.20 after this was completed in january 2017 we were informed that our services are based on the iso 9001 standard.23 future work is oriented to the automation of the qms protocol to go along with public policies aimed at paperless transactions at the ministry of health. references 1. gurbeta l, badnjević a. inspection process of medical devices in healthcare institutions: software solution, health technol 2017;7(1):109–117, doi:10.1007/ s12553-016-0154-2. 2. badnjevic a, gurbeta l, jimenez er, iadanza e. testing of mechanical ventilators and infant incubators in healthcare institutions. technol health care 2017;25(2):237–250. 3. gurbeta l, dzemic z, bego t, sejdic e, badnjevic, a. testing of anesthesia machines and defibrillators in healthcare institutions. j med syst 2017;41:133. https:// doi.org/10.1007/s10916-017-0783-7. 4. badnjevic a, gurbeta l, boskovic d, dzemic z. medical devices in legal metrology, 4th mediterranean conference on embedded computing, meco 2015, budva, montenegro. 5. u.s. department of health and human services. food and drug administration. medical devices. [online]. available at: https://www.fda.gov/medicaldevices/ default.htm 6. niles nj. basics of the u.s. health care system. burlington, va: james and bartlett learning; 2015. 7. world health organization. medical device regulations. geneva: author; 2003. https://doi.org/10.1007/s10916 https://doi.org/10.1007/s10916 https://www.fda.gov/medicaldevices/default.htm https://www.fda.gov/medicaldevices/default.htm mijares, utrera, sierra, gonzález, lugo, rincón, mijares: quality certification of medical devices in venezuela: process developed by simón bolívar university, caracas-venezuela j global clinical engineering vol.2 issue 3: 2020 14 8. gaceta oficial de venezuela # 36.843. registro y control de materiales y equipos médicos. resolución dm-001 0-99 del 3/12/1999. caracas; 1999. 9. fundación de investigación y desarrollo de la universidad simón bolívar. [online]. available at: http:// funindes.usb.ve/units/ 10. international standards organization (iso). [online]. available at: https://www.iso.org/standards.html 11. international standards organization (iso) 9001:2015. [online]. available: https://www.iso.org/iso-9001-quality-management.html 12. cook td. métodos cualitativos y cuantitativos en investigación evaluativa. 1986. [online]. available at: http:// books.google.es/books?isbn=847112310x 13. hernández r, fernández c, baptista c. y p . metodología de la investigación. caracas: mcgrawhill; 2010. 14. international standards organization (iso) 13485. [online]. available at: https://www.iso.org/standard/59752.html 15. mijares r and lara g. estudio del proceso de certificación de calidad de equipos médicos. propuesta de mejoras. ingeniería de producción dissertation. escuela de ing. de producción. metropolitana univ., caracas, venezuela; 2014. 16. food and drug administration. overview of device regulation. 2009 [online]. available at: http://www. fda.gov/medicaldevices/deviceregulationandguidance/overview/default.htm. 17. organización panamericana de la salud. ce126/14 equipos y dispositivos médicos. ops/oms 126a sesión del comité ejecutivo. washington, d.c., 26-30. 2000 [online]. available at: http://www.paho.org/ home_spa.htm 18. food and drug administration. classify your medical device [online]. available at: https://www.fda.gov/ medicaldevices/deviceregulationandguidance/ overview/classifyyourdevice/ 19. asociación venezolana de distribuidores de equipos médicos, odontológicos, de laboratorio y afines (avedem). 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https://www.avedem.com.ve https://www.jnjcolombia.com http://juris-line.com.ve/data/files/2382.pdf http://juris-line.com.ve/data/files/2382.pdf http://usbnoticias.usb.ve/post/49959 http://usbnoticias.usb.ve/post/49959 1 j global clinical engineering vol.4 issue 1, 2020 editor’s corner what should clinical engineering professionals know? as the year comes to an end (thank god), to say that 2020 was a devastating year would be an understatement. all over the world, the virus-causing pandemic kept the infection spreading, mutating, and pounding everything without relief and leading to the loss of precious lives, devastated economies, forced social isolation, and misery we never knew was possible. we are experiencing a changing world, and perhaps never did we need to support each other more than we do now. we each do it in our own way within groups of families and friends and by further backing colleagues as members of the clinical engineering community. will, how, or what impact the pandemic will have on future clinical engineers (ces) and technologists is not yet known. the question now is, how should future ces be better prepared for what is to come? one lesson learned from this abnormal pandemic era is the need for better technology lifecycle management methodology and tools. in healthcare past, the timeline separating discovery and innovation, from use to benefits, was measured in multiples of years. however, the success of operation warp speed1 has demonstrated how rapidly accelerated development and approval for the covid-19 vaccine can be completed. we are ready to meet similar growing challenges such as the lack of mechanical ventilators, oxygen generators, personal protective gear, and isolated care spaces within similar accelerated timelines. these timelines have been shortened from years to months and, in some instances, even less. through interdisciplinary collaboration (such as automotive and medical product manufacturing) and international research cooperation (such as the uk, germany, and usa) we have seen multiple medical triumphs, technological advances, and engineering solutions (public-private alliances) that have forever altered previous conventional approaches. the medical device industry has changed forever, and the forces that currently shape it will drive rethinking and expectations into the future. product innovation and development will become processes that are much closer to a specific patient’s needs, demographics, and experiences. modifying hospitals to also act as medical technology laboratories. the number of people in the world age 60 years and over is expected to grow by 56%, reaching nearly 1.5 billion by 2030.2 this suggests that care expectations will increase. in response, further demand will be placed on personalized care that is already being supported by extended reality (both virtual and augmented) tools and creative wearable products with embedded intelligence that can modify their function in response to the data collected. as i touch on lessons learned from the past year and on the anticipation for the creative future that has already begun to impact the healthcare industry, it begs the question: what about clinical engineering practitioners and members of the front-line healthcare team heroes? what is in-store for them? the demand for better access to and future growth in provisioning of healthcare services will undoubtedly magnify the system’s dependence on technological tools, their performance, and integration. this will translate into stronger demand for competent clinical engineering education and expertise. however, if everything around us is changing, and we chose to stay statically stationed, the opportunity will fade and perhaps be picked up by others. it is critically significant, therefore, that clinical engineering practitioners demonstrate the pursue of the following e.s.p. attributes that will deliver an advantage to their ability to successfully fulfill their future duties and to reach greater on-the-job satisfaction: education – increase your knowledge and expand your expertise to include subjects like artificial intelligence, digital health (telehealth/telemedicine/ehealth), extended reality, robotics, cybersecurity, wireless communications, and big data that are all part of the coming fields in need of engineering champions at the point-of-care. http://www.globalce.org http://www.globalce.org j global clinical engineering vol.4 issue 1, 2020 2 stewardship – understand your role expectations, learn to communicate clearly and rapidly, be reliant and provide update/follow-ups on projects assigned to you, do not avoid responsibility, and always be passionate about keeping equipment safe and patient-ready supporting the quality-of-care outcomes. remember, patients cannot fend for themselves. they depend on you to carry out your responsibilities. professionalism – members of healthcare teams are educated, credentialed in their field, engage with their society’s activities, collaborate with peers, read, and publish in their field’s literature. ces need to embrace such attributes and do it now to ensure you gain a seat at the table. specific examples in our own field provide evidence supporting the need for more international collaboration and stronger professional knowledge exchange as they are going to be part of our future. the call for papers for the 4th international clinical engineering and health technology management congress, scheduled to be held in orlando, florida, usa coming september 2021, is still open; however, it already broke the record established last year in rome for the number of abstracts submitted (reaching almost 350). further, this past october’s inauguration of the new global clinical engineering alliance3 is yet more evidence that as healthcare and technology are changing so are the needs in our field. these changes magnify the increasing dependency between ces, educators, practitioners and the persistent ensuring that goal for the intended care outcomes. as this is becoming more evident it mandates clinical engineering practitioners to declare their professional boundaries and become stewards for patient safety and care quality by updating their expertise and building opportunities for growing their professional competencies through training, reading, and networking. as ces, your ability to use knowledge for solving system problems reliably, safely, and quickly should be the navigating lights leading all of us into a brighter, happier future. the global clinical engineering journal and its editorial board experts will back you up and focus on sharing knowledge internationally, identifying best practices, communicating lessons learned, and highlighting innovations to make sure you are in the best position and are prepared to claim your seat at the table. we send you our very best wishes for fewer air hugs and more bear hugs in the coming new year! references 1. swan j. covid-19 vaccine distribution — challenges and perhaps opportunities [internet]. the hill. available at: https://thehill.com/opinion/healthcare/522036-covid-19-vaccine-distribution-challenges-and-perhaps-opportunities 2. haseltine wa. aging populations will challenge healthcare systems all over the world. forbes april 2 2018. available at: https://www.forbes.com/sites/ williamhaseltine/2018/04/02/aging-populationswill-challenge-healthcare-systems-all-over-theworld/?sh=7160c1952cc3 3. global clinical engineering alliance. homepage. available at: https://www.globalcea.org/home together we are making it better! dr. yadin david copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://thehill.com/opinion/healthcare/522036-covid-19-vaccine-distribution-challenges-and-perhaps-opportunities https://thehill.com/opinion/healthcare/522036-covid-19-vaccine-distribution-challenges-and-perhaps-opportunities https://www.forbes.com/sites/williamhaseltine/2018/04/02/aging-populations-will-challenge-healthcare-systems-all-over-the-world/?sh=7160c1952cc3 https://www.forbes.com/sites/williamhaseltine/2018/04/02/aging-populations-will-challenge-healthcare-systems-all-over-the-world/?sh=7160c1952cc3 https://www.globalcea.org/home j global clinical engineering special issue 1: 4-14; 2018 4 received february 2, 2018, accepted march 14, 2018, date of publication march 25, 2018. clinical engineering/health technology management 2015 global update by t judd,1 a hernandez,2 w gentles,3 and s calil4 1ifmbe ced secretary, acce, usa. 2who-paho / former senior advisor health technology (ht), acce ic chair, usa. 3bt medical technology consulting / past president, cmbes, acce, canada. 4ceb-feec – unicamp / professor, ifmbe ced past chairman, brazil. abstract medical device systems clinical engineering (ce)/health technology management (htm) strategies and best practices are now well established in most first world and many developing countries (dc). progress is being made to address identified gaps in dc ce/htm, such as appropriate equipment selection and lifecycle management. one contributor to this progress is the 25 years of ce/htm seminars provided by who-paho, acce, and more recently, ifmbe ced, to 80 countries. there is also a new emerging challenge; the requirement for medical device (clinical data) integration (mdi) into electronic health records (ehrs) to improve care quality and safety (aka ce-it). this study will review ce/htm progress, gaps, and new challenges since the last study in 2011. it will provide a framework to direct the global ce/htm movement forward in collaborative fashion, alongside other initiatives in 2015, such as the 1st international ce-htm congress and the global ce summit held in hanzhou, china, in october, 2015. keywords: clinical engineering, health technology management, ce, htm, ce/htm seminars, medical device lifecycle management, ce education, ce-information technology (ce-it), medical device integration, ifmbe ce division. introduction “in the 1980s, it became clear to the world health organization (who), academia, and various global nongovernment organizations (ngos) that there were many failed medical device technology transfer projects in the previous 2 decades, resulting in a large amount of inoperable sophisticated equipment and unmet healthcare needs in spite of significant financial investment.”1 “in 1988, who organized a virtual international roundtable with input from experts around the world and published the discussion in world health forum.2 the roundtable not only confirmed the 2 challenges identified earlier – acquisition planning and maintenance, but also pointed out fundamental underlying issues. first and foremost is the fact that unlike drugs and vaccines, medical equipment requires continual outlay of funds, on order of 6–15% of original acquisition price, for the life of equipment, often up to 10–20 years after acquisition.1 thus, it is useless for ngos and financing organizations to provide equipment donations or investment loans if the recipient countries cannot pay for recurrent expenses, https://www.globalce.org https://www.globalce.org t judd et al.: clinical engineering/health technology management 2015 global update 5 j global clinical engineering special issue 1: 4-14; 2018 figure 1. the main elements of developing country htm and its key health system relationships. even if adequate planning and maintenance are available. another serious deficiency is the lack of a framework for proper htm in most developing countries. without a framework defined and supported by policies, procedures, defined responsibilities, and earmarked resources for htm, it is difficult to perform technology planning in harmony with the country’s health policies and priorities, ensure appropriate human and material resources necessary to operate the equipment, and maintain it in safe and operational conditions.”1 definitions and context definitions health technologies (ht): the term refers to the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures & systems developed to solve a health problem and improve quality of lives.3 clinical engineer: a clinical engineer (ce) is a professional who supports and advances patient care applying engineering and managerial skills to health care technology. (sometimes also referred to as a biomedical engineer [bme].)4 health technology management (htm): for usa ce certification, defined by the acce body of knowledge survey of ce practitioners, htm is broadly defined as “lifecycle management of medical devices and systems.”5 context and key acronyms the main elements of developing country htm and its key health system relationships are outlined in figure 1.1 the 60th world health assembly, convened by who in 2007, passed the resolution wha60.29 relating to health technologies.6 this resolution urges member states: 1. “to collect, verify, update and exchange information on health technologies (ht); in particular medical devices as an aid to prioritization of needs and allocation of resources”; 2. “to formulate as appropriate national, strategies and plans for the establishment of systems for the assessment, planning, procurement and ht management in particular medical devices, in collaboration with t judd et al.: clinical engineering/health technology management 2015 global update j global clinical engineering special issue 1: 4-14; 2018 6 personnel involved in health technology assessment (hta) and biomedical engineering” (bme); 3. “to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, (risk,) safety and efficacy of devices and where appropriate participate in international harmonization” (htr, risk & safety or r&s); 4. “to establish where necessary national and regional institutions of health technology, and to collaborate and build partnerships with health care providers, industry, patients’ associations and professional, scientific and technical organizations;” (e.g., moh ht units); and 5. “to collect information that interrelates medical devices which deal with priority public health conditions at different levels of care and in various settings and environments, with the required infrastructure, procedures and reference tools;” (to improve maternal child health (mch), such as ht improving mch care outcomes). to illustrate these points, we include a figure from our previous article, which is a graphical representation of the main elements of health technology management, and how it relates to other areas of the health system (see figure 1). as a capital investment, equipment needs to be managed from deployment (strategic planning, acquisition, installation / acceptance) until retirement, guided by a country’s health technology policy (htp). during its useful life, proper maintenance and management are essential to ensure safe, efficient, and cost-effective patient care. often neglected, feedback provided by users and maintainers is essential to continually improve htm within the country or system, and avoid mistakes made previously. htm is intimately related to but distinct from health technology regulation (htr, and risk & safety), as the latter is focused on safety and efficacy, with little concern on costs and management challenges. health technology assessment (hta) is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value. despite its policy goals, hta must always be firmly rooted in research and the scientific method.5–7 hta provides the foundation for successful planning and subsequent use of health technologies. htm gaps and progress earlier htm study: our prior article1 described progress in htm in 51 countries, including africa (11 countries) asia (11 countries), latin america & the caribbean (19 countries), and other (10 countries). in that article, the following gaps in htm were identified: • a lack of competent staff (human resource development hr) • limited access to technical documentation & spare parts (htm) • poor planning and lack of commitment (htm) • irrational ht incorporation and deployment (htm) • limited influence with decision makers (e.g., <10 countries then had designated ministry of health, health technology-ht units) • donations provided that do not align with ministry of health (moh) priorities in addition, the article identified the following root causes of htm challenges: • lack of: training to develop human resources-hr; experience; awareness; and influence with decision makers regarding htm • equipment is often considered a status symbol instead of a service production tool • greed and short-sightedness of manufacturers and distributors • selfishness of some “aid,” “cooperation,” and “donation” programs that are actual sales-promoting schemes or publicity stunts • lack of vision and courage among htm professionals t judd et al.: clinical engineering/health technology management 2015 global update 7 j global clinical engineering special issue 1: 4-14; 2018 global htm seminars: further progress in htm has been documented in a series of seminars presented from 1991-2015 by acce and who-paho.8 as a result of these seminars, progress was seen in the following areas (with aggregate evidence noted below summarized): • ht policy (htp) developed, e.g., in 27 of 51 countries (>50%) • htm training provided (hr), e.g., 40+ of 51 countries (>80%) • national professional societies created; e.g., in 20 of 51 (~40%) who global forums: further progress in htm was documented in the who 2nd global forum on medical devices, 2013 (2gfmd).9 this progress was documented in a series of country reports presented at the forum, and is summarized in the following tables (tables 1a-d). the 2013 who 2nd global forum provided an important update on the information presented in our prior paper.1 we now see indications of further progress. africa (20 countries) • htm programs have doubled in the region. • increased ngo htm involvement has helped, such as, thet-zambia, mrc-gambia, and cmbes-ghana. • increasing ht involvement with moh decision makers. • growing hta and htr initiatives. • earlier htm programs now aggressively pursuing mch. • limited ce-it initiatives. asia (13 countries) • big 3: strong national programs in china, japan, and india. • moh unit in india comprehensively addressing ht. • continued growth of japan and its national ce society. • rapid growth of china ces, societies, & certification. • countries with prior htm (2011) pursuing hta and htr. • increasing involvement with moh decision makers. limited ce-it initiatives other than big 3. latin & central america (12 countries) • paho investment in htm and hr training anchored in academia. • freeing mohs to work on hta and htr. • big 4: historical ht strength of brazil & mexico + colombia & peru. brazil largest ce base; very multidisciplinary approach. • mexico moh unit; wide-ranging with decision makers. • colombia (strong ht history; introduced ihe to region); & peru (developed moh unit, key academia partnerships). others (26 countries) • group with extensive capabilities along ht continuum. • most have mature htm & are pursuing hta & htr. • several key htm contributors in region and or globally. • also among global leaders for ce-it and mch. 2015 htm seminar: in june 2015 another major htm seminar was organized by acce in collaboration with who-paho, with 32 htm leaders from 22 countries represented, and one usa ngo.10 table 2 lists the participants in this seminar, and their affiliations. this table illustrates the following indications of progress: ht units now more frequently created at moh level (15/22 countries) and htm leaders are emerging with increasing influence at the moh level. table 3 summarizes the gains and challenges in htm, hta, htp, htr, and ce-it that were reported at the seminar. the following detail the gains and challenges identified at the 2015 htm seminar: africa (5 countries reporting) • tend to have established htm, but need hr, htp, and htr asia (3 countries reporting) • rapid growth ht capabilities for 2 high population countries • india moh ht unit leading country-wide initiatives • bangladesh increasing scope of ht work latin & central america (8 countries reporting) • two in early stages of htm; most mature pursuing ce-it • mexico moh ht unit (cenetec) a global best practice • most countries also need moh htp and htr t judd et al.: clinical engineering/health technology management 2015 global update j global clinical engineering special issue 1: 4-14; 2018 8 table 1a. africa – 20 countries/entities presented at 2gfmd country major accomplishments references afro-who htm ndihokubwayo (afro), 2013 benin htm adjaratou et al (moh), 2013 burkina faso htm emmanuel et al (moh), 2013 cameroon htm, ce-it ngaleu-toko et al, 2013 cote d’ivoire htm yriéudenis (moh), 2013 ethiopia htm, mch mulegeta et al (moh), 2013 the gambia htm, mch nyassi et al, faye et al, 2013 ghana htm, hr, hta, mch adjabu, thet & moh, 2013 kenya htm, hr, hta, htr, mch owino, anyango, mwaru et al (moh), 2013 malawi mch mwanza et al (moh), 2013 nigeria htm, htr, mch ilonze et al (moh), fatunde, 2013 rsa htm, hta, htr poluta, khalaf et al, mueller, 2013 rwanda htm mukama et al (moh), 2013 senegal htm sow et al (moh), 2013 sierra leone htm kabia (moh), 2013 south sudan hta lilford et al, 2013 tanzania htr, mch kijo et al (moh), 2013 togo htm, mch tsolenyanu et al (ngo), 2013 uganda htm, hr, hta, mch wanda et al (moh), ssekitoleko et al, 2013 zambia htm, mch mullally, machbani, musiwa (moh), 2013 other (2 countries reporting) • albania ht unit a global best practice for small countries who • who desires the following global surveys in 2016: • value of donations, e.g., percent implemented and in use • number bmets needed at country level, for moh plans • htm outcome measures; influence moh decision makers • who facilitating bme/ce global recognition in 2018 by ilo • causing who to annually track key ce/htm measures the 2015 seminar participant recommendations were: 1. increase awareness of ce/htm influence on ht policy • who can assist countries to develop/implement ht policies 2. communicate global htm point of view to help countries • how to address when government not involved in htm t judd et al.: clinical engineering/health technology management 2015 global update 9 j global clinical engineering special issue 1: 4-14; 2018 table 1b. asia 13 bangladesh htm, hta, htr hasan, rabbani et al (moh), 2013 china htm, hta, htr, ce-it zhong et al, 2013 india htm, hta, htr, ce-it, mch sharma et al (moh), khambete et al, 2013 japan htm, hr, hta, htr, htp, ce-it fukuta (moh), nakazaki, sugiura, 2013 korea hta hwang et al, 2013 laos htm insal (moh), 2013 malaysia htr rahman (moh), 2013 myanmar htm lin (moh), 2013 philippines ce-it mojica et al, 2013 singapore hr, htr, hta goh et al (moh), 2013 sri lanka hta galappatthy et al (moh), 2013 thailand hta tantivess, wibulpolprasert (moh), 2013 vietnam htm, mch dajer, 2013 table 1c. latin & central america 12 argentina htm giles et al, 2013 bolivia htm urioste (moh), 2013 brazil htm, hr, hta, htr, htp, r&s garcia, calil, conto (moh), 2013 colombia htm, ce-it quintero, hernandez, castaneda, 2013 chile hta duarte et al, 2013 cuba htr pereira et al (moh), 2011 ecuador ce-it silva et al, 2013 haiti htm judd et al, 2013 mexico htm, hta, htr, htp cardenas, moreno (cenetec) 2013 paho-who htm, hta lemgruber, jimenez, 2013 peru htm, hta, htr rivas et al, pinedo, 2013 uruguay htp, hta galan et al (moh), 2013 t judd et al.: clinical engineering/health technology management 2015 global update j global clinical engineering special issue 1: 4-14; 2018 10 table 1d. australia, europe, middle east, ngos 26 australia hta, htr, ce-it babige, kearney, tang, mcewan 2013 belgium htm, htr demade, bogg, merlevede 2013 bulgaria hta dimitrova (moh), 2013 croatia hr magjarevic, 2013 egypt hta salem, elsaadany (moh), 2013 ewh htm malkin, 2013 euro-who hta, ce-it pedersen et al (euro), kulkarni, 2013 greece htm, htp, r&s pallikarakis, stavrianou, 2013 hungary hta szacsky, 2013 israel mch mayaan, 2013 italy htm, hta, ce-it iadanza, pecchia, musi, 2013 jordan htm rahim, dalou, 2013 kuwait hr, htr alzawadhi, 2013 ksa hta, htr, ce-it hassanain, al tayyar, 2013 laerdal mch laerdal et al, 2013 lebanon hta rihana, 2013 netherlands hr, hta hurts/hansen (moh), linnenbank, 2013 norway hta lauvrak et al, 2013 portugal hr, hta, htr secca, da silva, madureira et al, 2013 slovakia hta jadud (moh), 2013 spain hta, ce-it falcon et al, 2013 switzerland htm, htr zaugg, werlein, voelksen, 2013 tunisia ce-it ouhichi, 2013 turkey htm, hta, htr, r&s copur, demirbas, turgut/kuru, ozdemir, 2013 uk htm, htr, r&s murray/gammie/wasmuth/mcnerney 2013 yemen hta mujamal (moh) et al, 2013 t judd et al.: clinical engineering/health technology management 2015 global update 11 j global clinical engineering special issue 1: 4-14; 2018 table 2. 2015 htm seminar participants albania moh health technology (ht) director argentina moh ht coordinator argentina private hospital ce director australia / egypt who bme intern bangladesh university bme professor bangladesh university bme graduate student bhutan moh director ht unit botswana moh regional ht director brazil moh ht manager brazil private ce company coo canada who bme intern colombia moh director ht unit colombia moh laboratory ce director colombia university bme professor cuba moh hospital ce ethiopia moh bme advisor haiti national hospital ce director haiti / usa medical device consultant india moh who ht center director india moh consultant kenya moh hospital ce kosovo telecommunications engineer mexico moh hospital coordinator mexico university ce professor mexico university ce professor nigeria moh director ht unit peru moh consultant, university ce professor sierra leone/usa university ce professor suriname moh hospital ce director uganda moh director ht unit uganda moh senior bme usa ngo bme leader • how to enable, using resources & influence to help drive htm • who needs data from specific case studies to better assist 3. develop regional training centers (rtc) – improves hr & htm • need key htm process standardization • lessons learned to be applied: (1) create rtc for maintenance; (2) training that is university-based is more sustainable • incorporate ce/htm in health care clinical & business courses, such as for physicians and health administrators • share different methods of risk management across countries 4. develop standard medical equipment procurement documents • incorporate life cycle cost (lcc) analysis, as world bank has done for information and communication technologies • make use of who resources on device specifications • consider central/national public-private-partnership (ppp) 5. consider how to best facilitate “our group” ongoing communications and networking – e.g., infratech and who listservs 6. maintenance management • need inventory management system on line with history (cmms); such as, basic inventory, then layers • india is working on a national cmms that can be made available on line for free 7. who & medical equipment manufacturers • how to improve interactions? • who: has created a forum for manufacturers 8. improve domestic production of medical devices • affects htm, making best use of technology transfer 9. organize professional societies to extend influence • many benefits to join locally, nationally, regionally, globally t judd et al.: clinical engineering/health technology management 2015 global update j global clinical engineering special issue 1: 4-14; 2018 12 table 3. summary of participant gains/challenges [a-y] country (pop. in m) key gains key challenges albania (2.9) htm, htp, htr hr, ce-it argentina (43) htm, ce-it bangladesh (157) htm, hta, htp, ce-it hr bhutan (0.74) htm, hta hr, htp, htr botswana (2.2) htm hr, htp, htr brazil (202) htm, ce-it colombia (48) htm, ce-it htp, htr cuba (11) htm, hr ce-it ethiopia (92) htm, htp wider htp, htr haiti (10) htm hr, htp, htr india (1,250) htm, hta, htp, htr, ce-it wider ce-it kenya (44) htm, hr htp, htr kosovo (1.9) htm, ce-it hr, htp, htr mexico (122) htm, hr, htp, hta, htr, ce-it wider ce-it nigeria (140) htm hr, htp, htr peru (30) htm, hr, ce-it htp, htr suriname (0.57) htm hr, htp, htr uganda (40) htm hr, htp, htr case studies / success stories ghana improved htm and hr: in 2009, 2 htm seminars were organized by acce in collaboration with who, international aid, and the ghana health service. essential htm topics were covered. the curriculum for the htm workshop was based on the who-adopted “how to manage” series for ht.11 the seminars were well attended, with 135 at the first and 83 at the second. participants identified a number of htm challenges including: (1) a lack of training on htm topics. (2) inadequate tools and test equipment. (3) poor availability of spare parts. (4) a lack of communication between government policy makers and ht stakeholders affected by policies (htp). this indicates a need for future seminars to include more content for government policy makers. results professional society: at the conclusion of the second seminar, the attendees initiated the ghana biomedical engineering society (gbes). an email listserv was set up to facilitate communication among workshop attendees. global partnerships: in addition, the faculty members from canada initiated a formal partnership between the canadian medical and biological engineering society (cmbes) and gbes. there is also opportunity for cmbes and gbes to partner more closely with who via regional african societies under development and through joint who and ifmbe ced global initiatives. t judd et al.: clinical engineering/health technology management 2015 global update 13 j global clinical engineering special issue 1: 4-14; 2018 the cmbes-gbes partnership has resulted in the successful application for a research grant to examine medical equipment donation practices in canada, and the experiences of recipients of such donations in ghana. members of the 2 societies are in frequent communication. such ongoing partnerships are considered an important factor in the strengthening of htm programs. albania improved access and htm: before september 2014, moh albania had no maintenance strategy for its hospitals’ highest technology diagnostic equipment – linear accelerators, magnetic resonance imaging, computed tomography scanners and angiography – resulting in higher costs, significant downtime, and poor vendor relationships. they then implemented a new approach based on global best practices: full risk, 2-year service contracts via negotiation; vendor meetings to present our new approach and for authorized distributor confirmation; then open tender procedures for international participation, to avoid speculation of monopoly. mexico role model: established moh unit in 2004, cenetec; has become a global ce-htm role model with countrywide htp, htm, hta, htr, hr, and practice guideline development. brazil first moh unit – established at são paolo state level in 1980s. key leader in global htp, htm, hr, and ce-it. future: 2015–2020 what is needed for ce/htm profession?10 • ce-it: need education for mdi seamlessly into ehrs7 • technical, management, leadership, health it (ceit) standards, and regulatory (htr) framework • global drivers: ehealth, patient safety & risk management, medical device cybersecurity, patient & population health outcomes • clinical workflows: ce/htm leaders provide improved design • leading edge initiatives: ce/htm leading telehealth, smartphone/mhealth, in their countries and regions to improve quality, safety, access and affordability. • maternal and child health (mch), e.g., neonatal and newborn care, using who-vetted evidence-based interventions & practice guidelines • influence: stronger leaders, with wider impact on decision makers conclusions this study showed steady improvements globally in most indicators for health technology. health technologies will play an increasing role in global health care delivery with the emerging spread of ce-it (ehr-enabled care) to improve quality and continue to make care affordable. acknowledgment the authors wish to acknowledge the invaluable contribution made by dozens of volunteers from less-developed countries who provided information and suggestions in various means. they also want to apologize to countries from which no information was obtained, mostly due to their limited knowledge of those countries and their key stakeholders. conflict of interest the authors declare that they have no conflict of interest. references 1. wang b, judd t, cordero i, hernandez a, velazquez berumen a, “htm in less-developed countries: an untold success story” (50+ countries, 110 references), 2011, unpublished personal communication. 2. bloom g. the right equipment... in working order. world health forum 1989;10:3–27. 3. world health organization (who). medical device definitions. geneva: author; 2007. available at: http://www.who. int/medical_devices/definitions/en/. 4. american college of clinical engineering. about acce. plymouth meeting: pa; author; 1992. available at http:// accenet.org/about/pages/clinicalengineer.aspx. communication.bloom communication.bloom http://www.who.int/medical_devices/definitions/en http://www.who.int/medical_devices/definitions/en http://accenet.org/about/pages/clinicalengineer.aspx http://accenet.org/about/pages/clinicalengineer.aspx t judd et al.: clinical engineering/health technology management 2015 global update j global clinical engineering special issue 1: 4-14; 2018 14 5. american college of clinical engineering. acce 2010 bok summary. plymouth meeting: pa; author; 2011. available at: http://accenet.org/publications/newsletters/accenewssummer2011.pdf. 6. world health assembly. wha 60.29 resolution on health technologies. available at: www.who.int/medical_devices/ resolution_wha60_29-en1.pdf. 7. sloane e, welsh j, judd t. white paper: new opportunities for bme/ce health it education; 2014. available at: http:// accenet.org/publications/pages/referencematerials.aspx. 8. american college of clinical engineering. acce-who international workshops (aka acew or htm seminars); 19912015. plymouth meeting: pa; author; available at: http:// accenet.org/international/pages/previousworkshops.aspx. 9. world health organization. second global forum on medical devices. geneva: author; 2013. available at: http://www. who.int/medical_devices/global_forum/2nd_gfmd/en/. 10. judd t, hernandez, a gentles w, calil. s. 2015 denver – toronto acew report. acce newsletter: available at: http://accenet. org/publications/newsletters/accenewsmayjune2015.pdf. 11. health partners international. how to manage series. east sussex: uk. available at: http://resources.healthpartners-int.co.uk/ resource/how-to-manage-series-for-healthcare-technology/. 12. david y, judd t, medical technology management. biophysical measurement series, spacelabs medical inc., washington, usa; 1993. 13. wang b, acquisition strategies for medical technology-mt, international forum for promoting safe and affordable mt in developing countries, the world bank, washington, dc;2003. appendix the following listing is the country-level presentations made during the 2015 htm seminar in denver, co usa, and toronto, canada. they can be obtained from the authors and or the presenters. a. picari l, albania htm seminar country update, & moh ht unit maintenance of medical devices (high technology systems), 2015 b. giles g, lencina m, argentina htm country update, 2015 c. abir ar, rabbani ks, bangladesh htm seminar update, 2015 d. penjore t, bhutan htm seminar country update, 2015 e. tlhomelang b, botswana htm seminar country update, 2015 f. contó m, katz z, brazil htm seminar country update, 2015 g. garcía ibarra ar, rojas morales jm, colombia htm seminar country update, 2015 h. castro medina j, cuba htm seminar country update, 2015 i. mideksa m, ethiopia htm seminar country update, 2015 j. valliere m, chery j, haiti htm seminar country update, 2015 k. sharma dr. jk, arora p, india htm seminar country update, 2015 l. anyango amoko p, kenya htm seminar country update, 2015 m. abazi n, kosovo htm seminar country update, 2015 n. cardenas alanis c, leon de alba f, orencio e, moreno me, mexico htm seminar country update, 2015 o. bukola e, nigeria htm seminar country update, 2015 p. rivas r, peru htm seminar country update, 2015 q. jie g, suriname htm seminar country update, 2015 r. mulepo s, edward k, uganda htm seminar country update, 2015 s. castañeda m, business opportunities in health technology projects, 2015 (outcomes of august 2013 acce ht seminar, barranquilla, colombia) t. clark t, lemgruber a & caccavo f (paho), molina velasquez t (universidad ces colombia), graciá f (universidad national tech. argentina), rivas r & vilcahuaman l, (universidad pucp peru), biomedical technology online courses for the americas, 2015 u. hernandez a, trends on it and health technology (ce-it), 2015 v. painter f, risk management, 2015 (outline of device risk & safety issues) w. quintero dr. v, ihe colombia crash course on interoperability (ce-it), from universidad simón bolívar, barranquilla, colombia, 2015 x. sloane dr. e, medical device and ict convergence (ce-it), 2015 y. european network for health technology assessment. common questions. what is health technology assessment (hta)? accessed dec. 1, 2015 at: http://www.eunethta.eu/ about-us/faq#t287n73 http://accenet.org/publications/newsletters/accenewssummer2011.pdf http://accenet.org/publications/newsletters/accenewssummer2011.pdf www.who.int/medical_devices/resolution_wha60_29-en1.pdf www.who.int/medical_devices/resolution_wha60_29-en1.pdf http://accenet.org/publications/pages/referencematerials.aspx http://accenet.org/publications/pages/referencematerials.aspx http://accenet.org/international/pages/previousworkshops.aspx http://accenet.org/international/pages/previousworkshops.aspx http://www.who.int/medical_devices/global_forum/2nd_gfmd/en http://www.who.int/medical_devices/global_forum/2nd_gfmd/en http://accenet.org/publications/newsletters/accenewsmayjune2015.pdf http://accenet.org/publications/newsletters/accenewsmayjune2015.pdf http://resources.healthpartners-int.co.uk/resource/how http://resources.healthpartners-int.co.uk/resource/how http://www.eunethta.eu/about-us/faq http://www.eunethta.eu/about-us/faq 5 j global clinical engineering vol.4 issue 3: 2021 received april 10, 2021, accepted june 4, 2021, date of publication july 30, 2021 the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda by robert tamale ssekitoleko1, beryl ngabirano arinda1, solomon oshabahebwa1, lucy kevin namuli1, julius mugaga1, catherine namayega1, emmanuel einyat opolot, jackline baluka, charles ibingira2, ian guyton munabi2, moses lutakome joloba3 1 biomedical engineering unit, department of physiology, school of biomedical sciences, college of health sciences, makerere university, uganda 2 department of anatomy, school of biomedical sciences, college of health sciences, makerere university, uganda 3 school of biomedical sciences, college of health sciences, makerere university abstract backgrounds and objective: advancements in technology have led to great strides in research and innovation that have improved healthcare provision around the world. however, the majority of the technology available is underutilized in subsaharan africa. in addition, the ever-increasing sophistication and cost of medical equipment means that access and proper use is limited in lowand middle-income countries (lmics). there is, however, a general paucity of well-documented evidence for the utilization of medical equipment in lmics. therefore, this study evaluates the current availability and utilization of medical equipment in tertiary hospitals and research facilities in uganda and provides baseline information to clinical/biomedical engineers, innovators, managers, and policymakers. material and methods: the study evaluated the equipment currently used in 9 purposively selected public tertiary hospitals and 5 research laboratories representing different regions of uganda. data were collected by personnel specialized in biomedical engineering utilizing a mixed-method approach that involved inventory taking and surveys directed to the health workers in the designated health facilities. results: the hospitals contributed 1995 (85%) pieces of medical equipment while the research laboratories contributed 343 (15%) pieces amounting to 2338 pieces of equipment involved in the study. on average, 34% of the medical equipment in the health facilities was faulty, and 85.6% lacked manuals. discussion and conclusion: although innovative solutions and donated equipment address the immediate and long-term goals of resource-constrained settings, our study demonstrated several issues around existing medical devices, and these need immediate attention. keywords – medical devices, biomedical engineering, healthcare technology, clinical engineering, appropriate healthcare technologies, health technology management. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.4 issue 3: 2021 6 ssekitoleko, arinda, oshabahebwa, namuli, mugaga, namayega, opolot, baluka, ibingira, munabi, joloba : the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda introduction advancements in technology have led to great strides in innovations and research, resulting in a general improvement in healthcare provision, greatly impacting diagnostics, monitoring, and therapy. medical device technology has played a key role in preventing, diagnosing, treating, and rehabilitating many diseases and contributes to complex research and innovations such as understanding the entire human genome.1–3 many innovative devices have been applied to the early diagnosis of complicated diseases, including non-communicable diseases such as cancer, and management of chronic illnesses such as diabetes and hiv/aids. they have also been utilized to invent and track many drug regimens for most deadly diseases such as tuberculosis and hiv.4–7 access and effective use of healthcare technologies leads to improved quality of healthcare provision to most of the population worldwide.8,9 it is therefore essential to have functional equipment. this is particularly urgent in sub-saharan africa,10–13 a region with 24% of the world disease burden, 1% of the global financial resources and 3% of the human resource capacity.14 lack of functional equipment has a devastating effect on the quality of healthcare provision and research in resource-poor settings and affects the overall healthcare system.10,15 many medical technologies have been made available to improve healthcare services in hospitals and research laboratories in sub-saharan africa.16 application of these technologies in service delivery ensures improved work efficiency and enhanced quality, leading to cost-effective medical care for patients.9 however, the availability of medical equipment does not necessarily translate to improve health service delivery in health facilities in low resource countries.17 indeed, health institutions worldwide are still struggling with managing quality healthcare delivery in resource-constrained conditions.18 most sub-saharan countries hugely depend on medical equipment donations to facilitate healthcare and research technology needs.19 in fact, nearly 80% of medical devices available in healthcare facilities in developing countries are donated or funded by international donors or foreign governments.20 most of these devices are poorly maintained, under-utilized, and or out of service due to various reasons such as inaccessibility to spare parts, accessories, and consumables.21 in addition, the high rate of dysfunctional equipment is attributed to the rising costs of medical devices, lack of reliable power and water, lack of public infrastructure such as air-conditioned rooms, and inadequate planning.16,22 perry and malkin23 report that 38.3% of medical equipment in developing countries is non-functional because of the lack of trained professionals able to execute the needed repairs or maintenance, mainly biomedical engineering technicians (bmet) or biomedical engineers.23 several approaches were been taken to spur innovations in contextually appropriate healthcare technologies to respond to the challenges outlined above. funding mainly came from international donors and philanthropists.24 however, with the recent cessation or reduction of this funding due to shifting priorities such as the recent covid-19 pandemic, most of these innovations have been abandoned due to the absence of sustainability plans. this has led to a setback in this field with actual progress showing little clinical efficiency.25,26 apart from limited funding, who highlights other barriers that hinder the effective adoption of innovative solutions in lowand middle-income countries: inadequately trained support staff to manage the novel equipment, shortage of technical expertise, and designs not being suitable for the african setting.27 steps have been taken to avert the challenges in medical equipment management, including designing novel medical equipment suitable for sub-saharan africa setting,28,29 developing policies on donations and equipment procurement,30 and training biomedical engineers locally to enhance technical support.31 there is little evidence published on how these efforts have improved medical equipment access to the people in most need. therefore, this paper aimed to evaluate the current availability, status, and utilization of medical equipment in tertiary hospitals and research facilitates in uganda. methodology study design and setting this was a cross-sectional study that utilized a mixedmethod approach that involved inventory taking and surveys. the study evaluated the equipment in current use in 9 purposively selected public tertiary healthcare facilities and five research laboratories to represent 7 j global clinical engineering vol.4 issue 3: 2021 ssekitoleko, arinda, oshabahebwa, namuli, mugaga, namayega, opolot, baluka, ibingira, munabi, joloba : the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda different regions of uganda in january 2017. the research laboratories included three research-based institutions, that is, the microbiology laboratory at makerere university college of health sciences (central region), the microbiology and molecular biology laboratories at gulu university (northern region), and mbarara university of science and technology (must) clinical and research laboratory (western region) and two independent research laboratories; uganda virus research institute (uvri) and infectious disease institute (idi). each of these laboratories serves as a reference laboratory receiving samples from neighboring hospitals for clinical diagnosis support and analyzing samples for research and academic purposes. figure 1 below shows the spread of the facilities surveyed. the healthcare facilities selected serve about 21% of uganda’s population, translating to about 7.9 million people as of 2017 uganda population census estimates. data collection and analysis all data collectors had a bachelor’s degree in biomedical engineering and were given uniform data collection tools and were trained to conduct interviews and collect inventory. data on the collection inventory was aimed at generating information on the working condition of the various devices currently available in the study facilities. the inventory assessment included all medical equipment available at the study site when conducting the study and excluded furniture, instruments, drugs, computers, computer accessories, and disposable tools and instruments. the equipment details collected in the inventory included the medical equipment name, type, model, equipment number, serial number, functionality, manufacturer, year of manufacturer, and location. the condition of the medical equipment was recorded using an a to f scale recommended by the uganda ministry of health32 and the non-functional equipment in categories b, c, d, e, and f were further categorized as shown in table 1. the data were analyzed using stata version 14.0. discrete variables were summarized by their means and standard deviations, whereas categorical variables were presented as frequencies and percentages. logistic regression was used to compare the functionality of equipment between groups, and results were reported with odds ratios. all differences with a p-value less than 0.05 were considered statistically significant. ethical consideration ethical approval was obtained from makerere university school of biomedical sciences institutional review board and the uganda national council of science and technology (uncst; # ss 4166). informed consent was obtained from all participants before enrolment into the study. confidentiality was assured through de-identification of the data. figure 1. a map of uganda showing the different locations of the study sites and nearby regional biomedical engineering workshops. table 1. key to the a-f scale of medical equipment conditions used to assess medical equipment in this study category interpretation a equipment in good working condition and in use b equipment in good working condition but not in use c equipment in use but need repair d equipment in use but needs replacement e equipment out of use but repairable f equipment out of use, to be disposed of j global clinical engineering vol.4 issue 3: 2021 8 ssekitoleko, arinda, oshabahebwa, namuli, mugaga, namayega, opolot, baluka, ibingira, munabi, joloba : the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda results this study included 2338 pieces of medical equipment categorized in 255 medical equipment types, of which the hospitals contributed 85% (1995). table 2 shows the characteristics of the facilities included in the study. the out-patient department attendance per day characterized the study, number of admissions per day, population served, number of biomedical engineers and technicians (bmets), number of pieces of medical equipment found, the percentage of medical equipment classified as nonfunctional, the number of pieces of equipment without manuals, and the number of manufacturers supplying the hospital with medical equipment. a total of 12 biomedical engineers and technicians (bmets) were identified to be working in the hospitals studied, out of which only 3 had a bachelor’s degree while the 9 were diploma holders. in the hospitals where the availability of manuals was recorded, more than 50% of the medical equipment had no manuals. on the other hand, the idi research laboratory had manuals for all their equipment. the number of manufacturers was also relatively high, with the highest recorded being 120 manufacturers supplying a single hospital served by 2 bmets. table 2. characteristics of the hospitals and research laboratories included in the study health facility location (region in uganda) opd attendance per day admissions per day population served no. of bmets employed no. of pieces of equipment included (% of equipment nonfunctional *) % of equipment without manuals no. of manufacturers recorded regional referral hospitals (rrh) arua rrh north western 443 65 3.5 million 1 200 (50%) 91% 78 fortportal rhh western 254 70 2 240 (4%) hoima rhh western 413 65 3 million 2 53 (26%) 77% 31 kabale rhh south western 178 33 2 million 2 510 (30%) mbale rhh eastern 210 135 1 347 (36%) mbarara rhh south western 468 85 4 million 2 392 (52%) 53% 120 moroto rhh north eastern 160 20 1.5 million 1 138 52%) 74 general hospitals kotido hospital north eastern 77 15 0 59 (54%) 75% 29 health centre iv kawolo hospital central region 217 30 1.2 million 1 56 (50%) 68% 25 research laboratories must western 24 (29%) 14 uvri central 153 (29%) makerere univ. central 23 (22%) 11 gulu univ. northern 114 (10%) 41% 57 idi central 29 (7%) 0% 20 *all medical equipment in conditions b, c, d, e, f were classified as non-functional. 9 j global clinical engineering vol.4 issue 3: 2021 ssekitoleko, arinda, oshabahebwa, namuli, mugaga, namayega, opolot, baluka, ibingira, munabi, joloba : the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda table 2 shows the percentage of non-functional equipment was 4 to 54% with an average of 37%, while the research laboratories had a better performance with the non-functional equipment ranging from 7 to 29% with a mean of 20%. according to the a-f scale, further breakdown of the equipment categories (see table 1) revealed that the non-functional medical equipment was spread out in categories b, c, and e, as shown in table 3. out of 2338 pieces of equipment, 157 were identified in category b, 296 in category c, and 193 identified in category e. the top reasons identified for equipment in category b were lack of user training and lack of consumables. on the other hand, the equipment in categories c and e was usually there because of a lack of spare parts, testing equipment to identify faulty equipment, and technical knowledge on performing repairs. the medical equipment manufacturers were recorded at 6 of the health facilities and 4 of the research facilities. the number of manufacturers supplying the facilities ranged from 11 to 120, with an average of 46. this number varied with the number of pieces of medical equipment at each facility (figure 2). according to the study, 358 (15%) pieces of equipment were donated and the facilities bought 195 (8%) pieces of equipment. the remaining 77% of the equipment was classified as unknown because the interviewees could not ascertain whether they were donated or bought. the study also assessed the availability of user and technical manuals for the equipment and revealed that 345 (14.4%) pieces of equipment had manuals, whereas 2055 (85%) pieces of equipment had no manuals available (table 2). thus, 80% of the donated equipment had no manuals, whereas 86% of the equipment purchased had manuals. table 3 also shows the distribution of some of the equipment types identified in the six equipment categories. this table shows that a high number of oxygen concentrators and pipettes were found in category c. this was because the facilities did not have working oxygen sensors to determine the concentration of oxygen concentrators and lacked a clear basis for their use. similarly, the pipettes were never or rarely calibrated. many glucometers were not used despite being in good working conditions (category b) because of a lack of strips, while a large number of infant incubators and nebulizers in the same category were mainly due to lack of user training. the non-functional equipment (categories b, c, d, e, and f) was further categorized according to the host departments, and analysis revealed that dental and sterilization departments had the highest percentage of non-functional equipment. in contrast, the laboratory equipment in both laboratories within the hospitals and research laboratories had a significantly lower percentage of non-functional equipment than the mean. indeed, when all pieces of laboratory equipment were excluded from analysis, the average percentage of non-functional equipment in the other departments increased from 37 to 47%, as seen in figure 3. figure 2. bar graph showing variation in the number of equipment manufacturers supplying 6 of the 9 healthcare facilities and 4 of the 5 research facilities included in this study. the number corresponding to the highest point of each bar is the number of pieces of equipment in each facility and the number represented by the dot above each bar is the number of equipment pieces in that facility. figure 3. percentage of non-functional equipment categorized according to the department, the mean percentage of non-functional equipment and then mean percentage of the non-functional equipment excluding medical and research laboratory equipment. j global clinical engineering vol.4 issue 3: 2021 10 ssekitoleko, arinda, oshabahebwa, namuli, mugaga, namayega, opolot, baluka, ibingira, munabi, joloba : the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda discussion this study found that, on average, 37% of the medical equipment found both in the hospitals were not in use, needed repair, and was completely non-functional. these results agree with a similar study done in southwest ethiopia in 2016 that reported that 32.1% of healthcare equipment was broken.10,23 in addition, malkin in 2011 reported that, on average, 40% of medical equipment in resource-constrained countries is out of service.23 our studies showed that the percentage of non-functional equipment in research laboratories was reduced to 20%. strategies identified that led to this improvement included (1) the provision of technical and user manuals. the idi table 3. the condition of medical equipment in the hospitals, health facilities, and top medical equipment types are broken down into each of the six categories in the a-f scale equipment condition categories total # of pieces of equipmenta b c d e f total 66% 7% 13% 1% 8% 6% 2,338 hospitals 63% 7% 13% 1% 9% 6% 1995 research laboratories 80% 3% 11% 0% 4% 2% 339 medical equipment types refrigerator 77% 1% 5% 2% 4% 10% 135 weighing scale 58% 5% 9% 2% 18% 9% 126 patient monitor 66% 9% 12% 0% 11% 2% 117 suction machine 48% 5% 9% 0% 15% 24% 105 autoclave 53% 8% 19% 1% 8% 10% 98 microscope 76% 7% 8% 1% 6% 3% 90 centrifuge 76% 1% 4% 1% 1% 17% 78 bp machine 69% 9% 10% 0% 6% 5% 77 oxygen concentrator 67% 4% 21% 0% 3% 5% 76 operating light 57% 3% 10% 13% 11% 6% 63 examination lamp 59% 17% 7% 0% 9% 9% 46 infant incubator 65% 30% 4% 0% 0% 0% 46 pipette 7% 0% 70% 0% 0% 23% 43 freezer 74% 5% 5% 0% 13% 3% 39 anesthesia machine 62% 11% 14% 0% 8% 5% 37 glucometer 43% 37% 10% 0% 10% 0% 30 operating table 83% 3% 7% 7% 0% 0% 30 nebulizer 39% 25% 14% 0% 18% 4% 28 vortex mixer 88% 0% 8% 0% 0% 4% 24 ultrasound machine 43% 0% 13% 0% 30% 13% 23 hematology analyzer 86% 0% 0% 0% 9% 5% 22 ventilator 17% 11% 6% 0% 67% 0% 18 11 j global clinical engineering vol.4 issue 3: 2021 ssekitoleko, arinda, oshabahebwa, namuli, mugaga, namayega, opolot, baluka, ibingira, munabi, joloba : the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda research laboratories had manuals for all their medical equipment, whereas all the hospitals surveyed did not have manuals for more than 50% of their equipment, implying a lack of technical support in proper use, maintenance, and repair; and (2) the laboratory equipment in both hospitals and research laboratories were supplied with service contracts usually from a local distributor. the distributor is tasked with user training, regular preventive maintenance (usually on a 6-month basis), and corrective maintenance upon breakdown. in general, medical equipment in the other department was procured with hardly any plans for their service and maintenance during their life span; (3) research laboratories usually have funds to support medical equipment maintenance and repair. it was observed that 7% of medical equipment was in good condition but out of service. these results fall within the same range as another study conducted in ethiopia, which found the frequency of equipment in good condition but not in use ranging from 3 to 21%, with a mean of 12%.10 an example we saw in our study was glucometers, which have a huge potential in the fight against diabetes by providing fast and affordable point-of-care blood glucose measurement in low-resource settings. while the devices are cheap, the glucometer strips are unaffordable for many patients in low-resource settings thus are never used. other reasons for not putting functional equipment to use included not knowing how to use the equipment correctly, lack of installation space, and lack of required infrastructure and utilities.21 the results also show that 13% of the medical equipment identified in the health facilities was faulty but used on patients. for example, we found some oxygen concentrators in use but delivered oxygen concentrations as low as 45% compared to the recommended concentrations greater than 82%.33 this was often due to a lack of the right tools or testing equipment for the equipment functionality. there were also cases where the users were aware that the equipment was faulty but used it due to a lack of alternative options. this was usually coupled with a lack of spare parts and technical personnel and insufficient funds to support corrective maintenance. the use of faulty equipment on patients affected the overall outcomes in diagnosis and therapy.34 factors affecting medical equipment utilization medical equipment management this study found that hospitals did not have manuals for 68% of their medical equipment. logistic regression analysis showed that the lack of equipment manuals was statistically related to medical equipment being non-functional (p-value <0.001). without these guides, equipment maintenance becomes very difficult, especially in uganda, where nearly all medical equipment is imported with limited contact with the manufacturers. a survey conducted by the ministry of health in 2015 supported these findings, which found that only 13.4% of the health facilities in uganda had scheduled medical equipment maintenance and that only 37% of the health facilities in uganda have a budget for routine maintenance and repair of medical equipment.35 this failure to follow routine maintenance procedures results in the escalation of equipment faults. therefore, collective efforts from medical equipment manufacturers, local distributors, health facilities, and the ministry of health are essential to provide the technical and user guides for medical equipment, put measures in place to provide technical support, source and avail funding for medical equipment management, and carry out routine user training and preventive maintenance. technical human resource our results show that in each of the hospitals included in the study, one or two bmets, was responsible for maintaining and repairing the medical equipment at the health facility. when this workload is compared with the number of pieces of equipment identified and the number of manufactures supplying each hospital, on average, each bmet was charged with maintaining 167 pieces of equipment and from 51 variant manufacturers, each supplying a unique model of medical equipment. in addition, the bmets in the regional referrals were expected to maintain the medical equipment in the lower-level health facilities. with little funding, lack of spare parts, manuals, and limited technical support from the manufacturers, these bmets are indeed overwhelmed. there have been considerable efforts to train bmets locally; as of march 2021, seven teaching institutions train biomedical engineers and technicians at various levels. makerere university, which pioneered bachelor’s training j global clinical engineering vol.4 issue 3: 2021 12 ssekitoleko, arinda, oshabahebwa, namuli, mugaga, namayega, opolot, baluka, ibingira, munabi, joloba : the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda for biomedical engineers in uganda, has graduated 150 biomedical engineers at bachelor’s level. however, the level of uptake by the ministry of health into the public health care system has been low. this is reported to be due to limited financial recourses. in addition, inadequate personnel available in health facilities to guide the procurement process, train users, and conduct routine maintenance and repair of medical equipment significantly contributes to medical equipment failure.31,36 administrative support administrative structures play a crucial role in medical equipment management. this can explain the variations observed in the percentage of non-functional equipment among the health facilities in this study. for example, most research laboratories have autonomous or semi-autonomous administrative structures and considerable donor funding that enable fast procurement of the required spare parts, consumables, and contracting skilled human resources to increase medical equipment utilization.37 public hospitals, on the other hand, are characterized by long bureaucracies in the procurement process and minimal funding to support medical equipment maintenance.38 some hospitals have, however, streamlined their procurement process to support infrastructural and resource utilization. the biomedical engineering workshop in one of the hospitals, for example, operates with a framework contract in which a comprehensive list of spare parts and consumables is submitted to procurement at the beginning of each financial year, and the items are purchased in a batch.39 this, therefore, eases repairs of medical equipment that require spare parts previously identified and listed. thus, practical approaches to abridge convoluted administrative procedures to enhance infrastructural and resource utilization are paramount to improving medical equipment utilization in health facilities in low-resource settings. procurement guidelines despite recommendations by who30 and ministry of health40 to regulate donated equipment, many hospitals in uganda still accept medical equipment donations without following the guidelines to ensure that the equipment is fit for purpose and the setting.41 additionally, there is still a lack of adequate procurement tools to assist hospital administrators in the appraisal of new equipment before purchasing in low-resource settings.42 this primarily contributed to the observed 7% of medical equipment being purchased or donated but never put to use due to lack of installation space, lack of consumables, or incompatibility with existing infrastructure and resources in this study. additionally, it seemed that hospitals were eager to acquire medical equipment at low initial costs without considering the lifetime / hidden costs of the medical equipment, such as cost of consumables, maintenance costs, and cost of required utilities, among others. it was observed that medical equipment suppliers commonly offer health facilities medical equipment at low or no cost but charge them highly to procure reagents and consumables over long periods. however, the equipment procured under this contract ends up unused as the hospitals and patients cannot afford the cost of reagents. another example observed was sterilization equipment procured by the hospital, but it later realized that the equipment’s electricity consumption was way above the hospital’s budget, thus putting it out of use. these point to deficiencies in the procurement appraisal process and a lack of technical guidance during procurement. supporting infrastructure and resources system-wide deficiencies in infrastructure and resources to support medical technologies in low-resource countries have been shown to affect the utilization of medical devices. the lack of clean water, stable electricity supply, space, and administrative structures also affects medical equipment utilization, especially in the lower level health facilities and facilities in hard-to-reach areas. for example, some of the equipment identified in the study was designed for use with a 110v power supply, and yet uganda has a 240v power supply. without a step-down transformer, this equipment will remain unused in category b for years. another example is autoclaves designed to operate with distilled water, yet the hospitals struggle to get access to distilled water. these are thus used with ordinary tap water, which significantly reduces their lifespan. this is, therefore, vital to consider in the design of novel medical equipment or during the procurement process. innovations and implications novel approaches custom-made to suit low resource settings provide an alternative to the hugely dependent 13 j global clinical engineering vol.4 issue 3: 2021 ssekitoleko, arinda, oshabahebwa, namuli, mugaga, namayega, opolot, baluka, ibingira, munabi, joloba : the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda on donated equipment. development of these innovative inventions have been supported and financed by international donors and philanthropist.25 however, the majority of the funding comes to an end, and the inventions are abandoned26 while those that progress fails to translate to the african setting. the who highlighted that one significant barrier to the effective adoption of these inventions is that the design technology incorporated in these innovations does not suit the african setting.28 this study showed that most unused equipment in category b was new technologies that could not be applied to the ugandan setting. an example was the microscopes; contributing to the 7% equipment in category b were new microscopes in storage because of inadequately trained support staff to manage the novel equipment while other models applied sophisticated technologies that were not suitable for the ugandan settings. these findings align with who findings on the reasons for hindrances to the effective adoption and utilization of innovations in low and middle-income countries.28 there is, therefore, a need for more emphasis on the context when designing new technologies for lowand middle-income countries. conclusion although innovative solutions and donated equipment address the immediate and long-term goals of resourceconstrained settings, our study showed that most of this equipment does not translate to the african setting, with an average of 37% of the equipment in hospitals non-functional. research laboratories have successfully reduced non-functional equipment to 20% by ensuring that medical equipment is supplied with manuals and technical assistance, negotiating service contracts with the distributors, and securing funding for medical equipment management. other factors noted as affecting medical equipment utilization include medical equipment management, technical human resource, administrative support, procurement procedures, supporting infrastructure, and resources. grant support this research was funded by the nih forgarty international center under grant number 1d71tw010337-01. the funder provided funds as part of a large study and did not contribute in the design of this study and collection, analysis, and interpretation of the data or writing of the manuscript. references 1. ventola cl. challenges in evaluating and standardizing medical devices in health care facilities. pt 2008;33(6):348–59. 2. meyerson m, gabriel s, getz g. advances in understanding cancer genomes through 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identifies opportunities to strengthen healthcare systems. health technol (berl) 2018;8. 22. malkin ra. design of health care technologies for the developing world. ann rev biomed engineer 2007;9. 23. perry l and malkin r. effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? med biol engineer comput 2011;49. 24. masum h. et al. venture funding for science-based african health innovation. bmc int health hum rights 2010;10. 25. adelman hs and taylor l. on sustainability of project innovations as systemic change. j educat psychol consult 2003;14. 26. martelli n and van den brink h. special funding schemes for innovative medical devices in french hospitals: the pros and cons of two different approaches. health policy (new. york) 2014;117. 27. world health organization. medical devices : managing the mismatch: an outcome of the priority medical devices project: methodology briefing paper. world heal. organ 2010. 28. richards-kortum r and oden m. devices for lowresource health care. science 2013;342. 29. who. compendium of innovative health technologies for low-resource settings: assistive devices, ehealth solutions, medical devices. who library cataloguingin-publication data; 2014. 30. world health organization. guidelines for health care equipment donations; 1997. 31. ploss b. et al. part ii: u.s.—sub-saharan africa educational partnerships for medical device design. ann biomed eng 2017;45. 32. ministry of health. operation manual for regional medical equipment maintenance workshops and medical equipment maintenance guidelines a; 2013. 33. who. technical specifications for oxygen concentrators. who medical device technical series; 2015. 34. mosadeghrad, a. m. factors influencing healthcare service quality. int j heal policy manag 2014;3. 35. ministry of health. health sector development plan 2015/16 2019/20. rou 110; 2015. 36. malkin r and keane a. evidence-based approach to the maintenance of laboratory and medical equipment in resource-poor settings. med biol eng comput 2010;48. 37. uthman oa, et al. increasing the value of health research in the who african region beyond 2015 reflecting on the past, celebrating the present and building the future: a bibliometric analysis. bmj open 2015;5. 38. sekyonda z, et al. supply chain of routine orthopaedic implants in kampala, uganda: public-private 15 j global clinical engineering vol.4 issue 3: 2021 ssekitoleko, arinda, oshabahebwa, namuli, mugaga, namayega, opolot, baluka, ibingira, munabi, joloba : the status of medical devices and their utilization in 9 tertiary hospitals and 5 research institutions in uganda workarounds arising from poverty and scarcity. glob heal innov 2018;1. 39. auditor general. management of procurement and distribution of essential medicines and health supplies by national medical stores. 2016. available at: http://www.oag.go.ug/wp-content/uploads/2017/04/ procurement-distribution-of-essential-medicineshealth-supplies-by-nms.pdf. (accessed: 18th february 2021) 40. ministry of health. national medical equipment policy. 2009. 41. auditor general. report of the on acquisition and utilization of medical equipment under uganda health systems strengthening project (uhssp). 2015. 42. houngbo pt, et al. the root causes of ineffective and inefficient healthcare technology management in benin public health sector. heal policy technol 2017;6. http://www.oag.go.ug/wp-content/uploads/2017/04/procurement-distribution-of-essential-medicines-health-supplies-by-nms.pdf http://www.oag.go.ug/wp-content/uploads/2017/04/procurement-distribution-of-essential-medicines-health-supplies-by-nms.pdf http://www.oag.go.ug/wp-content/uploads/2017/04/procurement-distribution-of-essential-medicines-health-supplies-by-nms.pdf j global clinical engineering vol.2 issue 2: 26-36 ; 2020 26 received february 15, 2019, accepted may 20, 2019, date of publication march 1, 2020 logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest by r. p. ferreira, f. o. andrade, a. a. ramos, r. bernardes, s. j. calil center for biomedical engineering, unicamp, campinas, são paulo, brazil abstract background and objective in brazil, there are 896,917 indigenous people with 47% dwelling in the amazon rainforest region. to avoid expensive displacement of this population, especially for surgeries such as hernias and cataracts, the expedicionários da saúde nongovernmental organization (ngo) has visited this specific group 3 times per year since 2003. the visit is done through a field hospital (fh) and is supported by clinical engineering (ce). this article outlines the characteristics of logistics as well as the operation of medical and hospital devices in remote sites of the amazon region. the object of this paper is to describe the transportation processes, installation, operation, and maintenance involved in ensuring the safe use of medical devices in one fh in the amazon forest and to present solutions to adverse conditions encountered throughout the course of several expeditions. material and methods initially, a survey of the processes used for transportation, installation, operation, and maintenance of medical devices was collected from 28 expeditions to the amazon forest over a period of 10 years since the implementation of ce the team. a task-analysis process was performed to systematically identify the process used during these expeditions. to better understand the complexity and the specifics of each expedition, an evolutive planning process based on a software development spiral model was used to describe a continuous activity flow that was used to implement and test improvements in each new expedition. besides continuous improvement, the model also takes in consideration budget solutions once all the voluntary work by the ngo is done. the efficacy of the method was evaluated from indicators of use of medical equipment, the assessment of reported adverse events, and interviews with the professional from the ce team, the users of the medical devices, and the opinion of those responsible for managing of the expedition. results several improvements were observed specifically in the transporting and installation processes, mainly through the adoption of customized packages and manuals for assembly and disassembly of the medical equipment. further enhancements were obtained through customizations and adaptations of the devices to the hostile characteristics of the environment. both physicians and nurses were satisfied with the performance of the devices, and few procedures for repair and calibration were required after the equipment was installed. conclusion the ce team is crucial to the implementation of fhs, being essential in the management of medical technology and in the planning and operation of this type of health structure. the spiral planning method was shown to be very helpful mainly http://www.globalce.org http://globalce.org http://globalce.org 27 j global clinical engineering vol.2 issue 2: 26-36 ; 2020 ferreira, andrade, ramos, bernardes, calil: logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest because it takes into account the experiences and needs of the past expeditions and for allowing the continuous improvement of the already used processes. given the great complexity of the rainforest environment in which the technologies will be used and the unpredictability of the risks and challenges faced by the ec team the evolutionary work approach presents itself as an applicable solution when planning future expeditions. keywords – clinical engineering, field hospital, medical devices, amazon rain forest, expedicionarios da saude. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction in brazil, there are 896,917 indigenous people with 47% of them dwelling in a reserve forest in the amazon region.1 basic healthcare for this population is provided through the use of specialized health teams sent to their villages.2,3 for cases requiring specialized care, patients are sent to urban regions.4 however, this involves a significant increase in costs and great discomfort for patients because of the distance and difficulty associated with traveling to the closest specialized medical center. to reduce displacement of patients, especially for surgeries such as hernias and cataracts (prevalence of 2.1%),5 the non-governmental organization (ngo) expedicionários da saúde (brazilian health expeditions) has attended to this specific population 3 times per year since 2003. there were 44 expeditions with a total of 97,060 nonsurgical patient encounters and 8,773 surgeries.6 all of the work is done by voluntary professionals who, in addition to the provided care, also assist with the assembling of the field hospital (fh) used for this service. this fh contains a specialized surgical center, sterilized material center, and ophthalmology, pediatrics, odontology, gynecology, and general clinical medicine outpatient facilities.7 the fh is defined as a mobile, self-contained, self-sufficient health care facility capable of rapid deployment and expansion or contraction to meet immediate emergency requirements for a specified period.8,9 as with permanent structures, this hospital needs medical devices for patient diagnostics and therapy. according to finestone, the fh must be equipped appropriately to function independently.10 therefore, it should have all necessary external resources needed to function such as medical instruments, operational material, infrastructure, and additional equipment. support from the clinical engineering (ce) team is crucial to the implementation of fhs and is essential to the planning, management, and support not only of the structure but also of the facilities and the medical technologies used.11 the ce team is composed of 3 engineers who travel one at a time for the expeditions and one engineer who give support to the routine work in maintenance of medical devices. among the diverse medical technologies involved, it is necessary to recognize their technological complexities. consequently, the ce team is in charge of the transportation and assembling of items including electrosurgical units, physiologic monitors, imaging ultrasound, phacoemulsification machines, surgical microscopes, surgical lamps, portable laboratory, autorefractors/keratometers, pulse oximeters, colposcopes, slit lamps, and ocular biometers. a total of 15 tons of materials and pieces of equipment for the fh are transported to their remote sites in the amazon.12 the route includes roads, rivers, and airports with most lacking proper conditions for the landing of big-load aircraft and the transportation of delicate medical devices. all of the material is vulnerable to weather and local environmental conditions such as high humidity, temperature, sun exposure, dust, strong winds, and impacts related to loading and unloading of boats, trucks, and aircrafts.13 the main role of technology management done by ce team is to make sure the medical devices are available and are working properly and safely. this process is done through assembling, installation, maintenance, and very importantly, by the protection of medical devices to avoid damage during transportation.14 however, the high complexity transportation of medical devices in the amazon forest and the lack of available financial resources due to the project’s often philanthropic ferreira, andrade, ramos, bernardes, calil: logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest j global clinical engineering vol.2 issue 2: 26-36 ; 2020 28 origin demanded the development of a structured and evolutionary work process aiming for low-cost solutions. objective the object of this paper is to describe the transportation installation, operation, and maintenance processes used to ensure the safe use of medical devices in one fh in the amazon forest and to present proposed solutions to overcome adverse conditions throughout the course of several expeditions. methods task analysis initially, a survey of the processes used for transportation, installation, operation and maintenance of medical devices was done using the method called task analysis.15 data from planning, preparation, transport, and operation of medical devices were collected from 28 expeditions to the amazon forest over a period of 10 years since the implementation of the ce team. to facilitate the visualization of these process, see figure 1 and the survey of processes and description of stages. description of the stages of processes: 1.1 md selection: the amount, type and characteristics of the required medical devices depend on their estimated demand and on the types of patients and procedures that will need them. a contingency plan to have a 25 to 50% higher stock of medical devices is established. the corrective maintenance has a low chance of success in case of failures due to the lack of resources, such as spare parts, test equipment, tools, training, and more. figure 1. process diagram of medical devices. 29 j global clinical engineering vol.2 issue 2: 26-36 ; 2020 ferreira, andrade, ramos, bernardes, calil: logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest 1.2 md request to partners: partner companies provide equipment that is lacking. the number of devices requested is based on demand and the number of devices currently available. 1.3 own md stored: owned md equipment is stored in the distribution center (dc) in the southeast of brazil. this location was selected because of better availability of companies to perform maintenance, access to better storage conditions, and easy access to equipment by the team. the management of expiration dates of accessories and materials is done at this stage. 2.2 receipt of mds on dc: equipment lent by partners is delivered to the dc where it is checked after being previously tested by their providers. 2.4 proper operation: before the packing stage, the ngo’s equipment and accessories undergoe functional testing. 2.3 proper packaging: equipment provided by partners is inspected to ensure quality and viability of the packaging and is placed in a 180-liter standardized container as necessary. 2.5 and 6.2 corrective maintenance: 30% of corrective maintenance is done in house and managed by the ce team. however, the loaned mds are repaired by md’s partners. 2.6 and 4.5 packaging: the equipment is preferably packed in foam, cut in its own format, sealed with plastic bags, and put inside the 180-liter standardized containers. the container has a weight limit of 30 kg (66.1 lb) to allow manual loading. packages are recycled on their return. 3.1 and 4.6 proforma invoice: this is a checklist of the bill or goods (or items) to be included with the fh. all items receive numeric identification, sealing, and external identification with colored codes. 3.2 and 4.7 transport: the equipment is transported by road, air, and on water (e.g., by river). transportation from campinas (southeast region) to manaus (north region) can be by road or air, go through roads and highlevel airports with infrastructure, and via resources such as forklifts and warehouses. after manaus, the load is carried by military aircraft, ferry boats, wooden boats adapted to the rain forest rivers, and sometimes on unpaved roads which are subject to quagmires and dust. during transportation, the load can be exposed to rain. for this reason, it is protected by plastic tarps. when a load is delivered to the indigenous community or small towns that do not have proper infrastructure the unloading is manually conducted at the riverbank. 4.1 assembly: there is a visual inspection of each md for integrity before assembly. assembling procedures often differ from the original manuals as they are simplified to reduce assembling errors and the limited availability of trained manual labor. 4.2 final tests: before use, mds are tested and kept working in shifts of 2 hours. this testing ensures the functioning of equipment and the generator when fully loaded. 4.3 use of md: the use regimen for mds is that they will be available 13 hours a day for 6 days with the device operation monitored and controlled by the ce team. 4.4 disassembly: the equipment is disassembled following the same procedures used in the assembly process. 6.1 and 6.5 own md: the partners’ pieces of equipment are returned without going through internal maintenance procedures. 6.2, 6.3. and 6.4 corrective maintenance, preventive and inspection: before storage, owned pieces of equipment go through corrective maintenance when defects have been identified; after this, equipment goes through post-repair inspection or pre-storage preventive maintenance for devices not requiring repair. evolutionary planning cycle of expeditions we estimated through the 28 expeditions the equipment was transported for more than 163,000 km (approx. 101,000 mi). due to the highly complex environment and great diversity of problems faced in each expedition, an evolutionary and cyclic work process was developed based on the software development in the spiral (figure 2). this model, widely used in software engineering for the development of prototypes, describes a continuous activity flow, which allows for improvements for each new expedition.16 the spiral method is similar to the pdsa (plan, do, study and act) method of continuous improvement, being chosen by the team involved in this study due to its familiarity with the method. the evolutionary cyclic work process is divided into 4 stages and ferreira, andrade, ramos, bernardes, calil: logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest j global clinical engineering vol.2 issue 2: 26-36 ; 2020 30 always restarts from the last expedition where problems relating to transportation, installation, operation, and maintenance are identified. in stage 1 the identified problems are classified into 3 groups: technological, operational, and environmental. after classification, each problem is analyzed, and possible solutions are proposed based on its classification in stage 2. the proposed solutions are evaluated and chosen according to their cost × benefit × effectiveness (stage 3). this decision is influenced by limited financial resources and voluntary labor. in stage 4, the chosen solutions are implemented and tested; if successful, they are incorporated into future expeditions. identification of problems found in expeditions according to the process presented previously, after each expedition, several problems are identified and registered for the improvement of future expeditions. problems may be related to some of the following: • technological factors: related to the limitations of technology, the technology not being designed to the environment where it is used, such as the type of the material used in the equipment, design (size, weight, etc.), or device circuits not being compatible to the quality of energy available.17 • environmental factors: related to the natural characteristics of the environment which impacts both the use16 or transportation of devices, such as temperature, humidity, and condensation. • operational factors: related to the use of the device, such as operational, installation, transport, assembly, and disassembly errors. different processes of study and analysis were used to propose solutions for problems previously presented. solutions to technologyand environment-related problems are proposed after studying device operation manuals and information from the manufacturer’s websites. this study aims to identify the technical characteristics of device functioning and which critical elements can be modified and which protective measures must be implemented. protective measures can be implemented by improving procedures. operational problems are studied after task analysis and solutions are implemented with improvement of work processes and by modifying actual device-related protocols. results in the first stage of the spiral cycle of evolutionary planning, problems were identified according to their characteristics. in table 1 it is possible to see the problems identified during a series of expeditions regarding the lack of documentation. this indicates the temporal relation between the cycle and the solution. figure 2. representation of the evolutionary planning cycle of expeditions. table 1. relation of problems identified according to characteristics technological factor problems break of the fairing of the external part, premature break of the optic fiber, breaking of connectors during disassembly, assembly errors, bad internal contacts, equipment without battery backups, and external damage to the manufacturer’s packaging. environmental factor problems fungi in lenses, oxidation of parts, equipment not working in ambient temperature, incompatibility of power grids, burned out equipment due to lightning, wet equipment, condensation due to excess humidity. 31 j global clinical engineering vol.2 issue 2: 26-36 ; 2020 ferreira, andrade, ramos, bernardes, calil: logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest in some cases, there was uncertainty about how to classify a problem. for example, an md that was damaged during transportation could have been classified as a technological problem for not being protected before being transported (technological) or as an operational problem for not being properly protected during transportation. table 2 presents solutions related to problems identified in table 1. improvements that were part of an operational problem solution are: 1.1 md selection: inclusion of required md specifications, assessment, and field tests. 1.2 md request to partners: increase in quantity of contingency equipment, accessories, and inputs. 1.3 owned mds stored: increase in quantity of strategic equipment (essential equipment for the operation of the fh or where there are loaning difficulties between the partners). 2.3 proper packaging: inclusion of provider’s packaging assessment. in some cases, the provider’s packaging is not the most appropriate for the type of transportation used for the fhs. for example, cardboard packages that come without plastic protection, pieces of equipment without any packaging, wooden boxes without proper protection against storms. 2.4 proper operation: inclusion of the testing criteria. 2.5 and 6.2 corrective maintenance: inclusion of criteria for selection of maintenance providers and beginning of in-house maintenance. 2.6 and 4.5 packaging: improvements in the processes and packaging of materials. some pieces of equipment have to be disassembled to fit standardized plastic boxes and for those which disassembly was not possible, waterproof wooden boxes with external protection were made with key locks and handles for manual transportation. at the bottom of the containers, 8 cm of foam is used to protect against impacts and water infiltration. internal protection is achieved with medium-density foams and bubble wrap. 3.1 and 4.6 proforma invoice: computerization in the process of packing lists with double checking and logistical team training in the computer system. 4.1 assembly: increase in instructions and assembly training, simplification of the assembly procedures, use of devices with only one option for assembly, and standardization of electrical outlets. 4.2 final tests: more detailed tests such as the use of an eye phantom and testing of the generators with all equipment on. 4.3 use of md: in loco instructions to users and infrastructure improvement for generators and electrical facilities, such improvement and standardization of power distribution boards, standardization of ac cables, exchange of single-phase generators with three-phase generators with automatic voltage control 4.4 disassembly: more training of staff on disassembly and improvement to disassembly instructions. operational factor problems operational errors, equipment lacking software configuration, lack of localization of accessories/errors in checklists, lack of contingency accessories, partner equipment not working (not previously tested), lost parts during transportation, damage during transportation (error in optical measurements). table 2. solutions presented according to problems identified technology-related solutions spare accessories, corrective maintenance, change to errorfree connectors, improvements in the process of corrective maintenance, acquisition of uninterruptible power supply and change to original packages. environment-related solutions change in preventive maintenance protocols, equipment climate control, equipment replacement, packaging improvement, avoiding taking equipment out of climatecontrolled areas, and implementation of lightning protection. operational solutions improvement of processes (below). ferreira, andrade, ramos, bernardes, calil: logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest j global clinical engineering vol.2 issue 2: 26-36 ; 2020 32 6.4 preventive maintenance and inspection: inclusion of annual preventive maintenance and obligatory inspection for every expedition. 6.5 partner md return: inclusion of the checklist of mds that are returned along with information of any intra-expedition failures. discussion it can be observed that the spiral method aided the improvement of the work processes involving the management of the mds, allowing the implementation of solutions for each new expedition cycle. however, each new proposed solution still needed to be evaluated before being added as part of the work process. and, due to the characteristics of the use of temporary fhs, this process of improvement can be very slow. one way to reduce the time needed to evaluate the proposed improvements is to apply the proposed enhancements in simulated environments. once validated and tested they can safely be applied in the new expeditions cycle. the use of methods for risk assessment and risk mitigation during the selection and analysis of the proposals can also accelerate the process of adopting the improvements. performing the risk analysis processes for the proposed improvements while taking into account the existing financial criteria of the expedition, the physical characteristics of the load (volume and weight), and the composition of the team at hand would considerably increase the success of the improvement proposals. still, some difficulties need to be assessed in each cycle, with the main difficulties being, scarce resources, continuous change of team members due to the voluntary nature of the work, and the continuous need for training, documentation, labeling, and warnings. a critical part of the actual work process is the simplified documentation of the meetings themselves and the execution of improvements. efforts have been made to improve the environmental conditions of the fhs, improve electrical generators, and use energy stabilizers for those more critical cases. conclusions the use of the spiral method has shown positive results in the improvement of the work process, mainly within the assessment stages for every expedition, the implementation of modifications, and the posterior assessment as a continuous improvement process. the ce action done outside the boundaries of the perennial health structure is necessary for environments where patients need healthcare, with the proper support of the technology available so that such care be provided with safety and efficacy. this support has been crucial in the attending of the isolated population in the hostile and isolated environment of the amazon forest. concerning the fh, the ce is responsible for transport planning and for providing the proper conditions for storage, transportation, installation, operation, and equipment disassembly, even in environments with low availability of resources. the planning related to md must be careful, for both supplies and accessories and also for necessary contingencies such as having a sufficient supply of replacement parts, spare pieces of equipment, and other equipment due to the geographical isolation. this isolation makes it difficult to search for solutions outside of the workplace. considering the unique characteristics of the fhs and the costs involved in the acquisition of specific mds for this implementation, equipment acquisition must include the equipment standardization criteria and a reduction of device volume and weight, without any reduction in functionality. this continuous improvement process is required because the variability found in remote sites in the amazon challenges both transportation and implementation of fhs. acknowledgement special thanks to eds: ricardo ferreira (president), marcia abdala (general manager), rogério ulbrich (field engineer), joão galdino (local engineer) and tiago rodrigues (field engineer). 33 j global clinical engineering vol.2 issue 2: 26-36 ; 2020 ferreira, andrade, ramos, bernardes, calil: logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest references 1. instituto sócio ambiental. população indígena no brasil how many are they? brasília, df; isa 2018. available at: https://pib.socioambiental.org/en/ how_many_are_they%3f 2. brasil, ministério da saúde, secretaria executiva subsecretaria de planejamento e orçamento. programa anual de saúde programação anual de saúde (pas) in: objetivo 05, 1th edition. brasília; 2018:17–20. 3. ribeiro aa, fortuna cm, arantes cis. nursing work in an indigenous support institution. texto contextoenfermagem 2015;24(1):138–45. 4. dsei-mg/es. modelo assistencial para a saúde indígena. brazil; 2004. avaliable at: http://sis. funasa. gov. br/portal/publicacoes/pub42. pdf. 5. rehder jr, neto hs, carvalho f, et al. prevalência e causas de cegueira e baixa de acuidade visual entre grupos indígenas da amazônia legal. arquivos médicos do abc 2014;25(2). 6. brazilian health expeditions. results. campinas, sp brazil; eds 2019. avaliable at: http://eds.org.br/ english/. 7. ferreira r. o engenheiro clínico 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clinical engineering vol.2 issue 2: 26-36 ; 2020 34 appendix examples of transportation in the rain forest 35 j global clinical engineering vol.2 issue 2: 26-36 ; 2020 ferreira, andrade, ramos, bernardes, calil: logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest equipment packaging examples field hospital ferreira, andrade, ramos, bernardes, calil: logistics of medical devices for indigenous health care attending in remote sites in the brazilian amazon rain forest j global clinical engineering vol.2 issue 2: 26-36 ; 2020 36 cataract surgery general surgery ec team rogerio ulbrich, joão galdino, ryan ferreira and tiago rodrigues 15 j global clinical engineering vol.2 issue 3: 2020 received march 15, 2020, accepted april 15, 2020, date of publication may 11, 2020 the accuracy and feasibility of skeletal muscle measured by semi-automatic three-dimensional mri voi method: a study using pig forelimbs by q. zhou, q. hu, x. yang, y. chen, y. yu, j. zhang, q. ma, g. zhou, h. wei, b. zhang, h. zhang department of radiology, the affiliated jiangning hospital of nanjing medical university, no.168, gushan road, nanjing, jiangsu province, china abstract background and objective: we aimed to assess and verify the measurement accuracy and feasibility of semi-automatic magnetic resonance imaging (mri) volume of interest (voi) method by comparing its measurements with actual skeletal muscle volumes and discuss the clinical significance. material and methods: a total of 18 muscles from 2 pigs were measured by drainage method, voi method (vvoi), the summation method (vsum), and maximum section method (vmax) respectively after mri scanning. all measurements were performed by 2 musculoskeletal radiologists and repeated at 6 different times, recording the consuming time (minutes) of every muscle. the average result of the 2 radiologists was adopted. results: the 3-d structure of the skeletal muscles was distinct and vivid. a friedman test and the inter-class correlation coefficient (icc) indicated the voi method had a high intraand inter-reliability. the root mean square error (rmse) over 6 timepoints was 1.101 ml. a bland-altman plot represented a superior consistency. pairwise mann–whitney u testing demonstrated that the consuming time to measure each muscle by voi method was short. conclusions: the voi method could semi-automatically display the 3-d reconstruct of the skeletal muscle clearly, conveniently, with a great accuracy, and high repeatability. keywords – magnetic resonance imaging; skeletal muscle; dimensional measurement accuracy; muscular atrophy; pigs. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction age-related degeneration and some diseases can change skeletal muscle volume,1,2 especially in the upper limbs.3 as the volume of muscle determines the maximal muscle force it can generate,4 upper limb muscle atrophy can lead to instability of the shoulder joint, causing secondary joint damage, physical disability, persistent arthralgia, and dysfunction.5–7 the volume of muscle is a predictor of poor outcomes, including mortality, disability, and poor quality of life.8 on the other hand, its morphological change is an important indicator for the development of competitive sports training programs, clinical evaluations, and research observation in orthopedics and sports medicine.9–11 given http://www.globalce.org http://globalce.org http://globalce.org zhou, hu, yang, chen, yu, j. zhang, ma, zhou, wei, b. zhang, h. zhang: semi-automatic 3-d reconstruction measurement of muscle volume with magnetic resonance imaging j global clinical engineering vol.2 issue 3: 2020 16 the above, quantifying these features of the upper limb is important for providing context for healthy aging, musculoskeletal disorders, and is a functioning indicator whenever they occur in old or young patients. magnetic resonance imaging (mri) plays an important role in evaluating muscle volume and displaying 3-d structure.12 previous studies have reported the mri 3-d reconstruction and volume measurement by delineating the contour manually.4,12–15 however, the manual operation was tedious and less reproducible. in methods such as deformation of a parametric specific object, the mean time for reconstruction was one hour.4 it has been reported that the volume of interest (voi) method, a semi-automatic measurement based on routine mri, can detect age-related degeneration and rotator cuff tear by measuring the deltoid muscle volume conveniently and directly.16 however, the accuracy and feasibility of the voi method had not been verified, especially when its measurements were compared to the actual muscle volumes. considering that it is unrealizable to compare the measurements with the actual muscle volumes of the living human body, the ethical problems and limited availability of cadaveric specimens rarely has research on human corpses been reported.17–19 nevertheless, an animal model can easily solve the ethical problems and frozen tissue inactivation,20 and swine have proven to be an excellent alternative for practicing and simulating surgical strategies that cannot be performed on human cadavers.21,22 therefore, the primary purpose of this study was to evaluate the accuracy and repeatability of mri voi method by comparing the data measured by voi with the actual forelimbs' muscle volumes of pigs. we hypothesized that the voi method was accurate and reliable for measuring skeletal muscle volumes, and could provide a convenient and non-invasive way for clinical evaluation of sarcopenia or in orthopedics and sports medicine. material and methods experimental subject the pig forelimbs for experiment 2 adult middle-aged female domestic pigs were bought from a pig farm where they were reared and slaughtered. the animal ethics committee was provided with a waiver by our research ethics board. the 2 left forelimbs were transported to our hospital and received an mri scan immediately after slaughtering. the period between slaughter and mri scan was approximately 40 minutes. freshness was maintained at 4° in transportation. we marked these 2 left forelimbs as pig forelimb 1 (pf 1, weight: 3.54kg) and pig forelimb 2 (pf 2, weight: 3.40kg). mri scan mri procedures were performed with a 3.0t mri scanner (ingenia, philips, eindhoven, the netherlands) using an16-channel torso coil. these 2 left forelimbs underwent the standard general clinical mri protocol at our institution. t1-weighted turbo spin echo (tse) imaging in the axial: repetition time (tr) = 627.0 ms, echo time (te) = 20 ms, slice thickness = 3 mm, interlamellar space = 0.3 mm, number of excitations = 1, matrix size = 464 × 459; field of view (fov) = 240 × 240 (mm), and the acquisition time of this sequence was 6 minutes and 24 seconds. drainage method after the mri scanning, the 2 left forelimbs were dissected immediately by 2 orthopedics doctors. nine muscles were dissected from each skeleton, including extensor carpi radialis/ulnaris (ecr/ecu), extensor digitorum communis (edc), flexor digitorum profundus caput humeral/ulnare (fdpch/fdpcu), flexor carpi radialis/ ulnaris (fcr/fcu), flexor digitorum superficialis (fds), and pronator teres (pt)23 care was taken to ensure the entire muscle was removed from the skeleton. after dissection, excess connective tissue, tendons and fat were removed from the entire muscle. a total of 18 muscles are shown in figure 1. the actual volumes (vact) of 18 muscles were measured by the drainage method. figure 2 shows the detailed process. vact was defined as the actual volume of the muscles. all readings were executed independently and high-resolution photos were taken horizontally by one of the musculoskeletal attending physicians. after the drainage test we checked the results with amplifying photos (figure 2c), if inconsistent, the ultima vact of muscle was determined by the high-resolution photos. 17 j global clinical engineering vol.2 issue 3: 2020 zhou, hu, yang, chen, yu, j. zhang, ma, zhou, wei, b. zhang, h. zhang: semi-automatic 3-d reconstruction measurement of muscle volume with magnetic resonance imaging segmentation principle of the voi method a semi-automatic method to measure the muscle was applied (voi method software umr_770, united imaging healthcare, shanghai, china), which was still investigational. the algorithmic steps of the volume calculating method are presented in a compact form by the following: a. given the contours in slices that had been delineated, contours in intermediate slices were calculated using shaped-based interpolation to maintain continuous transition. 1. calculate the mask from the contour in slices and specify 1 inside the contour, while 0 outside. 2. convert the mask into a gray-value image through a distance function.24 3. estimate the contour in intermediate slices by interpolating the distance-representing gray-value slices and thresholding at zero.25 b. a horizontal scan line algorithm is applied to calculate the internal area of the contour. for each scan line: 1. find the intersections of the scan line with all edges of the polygon. 2. sort the intersections by increasing x coordinate. 3. find all pixels between pairs of intersections. as the calculation of intersections was slow, edge coherence was considered to avoid unnecessary calculation, therefore active edge table was adopted to store active edges related to the current scanline. the contour brings some ambiguity inevitably on whether the pixels should be treated as the interior of the polygon or not. our criteria are that only pixels whose centers are interior to the polygon are counted. therefore, the maximum error equals +/– the circumference of the contour multiplied by (largest pixel dimension) 2/2. to raise measurement accuracy, gui (graphical user interface) and images are zoomed in to diminish ambiguousness. c. the total areas were an accumulation of the areas in each slice. the volume equals the product of the accumulated area and the distance between the 2 slices’ center. the volume of a voi was the product of the spacing (normally the distance between 2 slices’ center) and the accumulated area of the voi projected in each slice. image processing by voi method the axial t1-weighted tse images of the 2 left forelimbs were passed to the local workstation, then the voi method software was performed to reconstruct the skeletal muscle morphology of the pig forelimb and the volume of each muscle was individually measured semi-automatically. one figure 1. a total of 18 muscles were placed on the operating table. the 9 muscles of the pf1 were displayed in the upper row, and the lower row placed the muscles of the pf2. ecr = extensor carpi radialis; edc = extensor digitorum communis; ecu = extensor carpi ulnaris; fdpch = flexor digitorum profundus caput humerale; fdpcu = flexor digitorum profundus caput ulnare; fcu = flexor carpi ulnaris; fds = flexor digitorum superficialis; fcr = flexor carpi radialis; pt = pronator teres; pf 1 = pig forelimb 1; pf 2 = pig forelimb 2. figure 2. a. water was placed in a custom-made cylinder, waiting until the water does not flow out. b. the pronator teres was put into the cylinder cautiously and a small-scale graduated cylinder was used to measure the volume of water flowing from the cylinder. c. the lowest scale of the crescent was read horizontally and a high-resolution photo was taken to record the scale. the actual volume of pronator teres was 20.2 mm3. zhou, hu, yang, chen, yu, j. zhang, ma, zhou, wei, b. zhang, h. zhang: semi-automatic 3-d reconstruction measurement of muscle volume with magnetic resonance imaging j global clinical engineering vol.2 issue 3: 2020 18 musculoskeletal attending physician and one musculoskeletal associate chief physician respectively identified every skeletal muscle and contour of the muscle. only the first/ last slice, as well as the slice where the morphogenesis changes need to be delineated manually. the 3-d shape of every muscle was reconstructed and the volume was output automatically. the 2 operators repeated the above image processing 6 times every few days and recorded the entire process time (minutes). the average volume measured by these operators were taken as the result of the voi method volume (vvoi). volume measurement by conventional method two musculoskeletal physicians measured all the 18 muscles by the conventional method in picture archiving and communication system. the summation method volume (vsum) showed the individual slice volumes, and is shown in equation 1. the maximum section method volume (vmax) was the largest interface to calculate the volume is shown in equation 2. where α was the area per slice, αmax was the area of the maximum section, l was the slice thickness, ⅈ was the interlamellar space, and n was the number of slices. repeated measuring 6 times at different times, record the measurements and the consuming time (minutes) of every muscle, adopt the average of the 2 physicians as the result. statistical analysis measurement data that conforms to a normal distribution were reported as mean ± standard deviation if not median was adopted. the intra-reliability in different time points were evaluated by friedman test and inter-class correlation coefficient (icc) was employed to evaluate the reliability of measurements between the 2 physicians. a kruskal-wallis h test was performed to compare the volumes and consume times in different measurement methods. root mean square error (rmse) was expressed as the difference between the 3 methods and the actual value. a bland-altman plot was applied to the data to display the distribution of measurements by various methods. a p value < 0.05 was considered statistically significant. statistical analyses were performed with spss software version 21.0 (international business machines corporation, chicago illinois, united states) and r program 3.5.0 with calculation of a two-sided p value. all graphics were created using graphpad prism version 5.00 for windows (graphpad software, san diego california, united states). results 3-d reconstruction the morphological structure and 3-d configuration of pig forelimbs from the reconstruction of mri voi method was distinct and vivid (figure 3), with a high-resolution and was consistent with the known anatomy. measurement repeatability verification a total of 18 pig forelimb muscles were measured 6 times by 2 physicians using the mri voi method (table 1 and table 2). a friedman test showed the mean rank of all the 6 measurements had no statistical difference (χ2 = 1.396, p = 0.925; χ2 = 9.38, p = 0.095, respectively), so there was a good reproducibility at different time points for one observer. the icc value calculated from the mean measurement over all time points for each observer was close to 1 (icc=0.999, 95% ci: 0.998~1.000). the above results indicated that the mri voi method demonstrated a high intraand inter-reliability and good repeatability of volume measurements. equation 1 equation 2 figure 3. a. the morphological structure and 3-d configuration of pig forelimbs from the reconstruction of mri voi method was distinct and vivid. b. the cross-section images displayed different muscles using different colors and their volumes showed up automatically. 19 j global clinical engineering vol.2 issue 3: 2020 zhou, hu, yang, chen, yu, j. zhang, ma, zhou, wei, b. zhang, h. zhang: semi-automatic 3-d reconstruction measurement of muscle volume with magnetic resonance imaging comparison of measurement accuracy the volumes of 18 muscles measured by drainage method, mri voi method and the other 2 conventional methods were shown in table 3 (the results were the mean measurement of 6 times by 2 observers). the mean rank table 1. the volumes of 18 muscles measured using voi method 6 times by one musculoskeletal attending physician and the results of a friedman test muscles volumes (pf 1/pf 2, mm3) mean χ2 p value 1 2 3 4 5 6 ecr 123.3/132.6 125.6/130.4 120.8/132.3 125.5/136.5 124.7/134.4 124.9/131.8 124.13/133.0 1.396 0.925 edc 82.7/88.2 81.5/89.6 84.7/89.2 81.4/92.1 83.8/90.5 80.1/88.4 82.36/89.67 ecu 12.5/13.7 11.6/13.2 12.3/12.8 13.8/12.84 12.8/13.2 12.9/13.7 12.65/13.24 fdpch 63.57/79.2 63.5/78.6 62.4/82.3 66.7/81.4 62.2/83.5 64.8/79.5 63.86/80.75 fdpcu 12.8/15.2 12.6/15.3 11.5/15.8 12.6/15.0 13.5/14.9 13.7/15.7 12.78/15.32 fcu 9.5/13 9.8/13.2 10.8/12.4 10.4/13.6 10.6/13.3 10.9/12.9 10.33/13.07 fds 65.9/60.7 62.8/59.3 64.6/61.3 66.3/59.4 62.6/59.6 64.2/59.1 64.40/59.90 fcr 13.8/16.9 14.2/16.4 15.6/16.7 13.8/15.4 15.3/15.9 13.5/15.7 14.36/16.16 pt 17.7/24.6 18.1/24.7 19.5/24.1 18.7/23.4 19.6/24.3 18.2/25.1 18.63/24.37 ecr = extensor carpi radialis; edc = extensor digitorum communis; ecu = extensor carpi ulnaris; fdpch = flexor digitorum profundus caput humerale; fdpcu = flexor digitorum profundus caput ulnare; fcu = flexor carpi ulnaris; fds = flexor digitorum superficialis; fcr = flexor carpi radialis; pt = pronator teres; pf 1 = pig forelimb 1; pf 2 = pig forelimb 2. table 2. the volumes of 18 muscles measured using voi method 6 times by one musculoskeletal associate chief physician and the results of a friedman test muscles volumes (pf 1/pf 2, mm3) mean χ2 p value 1 2 3 4 5 6 ecr 124.6/130.8 125.8/131.6 125.3/135.4 122.7/133.66 125.1/134.5 124.6/134.8 124.96/133.45 9.38 0.095 edc 84.6/87.6 86.7/88.7 87.2/86.5 86.9/88.4 85.3/88.9 84.6/89.3 85.95/88.23 ecu 12.6/12.4 12.7/12.7 12.4/10.0 12.3/11.9 11.9/12.4 13.2/11.9 12.53/11.88 fdpch 66.2/77.7 65.4/78.3 67.8/79.31 66.9/78.4 64.8/77.3 65.5/78.3 65.92/78.22 fdpcu 13.7/15.6 14.6/15.3 14.5/16.71 13.8/14.5 14.2/15.8 13.4/16.2 13.95/15.69 fcu 10.9/12.5 10.6/12.4 10.7/13.55 11.3/11.7 10.8/12.2 10.9/11.9 11.25/12.38 fds 61.9/58.3 62.4/58.4 63.2/61.25 62.8/57.3 61.6/57.6 62.4/57.7 62.42/58.43 fcr 14.8/16.9 15.2/16.8 15.3/15.88 14.7/16.3 15.7/16.5 15.6/16.5 15.28/16.48 pt 18.5/24.4 19.3/24.6 18.4/22.74 19.2/24.5 18.5/23.8 18.6/24.3 18.93/24.06 ecr = extensor carpi radialis; edc = extensor digitorum communis; ecu = extensor carpi ulnaris; fdpch = flexor digitorum profundus caput humerale; fdpcu = flexor digitorum profundus caput ulnare; fcu = flexor carpi ulnaris; fds = flexor digitorum superficialis; fcr = flexor carpi radialis; pt = pronator teres; pf 1 = pig forelimb 1; pf 2 = pig forelimb 2. of the 3 methods with kruskal-wallis h test were 28.50, 29.06, and 24.94 respectively, χ2 was 0.724, p value was 0.696, so no statistical difference existed among the 3 methods. zhou, hu, yang, chen, yu, j. zhang, ma, zhou, wei, b. zhang, h. zhang: semi-automatic 3-d reconstruction measurement of muscle volume with magnetic resonance imaging j global clinical engineering vol.2 issue 3: 2020 20 rmse of 3 methods in 6 time points was 1.101 ml, 1.523 ml, and 8.99 ml respectively. the rmse between vvoi and vact was the smallest of all, less than the rmse of vsum and vact or the rmse of vmax and vact. these data showed the voi method has the highest accuracy while the maximum section method with the lowest accuracy. bland-altman plot represented the minimum bias of −0.2219 between vvoi and vact (the other 2 were −0.5424 and 5.2162), equivalent to a superior consistency (figure 4). table 3. the average volumes of 18 muscles measured by three methods and its actual value volume (mm3) pf 1 pf 2 vact vvoi vsum vmax vact vvoi vsum vmax ecr 124.0 124.545 125.80 98.91 133.0 133.225 137.23 111.35 edc 85.0 84.155 83.17 77.27 89.0 88.95 88.96 74.52 ecu 13.0 12.59 12.62 11.34 11.5 12.56 11.12 10.54 fdpch 65.0 64.89 66.95 63.50 78.0 79.485 78.79 72.26 fdpcu 13.2 13.365 14.13 10.52 15.6 15.505 15.25 14.70 fcu 11.6 10.79 10.56 8.94 10.4 12.725 13.45 10.58 fds 61.5 63.41 60.98 62.28 57.5 59.165 57.93 53.10 fcr 16.4 14.82 16.43 16.11 16.0 16.32 16.66 12.92 pt 20.2 18.78 20.10 18.25 24.6 24.215 25.14 24.57 ecr = extensor carpi radialis; edc = extensor digitorum communis; ecu = extensor carpi ulnaris; fdpch = flexor digitorum profundus caput humerale; fdpcu = flexor digitorum profundus caput ulnare; fcu = flexor carpi ulnaris; fds = flexor digitorum superficialis; fcr = flexor carpi radialis; pt = pronator teres; pf 1 = pig forelimb 1; pf 2 = pig forelimb 2. figure 4. a bland-altman plot showed a comparison of the consistency of vvoi, vsum and vmax to vact. the bias between vvoi and vact was −0.2219, equivalent to a superior consistency. vvoi = the volume of mri voi method; vsum = the volume of the summation method; vmax = the volume of the maximum section method; md = mean value. measurement consumption time the median consuming time to measure each muscle by the mri voi method, summation method, and the maximum section method was 1.07, 12.68 and 1.25 minutes respectively. the consume time of the 3 methods exhibited significant differences by kruskal-wallis h test. pairwise mann–whitney u test and p value adjustment by fdr method exhibited the summation method taken the 21 j global clinical engineering vol.2 issue 3: 2020 zhou, hu, yang, chen, yu, j. zhang, ma, zhou, wei, b. zhang, h. zhang: semi-automatic 3-d reconstruction measurement of muscle volume with magnetic resonance imaging longest time (p = 0.00061), nevertheless, mri voi method and the maximum section method had no statistical difference (p = 0.2692). discussion the current examination for evaluating skeletal muscle volumes, includes bioimpedance analysis (bia), ultrasound, dual-energy x-ray absorptiometry (dxa), computed tomography (ct), and mri.26–30 nevertheless, mri has become the optimal method because of its non-invasiveness, high soft-tissue resolution, and 3-d configuration which could observe the morphological structure clearly and animatedly.4,31 in our study, the mri voi method was semi-automatic, merely to identify the interesting muscle and contour the enthesis of the muscle and slightly adjusted if the morphology was irregular. the internal slices were measured and delineated by the computer automatically based on the signal intensity, and the organization loss of the internal slices was compensated through interpolation calculation. its segmentation speed was rapid, and the median consume time to measure each muscle in this study was 1.07 minutes, which was much shorter than the summation method volume (1.07 minutes vs. 12.68 minutes, p < 0.001). for another, the pick-up algorithm of voi method was not only based on the interaction and transformation detecting techniques, but also the visual characteristics. it was seldom influenced by the image noise, so the method could be performed on conventional mri images and does not require high-resolution scanning, which would have a wider application. in this study 2 physicians completed the process independently 6 times, the friedman test and icc showed a high intraand inter-reliability, and a good repeatability of volume measurements. what's more, compared with the summation method and the maximum section method, the voi method has the smallest rmse, which approximated to the actual values (rmse of 3 methods was 1.101 ml, 1.523 ml, and 8.99 ml respectively). the innovation of this research was that the accuracy of voi method measurements was verified with the true muscle, which was more intuitive and credible. as the morphology and volume of the pig forelimb is similar to humans, using pig forelimbs in place of intravital human limbs could solve any ethical problems and reduce research costs.1 in the drainage method, several high-resolution photos were taken horizontally and rechecked by 2 observers (the photos were amplified and viewed repeatedly), which was conducive to collate the readings, ensure the results more veritably, and avoid errors. this current study has some limitations that should be considered. first, the sample capacity was low. only 2 left forelimbs (18 skeletal muscles) from 2 live domestic pigs were included in the study, although each method was measured 6 times using 3 methods. second, although the pig forelimbs were similar in shape and nomenclature to the human upper limbs, there were some differences inevitably. third, at present the voi method software was still semi-automatic, in the future, an automatic component analysis through artificial intelligence will be realized, which could reduce the working hours greatly. conclusion in summary, the 3-d reconstructs of mri voi method semi-automatically was used to display the morphological 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meschi t, narici mv, lauretani f, maggio m. muscle ultrasound and sarcopenia in older individuals: a clinical perspective. j am med dir assoc 2017;18(4):290–300. available at: https://www.ncbi. nlm.nih.gov/pubmed/28202349 27. mueller n, murthy s, tainter cr, et al. can sarcopenia quantified by ultrasound of the rectus femoris muscle predict adverse outcome of surgical intensive care unit patients as well as frailty? a prospective, observational cohort study. ann surg 2016;264(6):1116–24. available at: https://www.ncbi.nlm.nih.gov/pubmed/26655919 28. minetto ma, caresio c, menapace t, et al. ultrasound-based detection of low muscle mass for diagnosis of sarcopenia in older adults. pm r 2016;8(5):453–62. available at: https://www.ncbi.nlm.nih.gov/pubmed/26431809 29. kim ey, kim ys, park i, et al. evaluation of sarcopenia in small-cell lung cancer patients by routine chest ct. support care cancer 2016;24(11):4721–6. available at: https://www.ncbi.nlm.nih.gov/pubmed/27364150 30. lee js, kim ys, kim ey, jin w. prognostic significance of ct-determined sarcopenia in patients with advanced gastric cancer. plos one 2018;13(8):e0202700. available at: https://www.ncbi.nlm.nih.gov/pubmed/30125312 31. matsumura n, oguro s, okuda s, et al. quantitative assessment of fatty infiltration and muscle volume of the rotator cuff muscles using 3-dimensional 2-point dixon magnetic resonance imaging. j shoulder elbow surg 2017;26(10):e309–e18. available at: https:// www.ncbi.nlm.nih.gov/pubmed/28495576 author biographies qing-qing zhou received a master’s degree in radiology with nanjing medical university, nanjing, china, in 2018. she is currently a radiologist working in the radiology department of the affiliated jiangning hospital of nanjing medical university. research interests include deep learning in skeletal muscle system and its applications. j global clinical engineering vol.5 issue 1: 2022 18 received april 14, 2021, accepted may 18, 2022, date of publication may 23, 2022 application of the ahp method in prioritizing the criteria for the selection of calibration services provider by marcelo a. marciano1, anderson alves do santos2, william k. souza2 1 moinhos de vento hospital/clinical and hospital engineering coordination, porto alegre, brasil 2 moinhos de vento hospital/clinical engineering, porto alegre, brasil abstract schoosing the best instruments, measurement techniques and the most qualified service provider is of paramount importance for an equipment calibration service. for the definition of the most qualified company, selection criteria and weights related to the criteria will be used. thus, the main objective of this work is to choose the best service provider, that is, the most qualified to perform the calibration services of medical and hospital equipment, considering the listed criteria. the method used was ahp (analytic hierarchy process). it makes it possible to prioritize, give weight and validate the consistency of the evaluation criteria (considering the importance and relevance). as a result, the validation of the criteria weights was obtained. the company that obtained the best score was the company hired for the service. keywords – medical equipment, calibration, selection service provider, ahp method. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org 19 j global clinical engineering vol.5 issue 1: 2022 marciano, alves do santos, souza : application of the ahp method in prioritizing the criteria for the selection of calibration services provider introduction the calibration of equipment, that is, the comparison of biomedical/physiological quantities measured or provided by biomedical equipment, compared to a standard, provide each equipment's errors. an internal team can calibrate biomedical equipment, provided qualified, with defined calibration procedures, appropriate instruments, traceability, etc. when calibration is performed by a third-party service provider, it is appropriate to perform a calibration process, with defined criteria.1 enable the validation of the consistency of weights and measurements of the selection criteria. contribute in such a way that the best qualified company performs the calibration services of the equipment. maximizing patient safety. one of the known methods is the ahp (analytic hierarchy process) method,2 which makes it possible to prioritize, give weight and validate the consistency of the evaluation criteria (considering the importance and relevance).3 scb associates4 proposes a model to validate the consistency of the weights assigned to each requirement evaluated. it is possible to use a scale with paired views of evaluation parameters to assess the degree of importance.5 the main objective of this work is to choose the best service provider company, that is, the most qualified to perform medical-hospital equipment calibration services. considering that the selection criteria and their weights will serve as a reference to choosing the company that obtains the best score, the specific objectives are: to prioritize, give weight and validate the consistency of the evaluation criteria (considering the importance and relevance) for the selection of service providers of calibration of medicalhospital equipment.   method the method used was the ahp,2 which allows prioritizing the evaluation criteria (considering the importance and relevance). the model provided by scb associates,4 to validate the consistency of the weights assigned to each requirement evaluated. the following (fig. 1) demonstrates the fundamental scale, with nine classifications of importance used in this model. the initial weights for each criterion were defined by a specialized clinical engineering group composed of professionals with training of various academic levels and professional experiences of up to 25 years in the area. with expertise in calibration laboratory and calibration services. quality national and international certifications. as well as knowledge of norms related to the subject. a spreadsheet was sent with the 14 evaluation criteria for each service provider who participated in the selection to obtain the answers. results the matrix (figure 2) below demonstrates the degree of importance given, according to a fundamental scale (as shown in figure 1), in the paired comparations of 14 evaluation parameters. the consistency index achieved with the method was 7% (figure 3), indicating a good weight distribution.6 then, considering the response of the service providers to the selection criteria, the specialized group of clinical engineering, listed the notes to each of the companies (figure 4) so that it was possible to obtain the answer of which service provider was the best to perform the calibration of medical equipment.7 figure 1. the schematic diagram of dental units. j global clinical engineering vol.5 issue 1: 2022 20 marciano, alves do santos, souza : application of the ahp method in prioritizing the criteria for the selection of calibration services provider discussion it is important to highlight that it is necessary to evaluate and select the calibration service providers of biomedical equipment. the ahp methodology for the listed evaluation criteria was shown to be consistent. however, there can always be points to be improved and new versions to be proposed and tested, from this model. or considering other models. conclusion the ahp methodology proved to be adherent and assisted in the selection protocol of a calibration service provider. that is, it helped validate the weights of the criteria listed to evaluate the quality of the provider. thus, it contributed to hiring the most qualified company to perform the calibration services of biomedical equipment, considering the criteria listed. the application of this method improved the evaluation process and choice of the provider, impartially increasing confidence and comprehensiveness. considering that the equipment park is dynamic, each year changes with new approaches and technologies. given the above, it can be observed that the implemented proposition of improving this selection process was successfully achieved. references 1. critérios de seleção de serviços de calibração de equipamentos eletromédicos. marciano, marcelo antunes; santos, anderson alves. xv congresso brasileiro de engenharia biomédica, 2016. foz do iguaçu, paraná, brasil. 2. saaty tl (1980). the analytic hierarchy process. n. york, usa: mcgraw-hill. 3. saaty tl (2005). theory and applications of the analytic network process. decision making with benefits, opportunities, costs, and risks. pittsburgh, usa: rws. 4. scb associates ltd. barnard s. et al. (2012). processo de hierarquia analítica, ahp” planilha “ahp template scbuk.xls. disponível em: http://www.scbuk.com/ ahp.html. acessado em: 26/06/2019. figure 2. model provided by scb associates.4 figure 3. consistency index achieved with the method. figure 4. supplier's notes for each criterion. http://www.scbuk.com/ahp.html http://www.scbuk.com/ahp.html 21 j global clinical engineering vol.5 issue 1: 2022 marciano, alves do santos, souza : application of the ahp method in prioritizing the criteria for the selection of calibration services provider 5. marins fas, et al. (2010). métodos de tomada de decisão com múltiplos critérios. aplicações na indústria aeroespacial. s. paulo: blucher. 6. sloane eb. using a decision support system tool for healthcare technology assessments. ieee engineering in medicine and biology magazine 2004; may/ june:44-55. 7. hajdau c and spiridonica a. ahp — based weighting of criteria for medical equipment selection," 2015 e-health and bioengineering conference (ehb), iasi 2015; 1-5. doi: 10.1109/ehb.2015.7391519 1 j global clinical engineering, special issue 3, 2020 editor’s corner yesterday i was visiting my friend who manages one of the largest rental medical equipment company in the us. he told me that a customer desperately called him from a small town in the state of louisiana and begged for two mechanical ventilators for a local healthcare facility. the customer, a local medical equipment supplier, told my friend that he has been calling everywhere for days but so far came up without one. then, when my friend told him that he could immediately ship him the ventilators, the last two that the clinical engineers at his lab just serviced, this customer started to cry from happiness knowing that a couple more patients will be cared for. the pride and mission-accomplished look on the face of the clinical engineering staff standing next to me, silently listening to the story, was clear. they knew that their important job impacts and help real people, real patients in critical need. clinical engineering professionals from around the world, like many other professionals nowadays, are struggling with their feelings of being overwhelmed, navigating changing ambiguities, and of having such a burden of a life-critical mission. their mission, managing technology that now focuses on attending to the support of urgent safe patient care, is challenged by the loss of regular (or normal) access to supply chain sources. just a few weeks ago they could so simply and easily obtain medical equipment, disposable accessories, spare parts, manuals, and even qualified personal. now, they search for personal protective gear, for rental or refurbished devices, seek newly released guidance on how to disinfect devices, and understand the impact of the latest regulatory changes. simultaneously, they also have to deal with the sudden arrival of new inventory containing never-seen-before equipment for converting non-care locations into patient care isolation areas. all the while every country is trying to get a handle on what kind and how many medical devices are out there. we all share the challenges, but on top of that, we also see firsthand the loss of lives and the growing worries of the virus-contracted patient’s families, old and young alike. these are unprecedented times; these are not normal times and special measures are being deployed daily. in january, just 10 weeks ago, i was part of a group of colleagues who initiated a coronavirus call for action in response to emergency requests for assistance from our clinical engineering colleagues in china. three weeks ago, i was helping to gain access to coronavirus testing kits coming from china to the us. how quickly the world turns and how little we were prepared. everywhere, plans and processes are changing. it is critical that in such times, clinical engineers will be served by rapid and reliable news and updates. the internet contains many stories, and some are true and factual. but who has the time or knowledge to verify the source? not when you are so committed, as our clinical engineering readers are, to deliver the most optimal and safe technology possible that our healthcare system needs. we cannot afford the time to sift through all these postings. but figure. engineering technician, rocky, perform the final test on a ventilator before placing her signature on the tag that states – patient ready. http://www.globalce.org http://www.globalce.org j global clinical engineering, special issue 3, 2020 2 these professionals are in constant need for up-to-date and reliable information that will help them to speed the construction of health isolation facilities, the conversion of hospital bed areas into isolated patient areas, the testing and servicing of medical products arriving in their facilities for the first time, and locating manuals, accessories, integration tools, and user information. significant help is coming now in the form of the new ifmbe/clinical engineering division curated and daily updated social media site hacking covid19, you can register at http://eepurl.com/gxoqlz. this is one of the reasons that the global clinical engineering journal has committed to quickly assemble and publish a special issue of the journal on technology, engineering, and healthcare services that focus on improving our chances in the fight over the covid-19 pandemic. we have a target to get this done in two months’ time. we are committed to do whatever we can to help our readers learned from colleagues who have been through this fight. through the collection, reviewing, and publishing of a series of manuscripts about healthcare facility operation during this covid-19 pandemic from china, italy, the usa, and other localities we hope that our field will advance and be better prepared for future challenges. the sharing of lessons learned will no doubt contribute to the improvement of patient-care services everywhere. i am calling on every member practicing in our filed to commit to write diaries of what is taking place at their jobs and submit their stories so that the rest of us can learn from them. as i write this message, the combined effects of new capabilities and rapid information, along with virtual telehealthcare and 3-d printing have pushed us into territory that requires more evidence-based validation and professional engagement. if you do not believe that new products or services are being delivered with recognized and acceptable risks, you should sound the alarm. we, at the global ce journal, are working closely with ifmbe/ced on updating and expanding training and on resource sharing initiatives that will help you be successful in your career and fulfill patients’ expectations of our profession. on behalf of all the patients in the world, i thank the silent heroes who manage and service one of the most important building blocks of modern healthcare delivery. we care about your families not less than you care for our patients! stay healthy and safe. together we can do it better! dr. yadin david copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org http://eepurl.com/gxoqlz j global clinical engineering, special issue 2, 20191 proceedings iii icehtmc 2019 editor’s corner dear 3rd icehtmc congress participants, on behalf of the organizers and sponsors of the 3rd international clinical engineering and health technology management congress (icehtmc) it is our honor to offer this publication that contains all of the accepted abstracts for the oral and poster sessions. with the amazing support from the scientific program committee, consisting of several dozen reviewers from all over the world, all the submissions were subjected to strict peer review and the event has broken all previous ce congresses’ records for quality and quantity. major recognition must be given to the italian clinical engineers association (aiic) and ifmbe/clinical engineering division (ced) for hosting and collaborating on the organization of this event and for engaging early on practitioners around the world to respond to the call for papers and vendors to exhibit their ware. this is also the first time that the congress’s proceedings are published and available in print and on-line (globalce.org). the global clinical engineering journal’s commitment to the promotion and sharing of knowledge is evident by committing to and the timely accomplishment of this major task. rome, italy is a unique location to engage in professional development, networking, meeting friends, enjoy italian cuisine, and visit historic sites. we wish you success and hope that you will take advantage of all of these opportunities to carrying with you many special life-long memories from rome. yadin david together we can make it better! ciao a tutti e buon lavoro! editor-in-chief of globalce journal stefano bergamasco chair iii icehtmc globalce.org 9 j global clinical engineering issue 1:9-23; 2018 received april 22, 2018, accepted september 9, 2018, date of publication october 13, 2018 spin-off use of adverse events data: why and how. the case of fda’s maude by p malataras1 and n pallikarakis2 1university of patras 2institute of biomedical technology, inbit abstract objectives: this paper attempts to measure the impact of the second stage exploitation of fda’s maude database on patient safety, technology assessment and other scientific fields. methods: five bibliographic databases have been queried with the terms “manufacturer and user facility device experience database” and “fda and maude”. a number of eligibility criteria where applied on the results, which led to a final group of 117 papers. an extensive study of these publications resulted to a number of interesting findings. results: the results concern the evolution of the database exploitation over time, and are examined according to the device groups that the identified papers are referring to, the research goals of these papers, the reasons that led the authors of these papers to use maude data and finally how these data were used within their research methodology. conclusions: patient safety and technology assessment are two of the scientific fields on which maude database has the greatest impact. on average, more than 10 peer-reviewed papers each year involve maude data as a mean to reach their research goals. this proves that maude is an exploitable and valuable data source for research in these scientific fields. keywords – medical devices, maude, adverse events reports, patient safety, health technology assessment. introduction patient safety, health technology assessment and medical device vigilance are fields that heavily rely on data availability. they need valid data from various sources in order to extract useful information. a significant source of data for medical devices (mds) appears to come from the medical devices vigilance and post-market surveillance mechanisms that are imposed by the relevant regulatory systems, in most part of the world. the food and drug administration (fda) manufacturer and user facility device experience (maude) database is such a source. millions of medical devices are used today in various places (hospitals, clinics, houses, etc.) and thousands of new models enter the market every year. undoubtedly these mds have a significant contribution to the improvement of the healthcare services provided. however, medical technology, like any other technology, is not risk free. there are numerous cases where devices have been recalled because of their involvement in adverse incidents compromising patients’ health or cases where a “promising” innovative approach has to be withdrawn after a http://www.globalce.org malataras and pallikarakis: spin-off use of adverse events data: why and how. the case of fda’s maude j global clinical engineering issue 1:9-23; 2018 10 relatively short period of use, because it is not proven as safe as expected.1, 2, 3, 4 the largest mds markets today (usa, eu, japan, etc.) are ruled by regulatory frameworks (regulations, laws, directives, guidelines) according to which a medical device has to comply with specific safety provisions in order to enter these markets5, 6. one safety requirement, common to all these frameworks, is the adverse event reporting system or vigilance system that follows the medium and high risk devices, after they have entered the market, in parallel with the post-market surveillance.5, 6, 7 a mds vigilance reporting system aims to increase patient safety by preventing the recurrence of reported adverse events. this is achieved by mandating users and manufacturers of medical devices to report to the health authorities, incidents where a medical device contributes to an adverse event. according to this mechanism, whenever a medical device is potentially contibuted in a death or injury of a patient or user, the manufacturer has to report this event and assess if corrective actions should be taken. in parallel, a user reporting system encourages users to report to the manufacture and/or to authorities any such incident that comes to their attention. the principal purpose of the medical devices vigilance and user reporting systems is to improve the safety of patients, users and others, by reducing the likelihood of reoccurrence of a similar event elsewhere in the future. this is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such incidents. usa is the biggest medical device market8, 9 and fda, as the relevant organization for market surveillance, is also responsible for medical devices vigilance. fda has implemented since the 1990s a database called manufacturer and user facility device experience database10 for reporting of medical devices related with adverse events. nowadays, this database receives more than 800.000 reports annually.11 today, maude contains more than 4 million medical device reports (mdrs)11 of suspected device-associated deaths, serious injuries and malfunctions as well as other non-conformities such as packaging and labelling problems, unsterilized delivery etc. maude contains mdrs filed by manufacturers and importers from august 1996 to present, all mandatory user facility reports from 1991 to present and voluntary reports filed after june 199312. a portion of the database is open to the public, providing valuable information on mds safety. it is accessible through the fda’s website (www.fda.gov) and can be queried through a search form. in addition, all main datasets are provided to the public as text files importable to common databases. after an evaluation process, the high volume mdrs or the ones involved with a death are investigated by fda and in many cases this investigation leads to corrective actions, with obvious benefits for the safety of both patients and users. at a second stage, this huge amount of data appears to be a valuable source for further research. retrospective analysis studies, data extraction techniques and other scientific use of these data, offer spin-off benefits to patient safety, medical device technology assessment and other scientific fields13, 14. this study attempts to measure quantitatively and qualitatively the second stage exploitation of maude and the impact of this exploitation on scientific research. materials and methods five international bibliographic databases (sciencedirect, journals@ovid full text, pubmed, web of science and scopus) have been queried with the terms “manufacturer and user facility device experience database” and “fda and maude” in order to find all publications that contain these terms. the databases were queried in january 2015. the results of these queries were consolidated through the removal of duplicates, which led to an initial number of 1.016 unique publications. (the results from each database appear in table 1). this set of results was filtered according to the publication type, language and publication time so as to keep only peer-reviewed papers, written in english, from 2005 to 2014. books, editorials, commentaries, letters, comments on a paper, publications in conference proceedings, etc., were excluded from the final selection. after filtration, 381 scientific papers remained. the next step was to extract out of these 381 papers the ones that have used directly data from maude. this table 1. bibliographic search results bibliographic database maude and fda “manufacturer and user facility device experience database” sciencedirect 322a 269 journals@ovid full text 196a 175 pubmed 54 42 web of science 49 41 scopus 209a 322 total (without duplicates) 631 604 a the search has been performed with proximity indicators (maude w/10 fda) or (maude adj10 fda) www.fda.gov malataras and pallikarakis: spin-off use of adverse events data: why and how. the case of fda’s maude 11 j global clinical engineering issue 1:9-23; 2018 unsterilized delivery etc. maude contains mdrs filed by manufacturers and importers from august 1996 to present, all mandatory user facility reports from 1991 to present and voluntary reports filed after june 199312. a portion of the database is open to the public, providing valuable information on mds safety. it is accessible through the fda’s website (www.fda.gov) and can be queried through a search form. in addition, all main datasets are provided to the public as text files importable to common databases. after an evaluation process, the high volume mdrs or the ones involved with a death are investigated by fda and in many cases this investigation leads to corrective actions, with obvious benefits for the safety of both patients and users. at a second stage, this huge amount of data appears to be a valuable source for further research. retrospective analysis studies, data extraction techniques and other scientific use of these data, offer spin-off benefits to patient safety, medical device technology assessment and other scientific fields13, 14. this study attempts to measure quantitatively and qualitatively the second stage exploitation of maude and the impact of this exploitation on scientific research. materials and methods five international bibliographic databases (sciencedirect, journals@ovid full text, pubmed, web of science and scopus) have been queried with the terms “manufacturer and user facility device experience database” and “fda and maude” in order to find all publications that contain these terms. the databases were queried in january 2015. the results of these queries were consolidated through the removal of duplicates, which led to an initial number of 1.016 unique publications. (the results from each database appear in table 1). this set of results was filtered according to the publication type, language and publication time so as to keep only peer-reviewed papers, written in english, from 2005 to 2014. books, editorials, commentaries, letters, comments on a paper, publications in conference proceedings, etc., were excluded from the final selection. after filtration, 381 scientific papers remained. the next step was to extract out of these 381 papers the ones that have used directly data from maude. this table 1. bibliographic search results bibliographic database maude and fda “manufacturer and user facility device experience database” sciencedirect 322a 269 journals@ovid full text 196a 175 pubmed 54 42 web of science 49 41 scopus 209a 322 total (without duplicates) 631 604 a the search has been performed with proximity indicators (maude w/10 fda) or (maude adj10 fda) selection led to a final group of 117 papers. among these papers, there were 4 where the authors searched the maude database but the results were found to be irrelevant to this work. however, these 4 papers were decided to be included in the final group because, although they finally did not use any data from maude, they took into consideration the content of the database. the list of 117 papers appears in the reference section (ref: 14-25, 28, 31, 33-135). it should be mentioned that among the 264 excluded papers, more than 50 referred to maude data, but this reference was either limited to a single comment about one or two cases or indirect, using the results of other papers that had used the original data. the last step was to study again in more detail the final group of these 117 papers, focusing on the device groups that these papers referred to, the evolution of the database exploitation with time, the research goals of these papers, the reasons that led the authors of these papers to use maude data, how they finally used these data within their research methodology, etc. the flowchart for the query methodology is shown in figure 1. the bibliographic search results were processed initially with the mendeley desktop references management software and later with microsoft excel. sciencedirect (322+269) journals@ov id full text (196+175) web of science (49+41) pubmed (54+42) scopus (631+604) unique publications (1.016) eligibility criteria (publication time, language and type) (635) paper examined (381) out of scope (264) final set (117) results the analysis of the final set of 117 papers revealed the following: a) since maude is a database containing mdrs, each record is related with a medical device. hence retrieval of data for the second stage usage is also related with medical devices. the analysis carried out identified the device groups that were used as a reference in the papers. these device groups were grouped, where applicable, into more generic device categories. it should be mentioned that although 24 papers were focused exclusively on a device type rather than on a group as a whole, only the device group was considered for the purposes of this analysis. figure 1. prisma flow chart for fda maude system search table 2. number of papers per device group cardiology devices 29 stents 9 implantable cardioverter-defibrillators 7 vena cava filters 6 automated external defibrillators 2 angioplasty catheters 1 arterial closure devices 1 catheter introducing sheaths 1 catheters 1 vascular closure systems 1 www.fda.gov malataras and pallikarakis: spin-off use of adverse events data: why and how. the case of fda’s maude j global clinical engineering issue 1:9-23; 2018 12 according to the analysis performed, the general category of cardiology devices was the most frequently referred (29 papers), while implantable devices (22 papers) and endoscopy devices (14 papers) were the next ones. as regards the device groups, stents (9 papers), implantable cardioverter-defibrillators (7 papers), meshes (6 papers), vena cava filters (6 papers), septal occluders (4 papers), and cochlear implants (4 papers) were the leaders. finally, there were 8 papers that have not been included in this part of the analysis, since they used a implantable devices 22 meshes 6 septal occluders 4 cochlear implants 4 bmp2 protein 3 breast implants 1 cerebrospinal fluid valves 1 heart valves 1 silicone-polyurethane copolymers 1 spinal cord stimulator 1 endoscopy devices 14 endoscopy-general 4 endometrial ablation devices 3 endoscopic stapling 1 ercp 1 gastrointestinal endoscopy 1 microwave endometrial ablation 1 mucosal ablation devices 1 radiofrequency ablation 1 various 1 laparoscopy devices 6 hem-o-lok 3 laparoscopic morcellator 1 laparoscopic trocar 1 various 1 infusion devices -pumps 5 infusion devices 2 insulin pumps 2 infusion pumps 1 prosthesis 4 artificial discs 1 hip prosthesis 1 lumbar total discs 1 shoulder prosthesis 1 robot assisted surgery 4 transcervical sterilization 4 patient-controlled analgesia 3 stone extraction balloons and baskets 2 stone baskets 1 stone extraction balloons and baskets 1 extracorporeal oxygenation 2 extracorporeal membrane oxygenation 1 oxygenator 1 lasers – general 2 cosmetic laser 1 lasers 1 ambulance stretcher 1 bed rails 1 breast pumps 1 contact lenses 1 ethylene vinyl alcohol copolymer 1 feeding tubes 1 glucose monitors 1 mri 1 operating microscopes 1 peritoneal dialysis 1 piggybacks 1 tanning units 1 papers referring to various device groups 8 malataras and pallikarakis: spin-off use of adverse events data: why and how. the case of fda’s maude 13 j global clinical engineering issue 1:9-23; 2018 combination of data related with various device groups. the number of papers classified under each group is presented in table 2. b) as regards the publication time of these papers, 2014, 2012 and 2007 were the years with the most published papers (19, 17 and 14 papers respectively). the linear trend line shows that the number of papers that used the maude data increases with time (slope =0.6). (figure 2) c) although it was difficult and maybe risky to summarize and classify the research objectives of papers covering various scientific areas and subjects, into a few generic objectives’ categories, such an attempt was made in order to outline the research orientation of the papers that use data from the maude database. the most common objectives among these papers were “to review/identify the reported adverse events/complications related with a device group or type” (31 papers), “to evaluate adverse events” (22), “to evaluate design characteristics of a device group or type” (15 papers), “to explain why these events occur” (14 papers), and “to overview a medical technology and/or its performance” (10 papers). table 3 presents the results of this analysis. figure 2. number of papers published each year. table 3. research objectives papers’ objectives number of papers example of objective to review/identify reported adverse events/ complications 31 to collate world reports of adverse events (aes) resulting from lasers used in urology15 to evaluate adverse events/complications 22 to raise awareness of the potential hazard of auricular burns associated with operating microscope use during otologic surgery16 to examine/evaluate design characteristics of a medical device 15 we sought to determine if perforation rates are related to cannula design17 to explain why specific adverse events/ complications occur 14 this study was undertaken to analyze bleeding problems with tension-free vaginal tape (tvt) operations18 to overview a medical technology and/or its performance 10 this study sought to determine whether infusion device event logs could support accident investigation19 to assess the frequency and/or severity of adverse events/complications 8 the purpose of this study is to use large databases to assess the frequency and severity of such complications and compare them with those of surgical atrial septal defect closure20 to evaluate/test a method or a hypothesis 7 the aim of this article is to evaluate a new system and procedure, dedicated to oxygenator change-out21 to review a new technology/procedure 7 this document will review the biliary and pancreatic stone extraction devices that are currently commercially available in the united states22 to discuss regulatory issues 2 the present analysis aimed to compare the 510(k) and pma approvals and recalls on the basis of the number of devices approved in each group23 to estimate cost 1 to estimate the rates and costs of intravenous patient-controlled analgesia (iv pca) errors from the hospital or integrated health system perspective24 malataras and pallikarakis: spin-off use of adverse events data: why and how. the case of fda’s maude j global clinical engineering issue 1:9-23; 2018 14 d) equally difficult was the attempt to examine and classify the purpose for which the maude data were used within those papers. the findings of this analysis were similar with the findings of the analysis of the papers’ objectives. in brief, the main reasons for the use of maude data was “to summarize or review adverse events” (53 papers) as well as “to explain why these events occur” (42 papers). additionally, it was found that 36 papers dealt with the evaluation of adverse events or complications, and 32 papers provided directly suggestions for patient safety measures. finally, it should be noted that in each paper these data could have been used for more than one purpose. all the findings of this analysis are presented in table 4. discussion the final number of 117 papers that were found to have used maude data cannot be considered as covering the whole spectrum of the respective research activities. the actual range of maude data usage must be considered even greater if it is taken into account that among the publications that were excluded by the present study, there were many papers that a) refer to a unique case from maude, b) use partially or complementarily data from it or c) refer to other papers based on maude data analysis. in addition, it was also found that there were many other kinds of publications, such as books, editorials, and publications in conference proceedings, which were used on maude data. the device groups that the papers focused on were mainly cardiology devices (stents and implantable cardioverter-defibrillator), implantable devices (meshes and cochlear implants), endoscopy and laparoscopy devices. it is surprising that high risk device groups that are used widely in hospitals, such as respirators, anesthesia machines, ecg, etc., were not among the devices of this list. one possible reason for this fact is that the researchers have directed their attention to devices that had entered the market within or near the period under examination (drug eluted stents, robot assisted surgery, transcervical sterilization, etc.) or to device groups containing products which have been involved in serious recalls (stents, occluders, cardioverter, defibrillators etc.)1. the number of papers that use data from maude appears to increase with time, having a time trend with a rate of 0.6 (figure 1). it is expected that in the near future the second stage exploitation of maude data will further increase given that fda makes a constant effort to improve the quality of data and their accessibility (unique device identifier, total product life cycle, open fda etc.)2, 3, 11 25, 26 in combination with the fact that new or improved management and analysis techniques of big data emerge. table 4. purposes of maude data use the maude data have been used: number of papers to summarize the adverse events related with a device group or type 53 to explain why specific adverse events occur 42 to evaluate adverse events or complications 36 to suggest patient safety measures 32 to assess a device group or type 30 to estimate how frequent is the occurrence of an adverse event or to calculate trends 30 to assess the safety of a technology or of a medical procedure 24 to assess the severity of adverse events/complications 15 malataras and pallikarakis: spin-off use of adverse events data: why and how. the case of fda’s maude 15 j global clinical engineering issue 1:9-23; 2018 the examination of the papers’ research objectives clearly shows that the majority of the papers under consideration contributes directly or indirectly to patient safety by reviewing or summarizing the adverse events/ complications related with a specific device group or type (31 papers), by evaluating adverse events/complications (22 papers), by explaining why these events occur (15 papers) or by assessing the frequency or severity of adverse events (8 papers). additionally, the contribution to technology assessment is also significant through the evaluation of the devices’ design characteristics (14 papers), the overview of a medical technology and its performance (10 papers) and the review of new technology and/or medical procedures (7 papers). finally, the papers in question have a contribution in other fields too. for example, 7 papers used maude data in order to test or evaluate a method and 2 papers discussed the regulatory issues for medical devices. the fact that the maude database is a useful source for patient safety purposes is further supported by the examination of the manner in which these data are used in the papers. it was found that maude data have been used among others to summarize the adverse events related to a device or a medical procedure, to explain why adverse events occur and to suggest specific measures. the ultimate goal of the above-mentioned uses was to inform the medical community as well as md designers and manufactures about the problems that could arise, the likelihood for them to occur, the underlying mechanisms that lead to these complications, the ways to avoid or to deal with these events and the measures to eliminate their consequences. besides, maude appears to be a useful tool as regards technology assessment too, since its data have been used in order to assess the use of medical technologies and medical devices, as well as to estimate the risk of the utilization of a device or procedure. it is also worth mentioning that from this analysis, it was found that 14 of the papers used the maude database as a source in order to test or evaluate a method, a procedure or a hypothesis. for example, maude data were used to evaluate the role of human factors in acute care equipment decisions27 and to examine whether the log files could assist in an accident investigation19. during the papers’ analysis, other useful information was also gathered, pertaining to research limitations inserted by the use of maude data as well as to the quality and integrity of these data. in many papers it is mentioned that the maude data and the use of adverse event reports data in general, inserted certain limitations dealing with the reporting rate and the denominator issue28. as regards the reporting rate, there is a general belief that not only adverse events are under-reported but there is also a lack of information about the ratio representing the number of adverse events reported versus the number of real events that have occurred. similarly, there is a lack of baseline numbers (e.g. total number of surgical procedures relevant to a product, total number of specific devices used, etc.) that could be used as denominators. both these limitations make the data unsuitable for determining rates29, 30. moreover, there was criticism as regards the consistence and quality of the maude data. some researchers have doubts about their quality, stating that the data provided by fda are not structured in a common way, are not complete and their accuracy is debatable, thus obstructing the analysis procedures. others commented that the information and degree of detail contained within these reports are highly variable, making interpretation of the reports difficult and causality often uncertain29, 31. during the period 2005-2014, maude data could be searched either by an online search form provided by the fdas’ web site or by downloading them in txt formatted files. the majority of the studies have used the online search form. there were only a few that have used the maude data provided in txt format. this is probably because the insertion of these txt files into a relational database is not an easy task given the amount of data (some tables have more than 3 million rows) and because the txt files need some technical preparatory actions in order to be ready for insertion. it is expected that the openfda web site (https://open.fda.gov/) which provides capabilities for easier and more comprehensive access to the data in addition with the further use of the database with contemporary big data analysis tools or data mining techniques will lead to a more intense exploitation of maude database. https://open.fda.gov/ malataras and pallikarakis: spin-off use of adverse events data: why and how. the case of fda’s maude j global clinical engineering issue 1:9-23; 2018 16 finally, it is worth mentioning the positive impact of the transparency of maude database comparing it with the european databank on medical devices (eudamed). in the eu, legislative changes imposed stricter and more detailed monitoring and enforcement requirements for both notified bodies and national competent authorities, in response to increasing safety concerns. recently, the enforcement of a more rigorous new legislation in the form of two regulations136, 137 has been voted by the european parliament. the use of the european databank on medical devices (eudamed), containing regulatory information on mds available on the eu market, including recalls, is also reinforced. however, regarding the eu user reporting system for medical devices adverse events, there is not an overall collection of the reports submitted to the national competent authorities. this is due to the decentralised structure of the eu regulatory system, in combination with the fact that there is no provision for a centralised collection into the eudamed. additionally, the eu policy that does not allow the public access to all these data, including the recalls, prohibits their analysis by independent researchers. a research comparing the impact of the transparency of eu vigilance system with the one of fda for the period 2004-2015, found that there are no papers or reports, even from a central eu body, based on the eudamed data138. however it is a fact that eudamed can provide similar information. as an example, bliznakov et.al139 performed a survey on medical device recalls, concerning only devices using software, based on fda data for the period 1995-2002. it was found that about 25% of the recalls studied, were caused by software failures. as might be expected, the proportion of these recalls due to software problems increased, from 17% in 1995 to 34% in 2002. follow up studies140, 141 revealed that this proportion went up to 40% in year 2012. these authors, performed in parallel a survey on recalls caused by software failures using eudamed data, and found very similar results. unfortunately, those results could not be published due to the restrictions on the use of eudamed data. conclusions fda provides public access to a portion of its postmarket surveillance database, thus allowing researchers outside fda to carry out analyses and studies based on the raw data, with a consequent spin-off benefit for public health. the fact that, in spite of the limitations, more than 10 peer-reviewed papers each year use maude data shows that maude is an exploitable and valuable data source. according to the analysis of the papers, maude database is used mainly for research works related to patient safety and technology assessment compared to other scientific areas. it is also observed that the maude data are mainly used to evaluate devices that are relatively new to the market, or to investigate issues related with these devices. additionally, it was found that maude is a useful data source when it is required to summarize adverse events related with a device as well as when the reasons that could lead to an adverse event have to be examined. finally, maude data exploitation increases with time and is expected to be even more intensive in the future. undoubtedly, there are improvements that could increase the exploitation of maude database. however, despite limitations, restrictions and criticism, it is a common conclusion among the majority of the papers studied, that the maude database is a useful and valuable tool for patient safety and technology assessment. the benefits resulting from the maude use should be taken into consideration by the eu, so as to move in the direction of enhancing and improving the data collection procedures from the vigilance system as well as to increase the transparency of eudamed as explicitly stated in the regulations136, 137: “..vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding medical devices should be introduced, to improve health and safety … the objectives of the database are to enhance overall transparency, including through better access to information for the public and healthcare professionals …”. additionally individual researchers should be allowed to have access to relevant data, in order to be able to perform similar studies that significantly contribute to equipment improvement and patient safety. et.al malataras and pallikarakis: spin-off use of adverse events data: why and how. the case of fda’s maude 17 j global clinical engineering issue 1:9-23; 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(eds) xiv mediterranean conference on medical and biological engineering and computing 2016. ifmbe proceedings, vol 57. pp 1061-1065, springer, cham 139. bliznakov z, stavrianou k, pallikarakis n. medical devices recalls analysis focusing on software failures during the last decade. ifmbe proc. 2014;41:1174–7. 140. pallikarakis n. medical devices software. in: proceedings of the medical device software workshop, ec joint research centre, ispra, italy. 2003. 141. bliznakov z, mitalas g, pallikarakis n. analysis and classification of medical device recalls. in: world congress on 5 j global clinical engineering vol.4 issue 2: 2021 received december 26, 2020, accepted april 19, 2021, date of publication may 25, 2021 compilation about adverse events recorded in fda/usa and anvisa/brazil databases through models available in the literature concerning analysis and prioritization of actions for medical devices by j. carlos de souza, s. mehrpour, m. m. ferreira, y. l. coelho, g. de castro vivas, d. d. rodriguez, f. de assis santos. t. f. bastos-filho federal university of espírito santo, vitória, espírito santo, brazil abstract the development and application of medical technologies have grown steadily in all health fields, offering numerous benefits to users. however, adverse events, which may cause severe consequences for patients, also have increased. technical and human factors that provoke dangers are related to the complexity of the devices, quality control in manufacturing, software, maintenance procedures, materials, and mode of use. this work aims to present the main alerts, dangers, and failures and some ways to mitigate them related to the following medical devices: defibrillators, infusion pumps, physiological monitors, pulmonary ventilators, and ultrasonic scalpels. for that, we performed an analysis of adverse events reported in the food and drug administration (fda/usa) and the brazilian health surveillance agency (anvisa) databases since 2016. finally, we classified the events into different categories, according to their similarity. the results show a total of 3,100 cases registered in the fda for the six types of medical devices addressed in this work and 75 cases registered in the anvisa/brazil for two of them. based on the top ten health hazards provided by ecri (2016-2020), this work contributes to understanding the most significant hazards of the previously mentioned devices and the main ways to mitigate these risks. throughout our research, we found that the risks addressed in this work are common to several medical devices; therefore, there preventative measures to avoid them must be established, for example, training users to use and maintain the equipment, improving their quality, and also reporting adverse events to manufacturers. keywords – adverse events, anvisa, ecri, fda, medical devices, manufacturing, training, maintenance. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.4 issue 2: 2021 6 carlos de souza, mehrpour, ferreira, coelho, de castro vivas, rodriguez, de assis santos. bastos-filho: compilation about adverse events recorded in fda/usa and anvisa/brazil databases through models available in the literature concerning analysis and prioritization of actions for medical devices introduction according to the world health organization (who), a medical device is an “apparatus, instrument, machine, software, material or another similar article, intended for a medical purpose” as monitor treatments, help people with disabilities, diagnose and treat illnesses¹. in the current covid-19 pandemic, measures of prevention and control of health services have been defined by the brazilian association of clinical engineering, whose guidelines include checking the configuration and availability of intensive care unit (icu) beds and their primary devices: mechanical ventilator, multi-parameter monitor, defibrillator, and infusion pumps, noting the need for staff training to use them. in addition, it is also necessary to identify defective or unused equipment due to a lack of parts or inadequate maintenance.² in this sense, clinical engineers play an essential role in managing fundamental medical devices for treating patients affected by the disease.³ despite the importance and benefits of medical equipment in health care, adverse events are also associated with them. in brazil, the national health surveillance agency (anvisa) classifies adverse events like health problems caused to the patient by a device subject to a health surveillance regime, even used under recommendation from the manufacturer.4 these events can occur because the medical device environment is a complex system of human-machine interaction that requires understanding the environment and identify risk factors.5 every year, the food and drug administration (fda/ usa) receives many thousand reports of suspected medical device-associated injuries, deaths, and malfunctions.6 the fda uses these reports to detect potentially related safety issues, monitor device performance, and contribute to benefit-risk assessments of these products.7 since 1991, fda has received more than 4.4 million adverse event reports.8 in addition, the ecri/usa publishes the annual top ten of health hazards that assist in understanding risks in health procedures worldwide. this work addresses risks associated with six pieces of equipment commonly used in icus. the first is the automated external defibrillator (aed, non-wearable), which uses external electrodes to analyze the patient’s electrocardiogram (ecg) and automatically deliver an electrical shock to treat ventricular fibrillation on victims of sudden cardiac arrest.9 the second, direct-current defibrillator (low energy), delivers an electrical shock of up to 360j through paddles placed either directly across the heart or on the surface of the body, which is used for restoring normal heart rhythm in pediatric defibrillation or cardiac surgery.10,11 the third piece of equipment is the infusion pump (ip), which perfuses medications or nutrients to the patient at a controlled amount; a health professional programs the rate and duration of fluid delivery using the equipment’s software.5,12 fourth is the physiological monitor (pm), which is a device connected to the patient, able to identify clinical emergencies when vital signs like heart rate, blood pressure, and oxygenation exceed preset thresholds; in this case, alarms are activated.13 the fifth is the pulmonary ventilator (pv), which involves a breathing tube placed in the patient’s windpipe, connected to the mechanical ventilator, which delivers oxygenated air.14 pv is used during surgeries or treatment for lung disease, essential to treat respiratory failure caused by covid-19. sixth is the ultrasonic scalpel (us), which generates harmonic vibrations in a metal rod that denatures proteins, cuts tissues, and coagulates them simultaneously.15 unfortunately, there are harms associated with the use of these medical devices. estimates from 2008 to 2017 have shown alarming results: defective medical devices may have caused more than 1.7 million injured patients and approximately 83000 deaths worldwide.16 these data denote the importance of identifying types of failures, hazards, and their causes, as what can be done to reduce them. thus, this work aims to present the main alerts, dangers, and failures related to the use of pv, ip, aed, dc-defibrillator, pm, and the us. this overview of their main events can guide users for their most appropriate management and best practices when using these medical devices. methods the ecri’s top ten health technology hazards ranked annually (from 2016 to 2020) have guided our research 7 j global clinical engineering vol.4 issue 2: 2021 carlos de souza, mehrpour, ferreira, coelho, de castro vivas, rodriguez, de assis santos. bastos-filho: compilation about adverse events recorded in fda/usa and anvisa/brazil databases through models available in the literature concerning analysis and prioritization of actions for medical devices regarding the types of equipment that most offer danger to patients and the main ways to mitigate them. on the other hand, a review of documents published (since 2016) by fda/usa and anvisa/brazil was also analyzed here, which report adverse events related to medical equipment. several papers from the literature about that subject were analyzed too in our research. the fda database contains medical device reports submitted by mandatory reporters, manufacturers, importers, and facilities, in addition to voluntary reports by consumers, health care professionals, and patients.7 the medical devices addressed in our research (aed non-wearable and dc-defibrillator low energy; ip; non-continuous pv; pm without arrhythmia detection or alarms; and the us) were searched in the fda database within the period from january 1st, 2016 to april 30th, 2020. the cases from the fda were classified into six categories defined in this study, which are shown in table 3. it is worth mentioning that only reports of death and injuries for these devices were considered. the information found on the anvisa databases is shown in table 4. the searches for pv and aed were conducted considering the same period, and the alerts found were classified into three categories. results main causes of failures in medical devices in their historical development, medical devices have an increasing degree of complexity, with the development of new components and materials. this complexity impacted the maintenance and performance of the devices and their reliability,17 which is directly related to the increased failure rate (fig. 1). the analysis of contributing factors in the appearance of faults demonstrates that causes are varied. tables 1 and 2 respectively show the classification of incidents according to studies by amoore using ecri database and shepherd.18,19 in these tables, aspects as “device” are repeated, including manufacturing, materials, and maintenance. another common factor is the “user” or “operator,” i.e., ignorance, inadequate technical training, and staff negligence.17 figure 1. reliability conditioned by technical complexity17 table 1. ecri classification of medical device incidents17 device 1) human factor design 2) parts design unexpected failure 3) deterioration failure that requires preventive maintenance (e.g., battery) operator 1) training and use error 2) diverted attention 3) criminal intent facility 1) human factor design 2) parts design; unexpected failure 3) deterioration that requires preventive maintenance 4) maintenance error patient 1) active patient action affected the outcome 2) patient’s condition affected the outcome table 2. shepherd’s classification of medical device incidents17 device 1) design error 2) device or accessory failure 3) improper maintenance / testing / modification 4) manufacturing error user 1) device miss-assembly 2) failure in pre-use inspections 3) improper connection 4) improper reliance on an automated feature 5) incorrect clinical use and control settings external 1) electromagnetic or radiofrequency interference 2) power supplies (including gas) support system failures 1) error in hospital policy 2) failure to train 3) improper storage 4) lack of competent accident investigation 5) poor pre-purchase evaluation j global clinical engineering vol.4 issue 2: 2021 8 carlos de souza, mehrpour, ferreira, coelho, de castro vivas, rodriguez, de assis santos. bastos-filho: compilation about adverse events recorded in fda/usa and anvisa/brazil databases through models available in the literature concerning analysis and prioritization of actions for medical devices in the scientific literature, it is possible to identify models such as the swiss cheese, proposed by orlandella and reason, which allow understanding the system failures, which arise when protection measures are overcome (fig. 2).20 in that model, the human aspect is highlighted, which occurs when the error originates from inadequate actions from health personnel due to fatigue, stress, inattention, and negligence. regarding the system, it is possible to standardize the security measures taken from design, quality control, safety testing, maintenance throughout the life cycle, and adequate user training. each aspect is equivalent to a cheese layer, representing barriers to errors and present fragilities. therefore, it is crucial to scientifically determine which layers are involved in medical device failures and ensure that these “cheese holes” are not aligned, creating problems.17 another model is pareto analysis, which shows that many failures occur in critical devices, being possible to determine the causes, allowing focusing professional attention on the most relevant situations and corrective actions. this model showed that misuse, lack of maintenance, and use by untrained personnel are the leading causes of medical equipment failures.17 both models contain promising elements, which were applied in our research, detailed in the sections that follow. fda adverse events the data in table 3 shows adverse events related to devices of general clinical use (with important application in icus), such as the equipment addressed in our research: pm, ip, aed, and pv. in addition, table 3 also shows the us equipment used in surgical procedures. several cases were reported in the usa, totaling 3,100 events between 2016 and 2020. the highlights are the equipment aed and ip, which have 1,382 and more than 1,424 reports. the pv, us, and pm have, in that order, 187, 60, and 40 cases, respectively, whereas the dc-defibrillator has only 7 cases. the aed presented 831 cases of operating issues associated with malfunction and shock problems and problems in defibrillation and alarm errors. for this equipment, 77 cases were related to monitoring problems with incorrect messages, and 58 cases of assembly or structural defects due to the defective connection and impedance problems. cases of incorrect procedures were 59 due to inappropriate actions that lead to burns. hazards were 20 events of shock and burn to nurses and physicians. finally, unknown reasons were 337 events. regarding the dc-defibrillator, which is activated manually, the seven cases were related to device operating issues generated by inappropriate shock. all events were related to severe cases, with four deaths and three injuries (fig. 3). for ip, we analyzed a total of 1,424 events related to injury and death. most of them were related to device operating issues (913) due to stop working and failure to deliver medication. still, flow obstruction and alarm error were also reported. the assembly or structural defects had 124 cases reported due to the component disconnection and broken devices. the monitoring problems, with 30 cases, occurred due to incorrect messages on display. unknown reasons were 306 events. pv covers 187 events, with 73 being device operating issues that correspond to airway pressure and oxygen saturation defects. the 65 hazard cases were linked to loss of smell sense and respiratory distress. assembly or structural defects were 43 cases related to broken pieces, connection of tubing problems, and inadequate humidification. the pm comprised 40 cases, ten device operating issues related to alarm problems, software, and electronic motherboard problems. incorrect procedures were due to inadequate or insufficient training. seventeen monitoring problems were due to inappropriate electrocardiograms and incorrect display messages. the us had 60 cases, 43 due to device operating issues linked to failure to cut, malfunction during surgery, and energy output problems. the remaining cases were divided into assembly or structural defects and hazards, with 10 and 7 cases, respectively, including disconnecting components and fragmented material. figure 2. the swiss cheese model for events occurrence20 9 j global clinical engineering vol.4 issue 2: 2021 carlos de souza, mehrpour, ferreira, coelho, de castro vivas, rodriguez, de assis santos. bastos-filho: compilation about adverse events recorded in fda/usa and anvisa/brazil databases through models available in the literature concerning analysis and prioritization of actions for medical devices the fda’s adverse events are again shown in fig. 3, but in this case, separating death and injury provoked by the device. again, the data are alarming for aed, with 892 deaths and 490 injuries related to events. ip has 424 deaths and more than 1,000 injury cases. injuries were also more common than death for pv, pm, and the us. anvisa adverse events the data from anvisa/brazil is restricted to national and international events with medical devices used in brazil. the search on this public agency official page offers gross values, often unrelated to the device. thus, we identified 38 alerts for pv and 37 alerts for aed (table 4). pv presents most cases of device operating issues, totaling 26. of these, 24 are related to display and oxygen sensor failure, incorrect ventilation, and stop working; and two cases were caused by problems with equipment alarm, such as sound-related problems. the assembly or structural defects were eight cases due to lack of soldering on the plate, leading to loss of power and short circuit interrupting the ventilation. manipulation or installation problems (four cases) occurred due to problems in the power panel of the ventilators. for this type of device, three alerts contained records of death and 11 cases of patient hypoxia, which could cause sequelae and lead to death. aed presented 29 cases of operational problems, such as electric shock error, cable failure, attenuated discharge in defibrillation, and alarm error, which could lead to death and injury of the patient. for assembly or structural defects, there were 8 cases of battery drainage and component failures. table 3. adverse events reported in fda databases during january 1st 2016 to april 30th 2020(1). medical devices assembly or structural defects device operating issues hazards incorrect procedures monitoring problems unknown reasons total aed (non-wearable) 58 (4%) 831 (60%) 20 (1%) 59 (5%) 77 (6%) 337 (24%) 1,382 dc-defibrillator 7 (100%) 7 ip 124 (9%) 913 (64%) 10 (1%) 41 (3%) 30 (2%) 306 (21%) 1,424+ (1) pm 10 (25%) 10 (25%) 3 (7,5%) 17 (42,5%) 40 pv 43 (23%) 73 (39%) 65 (35%) 6 (3%) 187 us 10 (17%) 43 (72%) 7 (11%) 60 total 235 1877 112 103 130 643 3,100 figure 3. graph of death and injury found in fda referring to table 3(1) (1) considering up to 1,000 cases for ip related to injuries and all 424 cases related to death table 4. adverse events reported in the anvisa/brazil databases during january 1st 2016 to april 30th 2020. medical devices device operating issues assembly or structural defects manipulation or installation problems total pv 26 (68%) 8 (21%) 4 (11%) 38 aed 29 (78%) 8 (22%) 37 total 55 16 4 75 j global clinical engineering vol.4 issue 2: 2021 10 carlos de souza, mehrpour, ferreira, coelho, de castro vivas, rodriguez, de assis santos. bastos-filho: compilation about adverse events recorded in fda/usa and anvisa/brazil databases through models available in the literature concerning analysis and prioritization of actions for medical devices top ten health hazards of the ecri the ecri is a nonprofit organization, which develops guidance for improving the safety and quality of care across all healthcare environments worldwide. every year they produce a report of the top 10 health technology hazards, whose items represent hazards that managing technologies can minimize. ecri’s engineers, scientists, and clinicians select topics based on insight gained through investigating, testing, observing operations, reviewing the literature, and speaking with clinicians, clinical engineers, administrators, and device suppliers.21-25 comparing our results to ecri lists, we noticed a convergence regarding problems and errors presented by the six devices evaluated. devices alarm problems were present in all five lists considered. for pv and ip, alarm malfunction, overload, and loss of alarms could induce severe consequences in patients. infusion errors appear in the 2017 and 2019 lists. problems with device operation by the medical team were listed in 2016 and 2019; however, many other cases were related to inadequate procedures.21-25 regarding device cleaning, alerts were on the five lists due to patient infection or technical problems arising from incorrect cleaning. structural problems appeared in 2020 (such as the risk of loose nuts and bolts to device failures) and 2019 (about device battery charging defects). from 2017 to 2020, cybersecurity risks were emphasized due to system exploitation by hackers, causing health care disruption.21-25 discussion nowadays, practically all health specialties need modern technologies, going beyond health establishments to patients’ homes. however, the risk of adverse events concerning these technologies is growing rapidly. these events can result from a single cause or the simultaneous occurrence of several factors, with the clinical team generally being held responsible. however, we identified several causes to be considered in all processes: the choice of technology, proper installation, technical maintenance throughout the life cycle, and correct use in relation to the patient. the results shown in tables 3 and 4 suggest high reliability. however, it is worth commenting that in this sense, table 3 shows adverse events recorded at the fda/usa whereas table 4 presents alerts from anvisa/brazil. the hazard for patients occurs when: an alarm condition is not detected by a medical device (such as ip, pm, or pv); the condition is detected but not communicated to a staff member, or the condition is communicated but not appropriately addressed.20 regarding the pv, injuries occur mainly in the respiratory tract because the patient depends on this equipment for ventilation. errors in the air supply, if not rectified, can lead to damage like hypoxic brain or lung injury and death, as shown in some records in this study. these devices have alarms that indicate inadequate ventilation, so proper configuration is needed. however, the challenge is to manage the alarms, which are usually missed due to alarm fatigue (when the team is overloaded), lack of sound sensitivity, or failure in the notification of alarms, in which they are not effectively communicated to staff.26 other factors contributing to the inadequate ventilation implementation include insufficient knowledge of the best practices for ventilation and ventilator functionality.21 healthcare facilities need policies on setting ventilator alarms and protocols for verifying components. in addition, too often, lung-protective strategies and advanced ventilator tools are not commonly used, and best practices are not adopted.22,24 mitigate these problems by verifying that all staff members dealing with mechanical ventilation have a good understanding of how these devices work.21 pm is used in physiological monitoring. the improper customization of the alarms could make it more difficult for the operator to understand changes in the patient’s physiological conditions or problems with the device. these systems must be configured not to act too many alarms or too few alarms, as this involves settings based on the needs of a care area and the patient’s condition. in addition, establishing policies and educating staff about optimal alarm-customization practices can help reduce the risks of loss sounds and harm to the patient.13,24,27 11 j global clinical engineering vol.4 issue 2: 2021 carlos de souza, mehrpour, ferreira, coelho, de castro vivas, rodriguez, de assis santos. bastos-filho: compilation about adverse events recorded in fda/usa and anvisa/brazil databases through models available in the literature concerning analysis and prioritization of actions for medical devices a total of 424 deaths and up to 1,000 injuries (fig. 3) related to ip were recorded in this study. the incorrect programming procedure performed by the medical team occurs even with smart pumps that have a dose error reduction system. in this case, the patient can receive either too much or too little solution. the complex programming display and the absence of procedures to verify the programming can contribute to these errors. thus, the surest way to eliminate them is to use auto and double-checks programming. still, the staff needs to notice signs of damage to the ip components to guarantee the correct flow of medication.22,24 the aed has high values of death and injury, respectively 892 and 490 cases in fda. the relationship to the death of patients undergoing resuscitation is mainly linked to the operational failure of the device, for example, not providing an adequate charge or discharge. successful defibrillation depends on delivering the shock to the myocardium, as the longer brain and heart are deprived of oxygen, the more damage suffers.10,11 the us is reported to be quick for the cutting and coagulation of tissue.28 studies claim the benefits of this equipment, including allowing faster and safe surgical procedures.29 however, the alerts show that no device is exempt from technical and human failures; for example, there might be improper cutting. achieved results indicate the essential need for better protocols on activity verification and medical equipment quality control, especially for high-risk instruments. it is also necessary to provide medical staff training about the operation and execution parameters of all equipment to get good accuracy.11 another critical point is the medical equipment maintenance carried out by clinical engineers. thus, the predictive maintenance that accompanies equipment performance parameters, aiming to define the right moment of the intervention, with the maximum use of the asset, proves to be profitable, combining operational safety of the equipment and cost.30 on the other hand, preventive maintenance, according to nbr 5462-1994, “is carried out at predetermined intervals, or according to prescribed criteria, designed to reduce the probability of failure or degradation of the functioning of an item”31, therefore offering more safety. in brazil, to guarantee the safety and the values measured within the reliability standards of medical equipment and to obtain the brazilian certification by the national institute of metrology, quality and technology (inmetro), the clinical engineering team management performs testing and calibration of equipment following brazilian standards, such as rdc number 02 and nbr15943.4,32 the manufacturers and distributors have a great responsibility in producing equipment in compliance with regulations and quality requirements. on the other hand, health authorities must follow regulations, conduct technological surveillance, and collect information about events. in health establishments, the clinical and biomedical engineers are professionally trained to relate scientifically to devices, being increasingly important in product certification, choosing technologies and training of personnel, and thus helping to avoid serious failures.17 to evaluate the events addressed in our research, we used pareto’s analysis to prioritize corrective actions and quantify the causes of problems in medical devices, allowing focusing the professional’s attention on the most relevant causes. the swiss cheese model was used when protective measures of systems were overcome by circumstantial factors that combined them and produced an undesirable result. this model encompasses human aspects, such as faulty actions and the system, which need barriers against errors (cheese layers). the layers represent points in developing and using a device that can have weaknesses, so these layers cannot align.17 finally, the alerts, hazards, and adverse events registered allowed us to identify the best practices to be adopted concerning the highlighted medical devices. this included increasing the training of operators and technicians in maintenance, expanding predictive maintenance, changing the corrective maintenance modus operandi, adapting the infrastructure of the health care establishment (hospital, clinic, polyclinic, etc.), identifying the need j global clinical engineering vol.4 issue 2: 2021 12 carlos de souza, mehrpour, ferreira, coelho, de castro vivas, rodriguez, de assis santos. bastos-filho: compilation about adverse events recorded in fda/usa and anvisa/brazil databases through models available in the literature concerning analysis and prioritization of actions for medical devices to replace obsolete technologies, providing feedback to manufacturers and suppliers of medical technologies, and suggesting new public policies for the management of medical devices among other actions. conclusions the common faults in aed, dc-defibrillator, ip, pm, pv, and us are related to alarm conditions not being issued by the medical device or not being adequately addressed by the team of professionals. in addition, these professionals are often not adequately trained to deal with the devices, the scarcity of system verification protocols, errors in the automatic execution of standard processes, lack of maintenance and programming according to the patient’s needs. all medical devices can fail; however, the failures must be avoided by adequately selecting and maintaining these devices. for that purpose, it is necessary to pay attention to medical devices’ clinical and technical needs, perform regular equipment tests and maintenance, and medical team training. in addition, the medical devices must have adequate incorporation with an extensive search for suppliers, involving technical, clinical, budgetary, and infrastructure areas, allowing for a specification that meets the clinical, operational, and cost. to understand and mitigate adverse events, this work shows that it is essential to apply models to analyze their causes, for example, pareto’s analysis, which prioritizes corrective actions. in addition, it is necessary to stratify the types of adverse events for medical equipment, for example, using the layers of the swiss cheese model to help understand which stages of development and use of the device contributed to the failures. indeed, future research and studies with other international databases are necessary to widen the outcomes obtained in our research. nevertheless, we believe that all aspects brought through applying models from pareto’s analysis and swiss cheese can impact the mitigation of these adverse events and, consequently, offer end-users safer medical devices and more effective health care. acknowledgment the authors thank capes, cnpq, and fapes for their scholarships, and ufes for technical support. conflict of interest the authors declare no conflict of interest. references 1. world health organization. medical devices. who; 2020. available at: www.who.int/health-topics/ medical-devices#tab=tab_1 2. nota técnica nº 01/2020. orientações para enfrentamento à pandemia de covid-19. abeclin, 2020. available at: https://ced.ifmbe.org/images/covid-19_engenharia_cli%cc%81nica-equipamentos_e_infraestrutura. nota_te%cc%81cnica_n%c2%ba_01_abeclin_bahia_2.pdf 3. freitas e v s, artega m a p, cardoso p a, et al. a review about equipment for mechanical ventilation in intensive care to combat covid-19 and the role of clinical engineers. in: xxvii brazilian congress in biomedical engineering, 2020, vitoria. proceedings cbeb2020, 1054-1059. 4. anvisa. rdc nº 02: gerenciamento de tecnologias em saúde em estabelecimentos de saúde, 2010. 5. gao x, wen q, duan x, et al. a hazard analysis of class i recalls of infusion pumps. jmir human factors 2019;6(2):e10366. doi 10.2196/10366 6. united states food and drug administration. data mining at the center for devices and radiological health. fda; 2018. available at: https:// www.fda.gov/science-research/data-mining/ data-mining-center-devices-and-radiological-health 7. united states food and drug administration. medical device reporting (mdr): how to report medical device problems. fda, 2020. available at: https:// www.fda.gov/medical-devices/medical-device-safety/ medical-device-reporting-mdr-how-report-medicaldevice-problems. 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https://www.ecri.org/resources/whitepapers_and_reports/haz_19.pdf j global clinical engineering vol.4 issue 2: 2021 14 carlos de souza, mehrpour, ferreira, coelho, de castro vivas, rodriguez, de assis santos. bastos-filho: compilation about adverse events recorded in fda/usa and anvisa/brazil databases through models available in the literature concerning analysis and prioritization of actions for medical devices 31. abnt, nbr 5462. confiabilidade e mantenabilidade; 1994. 32. abnt, nbr 15943. diretrizes para um programa de gerenciamento de equipamentos de infraestrutura de serviços de saúde e de equipamentos para a saúde; 2011. 15 j global clinical engineering vol.2 issue 1: 15-22 ; 2019 received september 6, 2019, accepted october 30, 2019, date of publication november 9, 2019 analysis of ifmbe-ced 2017 worldwide clinical engineering survey by l. nascimento1, s. calil1, t. judd2, y. david3 1 department of biomedical engineering school of electrical and computer engineering. university of campinas, brazil 2 chair, ifmbe clinical engineering division. associate editor, health technology and quality, the permanente journal 3 biomedical engineering consultants, llc, university of texas school of public health abstract background and objective: clinical engineering (ce) professionals are fundamental to the deployment of healthcare technology and the management of its life cycle. as the role of technology grows in healthcare, so does the need for trained ce practitioners and the dynamic nature of the domain requires them to maintain their skills. however, the skills and activities required from clinical engineers around the world are not homogeneous, so the ce division at ifmbe promoted a global survey to identify a common body of knowledge and body of practices for the profession. material and methods: this survey, based on a previous one conducted by the american college of clinical engineering, was aimed at collecting data about clinical engineering practices and the importance of certain competencies for their practitioners. results: survey results indicate the profession still maintains certain traditional characteristics, such as the predominance of professionals with a background in electrical, electronic, or mechanical engineering and the prevalence of hospitals and clinics as employers. some patterns in the perceived relevance of certain kinds of knowledge among different regions were also identified. conclusion: overall, the survey seems adequate to reveal which skills and activities ces considered the most relevant, but more responses are required before a solid body of knowledge and body of practice can be defined. keywords – clinical engineering, body of knowledge, body of practice, clinical engineering survey. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction to reap the full benefits of deploying technology in healthcare delivery, healthcare programs require competent clinical engineering professionals to manage its life cycle. as the technology’s role rises over time so does the need for trained clinical engineering practitioners. clinical engineering (ce) is today one of the most dynamic professions in the world.1 this dynamic state challenges ce professionals to maintain their skills and stay current with the continuous progress of healthcare technologies. from the early stage of innovation throughout the rest of the technology life cycle, clinical engineers not only have to keep a constant update of their knowledge and expertise needed to develop their activities but also to periodically add, adapt, and learn new competencies and methodologies due to introduction of new and innovative technologies. clinical engineers must sustain and further http://www.globalce.org http://globalce.org http://globalce.org nascimento, calil, judd, david: analysis of ifmbe-ced 2017 worldwide clinical engineering survey j global clinical engineering vol.2 issue 1: 15-22 ; 2019 16 build their contribution to safe, efficient, and optimal life cycle stages and patient outcomes.2 while maintenance management, equipment specification, and acquisition composed the basic set of knowledge for clinical engineers in the seventies and eighties, the current basic set is composed of more than 18 subjects and it is still growing. table 1 compares the increasing number of subjects during the last 18 years. there are very few recent studies describing worldwide activities developed by ces. most surveys were either done a long time ago3,4 or are recent, but regional. to our knowledge, there are no recent publications on surveys conducted to investigate ce activities worldwide. in 2004, a comprehensive ce survey5 was developed to address two points via two questionnaires. the first one investigated the structure, personnel, responsibilities, and resources of the ce departments all over the world. the second questionnaire was to investigate trends and current ce practices. to identify such practices, respondents were requested to check a list of several activities such as equipment management, quality control, risk management, education, and training. the resulting analysis from the 174 valid answers received, indicated that the main problems were lack of highly qualified personnel (because of the lack of quality academic programs), limited funding for technical training to maintain staff competencies for all equipment types and continuous pressure to reduce costs by increasing department efficiency. additionally, the authors also concluded that despite the efforts for activities harmonization among ces regarding the management of healthcare technology in hospitals all over the world, this subject remains non-uniform, with great variations in terms of structure, personnel, responsibilities, resources, and outcomes. starting in 2004, the biomedea project (a europeanwide initiative) promoted the organization of three meetings aiming at the development and establishment of consensus on european guidelines and protocols for the harmonization and accreditation of high quality medical and biological engineering and science programs and for the training, certification and continuing education of professionals working in the health care systems.5 the third meeting took place through an international symposium on an important issue of quality assurance in biomedical/ce: patient safety. in 2005, a meeting co-sponsored by the university of stuttgart and the international federation for medical and biological engineering – ifmbe,6 produced several documents, which included an “agreement for mutual recognition of qualifications for clinical engineers”. a white paper produced by the clinical engineering division – ced/ifmbe7 described its contents. a further document was also produced: the “protocol for the training of clinical engineers in europe.” both were very important and valuable documents; however, some obstacles stopped the progress of such initiatives: table 1. new subjects added to the set of knowledge of clinical engineering in the last 18 years (based on personal observations) 1970 – 1980 1990 – 2015 • medical equipment management • safety • procurement • education • individual product management • individual thinking • medical equipment management → technology management • safety → risk management • procurement • education • disaster preparedness • cost control (tco. lcc) • technology assessment • telemedicine (homecare) • project management • contract management • mobile healthcare (events. transports. group assistance) • home care • quality management • information technology (interoperability) • human factor engineering • forensic analysis • artificial intelligence • systems integration and management • soft skills (writing. communication. supervision) • team practicing lcc = life cycle costs; tco = total cost of ownership 17 j global clinical engineering vol.2 issue 1: 15-22 ; 2019 nascimento, calil, judd, david: analysis of ifmbe-ced 2017 worldwide clinical engineering survey 1. there were no further discussions to carry on the work and the documents became just a source of consultation. 2. the documents were heavily based on the ce model adopted by the american college of clinical engineering (acce), meaning that it was an american model to be adopted in europe. 3. the document aimed the ce in europe and even though its development lacked further studies to understand the kind of ce activities practiced in many of the european countries. 4. the document contents would serve only as a source of consultation for countries outside europe and it did not fill the need to find a worldwide harmonization for knowledge among ces. then, also in 2005, ced/ifmbe launched a survey aiming to learn about the ce activities in different countries.8,9 the objective was to identify and develop a worldwide network of ces and understand their activities. this survey looked for characteristics such as age, time of experience in the ce area, type of employer, primary position and all the activities developed within the work. the results of this survey indicate some similarities among activities in several parts of the world. figure 1 shows the results of the 2005 survey and it indicated that technology management was practiced by a range of 55% (asian ces) to 85% (north americans and canadian ces) of the respondents. as another example, risk management practices varied from 39% (latin americans ces) to 70% (north americans and canadians ces). such similarities can be the basis for developing stronger international cooperation among clinical engineers and ce professional organizations. this set of activities can also be the basis to understand the core of ce practices worldwide and develop a core of knowledge to be taught by any academic unit that aims to train ces. it can also be used by countries/ societies that already have or are planning to develop a ce credentialing or certification system. this was, however, a primary set of data. to have a more reliable set of the knowledge needed by ces to develop not only their daily activities but to empower them to propose and develop advanced projects within the ce area, it was necessary to have a better understanding of the ce profile and practices worldwide. the results of the 2005 survey are outlined in figure 1. ten years later, in 2017, sponsored by ifmbe/ced it was possible to develop and launch a worldwide project called “body of practice and body of knowledge – bok & bop.” this project, led by senior ces from around the world, developed data collection tool (a survey), included additional questions designed not only to identify the ce activities practiced at their place of work but also what set of competencies is important for better development and successful outcomes from such activities. this survey was based on a similar tool used by the acce to identify the profile and practices of ces working in usa and canada.10 methods the topics and format of the questions were either extracted or modified from a survey kindly provided by the acce and eng. frank painter. the original survey was used by acce to determine the current knowledge and skills needed for competent ce practice mainly in the united states and canada. as the acce survey, this one was divided into five sections, aiming at collecting different pertinent types of information. figure 1. the results of the 2005 survey showing that, according to the respondents, technology management is one of the activities practiced by a range of 55% (asian ces) to 85% (north american and canadian ces). nascimento, calil, judd, david: analysis of ifmbe-ced 2017 worldwide clinical engineering survey j global clinical engineering vol.2 issue 1: 15-22 ; 2019 18 the first part of the survey – “contact information”, asked for identification and general data about the respondent. such as name, company, country and email address. in this part, only the country’s name of the respondent was mandatory. the second part – “job information,” was focused on acquiring data about the ce employer and educational background. it included questions about the type of employer, about how respondents describe their profession, the primary nature of their current position, their academic background (engineering or other), and about the existence of ce certification in the country. the third section – “knowledge”, presented a list of 28 knowledge topics and asked the respondents to rate the importance of those topics (minor, moderate, or high importance) in the development of their activities. the fourth part – “responsibilities,” presented eight classes of activities (technology management, service delivery management, product development management, it/telecommunications, education, facilities management, risk management/safety, and general management). a list of multiple skills related to each one of these classes was then presented. and respondents were asked to rate how important (no, minor, moderate, or high importance) each skill is to develop each of the “responsibility.” the final section of the questionnaire – “work activities”, asked the respondents to indicate the percentage of time they dedicate to each one of the eight classes of activities presented in the previous part. during the data analysis process, weights were assigned to the levels of importance indicated in the responses: for the knowledge topics where the answers had three rating levels; 0 (zero) was assigned for “minor,” 1 for “moderate,” and 2 for “high” importance. for the responsibility topics. where four rating levels were presented. 0 (zero) was assigned for “no,” 1 for “minor,” 2 for “moderate,” and 3 for “high.” though there are several ways to present the data in this article, it was decided to show the result by geographical region: latin america, oceania, asia, middle east, europe, africa and, usa and canada. the survey was developed and presented to the invited participants with google forms and 574 invitations were sent by email. results from the 574 invitations to respond to the survey, 199 responses were received from 35 countries. from those; 35% came from latin america, 20% from oceania, 14% from asia, 11% from the middle east, 10% from europe, 6% from africa and 4% from usa and canada. though it was below the expected number of responses, the results can already present important information regarding the objectives of the bok & bop project. due to the very low number of responses from usa and canada (7 responses), here it will be left out of the resulting graphics but will be at a later point compared with the 2015 acce survey.8 the african region also has few responses (12 responses) but is presented due to the very small number of ces working in that region. the total number of respondents with an electrical/electronic/mechanical engineering (b.sc.) degree is around 65%. as identified in the 2005 survey, the vast majority of ces (48%) are employed by hospitals or health clinics. government agencies are ranked in the second position as employers according to 12.5% of the respondents (figure 2). figure 2. percentage of the types of employers of clinical engineers worldwide. b.sc 19 j global clinical engineering vol.2 issue 1: 15-22 ; 2019 nascimento, calil, judd, david: analysis of ifmbe-ced 2017 worldwide clinical engineering survey respondents were also asked how they see themselves as professionals. nine different names that could define the profession were given (including the options “others”) and the question was presented as: “which of the following names do you believe best describes your profession?” around 48% describe themselves as ces and 18.1% as healthcare technology managers. asked about the primary nature of his/her present position, the three first positions selected worldwide were management (45.7%), service delivery (15%) and professional support (14.1%). however, this question also raised interesting information: management was the first position in all regions but it was placed second in oceania (34.15%) and service delivery (41.5%) was placed first. due to the small number of responses from each region, one can argue that such results lack reliability. however, by comparing this information with those obtained in 2015 (the usa and canada bok survey,8 with 472 respondents), the picture regarding technology management is the same, being in the first position. according to the respondents, there are great variations for other positions depending on the region. this can be seen in table 2 where latin american ces responded (70 responses) that professional support is the second position while in the middle east (21 responses), as oceania (41 responses). service delivery is the second position. one of the most important questions and the one that directly helps to achieve the objective of this project asked respondents to indicate, in a list of background knowledge topics, the level of importance of each one for his/her daily duties and responsibilities. three levels of importance were presented (minor, moderate and high importance). to present the results, the data processing was already explained in the chapter “methodology” previously. interesting observations can be made by looking at the results presented in figure 3. though not with the same level of importance, there are coincident “knowledge” rating tendencies. all respondent regions rated general medical/nursing equipment above moderate importance. the same happens to the “knowledge” regarding computers, networking and it. on the other hand, “knowledge” regarding telecommunications is below moderate to all regions. the same happens for chemistry and implants. other comments can be made about these results but, the most important one is to see that a primary profile of the body of knowledge for ces all over the world can already be traced, based on the rate tendency. this survey, as well as the 2005 survey7 and the one promoted by acce9, pointed out that the position of technology manager was the one held by most clinical engineers worldwide. presented with 20 different table 2. final results of option comparison by category africa asia europe latin america middle east oceania management 41. 67% 42.86% 50.00% 54.29% 42.86% 34.15% research 0.00% 7.14% 10.00% 4.29% 0.00% 2.44% manufacturing 0.00% 0.00% 0.00% 1.43% 0.00% 2.44% teaching 25.00% 10.71% 0.00% 7.14% 9.52% 2.44% consulting 16.67% 14.29% 10.00% 8.57% 0.00% 0.00% service delivery 8.33% 3.57% 10.00% 4.29% 28.57% 41.46% professional support 8.33% 17.86% 10.00% 15.71% 14.29% 14.63% other 0.00% 3.57% 10.00% 4.29% 4.76% 2.44% figure 3. level of importance of background knowledge for clinical engineers to develop their daily work activities. pacs = picture archiving and communication system nascimento, calil, judd, david: analysis of ifmbe-ced 2017 worldwide clinical engineering survey j global clinical engineering vol.2 issue 1: 15-22 ; 2019 20 activities within the scope of this position, they were asked to rate the importance of each activity (high, moderate, minor and no) to develop their work. the process used to present this information was already explained in the methodology chapter. again, figure 4 shows a great number of coincident tendencies regarding the activities. taking as an example the activity life cycle analysis, all regions rated it between moderate and high importance. on the other hand, the activity clinical trials management is rated as minor to moderate importance within the responsibilities of their work. as mentioned before, despite the low number of respondents, the importance of the activities among the regions follow the same pattern. figure 5 presents the percentage of time ces spent on each work activity during the work. confirming what was pointed out on table 2, most of the ces from the oceania region spent their time on service delivery (30%) while ces from other regions spent between 15% and 18% on this activity. important work profiles can be noticed here; while ces from the european region spent 11.7% of their time on risk management safety, this percentage is reduced to 6.7% by ces in the middle eastern region. another activity that presents a great difference in the percentage of dedicated time is education of others. while in latin america ces declared that this activity consumes 13% of their time, in the european and oceania regions it drops to 8.5%. the reasons for such percentage differences in some activities may be due to the group of respondents within each region, interpretation of the question (survey was done only in english) or cultural behavior. one may understand that education of others meant a short but formal lecture and others may understand that just the fact of orienting a new technician on repairing medical equipment is part of the time dedicated to education. the kind of activities the ces develop for each work activity was also explored, as shown in figure 5. a total of 18 different activities composing the risk management/ safety work activity was presented to be rated according to its importance to the development of the work. figure 6 shows a few differences in the importance of each activity given by the respondents according to the region. while in the oceanian and european regions the respondents considered forensic analysis as low importance, all other regions considered it above moderate. the figure 4. the importance of activities for clinical engineers within the technology management domain. emi = electromagnetic interference; rfi = radio frequency interference figure 5. percentage of time spent by clinical engineers on each activity during work. emi = electromagnetic interference; rfi = radio frequency interference 21 j global clinical engineering vol.2 issue 1: 15-22 ; 2019 nascimento, calil, judd, david: analysis of ifmbe-ced 2017 worldwide clinical engineering survey majority of other activities were rated between minor to moderate importance. discussion one of the most challenging tasks when designing mainly a worldwide data collection tool in the form of a survey is to develop a question that has the exact meaning to all respondents. due to language and culture differences as well as different academic systems and job titles, people tend to respond according to the regional characteristics, which cause some distortions in the analysis of the results. some of the data obtained can be corrected by a simple translation to english while others would be necessary to have a deeper understanding of the country’s academic system. adaptations from the acce survey were necessary to meet the objectives of this survey. it was not only to identify the ce body of practice and ce profiles worldwide but also to use the identified the body of practice to understand the body of knowledge required by ces to successfully develop such activities. it is expected that in the near future this set of knowledge would help to develop a scope of academic subjects necessary for graduating students to understand to optimally practice such activities. the structure of the survey allows a more detailed analysis of the data obtained. it is possible, according to the answers and number of responses, to have the profile not only of each respondent, but also the ce model practiced by the country, and the health unit he/she is working at. no doubt that a higher number of responses from clinical engineers and other countries would make the information more accurate. however, it is already possible to devise a core of activities practiced by ces all over the world. regarding the needed knowledge for better developing their work, the results showed that though its importance varies according to the ce model practiced in the country/region, there is also a set of knowledge that is commonly needed worldwide. there is a need to periodically update the information obtained in this survey due to the dynamic characteristic of the ce profession and the changing dependence of healthcare services on technology. for almost every new technology and procedure to be used in the health area there is an anticipated and required a new set of knowledge for the practicing clinical engineers throughout the technology life cycle stages from innovation to disposal and replacement. conclusion we hypothesized that a common body of knowledge and body of practice for ce would emerge from the analysis of a worldwide survey. despite some differences between regions, some patterns of perceived relevance of different fields of knowledge and activity responsibilities within the areas are visible. this suggests that ce does have something in common around the world but more responses are necessary to define a solid worldwide body of knowledge and body of practice for the profession. acknowledgements the authors wish to thank eng. frank painter for authorizing the adaptation and use of an earlier version of the survey he developed. figure 6. the importance of each activity within the work activity risk management/safety. nascimento, calil, judd, david: analysis of ifmbe-ced 2017 worldwide clinical engineering survey j global clinical engineering vol.2 issue 1: 15-22 ; 2019 22 references 1. us department of labor bureau of labor statistics. occupational employment and wages, may 2017. available at: https://www.bls.gov/oes/2017/may/ oes172031.htm 2. judd, t., & david, y. 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(2007) findings of the worldwide clinical engineering survey conducted by the clinical engineering division of the international federation for medical and biological engineering. ifmbe proc. vol. 16. 11th mediterranean conference on medical and biomedical engineering and computing 2007, pp 1085–1088. https://doi. org/10.1007/978-3-540-73044-6_280 8. calil. s. j., oliveira r. r. v., nascimento l. n. (2009) "findings of the latin america clinical engineering survey conducted by the clinical engineering division of international federation for medical and biological engineering." world congress on medical physics and biomedical engineering. september 7-12. 2009. munich. germany. springer. berlin. heidelberg. 9. suhan a. 2015 american college of clinical engineering body of knowledge survey results. j clin engineer 2017;42(3). https://www.bls.gov/oes/2017/may/oes172031.htm https://www.bls.gov/oes/2017/may/oes172031.htm https://doi.org/10.31354/globalce.v1i1 https://doi.org/10.31354/globalce.v1i1 https://doi.org/10.1007/bf02441772 https://doi.org/10.1007/bf02441772 https://link.springer.com/chapter/10.1007/978 https://link.springer.com/chapter/10.1007/978 http://www.vvb-bmt.nl/emailalerts/attach/20050722-01.pdf http://www.vvb-bmt.nl/emailalerts/attach/20050722-01.pdf http://cedglobal.org/wp-content/uploads/2018/06/ced-certification-white-paper-with-annexes.pdf http://cedglobal.org/wp-content/uploads/2018/06/ced-certification-white-paper-with-annexes.pdf http://cedglobal.org/wp-content/uploads/2018/06/ced-certification-white-paper-with-annexes.pdf https://doi.org/10.1007/978 https://doi.org/10.1007/978 j global clinical engineering, special issue 4, 2021i proceedings 4th icehtmc 2021 editor’s corner 4th international clinical engineering & health technology management congress (icehtmc) october 24-26, 2021, virtual congress dear 4th icehtmc congress community, on behalf of the organizers and sponsors of the 4th international clinical engineering & health technology management congress (icehtmc), it is our honor to offer this publication that contains all of the abstracts accepted for the oral sessions in this congress. through the amazing support received from the scientific program committee, consisting of several dozen experienced reviewers from all over the world, all of the submissions received were subjected to strict peer review process. this made the congress’s scientific program an event that exceeded all previous congress records for quality, quantity, and registration. major recognition must be given to the unique cooperation between the global clinical engineering alliance (gcea), the ifmbe clinical engineering division (ifmbe ced), and aami for hosting and collaborating on the organization of this event. especially, since due to the curtail of international travel during this covid-19 era, the organizers had to convert the congress from in-person to a global virtual congress, a first for the international clinical engineering field. the unabated commitment of organizers led by tom judd and yadin david who were endlessly supported by kallirroi stavrianou, and luis fernandez resulted in the engagement of clinical engineering practitioners from around the world, including pre-recording of over 200 presentations. keynote presentations included globally recognized speakers from the world health organization, india and the usa. support and presentations from sponsors zoom for healthcare, r-zero, healiom, and schiller americas provided a unique opportunity for global health technology shared learning and professional networking. this is the second time that the congress’s proceedings are published and available in on-line format (globalce.org). the global clinical engineering journal’s commitment to the promotion and sharing of knowledge is evident through its commitment to timely publication of subjects at the cross between engineering, technology, and patient care outcomes. these proceedings are a great accomplishment that well serve the ongoing and growing global clinical engineering publication task. conducting a virtual congress presents a different stage and an opportunity to engage with more members within our field as well as with other stakeholders around professional development, scientific debate, networking, strengthening friendships, and learning more about best practices from places we cannot yet visit in person. we thank all the participants and are confident that you will find these proceedings useful. we wish you success and hope to meet you at our next congress. yadin david together we can make it better! editor-in-chief of globalce journal and gcea interim president tom judd ifmbe ced board chair https://www.globalcea.org/home https://ced.ifmbe.org/ https://www.aami.org/ https://explore.zoom.us/docs/doc/zoom_for_healthcare.pdf https://rzero.com/ https://www.healiom.com/ https://www.schillerus.com/ http://globalce.org j global clinical engineering vol.4 issue 1: 2021 22 received april 23, 2020, accepted february 16, 2021, date of publication february 22, 2021 lean and computerized management system for nonhospital-owned medical equipment in hospital by y. y. wu, k. zheng, b. p. li, c. x. zheng department of purchasing/logistical/clinical engineering, the children's hospital zhejiang university school of medicine/ national clinical research center for child health, hangzhou 310052, china abstract many challenges exist in the management of non-hospital-owned medical equipment. this paper proposes implementing a novel kind of lean and computerized management method, including the management policy, procedures, agreement signing, equipment installation, acceptance and maintenance, and exit procedure. the result shows that the lean and computerized management system can improve oversight and assure the safe integration of non-hospital-owned equipment to reduce liability exposure and increase compliance with regulations. keywords – non-hospital-owned medical equipment, lean management, computerized management system, trial protocol, medical safety, assets control. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction with the rapid development of the modern hospital, increasing demand for the medical equipment and technology experienced both in clinical and research environments. due to the diversity of novel medical equipment, some are supplied for free by the vendors. vendors have a variety of reasons for bringing in their equipment. they may bring in as a service loaner or as a new model to demonstrate to clinicians. as this equipment may be left for weeks for a clinical trial and evaluation only, the new products' technical parameters and performance can be evaluated and compared in hospitals1. we define this kind of equipment as trial equipment in this article. the trial equipment we refer to here is not medical equipment in clinical trials for pre-market approval but equipment already approved for the market. all the indirect hospital purchased equipment are treated as non-hospital owned equipment, including trial equipment, research collaboration equipment, household appliances, among other things. the state of non-hospital-owned equipment is difficult to judge at times, and some of them may not meet the safety requirements, which can lead to safety problems2. valid concerns about non-hospital owned medical equipment include safety and effectiveness, compliance with applicable accreditation standards and legal requirements, proper integration, and technical support. therefore, they should be under the oversight of clinical engineering, and http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 23 j global clinical engineering vol.4 issue 1: 2021 y. wu, k. zheng, b. li, c. zheng: lean and computerized management system for non-hospital-owned medical equipment in hospital all medical equipment should receive any needed attention regardless of their ownership. in our hospital, all non-hospital-owned equipment is supervised by a lean and computerized management system. this article takes the trial equipment we defined before as an example and describes the relevant management program. materials lean management is designed to enhance productivity by improving work efficiency3. during the whole procedure, the manager's duty is specified and explicit, and the management process is standardized and systematized. on the one hand, the lean management's core idea is applied in non-hospital-owned medical equipment, and a strict management policy and procedure ensure its safety. on the other hand, information technology is applied to develop a customized tool for implementing the overall non-hospital owned medical equipment management4. our hospital's medical equipment management system includes the management functions of hospital-wide medical equipment such as testing, reporting for repair, and maintenance, among which the management of nonhospital owned medical equipment is an important module. a. design a rigorous management policy and procedure before its first clinical use, all non-hospital-owned medical equipment providers need to sign an agreement or protocol with the hospital represented by the clinical engineering department. any unauthorized or disapproval use of non-hospital-owned medical equipment is strictly forbidden. hence, the recommended procedure is shown in figure 1. step 1: trial application. the corresponding department is asked to complete the medical device clinical trials' application form, with a description of application reasons, device name, brand and model, quantity, regulation registration certificate number, vendor name. step 2: legal compliance examination and verification. all the necessary documents are reviewed by the department of clinical engineering, including the medical device registration certificate issued by the china food and drug administration (cfda), production enterprise license, business certificate business license, factory authorization letter, operation manuals. the copies of these documents are saved for future reference. step 3: approving or comments by the related functional departments such as the medical administration department and finance department. step 4: submission to hospital medical equipment management committee for consideration. step 5: signing a protocol of authorized usage for the non-hospital owned medical equipment. step 6: labeling the device and informed users. b. sign medical equipment trial protocol the trial protocol is signed by the hospital (party a) and the vendors such as the sales company or manufacturer (party b), in which the duties and obligations for both sides and the agreed usage duration (usually no figure 1. the access protocol for non-hospital owned medical equipment. y. wu, k. zheng, b. li, c. zheng: lean and computerized management system for non-hospital-owned medical equipment in hospital j global clinical engineering vol.4 issue 1: 2021 24 more than 3 months) are specified. according to the trial protocol, party b's equipment should be conforming to all the regulations made by cfda. also, party b should provide valid certificates, installation procedures, and user training. when the trial period ends up, the equipment should return to party b in time. party a should take good care of the devices during the trial period. if the device breaks due to the user's carelessness or abuse, the hospital (party a) will be responsible for the compensation. c. standardization of installation and acceptance process when the medical equipment trial protocol is implemented, the supplier shall be responsible for the trial equipment installation, and the engineers of the department of clinical engineering at the hospital will make an acceptance check to ensure the safety of the equipment. after the completion of the acceptance process, the supplier needs to conduct training for potential users. some of the non-hospital-owned equipment is surgical instruments in the operating room. such instruments may be used already many times in different hospitals. therefore, it might cause potential surgical infection if sterilization protocol is not carried out strictly or adequately5. for example, in orthopedic implant surgery, if the bacteria contaminate the implant, it will be quite challenging to tackle this problem since a layer of protective film is generated in the implant surface, which makes the antibiotics useless and brings about great pain for the patients6. hence, additional precautions should be taken, and relevant measures should be taken according to hospital infection control policy if the trial device is the surgical instrument7,8. the corresponding training, assembly, and disassembly demonstration should be provided for the central sterile supply department staff to ensure that all the operations conform to the disinfection and sterilization requirements9,10 and make sure that the instruments are used in a safe situation11. d. the application of non-hospital owned medical equipment management module after completion of the acceptance and training procedures, the trial equipment is commissioned. simultaneously, all the useful information will be loaded into the computerized management system by the clinical engineering department staff, including basic info, clinical department, maintenance record, and the trial's validity period. besides, a qr code label containing affiliation, equipment name, brand and model, serial number, and the clinical department is labeled on each piece of trial equipment (figure 2). in this paper, a lean and computerized management system is proposed and implemented in the hospital, in which non-hospital owned equipment is subject to oversight and control in a standardized framework, especially in terms of the following several aspects. 1. based on the strict management policy and procedure, some unnecessary and less prominent medical devices are filtered in the approval process. the quantity of external medical equipment is better controlled and quality is better guaranteed. there are no more than 10 cases of trial medical equipment in our hospital every year in recent years. 2. qr code label. more detailed information is obtained following the scanning of the qr code. it contains device type, serial number, registration certificate information. besides, repair and maintenance records can be documented in the computerized management system. figure 2. the qr code label. 25 j global clinical engineering vol.4 issue 1: 2021 y. wu, k. zheng, b. li, c. zheng: lean and computerized management system for non-hospital-owned medical equipment in hospital the registration certificate period for non-hospitalowned equipment will be monitored by the clinical engineering department's computerized management system. if the clinical department applies for extending the trial time, its validity period must be reviewed and confirmed. hence, the working efficiency is enhanced since the validity of the registration certificate and trial period validity can be checked by scanning the qr code. 3. planned maintenance. the computerized management system alerts the need for any maintenance due three days in advance, at which time the department of clinical engineering will contact the vendors for a timely inspection and maintenance. the maintenance task and its record can be easily accessed and carried out by scanning the qr code. all the corresponding information can be reviewed by logging in the system. 4. end of the trial. the computerized management system reminds the trial ending time three days in advance. the clinical engineering department is responsible for reminding and contacting the vendors to remove the trial equipment from the hospital. also, it is recorded in the information system. conclusions the lean management system we described takes key management elements of non-hospital owned medical equipment into consideration. combined with the government requirements of rules and regulations with hospital real-practice scenarios, the department of clinical engineering has designed and implemented an effective lean management system for non-hospital-owned medical equipment. furthermore, the whole management process is carried out with the support of an information system, in which all the corresponding information and certificates, and quality control activities are recorded and is reviewed together conveniently. by doing so, the management efficiency and performance improves. the risks and potential damages from non-hospital-owned medical equipment are effectively mitigated; medical safety for hospitals and patients is enhanced; compliance with regulations increases. acknowledgment this work was supported by national key research and development project (2017yfc0114107). we want to extend our sincere gratitude to dr. yadin david for his revising this paper. we are also deeply indebted to our other clinical engineering staff that supported our work. conflict of interest the authors declare that they have no conflict of interest. references 1. shi w j, kang d h, tong q r et al. (2015) risk control for the use of introduced trial medical equipment. china medical devices istic 30(1):125-126. 2. liu j y, li n, cai m et al. (2017) evaluation of preventive effect of the management of foreign medical instruments on surgical site infections in orthopedic surgery. chinese journal of nosocomiology 027(012):2849-2852. 3. collar r m, shuman a g, feiner s, et al. (2012) lean management in academic surgery. journal of the american college of surgeons 214(6): 928-936. 4. huang w (2018) review of the development status of domestic hospital information system. computer knowledge and technology 014(021):89-90,109. 5. qian w j, qian j j, wang w (2018) investigation and analysis on the management of surgical instruments in hospital. shanghai nursing 104(08):69-72. 6. epstein a k, pokroy b, seminara a, et al. (2011) bacterial biofilm shows persistent resistance to liquid wetting and gas penetration. proceedings of the national academy of sciences 108(3): 995-1000. 7. wang z h (2018) the effect of quality traceability management system for disinfection supply on the whole process monitoring of external medical devices. china medicine and pharmacy 8(19):183-185+250. 8. gao y h, chen y w, wang y l (2018) sterilization time of loaner instrumentation by structure and materials. academic journal of chinese pla medical school 039(003): 218-222. y. wu, k. zheng, b. li, c. zheng: lean and computerized management system for non-hospital-owned medical equipment in hospital j global clinical engineering vol.4 issue 1: 2021 26 9. ministry of health of the people’s republic of china (2009) the central sterile supply department in hospital, part 2. china standards press. 10. organization w h (2014) practical guidelines for infection control in health care facilities. manila: who regional office for the western pacific. 11. li s y, he x y, huang g j (2015) cleaning and management of external surgical instruments in cssd. for all health 9(9):279-280. 47 j global clinical engineering vol.4 issue 3: 2022 received september 6, 2021, accepted february 21, 2022, date of publication march 1, 2022 clinical engineering role in the development of emergency use medical devices by roberto ayala ce/htm consultant, mexico abstract clinical engineering (ce) professionals have a crucial role in healthcare institutions during the pandemic caused by the covid-19 disease, mainly by supporting the front line by allowing the proper and timely access to the medical equipment required to diagnose and treat patients affected. but another one of their roles, probably not so expected, has been their contributions to the development of emergency use medical devices, especially those for respiratory and oxygen therapy. using the case of critical care use ventilators, and as presented during an ifmbe-ced webinar on the topic, this paper mentions the role of ce for the rapid response manufacturing of such vital care devices in three main aspects: development, regulation, and education. the results from such efforts have paid off by having safe and efficient support equipment while the shortage from commercial products has been receding, by establishing international guidelines for future innovators to take into consideration, and by leaving valuable knowledge in the form of educational and training videos for future generations to consult from. keywords – clinical engineering, medical devices, ventilators, pandemic. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction covid-19 pandemic put healthcare and industry systems to the test, and it has been evident that healthcare professionals and workers were in the middle of it all. ces were no exception, and their responsibilities doubled as they were required to look after the medical technology needs of front-line workers and the rest of the clinical services personnel. ces did not hesitate when new challenges required their skilled efforts. for example, early in the pandemic expansion, there was a shortage of several types of medical devices needed for respiratory and oxygen therapy, and one, in particular, was the most indemand – ventilators for critical care units. as it became clear that the industry was struggling to cope with the shortage, several technical groups, including academia, professional organizations, and non-medical devices companies, started their own efforts to build locally produced ventilators. however, they soon realized that it was necessary to consult ce professionals with expertise in this vital equipment’s use, technical specifications, safety considerations, and normative and regulatory concerns. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.4 issue 3: 2022 48 ayala : clinical engineering role in the development of emergency use medical devices this collaboration focused on three main areas: contributions to the design and development of ventilators, health regulation considerations, and education and training. clinical engineering role in the development of medical devices medical device design and development is no easy task, especially with equipment that operates using mechanical, electrical, electronic, and pneumatic components, such as vital support devices like ventilators. many of the initial initiatives were non-invasive ventilation mechanisms that certainly couldn’t comply with safety and performance standards, and that’s where ces entered the scene to help with the efforts. ces contributed to the manufacturing of locally produced, emergency use ventilators with actions such including: • putting engineering knowledge and skills together with the development of the devices. • helping companies, academia, researchers, and investors to identify clinical needs and the right normative and tech specs for this type of device. • testing the prototypes and finished products through the proper metrology practices. clinical engineering role in health regulation no matter how urgent the need for a medical device may be, the authorization process must be approved by a competent health regulatory authority because such a device needs to prove its safety and efficacy. in the pandemic, authorities understood that they had to offer fast-tracking processes without losing their objectives related to the emergency use authorizations. once again, ces stepped up as the connection between the regulatory process and unexperienced ventilators developers with some of the following interventions: • identifying international standards and normative and best practices to establish a local, applicable normative. • developing technical specifications for local production based on established specifications but adjusting as necessary for a proper response. • support who/paho efforts for worldwide use guidelines and other relevant technical documentation. clinical engineering role in education because of their multidisciplinary approach, clinical engineers are well known as skilled trainers and educators, and this aptitude has helped share knowledge and experiences regarding the manufacturing, principles, operation, care, and safety topics for critical care use ventilators. in a world that was forced to social distancing, the use of web-based meeting platforms was rightly exploited for these purposes of education and training, something that clinical engineers used in the form of: (1) webinars on diverse topics related to patient ventilators, (2) training courses on manufacturing and standards applications, and (3) calls with other health professionals around the globe to exchange knowledge and experiences. one prime example of the noble and vital role of knowledge sharing has been the efforts from ifmbe-ced, which right away began with organizing and offering relevant webinars, with helping hands from experts from all corners of the world and with a variety of topics regarding clinical engineering approach for the pandemic. conclusions ce has been evolving almost at the same pace as medical devices increase in complexity, from participating in service and safety checks, going through integral management, and even collaborating with policymaking at a national health system level. these evolving skills now can cover research, innovation, and development of medical devices, and the pressing circumstances of the covid pandemic just set the stage for clinical engineers worldwide to showcase such abilities. the challenge now is to write down the experiences in scientific papers and pass the knowledge to younger generations because the inertia to strengthen these skills shouldn’t be subjected only to health emergencies. there is a lot of health technology yet to be discovered. references 1. forbes staff. gobierno de amlo presenta ventiladores hechos en méxico para atender covid-19. forbes. méxico cdmx. forbes staff; 2020. available at https://www. forbes.com.mx/politica-gobierno-de-amlo-presentaventiladores-hechos-en-mexico-para-atender-covid-19/. https://www.forbes.com.mx/politica-gobierno-de-amlo-presenta-ventiladores-hechos-en-mexico-para-atender-covid-19/ https://www.forbes.com.mx/politica-gobierno-de-amlo-presenta-ventiladores-hechos-en-mexico-para-atender-covid-19/ https://www.forbes.com.mx/politica-gobierno-de-amlo-presenta-ventiladores-hechos-en-mexico-para-atender-covid-19/ 49 j global clinical engineering vol.4 issue 3: 2022 ayala : clinical engineering role in the development of emergency use medical devices 2. world health organization. priority medical devices list for the covid-19 response and associated technical specifications. who. 2020. available at https://apps. who.int/iris/handle/10665/336745 3. ifmbe-ced. ifmbe-ced courses/webinars. author; 2020. available at https://ced.ifmbe.org/resources/ courses/gurupcategs.html 4. gobierno de mexico. información sobre los lineamientos de ventiladores. cofepris. méxico cdmx; 2020. available at https://www.gob.mx/cofepris/articulos/ informacion-sobre-los-lineamientos-de-ventiladoresactualizacion-9-de-mayo?idiom=es 5. biomédicos de méxico. canal de videos del colegio de ingenieros author. cib youtube. méxico; 2020. available at https://www.youtube.com/channel/ ucyuczx_6beemz26hxazy3vg https://apps.who.int/iris/handle/10665/336745 https://apps.who.int/iris/handle/10665/336745 https://ced.ifmbe.org/resources/courses/gurupcategs.html https://ced.ifmbe.org/resources/courses/gurupcategs.html https://www.gob.mx/cofepris/articulos/informacion-sobre-los-lineamientos-de-ventiladores-actualizacion-9-de-mayo?idiom=es https://www.gob.mx/cofepris/articulos/informacion-sobre-los-lineamientos-de-ventiladores-actualizacion-9-de-mayo?idiom=es https://www.gob.mx/cofepris/articulos/informacion-sobre-los-lineamientos-de-ventiladores-actualizacion-9-de-mayo?idiom=es https://www.youtube.com/channel/ucyuczx_6beemz26hxazy3vg https://www.youtube.com/channel/ucyuczx_6beemz26hxazy3vg j global clinical engineering issue 2:22-34; 2019 22 received january 30, 2019, accepted april 12, 2019, date of publication april 15, 2019 medical device donation practices in canada: a survey of donor and recipient perspectives by b. bradley1, c. yoon2, s. zahedi2, y. adusei-poku3, j. zienaa3, n. adjabu3, y. cheng1, w. gentles4, 1 centre for global engineering and the department of chemical engineering and applied chemistry, university of toronto, toronto, canada 2 institute of biomaterials and biomedical engineering, university of toronto, toronto, canada 3 ghana health service, ghana, africa 4 the canadian medical and biological engineering society, ottawa, canada abstract background and objective: although developing countries have been receiving donations of medical equipment for many years, a number of studies have indicated that a high percentage of donated equipment is never put into use.1,3,4 many of the reasons for this can be traced back to inadequate donation practices on the part of donor organizations. the objective of this study was to gain an improved understanding of the practices and challenges associated with medical equipment donations by canadian charitable organizations. material and methods: forty-one organizations (registered and non-registered charities, non-governmental organizations (ngos), non-profit organizations, medical clinics, and hospitals) completed an online survey, and 16 respondents were interviewed via telephone or in person. in addition, representatives from 28 hospitals in ghana were interviewed in person to gain an understanding of the recipient experience. results: we observed that for many canadian donor organizations there is room for improvement in formalizing procedures, testing to verify equipment functionality before shipping, providing additional support for recipients in the form of manuals, spare parts and training, and long-term monitoring of donated items to measure effectiveness. for recipients, the most common challenges faced were lack of spare parts, and lack of operating or service manuals. despite these challenges, all of the ghanaian survey respondents said that donated medical equipment benefited their hospitals. conclusion: we concluded that because of staffing limitations in smaller donor organizations, and in order to better meet the needs of recipients, it would be beneficial for canadian organizations to communicate and collaborate with one another to share resources and expertise when planning donations overseas. keywords – medical equipment donations, low resource settings, canada, ghana, best practices. 23 j global clinical engineering issue 2:22-34; 2019 bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives introduction previous reports have estimated that as much as 40% to 70% of medical equipment in developing countries is out of service or never put into use. 1,3,4 the reasons for this include a lack of infrastructure and resources (including spare parts and accessories), poor health technology management, and lack of training. 3 given that so many developing countries rely on medical equipment donations, donations that meet recipient needs are crucial to mitigating these challenges and reducing the burden of non-functional equipment. in the past two decades, numerous guidelines for the donation of medical equipment to low resource countries have been published. 2,4,11,12 despite the existence of these guidelines, recent studies suggest that equipment donation practices are a continuing problem. for example, a study in tanzania found that 78% of surveyed staff in a national hospital were dissatisfied with the quality of donated medical equipment, citing lack of supporting manuals and training, poor communication between the donor and the hospital, lack of clear equipment specifications, unneeded equipment, and poor donor planning as reasons for their dissatisfaction. 5 a case study about a donation of oxygen concentrators to the gambia demonstrates how something as simple as a mismatch in electrical requirements can lead to unusable equipment, not to mention wasted effort. 6 while many organizations across canada donate medical equipment and supplies to developing countries, no previous study has explored the donation practices of these organizations. the objectives of this study were: (a) to determine the scope of medical equipment donations by canadian charitable organizations, and better understand their specific donation practices and challenges; (b) to interview representatives of recipient health facilities in ghana, and learn from their experiences; and (c) to disseminate good practice guidance to donating organizations in canada and around the world. this study was initiated by the international outreach committee of the canadian medical and biological engineering society (cmbes), which has had a long-standing partnership with the ghana biomedical engineering association to support clinical engineering capacity in ghana. 7 methods canadian study canadian organizations actively engaged in the donation of medical equipment and/or supplies to developing countries were surveyed using an online survey tool. follow-up interviews were conducted with a subset of surveyed organizations. the list of prospective study participants was compiled through project partner connections and networks, internet search, and through canada’s registered charity search engine. 8 this phase of research resulted in a database of approximately 80 registered and non-registered charities, non-governmental organizations (ngos), non-profit organizations, medical clinics, and hospitals. organizations were then contacted by telephone and informed of our study and survey. organizations that were actively donating medical equipment were sent a link to a survey in a follow-up email. the online survey consisted of 20 multiple choice and short answer questions, grouped into the following categories: (a) general organization information; (b) process for determining recipient needs; (c) communication involved in planning donations; (d) sources of equipment; (e) process for verifying quality and safety before shipping equipment; and (f) follow-up methods for evaluating success of the donations. forty-one organizations completed the survey. from the organizations that participated in the survey, a list of 16 organizations was identified for follow-up interviews. the short list of organizations was strategically selected to cover a wide geographic range across canada, as well as a range in size of operations. the goal of the interviews was to gain a deeper understanding of different organizational processes. sixteen interviews of approximately one hour duration were conducted. interviews were conducted in person when possible, and by phone otherwise. the breakdown by province (in-person; phone) was as follows: british columbia (3; 1), saskatchewan (0; 1), ontario (2; 2), quebec (2; 0), maritime provinces (4; 1). the research protocol, survey tool and interview question guide were approved by the office of research ethics at the university of toronto. bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives j global clinical engineering issue 2:22-34; 2019 24 ghanaian study a second survey, consisting of 35 questions, was developed to gather information from ghanaian hospitals about their experiences receiving medical equipment donations. four questions collected information about the respondent. the remaining questions were a mix of multiple choice questions and open-ended long answer questions on topics such as: types of medical equipment received, communication with the donor before and after the donation, discussion of equipment needs, level of support from donors in terms of provision of training, manuals and supplies, maintenance and availability of spare parts for donated equipment, logistics such as shipping and customs, and common challenges encountered with donations. a geographically representative sample of 28 health facilities was chosen for the survey; at least two facilities were visited in each of ghana’s ten regions. we also sought to ensure that facilities receiving donations from canadian organizations were well represented in the sample (14 out of 28), and that a range of different hospital types was chosen (government, teaching, mission, etc.). since many hospitals did not have reliable access to the internet, surveys were administered in person and on paper by a research assistant (“surveyor”) rather than online. in some cases, the surveyor waited for respondents to complete the survey, while in other cases the survey was administered as an interview with the surveyor filling in responses. the research assistant in ghana was supervised by the deputy director, clinical engineering department, ghana health service. before conducting the survey, all respondents were given an introductory letter explaining the project. findings the types of canadian organizations that donate equipment include ngos, registered charities, and healthcare institutions. some donor organizations have been in operation for over 25 years (one for almost five decades), others are much newer (five years or less) or are just receiving charitable status. to date, these organizations have provided critical medical equipment to 48 countries around the world (fig. 1). the most common recipient countries were haiti, cuba, guatemala, and the philippines. from simple frontline equipment (e.g. thermometers, blood pressure monitors, pulse oximeters) to more complex and larger devices (e.g. x-ray, ultrasound machines) canadian donations help address everything from basic healthcare to supporting a healthy community. medical devices and consumables are the most commonly donated items, although clinical laboratory and dental equipment, and other items including pharmaceuticals, vehicles and computers, have also been provided as part of donation activities (fig. 2a). supplies and small, low complexity equipment are more commonly donated than large, highly complex devices (fig. 2b). the survey presented the categories as options for the respondents, with examples for each category. the respondents decided which category their equipment fell in to. the scale of operations varied considerably across organizations in terms of the frequency and size of shipments. there were also considerable differences in organizational structures and human resources. most relied entirely on volunteers for day-to-day operations, with no paid staff. for example, one organization has a team of about 50 volunteers, with about half in the recipient country who receive small monthly stipends, and the rest in canada or elsewhere. on the other hand, a minority of organizations have a mix of paid and volunteer staff figure 1. global distribution of recipient countries. shading indicates number of surveyed canadian organizations that send equipment to these countries. 25 j global clinical engineering issue 2:22-34; 2019 bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives (e.g., one having ten paid full-time employees and about 40 volunteers, and another having one paid staff and a volunteer board of directors. the next three sections summarize survey results on donor experiences related to three main phases of the donation process: consultation and communication with recipients, planning the donation process, and follow-up and monitoring. consultation how recipients are chosen most organizations chose recipient countries organically, through personal connections or member suggestions. for example, two interviewees told stories of having visited a certain country where they noticed a great need. in one case, this experience led to the inception and founding of the organization. in many other cases, the recipient country reached out to an organization because of having heard about their charitable work. another model that emerged for recipient selection (at least three organizations) was the existence of a ‘sister organization’ in the recipient country that could act as a partner for the donation initiative. in one case, the recipient cannot always be controlled because the organization relies on volunteers to bring supplies overseas and to find a suitable recipient upon arrival. unfortunately, when relationships are formed informally, they can also easily dissolve. for example, one organization said that they will no longer work with certain countries due to poor experiences that made them not want to go back. communication another key element of a donation initiative is communication between all stakeholders involved. fifty eight percent of 38 survey respondents said they communicate directly with the recipient hospital or clinic when planning a donation. with these cases of direct communication, the recipient contact person varied and included people involved in receiving/distribution, medical directors, and ministry of health representatives. one organization has local volunteers in the recipient country (1 to 3 per hospital) that help coordinate the donations and provide training to healthcare staff at the recipient hospitals. for those canadian organizations that do not communicate directly with the recipient hospital, their main point of contact was often another ngo working locally to coordinate the donation, or a sister or satellite branch of their own organization. forty-seven percent reported communicating with a sister charity or organization and 44% with an independent organization in the recipient country. only 31% reported they correspond with government officials in the recipient country. other stakeholders included sister organizations in the us, religious groups, and equipment providers in the us. sixty-one percent of organizations communicated with multiple stakeholder groups. the most common mode of communication was email (94% of 35 responses), however in-person communication was also common (71%). telephone was used more figure 2. percentage of organizations that reported donating (a) different types and (b) different sizes/complexity of equipment. in (a), the other category includes mobility aids, pharmaceutical supplies and medicines, school supplies, vehicles (buses, ambulances), office furniture, computers, and funding (to support other organizations that donate equipment) (n = 41). in (b), the other category includes medicines, vitamins and wound care supplies (n = 36). bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives j global clinical engineering issue 2:22-34; 2019 26 than skype (54% versus 20%), which could be indicative of widespread use of cellphones in low-resource settings and poor internet connections. one organization said they use shared file systems as a mode of communication (e.g., dropbox and google drive) when planning a donation. seventy-four percent of organizations rely on more than one mode of communication. meeting recipient needs one of the most important stages in planning a donation is determining the needs of the recipient. our interviews revealed many different needs assessment strategies employed by donor organizations. one organization has a system in place where potential recipients can submit a ‘wish list’ that the organization will try to fill. another said they perform a thorough needs assessment and impact assessment in person every three months at each of the hospitals they work with; the organization’s founder speaks directly with the health care staff (doctors and nurses) in every ward and asks what they think they need more than anything else. from this feedback, they produce a list of the most needed pieces of equipment. other organizations tend to respond to requests from recipients; one stated the needs assessment process is a long email exchange with potential partners in which they determine whether the partner is serious, credible, and capable of receiving a container and getting the equipment to work; another said that they identify needs through a doctor that has actually travelled to the country. two of the organizations interviewed deal exclusively in mobility devices. in one case, an advocate in the recipient community (typically a school principal, mayor, doctor) prepares applications for each potential wheelchair recipient hip size, length, what type of leg support is needed, etc. along with photos. the donor organization then works with the advocate who receives the shipment and coordinates getting the chairs to the right recipients. another organization mentioned that they are not always able to match needs directly and, based on the available supply, will send a standard set of equipment in their shipments, whether the recipient country has indicated a specific need or not. planning and the donation process while many individuals and organizations are highly motivated to provide aid where needed, all donors face significant challenges with the logistics of the donation process. unfortunately, for many donors, these challenges can prevent donations from reaching their intended recipients. equipment sources most organizations (62% of 37 responses) rely on several different sources for the equipment they donate to developing countries. for example, one organization stated in their interview that they collect equipment from hospitals, seniors’ homes, private homes, and group homes. another said about 75% of the equipment they send overseas is sourced from the us, some of it brand new but acquired at a considerable discount. based on the survey responses, medical clinics and hospitals were the most common source of equipment (about half of the organizations sourced equipment from such places), however manufacturers, second-hand equipment vendors, seniors homes, other non-profit organizations, institutions such as universities and colleges, and individuals (mainly from home care situations) were also listed as sources of equipment. pharmaceutical and drugstore companies also donate surplus pharmaceutical products such as pain killers, flu medication and burn gauze that are fully fda regulated, newly packaged and have six months or more until expiration. equipment testing once the equipment has been procured from their respective sources, some of the surveyed organizations conduct technical quality control and repairs before shipping to the recipient (fig. 3a). the most common check was for power compatibility (63% of 27 responses) and the least common was equipment calibration (30%). fifteen per cent of organizations performed no testing at all on the equipment they donate. only 13 organizations (43% of 30 responses) reported having a volunteer or staff biomedical engineer available, which may have implications for the level of technical testing that is possible before equipment is shipped overseas. for example, two organizations shared in their interviews that they get 27 j global clinical engineering issue 2:22-34; 2019 bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives volunteer technologists or engineers to inspect equipment as a quality control measure before it is shipped. one international organization relied on a workshop in their us location for repairs; they also partnered with a repair shop in the recipient country so that repairs could be done locally. due to limited time, resources, and capacity some organizations reported that they are simply unable to perform any equipment testing. shipping most organizations surveyed (72% of 32 responses) send shipments in 20’ or 40’ foot containers by sea. the next most common form of shipping was via checked baggage of volunteers traveling to the recipient country (25%) followed by air freight (19%). some organizations are able to send containers overseas monthly or every two months, while others send shipments annually. one organization estimated that they send 35 containers per year. it is also common that shipments are sent irregularly, for example, whenever a container is filled or when volunteers are traveling overseas and are able to take donations with them. shipping costs represent a major challenge for donor organizations when planning donations overseas. the surveyed organizations have reported shipping costs ranging from $4,000 $12,000 cad per shipment. these large sums of money are mostly gathered through fundraising efforts and sometimes through grant applications. in other cases, organizations have negotiated agreements with shipping companies to waive fees, arranged for embassies of the recipient countries to cover the costs of shipping, or even used connections to arrange for free transport between warehouses. one organization reported that in their case the recipient assumes the cost of shipping and that it depends on the organization whether they organize the shipping details or not. in an effort to help reduce overall shipping costs, it was reported in an interview that a canadian shipping company offers complimentary domestic shipping of wheelchairs from any canadian city to vancouver (to then ship internationally). unfortunately, donors often cannot transport the wheelchairs to the shipping company itself, so this service remains heavily underutilized. another organization was able to arrange free air cargo transport of donations through a canadian airline. figure 3. percentage of surveyed organizations providing different types of support (a & b) before and (c & d) after shipping a donation. (a) technical quality control prior to shipping, including compatibility with line voltage/frequency of destination country, functionality, electrical safety, completeness of accessories, and checking calibration against manufacturer specifications (n = 27). (b) supplementary materials or services provided with donated equipment (n = 27). other includes packaged goods, donations, clothing, funding to support sustainable projects, and biomedical engineer visitations. (c) information collected from recipients after the donated equipment has been delivered (n = 36). other includes installation, follow-up onsite visitations, ongoing usage reports, and patient data. (d) post-donation requests from recipients for additional support (n = 20). bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives j global clinical engineering issue 2:22-34; 2019 28 customs once the equipment has successfully been shipped outside of canada, the next major challenge is getting through customs. in addition to paying duties, differences in culture and infrastructure of the recipient country need to be considered. while some organizations prefer not to donate to countries if they are charged duty fees, others have partner organizations based in the recipient country who can negotiate the receipt of the equipment. organizations that deal directly with customs have reported incidences of port officials expecting bribes or additional payment. for example, in one case an entire shipment had to be abandoned at the port because the cost of storage was greater than the value of the goods being shipped. donating organizations have found that shipping items that are available in the local market, such as clothing, can introduce difficulties with customs clearance due to the impact these products can have on the local economy. one organization said they try to purchase goods locally whenever possible in an attempt to provide cash flow to the recipient country, helping the local economy in a different way and avoiding custom fees and shipping. regulatory and policy considerations another challenge organizations face is deciding how to interpret canadian medical device regulations drafted by health canada.9 as a result, some organizations have stopped donating altogether to avoid the issues of perceived liability. others have created their own legal documents and have the recipients sign a medical release waiver when they accept the donated equipment. support for recipients in addition to donating medical equipment, many organizations provide additional support materials and services in order to ensure successful equipment usage. operator manuals are the most common resource provided to recipients, but only about half of the organizations surveyed provide service manuals, spare parts, and disposables (fig. 3b). one organization told us since not all manuals are available online, it is difficult for recipients to find them, further exacerbated by downloading issues due to poor network connections. this could also explain why so few organizations (4% of 27 responses) make use of video-conferencing as an additional mode of support. sending people overseas to help with the arrival, installation, and training of donated equipment is a challenge for many organizations due to the cost and time commitment involved, but some (35%) are able to provide this extra support by one of the following ways: • returning to the same country year-after-year and has established a three-week camp where they repair and help fit users to wheelchairs; • providing training programs on how to use the equipment once it has been donated, and has contacts affiliated with their organization in the recipient country that play an ongoing role with equipment use and support; • sending a team of biomedical technicians overseas around four to five times a year along with service manuals, and ensures that the equipment is fully serviced before shipping it out; • sending volunteers overseas to help set up equipment (volunteers pay their own way). follow-up and monitoring the final stage in the donation process is long-term monitoring in order to measure the effectiveness of the donation. we asked organizations about the information they gather from recipients after a donation has been made, and whether or not they receive any follow-up requests from the recipients. most of the surveyed organizations (70% of 36 responses) request confirmation that the equipment was received and put into service, but only 50% verify that it arrived in good working condition (fig. 3c). even fewer (36%) collect reports of equipment faults or failures after it is put into service. seventeen per cent of survey respondents said they do not collect any information at all. we learned from the interviews that while some organizations request formal documentation or reports confirming receipt and/or functionality of equipment, in general the feedback that many receive is informal (e.g., thank you notes, pictures of the equipment at its final destination) and sometimes indirect (e.g., newsletters of recipient organizations). one organization we interviewed 29 j global clinical engineering issue 2:22-34; 2019 bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives was particularly committed to monitoring their effectiveness. they had a public health specialist conduct a program evaluation, identifying what their organization was doing well and where they were weak. their commitment to data collection and transparency has helped them to improve their effectiveness as an organization. another said they track each item they donate in case there is a manufacturer recall, in which case they are able to notify the recipient country. another measure of the effectiveness of a donation is the extent to which the recipient requests additional support and/or materials (fig. 3d). the most common follow-up request is for spare parts (which is consistent with our findings from the survey of recipients in ghana summarized in 3.2 recipient perspective) followed by disposables and training. as discussed above, not all organizations include operator and user manuals with their donations, and so it is perhaps not a surprise that these manuals are often requested. only three surveyed organizations (15% of 20 responses) reported that they did not receive any additional requests from recipients. recipient perspective surveys with stakeholders at 28 hospitals in ghana provided valuable insight into the recipient perspective with respect to medical equipment donations. note that not all of these hospitals necessarily received donations from canadian organizations. consultation communication an important element of the equipment donation process that we wanted to learn about was communication between donors and recipients, particularly when it came to the identification of equipment needs. when asked about the last donation received, 96% of respondents reported that there was communication with the donor agency before the donation was shipped, and 86% reported that the donor discussed their needs or asked what their greatest needs were in advance. equipment needs were requested or identified in several different ways, either through a form or survey given by the donor (18%), a wish list submitted in advance by the recipient hospital (18%), or simply via direct communication between the donor and hospital administrators (11%). in a couple of cases (7%), a representative of the donor organization came to the hospital to discuss the needs of the hospital in person. meeting recipient needs two-way communication between the donor and recipient to identify needs prior to delivery is extremely important for a donation to be effective. 7% of respondents added that this communication enabled them to make additional requests, some for very specific parts (e.g. fuses), allowing them to better operate medical devices they already had. the communication of equipment needs, however, did not always result in needs being met. one hospital mentioned that despite supplying a list of needed equipment, those items were not included in the shipment. 11% said they were not consulted at all about the equipment they needed, and one hospital commented that they had received a “surprise package” planning and the donation process equipment testing all recipient hospitals reported that donated equipment typically arrives in working condition, however 25% said they had received donations in the past that were missing accessories essential to the operation of the device, and 18% had received equipment that was faulty. for equipment that does arrive in working condition, 61% of respondents estimated that it lasts less than two years before breaking down. although 46% of hospitals said they can often repair broken equipment, repairs can take weeks or even months depending on the parts and or expertise required. support for recipients upon receipt of donated medical equipment, most donor organizations provide on-site installation of equipment, verification of functionality, and user training. on-site service training was less commonly provided (fig. 4). the types of support provided were installation, verification, user training and service training with service training providing the least support (fig. 4d) and verification the greatest support (fig 4b). when asked about common problems encountered with medical equipment donations, the most common bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives j global clinical engineering issue 2:22-34; 2019 30 problem mentioned was a lack of spare parts (57%), followed by lack of operating and/or service manuals (32%) and issues with consumables, either lacking or expired (21%). these percentages are based on responses to an open-ended question. for example, figure 5 shows the percentage of recipients who reported that the received donations included spare parts, and whether spare parts were available locally. all responses were either some or none (fig. 5). figure 6 shows that less than 35% of recipients always receive operating manuals, service manuals, consumables or accessories. other common problems encountered included: power issues (e.g., the equipment was meant for the wrong voltage, or was too sensitive to power fluctuations), or the equipment was not durable or appropriate for the setting (e.g., the climatic conditions impaired the functioning of some equipment). figure 4. on-site support for donated equipment – recipient facilities (n = 28) were asked if donor organizations provided (a) installation assistance, and (b) verification of functionality. they were also asked if donor organizations provided (c) user training, and (d) service training. yes = blue, no = red. recipient responses are given as a percentage. recipient feedback recipients were also asked to describe in their own words what they thought could be done to improve the effectiveness of medical equipment donations to ghana. the following are some illuminating responses: • “thorough needs assessments of beneficiary facilities should be done. equipment donated must meet these needs.” • “all donations must go with initial user trainings and monitoring by the donors as to the functionality of the equipment.” • “should make available consumables and if possible link users to sources of this items they can be procured by users when it’s finished.” • “tax exemptions on these equipment. removal of bureaucratic barriers.” despite the challenges and common problems encountered, when asked whether donated medical equipment benefited their organization 100% responded positively. donated electronic medical equipment allowed greater efficiency and accuracy for diagnosis, therefore reducing the burden on the nurses and staff, and allowing for better quality of care. 48% of respondents answered that donated equipment helped in cost reduction, with 51% stating that donated supplies either reduced the burden on health care providers or helped with patient management. furthermore, one of the facilities noted that figure 5. availability of spare parts. percentage of surveyed recipient hospitals (n = 28) that reported (a) donations included spare parts, and (b) spare parts were locally available. yes = blue, some but not all = green, no = red. figure 6. support materials for donated equipment. percentage of surveyed recipient hospitals (n = 28) that reported receiving (a) operating manuals, (b) service manuals, (c) consumables, and (d) accessories with donated equipment. yes = blue, some but not all = green, no = red. 31 j global clinical engineering issue 2:22-34; 2019 bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives medical equipment allowed for reduction in premature fetal mortality rates. discussion and next steps over 40 organizations and hundreds of volunteers across canada are involved in the donation of medical equipment to developing countries. we have found that these organizations varied considerably in terms of the size of their operation, the types of equipment donated and the processes they follow when carrying out a donation initiative. there are many resources available to help donor organizations effectively plan and execute all of the phases of a donation activity. 2, 10, 11, 12, 13, 14 these resources cover everything from deciding whether to donate to how to deal with international shipments to putting equipment into service at the recipient institution. a common theme in all the published guidelines on equipment donations is the importance of three core elements (fig. 7): (a) consultation ensuring that the needs of the recipient are well understood and have been established through communication with all parties involved; (b) planning and process having a clear donation plan identified and agreed to in advance by all stakeholders, including comprehensive quality assurance assessments; and (c) monitoring and follow-up developing a sustained and supportive relationship with the recipient institution, figure 7. three main phases of a medical donation process. consultation, planning & process, and follow-up & monitoring . ensuring long-term success and impact we have created a video which clarifies the benefits of including these core elements in the donation process.10 we have found through this study that many canadian organizations find it challenging to adhere to such guidance due to limited staff and financial resources. donation strengths and opportunities for improvement most canadian organizations appear to be doing well at identifying needs and communicating with a wide range of stakeholders in the recipient country including healthcare workers, representatives from the ministry of health, and sister or local charities when planning a donation. the recipient survey corroborated this finding as well, with the majority of respondents reporting their needs were discussed with the donor in advance. there is also much evidence of how these different canadian organizations are having a positive impact on the communities in which they work, for example, providing wheelchairs and other mobility aids to help people to become more active members of their community, or training local staff to repair & maintain wheelchairs. working with sister organizations in recipient countries helps the sister organization to continue actively working in their communities. despite these strengths, however, there are still opportunities for improvement (fig. 8). in the area of planning and process, we found that donor organizations had limited written policies and procedures to guide and govern their operations (e.g., only one interviewed organization had developed standard operating procedures (sops), and very few had systems in place for documentation). formalizing procedures is a widely accepted practice in well-run organizations. documenting every step in a process helps maintain quality and ensures that consistent practices are followed. (e.g. one organization uses a computerized inventory system such that boxes leaving a warehouse can be scanned and removed from inventory automatically; another organization uses an online tool, google forms, to solicit and track equipment donations.) based on our survey, we found a general lack of comprehensive quality assurance testing before equipment is shipped. recipients reported incompatible voltage, bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives j global clinical engineering issue 2:22-34; 2019 32 faulty equipment, and missing accessories as common problems, which could have been mitigated with proper inspection and testing. the fact that 57% of organizations did not have a volunteer or staff biomedical engineer to help with testing represents an opportunity for the biomedical engineering community in canada to become more involved and engage with donor organizations to help improve the effectiveness of donations. canadian organizations can also improve when it comes to providing additional support with equipment donations in the form of operator and service manuals, spare parts, accessories and training. spare parts in particular were the number one follow-up request from recipients (according to donors), and the number one problem encountered by recipients in ghana. when it comes to monitoring and evaluation, in general there is a lack of information sharing post-donation about short-term and long-term equipment functionality. this means that most organizations cannot measure the success of their donations or the impact they are having in the recipient countries. it was apparent from our interviews that organizations that have developed a long-term relationship with a particular recipient and return to the same location year after year are better able to monitor progress and identify issues, even without any formal feedback system. donors should be formally requesting feedback, and recipients should be proactive in communicating how well things are working, so that both parties can mutually track donation effectiveness. this process is facilitated when a figure 8. four main areas of improvement for canadian organizations to focus on: formalizing procedures through documentation, better equipment testing prior to shipping, better long-term support for recipients, and monitoring that includes evaluating donation impact. long-term partnership is formed between the donor and recipient, and the donation is not a one-off transaction. the wide range of capabilities among donor organizations suggests an opportunity to share knowledge and best practices, so that they can learn from each other and better address the four areas for improvement as shown in fig. 8. recommendations based on the disparities in practices observed in canadian donor organizations, and the disparities in resources available, it would be beneficial for all donor organizations to communicate and collaborate with one another when planning donations overseas (fig. 9). there could also be opportunities to economize (e.g., sharing a shipping container), improve the matching of available equipment with known needs, or share resources (e.g., volunteers, engineering expertise), to improve the efficiency of operations. it would also be beneficial for organizations to share their donation experiences and challenges with one another (positive and negative) so that others can learn from them, especially if they are doing something innovative. it may be beneficial to create a network for such communication, for example many internet based tools are available that could facilitate building such a community for the sharing of information. 33 j global clinical engineering issue 2:22-34; 2019 bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives lastly, since many organizations do not have the resources or volunteers available to travel to recipient destinations to help with equipment installation, training and maintenance, innovative solutions to the challenge of long-distance equipment support and maintenance are needed. while most organizations are able to use email for basic communications, other tools such as whatsapp, viber, or file-sharing applications such as dropbox or google drive, which are not bandwidth-heavy or do not require constant internet connections, could be used more frequently to help plan and support donations and share resources. conclusion thanks to the generous donations of canadian charities and non-profit organizations, almost 50 countries around the globe have received critical medical equipment to help improve the delivery of healthcare and support healthy communities. through this study, we found that these donations have provided everything from simple figure 9. donation community in canada. individuals, groups of volunteers, and small and large organizations across canada collectively have valuable knowledge and experience that could benefit others engaged in donation work. better communication, collaboration, and sharing of resources and expertise among these groups could lead to more effective donation practices for everyone and better impact globally. frontline equipment such as blood pressure monitors and pulse oximeters, to mri and x-ray machines.. the donation process presents challenges to donating organizations, most significantly in shipping equipment, passing customs barriers, ensuring compatibility of equipment, and providing support for recipients. based on our interviews with hospitals in ghana, the most prominent recipient challenges include a lack of spare parts, access to service manuals, and replenishment of consumable items. to overcome the challenges for both parties, successful donor practices include consultation with recipient countries to ensure needs are met, careful planning of the entire donation process to provide a clear plan, and finally monitoring and follow-up to facilitate long term success. we strongly believe that more effective collaboration and communication between canadian donor organizations would reap tremendous benefits for recipient countries, and create opportunities to economize and improve the effectiveness of medical equipment donations. acknowledgements project partners include: the international outreach committee of the canadian medical and biological engineering society (cmbes); food for the hungry, canada; centre for global engineering, university of toronto; and the ghana biomedical engineering association (gbea), with whom the cmbes has had an ongoing partnership. shahrzad mirzazadeh is acknowledged for conducting the survey and interviews in canada. we gratefully acknowledge all the canadian organizations that participated in our survey and/or interviews, as well as the health professionals in ghana that provided responses to our recipient survey. this work was carried out with the aid of a grant from the international development research centre, ottawa, canada. compliance with ethical standards ethical approval informed consent was obtained from all individual participants included in the study. conflict of interest the authors declare that they have no conflict of interest. bradley, yoon, zahedi, adusei-poku, zienaa, adjabu, cheng, gentles: medical device donation practices in canada: a survey of donor and recipient perspectives j global clinical engineering issue 2:22-34; 2019 34 references 1. dyro jf. donation of medical device technologies. clinical engineering handbook. elsevier academic press; 2004. pp. 155–158. 2. world health organization. medical device donations: considerations for solicitation and provision. in: world health organization [internet]. 2011 [cited 11 oct 2018]. available: http://apps.who.int/iris/bitstr eam/10665/44568/1/9789241501408_eng.pdf 3. perry l, malkin r. effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? med biol eng comput. 2011;49: 719–722. 4. world health organization. guidelines for health care equipment donations [internet]. 2000 mar. [cited 11 oct 2018] available: http://apps.who.int/iris/ bitstream/10665/70806/1/who_ara_97.3_eng.pdf 5. zomboko fe, tripathi sk. challenges in procurement and use of donated medical-equipments: study of a selected referral hospital in tanzania. researchers world. educational research multimedia & publications; 2012;3: 41. 6. howie s, stephen h. beyond good intentions: lessons on equipment donation from an african hospital. bull world health organ. 2008;86: 52–56. 7. authors, a canadian-ghanaian partnership for improving health technology management. 7th international conference on appropriate healthcare technologies for developing countries. 2012. doi:10.1049/cp.2012.1469 8. charities and giving [internet]. 17 jun 2007 [cited 11 oct 2018]. available: http://www.cra-arc.gc.ca/ charitiesandgiving/ 9. canadian medical devices regulations. in: government of canada, justice laws web site [internet]. 17 jul 2016 [cited 11 oct 2018]. available: http://laws-lois.justice. gc.ca/eng/regulations/sor-98-282/ 10. cmbes donations video [internet]. youtube; 2015. [cited 11 oct 2018] available: https://www.youtube. com/watch?v=r27cppawl1y&feature=youtu.be 11. mullally s. making it work: a toolkit for medical equipment donations to low-resource settings [internet]. 2013 [cited 11 oct 2018]. available: https://www. thet.org/wp-content/uploads/2017/08/thet_makingitwork_toolkit_final_online.pdf 12. keller k. pqmd guidelines for quality medical product donations [internet]. the partnership for quality medical donations; 2016. [cited 11 oct 2018] available: http://www.pqmd.org/wp-content/ uploads/2015/07/pqmd-standard-v5-april-2016.pdf 13. bmet digital library [internet]. [cited 11 oct 2018]. available: http://library.ewh.org/ 14. frank’s hospital workshop [internet]. [cited 11 oct 2018]. available: http://www.frankshospitalworkshop. com/index.html 9 j global clinical engineering vol.5 issue 3, 2023 in our continuous efforts to encourage sharing of knowledge and publication of engineering and scientific work related to the clinical engineering field, we were invited to review this newly published book. we hope that you will find it helpful to your career and at the same time promote the submission of other books for review by our community experts who serve the benefit of all our readers. biomedical device technology principles and design, (3rd edition), by anthony y.k. chan, isbn 978-0-398-09392-1 (hard copy), isbn 978-0-398-09393-8 (ebook), charles c thomas, publisher, ltd., published february 2023. price $79.95us. biomedical device technology: principles and design: 9780398093921: medicine & health science books @ amazon.com (last visited on april 26, 2023). this book review is a combined summary of three practitioners from the clinical engineering global community. an academician, a national health technology and quality manager, and an international consultant. for this purpose, charles c thomas publisher, ltd., provided copies of the books to the reviewers. the author dr. anthony chan is a well-qualified professional engineer, a chartered engineer, and a certified clinical engineer. he holds a ph.d. in biomedical engineering and a certificate in health services management. during his career, he has presented and published in both domestic and international congresses, on safety, risk management and technology management. in the preface section of the book, the author writes that “this book focuses on applications, functions and principles of medical devices… and uses specific designs and constructions to illustrate the concepts where appropriate.” the primary function of this book is to describe the basic working principles of medical devices used for diagnostic and therapeutic in the healthcare area, though imaging equipment is not included. for a better understanding of the equipment working principles, the author presents a brief but sufficient description of the physiologic parameters and transducers used for the measurements of these parameters for each of the devices described in the book. some mathematical concepts are introduced to help the understanding of the capturing and processing system used by these devices. in addition to the preface, the book is organized into four parts consisting of 38 chapters, four appendices, an interesting set of review questions, and an index for a book review by thomas judd1, saide calil2 and yadin david3 1 ifmbe ced past chairman and gcea’s liaison director 2 gcea’s professional development and educational program committee chairman 3 gcea’s interim president biomedical device technology principles and design, (3rd edition) anthony y.k. chan isbn: 978-0-398-09392-1 (hard copy) isbn 978-0-398-09393-8 (ebook) academic press: charles c thomas, publisher, ltd first edition: published february 2023 book price: us$ 79.95 http://www.globalce.org http://www.globalce.org http://amazon.com j global clinical engineering vol.5 issue 3, 2023 10 total of 901 pages. part i – presents a miscellaneous set of basic concepts about; how to classify medical devices, biopotentials, physiological signals, safety, biocompatibility, human factors, and several other subjects. in fact, the author’s intention is to lay the foundation and prepare the reader for what is going to be presented in the following chapters of the book. it also includes an introductory explanation of the mathematical concepts related to error measurements, signal processing, and analysis. such concepts can help the reader to have a better general understanding of the scientific instrumentation foundation involved in medical devices. part ii – presents a wide variety of transducers used by medical devices. it is divided into eight chapters dedicated to explaining several specific types of transducers. each chapter presents a quite didactic explanation of the operating principles of: pressure and force transducers; temperature transducers; position and motion transducers; flow transducers; optical transducers; electrochemical transducers; and biopotential electrodes. each chapter provides an educative concept about transducers that are not only used in medicine but in a wide range of measuring instruments used from maritime exploration to kitchen devices. part iii – has three chapters that bring the concept of building blocks of medical devices and explain the basics and most common electronic circuit used to capture and process the electrical signals sensed by the transducer and the associated instrumentation amplifier. this part also discusses issues related to electrical shock hazards, including macro and micro shocks, grounded and isolated power systems, and methods to reduce electrical hazards. part iv – presents a total of 24 medical devices, generally explaining their applications, basic building blocks, different applications for the device, and common problems and hazards. it is not an extensive but sufficient description for the reader to understand the device well. an added feature is that in addition, each device has a specific description of issues that helps the reader to better understand its working principles. this section also presents a dedicated set of bibliographic references for each piece of equipment. like previous sections of the book, most of the references noted material up to 2016 from when the 2nd edition was published. as the author writes in the preface “…medical devices have a life span of about 5 to 7 years.” which suggests that more recent references will add to the readers’ knowledge. the book also contains four appendices where the first presents a primer on fourier analysis, the second an overview of telemetry development, the third is about medical gas supply systems, and the fourth offers an explanation of the concepts of surgical asepsis and device infection control. complementing the book, the author elaborated with a list of review questions, one set for each of the chapters previously presented. in general, it is a very useful foundation of design and principles of devices that are used within and outside the healthcare environment and is useful for the training of clinical and biomedical engineers. some important technological areas, such as digital health or mechanical ventilation are omitted. covid-19 pandemic instrumentation like cpap and oxygen concentrators are limited or missing. we like the structure of the book content and note that the book delivers fair depth and scope well-suited for academic programs. however, the book could be strengthened by offering more recent references than those already included in the 2nd edition, and more recent applications of pandemic-related devices. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering issue 2:4-16; 2019 4 received november 18, 2018, accepted march 02, 2019, date of publication march 21, 2019 evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer by m. a. hossain1, m ahmad2, m r islam2, and y david3 1 national electromedical equipment maintenance workshop & training center, dhaka under the ministry of health & family welfare, government of the people's republic of bangladesh 2 department of electrical and electronic engineering, khulna university of engineering & technology (kuet), khulna-9203, bangladesh 3 principal, biomedical engineering consultants, llc, usa abstract with the rapid development of medical equipment technology, the quality of patient care becomes under the spotlight of clinical engineering management of medical equipment since the past 4 decades and it is continually. researchers give in-depth attention to minimize undesired incidents which are associated with medical and surgical equipment such as patients' unnatural deaths and injuries. this proposed research work investigates the relationship between performance outcomes of medical equipment technology management/patient-care technology and the reduction in undesired events like injury and even unnatural deaths. this proposed research work investigates the effect of varying levels of performance on quality of patient care and uses an indicator such as patient safety (ps) and cost-effective care by applying mathematical modeling of clinical engineering approach methodology to medical equipment technology management. in this study the quality model of clinical engineering departments is determined by educational qualification, clinical engineering (ce) certification, training, and duration of experiences in this field. the standard performance of patient-care technology management is determined by the parameters of medical devices and the outcomes performance of medical equipment is determined. data for this study was collected from 18 countries including from high, upper and lower-middle income regions. we were able to collect and analyze data of different performance levels of ce and biomedical engineering programs. the analysts' report measures the performance outcomes of medical equipment technology management system (metms) and its impact on patient-care outcomes specifically impact on the reduction of patient risk factors associated with medical and surgical equipment. the findings should encourage researchers and healthcare stakeholders to better integrate the clinical engineering professionals in a hospital in order to achieve a safe functional condition of medical equipment to keep its scheduled life span in compliance with recommended span declared by manufactures. cost-effective clinical engineering department (ced) model can be designed and monitored through the methodology of this study. we hope that this study will motivate the deployment of senescence methodology for conventional electro-medical assets, by biomedical engineering and medical professionals, healthcare policymakers, equipment users, and vendors to improve outcomes as proposed by the research work described in this paper. keywords – clinical engineer, clinical engineering department, medical equipment technology, hospital, quality of patient care 5 j global clinical engineering issue 2:4-16; 2019 hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer introduction ensuring the quality of patient care when medical equipment is deployed becomes a global issue and must be addressed in order to avoid unintended patient outcomes. qualified clinical engineer's knowledge and methodologies are used as an approach to reduce risk factors associated with the use of medical and surgical equipment.1,2 this proposed research work investigates the relationship between performance outcomes of medical equipment technology management/patient-care technology and the reduction in undesired events like injury and even unnatural deaths. despite the continuous necessity to ensure the quality performance and impact on patient outcomes of medical equipment technology the establishment of the standardized ratio of clinical engineering department (ced) in hospitals under public healthcare system, many countries could not fully accept it. as a result, every year, many patients have been subjected to serious risks and even unnatural death which was not reported to agencies in many countries. for lowerand middle-income counties, this data is often hidden and frequently, both the doctors and patients were not aware of the cause.3–5 this proposed research work investigates the effect of varying levels of performance on quality of patient care and uses indicators such as patient safety (ps) and cost-effective care by applying mathematical modeling of the ce approach methodology to medical equipment technology management. in this study quality model of ced's is determined by educational qualification, ce certification, training and duration of experiences in this field. the standard performance of patient-care technology management is determined by the parameters of medical devices and the outcomes performance of medical equipment is determined.6–8 data for this study were collected from 18 countries including from high, upper and lower-middle income regions.9 while technology reliant patient-care services can vary widely in their dependency, the ratio of clinical engineering professionals serving the population can be one indicator that is common to many regions. one clinical engineering professional (cep) can adequately service technologies supporting a population of 10,000 persons, and one ced can manage ce service program for region with a population of 10,000.9 quality performance of cep and medical equipment technology management system (metms) can be standardized by adopting parameters that relate to equipment performance such as unintended incidents, downtime, cancellation of patient examinations due to equipment issue, and similar known indicators.10,11 by using mathematical analysis, the performance outcomes of metms can be benchmarked and compared with other facilities.10 it must be remembered that even a 100-bed modern hospital operation is ensuring the quality and safety of patient-care in any zone of a country.10 the performance outcomes thus relate to patient-care outcomes and the status of patient safety (ps) can be measured by tools such as laptops, pen drives, internet modems, cell phones, and testing analyzer use for data collection. this investigation interpreted correctly, can contribute to the development of voluntary guidelines for adopting and improving performance reporting. similarly, patient-care organizations and groups actively involved in furthering measurement, management and reporting may use this methodology in assessing the impact of work carried out by them in adopting the ced model in hospitals to evaluate and enhance the performance of patient care like ps and educating them for ensuring the standard performance of memts.11 we were able to collect and analyze data of different performance levels of ce and biomedical engineering programs. the analyst’s reports measure the performance outcomes of memts and its effect on patient-care outcomes specifically on the reduction of patient risk factors associated with medical and surgical equipment. the findings should encourage researchers and healthcare stakeholders to better integrate the ceps in their hospitals in order to achieve a safe functional condition of medical equipment and to keep its scheduled lifespan in compliance with those recommended by the manufactures.12 a cost-effective ced model can be designed and monitored through the methodology of this study. despite barriers including low willingness, competing business group interests, and unethical pressure from some personnel within the healthcare system,13 it is for the benefits of the patients, their relatives, and taught stakeholders that well-managed healthcare technology has a positive impact on care outcomes and on the optimal use of limited healthcare resources. this investigation, if hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer j global clinical engineering issue 2:4-16; 2019 6 interpreted correctly, can contribute to the development of voluntary guidelines for adopting and improving performance reporting. similarly, patient-care organizations and groups actively involved in furthering measurement, management and reporting may use this methodology in assessing the impact of work carried out by them in adopting the ced model in hospitals to evaluate and enhance the performance of patient care like ps and educating them for ensuring the standard performance of metms. but, in spite of some challenges, the need for this proposed research work cannot be denied.13,14 we hope that this study will motivate the deployment of senescence methodology for conventional electro-medical assets, by biomedical engineering and medical professionals, healthcare policymakers, equipment users, and vendors to improve outcomes as proposed by the research work described in this paper. while an analytical approach to ps and cost-effective care has become the expectations of patients, this topic is starting to be explored in the literature, mostly concluding that additional data is needed. related definitions and terminologies while it is unreasonable to assume that clinical engineethis section uses definitions and terminologies related to the proposed research with subsequent subsections presenting different definitions and terminologies. evaluation evaluation is a systematic determination of a subject's merit, worth, and significance using criteria governed by a set of standards. it can assist an organization, program, project, or other intervention or initiative to assess any aim, realizable concept/proposal, or alternative that would help in decision-making, or to ascertain the degree of achievement or value in regard to the aim and objectives and results of any such action that has been completed. the primary purpose of evaluation, in addition to gaining insight into prior or existing initiatives, is to enable reflection and assist in the identification of future changes.15–17 in this study, we evaluate the performance outcomes of metms to understand the situation of ps. medical equipment technology management confusion is often seen in research with the use of some of the terminology such as healthcare technology (ht), medical technology (mt), medical devices technology, medical equipment technology (met). for better understanding, we submit an explanation in this section. the world healthcare organization (who) has defined ht as the “application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of life.18” the international network of agencies for health technology assessment has stated that ht includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems.19 but our proposed study deals with met which is one of the major elements of ht. in the united states, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients.20 wikipedia has stated that htm sometimes referred to as ce, ce management, clinical technology management, ht management, medical equipment management, biomedical maintenance, biomedical equipment management, and biomedical engineering.21 mt may broadly include medical devices, information technology, biotech, and healthcare services.21 alternatives terms have mentioned in 2 statements. among them, the term “clinical engineering management” is appropriate for the proposed research work. the justification for the selection of met management for this proposed study has given as the statement in the next paragraph. the synonym of clinical engineering is medical engineering and besides technology is one of the parts of engineering and clinical engineering role is to maintain the management of medical equipment. so according to references and discussions, the term clinical engineering management" can be used as "medical equipment technology management." for the entire proposed research work, the term medical equipment technology management is to be used. metms can be defined as the mechanisms for interaction and oversight of the medical equipment used in the diagnosis, treatment, and monitoring of patients. 7 j global clinical engineering issue 2:4-16; 2019 hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer the related policies and procedures govern activities from selection and acquisition to incoming inspection and maintenance of medical equipment. the main goal of metms is to ensure that the equipment used in patient care must be safe, available, accurate, and affordable. this article deals with the evaluation of the performance outcomes of medical equipment technology management system that are related to patient safety. advanced clinical engineer's approach although procedures can vary from one field of inquiry to another they are often quite similar. the process of a skilled ce method involves making hypotheses, deriving predictions from them as logical consequences, and then carrying out experiments or empirical observations based on those predictions such as quality of ced models and their contributions for appropriate controlling of met to ensure the ps.24 methodology the safe functional condition of medical equipment ensures it reaches its scheduled life span in compliance with manufacturers recommendations. these are the outcomes of ht management and it is actively related to patient satisfaction parameters such as ps, quality, and cost. however, this can not be ensured by many countries due to a lack of a skilled clinical engineer's approach. while the global ce forum has been trying to improve the quality of ceps in many higher, upper-middle income countries, lower-middle-income countries have not yet implemented the conventional engineering approach for managing the medical equipment in their countries. authors have stated that a conventional cep is 14% of the skills on metms. investigation reports show that the ps of these countries has become questionable and it is continually.25 subsequent studies provided additional quantitative data. in a landmark report, “to err is human: building a safer health system,” the institute of medicine estimated that medical errors cause 44,000 to 98,000 deaths annually in u.s. hospitals.26 we did not find any articles regarding met assessment in lowermiddle income countries such as bangladesh due to a chronic lack of a ce approach. investigation reports by the who in 2017 report that the density of biomedical engineering professionals and density of hospitals with biomedical engineering department unit/service are very poor to negligible in lower-middle income countries like bangladesh, bhutan, pakistan, nepal, sri-lanka and so forth.9 as a result, the performance outcomes of metms in these countries have not been good. the investigation report of the world bank has stated that more than 65% of medical and surgical equipment were not functioning in bangladesh public hospitals.27 functional equipment in the intensive care units of bangladesh hospitals provided much error-filled data. from the investigation report, we have observed that ps is very poor in the intensive care units of 6 modern hospitals in bangladesh due to the absence of hospital ceds.28 some of the issues are outlined below: a. the staffing model of the ced could not design and develop to match the workload and activities of the hospitals. b. the message of modeling a ce approach for evaluating the quality of patient care could not be properly disseminated among healthcare stakeholders properly thus eliminating the conventional engineering approach by the research. c. the concept regarding the importance of modeling of ceds and their relation to obtaining safe outcomes performance of metms as well as its relation with parameters of quality of patient have yet to be unexplored in the literature. d. both patients and medical doctors are not yet aware of the benefits of introducing quality ced models in the hospitals. objectives of this study are as follows: 1. to define the outcomes of metms and its impact to ensure ps 2. to investigate the present densities of cep and ced per 10,000 population 3. to analyze the outcomes of metms related to ced 4. to specify densities of cep and ced and their quality related to outcomes of metms 5. to evaluate the performance outcomes of metms to ps 6. to submit a recommendation for improving the present poor conditions hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer j global clinical engineering issue 2:4-16; 2019 8 the purpose of this section is to undertake a literature review focusing on ps by applying the quality model of ced. shaffer has submitted a statement regarding the selection criteria of one clinical engineer professional based on population and bed numbers of the hospital.26 the author stated “the recent history of this sub-discipline is somewhat erratic. in the early 1970s, ce was thought to be a field that would require many new professionals. estimates for the u.s. ranged as high as 5,000 to 8,000 clinical engineers or 5 to 10 clinical engineers for every 250,000 of the population, or one clinical engineer per 250 hospital bed.”26 from this statement, it is found that one cep was needed per 31,250 people in the u.s. the who literature has suggested that one cep is required per 10,000 people in general regions.9 from this statement, we have observed that the current demand for biomedical engineering professionals has significantly increased more than threefold over the past 48 years. this has been revealed by the earlier publication by shaffer.26 besides the densities of cep/bemp and hospital with ced/biomedical engineering unit/service were presented for per 10000 population of who enlisted countries respectively. the data are very much helpful for this study. pietro et al stated that an ht or met assessment process is conducted by interdisciplinary groups using explicit analytical frameworks drawing from a variety of methods.2 given the variety of impacts addressed and the range of methods that may be used in an assessment, several types of experts are needed in hta. among them, clinical and biomedical engineers are considered the key components for the hta. acce defines, the clinical engineer as a professional, who supports and advances patient care by applying engineering and managerial skills to ht.23 the performance of metms is very much important and related to the outcome of patient care and safety.9 eighty percent of metms is maintained by the hospital in-house ced, and clinical departments are responsible for maintaining the remaining 20% of metms.23 hossain et al have stated that a skilled clinical engineer maintains 52% of metms in the modern hospital and subsequently, a typical metm cycle is represented in figure 1.28 the who has stated that introducing quality biomedical/clinical engineering department unit/service is compulsory in modern hospitals to obtain the quality outcomes of metms.9 from a comprehensive literature review,11 it was found that it is very important to develop a model of ced which consists of a skilled clinical engineer, a ce technologist, and a biomedical equipment technician. their performances can be determined by basic education, accredited certificate on met, and length of services in this field. regardless of the necessity to design and introduce a quality ced model to optimize the use of met, many countries could not yet do so. as a result, the lower performance outcomes of patient-care technology reduced the quality of patient outcomes. a group of search results explored that ps has been reduced with rapid increases of complex medical devices in lower-middle income countries. this study investigated the quality model of a ced and its performance outcomes related to ps.6,11 it has also been shown common models of ced for ht management system for the hospitals. for example, a ced model is shown n figure 2. figure 2. does not include a clinical engineering technologist (cet) to ensure the safe operation of critical equipment such as a heart-lung pump machine. whereas, a group search results suggested that 3 types of engineering professionals must be considered such as engineers, technologists, and technicians.29 other studies (e.g., japan, malaysia) have also emphasized this to ensure safe figure 1. roles of the clinical engineering department to ensure the performance of medical equipment technology management systems parameters. 9 j global clinical engineering issue 2:4-16; 2019 hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer operation and preventive maintenance tasks.9,23 recent publications note that cets are very much important human resources to ensuring the safe operation of life support, therapeutic, and monitoring equipment in the critical care departments in a hospital.22 other studies suggest that cets are the best operators of life support, therapeutic, and monitoring equipment in the critical care unit, the intensive care unit, the operating theatre, and the dialysis, anesthesia, and emergency departments as well.29,30 integration of ces, cets, and biomedical equipment technicians (bmets) are shown in figure 3. metms are very much closed to ceds for patient care. certified staff from ceds are much better than conventional engineering department in hospitals. but, it is not possible to ensure all parameters of metms by ces because some parameters of metms are actively related to cets and bmets. the overdependence on the use of technology in every treatment step can result in severe figure 2. clinical engineering department model for a hospital in the u.s. figure 3. a basic model of a clinical engineering department for a hospital. ce = clinical engineer; cet = clinical engineering technologist; bmet = biomedical equipment technician. economic burdens for families and individuals. however, the cost can be minimized by ensuring the desired lifecycle of the medical equipment. from literature review results it was observed that the model of a ce approach can ensure the safe use of equipment up to the expected life span.22 the world health organization noted that one cep can be considered per 10,000 population. from the literature review results,22 the performance of ap can be considered as 100% subject to accessibility of the density of cep=1, per 10,000 people and the performance of gp can be considered as 100% subject to density of hospital with ced unit/service of 3.00 per 10,000 people to ensure 24-hour services. so, the performance of ap = 1 @ density of cep=1, and gp=100%. @ hospital density with ced unit/ service ced= 3 for per 10,000 population in a country. research methodology goal of the prospective research the main aim of the proposed study is to evaluate the performance outcome of metms by applying skilled a ce's approach to enhance the present ps. the sub-objectives of this proposed study are explained below: 1. to investigate and standardize the performance of ceps per 10000 people in a country. 2. to investigate and standardize the performance of ceds per 10000 people in a country. 3. to control the performance of ceds by ceps to obtain a standard output of metms for ensuring ps. research methodology and materials let rp and cp are the desired input and actual output metm that depends on the standard performance of ced. from the literature review results,3-5 it has seen that the performance of metms is dependent on the quality of the performance of the ceds. the ceps are the controller or regulator of the ceds and which control the performance of the ced (i.e., cep controls the performance of metms). here, cep is defined as the clinical engineering manager who monitors and evaluates the performance output of the ced. according to the basic argument in the literature review results and discussions, the methodology of the proposed study can be presented by figure 4.17 hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer j global clinical engineering issue 2:4-16; 2019 10 figure 4. proposed research methodology to evaluate the performance outcomes of metms that is with patient safety. based on the desired input quantity being improved, and on the actual output condition, the input and output variables can be modeled as safe functionality of medical devices up to their standard life span. according to fig.4 & basic feedback control theory, the output performance of gp can be measured by the following eq. (1) from eq. (1), it is seen that the value of cp is dependent on the value of ap and gp. so, this is needed to standardize the performance of ap and gp and thus from eq. (1), the value of cp can be measured. basic analysis of the proposed study the value of cp is dependent on gp and ap. figure 4 shows that ap works as a sensor for the system. so, for an enhancing output and stability of the system, the performance of ap must be kept in a standard setting point. besides, it is needed to keep the performance of gp as standard. we can consider the desired input or reference input such as the safe functional condition of medical devices up to their standard life span= rp=100%. as it is related to the ps and desired by the patient, 100% can be considered. it is obvious that patients do not expect to suffer unintended outcomes including accident, injury, or other harm from medical devices. for any value of gp, the value of (1+ap.gp) should be greater than gp and the value of cp/rp will be less than 1 or the value of cp will be less than 100%. for testing the proposed work methodology, let us consider ap=1 and gp=100% and by the calculated of cp will be 99%. from a group of search results it is found that the sensor's setting point 1 is standard.8,9,11 to set the standard value of ape=1, it is needed to standardize the performance of ap. besides, the performance of gp is needed to standardize. standardize performance of ap and gp the performance of ap of gp can be standardized by the following eq. (2) and eq. (3). from the literature review results, the performance of ap can be considered as 100% subject to accessibility of density of cep=1, per 10,000 population and the performance of gp can be considered as 100% subject to the density of hospital with a ced unit/service of 3.00 per 10,000 population to ensure 24-hour services.17 so, the performance of ape= 1@density of cep=1, and gp=100%. according to the literature it is observed that the density of a hospital with a ced is 3. 5 per 10,000 people in japan.9 it can also be considered that the density of a hospital with a ced service is 1 for 8 hours per 10,000 people. for ensuring 24-hour ced services with a minimum density of a hospital with a ced per 10,000 people can be considered as 3. according to a statement by hiroki igeta from the clinical engineering bank,9,31,32 it was observed in staff for a ce service structure that the quality of patient care was related to the number of the skilled human workforce. for example; the optimal ratio for medical doctors to population are 1:1000. available statistics show that over 45% of who member states report to have less than 1 physician per 1000 population. ceps and ces are not at the same levels. a cep is defined as a senior skilled ce. so, one cep can be considered for 10,000 people a standard setting point of ap. from a group of literature review results, it was observed that 24 hours of equipment services are required to ensure ps in the critical care unit.7–9,11 so, the ceds services are (2) (3) (1) ced = clinical engineering department; metms = medical equipment technology management system. 11 j global clinical engineering issue 2:4-16; 2019 hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer considered as 3 times for 24 hours. staff duty is considered as 8 hours and regarded as fulltime employ (fte). therefore, the density factor has considered as “3”. from the discussions, the value of ap and gp can consider as ap=1, to ensure 100% performance and ced= 3 to ensure the 100% performance of gp. so, the value of the sensor can be determined by the density of cep for 10000 population (d1). so, the relation between ape and d1 is inversely proportional. standard performance of d1 is set table 1. standard data related to the proposed study integer d1 ap d2 gin 1. 1 1 3 100% 99% 2. 0.9 1.11 2 66.67% 88.88% 3. 0.8 1.25 1 33.34% 78.12% 4. 0.7 1.43 0.9 30% 68. 34% by d1=1 and its inverse corresponding values are shown as ap. standard performance of d2 is set by d2=3 and its proportional values are shown by gp. for validation, the proposed work methodology the values of cp are shown. the standard data of ap and gp and their corresponding values cp are shown in table 1. table 1 shows the validity of the prospered research work methodology. next section uses for data collections and data analysis related to ap and gp. data collection to standardize the performance of ap and gp data collection has been accomplished by a survey conducted by the who in 2017. global dimensions of biomedical engineers,9 has submitted a survey report on d1 and d2. based on data and the basic theme, the existing data were analyzed and as ap and gp and outlined in table 2. table 2. present data of ap and gp for 18 countries country code the density of cep per 10,000 people (d1) ap density hospital with ced unit per 10,000 people (d2) gp in% any country 1 1 3 100 jpn 1.58 0.64 3.5 116 svn 0.84 1.2 1.35 45 bel 0.87 1.5 1.25 42 irl 0.7 1.42 1.21 41 kir 0.27 3.7 2.93 97 mys 0.82 1.2 0.84 28 pan 0.83 1.22 0.74 25 mng 0.81 1.18 0.74 25 fin 2.73 0.37 0.09 3.9 isr 2.48 0.42 0.09 3.9 rou 0.64 1.56 0.30 10 hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer j global clinical engineering issue 2:4-16; 2019 12 country code the density of cep per 10,000 people (d1) ap density hospital with ced unit per 10,000 people (d2) gp in% jor 0.67 1.49 0.16 5.33 aus 0.13 7.69 0.43 14.33 ind 0.34 2.94 0.12 4.00 zaf 0.06 16.67 0.34 11.33 mds 0.03 33.34 0.037 1.23321 btn 0.08 12.5 0.047 1.56651 pak 0.02 50 0.1 3.333 data collection and statistical analysis based on the analysis, the value of cp can be evaluated using eq.(4) below. so, the standard value of cp=99% and it is the output of metms(gp). cp=safe functional condition of medical (4) table 3. statistical data analysis of cp of 18 countries country code ap gp % cp jpn 0.64 116 178.841 svn 1.2 45 36.82 bel 1.5 42 27.60 irl 1.42 41 28.40 kir 3.7 97 26.14 mys 1.2 28 22.62 pan 1.22 25 19.84 mng 1.18 25 20.50 fin 0.37 3.9 6.25 isr 0.403226 3.9 5.92 rou 1.5625 9.999 6.01 jor 1.492537 5.3328 3.18 country code ap gp % cp aus 7.692308 14.3319 1.85 ind 2.941176 3.9996 1.25 zaf 16.66667 11.3322 0.68 mds 33.33333 1.23321 0.037 btn 12.5 1.56651 0.12 pak 50 3.333 0.067 equipment to reach its scheduled life span in compliance with the manufacturer’s recommendations. but, this factor is related to ps and thus the values of cp are proportional to ps. this research methodology can be used as the standard for any country. the analyst’s data in table 3 regarding ap & gp were used to evaluate the values of cp using eq.(1) and these values are shown in table 3. results and discussion the maximum value of cp has found as 178.84% in japan and the minimum value of cp has found 0.067% in pakistan. for authentication of the results, we examined the in-house ce models of japan and pakistan. according to the standard guideline of the who, we have seen that the maximum 12 ces were necessary for the aso hospital in japan.28 but igate and colleagues suggested 63 ces under the ced in aso hospital.32 he has stated 13 j global clinical engineering issue 2:4-16; 2019 hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer that improvement to the level of service for patients was a result of standardized clinical techniques ensuring the efficient and safe use of medical equipment. the performance of the ap has found as more than 1 and its corresponding sensor setting point of the feedback controller is 0.64 and is shown in table 2. on the other hand, the value of d2 is 3.5 and it is more than 3. this indicates that the performance of gp is higher than 100%. from the data of cep and ced, we have seen that japan has introduced more ces to cover 24-hours of services such as other intensive care unit professionals. besides, it is found that common medical equipment such as ventilators, defibrillators, hyperbaric oxygen therapy, hemodialysis, cardiac pacemakers, and surgical equipment have been operated by the cets. therefore, the performance output value of memts in japan is (1.80×99%) = 178.84% and that is 1.8-times higher than that of the standard actual value of cp. from the data, it was found that 10% of hospitals of pakistan have introduced the biomedical engineering department and the number of biomedical engineers was 0.02 per 10,000 people. therefore, the measuring feedback sensor setting point of this country was 50. the values of cp was found as 0.07% which is quite poor.9,32 analysis and discussion despite being developed countries, fin, isr, and aus, showed poor values of cp. the evaluated value of cp in japan was found to be much higher than the standard among the 18 countries. although the performance outcomes of metms of 7 countries were found to be less than that of the actual standard value of cp, it can still be considered. the analysts' reports also show that the cp values of 10 of the 18 countries were much poorer than that of the standard. limitation of data collection and analysis it is complex to get the data of ced models including staff numbers and hence we consider only the data of hospital with a ced. our proposal was to skilled ce’s approach and for this reasons cet and bmet data could not be collected due to a lack of secondary data in the literature. and thus, we evaluated the cp on combined data. but hossain et al stated that a skilled ce is responsible for ensuring 52% of the outcomes of the metm cycle.33 based on data, the standard cp and actual evaluated cp are shown in table 4. table 4 shows a comparative statement between standard and evaluate cp according to skilled ce’s approach and the data was validated by the secondary research method.9,30 patient safety and outcomes of metms summary of the literature review results confirms that patient safety is proportional to the outcomes of metms.34 table 4. standard and evaluated performance of outcomes of medical equipment technology management systems in 18 countries country code standard cp as published evaluated cp according to present data svn 52 36.82 bel 52 27.60 irl 52 28.40 kir 52 26.14 mys 52 22.62 pan 52 19.84 mng 52 20.50 fin 52 6.25 isr 52 5.92 rou 52 6.01 jor 52 3.18 aus 52 1.85 ind 52 1.25 zaf 52 0.68 mds 52 0.037 btn 52 0.12 pak 52 0.067 hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer j global clinical engineering issue 2:4-16; 2019 14 we note patient safety as ps and the outcomes of metms as cp. so, the relation between ps and cp can be explained by the relationship below in eq.(5). ps α cp the data from table 4 shows that ps is very much negligible in lower-middle income countries although the ps of some higher income countries was found to be poor as well. also, employing an outsourced ced is very expensive and risky for the patient. conclusion the goal of this paper was to understand the current performance outcomes of metm that are related to ps in 18 high, upper and lower-middle income countries. most of the developed countries have introduced a bmed service unit for their hospitals without studies which has led to overstaffing and understaffing models of ced/bmed that are not what is best for the patients. overstaffing can be expensive while understaffing models of ced are very inefficient when it comes to ensuring outcomes performance of metm and puts the patient at risk. while high and upper middle-income countries have been aware of ce issues, healthcare stakeholders in lower-middle income countries are generally not aware of this subject. this study brings effective results to raise the awareness of the present healthcare stakeholders to introduce one ced in the modern hospitals according to the workload and complexity of the met. this will improve the present undesired outcomes of metm and the associated patient risks. necessary recommendations to improve the present undesired conditions are included below. recommendations based on results and discussions, the following suggestions/recommendations have submitted to improve the present undesired conditions. 1. it is necessary to establish a ce association in each country under the umbrella of the global clinical engineering forum to disseminate the global clinical engineering issue. (5) 2. it is necessary to evaluate the performance of metm by utilisation of an advanced ce as the representative in countries that have not yet introduced models of ced in their hospitals. 3. the assigned advanced ce in a position to measure the performance outcomes of metm and publish reports in a yearly “health system review” of their concerns to motivate and to raise awareness among healthcare stakeholders. online course can be started to ensure certified globally ceps are available. 4. the local office of who in each country can invite workshop/seminar/national conference/quarterly meetings with healthcare stakeholders by lead by an advanced ce. 5. a member or country ambassador should be selected by the ced of the international federation of medical and biological engineering to further and share updated enhancements in ce. 6. more case studies should be published in gcej to promote the advantages and benefits of having an inhouse ced such as the reduction of patient risks and the reduction in healthcare operating costs associated with medical and surgical equipment management. 7. it is necessary to invite academic biomedical engineering departments from lower and middle-income countries to submit of research articles in this field. 8. there should be an effort to encourage the representatives from the who, jica, world bank, cida, usaid, and unicef to help in disseminating the message of “global clinical engineering” in their respective countries. acknowledgments we acknowledged this research work to the ministry of health & family welfare, government of bangladesh, biomedical engineering department, khulna university of engineering &technology, khulna-9203, bangladesh, nememw& tc, ministry of health & family welfare, dhaka, and global clinical engineering leaders. conflict of interest the author declares that there is no conflict of interest regarding the publication of this paper. 15 j global clinical engineering issue 2:4-16; 2019 hossain, ahmad, islam, 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20. inahta (international network of agencies for health technology assessment). hta glossary. inahta. archived from the original on may 26, 2009. 21. temple-bird. how to organize a system of healthcare technology management. healthc technol manag who 2015. 22. forum for asian clinical engineering. to face the globalization age of asian clinical engineering. proc. of first forum for asian clinical engineering (fface), osaka, japan, 2012. available at: http://osaka.jikeigroup.net/face/. 23. joseph d. clinical engineering definition of acce 1992. the biomedical engineering handbook, third edition. crc press; 2006. 24. wikipedia. scientific method. 2017. available at: https:// en.wikipedia.org/wiki/approach#other_uses 25. kohn lt, corrigan jm, donaldson m. to err is human: building a safer health system, institute of medicine (us) committee on quality of health care in america; washington (dc): national academies press (us); 2000.pmid: 25077248. 26. shaffer mj. clinical engineering: an in-depth review of its economic potential. med care 1977;xv(7)552–67. 27. clinical services / departments. christian medical college clinical engineering in india. available at: http:// en.wikipedia.org/wiki/clinical_engineering. 28. hossain ma, ahmad m, et al. clinical engineering and healthcare delivery performance measurement: basic module of clinical engineering department for 250 beds hospitals in bangladesh. proc med tec 2016. 29. hossain ma, ahmad m, islam mr, david y, et al. clinical engineering approach to improve healthcare technology management for enhancing healthcare delivery system in middle-income countries, proceedings of iccehtmc, brazil; 2017. hossain, ahmad, islam, david: evaluation of medical equipment technology management performance outcomes related with patient safety: a mathematical analysis of advanced clinical engineer j global clinical engineering issue 2:4-16; 2019 16 30. gurses ap, doyle p. medical devices in the "wild”. ahrq patient safety network. 2014. available at: https://psnet. ahrq.gov/webmm/case/337/medical-devices-in-the-wild. 31. clinical engineering bank. website: https://www.clinicalengineeringbank.com/cefunctions.htm. 32. igeta h. the role of clinical engineers in japan a case of aso iizuka hospital. japan association for clinical engineers; 2015. 33. hossain ma, ahmad. m, islam mr, et al. current status of skilled clinical engineers in developing countries, science direct. proc soc behav sci 2015;195:688–93. 34. nelson al, powell-cope g, and et al. technology to promote safe mobility in elderly. nurs clin north am 2004;39:649–71. author’s biography anwar hossain has completed bsc in electrical & electronic engineering since 1990 from khulna university of engineering & technology (kuet), bangladesh. he joined as an electro-medical engineer at the national institute of cardio-vascular disease & hospital, dhaka, bangladesh since 1991 and then was moved to national electro-medical equipment maintenance workshop & training center, dhaka under the ministry of health & family welfare, government of the people's republic of bangladesh. as an assistant medical electronics engineer. currently, he is working in the same organization as the technical manager (repair) cum chief training counselor. he has obtained 10 fellowships such as who, jica, frg, gob, world bank, 2nd face. he completed his msc in biomedical engineering from kuet and is a phd candidate in the biomedical engineering department of kuet, bangladesh. he has published research articles in different renowned journals and conference proceedings. his research interests include advance clinical engineering management to enhance the quality of healthcare. j global clinical engineering vol.4 issue 3: 2022 50 received june 27, 2021, accepted februry 23, 2022, date of publication march 1, 2022 analysis and solution of dental unit failure by j. j. jin1, h. liu1, k. li2, y. h. chu1 1 department of clinical medical engineering, the second affiliated hospital of zhejiang university school of medicine, hangzhou 310009, china 2 equipment department, ningbo chinese medicine hospital, ningbo 315010, china abstract objective: to discuss and analyze the common causes of dental unit failures and summarize maintenance experiences. methods: the failures were studied through retrospective analysis in our dental clinic from january 2019 to december 2019. causes for four common failures were analyzed deeply, and the corresponding improvement solution was implemented. results: these solutions reduced the failure rate for dental units and improved understanding of the importance of using and maintaining the equipment correctly. conclusion: analysing and improving proper maintenance can save costs for the hospital and effectively enhance the management level of medical equipment maintenance. keywords – dental unit, failure, solution, maintenance. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction with the improvement of people’s living standards and the enhancement of oral health awareness, oral health has been paid more and more attention. the dental clinic of most domestic hospitals is often overcrowded, and the number of patients treated every day is much higher than in some foreign hospitals. the dental unit is a piece of essential medical equipment in the clinic. since the establishment of binjiang hospital, 30 a-dec dental units, including 4 a-dec 500 units and 26 a-dec 300 units, have been introduced and installed. with preventive maintenance and emergency repair by hospital engineers’, they run stably. as we all know, dental units are generally composed of a dental chair, delivery system, cuspidor, and support center, dental light, etc. the schematic diagram is shown in figure 1. http://www.globalce.org http://globalce.org http://globalce.org 51 j global clinical engineering vol.4 issue 3: 2022 jin, liu, li, chu : analysis and solution of dental unit failure the structure of dental unit is complex and includes a waterway, electrical circuits, and gas circuits. during the installation of the dental units, dealers generally recommend that the hospital use an independent water storage tank with pure water or a treated centralized water supply as oral treatment water. the hospital should use oil-free and dry air, in which the pressure is not less than 80 psi to drive high-speed air-powered handpieces. considering the actual diagnosis and treatment needs in china, most hospitals will choose a centralized water supply, and the water quality should meet the requirements of gb 57492006. after the dental units are installed, the hospital engineer will carefully check whether the functions of the equipment are normal and whether the accessories are consistent with the contract. however, many accessories may not be original but might be domestic accessories, so the service life cannot be accurately judged. during the use of the equipment, the manufacturer recommends preventive maintenance and regular replacement of some wearing parts. the hospital will also handle it according to the actual situation. to ensure the water quality of dental units, many domestic hospitals will regularly use sodium hypochlorite or other disinfectants to sanitize waterways. however, this solution will cause certain damage to the internal valve and pipeline of dental units and increase the failure rate, bringing some challenges to hospital engineers.1 as a maintenance engineer, the author has been responsible for oral-related equipment maintenance work for many years and has accumulated rich experience in maintenance. in the following, the author summarized and analyzed the care of our hospital dental units by using the a-dec brand as an example in recent years. from the engineers’ point of view, the corresponding improvement measures were put forward to prevent and solve the common malfunctions for peer reference. fault statistics according to the statistics, from january 2019 to december 2019, our hospital’s dental unit received maintenance 780 times. specific failure conditions are shown in table 1 below. as can be seen from the table, the failure rate of dental units is relatively high in the waterways, electrical circuits, air circuits, and human factors. particular failures include water pipe rupture, water valve failure, saliva ejector failure, and dental syringe accessories absence.2 methods cause analysis and solution of four common failures replace worn parts and plug potential water leaks the waterway is an essential part of the dental unit and provides the water supply during oral diagnosis and treatment. a water leakage problem is one of the most common malfunctions of the dental unit. at the initial installation stage, the manufacturer equipped each unit with a water heater to heat the internal waterways. the structure of the heater was simple, the appearance of the heater was made of stainless steel, it was supplied by 24v power, and the material of the inlet and outlet water pipes was brittle. therefore, it was common to see cracks that can lead to water leakage after 2-3 years of use. this phenomenon had a high failure rate. engineers assessed the situation and determined that the water leakage problem was caused by unapproved material supplied by the manufacturer. so the engineer comprehensively checked all the pipes inside all the dental chairs, recorded the pipe diameter and length details, purchased approved water pipes, and replaced the water pipes at potential leakage risk one by one to prevent the occurrence. after monitoring over time, all dental units did not have a recurrence of the problem. figure 1. the schematic diagram of dental units. j global clinical engineering vol.4 issue 3: 2022 52 jin, liu, li, chu : analysis and solution of dental unit failure table 1. failure statistical table of dental units in 2019 fault classification fault point fault phenomenon fault cause number of cases proportion % waterway delivery system handpiece drips water or no water handpiece failure 18 2.31 water valve failure 38 4.87 cuspidor and support center heater leakage water water pipe rupture 19 2.43 spittoon or gargle cup leakage water or no water solenoid valve failure 19 2.43 circuit board failure 2 0.26 communication failure 21 2.69 cuspidor water contains air diaphragm rupture 22 2.82 circuit dental chair chair base can’t move circuit board failure 2 0.25 communication failure 13 1.67 chair back can’t move sensor failure 1 0.13 delivery system panel error panel failure 22 2.82 handpieces failure pipeline rupture 32 4.10 shelf valve loose 46 5.90 handpiece failure 15 1.92 circuit board failure 5 0.64 cuspidor and support center no water solenoid valve failure 6 0.77 circuit board failure 4 0.51 communication failure 15 1.92 dental light cannot work bulb failure 12 1.54 switch failure 3 0.38 gas circuit delivery system handpiece failure handpiece lack of driving gas 5 0.64 improper regulation 21 2.69 handpiece failure 12 1.54 water pipe rupture 31 3.97 cuspidor and support center small negative pressure saliva ejector failure 68 8.72 no negative pressure relay failure 5 0.64 positioning valve malfunction 11 1.41 human causes delivery system plate tilt overuse 18 2.31 handpiece failure incorrect setup 5 0.64 handpiece leakage water incorrect installation 7 0.90 handpiece no water panel incorrect setup 5 0.64 water master switch off 12 1.54 dental syringe leakage water accessories absence 74 9.49 53 j global clinical engineering vol.4 issue 3: 2022 jin, liu, li, chu : analysis and solution of dental unit failure improve the existing structure to ensure adequate disinfection and instrument integrity the study showed that the water supply of the dental unit was seriously polluted due to multiple factors such as the suction effect of the treatment instruments and water stagnation, and regular disinfection of the water, which is vital in controlling nosocomial infections.3 our hospital disinfects the water pipes of dental units every quarter. the hospital infection management department uses a 500 mg/l sodium hypochlorite solution to disinfect the lines. the medical staff in the department of stomatology discharge water on all the effluent parts of dental units one by one, and the continuous discharge time shall not be less than 10 minutes so that the disinfectant can flow out of each terminal effluent point, ensuring effective disinfection. however, the high concentration of this chlorine-containing disinfectant can corrode the internal structure of the dental unit, mainly the valve, rubber band, and diaphragm. specifically, high-speed handpieces, lowspeed handpieces, motors, and tooth cleaning machines hung on the valve after use will automatically leak water in varying degrees from spittoons and cup water spills.4 looking back to 2019, this kind of failure frequently occurred about 3-5 days after each pipe disinfection, and several dental units leaked varying degrees. given this phenomenon, engineers searched for relevant information, consulted manufacturers, analyzed, and discussed the main reason for such failure. specifically, the disinfectant had a particularly corrosive effect on the copper and rubber parts inside the dental unit. specific damaged parts included water valve, solenoid valve assembly, diaphragm, etc. considering the balance between disinfection effectiveness and the damage rate fault classification fault point fault phenomenon fault cause number of cases proportion % human causes dental chair armrest failure external force 3 0.38 cuspidor and support center unreasonable flush time incorrect setup 81 10.38 footswitch handpieces work automatically when lift footswitch failure 12 1.54 doctor’s chair or assistant chair the assistant chair sprang up hydraulic failure 59 7.56 back failure lack of parts 36 4.61 of the dental unit component, we proposed a preventive strategy. after each disinfection, the nurse extended the discharge water time to 20 minutes on the day. before starting the machine, the nurse discharged water for 10 minutes every morning for the next 5 days to remove the residual disinfectant in the pipeline and reduce the corrosion of the disinfectant on the dental unit parts. because the discharge water at all the outlet points of the existing dental unit cannot be controlled with one key, and the discharge and disinfection time cannot be controlled, the medical staff need to discharge water manually, which undoubtedly increases the workload of medical staff. for this reason, based on existing dental units, our engineers have added an automatic discharge water control device.5 this design has been authorized national utility model patent. the specific structure is shown in figure 2 below. figure 2. structure drawing of automatic draw water control device. j global clinical engineering vol.4 issue 3: 2022 54 jin, liu, li, chu : analysis and solution of dental unit failure the specific working process is as follows: firstly, select the knob above of the time relay to 10min, and then press the switch, the time relay starts the timing, the exhaust solenoid valve opens, the backup air of dental unit will open four water valves in the water and air control module, four handpieces will drain away water at the same time, the solenoid valve of cup water and spittoon water will open, and cup water and spittoon water will also drain away water at the same time. after the timing is over, pin 1 and pin 4 of the time relay will disconnect, pin 1 and pin 3 will pull, pin 5 and pin 8 will disconnect, and pin 6 and pin 8 will pull. the exhaust solenoid valve, cup water solenoid valve, and spittoon water solenoid valve will stop working, the water valves in the water and air control module are closed, and the handpieces will not drain away water. cup water solenoid valve and spittoon water solenoid valve are closed, cup water and spittoon water will stop drain away water. the clinical use of the device can not only realize the one-button control discharge of water and effective disinfection at all outlet points of the dental unit, but control the time of water discharge and disinfection accurately. however, this will also reduce the workload of medical staff and improve the compliance of medical staff in daily waterway disinfection, which is of great significance to clinical diagnosis and treatment in the department of stomatology. do a good job of regular maintenance to reduce the occurrence of suction malfunction attract tube oral suction has a high utilization rate in daily oral diagnosis and treatment, and the subsequent failure rate is relatively high. the suction tube absorbs a large amount of dental debris and blood in the patient’s oral cavity every day, and the oral pollutants are discharged underground through a long and thin tube, which is prone to pipe obstruction or suction failure. the negative pressure pump in the center of the hospital generates suction, and the positioning valve on the dental unit controls the start and stop of the negative pressure. then the doctor can attract the patient’s mouth through the suction tube to remove the dirt in the mouth. the main fault phenomena in the use process are suction pipe obstruction resulting in reduced suction, pipe aging rupture resulting in insufficient suction, positioning valve failure resulting in no negative pressure. if the suction malfunctions, it will negatively impact the doctor. for this kind of problem, engineers analyzed: (1) the high frequency of use, and (2) the lack of effective maintenance of the dental unit. notably, medical staff only knew the use but did not know the regular maintenance for the suction tube.6 for this reason, the engineer actively communicated with the users of the equipment and formulated a routine maintenance items list for the dental chair according to the infection control guidelines recommended by the centers for disease control and prevention of the united states and the australian dental association,7 as well as the manufacturer’s maintenance manual. the guidelines were implemented in april 2020, and relevant records were made. the specific contents are shown in table 2. strengthen medical education to prevent the loss of dental syringe accessories each dental unit in our hospital is equipped with a three-use spray gun for the doctor and a three-use spray gun for the assistant. engineers often receive repair calls during daily use, such as leaking or unusable dental syringes. after careful observation of the use and malfunction of the three-use gun in the oral clinic, it was found that most malfunctions were caused by the absence of accessories. engineers analyzed such problems mainly table 2. routine maintenance items list of dental units in dental clinics project content maintenance frequency suction tube after use, draw clean water and rinse for 1 min once per person after treatment, detergent was attracted for 3 min once per day clean suction tube solid strainer two times per week handpieces flush the pipeline for 2-3 min daily before use flush waterway for 20-30 sec between each patient spittoon and mouthwash cup stand rinse and wipe between each patient 55 j global clinical engineering vol.4 issue 3: 2022 jin, liu, li, chu : analysis and solution of dental unit failure due to improper operation of medical staff and insufficient understanding of the spray gun structural components. prevention measures could be taken from two aspects: first, strengthen the education and training of medical staff. the engineer communicated with the director of the department using the equipment and organized training on daily use and other matters of attention with the dental unit. this ensures that the medical staff can understand the structure of the dental unit, be familiar with the structure of the three-use gun, master the daily disassembly and assembly, and put the three-use gun into the daily inventory list. the nurse at each position was responsible for checking the related accessories of each tooth chair and reported if anything was missing.8 second, engineers should strengthen regular inspection and prepare relevant accessories as needed. results since the beginning of 2020, engineers have purchased and replaced all the internal pipes of our dental units to prevent water leakage from the heater. figure 3 (a) shows the heater failure trend, and the number of failures is reduced to zero. after the dental unit pipes are disinfected, the failure rate of water valves are significantly reduced, and water valves replacement costs are saved through the installation of automatic discharge water control device and the implementation of relevant measures. figure 3 (b) is the failure trend diagram of the water valve. since the routine maintenance items list of the dental unit was implemented in april 2020, the saliva ejector’s failure rate has decreased significantly. figure 3 (c) shows the trend chart of the failure rate of the saliva ejector. in addition, since the management of the dental syringe was 3(a). heater fault trend chart 3(b). water valve failure trend chart 3(c). saliva ejector fault trend chart 3(d). dental syringe fault trend chart figure 3. chart showing the different kinds of fault trends before and after improvement measures. j global clinical engineering vol.4 issue 3: 2022 56 jin, liu, li, chu : analysis and solution of dental unit failure strengthened in may 2020, the failure rate of the dental syringe decreased significantly. figure 3 (d) shows the failure trend of the dental syringe. although the daily maintenance will increase a certain amount of work and maintenance time, it can effectively reduce the downtime of dental unit failure, reduce the number of repairs, reduce the repair expenditure, prolong the service life of the equipment, and improve the quality of clinical diagnosis and treatment. comparison of items before and after maintenance are shown in table 3. among them, the average downtime was based on the time of failure to treat patients caused by each repair, and the average maintenance time was based on the time spent to complete the maintenance project. the average number of repairs was based on the number of repairs per dental unit in a year. the repair cost mainly includes replacing the water valve, saliva ejector, and position valve. the average repair expenditure was based on the repair expenditure per dental unit in one year. discussion in this paper, by sorting out the common failure cases of the dental unit and selecting several typical problems with a high failure rate, the causes of the failures are deeply analyzed, and the corrective measures are put forward.9 the reasons for each failure type are analyzed from different perspectives in these cases, such as failing to replace wearing parts in time, inadequate equipment maintenance, incorrect operation, etc. there is also the question of balancing the requirements of hospital disinfection with the damage of dental unit components. finally, engineers put forward the improvement schemes from their own point of view. the practice has proved that our dental units are running well, and the failure rate of several typical malfunctions is obviously reduced. conclusions maintenance engineers not only need to deal with daily failures but also need to deeply analyze the causes of failures and how to prevent similar failures. medical engineers and technicians should use their professional knowledge to make appropriate innovations and feasible improvements to the existing equipment to solve the current problems.10 in the context of the current advanced management of medical equipment, engineers should improve their maintenance concepts, transform their experience into practical maintenance practices, and use information technology and quality management methods to improve medical equipment maintenance.11 acknowledgment we want to extend our sincere gratitude to dr. yadin david for his revising this paper. we are also deeply indebted to our other clinical engineering staff that supported our work. conflict of interest the authors declare that they have no conflict of interest. references 1. ma hx, zhu j, zhang m, et al. research on maintenance optimization management method based on common fault analysis of oral comprehensive treatment table. chinese j med equip 2019;16(3):132-135. 2. li xy, fan bl, wu sb. continuous improvement of the quality management of dental handpiece power deficiency in dental units. china med equip 2018;15(3):40-43. 3. zhu cp, yu xf. research progress of dental comprehensive treatment waterlines system pollution and prevention. nurs rehabil j 2018;17(8):31-35. 4. wang c, liao x, wang yt, et al. biosafety evaluation of four disinfectants applied to microbial contamination control in dental unit waterlines. oral med 2019;39(7):596-600. 5. lei jj, zhou w, wang gh. design of a simple waterlines disinfection device for dental unit. china medical equip 2018;15(6):168-169. table 3. comparison of items before and after maintenance items before maintenance after maintenance average downtime/ min 20±5 5±2 average maintenance time/ min 3±1 30±3 average number of repairs/time 26±1 5±1 average repair expenditure/ ¥ 353±3 13±3 57 j global clinical engineering vol.4 issue 3: 2022 jin, liu, li, chu : analysis and solution of dental unit failure 6. chen y, chen mr,wang sd. application of root cause analysis in reducing the failure rate of soft electronic endoscope. china med devices 2017;l32(10):97-99,104. 7. han m, li xe, lu q. research progress on contamination of dental unit waterlines. chinese j infect control 2018;17(3):273-276. 8. li z, zhong h, cheng ds, et al. analysis and solution to hemodialysis machine & accessories faults. chinese j med lnstrument 2019;43(1):75-78. 9. wang zx, wang ec, chen yp. retrospective analysis and countermeasures of olympus electronic endoscope failure. j clin nursing practical 2019;4(28):190-192,196. 10. jin jj, liu h, chu yh. maintenance of a-dec dental unit. chinese j med device 2015;28(11):62-63. 11. yin ln, shao zy, zhang xp. malfunction of dental high speed turbine handpiece and cause analysis: a retrospective study 7 years. chinese j modern nurs 2020;26(9):1151-1155. 5 j global clinical engineering vol.5 issue 2: 2022 received december 2, 2020, accepted july 8, 2022, date of publication july 20, 2022 defects detected in rigid endoscopes by william k. de souza and marcelo a. marciano hospital moinhos de vento, porto alegre, rs, brasil abstract surgical procedures using rigid endoscopes are well known for having advantages over conventional surgical procedures. however, these instruments are fragile and are subject to breakage. the objective of this study was to record and analyze the frequency and types of repairs required for different types of rigid endoscopes used in surgical procedures. as a result, it was possible to correlate the number of defects with the amount and types of procedures, incidences of repairs by types of optics, and types of defects by types of rigid endoscopes. according to the survey, smaller instruments are more subject to damage and need repairs. keywords – surgery video; defects in rigid endoscopes; analyses and correlations. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.5 issue 2: 2022 6 de souza and marciano : defects detected in rigid endoscopes introduction minimally invasive surgical procedures have many advantages over conventional procedures.1-3 the device used to enable the visualization of the site of the procedure by video surgery is called a rigid or optical endoscope. different optical models are used in pediatric and adult surgeries with different sizes and thicknesses. the design of a rigid endoscope also has the technical characteristic of tip angulation that varies between 0° and approximately 135°.3 rigid endoscopes are widely used in surgical procedures, particularly in hospitals. however, rigid endoscopes are fragile, so monitoring use at all stages of the instrument’s workflow is essential. due to this fragility, there is a high incidence of malfunctions and defects throughout the instrument’s use. these defects leave the devices unusable and impact the surgical schedule. also, when malfunctions are not diagnosed in the flow stages, problems may only be perceived at the time of surgery. it is important to check if the optic lenses are cracked or scratched or the optical rod is dull. a blurry image may be the result of moisture entering the optical system. given the reflected light view, the surfaces should appear smooth and bright.3 because of the above, collecting data on the number of device defects in specific hospitals and their possible causes was considered necessary to help evaluate and minimize future failures. therefore, the main objective of this work was to map the defects and understand the possible causes of failures of these devices used in the operating room of a private, non-profit 500-bed hospital in southern brazil. more than 2,000 surgical procedures are performed monthly in this hospital, and more than 600 are watched by video. methods for the management of rigid endoscopes, all optics belonging to the organization were recorded by type (such as arthroscope, hysteroscope, laparoscope), size, composition and angulation, model, and brand. as a result, more than 50% of rigid endoscopes in the hospital’s operating room were acquired after 2017 and had less than 5 years of use, as shown in table 1. a form was developed and adopted to record the use of rigid endoscopes in the surgical center that could perform traceability of the flow of use of this device. when rigid endoscopes are returned to the material and sterilization center, they are examined by a nursing professional to ensure that the device is returned in good condition. if it is found that the device is not fit for use after the cleaning procedures, it is sent to the clinical engineering team to do the initial technical analysis. the engineering clinic opens the service order, evaluates the device, and if it is impossible to perform the internal repair, it is sent to qualified technical assistance. when the rigid endoscope returns from repair, it is inspected, and the data and information are recorded in a checklist. finally, the device is delivered to the material and sterilization plant if deemed fit for use. work orders with the defect data of rigid endoscopes between 2017 and 2020 were then analyzed, and some of the results are shown below. findings it was possible to observe that the relationship between procedures using rigid arthroscopy endoscopes is approximately 4 times lower than the number of procedures with hysteroscopy and laparoscopy. however, figure 1 illustrates that arthroscopes have four times the repair density concerning the number of failures in hysteroscopy and laparoscopy endoscopes. results it was possible to observe that the relationship of procedures using rigid arthroscopy endoscopes is approximately 4 times lower than the number of procedures with hysteroscopy and laparoscopy. however, figure 1 illustrates that arthroscopes have four times the repair table 1. rigid endoscopes acquisition year year of acquisition endoscopes <2017 43% 2017 14% 2018 27% 2019 14% 2020 2% total 100% 7 j global clinical engineering vol.5 issue 2: 2022 de souza and marciano : defects detected in rigid endoscopes density in relation to the number of failures in hysteroscopy and laparoscopy endoscopes. figure 2 illustrates the number of repairs required for the devices between 2017 and 2020. arthroscopes are, first and foremost, the equipment that most needs repair over the years. hysteroscopes vary widely in the total number of repairs required. this was especially notable between 2018 and 2019 when a 50% drop in the number of repairs occurred. by 2020, there was a very low total number of repairs on all types of endoscopes. because many elective surgeries were canceled due to the covid-19 pandemic. a survey of the main types of defects by optical types was also carried out. figure 3 illustrates the incidence and types of defects in the different endoscopes. hysteroscopes can be found to have a higher incidence of tube defects and broken internal lenses due to their manipulation during surgery. arthroscopy optics, on the other hand, suffered more damage due to contacts with surgical motors, which damaged the distal window and the internal lenses. as shown in figure 3, arthroscopes have 8 types of defects. hysteroscopes 7 and laparoscopes 6. conclusion paying attention to the entire operational flow of rigid endoscopes is imperative from purchase (acquisition of a good quality instrument), through the decontamination process and use, to the maintenance of instruments for video surgery. how they are sterilized, used, maintained, and inspected after repairs is the key to minimizing operational failure. a specialized team is required to supervise figure 1. relationship between types of procedures for video and breaks of rigid endoscopes. figure 2. relationship between maintenance by type of rigid endoscopes. figure 3. types of occurrences by optical type. j global clinical engineering vol.5 issue 2: 2022 8 de souza and marciano : defects detected in rigid endoscopes the use of these instruments and evaluate their conditions at each stage of the workflow, to ensure a quick diagnosis the moment a malfunction occurs. the procedures for the development and qualification of professionals and companies providing maintenance services of these instruments are paramount, as they are decisive factors in the quality of repair and avoiding rework. with the study, it was possible to correlate the amount of defects with the amount and types of procedures, incidences of repairs by types of optics, and types of defects by types of rigid endoscopes. according to the survey, smaller instruments are more subject to damage and the need for repairs, as in the case of arthroscopes, which also presented the most diversity of defects. it was also appropriate to share the statistics of failures, defects, downtimes, and costs with the users of these devices. and try collaboratively to think of actions to mitigate the damage. since the costs of purchase are high, as well as the costs of maintaining and repairing these delicate instruments. in addition to impacting the agenda of surgical procedures. as these video procedures have been well disseminated for some time, the savings in acquisition, the proper use, and reduction of repairs can contribute to the control of the costs of medical-surgical procedures. references 1. sobracil. homepage [internet]. available at: https:// www.sobracil.org.br/consultapublicaans/index.asp. last accessed 03/19/2018. 2. couto neto j. homepage [internet]. available at: http:// www.drjoaocouto.com.br/atuacao/videocirurgia/. last accessed 03/19/2018. 3. smith & nephew. otica rigida for endoscopy smith & nephewifu 0051. available at: https: //www. smithnephew.com/global/assets/pdf/products/brasil/201604/80804050051%20%20otica%20rigida%20 para%20endoscopia%20smith%20nephew-%20 ifu%200051-%20reva.pdf. last accessed 03/30/2018. https://www.sobracil.org.br/consultapublicaans/index.asp https://www.sobracil.org.br/consultapublicaans/index.asp http://www.drjoaocouto.com.br/atuacao/videocirurgia/ http://www.drjoaocouto.com.br/atuacao/videocirurgia/ http://www.smithnephew.com/global/assets/pdf/products/brasil/201604/80804050051%20%20otica%20rigida%20para%20endoscopia%20smith%20nephew-%20ifu%200051-%20reva.pdf http://www.smithnephew.com/global/assets/pdf/products/brasil/201604/80804050051%20%20otica%20rigida%20para%20endoscopia%20smith%20nephew-%20ifu%200051-%20reva.pdf http://www.smithnephew.com/global/assets/pdf/products/brasil/201604/80804050051%20%20otica%20rigida%20para%20endoscopia%20smith%20nephew-%20ifu%200051-%20reva.pdf http://www.smithnephew.com/global/assets/pdf/products/brasil/201604/80804050051%20%20otica%20rigida%20para%20endoscopia%20smith%20nephew-%20ifu%200051-%20reva.pdf http://www.smithnephew.com/global/assets/pdf/products/brasil/201604/80804050051%20%20otica%20rigida%20para%20endoscopia%20smith%20nephew-%20ifu%200051-%20reva.pdf 19 j global clinical engineering vol.3 issue 2: 2020 received february 20, 2020, accepted august 28, 2020, date of publication november 9, 2020 modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa by m. h. ahouandjinou1,2, d. medenou1,2, l. pecchia3, r. c. houessouvo1,2, t. r. jossou1,2 1 département de génie biomédical, ecole polytechnique d’abomey-calavi (department of biomedical engineering, ecole polytechnique d’abomey-calavi) 2 laboratoire d’electrotechnique de télécommunications et d’informatique appliquée, ecole polytechnique d’abomey-calavi (electrotechnical laboratory of telecommunication and applied informatics, ecole polytechnique) université d’abomey-calavi, benin (university of abomeycalavi, benin) 3 school of engineering, university of warwick, coventry, cv4 7al, uk. abstract background: as a result of globalization it is important to examine health systems organization in africa to highlight the failures and propose possible solutions in terms of patient care. objective: modeling was based on the internet of things (iot) an integrated network for monitoring patient data in west african health systems. methodology: to achieve the objective three steps were followed. (1) identification of the different characteristics of iot-based health surveillance systems, wireless body area network (wban) systems, and the physiological parameters that are monitorable on a patient. (2) the modeling of the architecture of west african health systems in the form of a cloud of technocenters. (3) cross analysis between different iot technologies, characteristics, and identification of any functional requirements. all this was based on wireless medical sensor networks in the wban systems. result: this work has been used to model health systems in africa as a remote monitoring network for patients. conclusion: the implementation of this model of monitoring networks will be a tool to support large-scale decision-making for health systems in africa. it will enable an information database for the west african health system. keywords – modeling, integrated network, internet of things, health system, technocentre. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. résumé contexte: du fait de la globalisation des systèmes sanitaires, il est important d’examiner l’organisation des systèmes de santé en afrique, sous l’angle de prise en charge des patients, pour mettre en évidence les défaillances et proposer des pistes de solutions. objectif: modéliser à base de l’internet des objets (iot) un réseau intégré de monitoring de données des patients dans les systèmes sanitaire de l’afrique de l’ouest. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ ahouandjinou, medenou, pecchia, houessouvo, jossou: modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa 21 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 20 ahouandjinou, medenou, pecchia, houessouvo, jossou: modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa this review of the literature revealed that the challenges of health surveillance are very topical. most of the work has not been in favor of a particular health system from a country, region, or area depending on its configuration but has shown there is an opportunity presented by technological progress to aid in monitoring several aspects of a patient's state of health including managing patient data,1,2 wban networks and architecture, security in health data management systems and many other areas.3,4 all of militated in favor of the results obtained. related work a total of 128 articles between 2010 and 2019 were found, with an emphasis on research between 2014 and 2016. the 128 articles were then sorted to rank those that best met the criteria of research. in the end, 34 articles were excluded and 94 were included as the subject of our study. the results are shown in table 1. the iot is of great potential interest for medical applications and healthcare. many technologies are related to iot. technologies such as wireless medical body sensors, advanced healthcare systems, wearable sensors, cloudbased platform for wireless transfer, storage, and display of clinical data (see table 2, in appendix) carry particular interest. in conclusion, we note that the challenges of any medical surveillance system lie in the proper design of the network architecture. in light of this, our work aims to model an integrated patient monitoring network (rimp) in the west african health system, based on the iot. this article presents the methodology adopted for the work, the results obtained, and the analysis, discussion, and perspectives envisaged. results despite the specificities observed in each country, the health pyramid of west african countries generally includes first-level structures (dispensaries, health huts, etc.), so-called reference structures (general hospital), specialized structures (dedicated to a disability or illness), and university hospitals. in principle, so-called primary health care is the foundation of health systems, whose national health development programs (pnds) stipulate that the structures responsible for it must cover n thousands of inhabitants in a given geographical area [org]. such a health pyramid has enormous advantages for mastering health data from scratch when it comes to diagnosis and care, so it has a modern remote monitoring architecture. for better monitoring of patients in african health systems, we propose an architecture integrating the different levels of each health system facilitated by a cloud of technocentres from remote monitoring networks. this would include surveillance centers allowing centralized accessible health information. iot architecture of an integrated patient monitoring network several physiological parameters can be monitored sixteen different groups of physiological parameters can be monitored using iot sensors placed at 17 different locations on the patient’s body.5 figure 1 shows an outline of some of the physiological parameters ([a] blood pressure, [b] electrocardiogram, [c] pulse oximeter, [d] electromyogram, [e] inertia). the iot architecture of the integrated patient monitoring network shows the interaction of the different iot components of our system and its network and computer technologies. the different iots in this architecture include intelligent medical sensors of different sizes and types that monitor patient health parameters and also process and record the raw data from the sensors. the transceiver modules of the medical sensors communicate with the base stations via a wireless interface. the most introduction the current challenges and goals of information and communication technologies (icts) are to provide effective and efficient healthcare. one of the latest advances in icts is the internet of things (iot) providing global connectivity and management of sensors, devices, users, and information. the iot concept provides the ability to search for information about a tagged object or person by browsing internet addresses or a database entry that matches a particular active radio frequency identification (rfid) with a detection function. in the last decade, wireless medical sensors, smartphones, and other mobile devices have attracted growing interest as tools that can be used for personal healthcare, and monitoring activities and physical condition. some research has been done on the clinical applications of these technologies in remote healthcare surveillance architectures for long-term management, registration, and clinical access to patient physiological information based on these current technological advancements, it is easier to plan or schedule your physical examination, which is preceded by a period of a few days of continuous monitoring of your physiological state with less expensive wireless medical sensors. during this monitoring, wireless medical devices continually record signals correlating with the patient’s important physiological parameters and sends them to a database of medical records. this scenario allows the medical professional (doctor and other) to have more information about the patient’s state of health before the next appointment. using this information and making it available to health professionals who also have access to a vast body of observational data for other individuals, the medical professional can make a better diagnosis and recommend appropriate treatment regarding early intervention and particularly effective lifestyle changes that can improve the patient’s quality of health. these technological advances have a transformative impact on global health systems by dramatically reducing health costs and improving the speed and accuracy of diagnostics. the vision presented previously from the technological point of view has been available for some years now in several sanitary systems around the world not within the african health systems and especially west africa despite the technology already on hand. the west african health system presents for the most part the same configuration and structuring inherited from their time as colonies. in this article, we are particularly interested in modeling an architecture that takes into account the current structure of west african health systems while implementing the healthcare surveillance architecture. methodology it is very important to choose the appropriate techniques and methods in the literature search and data analysis. to ensure the integrity of the data, the means used to perform the analysis will depend on the information provided by the various search engines such as google scholar and scientific databases such as pubmed, wiley, ncbi, ieee xplore, scopus, and web of science. google scholar and ieee xplore are the two most used in our research. the keywords used for data collection were: "iot and health surveillance", "internet of things and health system", "remote patient monitoring with iot". these three combinations of keywords were used on google scholar for the documentary review. méthodologie: pour y parvenir, trois étapes ont été suivies. (1) le recensement les différents caractéristiques des systèmes de surveillance sanitaires basés sur iot, des systèmes wireless body area network (wban) et les paramètres physiologiques monitorables sur un patient. (2) la modélisation de l’architecture des systèmes sanitaires ouest-africain sous forme d’un nuage de technocentres. (3) l’analyse croisée entre les différentes technologies de l’iot, les caractéristiques et les exigences fonctionnelles identifiées. tout ceci en se basant sur des réseaux de capteurs sans fil médicaux dans les systèmes wban. résultat: ce travail a modélisé les systèmes sanitaires d’afrique comme réseau de monitoring de données des patients. conclusion: la mise en œuvre de ce modèle de réseaux de monitoring consistera un outil d’aide à la prise de décision de grande envergure pour un système sanitaire en afrique. il permettra au système sanitaire ouest africain de disposer d’une banque de données d’information. mots-clés – modélisation, réseau intégré, internet des objets, système de santé, technocentre. table 1. year number of articles found per year number of articles excluded per year 2010 3 0 2011 4 0 2012 3 1 2013 3 0 2014 27 2 2015 37 1 2016 29 18 2017 19 12 2018 2 0 2019 1 0 total 128 34 ahouandjinou, medenou, pecchia, houessouvo, jossou: modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa 23 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 22 ahouandjinou, medenou, pecchia, houessouvo, jossou: modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa make it possible to know any health antecedent of a patient wherever they are. this multifunctional health card will also allow the payment of the patient's health services since it integrates a virtual account. the patient's localization feature will be integrated with the patient's cisu-p card to find it through gps on an integrated platform. this feature will allow a patient's hospitalization to be known in real time. more interesting in this architecture is that the position of the patient is known even outside of the hospital in real time as long as they have the health card on them. the architecture of the platform integrates all the entities (surgery, medicine, emergency, laboratory ...) of the hospital so that the patient record can be seen by all (except for any access restrictions added as required). discussion faced with the challenges of the west african health systems and in particular, the beninese health system, which are (i) to provide quality health care to a growing population, (ii) to optimize the availability of health care personnel, and (iii) to utilize patient health data in a more predictive health system; we proposed in this work an integrated iot architecture for patient monitoring and the functional architecture of the hospital platform whose implementation could revolutionize the west african health systems in general and benin in particular. the implementation of this solution would go through several stages: first, choosing a health zone in benin that has village, district, and communal health centers, departmental hospitals, and university hospitals. once the expected positive results in this first zone were confirmed we would consider the extension of the architecture to other health zones. constraints of wban networks (i.e., scalability, quality of service [qos], energy consumption, wireless technology) will have to be taken into account.6,7 there is a large amount of work in the literature that deals with the application of wbans in a healthcare setting.8,9 this research outlines the characteristics and requirements of the medical application of wbans as well as the characteristics and design factors. another consideration in the design of wban networks involves security requirements (wban and traditional networks have the same security requirements).10,11 however, this does not present a functional issue for the architecture of the hospital platform, which is the focus of our work. moreover, we can see that the multitude of work in the literature does not consider a global architecture of a health system but often speaks of service architecture, while at the security level the security of patient and billing data will be considered when implementing the proposed solutions. security threats or attacks, such as modifying and eavesdropping on medical data, detecting and locating activities, and hacking into security systems and alarms, can occur and must be taken into account.10,11 also, data flow and network capacity are also among the parameters that have an impact on system performance. in this scenario, the choice of high-speed wireless technology offers advantages to meet the scalability of the network and increase the number of people being monitored. on the other hand, other technologies allow for lower power consumption, but have higher delays (production) and/ or lower transfer rates. the technology chosen will therefore be a compromise between throughput and energy consumption. as several technologies are used in patient monitoring architectures to provide multiple services9,12 we started to identify all technologies used within the different services. on this basis, our work extends this knowledge by proposing the essential characteristics of any monitoring system adapted to the beninese health system as well as the different possible positions where the sensors could be placed on a patient's body as mentioned in our previous work.5,13 conclusion in this work, we modeled west african health systems by proposing an iot architecture for patient monitoring and the functional architecture of the hospital platform. this model incorporates the cius-p which allows the patient information to be available in all areas across the west african health system. this architecture will allow the west african health system to respond to health challenges and provide data for better health forecasting. future work will allow this architecture to be implemented in benin to analyze its effect and any limitations. the implementation will occur through the choice of a health zone in benin and take advantage of the unique identification database of the population set up, the project to interconnect all the health systems in benin, the national data center, and powerful base stations will act as data aggregators, well nodes, or gateways to servers. the different iot gateways work with the different types of devices and associated network protocols to provide overall connectivity. the integrated iot patient monitoring architecture is made up of several levels. the first level is the iot sensor level, which fits the patient with several sensors to measure the desired physiological parameters (emg, ecg, blood pressure, heart rate...). the second level of the architecture shows the connectivity elements. this level shows the symbols of the different communication networks used to route the data collected by the sensors to the treatment centers. depending on the application, wifi, bluetooth, or zigbee can be used to route measured physiological data to the sensor nodes and then to the treatment centers called here technocenters. technocenters are data processing centers available at all levels of the health system including those in village health centers, district health centers, communal health centers, departments, and zones at the national level. these technocentres are interconnected through a network. to allow different requests from users of the network including healthcare providers, the healthcare administrator and the patients, we are implementing a dns service so the users can successfully request the data from the closest server with a different zone access from the internal and external users of the network. the patient’s personal digital devices (pdas) will allow healthcare providers to capitalize on the capabilities in smartphones that patients already carry. since these smartphones can be connected to the internet through their gsm network, it would be enough to install ehealth applications allowing the patient’s phones to receive and send the necessary information to and from the treatment center. recommendations could easily be made for these smartphones regarding their specific characteristics as needed. functional architecture of the hospital platform we propose the functional architecture of the hospital's platform detailed in figure 2 to enable the west african health system to monitor patients effectively. the functional architecture of the hospital platform that we propose takes into account several aspects for the monitoring and the traceability of the patient inside and outside the hospital. we propose the use of the country unique patient health identification (cius-p) for patients in the west african health system. this will allow a patient in benin or any other african country to have a unique identity card from his country of origin. this new health card will make it possible for any hospital in the african health system to have access to the patient file and will figure 1. iot architecture of an integrated patient monitoring network. figure 2. functional architecture of the hospital platform. ahouandjinou, medenou, pecchia, houessouvo, jossou: modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa 25 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 24 ahouandjinou, medenou, pecchia, houessouvo, jossou: modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa the availability of the gprs network of gsm networks in the various health zones in benin. references 1. kodali rk, swamy g, and lakshmi b. an implementation of iot for healthcare in 2015 ieee recent advances in intelligent computational systems (raics), trivandrum, kerala, india; 2015. doi: 10.1109/raics.2015.7488451. 2. 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engineering vol.3 issue 2: 2020 28 ahouandjinou, medenou, pecchia, houessouvo, jossou: modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa appendix table 2. n° ref. aspect covered 1 [14] put in place a solution to address drug issues based on iot technologies like smartphones and the web to support ubiquitous access, 6lowpan technology for ubiquitous patient data collection, sensors and hospitals, rfid / nfc (near field communication) and barcode identification technologies. 2 [15] propose iot communication framework as primary tool for healthcare applications spread around the world. they presented the iot protocol stack and the benefits it brings to health care scenarios. 3 [16] proposed a cooperative approach of iot to improve the monitoring and control the health of rural and poor human health parameters. 4 [17] analyze the possibility and related issues of providing advanced services for human health management in the real world of medical technology on iot. 5 [18] shows an overview of the challenges and opportunities of iot. 6 [19] present a prototype of a cloud-based system, compliant with the iot concept. including those related to the authentication of entities and data confidentiality. the proposed system manages the data collected by the portable sensors and transmitted them to a gateway using cloud infrastructure techniques. 7 [20] worked on interoperability and security issues related to the limitations of devices used in the iot, preventing their proper use in health systems. 8 [21] presents with a cloud-centric vision for the global implementation of the iot. the authors' work allowed to make a cloud implementation using aneka, based on the interaction of private and public clouds 9 [22] showed how rfid, multi-agent technologies and the iot can be used to allow people access to affordable and quality health services. the authors show that using the iot and multi-agent technologies can reduce medical errors, improve patient safety, and optimize healthcare processes. 10 [23] presents an ontology-based design methodology for intelligent reeducation systems in iot. 11 [24] worked on home health services based on the iot. they proposed a smart home platform, named ihome health-iot. 12 [25] presented a mobile home health system (mhealth) for wheelchair users, based on emerging technologies of the iot. the authors focused on the proposed system architecture and the design of wireless body sensor networks (wbsn). 13 [26] review the current research on the iot, generic key technologies, key iot applications in industries, and identify trends and challenges in research. 14 [27] structured in this work a review of the state of the art on iot by bringing out its history, the different technologies of iot and its different applications. 15 [28] present a novel architecture model for iot with the help of semantic fusion model (sfm). 16 [29] present h3iot, a new architectural framework for a home health center based on the internet of things, which aims to monitor the health of elderly people at home. 17 [30] present the integrated services that are part of a ubiquitous health system that enables automated and intelligent monitoring and utilizing ip and internet connectivity for end-to-end communication. 18 [31] present the definitions, architecture, fundamental technologies, and applications of iot. various definitions of iot are introduced, emerging techniques for the implementation of iot are discussed. n° ref. aspect covered 19 [32] worked on self-care through iot through personal health devices. by introducing the collaborative protocol that transfers risk factors between iot personal health devices. 20 [33] worked on data security and confidentiality in the healthcare sector given the increasing data growth in this sector. 21 [34] examined the applications of iot in personalized health care to obtain excellent health care at affordable costs through detection and wireless techniques. 22 [35] worked on the concept, the architectural components of the wearable iot because of their detection and communication capabilities. 23 [36] worked on the energy efficiency in the architectures of the iot in exploiting the advantages related to the standard poe (power over ethernet). 24 [37] worked on an iot architecture and system implementation for health applications to offer a simple and economical way to analyze and monitor health data in real time. 25 [38] worked on the security and confidentiality of tracking physical conditions through portable connected objects. 26 [39] have worked on the different opportunities and challenges of iot. 27 [40] worked on the development of a general architecture for iot-based health care systems to ensure and increase patient safety, quality of life, and other health care activities. 28 [41] worked on the use of rfid for personal health care based on the iot. 29 [42] secure medical data transmission model in health systems based on iot. 30 [43] iot and big data for intelligent healthcare, individualized telehealth to enable healthier lifestyles. 31 [44] operation of the gateway between the network of medical sensors and the internet in a health care surveillance system to offer several services. 32 [45] a semantic interoperability model for big data in the iot. 33 [46] iot architecture to identify and control the chikungunya virus. 34 [47] a reliable iot architecture based on onem2m for personal healthcare devices 35 [48] iot-based healthcare surveillance architecture to move to proactive and preventive healthcare. 36 [49] wban sanl fil <au: please clarify sanl fil> network based on iot for healthcare. 37 [50] smart city cloud platform with iot 38 [51] three-level iot architecture composed of the device layer, the fog layer, and the cloud layer. 39 [52] a new architecture for health services based on iso / ieee 11073 on the iot platform. the proposed architecture meets onem2m and iso / ieee 11073. standards with a stack of protocols for constrained healthcare devices on the ble network. 40 [53] a cooperative key establishment protocol to create a secure end-to-end connection for resource-limited sensor nodes with any remote server or entity. security analysis and performance appraisals prove to be a considerable improvement in security as well as protocol resilience against known attacks and security breaches. 441 [54] a cloud-integrated health iot monitoring framework, where health data is watermarked before being sent to the cloud for secure, high-quality, health monitoring. 42 [55] a new user-oriented world of iot. in this world, users are empowered by their ability to control access to the data that has been knowingly or unknowingly generated and belongs to them. this data can be requested by other users and organizations to be analyzed collectively and potentially bring value to society. ahouandjinou, medenou, pecchia, houessouvo, jossou: modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa 31 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 30 ahouandjinou, medenou, pecchia, houessouvo, jossou: modeling an integrated network for remote patient monitoring, based on the internet of things for a more preventive and predictive health system in west africa n° ref. aspect covered 43 [56] security and confidentiality issues in health applications using the body sensor network (bsn). they proposed an iot-based secure health system using bsn, called bsn-care, which can effectively meet various security requirements of the bsn-based health system. 44 [57] an iot system capable of improving assistance requests and the detection of anomalies in an alf <au: please expand alf> using portable devices. with this healthcare support system, caregivers can be automatically alerted to potentially dangerous situations that occur to residents while they are out of sight. the system design focused mainly on portability and ubiquity. 45 [58] an iot h2u predictive health care system to provide early treatment and detect danger signs early enough to avoid the need for hospitalization. hospital stay is minimized and doctors and nurses can be connected and monitor patients based on the report generated by the sensors in real time and daily clinical updates by the patient on the base server of data. interaction via this iot system is quite profitable and guarantees a higher level of security in terms of communication. 46 [59] exploited the concept of self-awareness to create a personalized ews alert score system<au: please expand ews> based on the iot. the system is designed to be adaptive in various situations and to be able to be automatically personalized according to the needs of the patient. 47 [60] the use of the internet of things for the efficiency of the health system by exploring the challenges of these systems. their work provided an architecture / methodology for extracting information from health care data. 48 [61] the use of the internet of things for the efficiency of the health system by exploring the challenges of these systems. their work provided an architecture / methodology for extracting information from healthcare data. 49 [62] implementation of a data aggregation solution for interdisciplinary healthcare research after comparing the different existing iot applications which focus mostly on the physical condition of people. they proposed the architecture for monitoring healthcare with multiple functions for the acquisition of bio-signals (eeg, emg, ecg) 50 [63] computer haze in the iot in health surveillance systems by exploiting the concept of calculating fog with intelligent gateways applied to ecg signals. 51 [64] the security of private information in a health care information system using the internet of things. the authors have implemented an algorithm to secure health data. a prototype based on both software and hardware has also been implemented. 52 [65] implementing a system for continuous monitoring of the eeg and other vital parameters using algorithms based on raspberry pi. the raspberry pi is a small computer with an integrated microprocessor card. 53 [66] the different opportunities and benefits of using the iot in remote health monitoring. the use of portable sensors is necessary to record data in various environments for health surveillance. 54 [67] the security requirements of rfid authentication schemes for internet of things-based healthcare surveillance systems. the authors presented the overall architecture of the rfid-based authentication system and their requirements 55 [68] the security of iot-based health systems. they proposed a communication architecture based on sensors in health service systems integrating a secure authentication scheme and a protocol for the coexistence of multiple health systems operating under the technology of the iot. 56 [69] implementation of the iot in a hospital system using zigbee which is a mesh protocol. 57 [70] the classification and structuring of iot applications in healthcare. the results of the authors' work show that applications in the health of the iot can be classified into three categories of systems. 58 [71] a new approach to the iot with devices compatible with iot thanks to the xmpp protocol. n° ref. aspect covered 59 [72] share the use of medical equipment used in a health service or office through the iot. they proposed a personalized health service model that can be used in family or public offices. 60 [73] health self-management systems for support. they proposed the establishment of a personal health monitoring system adapted to the needs of the user (do-it-yourself). 61 [74] medical data capture and confidentiality architectures. the work allowed the authors to develop an architecture of authentication and authorization that is secure and efficient for healthcare based on iot while taking into account the constraints of the resources of medical sensors. 62 [75] big data technologies, iot and complex event processing (cep) and their importance in the healthcare system revolution. 63 [76] a remote health monitoring system based on iot, after identifying the main network requirements and studying the coap, mqtt and http protocols. 64 [77] smart gateways in e-health which is a transition point between the sensor and internet networks. they proposed an intelligent e-health gateway between the sensor and the internet for remote monitoring of health care. 65 [78] an intelligent collaborative security model to minimize security risks; and propose how different innovations such as big data, ambient intelligence and portable devices can be used in healthcare establishments. 66 [79] it fog which is a new architecture for migrating certain tasks from the data center to the periphery of the server. the authors present the characteristics of fog computing and the services it can provide in the health system by ensuring low latency of applications in health services. 67 [80] the iot remote healthcare monitoring system that provides patient status via a web browser using os contiki with the 6lowpan protocol. proceedings 5th icehtmc 2023 j global clinical engineering, special issue 5, 20231 proceedings 5th icehtmc 2023 editor’s corner 5th international clinical engineering & health technology management congress (icehtmc) november 10-13, 2023, visakhapatnam, india dear 5th icehtmc congress community, on behalf of the organizers and the organizers and sponsors of the 5th international clinical engineering & health technology management congress (icehtmc), it is our honor to offer this publication that contains all of the abstracts accepted for the oral and poster sessions in this congress. the strict peer review process of the submissions received that was accomplished through the amazing support received from the scientific program committee members and global clinical engineering journal team, that together have over 100 experienced reviewers from all over the world, resulted in these proceedings. this made the 5th icehtmc congress an amazing scientific as well as professional networking event. this program exceeds all previous congress records for quality and quantity. major recognition must be given to the unique cooperation between the global clinical engineering alliance (gcea), the ifmbe clinical engineering division (ifmbe ced), aami, and the local hosts amtz. this is the 3rd time that the congress’s proceedings are published and available in an on-line format (globalce.org). the global clinical engineering journal’s commitment to the promotion and sharing of knowledge is evident through its selected editors community of experts and obligation to timely publication of subjects at the cross between engineering, technology, and patient care outcomes. these proceedings are a great accomplishment that will serve the ongoing and growing global clinical engineering field into the future. conducting a hybrid style international congress presents a different stage and greater opportunity to engage with more members within our field as well as with other healthcare stakeholders interested in professional development, scientific debate, networking, collaboration, strengthening friendships, and learning more about best practices from faraway places. we thank all the participants, exhibitors, local hosts, and are confident that you will find these proceedings useful. we wish you success and hope to meet you at our next congress. yadin david together we can make it better! editor-in-chief of globalce journal and gcea president 29 j global clinical engineering vol.6 issue 1: 2023 received july 24, 2023, accepted october 13 2023, date of publication decemvber 5, 2023 application of statistical processes control for the performance improvement of a clinical engineering department by edgar gonzález campos1, andrea elizabeth vázquez rodriguez2, fátima jaqueline rodríguez trujillo2, catherine jazmín ramírez mendiola2 1 instituto de salud pública del estado de guanajuato, mexico 2 división de ciencias e ingenierías, universidad de guanajuato, mexico abstract this article addresses the fundamental role of statistical process control (spc) as a quality tool in the field of clinical engineering, to improve and optimize internal processes. this study describes the methodology used to apply the spc in a reference hospital's clinical engineering department. data was collected over an extensive period, involving multiple medical equipment and verification procedures. these data were analyzed using various statistical tools, such as control charts, pareto charts, and descriptive statistics. the results showed stability in the department's processes, which made it possible to identify areas for potential improvement. statistical analyses revealed behavior patterns and trends that were not previously apparent. based on these conclusions, specific modifications were proposed in the department's processes to optimize efficiency, reduce costs, and improve service quality. the implementation of these modifications based on evidence suggests that they would positively impact the general performance of the clinical engineering department if applied. key indicators could improve significantly, reflecting increased medical equipment reliability and availability, decreased unscheduled downtime, and increased satisfaction for department staff and equipment users. in summary, this study highlights the importance of using spc as a powerful improvement tool in clinical engineering. by adopting an approach based on data and scientific evidence, clinical engineering departments can achieve more efficient and effective management of their processes, contributing to higher-quality medical care and patient safety. keywords – control chart, equipment maintenance, spc. copyright © 2023. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ gonzález campos, vázquez rodriguez, rodríguez trujillo, ramírez mendiola: application of statistical processes control for the performance improvement of a clinical engineering department j global clinical engineering vol.6 issue 1: 2023 30 introduction the performance and efficiency of clinical engineering departments can be influenced by various factors involving human, material, and financial resources. in the same way, the intellectual capital of "know how" to carry out critical activities i.e., to have a sound and effective standardized methodology to realize procedures within the department's operation, serves as an asset of great value in organizations. within these activities, equipment maintenance and continuous verification to ensure its correct operation emerge as critical activities. although a series of classic activities are carried out in most clinical engineering departments, each department establishes its processes based on its conditions and scope. the standardization of methodologies that ensure the quality of the processes takes on significance in the impact these activities can have on the general operation of the department.1,2 the measurement of data on these processes and their statistical use represents a tool of great value in the search for improvement in their performance.3 statistical process control (spc) represents a series of tools among which control charts stand out. this has traditionally been used within different industries to improve processes based on evidence generated by their own data.4 within the healthcare field, it has been considered a tool for research and improvement issues,5 as a tool for improving the culture of data measurement,6 and even for improvements in clinical issues.7–9 there are many statistical tools with endless applications within the field of biomedical/clinical engineering to be used in the search for improvement of the efficacy, effectiveness, and efficiency of its activities.10 in the same way, there are studies in which tools used within the statistical control of processes, such as the pareto diagram, are deployed to improve the activities of a clinical engineering department, as cecchini, masselli, et al. described.11 or the evidence-based maintenance method proposed by wang12 in which using data generated by a medical equipment maintenance program could modify the entire program itself. however, the use of control charts as a complement to traditional statistical techniques and those associated with quality improvement may represent a valuable option in the search for effective evidence-based improvements. this article aims to exemplify what was previously explained through the use of spc tools for formulating improvement strategies in standardized processes of a clinical engineering department. methods the methodology followed can be divided into the five main phases shown in figure 1. only procedures related to routine verification of medical equipment in different hospital areas were considered. to find opportunity areas through spc, it is necessary to comply with specific characteristics to be evaluated in the processes. the first two activities were focused on this: the definition of criteria, evaluation of these criteria and selection of procedures to be analysed. the next two phases correspond to the deployment of the statistical analysis, first through data capture, followed by the development of control charts. finally, based on the results obtained, improvement proposals were made to the department's management to be evaluated and, where appropriate, implemented. each phase is explained in more detail below. figure 1. followed methodology. 31 j global clinical engineering vol.6 issue 1: 2023 gonzález campos, vázquez rodriguez, rodríguez trujillo, ramírez mendiola: application of statistical processes control for the performance improvement of a clinical engineering department selection criteria definition definition of selection criteria for the opportunity areas search was carried out considering the following factors: • standardized processes: the selected processes must be well standardized so that the data collection when performing them is carried out in a homogeneous way regardless of the personnel that carries it out, in addition to having written tools for capturing data generated during the routine. • more than nine months of registers: generated data by the processes in the lapse of the last nine months of operation were only considered to have an extended operation period, so the data reflects the closest possible reality of the department. • percentage compliance greater than 90% on the scheduled verification routines. the continuity and quantity of data in the measurements represent important factors in carrying out the statistical analysis of the processes since the consistency of the process with the generated data can be detected. processes selection based on the criteria of compliance once the selection criteria were defined, it determined which was compliant. table 1 shows eight standardized procedures for carrying out verification routines in the department that met the first two selection criteria. the routines for the vacuum and medical air systems imply verifying the work pressures for both hospital equipment. the operation theatres, intensive care units and emergency department routines demand the verification of technical aspects of the medical equipment installed in those areas, such as correct functioning, autotest, etc. this equipment ranges from vital signs monitors to stretchers. finally, the verification routine of the defibrillators involves physical and functional verification of all the defibrillators installed within the hospital through autotest and discharge proof. after identifying the standardized processes, it verified the percentual compliance with carried-out routines. figure 2 shows the results for this verification, obtaining compliance with the criteria in four of the eight processes; these correspond to: • emergency departments • defibrillators • medical air • vacuum systems these were the procedures on which the statistical study was studied further using spc tools. record capture in the database and selection of tools the next phase of the methodology implied the capture of the registered data in department formats in the form of table 1. verification routines processes of the clinical engineering department. figure 2. percentual compliance of done routines. gonzález campos, vázquez rodriguez, rodríguez trujillo, ramírez mendiola: application of statistical processes control for the performance improvement of a clinical engineering department j global clinical engineering vol.6 issue 1: 2023 32 verification sheets in a digital database within statistical software. in this stage, the types of control charts to be used were selected based on the information generated by the verification routine. individual values and moving range, or i-mr charts, were selected for medical air and vacuum system verification. this is due to the measured variable in each verification routine corresponding to an individual value, not a subgroup. in this way, the behaviour of the systems can be explored based on measurements made periodically to the pressure variable generated by the system itself. the moving range chart indicates the variability between each measurement caused by comparing it with the immediate previous measurement; this information makes it possible to verify the process stability statistically. nonconforming units, also known as np charts, were selected regarding the verification routines of medical equipment in the emergency department and for the installed defibrillators. this chart evaluates the nonconforming portion of several measurements made. this chart was selected because there are a certain number of variables to be verified in each routine, which may be compliance or non-compliance. this number is constant in each routine. each test variable was categorized depending on its result: "compliant" in case it was performed without problems or "non-compliant" in case it presented any detail. control charts development the next phase consists of developing the control charts and the statistical analysis of the obtained results. only i-mr charts were generated for the verification routines of the medical air and vacuum system; this is due to the results obtained that denote procedures in statistical control and it was not necessary to explore further. regarding the defibrillator verification routine, derived from the results obtained, the decision was made to go deeper through a pareto diagram to make an improvement proposal that could impact the department's work. finally, in the case of the emergency area and derived from the results obtained, it was not necessary to carry out a significant analysis to make proposals. improvement proposals after the analysis of the obtained results, proposals for improvements in the processes of the clinical engineering department were formulated. all based on evidence from the same information that this department generated. results figure 3 shows the np chart obtained for the emergency department's equipment verification routine. it can be seen that the upper control limit is located at a value of 1.008, which indicates a maximum of one non-conformity found per verification routine carried out in the period analysed. the nonconforming portion is located at the value of 0.093, which corresponds to a value of less than one non-conformity per verification routine performed. lastly, the lower control limit is located at zero and corresponds to zero nonconformities found by the verification routine as the minimum value in the evaluated period. within the presented values in the measurement period, only two values can be found in the upper control limit and one outside said limits. the value outside the control limits indicates two nonconformities in a verification routine. this value is considered atypical due to the stable trend of the evaluated process. the emergency department dynamics implies an active role on the part of the equipment user in terms of continuous verifications; this is due to the high patient turnover in the service. this is reflected in the data in the control chart, and it is difficult to find technical failures related to the equipment. regarding the verification routines for hospital defibrillators, figure 4 shows the obtained results. it has a value of 3.45 for the upper control limit, zero for the lower control limit, and 0.79 for the fraction nonconforming. the chart interpretation indicates that, on average, there can be a maximum of between 3 and 4 technical failures per verification routine for the 15 equipment distributed throughout the hospital, approximately one failure per routine performed, and a minimum of zero failures found. two atypical values outside the control limits are identified, carrying out a study regarding the type of failures that led to these values; a special situation 33 j global clinical engineering vol.6 issue 1: 2023 gonzález campos, vázquez rodriguez, rodríguez trujillo, ramírez mendiola: application of statistical processes control for the performance improvement of a clinical engineering department was detected where the supply of printing paper for the equipment presented a delay in delivery by the supplier. derived from these results, it was decided to carry out a deeper analysis that could offer a broader perspective of the behaviour of this process. figure 5 shows a pareto diagram that identifies the equipment with the highest number of nonconformities in the measured period. it can be seen that 80% of the failures come from five specific defibrillators of the fifteen installed. these are installed in the areas of nursery, operating theatre 1, radiological imaging, emergency department and operating theatre 2. finally, for the case of verification routines of the gas system, figure 6 and figure 7 show the i and mr control charts, respectively, for the case of the vacuum system. chart i shows an upper control limit of ˗13.480 inhg, a lower control limit of ˗21.75 inhg, and an average value of ˗17.63 inhg. it is observed that there are no values outside the control limits; for its part, the system was programmed to operate at a value of ˗18 inhg, so this behavior presents reasonable statistical control. on the other hand, the chart of moving ranges in figure. 7 also denotes an excellent statistical control of the process with only one atypical data outside the control limits. regarding this atypical value, a significant variation figure 3. np control chart for the emergency department. figure 4. np chart for the defibrillator verification routines. figure 5. pareto chart for defibrillator failures. figure 6. i chart for the vacuum system verification routines. gonzález campos, vázquez rodriguez, rodríguez trujillo, ramírez mendiola: application of statistical processes control for the performance improvement of a clinical engineering department j global clinical engineering vol.6 issue 1: 2023 34 in the hospitalized patient number between one measurement and another was detected as a possible attributable cause. this issue caused variability in the range of data. however, outside of said identified cause, the data presents consistency in the statistical control denoted in the chart of figure 6. discussion the data obtained for the selected processes denote their stability over time. this means the data tends to behave similarly except for specific and atypical situations. however, it would be essential to conduct more extensive analysis in time. it is suggested to analyse the time of at least one year of data collection to rule out that the behaviour may be affected by temporary issues. in the case of the verifications of the equipment in the emergency department and the gas systems, it was recommended to the clinical engineering department to extend the time between verifications so that they could focus their work on other activities that require higher priority. the stability represented in the control charts gives the certainty that no values will require monitoring as closely as it was carried out; therefore, it is possible to carry out fewer verifications with the certainty that the processes work correctly. if problems arise from implementing this strategy, it would be convenient to return to close monitoring. regarding the results obtained from the verification process of the hospital defibrillators, a proposal was made to the clinical engineering department to reinforce the monitoring of the equipment that represents the largest number of failures to control the nonconformities that the equipment could present. when dealing with life support equipment, a failure at the time of the operation could have serious consequences. once the failures have been solved or the processes regarding the nonconformities presented have been controlled, it could be considered to return to the weekly verifications or extend the time between them. conclusions the results show good general statistical control for the selected processes. based on these data, it can be assumed that the proposed strategies respond to real situations that occur in hospital operations. however, it is important to highlight that the process selection was done to comply with the necessary characteristics mentioned for the data. the standardized collection of data and sufficient data over time encourage the behaviour description of the process to be as similar to reality as possible. in this context, it is possible to make effective suggestions for improvement strategies based on evidence, in the opposite case for the other processes whose data was insufficient to develop the tools satisfactorily. accomplishing all the data characteristics, statistical process control arises as an effective strategy for evidencebased efficiency improvement in the clinical engineering department. the proposals to the clinical engineering department aim to guide its operation toward the needs detected through the statistical analysis of its generated data. if they were developed with insufficient or incorrect information, it is possible that the improvement strategies had been guided towards incorrect guidelines and were not effective. similarly, modifications could be considered to be done to all the department's verification processes so that while the verification times are prolonged in some of them, in others, they become more constant, focusing on priority figure 7. mr chart for the vacuum system verification routines. 35 j global clinical engineering vol.6 issue 1: 2023 gonzález campos, vázquez rodriguez, rodríguez trujillo, ramírez mendiola: application of statistical processes control for the performance improvement of a clinical engineering department points and detection based on evidence. however, it would be necessary first to achieve the correct standardization of each process and capture sufficient data over time to deploy the same strategy. finally, it could be considered to go even deeper into the analysis of the statistics generated through individual studies of the non-conformities found. through a categorization by type of non-conformity, improvement strategies regarding verification routines could be directed toward more specific issues. acknowledgments the research team acknowledges biomedical engineer césar gonzález for giving access to the clinical engineering department data to elaborate on this work. references 1. correa m, villalba mp, garcía jh. protocolos para evaluación de desempeño en equipos médicos. revista ingeniería biomédica [internet]. 2017; 11(22):65-71. 2. li j, mao y, zhang j. maintenance and quality control of medical equipment based on information fusion technology. computational intelligence and neuroscience [internet]. 2022. 3. sherwood mk. quality assurance in biomedical or clinical engineering. journal of clinical engineering [internet]. 1991;16(6):479-83. 4. ropella km. introduction to statistics for biomedical engineers. synthesis lectures on biomedical engineering. cham: springer international publishing; 2007. 5. benneyan jc. statistical process control as a tool for research and healthcare improvement. quality and safety in health care [internet]. 2003; 12(6):458–64. available from: https://qualitysafety.bmj.com/ content/12/6/458 6. bareño j. guía pedagógica control estadístico de procesos como generador de una cultura de la medición en las organizaciones de salud (ips) [internet]. 27-87 7. govindarajan r, llueguera e, melero a, molero j, soler n, rueda c, et al. el control estadístico de proceso puede ayudar a prevenir los errores de tratamiento sin aumentar los costes en radioterapia. revista de calidad asistencial [internet]. 2010; 25(5):281–90. 8. van de glind emm, willems hc, eslami s, abu-hanna a, lems wf, hooft l, et al. estimating the time to benefit for preventive drugs with the statistical process control method: an example with alendronate. drugs & aging. 2016; 33(5):347–53. 9. baker aw, haridy s, salem j, ilieş i, ergai ao, samareh a, et al. performance of statistical process control methods for regional surgical site infection surveillance: a 10-year multicentre pilot study. bmj quality & safety. 2017; 27(8):600–10. 10. ropella km. introduction to statistics for biomedical engineers. synthesis lectures on biomedical engineering. cham: springer international publishing; 2007. 11. cecchini a, masselli gmp, silvestri s. evaluation and optimization of ces performances: application of pareto principle to kpis. glob clin eng j [internet]. 2021;4(1):14–21. available en: http://dx.doi. org/10.31354/globalce.v4i1.87 12. wang b. evidence-based maintenance of medical equipment: an outcomes-based method of keeping medical equipment safe and reliable,1st edition. usa: independently published. 2019. https://qualitysafety.bmj.com/content/12/6/458 https://qualitysafety.bmj.com/content/12/6/458 http://dx.doi.org/10.31354/globalce.v4i1.87 http://dx.doi.org/10.31354/globalce.v4i1.87 5 j global clinical engineering vol.5 issue 1, 2022 this book review is about the elsevier academic press newly published cybersecurity for connected medical devices by author arnab ray, ph.d. in addition to the preface, the book contains nine chapters, an afterword, and an index for a total of 332 pages. this book contains a bevy of information that could overwhelm on first reading, but helpfully, from chapter 2 onwards, every chapter serves up a summary and key takeaways that consolidate the key messages. arnab ray is a computer scientist with a background in critical software development and cybersecurity design of medical devices that provides a cybersecurity developer’s perspective throughout this book. whilst the key audience is manufacturers of medical devices who are responsible for designing a cyber secure product, clinical engineers with an interest in cybersecurity should find this book a handy supplement to make sense of the fast-evolving landscape. they will gain a broad understanding of basic cybersecurity principles, which can help influence integration choices in a healthcare delivery organization (hdo). often medical device manufacturers (mdm) have not given enough consideration to the challenges of incorporating and maintaining a medical device in an hdo it network. importantly, arnab recognizes that cybersecurity is a shared responsibility between the manufacturers and healthcare providers, but does not propose an effective mechanism for defining and sharing such responsibility. the introduction provides context to support the assertion that the cybersecurity of medical devices is a growing concern. it cites some high-profile examples of cyber-attacks on medical devices in a controlled environment to provide proof of concept. while there are no reports of cybersecurity incidents in a real-life context it warns, that since most devices do not log cyber-related issues, a cyber incident could be incorrectly diagnosed as equipment malfunction. it would have been useful to highlight tools available to hdos such as intrusion detection, dynamic network segmentation, and malware prevention systems and to examine how they impact medical devices’ performance. with the increasing integration of connected medical devices, with varying levels of endpoint security, to information systems, there are more opportunities for cybercriminals to gain illegal access to confidential information and disrupt wider operations within a healthcare book review by lloyd m. c. lilley medical devices it lead, clinical engineering, nottingham university hospitals nhs trust, uk cybersecurity for connected medical devices arnab ray isbn: 978-0-12-818262-8 academic press: elsevier first edition: published november 2021 book price: us$84.95 http://www.globalce.org http://www.globalce.org j global clinical engineering vol.5 issue 1, 2022 6 delivery organization. this chapter helpfully discusses the development of national cybersecurity policies in the u.s. with some acknowledgment of similar policies in the e.u. acknowledgement of the widely accepted challenge of designing a cyber secure product without introducing unintended negative consequences on usability and patient safety, highlights the limitations in designing a cyber secure product. medical device manufacturers (mdm) are encouraged to consider risk-based controls, which conflicts with the recommendation of a controls-based approach, mentioned in chapter 4. the introduction concludes with cybersecurity lifecycle challenges, and a suggestion for the development of a manufacturer’s business model, that makes cybersecurity a distinct structural part of the business. a helpful analogy of a home, bank vault, and a precious asset is referred to throughout chapter 2, basic cybersecurity concepts, which effectively convey the fundamental concepts and challenges of cybersecurity and risk management. the key concepts of vulnerability and threats are articulated in simple, easy-to-understand terms. as the cybersecurity landscape evolves around the globe, terminology develops meanings that can seem rather vague, and often mean different things to different people, which might be a little disconcerting to a novice. the author approaches this conundrum by adopting certain definitions from authoritative sources and using them consistently throughout the book. as a result, the reader has a stable foundation from which to explore and understand the core principles. the medical device’s information security objectives are described as availability, integrity, and confidentiality in order of priority. however, one could argue that integrity has a higher priority since an altered record is more likely to go unnoticed, potentially causing widespread harm before it is detected, whereas the unavailability of information is obvious and should result in the implementation of contingency plans. this chapter clearly describes five categories of controls used to reduce the likelihood of an attack being successful. one of the categories, cryptography, is explored in detail with a study of the major cryptographic techniques used to establish secure communications between the sender and the intended receiver. the level of detail given is appropriate for one who is new to this discipline and is informative enough to help a designer make decisions about the most appropriate method to implement. standards and regulations, which aim to ensure manufacturers build safe medical devices, are developing to include cybersecurity requirements. the increasing focus on cybersecurity is the subject of chapter 3, regulatory overview and includes a summary of the current us and eu regulatory frameworks. it is recognized that a robust quality management system (qms) is necessary for manufacturers if they are to meet the standards expected by the regulatory authorities. this chapter discusses key manufacturing quality standards, suggesting cybersecurity is not yet fully formed in them, and in fact lags behind some standards that hdos have had access to for some time. manufacturers struggling to adapt are offered useful guidance on how to achieve a cyber aware qms with a suggested 5 step process for introducing regulatory requirements into an existing system. in chapter 4, the product cybersecurity organisation, the author suggests that with few tools available to quantify cybersecurity impact it is difficult for mdm’s decision-makers to be convinced of the benefits of investing. one could argue that making the case for investing is not difficult because of many well-known instances where damage has occurred from cyber-attacks on it systems – the connected medical device is another type of it system prone to the same attacks therefore, much is already known about exploitable system weaknesses. the author prefers a controls-based framework as opposed to a risk-based framework for building a cyber secure product. i believe that both frameworks have a place in design and there will always be an element of risk-based design due to the costs in terms of build and device performance. recommendations for addressing http://www.globalce.org http://www.globalce.org 7 j global clinical engineering vol.5 issue 1, 2022 copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. organizational shortfalls are made by offering key building blocks to achieving a product cybersecurity organization. cybersecurity risk management is a complex field and the author clearly wanted to give more attention to this area therefore it occupies chapters 5 and 6. chapter 5 predominantly addresses risk assessment and looks at threat modeling from system and subsystem levels. to help demonstrate a systemic threat and vulnerability modeling approach, an infusion pump with network connectivity is specified, and used as an example. this provides a convenient vehicle to explain the transferrable process for assessing cybersecurity risk. there is a lack of threat modeling tools specific to medical devices but there are modeling tools for it systems that can be adapted. the author demonstrates this by using microsoft’s stride framework to identify system threats and complete a threat model. chapter 6, cybersecurity risk management-ii, builds on the previous chapter with an illustration of a complete system cybersecurity risk model. the main theme of this chapter is the response to an identified risk. the infusion pump example specified in chapter 5, again proves useful but this time to explore system threats and the corresponding responses or controls. the mdm cybersecurity designer is walked through high-level examples of threat articulation, responses, and undertaking a risk-benefit analysis. it is recommended that technical controls are traceable to regulations and standards. chapter 7, cybersecurity design engineering, takes a look at these controls identifying them as master controls, and with examples, key factors for building cyber-secure medical devices are considered. a brief look at the limiting factors in the hardware and battery-operated devices clearly demonstrates the challenge of incorporating effective cybersecurity controls without degrading performance. it would have been useful to provide examples from other safety-conscious industries such as aviation or nuclear power, which are at an advanced stage of maturity. chapter 8 delves deeper into five more capabilities of an mdm that were defined in chapter 4. each capability is clearly described, providing industry insights with recommended best practices. the final chapter, chapter 9, product security governance and regulatory compliance explores two more capabilities that an mdm should demonstrate. this chapter describes the governance elements required to satisfy regulations, which are fundamentally supported by a qms. the advice given here is simple and clear mdm’s need to continually refresh their resources and processes, and be transparent about the product’s cybersecurity posture. although this book is aimed at medical device manufacturers (mdm), i feel it is suited to anyone with an interest in medical device cybersecurity, including those working in healthcare delivery organizations. a lot of ground is covered mostly from a regulatory and compliance challenges angle; as a result, it only provides an overview, which the author concedes. however, the reader will find this book a useful springboard, from which to develop a greater understanding of a fast-evolving domain. this book successfully provides a framework for mdms to design a cybersecurity-focused organization. http://www.globalce.org http://www.globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 1 j global clinical engineering vol.2 issue 3, 2019 editor’s corner i am not sure to whom the credit is due for the saying take pride in how far you have come and have faith in how far you can go! but it is reflective of the feelings of most clinical engineers (ces) including me – the pride of being a practicing ce. i am routinely in continuous communication with professional colleagues all over the world. a couple of evenings ago, i was chatting with one such colleague who works in a mid-west hospital in the united states. he is known as a caring manager with vast experience. he is hardworking and expects no less from his ces and biomedical equipment technicians. during our chats, he was never at a loss for words and always centered his talks on the latest sports scores (especially if his favorite team won) and about finding ways to collaborate with clinical, administration, and it departments to improve his program’s impact on patient care outcomes while at the same time saving on hospital expenses. after years of these conversations, i could predict the flow. the topics did not change much but the order did and there was a greater emphasis on his first passion – ce. he is a caring manager of the first kind. however, a couple of nights ago, our chat was completely different. his conversation was short, there was no monday morning quarterbacking or any sports chat at all. after a short while, i quickly realized that he was not himself. i asked him what was going on as i found him to be so different. his spirits were up but his response shocked me. myself, i practice ce in the largest medical center in the world (the texas medical center) where we’ve been through hurricanes, floods, and evacuations. as far as i can remember, i had never witnessed a colleague’s behavior turn as his did that evening. he shared the demands of his work that were similar to those that i had been hearing from many other colleagues over the previous 14 weeks. during these abnormal times, he had been working an average of 10 hours a day almost seven days a week. he was lost in an environment created by the ever-changing knowledge around covid-19, about its spread, diagnosis, care protocols, and the reality of shortages of equipment and supplies – and was constantly challenged to quickly come up with workarounds and safe solutions. but it was the second part that shocked me. there are many challenges around the reuse of single-use protective gear, to the support of multiple patients from a single ventilator, to devising isolation care spaces. at this point, he felt that maybe he was not doing enough for his patients. the burden was heavy. successful solutions needed to be trialed and were expected in rapid succession, yet the resources of both qualified labor and appropriate technology were in short supply. i know him and his program, it runs like a swiss clock. yet he was frustrated by not being able to do more. by any measure, he is one of the silent heroes, one of the ce professionals who use their competencies, experience, and open their hearts every day in the committed pursuit to provide safe and efficient patient-ready technology that supports the mission of their organization. ces perform their many tasks all over the world 24×7×365 but their critical contribution mostly goes unrecognized. the ce profession has certainly evolved and has begun to enjoy more input into the needed and effective programs they provide and manage, especially during this present huge demand for ce knowledge and leadership. however, we still have a long way to go to increase the awareness of the public and medical decision-makers. they need to know that by including the unique expertise of competent ce practitioners within the healthcare system’s decisions, improved safety and quality will follow. this will result in healthcare delivery that is more accessible to a larger volume of patients that would not be possible otherwise. http://www.globalce.org http://www.globalce.org j global clinical engineering vol.2 issue 3, 2019 2 it is no mistake that the journal made the decision to dedicate our front-page cover to recognizing all ce professionals. these are the people that are working deliberately to maximize the availability of proper technology and ensure that care providers have what they depend on to manage and help their patients. in other words: to always have the needed safe technology in “patient-ready state,” always appropriately selected, and in optimal operational performance administered under frugal use of resources. as you all know, this part we are already delivering. so, what else could a hospital administrator wish for? if they think of anything, we are listening! big thanks to my colleagues and all the ce heroes all over the world! today, tomorrow, together! dr. yadin david copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org j global clinical engineering vol.2 issue 2: 22-25 ; 2020 22 received january 31, 2020, accepted february 9, 2020, date of publication february 14, 2020 ifmbe/ced recognition of certification/registration programs for clinical engineering practitioners by j. wear scientific enterprises, inc. abstract the ifmbe/clinical engineering division (ifmbe/ced) has recently established an international credentialing board (icb) [https://ced.ifmbe.org/projects/ce-htm-credentialing.html] to recognize organizations that certify or register clinical engineering practitioners (ceps). the icb has 9 members appointed by the ced board and these members are experienced clinical engineering practitioners with several certified or registered. the icb will maintain a list of recognized organizations that certify or register ceps but will not maintain a list of the individuals certified/registered by these organizations. the national examining authority (nea) that performs national certification/registration can submit information on their program to the icb and request to be globally recognized. this will include detail information on the program and how it administers their certifying or registering their individuals. once recognized a program will be subjected to renewal reviews every three years to assure that it is still a valid and compliant operational program. since there are yet no specific guidelines for programs to certify/register ceps, the icb will have to evaluate each nea submission in detail. the icb will need to determine that the individuals certified/registered are qualified practicing ceps and the program is well managed and fulfills its objectives. to be qualified the nea must have a set of by-laws and a code of ethics amongst other requirements. certification programs may be based on credentials only or programs based on exams and credentials. registration programs may be based on credentials including experience. the recommendations are that certification/registration programs should meet individual countries needs and how clinical engineering is practiced in a country. in lieu of an engineering degree requirement the nea may substitute experience history since not all clinical engineering practitioners have engineering degrees due to the lack of education opportunities in their local. the icb will also aid professional groups that are trying to establish certification/registration programs for ceps. keywords – clinical engineering, certification, registration, practitioner, board, clinical engineer, education. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction the credentialing project team of the clinical engineering division (ced) of ifmbe https://ced.ifmbe.org/ projects/ce-htm-credentialing.html worked for three years on the development and adoption of the framework for recognition of certification or registration programs for clinical engineering practitioners (ceps). the previous work of the ced was examined. next existing certification and registration programs for ceps were reviews to determine if there were any common requirements and operations for the programs. there are major differences between certification and registration programs and significant differences in each of these approaches [link here] https://aamalegaleye.wordpress.com/2017/09/06/ registered-vs-certified-a-question-of-terminology/. it was http://www.globalce.org http://globalce.org http://globalce.org https://ced.ifmbe.org/projects/ce-htm-credentialing.html https://ced.ifmbe.org/projects/ce-htm-credentialing.html https://ced.ifmbe.org/projects/ce-htm-credentialing.html https://aamalegaleye.wordpress.com/2017/09/06/registered https://aamalegaleye.wordpress.com/2017/09/06/registered 23 j global clinical engineering, special issue 3, 2020 wear: ifmbe/ced recognition of certification/registration programs for clinical engineering practitioners determined that all of the major certification/registration programs for ceps appeared to recognize only qualified ceps. “ifmbe ced white paper entitled “certification/ registration of clinical engineering practitioners” james wear was submitted 1 september 2017. http://cedglobal. org/wp-content/uploads/2018/06/ced-certificationwhite-paper-with-annexes.pdf the team that worked on this project represented different countries and different sections of the world. the present team members are listed here: • james o. wear (usa) • fabrola martinez (mexico) • mario medvede (croatia) • adrian richards (australia) • ewa zalewska (poland) since the members were scattered around the world, most of the meetings were by teleconferences. the team submitted the “proposal for recognizing certification/ registration programs for clinical engineering practitioners” to the ifmbe ced board in the summer 2019 and it was afterwards approved by this board. program clinical engineering practitioners perform many technology-related functions in the healthcare field and are called by different names even in the same country. therefore it was necessary for the team to develop a definition for clinical engineering practitioners for this project. the definition the team developed is: “a clinical engineering practitioner is a clinical engineer, biomedical engineer, healthcare technology manager, clinical engineering technologist or clinical/biomedical engineering technician who practice technology management at a qualified level.” the purpose of the project was to develop a method for recognizing programs that certify or register clinical engineering practitioners and to facilitate evolution of common program elements. it will not be a program to recognize individuals who have been certified or registered as ceps. the program will only develop a list of recognized programs and will not maintain a list of individuals certified or registered by the recognized programs. to maintain a list of individuals would be time consuming and therefore lead to the need for significant administrative and clerical time. this also would require significant additional funds. the recognized programs will be expected to have an upto-date list of individuals they have certified/registered. a requirement for recognition will be that such a list be included and will stimulate individuals to maintain their certification/registration. the program should provide information on the certification/registration of individuals. recognized programs will be listed on the ifmbe/ced website with associated contact information. this will be an added benefit of their recognition. this will also provide a method that can be used to determine if an individual is certified/register by a recognized program. the ifmbe/ ced board has appointed the first international credentialing board (icb). there are to be 9 members with some members being representative of the ifmbe/ced board. their service terms are to be the same as the ifmbe/ced board members having staggered terms. they also are to be certified/registered or well qualified ceps and representing the different parts of the world. the members in this first appointment are: • fabiola martinez (mexico) co-chair • li bin (china) co-chair • ewa zalwska (poland) • jitender sharma (india) • adrian richards (australia) • ricardo silva (usa/venezuela) • ashenafi hussein (ethiopia) • tomokazu nagusawa (japan) • riad farah (lebanon) this icb has representatives from 9 countries and 6 continents. three or four are from countries that have programs that could seek recognition for their country’s certification/registration program of ceps. the icb will have to examine each application in detail to determine if it meets the requirements to be recognized. this will require the application for recognition to be very detailed and in specific format. the sponsoring organizations of the certification/registration programs do not have to be members of ifmbe http://cedglobal.org/wp-content/uploads/2018/06/ced-certification-white-paper-with-annexes.pdf http://cedglobal.org/wp-content/uploads/2018/06/ced-certification-white-paper-with-annexes.pdf http://cedglobal.org/wp-content/uploads/2018/06/ced-certification-white-paper-with-annexes.pdf wear: ifmbe/ced recognition of certification/registration programs for clinical engineering practitioners j global clinical engineering, special issue 3, 2020 24 for the program to be able to apply for recognition. since initially the number of programs applying is expected to be small, there will not be any fee to make application or to be recognized. this will also encourage programs to apply. the program will be administratively supported by the ced secretariat and icb board members. the ced may later initiate fees if the administrative costs becomes sufficient to justify it. the organization that makes the application for recognition must be the one that operates the program and is called the national examining authority (nea). the organization can be a professional organization, a government entity, an academic entity or some other form of a national or regional program. it can also be a for-profit program. requirements for a national examining authority to make a submission for recognition of their certification/ registration program are not as simple as it appears. existing certification programs are very different and registration programs are very different from certification. some basic requirements can be made for a submission and these follow in the next section. submission requirements 1. all submissions must be typed in english. 2. the submission must have a single contact person which is the chair person of the nea or the secretariat of the nea. an address, email and phone number must be provided so they can be contacted if there are issues with their submission or administration. the icb may at any time request additional information on a program through this individual. 3. the date the program was established will be submitted. there are no minimum years of operation since this might discourage new programs from developing. the critical factor is that a nea is operational and has all the appropriate requirements for consideration of recognition. also the programs will have a renewal every three years for their recognition. this will allow the icb to recommend withdrawal of recognition of a program that has not fully developed. 4. the submission must have a sponsoring organization including how the program is involved with the sponsoring organization. this needs for the submission to be very specific for instance one of the major certification programs is sponsored by a national society, but it is independent of the sponsor for operation. the sponsor only provides administration support including budget but not fund raising. 5. the submission must provide all the names and affiliation of the nea board members that are current, their terms, how they were selected and if they are certified/registered and by whom. 6. the submission must include the number of people currently certified/registered as clinical engineering practitioners. the number should show the number in each clinical engineering group if there is more than one. 7. the national examining authority must be governed by a set of by-laws included in the submission. if it is a problem for a new program to develop a legal set of by-laws, the icb should be able to provide an example of by-laws to assist in their adoption. 8. since ethics is a general important issue also for clinical engineering, the nea must have a code of ethics that each certified/register person will abide by. the icb can provide samples of codes of ethics to any organization applying. the major part of the submission shall include a detail of the program including how it is financed. this part of the application can be different for each program and probably will be different for certified programs and registration programs. this shall include at least the following: • when program started • program by-laws • forms for individual applications • forms for renewal applications • how applications are reviewed • if written or oral exams are required • how many are certified/registered in clinical engineering 25 j global clinical engineering, special issue 3, 2020 wear: ifmbe/ced recognition of certification/registration programs for clinical engineering practitioners • years of experience required including type of experience • education requirements including any specific courses • fees required there is no time limit on how long a program has been in operation, but it must be currently operating. no individual practitioner exams are required for a program to be considered for evaluation and some existing programs are based on experience and credentials. programs like the us and taiwan started based on experience and credentials and now require both written and oral exams. if the program has a handbook on how to become certified/registered cep and renew, a copy must be provided. a program will normally have a renewal for certification/ registration and if so, this must be submitted. this will normally include the completion of continuing education ceus, experience and professional activity. the renewal time period is usually for 3 to 5 years during which time the person must be practicing in the field. the submission should include how the program is promoted in general to individuals in the field and to healthcare administrators. this would include how clinical engineering practitioners are informed that the program exists in their area. this might be with presentations at their professional meetings as well as presentations at healthcare providers and administrator meetings. the program should be promoted to other healthcare providers such as administrators, physicians, nurses, technologists and to government agencies. this can be done with their interactions with these individuals. offering to make presentations to their professional meetings and submitting articles about clinical engineering practitioners certification/registration to their professional journals. after considering the application and the support documentation the icb will determine if the application met the requirements and qualified for inclusion in the roster of icb recognized nea. the icb may make specific recommendations for changes to a non-recognized program which can then resubmit an application. a recognized program will be reviewed periodically to assure that it is still operating and if it has made any changes in operations. the icb will have to determine how frequently this will occur and what will be required for demonstration of compliance. conclusion the newly established international credentialing board currently conducts its business through virtual platform that support participation of its members from different parts of the world. it is working to encourage existing certification/registration programs to submit application for their program to be recognized. it is also developing materials and support that can aid in the development of new programs. the icb can be contacted through the ifmbe ced. 45 j global clinical engineering vol.3 issue 1: 2020 rezer, marciano, santos, souza: flow analyzer for blood pump j global clinical engineering vol.3 issue 1: 2020 44 received april 2, 2019, accepted june 16, 2020, date of publication august 19, 2020 flow analyzer for blood pump by r.l. rezer1, m.a. marciano2, a.a. santos,1 and w.k. souza1 1 moinhos de vento hospital/clinical engineering, porto alegre, brasil. 2 moinhos de vento hospital/clinical and hospital engineering, porto alegre, brasil. abstract medical equipment that supports life, relieves diseases, and overcomes disabilities can also cause damage and death due to operational failures, user failures, and misuse. hemodialysis machines include roller pumps that control the flow of blood, and these pumps have to be calibrated accurately to ensure they are working properly. this article describes the development of a low-cost, open source prototype that automates the flow analysis (measurement and recording) of the blood pumps in hemodialysis machines. being able to accurately inspect the machine’s operation improves the quality and safety of its use. through this technology (this process automation), it is believed equipment downtime and total tests cost will be reduced. this device has a system that collects data in real time, generated by the blood pump dialysis. mathematical calculations are used to present flow information, including the standard deviation of the measurement, which is reported at the end of the test in an objective and simple way. through a software and human machine interface (hmi), the test can be monitored and generate a report that contains the name and model of the equipment, the quantitative results of the flows, and the standard deviations of the measurements. the device can be used by clinical engineering teams in preventive maintenance and after corrective maintenance, as a control practice, making the calibration process easier and more cost-effective. keywords – hemodialysis, quality control, biomedical analyzer, arduino. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction renal insufficiency occurs when the kidneys are unable to function properly.1 hemodialysis is performed from a venous access allowing high blood flow. the blood is transported through an extracorporeal circulation system to a capillary filter, where it is purified and then returned to the body. it is usually performed three times a week, for an interval of three to four hours.2 hemodialysis is susceptible to adverse events (ae) since it involves several risk factors, such as complications of invasive procedures, the use of complex equipment, critical patients, high patient turnover, and the administration of potentially dangerous drugs.3 the increasing use of hemodialysis worldwide is worrying specialists, researchers, managers, and health professionals. data from the world health organization indicate that, annually, tens of millions of people worldwide suffer disabling injuries or death due to aes following hemodialysis.4 medical equipment that supports life, relieves diseases, and overcomes disabilities can also cause damage and death due to operational failures, user failures, and misuse.5 hemodialysis machines include roller pumps that control the flow of blood. the pumps should contain various alarms and other devices to ensure patient safety. specific calibration is an important step for the correct operation of the equipment because the volume infused is the main parameter of the pump. it is essential that the methodology used in calibration be adequate for the tests to be validated as failure to do so can cause complications, including phlebitis, venous spasm, and pulmonary edema.6 the tests involve two parts – a qualitative evaluation (consisting of visual inspection of the structural conditions of equipment, parts, modules, and accessories) and quantitative tests (consisting of measuring or simulation of the parameters and/or the biomedical magnitude of the equipment).7 some trials are still done manually making the process time-consuming and decreasing the availability of dialysis equipment in a busy center. the calibration of the rollers involves adjusting the distance between the roller and the rigid bed (occlusion).8 at present, to perform calibration of the blood pump assembly, a precision scale, a graduated glass, and a digital timer are used, all of them traceable. among the restrictions of this method are the uncertainties generated by the technical measurement process itself and the delay to carry out the measurements.9 the main objective of this work is to develop a flow measurement device for blood pumps of hemodialysis machines. whereas flows generated by hemodialysis machines are greater than 1200 ml/h (maximum flow measured by the analyzers present in the market). the specific objectives to be achieved are (a) improving the process of inspecting the operation of the device, (b) reducing equipment downtime, (c) reducing costs related to the process of inspecting and testing quantitatively the equipment, and (d) improving the quality and safety of equipment use. for this development of the process automation, open source devices will be used, reducing the cost of the process. methods method flow figure 1 shows the flow of the steps followed for the development of this work. with the data specified, calculated, modeled, and simulated, the prototype was designed, developed, and tested. initially a group of studies was organized to evaluate possible solutions for a low-cost prototype for the blood pump flow analyzer. several follow-ups were conducted at the hemodialysis center, along with the nursing group to measure the real complications of the conventional hemodialysis therapy. as shown by the flowchart if figure 1, the other steps are described below. in order to perform this stage, three calculations were used: one to generate the flow, another to generate the volume, and a third to determine the standard deviation, within the limits of the processor and the requirements to analyze the blood pump flow, according to the following equations: figure 1. flow of the working method. http://www.globalce.org http://globalce.org http://globalce.org rezer, marciano, santos, souza: flow analyzer for blood pump 47 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 46 rezer, marciano, santos, souza: flow analyzer for blood pump conversions through the equations, tables 1, 2, and 3 were developed with parameters for program development and report generator. the largest number of variables of the circular constant or ludolph number (called “π”, being π = 3.14159265) was used to obtain the most accurate number possible. programming at this stage the arduino platform was programmed (figure 2), with a c language principle. based on tables 1 and 2, the volume and flow were described in the program. after this stage, the ultrasound sensor signal was programmed, making it a height meter to detect the volume of water and the valve, as a mechanism for releasing the water from the container in order to keep the blood pump always on, without overflowing the graduated container. the maximum level of volume was limited to 800 ml, and the minimum was 50 ml for the beginning of the readings. finally, the serial port was programmed where the name of the technician, the type of equipment, and the date and time of the service execution were introduced. on the display it shows only the flow values and the (1) (2) (3) table 1. conversion – relation between height (cm) and volume (ml) in the recipient (1) v=hπr2 direct reading container (ml) direct reading height (cm) calculated volume (ml) 0 0 0 50 0.63665 50.00237407 100 1.2733 100.0047481 150 1.90995 150.0071222 200 2.5466 200.0094963 250 3.18325 250.0118704 300 3.8199 300.0142444 considering r = 5.0000 table 2. conversion – relation between volume (ml) and the time (minute) (2) q= volume/time volume (ml) time (minutes) flow (ml/min) 50 1 50 300 6 50 600 12 50 this table represents the analysis of a flow of 50 ml/minute. table 3. conversion – relation between flow readings and the standard deviation of the readings performed in the range of 50 ml/minute reading numbers flow (ml/min) standard deviation (ml/min) 1 51 1 2 50 3 49 4 51 5 49 figure 2. electronic diagram of the circuit with the arduino platform. standard deviation. figure 3 shows the flow and standard deviation in the display, data transmitted by the serial port and the final report. materials peripherals peripherals installation – the system used a selector switch. the power to the board and the peripherals was through a computer source. for the control of the electromechanical device (valve), which is responsible for the release of water from the container, a normally open 5v relay was used. the ultrasound sensor (hc-sr04) was applied to read the height of the water in the container, connected directly to the arduino´s inlet. the display uses i2c communication to transmit data from the arduino to the hmi (human machine interface). we used a serial output for communication of the arduino with the computer. we can see the circuit of the project in figure 2. microcontroller the arduino mega was used in this prototype, a free hardware and code platform that has its own compiler, designed to reach people who have little programming knowledge. the microcontroller used is the atmel atmega 2560, an 8-bit microcontroller of advanced risc architecture. it has 256 kb flash (plus 8 kb that are used for the bootloader), 8 kb ram and 4 kb eeprom. there are 16 mips, operating on 16 mhz. arduino based on atmel atmega, among which we can highlight 3 serial communication channels, 16 analog inputs and 15 pwm outputs. it has also spi,12c communication and 6 pins for external interruptions. the mega2560 board has 54 pins of digital inputs and outputs that can be used as input or output. the pins operate at 5v voltage and can supply or drain up to 40 ma. each pin has internal pull-up resistor which can be software-enabled. it has 16 analog inputs (pins a0 to a15), where the conversion can be made with a resolution of 10 bits, that is, the value will be converted between 0 and 1023. ultrasound the hc – sr04 ultrasound module provides 2 to 400 cm without contact and measuring function, with precision of 3 mm. hmi in order for the simulator to have mobility and an easy interface between the operator and the device, it was decided to use the hmi system of the arduino platform with i2c communication. power supply standard 12v, 2.3a, real power of 500 watts, efficiency > 70%, tbf of 100,000 hours, 25ºc, internal protection against ovp / ocp / scp short circuit, ac input with manual switching 110 / 220 v, low acoustic noise, cables with protective cover, thermal cooling control system, 120 mm silent fan, technical standards iec60950 (electrical safety), iec61000 (electromagnetic safety) and on / off switch. relay na/nf of 5v. valve valve with 12v solenoid. mechanical assembly for the assembly of the device, 5 threaded rods of ½ with nut and washer were used, 1 50x50cm acrylic sheet, as shown in its assembly in figure 6. container a cylindrical container was used as a reservoir, graduated with a total volume of 1000 ml. figure 3. data shown on the serial output. rezer, marciano, santos, souza: flow analyzer for blood pump 49 j global clinical engineering vol.3 issue 1: 2020j global clinical engineering vol.3 issue 1: 2020 48 rezer, marciano, santos, souza: flow analyzer for blood pump flange a flange of ½ inch was attached to the bottom of the container for the water outlet. connector a connector with the same diameter of the extender used in the conventional hemodialysis kit was installed for liquid inflow into the container. results to obtain the final results of the electronic part, the circuit was assembled. after the connection of the ultrasound sensor to the valve in the arduino platform, four tests were performed and the analyzer responded satisfactorily. the final report is shown in figure 3. to obtain the final results of the mechanical part, the set was assembled as shown in figure 4. after assembly of all electronic and mechanical parts, four tests were performed. with the design mounted, the set responded satisfactorily as shown in figure 5. after the complete assembly of the prototype in the initial verification form, bench tests were performed comparing the readings from this prototype with those from conventional manual methods. after all adjustments, a test with the blood pump of the hemodialysis machine was performed. at the end of the test, a detailed analysis report was generated. conclusions tools and support devices in the analysis and simulation of biomedical information are of great value in mitigating the risks related to the use of biomedical devices. this article describes the development of an automated blood flow analyzer prototype to improve quality standards in the tests performed by clinical engineering services on hemodialysis machines. this prototype was found to reduce equipment downtime, reduce costs related to the testing process, and increase the safety of therapy with hospital devices that use blood pumps. conflict of interest the authors declare that they have no conflict of interest. references 1. ribeiro rchm et al. characterization and etiology of chronic renal failure in a nephrology unit in the interior of the state of são paulo. acta paul. enferm 2008;21(special issue):207–11. 2. mariotti c. quality of life in hemodialysis: impact of an occupational therapy program. scand j occupat ther 2009;18(3):172-9.curitiba available at: http://dspace.c3sl. figure 4. mechanical design of the flow simulator for blood pumps. figure 5. the final project. ufpr.br:8080/dspace/bitstream/1884/21795/1/ mariotti. pdf. accessed on: may 2017. 3. holley jl. a descriptive report of errors and adverse events in chronic hemodialysis units. nephrol news issues 2006;20(12)p.57–8; 60–1, 63. 4. ecri emergency care research institute. digital consultation. [internet] 2017. available at: http://www.ecri.org/. 5. júnior s. et al. system for evaluating the functionality of infusion pumps brazil. 2004;17-19 pp. 6. lucatelli mv. proposal of maintenance application focused on reliability in medical-hospital equipment. florianópolis. 270f. thesis (doctorate in information systems) graduate program in electrical engineering federal university of santa catarina, brazil. 2002. 7. vlchek dl, burrows-hudson s and pressly na. quality assurance guidelines for hemodialysis devices. hhs publication fda 1991;91(4161):233. 8. tamari y, lee-sensiba k, leonard ef, tortolani aj. a dynamic method for setting roller pumps nonocclusively reduces hemolysis and predicts retrograde flow. asaio 1997;43(1):39–52. 9. d’ausilio a. arduino: a low-cost multipurpose lab equipment. behav res methods 2012;44(2):305–13. 172-9.curitiba http://dspace.c3sl.ufpr.br http://dspace.c3sl.ufpr.br mariotti.pdf mariotti.pdf http://www.ecri.org 27 j global clinical engineering vol.4 issue 1: 2021 received august 6, 2020, accepted february 16, 2021, date of publication february 27, 2021 quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil by a. e. l. alvarado1, d. a. o. rosa1, s. g. mello2, m. s. dias2, m. f. barbosa2, k. n. barros2, b. a. lemos2, r. l. vitorasso1, v. p. bartholomeu1, p. p. americano1, e. s. filho1, j. c. t. barros moraes1, a. f. g. ferreira junior2, h. t. moriya1 1 escola politécnica, university of são paulo, brazil 2 institute for technological research, são paulo, brazil abstract this technical report presents the quality assessment process for the emergency corrective maintenance of critical care ventilators in a node, ipt-poli, of a voluntary network that is part of the initiative +maintenance of ventilators, led by the national service of industrial training (senai) and its integrated manufacturing and technology center (cimatec) to perform maintenance on unused mechanical ventilators in the context of the covid-19 pandemic in brazil. a procedure was established for the quality assessment of equipment subjected to corrective emergency maintenance, covering the essential aspects of the three primary standards (abnt nbr iec 60601-1: 2010+a1:2016, abnt nbr iso iec 62353: 2019, and abnt nbr iso 80601-2-12:2014) for performance and safety assessment. a set of nine critical care ventilators was evaluated considering the following parameters: leakage current, protective ground resistance, control accuracy, delivered oxygen test, and alarms. the evaluated ventilators underwent corrective emergency maintenance before performance and safety assessments. in the electrical safety tests, all equipment presented values prescribed for the standard. however, the assessment of ventilator parameters revealed that their performance was below the standard. finally, quality assessment reports were sent to the clinical engineering departments at hospitals. thus, it can be concluded that criteria selection for the quality assessment in critical care ventilators is crucial and of great significance for future pandemic scenarios, such as the situation experienced during the covid-19 pandemic. keywords – quality assessment, critical care ventilators, standards, corrective maintenance, ventilation modes, covid-19. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction faced with the pandemic due to the novel coronavirus (sars-cov-2), the brazilian health system experienced limitations in the number of critical care ventilators due to the increased demand. these ventilators were fundamental for the treatment of patients suffering from the most severe levels of the disease. the number of beds in intensive care units at hospitals was monitored as the disease progressed, and it was observed that certain regions had insufficient capacity.1 the institute of technological research (ipt) and the escola politecnica (poli) of the university of são paulo set up a laboratory (ipt-poli) to perform maintenance, inspection, electrical safety tests, and quality assessment http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ alvarado, rosa, mello, dias, barbosa, barros, lemos, vitorasso, bartholomeu, americano, filho, barros moraes, ferreira junior, moriya: quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil j global clinical engineering vol.4 issue 1: 2021 28 of mechanical ventilators to provide support to public hospitals in são paulo, brazil. medical devices that were unusable due to technical failures were repaired and returned to hospitals. there was a voluntary network of 39 maintenance points in all brazilian states, that are part of the national initiative (+maintenance of ventilators) led by the national service of industrial training and its integrated manufacturing and technology center. the maintenance and quality assessment processes were based on abnt nbr 77, abnt nbr iso iec 62353: 2019, and abnt nbr iso 80601-2-12:2014. this technical report addresses the quality assessment process conducted during the first months of activity and the set of critical tests selected as criteria for quality assessment after the maintenance process. specific electrical safety tests were conducted per abnt nbr iec 60601-1: 2010+a1:2016 (general requirements for basic safety and essential performance). the selected tests were leakage current to earth, to the patient, and in the medical device enclosure, considering the manufacturer's classification in accompanying documents.2 another essential standard used for evaluation was abnt nbr iso iec 62353: 2019 (recurrent test and test after repair of medical electrical equipment) that presents the requirements to be analyzed before the medical device is put into service, during maintenance and inspection, and after repair.3 the abnt nbr iso 80601-2-12:2014 (particular requirements for basic safety and essential performance of critical care ventilators) provides tests to evaluate ventilation modes, analyzed according to the pressure, volume, breath rate, inspiratory time, and oxygen concentration measurements. also, the standard prescribes testing to describe several failure conditions and alarm verification, emphasizing alarm priorities.4 critical care ventilators are medical life support devices, and the maintenance and calibration processes must be evaluated carefully to guarantee electrical safety and essential performance in ventilation. however, in the crisis scenario, it was not possible to thoroughly conduct all recommended tests; hence, there was a need for a study to select the points considered critical within a set of standards. a procedure for quality assessment of equipment subjected to corrective emergency maintenance was developed, covering the main aspects of the three standards for performance and safety assessment. this procedure was applied to a small set of critical care ventilators, and the results are presented and discussed. methods the electrical and optical equipment laboratory of ipt and the testing and calibration division of poli were used to regularly conduct electrical safety tests on medical equipment before the covid-19 pandemic and joined skilled labor metrology systems for this endeavor. ipt-poli organized four areas inside the ipt campus (são paulo, brazil) to conduct maintenance and quality assessment procedures. a brief description of these areas is presented below. the medical devices were registered and disinfected in a reception area. after 12 h, critical care ventilators were transferred to the waiting area, which is also utilized to store devices that were not compliant with the requirements. then, maintenance and quality assessment procedures were performed in the service area. this two-room area had four workbenches, two for electrical safety evaluation and two for ventilation assessment. two oxygen gas cylinders, medical oxygen (99 %) and high-purity oxygen (99.995 %), of 10 m^3 with two-stage regulators (from 4–6 bar) (prg-108, prostar, brazil) and an air compressor (1201bf, schulz, brazil) were connected to a delivery system in the service area to supply oxygen and air. compressed air and oxygen lines were installed to supply an adjustable pressure between 4.5–5.5 bar on each workbench to accommodate critical care ventilators. finally, compliant medical devices are stored in the dispatch area. leakage current measurement an electrical safety analyzer (601 pro series, fluke, usa) was used to perform the tests. briefly, the test consisted of supplying the medical device with 110 % of the rated electrical voltage, measuring the leakage current under normal conditions for all parts indicated by the abnt nbr iec 60601-1: 2010+a1:2016 (leakage current to 29 j global clinical engineering vol.4 issue 1: 2021 alvarado, rosa, mello, dias, barbosa, barros, lemos, vitorasso, bartholomeu, americano, filho, barros moraes, ferreira junior, moriya: quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil earth, to the patient, and the enclosure). the test must be repeated by applying the electrical failures prescribed for the standard and measuring the corresponding leakage current. critical care ventilators in this study, per the manufacturer, were classified as class i. this classification refers to medical equipment that has basic insulation and grounding protection against electrical shock. the standard also provides the permitted limits for class i equipment: leakage current (<5 ma), patient leakage current (<10μa), and enclosure leakage current (<100μa). resistance of protective ground an electrical safety analyzer (19032, chroma, germany) was used to perform the tests. the test consisted of circulating an alternating current of 25 a through the medical device. the abnt nbr iec 62353: 2019 standard was used for this test. the resistance of the protective ground was measured with an electrical safety analyzer and must be less than or equal to 300mω for equipment with a detachable power-supply cord. accuracy of control: volume control and pressure control inflation type the prescriptions related to volume control and pressure control inflation type correspond to items 201.12.1.101 and 201.12.1.102 of abnt nbr iso iec 80601-2-12: 2014. to test the volume control inflation type, it is necessary to measure the volume (ml), inspiratory time (s), positive end expiratory pressure (peep) (hpa), respiratory rate (breaths/min), and fraction of inspiratory oxygen (fio2) (%). for the pressure control inflation type, it is necessary to measure pressure (hpa), inspiratory time (s), peep (hpa), respiratory rate (breaths/min), and fio2(%). during the first month (april), to verify the accuracy of control, the setup was adopted as described in items 201.12.1.101 and 201.12.1.102 with modifications in resistance and compliance values, as shown in figure 1. a ventilator tester (avm100, néos, brazil) was used for data acquisition. an adult test lung (smartlung adult 2000, imtmedical, switzerland), an air compressor, and gas cylinders of medical oxygen (99 %), and high-purity oxygen (99.995 %) were applied to vary some parameters, such as compliance (ml/hpa), resistance (hpa/l/s), airflow (l/min), pressure (hpa), and fio2 (%). tables 1 and 2 list the parameters set for the critical care ventilators and test lungs. dark gray columns represent the parameters adjusted in the test lung, and light gray columns denote the parameters configured in the critical care ventilator. figure 1. experimental setup with the adult test lung and the ventilator tester. the orange arrow indicates the direction of the ventilator. table 1. adaptation of volume control inflation-type testing from item 201.12.1.101 of the abnt nbr iso iec 80601-2-12: 2014 test number test lung parameters ventilator parameters compliance* (ml/bar) linear resistance* (hpa/l/s) volume (ml) inspiratory time (s) set rate (breaths/min) fio2 (%) peep (hpa) 1 60 5 500 1 20 21 5 2 60 20 500 1 20 21 10 3 25 5 500 1 20 21 5 4 25 20 500 1 20 21 10 5 25 20 300 1 20 21 5 6 25 50 300 1 20 21 10 (*) modified values of compliance and resistance. alvarado, rosa, mello, dias, barbosa, barros, lemos, vitorasso, bartholomeu, americano, filho, barros moraes, ferreira junior, moriya: quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil j global clinical engineering vol.4 issue 1: 2021 30 in may, ipt-poli acquired another test lung simulator (dual adult ttl, michigan, usa). the instrument made it possible for the laboratory to verify the control's accuracy (items 201.12.1.101 and 201.12.1.102) of critical care ventilators without any modification of resistance and compliance (tables 3 and 4). also, the capability of the test lung simulator increased the number of tests from six to eight. figure 2 illustrates the experimental setup with the test lung simulator and the ventilator tester for this case. based on the abnt nbr iso iec 80601-2-12:2014, all critical care ventilators must declare in their instructions for use the maximum error to expiratory volume, airway pressure (paw), peep, respiratory rate, inspiratory time, and oxygen concentration. table 2. adaptation of pressure control inflation-type testing from item 201.12.1.102 of the abnt nbr iso iec 80601-2-12: 2014 test number test lung parameters ventilator parameters compliance* (ml/bar) linear resistance* (hpa/l/s) pressure** (hpa) inspiratory time (s) set rate (breaths/min) fio2 (%) peep (hpa) 1 60 5 10 1 20 21 5 2 60 20 15 1 20 21 10 3 25 5 25 1 20 21 5 4 25 20 25 1 20 21 10 5 25 20 15 1 20 21 5 6 25 50 25 1 20 21 10 (*) modified values of compliance and resistance. (**) set pressure above peep level. figure 2. test setup using test lung simulator (dual adult ttl, michigan, usa). the orange arrow indicates the direction of the ventilator. table 3. volume control inflation-type testing of item 201.12.1.101 of the abnt nbr iso iec 80601-2-12: 2014 test number test lung parameters ventilator parameters compliance (ml/bar) linear resistance*(hpa/l/s) volume (ml) inspiratory time (s) set rate (breaths/min) fio2 (%) peep (hpa) 1 50 5 500 1 20 21 5 2 50 20 500 1 20 21 10 3 20 5 500 1 20 21 5 4 20 20 500 1 20 21 10 5 20 20 300 1 20 21 5 6 20 50 300 1 20 21 10 7 10 50 300 1 20 21 10 8 10 20 200 1 20 21 5 31 j global clinical engineering vol.4 issue 1: 2021 alvarado, rosa, mello, dias, barbosa, barros, lemos, vitorasso, bartholomeu, americano, filho, barros moraes, ferreira junior, moriya: quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil delivered oxygen test a ventilator tester (avm100, néos, brazil) and the lung test were used, as shown in figures 1 and 2 to check the oxygen sensor on the critical care ventilator. the test lung (smartlung adult 2000, imtmedical, switzerland) was adjusted to a resistance of 5 hpa/l/s and compliance of 60 ml/hpa; in the case of the test lung simulator (dual adult ttl, michigan, usa), it was configured with a resistance of 5 hpa/l/s and compliance of 50 ml/hpa. the critical care ventilator was configured for control pressure mode, inspiratory time (1 s), pressure (10 hpa), frequency (20 breaths/min), and peep (5 hpa). the inspiratory oxygen concentration (fio2) was measured as 25 %, 50 %, 75 %, and 100 %. alarm verification a set of alarms were analyzed based on item 201.4.3, which was prescribed for abnt nbr iso iec 80601-212:2014. alarm conditions were generated according to the indications for each sub-item. the evaluated alarms are listed in table 5. calibration and verification calibrated instruments are mandatory to perform maintenance and quality assessment procedures. the ventilator tester parameters were calibrated according table 4. pressure control inflation-type testing of item 201.12.1.102 of the abnt nbr iso iec 80601-2-12: 2014 test number test lung parameters ventilator parameters compliance* (ml/bar) linear resistance* (hpa/l/s) pressure* (hpa) inspiratory time (s) set rate (breaths/min) fio2 (%) peep (hpa) 1 50 5 10 1 20 21 5 2 50 20 15 1 20 21 10 3 20 5 25 1 20 21 5 4 20 20 25 1 20 21 10 5 20 20 15 1 20 21 5 6 20 50 25 1 20 21 10 7 10 50 30 1 20 21 5 8 10 20 25 1 20 21 10 (*) set pressure above peep level. to table 6 with requirements based on the abnt nbr iec 60601-2-12:2014 and the international system of units. the ventilator tester was calibrated following the available laboratory standard (lmr metrologia, certificate number l613420, 2020-04-23). table 5. list of alarms test number item test 1 201.11.8.101.1 technical alarm condition for powersupply failure 2 201.11.8.101.2 internal power supply 3 201.12.4.101 oxygen monitor 4 201.12.4.104 maximum limited pressure protective device 5 201.12.4.103.1 ventilators intended to provide a tidal volume > 50 ml 6 201.12.4.105 high airway pressure alarm condition and protective device 7 201.12.4.106 peep alarm conditions 8 201.12.4.107 obstruction alarm condition 9 201.12.101 disconnection alarm condition 10 201.13.102 failure of one gas supply alvarado, rosa, mello, dias, barbosa, barros, lemos, vitorasso, bartholomeu, americano, filho, barros moraes, ferreira junior, moriya: quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil j global clinical engineering vol.4 issue 1: 2021 32 the electrical safety analyzer was calibrated for current, voltage, frequency, and resistance (ipt-laboratorio de metrologia eletrica/ctmetro, certificate number 173117-101, 2019-05-16). the ipt-poli acquired a certified oxygen cylinder with a purity of 99.995 % (air products brazil ltda, certificate number 256461, 2018-11-19) to verify the ventilator's galvanic cell tester that needs to be verified every day before the first use. a nitrogen gas sample was used to emulate the absence of oxygen for verification of the tester. uncertainty of measurement (u) for the ventilator parameters, pressure (hpa), volume (ml), fio2 (%), peep (hpa), and respiratory rate (breaths/min), three measurements were carried out and, consequently, the conventional quantity value and the measurement uncertainties were calculated. to calculate measurement uncertainties, type a evaluation of measurement uncertainty, derived from a statistical source, and type b evaluation of measurement uncertainty, which is the information from the accuracy of the verification certificate and information from the instrument's manual, were used. type a and b uncertainties were integrated to provide a combined standard measurement uncertainty.5 for each test, leakage current, and resistance of the protective ground, only one measurement was taken, and type b uncertainties were adopted. the uncertainties were calculated using combined and expanded uncertainties with a coverage factor (k = 2 and 95.45 %) as prescribed in the iso gum series guide to the expression of uncertainty in measurement.6 assessed critical care ventilators in total, nine critical care ventilators from two large public hospitals in são paulo were assessed. seven critical care ventilators (vela, carefusion, usa) were evaluated in april (tables 1 and 2). in may, two critical care ventilators (inter 5 plus, intermed, brazil) were assessed, as shown in tables 3 and 4. the medical devices were named a, b, c, d, e, f, g, h, and i in this study. the maximum errors for evaluating the first seven ventilators (a, b, c, d, e, f, and g) (vela, carefusion, usa) were obtained from its instruction for use and should be per the listed values: expiratory volume ±10 % of the monitored volume, respiratory rate ±2 bpm, airway pressure ±5 hpa, peep ±2 hpa, inspiratory time ±0.05 s, and oxygen percentage ±2 %. for the last two ventilators (h and i) (inter 5 plus, intermed, brazil), the maximum errors were: expiratory volume ±10 % of the monitored volume, airway pressure ±0.05 cmh2o, peep ±5 cmh2o, inspiratory time ±0.05 s, and oxygen percentage ±5 %. volume control inflation type and pressure control inflation type were evaluated for the ventilators using preset modes: continuous mandatory ventilation pressure control (cmv-pc) and continuous mandatory ventilation volume control (cmv-vc). results all ventilators passed electrical safety tests for protective ground resistance, leakage current, patient leakage current, and enclosure leakage current. tables 7 and 8 summarize the measurement results for ventilators that did not comply with the stipulated limits. table 6. calibration points for the ventilator tester parameters calibration points flow (l/min) 0.05, 0.1, 0.25, 0.5, 1, 10, 25, 50, 100 low pressure (mbar) 0, 5, 10, 15, 20, 30, 60, 120 high pressure (bar) 0, 2, 4, 5, 8, 9.5 barometric pressure (mbar) 650, 700, 750, 800, 850, 900 volume (ml) 0.005, 0.01, 0.02, 0.03, 0.05, 0.2, 0.3, 0.5, 1, 1.5 inspiratory time (s) 0.2, 0.4, 0.6, 1, 2 respiratory rate (breaths/ min) 10, 15, 20, 25, 30, 60, 80 fio2 (%) 21, 30, 60, 80, 90, 100 33 j global clinical engineering vol.4 issue 1: 2021 alvarado, rosa, mello, dias, barbosa, barros, lemos, vitorasso, bartholomeu, americano, filho, barros moraes, ferreira junior, moriya: quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil because of the ventilators' problems, alarm verification was performed only on ventilators a, h, and i. all ventilators were not compliant with the oxygen level alarm. discussion the ipt-poli adopted some of the essential performance requirements prescribed by item 201.4.3 abnt nbr iso iec 80601-2-12:2014 to evaluate critical care ventilators. tables 201.103 and 201.104 of items 201.12.1.101 and 201.12.1.102 of abnt nbr iso iec 80601-2-12: 2014 were taken into consideration; however, within the first weeks, due to the limitations of the available test lung at ipt-poli, the values of resistance and compliance were adapted according to the nearest values of resistance and compliance, as these configuration scenarios were shown in tables 1 and 2. another point was the time to carry out all 21 items in tables 201.103 and 201.104. as hospitals urgently needed critical care ventilators due to covid-19, only the first six test numbers were performed. all tests were performed with fio2 adjusted to 21 % (atmospheric concentration) to evaluate the accuracy of the control and the oxygen concentrations were evaluated separately. after the test lung simulator (dual adult ttl, michigan, usa) was acquired, all tests to verify the control's accuracy were conducted using tables 3 and 4. it was not possible to fully assess ventilators according to tables 201.103 and 201.104 because the test lung did not attend the prescribed compliance values (0.5, 1, and 3 hpa/l/s) for neonatal ventilators; nevertheless, the setup made it possible to assess critical care ventilators for adult configuration. the purchased equipment (test lung and ventilator tester) to assess the volume and pressure control inflation-type modes were those with the shortest delivery time. the equipment was not the most capable; they lacked some features, such as external trigger input and well-sampled data; however, they met the quick application criteria. tables 7 and 8 indicate ventilators that did not comply with the delivered oxygen, volume, and pressure control inflation-type tests. this was expected because ventilators were out of use for more than two years and received only emergency maintenance without replacing the maintenance kit. the fio2 the measurement test was essential to evaluate the delivered oxygen; as shown in tables 7 and 8, eight ventilators did not comply with the prescribed limits due to problems with internal leakages and control valves. external blenders controlled the percentage of oxygen in the ventilators (inter 5 plus, intermed, brazil); the blenders presented leakages in all configurations (21–100%). critical care ventilators commonly use galvanic cells to measure oxygen concentration, and those cells, depending on the manufacturer, have a life span of approximately 1–2 years. also, eight ventilators did not monitor oxygen concentration correctly because of problems related to the galvanic cell or its absence. leakages in the ventilator breathing system (devices e and i) were observed during the tests. one significant issue was noticed during tests with high medical oxygen concentrations, and the two ventilators presented inconsistent results. the results were doublechecked with a high-purity oxygen delivery system, and there were improvements in the performance of both ventilators. therefore, we noticed that the pressure loss in the delivery system of medical gas during high flow occurred due to particle debris in the pipes, which were removed. even though pressure setup in critical care ventilators was performed extensively using pressure values in mbar or cmh2o by the clinicians, the abnt nbr iso 80601-2-12:2014 indicated pressure values in hpa. even these units of measurement present a slight difference between them. at the end of each critical ventilator quality assessment, all evaluated parameters were summarized in a quality assessment report and forwarded to the hospital's equipment control staff. therefore, the quality assessment report could play an important role in hospital equipment usage decisions during the pandemic period. alvarado, rosa, mello, dias, barbosa, barros, lemos, vitorasso, bartholomeu, americano, filho, barros moraes, ferreira junior, moriya: quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil j global clinical engineering vol.4 issue 1: 2021 34 table 7. results of the critical care ventilators (vela, carefusion, usa) assessment continuous mandatory ventilation volume control (cmv-vc) ventilator test number results (ml) tidal volume uncertainty of measurement (u) c 1 570 13 e 1 96.4 7.2 continuous mandatory ventilation pressure control (cmv-pc) ventilator test number results (ml) pressure uncertainty of measurement (u) e 1 37.1 1.5 f 4 33.22 0.47 oxygen concentration (%) ventilator set value measured value* uncertainty of measurement (u) monitored value a 50 52.20 0.68 52 b 75 71.07 0.86 133 100 82.97 0.90 155 d 25 29.27 0.41 24 50 46.47 0.59 30 75 68.57 0.84 38 100 94.8 1.3 48 e 25 25.57 0.34 ** 50 47.40 0.56 ** 75 68.40 0.80 ** 100 87.6 1.2 ** f 25 27.00 0.33 ** 50 62.03 0.76 ** 75 89.8 1.1 ** 100 99.9 1.2 ** g 50 54.50 0.81 63 75 82.83 0.97 100 (*) this refers to the monitored o2 % value displayed on the ventilator.. (**) the monitored o2 % value is not shown because the galvanic cell was not installed. 35 j global clinical engineering vol.4 issue 1: 2021 alvarado, rosa, mello, dias, barbosa, barros, lemos, vitorasso, bartholomeu, americano, filho, barros moraes, ferreira junior, moriya: quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil table 8. results of the critical care ventilators (inter 5 plus, intermed, brazil) assessment continuous mandatory ventilation volume control (cmv-vc) ventilator test number results (ml) tidal volume uncertainty of measurement (u) h 2 392 10 3 407.1 9.8 4 447 11 6 261.8 6.7 7 265.6 8.0 8 170.5 4.3 i 2 395.3 12 3 421 10 6 262.4 6.1 8 168.1 4.0 continuous mandatory ventilation pressure control (cmv-pc) ventilator test number results (ml) pressure uncertainty of measurement (u) h 1 15.8 0.7 3 32.1 0.8 8 35.0 0.5 i 1 17.4 0.9 3 32.7 0.9 8 37.0 0.7 oxygen concentration (%) ventilator set value measured value* uncertainty of measurement (u) monitored value h 25 22.6 0.3 ** 50 44.4 0.6 ** 75 69.7 1.7 ** i 25 28.9 3.7 ** 75 69.2 0.5 ** 100 93.9 1.1 ** (*) this refers to the monitored o2 % value displayed on the ventilator.. (**) the monitored o2 % value is not shown because the galvanic cell was not installed. alvarado, rosa, mello, dias, barbosa, barros, lemos, vitorasso, bartholomeu, americano, filho, barros moraes, ferreira junior, moriya: quality assessment of emergency corrective maintenance of critical care ventilators within the context of covid-19 in são paulo, brazil j global clinical engineering vol.4 issue 1: 2021 36 conclusion although all medical devices underwent corrective maintenance, eight out of nine failed the delivered oxygen test. moreover, eight ventilators did not monitor oxygen, and four ventilators were not compliant with volume control and pressure inflation tests. the results are summarized in tables 7 and 8. notwithstanding the urgent requirement of critical care ventilators for covid-19, the performed tests revealed the necessity of conducting quality assessment after the maintenance of critical care ventilators to avoid risk to patients. justified by the fact that severe covid-19 cases required safe delivery of ventilation oxygen support,7,8 the tests listed in this study aimed to cover the basis of ventilation assessment to guarantee the accuracy of the critical care ventilator's performance. the minimum infrastructure and instrument requirements to perform a quality assessment of emergency corrective maintenance of critical care ventilators during the beginning of covid-19 in brazil are presented herein. conflict of interest the authors declare that they have no conflict of interest. acknowledgements this study was financed in part by: the endowment fund of university of sao paulo engineering school" amigos da poli" (+ventiladores project) and sao paulo state government (42960p comitê de crise do covid-19). references 1. rache b, rocha r, nunes l et al. necessidades de infraestrutura do sus em preparo ao covid-19: leitos de uti, respiradores e ocupação hospitalar. são paulo: instituto de estudos para políticas de saúde; 2020. available from: https://ieps.org.br/pesquisas/ necessidades-de-infraestrutura-do-sus-em-preparoao-covid-19-leitos-de-uti-respiradores-e-ocupacaohospitalar/. 2. associação brasileira de normas técnicas. nbr iec 60601-1: 2010+a1: 2016 requisitos gerais para segurança básica e desempenho essencial. abnt; 2010. available from: https://www.abntcatalogo.com.br/ norma.aspx?id=355495 3. associação brasileira de normas técnicas. nbr iso iec 62353: 2019 ensaio recorrente e ensaio após reparo de equipamento eletro médico. abnt; 2019. available from: https://www.abntcatalogo.com.br/ norma.aspx?id=416843 4. associação brasileira de normas técnicas. nbr iso 80601-2-12: 2014 requisitos particulares para a segurança básica e o desempenho essencial de ventiladores para cuidados críticos. abnt; 2014. available from: https://www.abntcatalogo.com.br/norma. aspx?id=326196 5. vocabulário internacional de metrologia: conceitos fundamentais e gerais e termos associados (vim 2012). rio de janeiro: inmetro; 2012. available from: http://www.inmetro.gov.br/inovacao/publicacoes/ vim_2012.pdf 6. avaliação de dados de medição: guia para a expressão de incerteza de medição. rio de janero: inmetro.; 2012. available from: http://www.inmetro.gov.br/ noticias/conteudo/iso_gum_versao_site.pdf. 7. lyons c, callaghan m. the use of high-flow nasal oxygen in covid-19. anaesthesia. 2020; 75:843–847. available from: https://onlinelibrary.wiley.com/doi/ full/10.1111/anae.15073 8. baker t, schell c, petersen d, et al. essential care of critical illness must not be forgotten in the covid-19 pandemic. the lancet. 2020; 395:1253–1254. available from: https://www.thelancet.com/pdfs/journals/ lancet/piis0140-6736(20)30793-5.pdf https://ieps.org.br/pesquisas/necessidades-de-infraestrutura-do-sus-em-preparo-ao-covid-19-leitos-de-uti-respiradores-e-ocupacao-hospitalar/ https://ieps.org.br/pesquisas/necessidades-de-infraestrutura-do-sus-em-preparo-ao-covid-19-leitos-de-uti-respiradores-e-ocupacao-hospitalar/ https://ieps.org.br/pesquisas/necessidades-de-infraestrutura-do-sus-em-preparo-ao-covid-19-leitos-de-uti-respiradores-e-ocupacao-hospitalar/ https://ieps.org.br/pesquisas/necessidades-de-infraestrutura-do-sus-em-preparo-ao-covid-19-leitos-de-uti-respiradores-e-ocupacao-hospitalar/ https://www.abntcatalogo.com.br/norma.aspx?id=355495 https://www.abntcatalogo.com.br/norma.aspx?id=355495 https://www.abntcatalogo.com.br/norma.aspx?id=416843 https://www.abntcatalogo.com.br/norma.aspx?id=416843 https://www.abntcatalogo.com.br/norma.aspx?id=326196 https://www.abntcatalogo.com.br/norma.aspx?id=326196 http://www.inmetro.gov.br/inovacao/publicacoes/vim_2012.pdf http://www.inmetro.gov.br/inovacao/publicacoes/vim_2012.pdf http://www.inmetro.gov.br/noticias/conteudo/iso_gum_versao_site.pdf http://www.inmetro.gov.br/noticias/conteudo/iso_gum_versao_site.pdf https://onlinelibrary.wiley.com/doi/full/10.1111/anae.15073 https://onlinelibrary.wiley.com/doi/full/10.1111/anae.15073 https://www.thelancet.com/pdfs/journals/lancet/piis0140-6736(20)30793-5.pdf https://www.thelancet.com/pdfs/journals/lancet/piis0140-6736(20)30793-5.pdf 11 j global clinical engineering vol.5 issue 3: 2023 received november 28, 2022, accepted december 2, 2022, date of publication february 1, 2023 application of molecular sieve oxygen generation miniplant under harsh environment by jixun liu1, chao qiu2, jianxiong zuo2, xiaomin lou3 1 zhejiang shuren university, china 2 hangzhou medoxygen technology co., ltd., china 3 hangzhou red cross hospital china abstract pressure swing adsorption (psa) oxygen generation mini-plant is widely used in all various hospitals for its fast, convenient, and cost-effective features. however, considering the landscape of global markets, the psa medical oxygen generation miniplant design basis varies from location to location. therefore, it forces the manufacturer to design and build the psa oxygen generation mini-plant more flexibly to enable its compatibility in different extreme ambient conditions (temperature, humidity, pressure, cleanliness) of installation location. for the sake of these concerns, this paper employs the concept of modularity as an approach to psa medical-grade oxygen generation mini-plant design and application and elaborates 10 key components for 4 modules of psa medical-grade oxygen generation mini-plant, namely (a) air compressor module; (b) psa module; (c) oxygen compressor module; (d) smart control module. under this modularized design approach, this paper investigates the technical features and the design criticality of modular and key components in fulfilling the expected performance, finally achieving and maintaining the overall performance of psa oxygen generation mini-plant with the selected modules which may be installed worldwide. this paper helps to highlight the variability of psa oxygen generation mini-plants in harsh environments in four dimensions (temperature, humidity, pressure, cleanliness) and briefs the methodology of the phase gate model for modular approach in oxygen generation mini-plant. it contributes to the literature on this important subject in the modularized design method, adsorption technology, air separation process, etc. keywords – psa oxygen generation mini-plant; harsh environment; modularized design; process design; medical-grade oxygen . copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction oxygen for industrial purposes is generated through several techniques such as cryogenic air separation units, and membrane-based or adsorption technology. therefore, it is vital for industrial production, environmental management of food & and beverage, and healthcare. as of 2021, the global annual oxygen turnover has reached usd 46.24 billion and will steadily increase.1 since the first mention of oxygen therapy in the medical journal; the principles of medicine by dr. william osler in 1898, the rapid growth of medical oxygen is continuously driven by innovative technology and capital, today medical-grade oxygen is an indispensable part of medical care in hospital and at home, which the importance and http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ liu, qiu, zuo, lou: application of molecular sieve oxygen generation mini-plant under harsh environment j global clinical engineering vol.5 issue 3: 2023 12 criticality of it have been demonstrated in the context of covid-19. air separation by adsorption to produce oxygen for medical-grade applications represents one of several important commercialized adsorption processes: adsorptive air separation technologies, nitrogen-selective zeolite technologies, and intensification technologies. furthermore, owing to the development of synthetic molecular sieves, the pressure swing adsorption (psa) technology, thus the psa oxygen generation mini-plant is widely used in all various hospitals for its fast, convenient, and costeffective features. in this paper, we have drawn the modularity concept and cascaded the psa oxygen generation mini-plant into 4 modules. next, 10 key components (units) are defined and elaborated with their respective functionality. thirdly, we discuss how the module approach demonstrates flexibility to meet the various ambient conditions with its outstanding technical features. lastly, we introduce the phase-gate review to ensure the module approach achieves the overall psa oxygen generation mini-plant performance. this paper contributes to the literature on the modularized design method, adsorption technology, air separation process, etc. design concept adsorption air separation technologies can generate oxygen from the ambient air in the range of several kilograms to hundreds of tons of per day oxygen (tpdo, normally limited to 300 tpdo) at a purity of 93%±3%. such oxygen purity levels are simply because the heavy component (nitrogen) accounts for ~78% of the feed air. other elements, such as argon and moisture, must be pretreated or integrated into the separation process. therefore, it is understood that adsorption technology’s basis is the adsorbent’s variable absorptive capacity, depending on the consumption scale of hospitals and medical institutions and the characteristics of their oxygen therapy. further, as a pressure swing cycle is tailored to the characteristics of the adsorbent, the final capacity very much relies on the temperature, pressure, and other ambient conditions such as humility and cleanliness of the feed air. to fulfill the customer’s requirements flexibly while managing balance of quality and costs, a product management methodology is introduced to ensure a consistent product portfolio across all markets and drive the standardization and modularization of psa oxygen generation mini-plants for medical applications. it combines standardization and modularization, such as standardized components designed to ensure exchangeability. meanwhile, the whole mini-plant is organized by combining several fixed & adapted modules engineered on a project basis to improve its constructability, as it is usually preassembled and skid-mounted. the concept of modularity modularity is very popular in design and manufacturing, and it is widely used in medical devices for its compatible assembly and flexible adaption to various applications. modularity generally refers to breaking down complex product systems into simpler units called modules that may function independently. specifically, modules are self-contained functional units that connect with other units, but do not rely on those other units for their own stable operation.2 the properties of modularity the modular approach featured four defined key properties. when defined in terms of these properties, modularity is not an all-or-nothing feature of designs but can be described in degrees.3 1. partial decomposability. it refers to the notion that a complex system may be partially divided into smaller meaningful functional units – modules.4 depending upon the complexity of product systems and the necessity of product management, it can be divided from 3–5 modules to hundreds of modules with clear boundaries called battery limits. 2. proper functioning. it signifies that the operation of each module in the design is expected to produce the intended result. this intended result is an integral part of the whole function of the designed complex system. for instance, the air compressor module generates the compressed air to feed gas into psa module with the proper technical specifications range of pressure, temperature, and dew point. 13 j global clinical engineering vol.5 issue 3: 2023 liu, qiu, zuo, lou: application of molecular sieve oxygen generation mini-plant under harsh environment 3. standardized interface. it denotes that modules within the design can connect or communicate with each other in a structured fashion. interface management systematically controls all communications that support a process operation. in the most basic sense, this property is similar to the property of children’s lego building blocks – pieces are designed so that one can plug into the next. 4. information hiding. it is also known as “encapsulation” and refers to keeping the specific operation details within a module.5 for example, the smart control module aims to control the whole product system. but its control philosophy, logic, process parameter, and value are not disclosed to others unless specified. sketch of molecular sieve oxygen generation mini-plant psa oxygen generation mini-plant has been developed steadily over the last four decades since praxair built the first small-scale prototype in 1985.6 which turned out from early progress driven primarily by large-scale industrial application. this development contributes to the on-site medical oxygen supply solution that prevails in hospital and other medical institutions. to fulfill the more flexibly designated function of the psa oxygen generation mini-plant, the concept of modularity is applied and fixed modules and adapted modules were developed. further, to make the modules more stable and minimize the cost, the components forming these modules are standardized, which could be sourced from off-the-shelf market or inhouse manufactured. modules definition considering the definition of modularity and the proper functioning above, we have described 4 modules of the psa medical oxygen generation mini-plant, 3 of them are mechanical, and 1 module is instrumentation & control related. their functionalities are introduced as follows: 1. air compressor module. the system compresses atmospheric air by a screw-type air compressor to a required pressure and cools to ambient temperature through refrigerating drier. the condensed moisture is drained out automatically from the air receiver through an automatic drain valve. as a meaningful functional unit, it has clean compressed dry air as feed gas at 7–8 bar, with air quality that optimally fits the oxygen generator. 2. psa module. the compressed air at constant pressure is passed through filters set and then passed through twin tower psa module packed with special grade zeolite molecular sieves, where compressed air is separated to oxygen at the purity of 93%±3% and at a pressure range of 4.5–6 bar. in a few cases, it can be directly delivered to the downstream user. 3. oxygen compressor module. the produced oxygen is filled in the oxygen buffer tank and then boosted by an oxygen compressor to higher pressure. it typically has two configurations: (i) it is boosted to 6–8 bar to achieve oxygen reservation, then delivered to the central pipeline system; (ii) it is additionally pressured to 150 bar for filling oxygen cylinders; however, this is not allowed in china. 4. smart control module. the system has a 7” color touch screen control panel with an integrated oxygen monitor. the touch screen provides a normal user interface for the start-up system, monitors/controls the operation of the process valves, monitors signals coming from the pressure transducers, and provides an alarm system when conditions require it, as well as a fail-safe shutdown mode. this control panel also features diagnostic capabilities and remote monitoring of process parameters. standardized components the total 10 key components are standardized in series: figure 1. typical psa medical oxygen generation mini-plant liu, qiu, zuo, lou: application of molecular sieve oxygen generation mini-plant under harsh environment j global clinical engineering vol.5 issue 3: 2023 14 • (1-a) feed air compressor system. the mechanical compressor is the essential component in the generation mini-plant. it gives the compressed air at 7–8 bar for air separation. it typically consumes more than 90% of the generation mini-plant’s power and generates most of the noise and vibration. it is either oil-free or oil-injected rotary screw type and air-cooled. it should have a built-in oil separator and air filter; its controls are suction throttle valve type with on-off line control and motor stopper start control. normally, the advanced compressor should be provided with a soft start or variable speed drive and have a digital display indicating failure, lcd display, and records at least 24 hours of operational data. • (1-b) air dryer. this is a refrigerant-type capacity air dry with a dew point of <+3℃ and pre-filters with automatic drains. the alternative is a desiccant type with auto-regenerating. it removes more than 90% of water in compressed air from the compressor to protect the molecular sieve and piping. • (1-c) air receiver tank. there is at least one set of air receiver tanks after the compressor. it is made of painted carbon steel with a capacity of at least 1000 l, depending on the compressor. it is equipped with a pressure gauge to indicate the vessel pressure, a safety valve, and a level-sensing auto drain valve. • (1-d) filter system. a three-stage air filter removes the compressed air’s dust, oil, and other impurities. the micro and active carbon layers remove oil and dust up to < 0.01 mg/m³. the filtration level should comply with iso standard 8573-1:2010.1.4.1. • (2-a) psa oxygen generator. the duplexed tower psa oxygen generator packed with special zeolite molecular sieve is skid mounted. it produces 93±3% oxygen from compressed air with a capacity of 3 nm3/h to 60 nm3/h and usually not less than 4 bar outlet pressure. • (2-b) medical grade oxygen receiver tank. the oxygen is separated through a psa generator and received in an oxygen tank with less than 1000 l capacity with a bacterial/sterile filter. the oxygen receiver tank should be equipped with a pressure sensor. as aforesaid, the oxygen can be supplied to the central pipeline system. • (3-a) oxygen booster. the oxygen booster is configured for dynamic oxygen reservation. this has two primary purposes: backup to a short-time turndown case or adjusting the peak oxygen demand. in this scenario, a medical oxygen compressor with an aftercooler is required to boost the oxygen pressure back to 8 bar at a similar feed-in temperature. after that, the boosted oxygen is connected to the high-pressure oxygen receiver with a capacity of 1000–3000l. • (3-b) cylinder filling station. this component is optional and could be added at the client’s request and as local regulations allow. the system comprises an oil-free oxygen-filling compressor at 150 bar pressure and a filling ramp for cylinders to be connected simultaneously. for filling the cylinder, wall-mounted racks shall be on the other side of the wall of the psa mini-plant room. • (4-a) measurement devices. several technical parameters are measured, such as the process’s temperature, pressure, and flow rate. the measurement devices are installed in-field for easy checking. they are also transmitted to the centralized control system. further, there is an integrated and continuous oxygen quality monitoring unit with the following alarm setting: carbon monoxide (co) @ 5 ppm, carbon dioxide (co2) @ 300 ppm, water vapor (h2o) @ 67 ppm, oxygen (o2) @ 90%. • (4-b) smart control system. with the installed sensor and transmitter of in-field measurement devices, the process data is automatically collected, recorded, and self-diagnosed under configured program embedded with the control philosophy and algorithm. considering the tolerance of normal operation, alarm, and trip, as the three safety zones are pre-defined, the control system will be automatically triggered once the collected data is out of the normal operation range to protect against the potential damage of the psa oxygen generation mini-plant. consequently, the oxygen supplies will be shifted to other oxygen sources immediately. 15 j global clinical engineering vol.5 issue 3: 2023 liu, qiu, zuo, lou: application of molecular sieve oxygen generation mini-plant under harsh environment matrix of design basis covering harsh environment the performance of the psa oxygen generation miniplant is determined by the adsorption and desorption process, which takes place in the duplexed adsorbers. the key variables for the adsorption and desorption process are multi-component thermodynamics and kinetics. therefore, how to select and optimize those key variables are heavily linked to the physical properties of the adsorbent particles.6 moreover, their operating environment is even more discrete when exporting them to the global market. therefore, a design basis rooted in local operation conditions has to be seriously considered to capture these key variables. matrix of design basis the landscape of china from the eastern coast to western tibet is totally different, and the operating condition of psa oxygen generation mini-plant is remarkably changed. assuming this psa oxygen generation mini-plant will be installed not only in china but also for global marketing, the full range of design basis has to be assured. the actual operating condition is very complicated, but in this paper, we focus on the four main factors: temperature, humidity, atmospheric pressure, and cleanliness. while optimizing the cost and balancing the design standardization, we define that the normal case shall cover 80% of application cases and extend to the extreme case in the remaining 20%. ultimately the design basis is specified as follows in table 1. ambient temperature in the normal design, the ambient temperature is in the range of 20℃±15℃. as the suctioned air as feed gas is compressed, the temperature will be increased, and an air-cooled aftercooler is installed to ensure the discharged compressed air temperature is less than 10℃ rising to the original ambient temperature. further, the air dryer will continue to cool down to the pre-defined temperature before entering the psa module. this cooling-down will generate cold, dry air for the temperature and minimize feed-gas moisture. there are two sources for the extremely high ambient temperature. one is the high ambient temperature originating from hot summer land, a common understanding. however, another source actually comes from the air compressor. the heat radiation leads to heat accumulation, thus, high temperature. therefore, ventilating fan and pipe duct shall be connected to the compressor’s terminal to remove discharged hot air to minimize the negative compact on the ambient temperature of feed gas. in addition, an air conditioner shall be added for the area with the highest ambient temperature over 35℃. however, heat preservation is required in cold areas in winter to maintain indoor temperatures above 5℃. therefore, the discharged air of high temperature could somehow be utilized to warm the feed gas to meet the minimum requirement of 5℃. therefore, in case of the gap to the normal range of 5–35℃ is still extant after all heat balance and recycle measures, then a heater as an auxiliary facility shall be added and switched on in case the indoor temperature of the mini-plant house is lower than 5℃. ambient humidity in the normal design, the relative air humidity ranges from 60±20%. the air that leaves a compressor reaches 100% humidity as the air is compressed and has a higher temperature. unfortunately, the compressed air also contains limited oil (unless you use an oil-free compressor) and solid particles. together, they form an abrasive, often acidic, oily sludge. without air treatment, this murky mix will enter the psa module, harming the molecular sieve adsorbents, corroding pipework, damaging pneumatic tools, and potentially compromising oxygen products. the air treatment typically includes three parts. firstly, the condensate shall be drained out by the steam traps. table 1. matrix of design basis ambient condition temperature humidity pressure cleanliness normal 5–35 ℃ 40–80% 0.09–0.1 mpa ≤10 mg/m3 extreme high 55 ℃ 95% (not applicable) 400 mg/m3 extreme low −30 ℃ (be better) 0.059 mpa (be better) liu, qiu, zuo, lou: application of molecular sieve oxygen generation mini-plant under harsh environment j global clinical engineering vol.5 issue 3: 2023 16 although an automatic trap is usually mounted, in some cases, a manual trap also makes sense, depending on the amount of condensate. in addition, a humidity sensor is recommended to install to capture the failure of condensation prevention. secondly, as a partial air dryer, the saturated air with 100% humidity is cooled down to dewpoint; thus, the moisture in the compressed air is removed. as aforesaid, there are two types of air dryers. one is a refrigerant type with a pressure dewpoint of <3℃ (100% relative humidity at 20℃), and another is a desiccant type with auto regenerating. in the normal case, both are suitable. however, if the ambient humidity is high, the refrigerant type is strongly recommended to ensure its higher reliability. further, to meet the high humidity, the sufficient design margin of the air dryer shall be considered. for instance, 130–150% of the calculated capacity shall be configured. atmosphere pressure when addressing the pressure, it refers to the plateau area where the atmospheric pressure is less than 0.1 mpa. in the normal design, the mini-plant is assumed to be installed at an elevation no more than 1000 meters, which equals its atmosphere pressure in the range of 0.09-0.1 mpa. therefore, when the atmospheric pressure decreases by 0.01mpa, the compression ratio of the air compressor will increase by 6~8%, and the compression energy consumption will increase accordingly. in addition, the reduction of atmospheric pressure will reduce the displacement of the air compressor, and the corresponding oxygen production will also be reduced. to maintain the feed-air to the psa module at the optimum pressure, the logical thinking is to enlarge the compressor’s power to compensate for the insufficient pressure from the atmosphere. adjustment to the atmospheric pressure by selecting the suitable compressor model is possible, while it should keep in mind that each compressor has a maximum compression ratio that cannot be exceeded. further, for the compressor and its auxiliary equipment, in practice, it will have a significant impact on power consumption and air consumption. meanwhile, changes due to altitude will also affect the rated power provided by the motor and internal combustion engine. external cleanliness cleanliness is very crucial for the oxygen industry. there is a significant issue regarding internal surface cleanliness resulting from machine and equipment, process-compatible coatings, and, more important, the grave consequence of molecular sieve pulverization. this is a profound issue that can be addressed in another special edition. in this paper, we only concentrate on external cleanliness, which is affected by the external environment, such as the oil, grease, particles, and liquid moisture in the feed air. therefore, it is heavily linked to two portions: (1) the inlet self-protected dust filter by the compressor. it is designed to remove dust and other physical impurities from the ambient air before it is further compressed in the air compressor; (2) the three-level filtration system for compressed air. untreated compressed air can be contaminated by dust, water, and oil. this makes filtration a crucial component in the air compressor module. depending on the external cleanliness, a series of filtration solutions are needed to protect the air-proceeded equipment and the final oxygen products. for instance, wrapped media for wet particles, pleated media for solid particles, macro-structured activated carbon for oil vapors, cyclone for moisture, etc. discussion the adsorption and desorption processes within the duplexed adsorbers are affected by pressure and pressure drop, heat and mass transfer, temperature gradients, and airflow velocity of the feed gas. these elements jointly determine the dense packing of the adsorbents and their fluidization for achieving optimum oxygen production. taken individually, many of these elements may seem to be conceptually straightforward. however, integrating them to achieve a high-performance process concerning high oxygen purity, high oxygen productivity, and low power consumption at a competitive cost is not trivial. modular approach the modular approach is widely used for complex product systems, including process plants. however, how to define the modular boundaries, the input and output 17 j global clinical engineering vol.5 issue 3: 2023 liu, qiu, zuo, lou: application of molecular sieve oxygen generation mini-plant under harsh environment of the modules, and their coordination interface become more important. before applying and executing a project, a phase gate review is recommended to ensure the standardized components are properly selected and maintained in due time. specifically, the phase aligns with the project’s time frame, and the gate has a strictly defined project quality. for example, for successfully applying modules for psa oxygen generation mini-plant, we recommend splitting them into the following phases: conceptual design, basic engineering, and detailed engineering. for the gate review, the gate requirement is specified in advance in table 2. temperature ambient temperature is a key parameter influencing the performance of oxygen generation mini-plant. the ambient temperature will have three impacts on the mini-plant’s performance, finally determining its uptime in the harshest conditions and its build-up cost. firstly, each compressor has an ideal operational range, reflecting the operation temperature, pressure, and flow rate. thus, the model selection shall be fixed during the conceptual design, and the deviation from the optimal operating temperature will decrease the compressor efficiency. when the ambient temperature rises, the discharge flowrate of the air compressor will decrease, which means that the shaft power will increase. the record shows that the shaft power increases by about 1% for every 3℃ increment in ambient temperature. secondly, increasing the ambient temperature will also increase the exhaust temperature of the air compressor, which requires more refrigeration capacity to compensate for the cooling loss, ultimately leading to increased energy consumption. furthermore, the higher ambient temperature will also decrease the efficiency of the air dryer by 10% for every 5℃ and leads to a higher dew point of compressed air, which will have a grave consequence of molecular sieve pulverization. therefore, the high ambient temperature needs more heat exchange by the pre-cooler or aftercooler of the air compressor. therefore, it is calculated and additionally configured. alternatively, a higher-capacity of air dryer is also possible. thirdly, the low ambient temperature will decrease adsorption efficiency and oxygen purity in northern winters, especially in extremely low-temperature conditions. further, in the winterization, the electrical and instrumentation parts, including in-field measurement devices, could be blocked or malfunction, and the safety of the mini-plant could be destroyed. in summary, besides the process engineering calculation and modules matching as a basis, additional measures should be tailored to the local conditions of hot/cold are assumed. for instance, the air conditioner, ventilating fan and/or electric heater shall be installed indoors to reduce ambient temperature deviation. in addition, of course, the manual assistance to keep the door of the mini-plant house full-open, half-open, and full-close (if still possible to guarantee its safety) is helpful to maintain the normal range of 5–35℃ and save power. table 2. phase gate review for modular approach in oxygen generation mini-plant phase gate typical gate requirement conceptual design cd • process topology defined • utility consumption estimated • process and environmental safety concepts prepared • process flow diagram released for basic engineering basic engineering be • p&id released for mini-plant design • plot plan completed • mechanical datasheet/inquiry spec completed • mechanical tie-in data, installation dimension, and weights fixed • basic requirements for operation and automation completed detailed engineering de • p&id released for construction and commissioning • electrical and instrumentation materials ordered • equipment foundation completed • isometrics drawing completed • factory acceptance test (fat) for key equipment completed liu, qiu, zuo, lou: application of molecular sieve oxygen generation mini-plant under harsh environment j global clinical engineering vol.5 issue 3: 2023 18 humidity as aforesaid, the murky mix caused by high humility could harm the downstream units by grinding, corrosion, and polluting the process air. secondly, it also could influence electric insulation seriously. thirdly, it will increase power consumption, leading to a high-pressure drop resulting from a block by water vapor or moisture. last but not least, high humidity will increase the operating load of the air filter at the compressor inlet and increase the replacement cycle. although the air that leaves a compressor reaches 100% humidity, the remaining humidity in compressed air turns into water as the air cools while it moves through the system. because water causes corrosion and damage, proper drains function must be installed, whether automatic, electronic, or manual, to keep downstream equipment working optimally. one of the most important issues is that the compressor shall be equipped with an aftercooler. it cools the air, turning up to 70% of the humidity into water, which is immediately drained. however, production facilities with extremely high ambient temperatures might need additional cooling, meaning double capacity or add-on aftercoolers in parallel, preventing excess moisture from entering the downstream equipment. pressure when addressing the pressure, it often refers to the plateau area. there are two related two issues. one is the atmospheric pressure in a plain area or plateau area. in the plateau area, lots of atmosphere pressure-related factors shall be considered. for instance, is a specific mass flow or volume flow required? can the compression ratio, absolute pressure, or gauge pressure be measured? is the temperature of compressed air significant? but of course, the most crucial factor is that the suction pressure of feed air varies with the altitude. for example, a compressor with a compression ratio of 8.0 at sea level will increase to 11.1 at 3000 meters above sea level. furthermore, the atmospheric pressure also depends on the weather. for a specific place, seasonal temperature changes can also affect the pressure value by up to 5%. by the way, high altitude locations always lead to low atmospheric pressure and temperature, which shall be considered in advance. for the details, please refers to the section on “temperature.” another issue is the process pressure inside the miniplant, precisely the working pressure of the adsorption and desorption process, which is jointly determined by atmosphere pressure, compressed air, and the pressure drop in the process. there are two main adsorption technologies for air separation by adsorption: psa and temperature swing adsorption (tsa). psa methods require electricity to be supplied to the compressor or vacuum pump, while the tsa method involves heating the adsorption bed during the regeneration stage. here is just a short discussion on psa pressure setting. for pressure ratio (ph/pl) is determined from the pressures at the end of the feed step (ph) and at the end of the desorption step (pl). these end pressures establish the boundaries for the n2 and o2 working capacities. selecting ph, pl and ph/pl is a compromise between o2 recovery and energy consumption, all within the constraints of the available compression equipment.7 cleanliness filtration is essential, so the diversified filter types offer a range of purity grades to meet the specific requirements for removing the smallest contaminants, including bacteria and viruses. however, three negative impacts shall be considered when selecting the suitable solution for every application: the pressure drop, the contamination, and the cost of spare parts for filter elements. in the heavy industrial zone, the inlet filter has to be reinforced, which leads to a pressure drop rising and increases the motor’s load; otherwise, too many impurities in the air will increase the purification load of the molecular sieve adsorber and filters. if the purified air fails to meet the expectation, it will also affect the production efficiency of the psa system and the production quality of oxygen. 19 j global clinical engineering vol.5 issue 3: 2023 liu, qiu, zuo, lou: application of molecular sieve oxygen generation mini-plant under harsh environment conclusion this paper introduces the psa oxygen generation miniplant, a small-scale complex product system widely used in various hospitals, which was neglected in innovation. it addresses how to design and build the psa oxygen generation mini-plant more flexibly to enable its compatibility in different extreme ambient conditions (temperature, humidity, pressure, cleanliness) of installation location. specifically, this paper employs the concept of modularity and elaborates 10 key components for 4 modules of psa medical oxygen generation mini-plant, namely (a) air compressor module; (b) psa module; (c) oxygen compressor module; (d) smart control module. under this modularized design approach, this paper further investigates the technical features and the design criticality of modular and key components in fulfilling the expected performance, finally achieving and maintaining the overall performance of psa oxygen generation mini-plant with the selected module installed worldwide. this paper helps to illuminate the variability of psa oxygen generation mini-plants in a harsh environment in four dimensions (temperature, humidity, pressure, cleanliness) and briefs the methodology of the phase gate model for modular approach in oxygen generation mini-plant. furthermore, it contributes to the literature on modular design methods, adsorption technology, air separation process, etc. recommendations psa oxygen generation mini-plant has been widely used in all-levels of hospitals and medical institutions. to overcome the harsh environment, a new product development process has been established and optimized via s/m/p (standardization/modularization/platform) approaches to ensure product portfolio management and successful application with the selective serialized & standardized components. acknowledgements we acknowledged this research work to the national institute of hospital administration, nhc, china, for their funding to the project of intelligent energy saving solution for medical gas system [gyz2022hq45]. references 1. global info research. chemical & material market research report 2022-01-04. available at: www. globalinforesearch.com.cn/reports/142044/oxygen 2. chorpita bf, daleiden el, weisz jr. modularity in the design and application of therapeutic interventions. appl prevent psychol 2005:11.3:141–56. 3. mikkola jh, gassmann o. managing modularity of product architectures: toward an integrated theory. ieee transact engineer manage 2003;50(2):204–18. 4. simon ha. the sciences of the artificial 3rd ed. mit press: cambridge; 1996. 5. parnas dl. on the criteria to be used in decomposing systems into modules. in: pioneers and their contributions to software engineering. springer: berlin, heidelberg; 1972. 479-498. 6. ackley mw. medical oxygen concentrators: a review of progress in air separation technology. adsorption 2019;25(8):1437–74. 7. smolarek j, et al. radial bed vaccum/pressure swing adsorber vessel. u.s. patent no 5,759,242; 1998. http://www.globalinforesearch.com.cn/reports/142044/oxygen http://www.globalinforesearch.com.cn/reports/142044/oxygen j global clinical engineering vol.4 issue 2: 2021 26 is clinical engineering an occupation or profession? by y. david1, s. calil2, n. pallikarakis3, m. poluta4, s.bergamasco5, d. clark6, t. judd7, j. wear8, k. fukuta9, s. mullaly10, w. morse11 1 global clinical engineering summit chairman, usa 2 clinical engineering professor, brazil 3 chairman of the institute of biomedical technology, greece 4 clinical engineer, south africa 5 italian clinical engineers association (aiic), italy 6 clinical engineering, nottingham university hospitals nhs trust, uk 7 ifmbe/clinical engineering division chairman, usa 8 clinical engineering consultant, usa 9 clinical engineer lecturer at osaka university, japan 10 biomedical engineer at consultant, ottawa, ontario, canada 11 founding member of acce and president in bellegrove medical, usa abstract in this paper, we examine the practice level of engineers and discuss whether clinical engineering is a profession or an occupation. many think that occupation and profession are synonyms, but are they? one must explore the difference, if it exists, between these terms, and to accomplish that, clarification of these terms is being offered and established first. we conducted a review of the terms and proceeded to identify if the tenants that are expected to be associated with professional standing are included in applying clinical engineering practices and to what level if it is. engineering is a profession that improves the quality of living and for the common good. the professional education of engineers requires the education to contain a body of specialized knowledge, problem-solving skills, ethical behavior, and good analytical judgment in the service of all people. the engineering education domains aim to form individuals who are intellectually trained, practically adept, and ethically accountable for their work. especially within the healthcare delivery system, engineering work engages problem-solving dependent upon sufficient body of knowledge to deal with practical problems by understanding the why, knowing how and identifying the when. there are various levels of the expected body of knowledge within the clinical engineering field ranging from engineers with formal academic training at undergraduate and graduate levels to clinical engineering technologists and technicians having graduated from between 1-4 years of academic training. engineers may further select to publicly proclaim their adequate preparation and mastering of knowledge to conduct their work through a credentialing process that can confer the term professional, registered, or certified engineer if successfully achieved. once the differences of working characteristics and obligations between occupation and profession are understood, it is clear that clinical engineers must continuously commit to pursue and fulfill these obligations. therefore, every professional engineer is called on to achieve a certain degree of intellectual and technical mastery and acquire practical wisdom that brings together the knowledge and skills that best serve a particular purpose for the good of humanity. clinical engineers and technologists are critical for sustaining the availability of safe, effective, and appropriate technology for patient care. it is as important for their associations to collaborate on compliance with professional obligations that their jobs require. keywords – profession, occupation, vocation, engineering, clinical engineering, credentialing, certification, healthcare job, qualification, alliance, engineer. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org 27 j global clinical engineering vol.4 issue 2: 2021 david, calil et all: is clinical engineering an occupation or profession? introduction to answer the question is clinical engineering an occupation or profession, one must explore the difference, if it exists, between these terms. an excellent point to begin is with a practical understanding of the task at hand, i.e., terminology. when humans spend time trying to achieve something, especially when this involves using some effort, it is called work.1 there are many different types of work. occupation2 is one of many types of work which one occupies oneself with; usually refers to productive activity, task, service, trade, or craft for which one is paid. it is of a long term, perhaps as long as a lifetime, and is a path one embarks upon to fulfill goals, passions, and or ambitions. such a path is a career that requires a certain level of education or training preparation to achieve the goals and ambitions successfully. the benefits of pursuing a career are often associated with monetary, work satisfaction, personal pride, economic independence, become part of the community, and self-worth, to name a few of them. throughout a person's career, they will probably hold several jobs3 or tasks identified as work performed to earn money to support basic needs and also help create relationships or develop a working network to advance one's career. many think that occupation and profession are synonyms, but the fact is that they are different. an occupation is a work activity undertaken by a person to earn a living. it can be business, profession, or employment that a person undertakes to increase their wealth. occupation refers to the kind of economic activity endeavored by a person regularly for earning money. when someone engages or occupies themselves in any economic activity, that activity is known as their occupation. an occupation does not necessarily require specialized schooling in a particular area and applies to any category of work that is consistently performed. an occupation includes jobs involving both physical work and mental effort. an occupation is a job that may include a profession which leads to most official forms using the term occupation when asking for an applicant's job or profession. examples of occupations include jobs such as vehicle drivers, shopkeepers, civil servants, clerks, bookkeepers. occupations can be further divided into subcategories like: • business: a person engaged in any trade, commerce, or manufacturing activities, is assumed to be doing business. • employment: a type of occupation in which a person works for others, is being supervised, and gets a fixed and regular income. • profession: the type of occupation in which a person renders services to others and holds themselves out as an expert by applying his specific knowledge and skills is a profession. the line of demarcation between occupation and profession exists but is blurred when given insufficient attention to the attributes that clarify the difference between these terms. for example, when a professional is paid for his skill or talent, it is known as an occupation. however, this represents more specific and different types of occupation when independent creative thinking, based on long and specific training, and compliance with achieving professional credentialing show the public achievement of practice competency we call a profession. therefore, a profession is an occupation for which a person undergoes specialized training or internship to get a higher degree of education and expertise in the concerned area. profession4 is an activity that requires specialized training, knowledge, qualification, and skills. it implies membership in a professional body, credentialing, and certificate of practice. the individuals who undertake a profession of rendering personalized services are called professionals, guided by a specific professional body code of conduct. a profession refers to specific categories of occupations that typically require advanced education or training and acquisition of the previous knowledge5 pertains to the research and practice of the field of study. the main objective of the profession is to render services to those who need them. a professional body or statute governs the profession. to be called a professional, a person has to pursue higher studies and qualify for an exam conducted by the governing body. typically, a professional is said to be an expert in the field. in addition, the professional body develops ethical codes that the professionals must follow to ensure uniformity in their work. david, calil et all: is clinical engineering an occupation or profession? j global clinical engineering vol.4 issue 2: 2021 28 the primary feature of any profession is the special relationship between the profession and the society and the commitment to serve responsibly, selflessly, and wisely. at times, this can create tension between the two elements of professional responsibility: the duty to serve the interests of one's immediate client and the obligation one has to society. examples for profession include jobs like medical doctors, architects, lawyers, chartered accountant, clergy, nursing, and engineers, "at present, few would dispute the claim that physicians, lawyers, architects, accountants, engineers, and clergy are professionals."6 it is helpful at this juncture to point to what are the major differences between occupation and profession. 1. unlike an occupation, a profession has an expected code of conduct. 2. an occupation does not require lengthy training in a particular field, but a profession requires specialized training in a specific area. 3. in general, the practice in a profession is regulated by a particular or professional body statute while an occupation is not. 4. a person with an occupation is paid for what he produces. whereas in a profession, one gets paid according to his knowledge and expertise. 5. the profession is also an occupation when the person is paid for utilizing his skills and expertise. 6. a professional is independent, and any external force does not influence their work. however, conversely, there is a lack of independence in an occupation because the person performing it has to follow the commands of his supervisors. 7. some conduct responsibilities are associated with the practice of a profession. however, an occupation does not have such responsibilities. 8. the basic pay in a profession usually is higher than in an occupation. 9. professionals are usually respected more by people and have a higher status in society than those in an occupation. evolution of other professions few practice fields are accepted as professions.7 some more than others. these include, for example, medicine, law, and nursing. the nursing field went through a developmental evolution of its profession following the challenge such as described in an article published by the new york medical journal stating that nursing is not a profession since "… it is not primarily designed to contribute to the sum of human knowledge or the advancement of science."8 the response from the nursing field was clear: "with all due respect to the new york medical journal, nursing today does require, not only skill and intelligence but education. it is true that there are many mechanical duties in a nurse's life which require only skill but to be an efficient nurse demands also special knowledge and attainments. we have only to look backward a little over a century to notice how education, special knowledge and attainments in nursing affairs have changed the whole system of nursing."8 the medical profession today is also facing a challenge with the extent of the regulatory nature of the profession, which is critical to the consideration of its professional standing.9 in medicine, the regulation is practiced at several levels: medical schools must adhere to a standard, licensure as a process at the state level. at the same time, certification is administered through national organizations adopting a minimal level of professional practice requirements and standards. "most doctors will find a way round this new regime, but short-term pettyminded bosses are beginning to view doctors as factory workers. their limited vision considers doctors to be dangerously independent, malfunctioning cogs in their wobbly healthcare machine, a species to be controlled and beaten into the shape of the appropriate widget."10 the medical profession: "a vocation characterized by a specialized body of knowledge of medicine that its members must teach and expand, by a code of ethics and a duty of service that put patient care above self-interest, and by the privilege of self-regulation granted by society."11 this establishes a career in medicine as one of the oldest and most respected professions; it affords the potential to impact human life genuinely and is usually associated with a high level of job satisfaction. 29 j global clinical engineering vol.4 issue 2: 2021 david, calil et all: is clinical engineering an occupation or profession? engineering and engineers like medicine, in engineering, public health, safety, and welfare tasks are expected to be protected from unintended consequences. as shown in a public survey following the fatality caused by an uber autonomous car accident, public distrust follows public harm. the survey showed that trust in such vehicles dropped by 27%12 following increased perception of insufficient harm control. other disasters show a similar trust impact, for example, following the space shuttle explosion after lift-off.13 under the practice of engineering's obligation to public health, safety, and welfare, it is critical to understand what engineering is. engineering is defined as the "application of science and mathematics to solve problems useful to people."14 the practice of engineering is defined as "any service or creative work requiring engineering education, training, and experience in the application of engineering principles and the interpretation of engineering data to engineering activities that potentially impact the health, safety, and welfare of the public."15 engineers are practitioners of material products of human making just as physicians are practitioners of medicine.16 an engineer is defined as "an individual who is qualified to practice engineering by reason of engineering education, training, and experience in the application of engineering principles and the interpretation of engineering data."17 and professional engineer means "an individual who has been duly licensed as a professional engineer by the board. the board may designate a professional engineer, on the basis of education, experience, and examination, as being licensed in a specific discipline or branch of engineering signifying the area in which the engineer has demonstrated competence."17 professions lay claim to a theoretical knowledge base such as a body of research, conceptions, and experience thresholds for its services. whether that knowledge base is a body of biomedical or clinical research and theory, a collection of published manuscripts, or a body of laws, regulations, and legal decisions, professions rest much of their authority on the knowledge accumulated during the practice of the profession. this is one of the challenges clinical engineering faces—a lack of sufficient academic preparation programs and uniformity of public expectations from practicing engineers. one of the fundamental pillars on which a profession stands is the mastery of a domain of practice. the technical skills of analysis and presentation of a solution or treatment, the practice of diagnosis, action, and interaction are all features of any profession. a profession is identifiable by the very practices in which its members engage. professions rest much of their authority on the knowledge that their domain develops together with the profession's practice and higher education academic programs. during professional education and through the engineer's career, the practicing professional is expected to remain current with the growth and changes in that knowledge base and establish a threshold for demonstration of competent practice.18 professional practice can be routine at times. however, challenges during professional practice are the need to make complex judgments and decisions leading to skilled actions, sometimes under uncertain conditions. this means that professional practice is frequently pursued at or beyond the margins of previously learned performances. therefore, professionals must be appropriately trained to operate at the uncertain limits of their previous experience and must also be prepared to learn from the consequences of their actions to develop new understandings and better routines. hand in hand, professional engineers must engage in exchanging those understandings with other professionals so the entire professional community benefits from their insight. such an engagement is another deficiency in clinical engineering practitioners lacking the motivation and the available opportunities to publish their lessons learned. this is one of the profession's characteristics of learning from one's experience to improve future outcomes and create better-skilled practitioners. the conditions of professional practice and professional learning demand the establishment of and cross-functioning between professional communities. in addition to knowledge, the engineering profession should also teach their practitioners how to be a member of a professional community, with obligation for establishing and renewing thresholds for both practice and professional education, for critically reviewing new ideas, methods, and techniques, and disseminating it within the community of practice, for overseeing the quality of performances at all stages of engineer's career, and for contributing back to the community where they live. david, calil et all: is clinical engineering an occupation or profession? j global clinical engineering vol.4 issue 2: 2021 30 clinical engineering practice engineering is, at its core, problem-solving. being an engineer means being a problem solver, capable of diagnosing, analyzing a situation, and finding a solution within a set of constraints even if it is not optimal. similarly, one of the most required skills to be a clinical engineer is to solve problems quickly.19 also needed is the capacity to formulate the problem in technical and non-technical ways and partition the problem into subparts to achieve a satisfactory and safe resolution., clinical engineers are uniquely prepared to accomplish this task20 and determine the requirements and constraints while applying varied knowledge and experience to reach a timely, optimal resolution. such an approach depends on knowledge and analysis of the state of specific phases in the technology lifecycle, non-compliance issues, risk tolerance management, user's competence, system integration impact, or financial analysis, all in a short duration. perhaps faster than in the other professions we discussed earlier, the knowledge that a clinical engineer draws from is continually expanding and evolving because of the technological evolution and clinical practice itself. as outlined in the article the professional clinical engineer,21 there are common characteristic considered stewardship of all professions: a commitment to serve in the interests of specific clients and the general welfare of humankind; a body of knowledge and principles; a required specialized set of skills, practices, and performances unique to the profession; the capacity to render judgments ethically and with integrity under uncertain conditions; a commitment to engage in continuing education and learning attitude to absorb new knowledge from the contexts of practice; and the development of a professional community responsible for the oversight and monitoring of quality in both practice and professional education. clinical engineers are mostly reflective, alert, and methodical as they carry out their clinical engineering projects, hopefully making their wider professional community better practitioners at the end of the project. a recent international survey22 about the body of knowledge (bok) and body of practice (bop) practiced by clinical engineering practitioners demonstrate international variability in the definition of the practice domain with new knowledge subjects added during the last 25 years, such as technology assessment and forensic analysis. the majority of the clinical engineers who responded to the survey were employed within the healthcare delivery system. this population demonstrated that common domain elements across the world exist both in the bok required to practice and in the bop performed. having identifiable domain boundaries is an essential characteristic of a profession, and this survey and others23 support compliance of the clinical engineering field with this requirement. goodman argued that clinical engineering is a profession embarking on an identified path of: "the progress of an occupation toward professionalization involves: the table 1. comparison between job characteristics. basis for comparison occupation profession clinical engineering meaning occupation refers to the regular activity performed by a person to earn a living a profession is an occupation or vocation which requires academic preparation for knowledge and expertise in the specific field requires a degree of knowledge and expertise in the specific field code of conduct no yes partial training not necessary compulsory necessary regulated by statute no mostly yes country dependent basis of pay produce skill and knowledge skill and knowledge higher education not compulsory yes not compulsory degree of independence usually there is no independence a profession is completely independent some degree of independence responsibilities very limited yes yes respect and status low very high partially 31 j global clinical engineering vol.4 issue 2: 2021 david, calil et all: is clinical engineering an occupation or profession? appearance of training schools; establishment of university educational programs; licensure or certification; a formal code of ethics; and establishment of one or more national professional associations."24 he further supports his argument by showing a bok, a structured educational system, and professional organization representing them in the healthcare field. discussion the u.s. department of labor describes engineering as applying "the theory and principles of science and mathematics to research and develop economical solutions to technical programs. [this work] is the link between perceived social needs and commercial applications."25 this site continues to identify that "engineering fields can be practiced at the associate degree level include electrical and electronics drafters, civil engineering technicians, and aerospace operations technicians. however, a bachelor's degree is needed for civil, electrical, and mechanical engineering, as well as the less commonly known engineering fields in aerospace, biochemical, energy, industrial, robotics, marine engineering, and naval architecture." in furthering narrowing the career's focus this source reports on bioengineers and biomedical engineers jobs (there is no category to be found for clinical engineers) as required to "apply knowledge of engineering, biology, chemistry, computer science, and biomechanical principles to the design, development, and evaluation of biological, agricultural, and health systems and products, such as artificial organs, prostheses, instrumentation, medical information systems, and health management and care delivery systems."26 having typical job duties that are, in most part, similar to yet not the same as clinical engineer's job. • conduct research, along with life scientists, chemists, and medical scientists on the engineering aspects of the biological systems of humans and animals. • adapt or design computer hardware or software for medical science use. • evaluate the safety, efficiency, and effectiveness of biomedical equipment. • develop models or computer simulations of human biobehavioral systems to obtain data for measuring or controlling life processes. • research new materials to be used for products, such as implanted artificial organs. • write documents describing protocols, policies, standards for use, maintenance, and repair of medical equipment. • conduct training or in-services to educate clinicians and other personnel on the proper use of equipment. • analyze new medical procedures to forecast likely outcomes. • advise hospital administrators on the planning, acquisition, and use of medical equipment. table 2 below, articulate few of the shared as well as the different duties between biomedical engineer and clinical engineer professions. on the other hand, in addressing the question "what is engineering practice?" in a less detailed and more generalized picture of the work, we also need to consider whose point of view is expressed in the answer. one group is individuals and organizations engaged in engineering work based on, for example, surveys and interviews of practicing engineers. alternatively, there is the view offered by researchers observing the work of engineers, then synthesize these observations into patterns and a more generalized understanding of the nature of engineering practice. alternatively, yet still, there is the view that may be offered by those engaged in engineering education, namely engineering faculty and students. these view angles will produce the following answers: engineering is problem-solving, considering the systematic processes that engineers use to define and resolve problems; engineering is knowledge, considering the specialized knowledge that enables or fuels the process; engineering is the integration of process and knowledge. all are acceptable descriptions for the practice of engineering. critical differentiators between an occupation and a profession are whether or not members of the field, in our case clinical engineers, having attributes such as: (1) a bok with high degree of systematic continuous training, (2) mastery of their domain, (3) commitment to selflessly and ethically serve, (4) ability to render professional judgement, and david, calil et all: is clinical engineering an occupation or profession? j global clinical engineering vol.4 issue 2: 2021 32 (5) self-governance by monitoring the quality-of-service members provide through a credentialing program. according to the us national society of professional engineers (nspe),27 the practice of engineering is a professional service regulated by each of the states' governments that in the usa is governed by the first engineering licensure law28 enacted in 1907 "to ensure public safety by granting only professional engineers (pes) the authority to sign and seal engineering plans and offer their services to the public." this is an example of one of the profession's attributes, self-governance of service quality through a credentialing program. following licensure as a professional engineer, individuals may voluntarily have their expertise in a specified field of engineering recognized through an appropriate specialty certification program. such certification does not imply that other licensed professional engineers are less qualified for practice in their particular field of specialty. table 2. comparison of job duties between biomadical and clinical engineer. biomedical engineer clinical engineer conduct research, along with life scientists, chemists, and other medical scientists, on the engineering aspects of the biological systems of humans and animals evaluate the safety, efficiency, and effectiveness of biomedical equipment evaluate the safety, efficiency, and effectiveness of biomedical equipment research new materials to be deployed in products, such as implanted artificial organs conduct training or in-services to educate clinicians and other personnel on proper use of equipment conduct training or in-services to educate clinicians and other personnel on proper use of equipment. advise hospital administrators on the planning, acquisition, and use of medical equipment advise hospital administrators on the planning, acquisition, and use of medical equipment. adapt or design computer hardware or software for application in medical science uses adapt or design computer hardware or software for application in medical science uses develop models or computer simulations of human biobehavioural systems to obtain data for measuring or controlling life processes create guidelines, documents describing protocols, policies, standards for use, maintenance, testing and repair of medical equipment create guidelines, documents describing protocols, policies, standards for use, maintenance, testing and repair of medical equipment analyse new technology-based medical procedures to forecast likely outcomes analyse new technology-based medical procedures to forecast likely outcomes manage medical devices performance assurance program (i.e. maintenance) design, implement, monitor, and manage healthcare technology safety program design, implement, and monitor a service contract management system most job duties performed in research laboratories most job duties are performed at the point of care apply forensic engineering, health technology assessment, disaster preparedness, and human factor engineering principles operate at the point of care complex healthcare systems in selected countries 33 j global clinical engineering vol.4 issue 2: 2021 david, calil et all: is clinical engineering an occupation or profession? professional engineering licensure, in several countries, is the only qualification for engineering practice. a less successful example but yet crucial for the clinical engineering profession debate was documented by the world health organization (who) summarizing the work of a task force on manpower development for a health care technical service29 where the minimum qualifications for a clinical engineer i states "must be willing to work towards becoming a certified clinical engineer." moreover, clinical engineer ii states, "clinical engineering certification and/or professional engineering registration are required." so far, these recommendations have not shown significant impact on the concept of adopting selfgovernance for clinical engineering practitioners. more substantial adoption will lead to more robust compliance with professional characteristics. it may now be better to initiate a new internationally coordinated effort to achieve broad adoption of this crucial professional trait. while credentialing is a program administered by a third party and is proof of an individual's qualification in a given subject, a certification program30 is a process that recognizes and validates an individual's qualification that is usually administered by the profession itself. clinical engineering as a professional field will gain recognition through a better definition for practicing clinical engineers' minimum academic preparation requirements, increase compliance with a public declaration of practice proficiency (certification), commitment to continuing education, and adoption of expected ethical behavior. all of these cannons are already integral parts of the present clinical engineers' practice. it will gain further recognition when an international uniformity is adopted. conclusion following the above discussion, it can be said that the occupation is a broader term, and it includes profession. all work deserves respect, and while occupation includes ordinary jobs and hence does not receive high recognition from society, professionals are mainly known by the knowledge base required to provide their service and professional judgment as part of their jobs. they were perhaps suggesting that such contribution to society draws a higher level of respect and recognition. a profession is usually a higher-order occupation or a calling, especially involving a high level of education, career long continuous training, formal credentialing, mastered knowledge domain, adoption of rules for ethical behavior, and self-governance monitoring program of its members. in general, we found that engineering education programs attempt to prepare graduates for professional engineering practice. the programs include elements that illustrate and teach engineering problem-solving skills, provide engineering graduates with competent technical and managerial skills, and provide cultural education in the humanities and social sciences. societies of professional engineers support the notion that engineering curricula must incorporate instruction designed to instill in engineering students the concepts of professionalism and the ethical practice of engineering. engineering education is and should be a lifelong learning experience. the depth of engineering knowledge continues to expand rapidly, and practicing engineers must renew their knowledge to remain effective and competent. the portion of the lifelong learning experience that follows formal engineering education is referred to as continuing professional development and is one factor that establishes that one's occupation is a profession. however, to fully meet such a mandate, clinical engineers need to demonstrate more comprehensive global compliance. academic institutions can support this by offering clinical engineering curricula and continuing education training opportunities for their graduates. at all of the engineering branches, the us nspe supports the premise that, "the public interest is best served by the licensure of all qualified individuals within the engineering profession." credentialing has many forms, and clinical engineering should be no exception. clinical engineers also need to recognize, like other professions that when establishing defined requirements to enter the professional practice, there needs to be consensus about and adopting clinical engineering practice criteria. this includes domain boundaries, establishing a minimum qualifications criterion for entering clinical engineering practice in healthcare, a commitment for compliance with life-long continuing education, adherence to ethical behavior, service stewardship to their communities, and rules for self-governing. adoption of these cannons will gain wider recognition and elevate the professional standing they desire. we recommend that the global clinical engineering alliance will best serve as a leader for 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https://www.neha.org/professional-development/education-and-training/differences-between-credentials-certifications https://www.neha.org/professional-development/education-and-training/differences-between-credentials-certifications j global clinical engineering vol.5 issue 1, 2022 2 editor’s corner a public-private medical technology model – india case study the medical device development landscape has changed significantly post covid. the pandemic has put the medical technology sector in top gear, pushing industries to innovate, develop, and manufacture products quickly. countries like india have witnessed tremendous growth in the health technology sector, fueled by an exponential rise in government health allocation each year. one of the most significant efforts towards furthering medical device development has been the establishment of the andhra pradesh medical technology zone (amtz). amtz is india’s first and one of the world’s largest medical technology manufacturing cluster with over 100 companies working on research, development, and production of life-saving medical devices. it is india’s premier medical technology park with common manufacturing facilities & common scientific facilities, including specialized laboratories, warehousing, and testing centers. the center for electromagnetic compatibility and safety testing, center for biomaterial testing, center for 3-d printing, centers for lasers, mri super conducting magnets, gamma irradiation centre, mold & machining centre, among many others, have played a key role in accelerating product development. this cluster of scientific facilities, access to raw materials, critical component supply chain within the zone, trained human resources, and ready-touse infrastructure makes amtz the engine of growth for medical technology globally. in the nation’s battle against the pandemic, amtz contributed by producing over 100 ventilators, 500 oxygen concentrators, and 1 million rt pcr kits every day. in addition, many innovations from amtz, such as mobile container hospitals, mobile rtpcr vehicles, and mobile oxygen plants, were sent to even the most remote parts of the country. built-in a record time of 342 days, amtz showcases modern india as a leader in the global medical technology stage. amtz works to reduce the cost of manufacturing up to 40%, simplify the end-to-end operations, and reduce import dependency, which is presently around 75%. furthermore, it believes in creating and operating an ecosystem that boosts innovations and supports affordable manufacturing scale-up, allowing technology accessible to every citizen globally. the kalam institute of health technology (kiht) at amtz has recently been designated as india’s first who collaborating centre (who-cc) for innovations. the who-cc will work directly with who headquarters to further health innovations and innovative technologies towards rapid development and global deployment. another essential element to success is the availability of a workforce that can be readily integrated into industrial design, development, and manufacturing. amtz understands that as india’s medical sector experiences unprecedented growth, there is a strong demand for a dynamic, skilled, and capable workforce and a need for a new paradigm in training and development. fortunately, the interdisciplinary nature of medical technology allows engineering professionals from the conventional domains of mechanical, electrical & electronics, instrumentation, and computer science, to specialize as biomedical engineers and fill the enormous vacuum domestically and globally. currently, the demand for a master’s level program in india for medical technology far outweighs the limited options available. recognizing this shortage, amtz is partnering with skill-lync to launch the country’s first “executive pg program in medical technology.” this will be a one-of-a-kind program that will offer students a flexible pedagogy, integrating online and offline learning through solid industry collaboration. http://www.globalce.org http://www.globalce.org 3 j global clinical engineering vol.5 issue 1, 2022 during the first 6 months, students will be offered 9 fundamental courses in a self-paced online environment in the skill-lync platform. then, for the next 6 months, students will be engaged in taking coursework related to a specialization of their choice while undergoing hands-on training at the various medical device manufacturing facilities in amtz. this will provide the students with first-hand exposure to product design, development, and manufacturing while studying. during the final lap of the program, the students will take a certification exam and get skill-certified by indian biomedical skill council (ibsc). the ibsc is yet another notable initiative of amtz established jointly with the association of indian medical manufacturers of medical devices (aimed), under the support of the quality council of india (qci), to provide a certification system for biomedical engineers in the country who serve as the backbone of the healthcare services. furthermore, it aims at strengthening the biomedical skill sector in the country and, with this objective, develop job roles supported by the national skill development agency (nsda) under the ministry of skill development & entrepreneurship (msde). the current vuca environment requires continuous adaptation and assessment of learning paradigms to cater to industry requirements. therefore, amtz strongly feels that this new foray into online learning combined with practical industry exposure will help create the ideal workforce. we all know too well how much loss of life, suffering, ending family’s livelihood and disrupted bread earnings routine this pandemic caused. however, this necessitated forward-thinking, innovation, and capturing of unique new public-private collaborations that were not achievable previously. i focused on this india case study, but other initiatives hopefully are taking place around the world. i am looking forward to hearing from you about your local situation and will be happy to respond to comments and questions relating to our successful model. the author wishes to place on record, with sincere gratitude, the support received from yadin david, tom judd, and a very large family of global clinical engineering leaders. together we are making it better! dr. jitendra sharma copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org 25 j global clinical engineering vol.7 issue 1: 2025 received february 14 2024, accepted december 15, 2024, date of publication february 15 2025. original research article a study on the legal environment of medical devices and enhancing the regulatory system gerelt-od namdag1, munkh-erdene luvsan1, amarsaikhan dashtseren2,* 1 department of health policy, school of public health, mongolian national university of medical sciences, ulaanbaatar, mongolia. 2 department of preventive medicine, school of public health, mongolian national university of medical sciences, ulaanbaatar, mongolia. * corresponding author email: amarsaikhan.d@mnums.edu.mn abstract the regulation of medical devices is governed by the law on health, the law on medicines and medical devices, and the law on metrology. while these laws provide definitions of key terms, they lack detailed regulations. the law on health addresses issues related to special licenses, while the law on metrology covers metrological inspections. according to the “methodology for assessing the consequences of the implementation of legislation”, as approved by appendix 6 of government resolution no. 59 of 2016, the implementation of these laws, including the law on medicines and medical devices, the law on health, and the law on metrology, has not fully aligned with reality. this misalignment has failed to regulate certain essential relationships, leading to negative societal impacts. consequently, we assessed the implementation and consequences of these laws, considering the lag between social changes and legal developments. additionally, comparing medical device regulations with the standard regulations of countries around the world revealed several differences, starting from the definitions of key terms. we concluded that there is a need to improve the legal and regulatory environment to establish unified policies and regulations for registration, quality, safety, optimal asset planning, and maintenance management, particularly for medical equipment. keywords—specialists, consequences, equipment, medical devices, medical supplies, regulation. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ namdag, luvsan, dashtseren: a study on the legal environment of medical devices and enhancing the regulatory system j global clinical engineering vol.7 issue 1: 2025 26 introduction the medical device market in mongolia is small, which limits the potential for major manufacturers to establish businesses in the country. mongolia does not produce any medical devices, except for disposable syringes and a few other minor items. as a result, nearly all medical devices are imported from various countries and manufacturers. this situation leads to many unregistered medical devices of uncertain quality. supplying government hospitals with modern, high-quality, safe, and reliable equipment and ensuring regular preventive maintenance and repair services has been one of the biggest challenges in the mongolian healthcare sector. state budget investments in medical equipment have varied over the years: in 2019, usd 2.4 million were allocated; in 2020, usd 11.2 million; in 2021, usd 32.7 million; in 2022, usd 4.3 million; and in 2023, usd 3.5 million. before 2017, the budget for medical equipment maintenance was included in the organization’s operational expenditure. however, starting in 2018, the maintenance and service costs for major technologies, such as magnetic resonance imaging (mri) scanners, computed tomography (ct) scanners, and angiography machines, were separately allocated within the state budget. in 2018, usd 0.7 million were dedicated to this purpose, followed by usd 0.8 million in 2019, usd 1.1 million in 2020, and usd 1.6 million in 2021. from 2022 onward, due to performance-based financing, a separate budget for these services is no longer allocated.1 many developing countries today face similar challenges with medical devices due to their complex nature, as they combine mechanical, electronic, software, and chemical components. this complexity necessitates a higher level of safety and an improved regulatory system. medical devices play a crucial role in diagnosing, preventing, monitoring, and treating diseases. unlike drugs or biologics, medical devices can range from simple devices that pose little or no risk to the user (e.g., a suction pump) to life-sustaining devices (e.g., a pacemaker). the solution to these challenges lies in developing a comprehensive regulatory system for medical devices. regulatory systems for medical devices are generally less developed than those for other health products such as medicines or vaccines. a desk survey conducted in 2015–2016 revealed that 58% of world health organization (who) member states had some form of regulation for medical devices, even if limited.2 many governments, including mongolia, that have drafted medical device regulations have made limited progress in implementing them. in mongolia, medical device regulatory systems are less developed than in other countries. having an appropriate and comprehensive policy that guides medical equipment selection, procurement, and maintenance in compliance with international standards. while mongolia has some ministerial orders and policy documents related to medical devices and health technology, there is still a need for improvement. additional regulatory systems are required, including import control, product registration, classification, packaging and labeling, advertising, use, and disposal. methodology we assessed the implementation of laws and regulations related to medical device regulation to identify areas for improving the regulatory system. we reviewed relevant articles, audit and evaluation reports, and other documents from authorized organizations to analyze the practical compliance of laws and regulations with their provisions and compare them with the most significant and influential international standards. additionally, recommendations, documents, and standards from the who and international regulatory organizations were analyzed. comparative studies were conducted on the regulations of other countries in relation to mongolia’s legal environment. data collection involved meetings, discussions, and feedback exchanges using the following methods. the descriptive study included audit, monitoring, assessment reports, news from authorized organizations, and recommendations, documents, standards, and regulations from the who and international regulatory organizations. additionally, three focus group interviews were conducted, involving 26 participants divided into three groups: 9 medical equipment engineers from local healthcare facilities, 8 university faculties, and 9 medical equipment engineers from the private sector. the focus group interviews were analyzed using the content 27 j global clinical engineering vol.7 issue 1: 2025 namdag, luvsan, dashtseren: a study on the legal environment of medical devices and enhancing the regulatory system analysis method to assess the implementation of legal documents related to medical equipment, the quality and accessibility of equipment, the capacity and adequacy of human resources, and the challenges encountered while implementing the laws. results the who defines “medical devices” as a broad category encompassing items ranging from small medical instruments and supplies to large diagnostic and therapeutic equipment.3 the international medical device regulators forum (imdrf)/ghtf also defines “medical devices” as encompassing a wide range of products, from relatively simple non-implantable devices, such as tongue depressors, thermometers, blood pressure monitors, stethoscopes, scales, disposable gloves, wound dressings, hospital beds, and crutches, to highly advanced imaging diagnostic devices and implants. they recommend classifying medical devices to patients and medical professionals based on their risk level, with appropriate regulations tailored to each category.4,5 the imdrf is a voluntary coalition of regulatory authorities that fosters international collaboration in regulating medical devices. established in 2011 as a part of the global harmonization task force (ghtf), the imdrf aims to harmonize and enhance the global regulation of medical devices. in the countries of the who western pacific region, including australia, japan, korea, china, and the philippines, medical devices are classified based on the risk they pose to patients and medical professionals. these classifications include categories a, b, c, and d, and classes ⅰ, ⅱ a, ⅱ b, and ⅲ. regulations are tailored to these classifications, with high-risk devices, such as those in categories c, d, or classes ⅱ b, and ⅲ, requiring registration, while lowerrisk devices are listed separately.6–10 these classifications align with the “global model regulatory framework for medical devices” issued by who11 and the general regulatory models provided by imdrf. in terms of the legislation in mongolia, the regulation of medical devices is as follows: the law on health provides definitions of four terms: 3.1.13 “medical equipment”, 3.1.14 “medical instrument”, 3.1.15 “accessories for medical equipment”, and 3.1.16 “prosthesis”, and article 19 of the law includes a group of provisions related to licenses to engage in healthcare activities. the law on medicines and medical devices defines two terms: 3.1.4 “diagnostic device” and 3.1.5 “medical device”, and article 8.1.1 of the law on metrology regulates them separately. according to the descriptive study, within the framework of the above legislation, the following standards have been approved: structure and operation standards-7, medical equipment standards-16, order of the deputy prime minister of mongolia-1, order of the minister of health-14, and order of the director of the mongolian agency for standard metrology-2. in a survey on implementing laws and regulations related to medical equipment, 86.1% of respondents said that a state inspection and regulatory system for medical equipment had not been established. 91.7% indicated that a legal framework for regulating medical equipment was absent. 91.9% reported no legal framework for ensuring the quality and safety of medical equipment. 91.7% said a legal framework for the optimal planning and regulation of medical equipment assets was not established. 97.3% indicated a legal framework for regulating medical equipment maintenance and service management was not in place. 75% of respondents said that a state inspection and regulatory system for medical equipment had been established, while 25% disagreed. a total of 25.7% felt that regulating medical equipment licenses was sufficient, while 74.3% believed it was insufficient. implementation of legal documents and reflection of stakeholders’ feedback there is limited regulation related to medical equipment in sectoral laws, and existing regulations are scattered across individual laws. although healthcare facilities follow ministerial order no. 439 of 2006, the implementation of this order varies depending on the hierarchy of healthcare facilities, with local areas facing particular challenges. it namdag, luvsan, dashtseren: a study on the legal environment of medical devices and enhancing the regulatory system j global clinical engineering vol.7 issue 1: 2025 28 are not always included, and it is emphasized that the participation of other professionals is also crucial. equipment quality, availability, and regular maintenance investment and supply of medical equipment have improved due to the coronavirus pandemic. however, the lack of routine maintenance, inadequate funding planning, and the pressure to operate in high-demand conditions contribute to increased equipment damage. while performance financing and management privatization have positively impacted equipment supply, some hospitals are forced to cut their maintenance budgets to remain profitable “a hospital can only attract customers if it has both good equipment and skilled specialists.” (engineer of the medical equipment, healthcare facility) “our hospital has a budget of usd 0.6 million for normal operations, covering everything from vehicles and buildings to computers. however, only about usd 500-600 are allocated for hospital equipment, which is insufficient even to cover the spare parts for a single device.” (engineer of the medical equipment, healthcare facility) “there is no stock of spare parts for the equipment, and availability is always uncertain. the order is constantly dependent on someone else. after the equipment is installed, if a failure occurs later, the spare parts may already be outdated, or the equipment may no longer be produced. as a result, we engineers are left with no choice but to resort to a ‘mongolian way’ of handling it.” (engineer of the medical equipment, supply organization)1 medical equipment purchases are often organized by unqualified individuals without obtaining quotes based on technical specifications. as a result, the manufacturer is often unknown, and expensive, substandard equipment is frequently purchased. “there was an instance where a company selling toys in the market won the tender to supply cpap machines for infants, claiming there were no professionals available for the local tender. when the equipment was delivered, two salesmen—who were not professionals at all—came is emphasized that human resources and room requirements are insufficient in these areas. in private healthcare facilities, regulations are created based on the internal rules and regulations of the institution, which prioritize customer requests. since the rules and regulations concerning equipment regulation are separate, there is a recognized need for an integrated legal framework. this would involve consolidating and updating the existing regulations, including ministerial order no. 439 of 2006, ministerial order no. 404 of 2006, and mns5097:2017 general hospital structure and operation standards. ministerial order no. 439 of 2006 states that there should be 1 engineer for every 100 pieces of equipment. however, it is necessary to define which types of equipment should be included in the 100-piece count. additionally, it should be clarified that one engineer should specifically be assigned to high-cost equipment, and there needs to be clear criteria for identifying what qualifies as highcost equipment. overall, an integrated legal regulation is needed, rather than relying solely on ministerial order no. 439 of 2006.” (engineer of the medical equipment, healthcare facility) “in the mns5097:2017 standard, equipment is evaluated as either present or absent. for example, a hospital bed is considered ‘present’ even if it is broken. we would like to change this evaluation to a numerical system, where the condition of the equipment is assessed with plus or minus signs, rather than simply being counted as present or absent. a numerical evaluation would provide a more realistic assessment of the equipment’s status.” (engineer of the medical equipment, healthcare facility) “it would be beneficial to include criteria for buildings, rooms, and human resources in the accreditation standards, so that these aspects can be properly evaluated.” (engineer of the medical equipment, healthcare facility) “in the future, the regulations should require the medical equipment manuals in a simplified format with two categories: user and engineering.” (engineer of the medical equipment, pharmaceutical supply organization)1 representatives from faculties and researchers have recently been involved in developing policy documents. however, representatives of engineers and technicians 29 j global clinical engineering vol.7 issue 1: 2025 namdag, luvsan, dashtseren: a study on the legal environment of medical devices and enhancing the regulatory system to hand it over.” (engineer of the medical equipment, healthcare facility) “it is difficult to obtain spare parts for expensive equipment, and it would be beneficial if a certain percentage of the budget received from insurance were allocated specifically for spare parts.” (engineer of the medical equipment, healthcare facility)1 it is believed that the equipment registration system needs to be updated. human resource capacity and accessibility four universities train medical equipment engineers and technicians, with an employment rate of 95%. however, the high workload, part-time work, low salaries and benefits (which are set for non-medical professionals), and the lack of opportunities for postgraduate training and specialization contribute to a shortage of human resources, particularly in public hospitals and rural areas. “there should be one engineer for every 100 pieces of medical equipment, but in reality, one engineer is responsible for 200–300 pieces of medical equipment.” (university professor) “our hospital has over 600 pieces of medical equipment, and we have one engineer and two technicians working here. however, there are no engineers specifically responsible for ct, hemodialysis, and oxygen equipment, so three people are handling these tasks. additionally, there is extra work related to occupational safety and hygiene (osh).” (engineer of the medical equipment, healthcare facility) “we are performing tasks similar to surgeries, such as assisting with hemodialysis, and working with ct, yet we are paid at the government service (gs) level. therefore, we want to be included in the gs of the health sector.” (engineer of the medical equipment, healthcare facility) “there are many people who don’t fully understand the responsibilities of a medical equipment engineer or what their role should entail. they assign tasks to engineers simply because the work is related or similar.” (engineer of the medical equipment, healthcare facility) “we want to hire new specialists, but they are not coming to local areas. students graduating from private universities are entering engineering fields, not medical technology. additionally, graduates often lack the ability to distinguish between different types of equipment. therefore, we need to focus on improving the quality of training.” (engineer of the medical equipment, healthcare facility)1 medical equipment engineers often have to take on various additional tasks due to the ambiguity of their responsibilities and are frequently employed as osh staff. medical equipment engineers can be compensated through the health sector government service (gs). discussion based on the recommendations from the who and international regulatory bodies, as well as the legal frameworks related to the regulation of medical devices and other products in various countries, a wide range of products, from small medical instruments to large diagnostic and therapeutic equipment, are defined as “medical devices”. these devices are then classified as a, b, c, and d, or class ⅰ, class ⅱ a, class ⅱ b, and class ⅲ, based on the level of risk they pose to patients and medical professionals. regulations are being developed according to these categories, including the registration of high-risk products, such as those in categories c, d, or class ⅱ b, and class ⅲ, while other products are listed separately in the remaining categories. the survey, conducted among medical equipment engineers, technicians, representatives of supply organizations, and faculties regarding the implementation of legislation, included 35–37 participants in each group. the findings indicate that the legal and regulatory framework concerning medical equipment is insufficiently developed, and state inspection and regulation are weak. when comparing the regulations on medical equipment and other products included in major healthcare sector laws in our country with the standard regulations on “medical devices” in countries around the world, differences are evident, starting with the definition of the term. establishing a legal framework for integrated policies and regulations covering medical equipment registration, namdag, luvsan, dashtseren: a study on the legal environment of medical devices and enhancing the regulatory system j global clinical engineering vol.7 issue 1: 2025 30 quality, safety, rational asset planning, and maintenance management is essential. conclusion when comparing the regulations related to medical devices in mongolia, particularly those concerning medical equipment, with the who recommendations, the imdrf general regulatory models, and the regulations of countries such as australia, japan, korea, china, and the philippines significant differences emerge. these include discrepancies in the definitions of terms, the absence of a classification system for medical devices, a lack of postmarket quality surveillance, and no regulations regarding packaging, labeling, advertising, or proper disposal. however, the regulations for importing medical devices through licensed suppliers are in line with the medical device regulations of the aforementioned countries and who recommendations. author contributions conceptualization, a.d., m-e.l., g-o.n. ;methodology, a.d., m-e.l.; formal analysis, a.d., g-o.n.; writing – original draft preparation, g-o.n.; writing – review & editing, a.d., m-e.l.; supervision, a.d.; project administration, m-e.l.; funding acquisition, g-o.n. acknowledgments not applicable. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare they have no competing interests. ethics approval and consent to participate the study methodology was reviewed and approved by the research ethics and monitoring committee of the mongolian national university of medical sciences during its meeting on january 21, 2022 (approval no. 2022/3-01). consent for publication not applicable. further disclosure part of the findings from this study, titled “assessment of the implementation of medical equipment policy in mongolia”, authored by gerelt-od namdag, munkh-erdene luvsan, and amarsaikhan dashtseren, was presented at the 5th international clinical engineering and health technology management congress (icehtmc), held from november 11 to 23, 2023. additionally, the abstract of this study was published in the global clinical engineering journal (gcej) special issue 5. references 1. ministry of health of mongolia. health sector investment report. unpublished internal document. ulaanbaatar, mongolia, 2025. 2. world health organization. health products policy and standards. available online: https://www.who. int/teams/health-product-policy-and-standards/ assistive-and-medical-technology/medical-devices/ regulations. 3. world health organization. medical device. available online: https://www.who.int/health-topics/ medical-devices#tab=tab_1. 4. medical device regulatory review report: guidance regarding information to be included. available online: https://www.imdrf.org/sites/default/files/2024-04/ imdrf%20grrp%20wg%20n71%20%28edition%20 2%29_0.pdf. 5. ghtf archives. available online: https://www.imdrf. org/ghtf. 6. wizemann, t. public health effectiveness of the fda 510(k) clearance process: balancing patient safety and innovation. national academies press (us): washington, usa, 2010; pp. 41–42. 7. bhattacharya, r., parua, s., das, d., et al. global perspective on medical device regulations. int j pharm sci res. 2024;15(11):3148–3164. https://doi.org/10.13040/ ijpsr.0975-8232.15(11).3148-64. https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations https://www.who.int/health-topics/medical-devices#tab=tab_1 https://www.who.int/health-topics/medical-devices#tab=tab_1 https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n71%20%28edition%202%29_0.pdf https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n71%20%28edition%202%29_0.pdf https://www.imdrf.org/sites/default/files/2024-04/imdrf%20grrp%20wg%20n71%20%28edition%202%29_0.pdf https://www.imdrf.org/ghtf https://www.imdrf.org/ghtf https://doi.org/10.13040/ijpsr.0975-8232.15(11).3148-64 https://doi.org/10.13040/ijpsr.0975-8232.15(11).3148-64 31 j global clinical engineering vol.7 issue 1: 2025 namdag, luvsan, dashtseren: a study on the legal environment of medical devices and enhancing the regulatory system 8. world health organization. global atlas of medical devices 2022. available online: https://www.who.int/ publications/i/item/9789240062207. 9. ministry of food and drug safety. medical device regulation. republic of korea. available online: https:// www.mfds.go.kr/eng/index.do. 10. tuv sud. australia’s therapeutic goods regulations. available online: https://www.tuvsud.com/en-us/industries/ healthcare-and-medical-devices/medical-devices-andivd/medical-device-market-approval-and-certification/ australia-therapeutic-goods-regulations. 11. world health organization. who global model regulatory framework for medical devices including in vitro diagnostic medical devices. available online: https:// www.who.int/publications/i/item/9789241512350. https://www.who.int/publications/i/item/9789240062207 https://www.who.int/publications/i/item/9789240062207 https://www.mfds.go.kr/eng/index.do https://www.mfds.go.kr/eng/index.do https://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/australia-therapeutic-goods-regulations https://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/australia-therapeutic-goods-regulations https://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/australia-therapeutic-goods-regulations https://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/australia-therapeutic-goods-regulations https://www.who.int/publications/i/item/9789241512350 https://www.who.int/publications/i/item/9789241512350 1 j global clinical engineering vol.3 issue 2, 2020 editor’s corner magic and miracle might mean the same thing to some people, but there is a vast difference between the two terms. what is the difference between magic and miracle? to a large degree, the response depends on who is answering. a gambler would say perhaps it depends on the size of the booty. while a faith-based person might respond that a miracle is the extraordinary work of god or his/her disciple, while magic is the extraordinary act of a person. one would be considered a sage or miracle worker while the other would be considered a sorcerer or magician. magic may also be used in a derogatory way, suggesting deception, particularly in discussions of spirituality and stewardship. miracles on the other hand are used to describe things we do not understand and are related to various faith traditions as being perhaps the result of some powerful super being intervening in the world. as someone who, over the past three decades, has helped create organizations whose purpose was to improve patient care outcomes by strengthening the communities of clinical engineers (ces), i’ve pondered these very questions. each time a new organization has been established i’ve wondered if i am witnessing a miracle or magic? this started over 30 years ago with the creation of the american college of clinical engineering (acce),1 and continued with the formation of the center for telehealth & ehealth law (ctel),2 5 years later. this was followed about 18 years ago by the establishment of the healthcare technology foundation (htf).3 all these organizations filled a specific gap, empowered professionalism, gave a voice, and became impactful over time as well as operationally effectively elevating the level of cooperation and knowledge sharing among peers. in recognition of the growth in the number of aging persons around the world, the need for faster adoption of new technological tools, rising expectations of consumer’s from health care programs, and the changing regulations of healthcare products, the 2019 global ce summit, held during the 3rd icehtmc4 congress in rome, italy, focused on identifying paths that ces can take to optimally address these issues. the top-ranking action path at the congress was a vote to “increase the ce role in decision-making processes.” but, a couple of months later the world was engulfed with the devastation of the covid-19 pandemic. the world we were living in had changed forever and we’re facing a new set of challenges. this challenge involved the need to urgently improve availability and access to need healthcare technological tools. this included personal protection equipment, mechanical ventilators, oxygen supplies, and safe spaces for caring for infected patients. just as important was the need to manage the safety and quality of inventories and disinfecting processes. as the world keeps on changing, ces are searching for valid guidance on how to optimally manage the lifecycle and scarcity of these technological tools. these tools are not only critical for healthcare providers but the public as a whole and populations have grown to depend upon their ability to help save lives. the role of ces has increased significantly and has become more critical than ever within just the past few months (see the global ce journal issue on covid-195). with an aging vulnerable population, the inability of the supply chain to deliver life-critical technological products and adapt to a shifting focus on safety and quality has been apparent.6 in an article published in this issue of our journal “international survey of clinical engineering professionals,” the authors concluded that “patient care outcomes stand to improve when healthcare technology is optimally managed. identifying the global challenges faced by the international community of ces is the first step towards overcoming them and the shared goal of better healthcare outcomes can then be better guided. establishment of global collaboration and structure to achieve partnerships will help to overcome barriers, http://www.globalce.org http://www.globalce.org j global clinical engineering vol.3 issue 2, 2020 2 support professional development, and increase recognition, as well as addressing other challenges facing the ce profession.”7 the combination of evolution and covid-19 as an inflection point has magnified the dependence of the future of healthcare outcomes on access to a pool of competent practitioners in each phase of the technology lifecycle. from ideation to commissioning and integration to servicing and program managing, we have no choice but to empower all national ce groups. this can be accomplished by joining a global alliance of clinical engineering that advances the field via cooperation, collaboration, increased visibility, and unique unified relevant representation that seeks to improve the delivery of safe, effective, and high-quality care and its outcomes and thus gain a seat at the decision-making table. there is no miracle or magic here. rather hard work, persistence, and the commitment to act as professional members of the healthcare team is what’s needed. and that is my colleagues, the purpose of the new global clinical engineering alliance (http://globalcea.org). i am sure that you will join me in welcoming this new baby to a safer and better world (welcoming video: https://youtu.be/hz_y5l6ezp0 ) references 1. the american college of clinical engineers. homepage. available at: https://accenet.org 2. healthcare technology foundation. homepage. available at: http://www.thehtf.org/ 3. the center for telehealth & e-health law. ctel digital health summit. homepage. available at: http:// www.ctel.org 4. international clinical engineering health technology medical congress. the 3rd icehtmc congress rome, italy, october 2019. available at: http://www.icehtmc2019.com/index.html 5. global clinical engineering journal. special issue on covid-19. available at: https://www.globalce.org/ index.php/globalce/issue/view/9 6. us food and drug administration. fda emergency use authorization. [internet]. available at: https:// www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/ emergency-use-authorization 7. david y. et al: international survey of clinical engineering professionals. global ce journal 2020;3(2). https:// globalce.org/index.php/globalce/article/view/111 together we are making it better! dr. yadin david copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org http://globalcea.org https://youtu.be/hz_y5l6ezp0 https://accenet.org http://www.thehtf.org http://www.ctel.org http://www.ctel.org http://www.icehtmc2019.com/index.html http://www.icehtmc2019.com/index.html https://www.globalce.org/index.php/globalce/issue/view/9 https://www.globalce.org/index.php/globalce/issue/view/9 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.7 issue 2: 2025 62 received november 19, 2024, accepted march 06, 2025, date of publication june 20, 2025. letter a hybrid model of in-house and outsourcing maintenance for medical devices in africa ashenafi hussein ababau* provisional project office, national medical device manufacturing, ethiopia. *corresponding author email: ashuab007@gmail.com dear editor, the recent discussion on adopting a hybrid model that combines in-house and outsourced maintenance for medical devices in africa presents a promising strategy to improve healthcare infrastructure sustainability. background many lowand middle-income countries (lmic) in africa cannot afford to procure medical devices every year or every time a device breaks or malfunctions. it is essential for all health care facilities, regardless of their size, to implement a maintenance program for medical equipment. the complexity of the program depends on the size and type of facility, its location, and the resources required.1 basic diagnostic, therapeutic, and rehabilitation devices are maintained within the in-house facility. however, maintaining capital and high-tech medical devices is a headache in many african countries. in africa, maintenance problems as well as many recommended solutions are also complex. entrusting a new graduate biomedical engineer/ clinical engineer with the responsibility of maintaining high-tech devices without providing proper training, spare parts, toolkits, etc., is a major concern for clinical/biomedical engineers. medical device repair and maintenance are extremely important, and the healthcare center has to manage the periodic schedules and updates of the devices. most maintenance and repair activities are done in response to the operator’s request for support. the maintenance and repair service should include a planned preventive maintenance design.2 http://www.globalce.org http://globalce.org http://globalce.org mailto:ashuab007@gmail.com 63 j global clinical engineering vol.7 issue 2: 2025 ababau: a hybrid model of in-house and outsourcing maintenance for medical devices in africa methods sampling techniques are used to compare the results of in-house maintenance and outsourcing methods of maintenance. a mathematical tool/model will be developed to identify the method of maintenance that is best suited for a specific device. currently, there are generally two approaches for managing medical device maintenance: in-house and outsourcing. but there is also a third approach, which is a “hybrid of in-house and outsourcing maintenance”. capital medical devices and high-tech gadgets require expert maintenance, which is often unaffordable for inhouse workshops in many african countries. it is usually recommended to outsource the maintenance of such highend equipment to suppliers/manufacturers. sticking to a single approach is not advisable for resource-constrained countries in africa. thus, the hybrid approach incorporating both in-house maintenance and outsourcing is found to be very effective. the key factors of cost, work quality, obtaining expertise, tools, equipment, and technology, risk reduction, response time, and management focus on core health service activity should be considered when deciding on the best approach for a health facility. sampling techniques are used to compare the results of in-house maintenance and outsourcing methods of maintenance. a mathematical tool/model will be developed to identify the method of maintenance that is best suited for a specific device. currently, there are generally two approaches for managing medical device maintenance: in-house and outsourcing. but there is also a third approach, which is a “hybrid of in-house and outsourcing maintenance”. capital medical devices and high-tech gadgets require expert maintenance, which is often unaffordable for inhouse workshops in many african countries. it is usually recommended to outsource the maintenance of such highend equipment to suppliers/manufacturers. sticking to a single approach is not advisable for resource-constrained countries in africa. thus, the hybrid approach incorporating both in-house maintenance and outsourcing is found to be very effective. the key factors of cost, work quality, obtaining expertise, tools, equipment, and technology, risk reduction, response time, and management focus on core health service activity should be considered when deciding on the best approach for a health facility. conclusions in general, the health facility can choose which approach is apt depending on the frequency of maintenance, skill, training, and budget availability. performance evaluation and calibration are the missing links occurring during the in-house maintenance activity. thus, it is important to outsource high-tech and capital medical devices that offer features of cost-effectiveness, control, and flexibility. different medical devices, from simple to complex, different brands, availability/lack of spare parts, availability/lack of training, and workshops will make it very difficult for in-house technicians and engineers to take care of everything in the health facility. basic medical devices can be maintained by in-house service personnel, but complex devices can be maintained only by outsourcing maintenance to suppliers/companies. thus, a hybrid in-house outsource maintenance approach is highly recommended in resource-limited countries in africa. it will avoid debate and confusion as to which approach is better for lmic, because one approach cannot replace the other. ababau: a hybrid model of in-house and outsourcing maintenance for medical devices in africa j global clinical engineering vol.7 issue 2: 2025 64 author contributions a.h.a. is the sole author of this work and is responsible for all aspects of the research and writing. conflicts of interest the author declares he has no competing interests. ethics approval and consent to participate not applicable. consent for publication not applicable. references 1. who medical equipment maintenance program overview, june 2011. available online: https://iris.who.int/bitstream/ handle/10665/44587/9789241501538-eng.pdf. 2. ababu, a.h. reengineering the medical equipment management systemthe provider—regulator—purchaser aspect. master’s thesis, addis ababa university, addis institute of technology, 2014. available online: https://etd.aau.edu.et/server/api/ core/bitstreams/8511f6ce-ece6-4728-b033-ffc2ab901994/content. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. https://iris.who.int/bitstream/handle/10665/44587/9789241501538-eng.pdf https://iris.who.int/bitstream/handle/10665/44587/9789241501538-eng.pdf https://etd.aau.edu.et/server/api/core/bitstreams/8511f6ce-ece6-4728-b033-ffc2ab901994/content https://etd.aau.edu.et/server/api/core/bitstreams/8511f6ce-ece6-4728-b033-ffc2ab901994/content https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 29 j global clinical engineering vol.5 issue 2: 2022 received july 28, 2022, accepted august 27, 2022, date of publication september 1, 2022 global clinical engineering status: post-covid19 review by tom judd1, yadin david2, fabiola martinez3, and kallirroi stavrianou4 1 gcea liaison officer 2 gcea interim president 3 ced chairperson 4 university of warwick, uk abstract many colleagues have written about the global reliance on health technologies whose innovation, deployment and support continue to improve worldwide healthcare and its delivery. the world health organization’s-who 2007 resolution wha60.29 called for the effective use of health technologies (ht), in particular medical devices, through proper planning, assessment, acquisition and management. the community of professional clinical engineering (ce) practitioners’ pre-covid19 stories are captured in the global clinical engineering journal. an article from 2022 shows the reasons for the increased contributions of this community especially during the pandemic in the growing role of clinical engineering: merging technology at the point of care. this article will answer questions such as to how this global reliance was demonstrated during the covid19 period. how the status of the clinical/biomedical engineering (ce/bme) profession that serves at the point of care changed as the world emerges from the huge stresses of the pandemic. the article reviews the evolution of the ce profession since 2020, how it partnered with who between 2020-2022 and what lessons were learned in the process. it reports future ce priorities to improve country, regional, and global practice in 2023 and beyond. this timely preliminary report shares important findings related to patient care support services. keywords – covid 19, clinical engineer, technologist, devices, patient, outcomes, engineering, global copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. engineering report http://www.globalce.org http://globalce.org http://globalce.org https://apps.who.int/iris/bitstream/handle/10665/22609/a60_r29-en.pdf https://globalce.org/ https://globalce.org/ https://globalce.org/index.php/globalce/article/view/146/87 j global clinical engineering vol.5 issue 2: 2022 30 judd, david, martinez, stavrianou : global clinical engineering status: post-covid19 review introduction clinical engineering professionals (ces) support and advance patient care experience and outcomes by applying engineering, life sciences, and managerial skills to optimize healthcare technology during its life cycle deployments. ces are sought for their system thinking expertise, to conduct independent validation of healthcare products, to identify technical support requirements, to ensure that medical device users’ needs are met and that products are accessible and ready for patient care. they assess and manage the use of health technologies, which who defines as “the application of organized knowledge and skills in the form of (medical) devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of care and/or life,” including both traditional medical devices and emerging digital health tools.1 during 2020-2022, who’s world health assembly (includes ministers of health-mohs from who’s 194 member states) focused on the need for intensive care mechanical ventilators (2020) and medical oxygen production (2021).2 who has specifically recognized the clinical engineering community for expertise to optimally manage assets such as medical devices, personal protective equipment, oxygen, and digital health tools, particularly in low-resource settings.3 two ce organizations, the international federation of medical and biological engineering clinical engineering division4 (ifmbe ced) and the global clinical engineering alliance5 (gcea), add different expertise to meet global challenges, grew tremendously during the pandemic following a surge in the need for their members’ expertise. in partnership with who, these organizations are now networked to colleagues in 200 countries, sharing best practices and solutions to common complex challenges. today, ced and gcea together form a global ce community & network (fig. 1). one key pandemic lesson learned was that this community needed to better understand how practitioners are not only distributed around the world, but how ce practice differed from country to country to help drive relevant improvement, with regional focus, and specific training. this was supported by the opportunity to build on our earlier ce practitioner body of knowledge (bok) – body of practice (bop) survey from 2017. background prior to the pandemic, ced and who had been partnering closely, particularly since 2009 when dr. yadin david became ced chair and ms. adriana velazquez became who’s medical devices/health technologies (ht) leader. together, a series of international ce-health technology management (htm) congresses (icehtmc) began to convene in 2015 in china, 2017 in brazil, and 2019 in rome. the rome congress had 1000 attendees from 70 countries. during these meetings, global ce summits events were conducted to identify and prioritize action on global ce-htm challenges, with 15 countries participating in 2015, 30 in 2017 and 48 in 2019. a virtual congress in 2021 drew 2100 registrants from 128 countries and had a virtual global ce summit with attendees representing 51 countries (fig. 2). during the period between 2015-2019, consensus priorities such as increasing professional recognition, improving training opportunities, creation of the dedicated figure 1. global clinical engineering leadership teams figure 2. clinical engineering global summits https://globalce.org/index.php/globalce/article/view/70 https://globalce.org/index.php/globalce/article/view/70 31 j global clinical engineering vol.5 issue 2: 2022 judd, david, martinez, stavrianou : global clinical engineering status: post-covid19 review global ce journal (fig.3), and considering professional credentialing approaches began to be addressed. this resulted in an enhanced ced website, the startup of relevant projects with an awards program (fig. 4), promotion of country and regional events, and a global ce day focus on october 21, 2015 and following years. global ce day is an annual recognition of contributions ces make to healthcare in their countries daily. the program over the years grew from 1 day to 1 week, and most recently in 2022, more than a dozen streamed events in several countries over two weeks (fig. 5). for example, the october 2020 program broadcast from china had 22 hours of streaming global content from 50 countries, had over 500,000 social media views, and introduced gcea as the new global ce partner organization. that same week in october 2020, who engaged with gcea who utilized ced’s global ce network to lead the engineering and management section of the who compendium of innovative health technologies for lowresource settings. since 2020 gcea has been growing globally, has offered over a dozen global best practice webinars, and has enhanced its website gcea website. pandemic era results prior to covid19, the global ce community consisted a team from 100 countries. following ced's and gcea's 60 best practice webinars6,7 that assisted in the global pandemic response, today the team has grown to over 560 collaborators from 200 countries with connection to 110 national ce societies (fig. 6). a key focus of over half of these webinars was implementing a global ce covid19 knowledge network. the other area of focus was detailing various country approaches to demonstrating ce competencies and leadership qualities (fig. 7); and increasingly, showing how ce competencies have had a unique covid19 impact. figure 3. global clinical engineering journal issue covers figure 4. clinical engineering community projects figure 5. global clinical engineering day and week. figure 6. global clinical engineering footprint https://ced.ifmbe.org/ https://www.who.int/publications/i/item/9789240032507 https://www.who.int/publications/i/item/9789240032507 https://www.who.int/publications/i/item/9789240032507 https://www.globalcea.org/home https://ced.ifmbe.org/who-we-are j global clinical engineering vol.5 issue 2: 2022 32 judd, david, martinez, stavrianou : global clinical engineering status: post-covid19 review 2022 global ce priorities, teams and results at the 4th icehtmc (international clinical engineering and health technology management congress) virtual congress in 2021 – besides giving voice to both the traditional competencies and to the increasing global scope of ce-htm practice during covid19 – e.g., digital health, ppe, facility design and oxygen management, (fig. 8), the global ce summit/community decided on the 2022-2023 priorities as follows: 1. capacity building • sufficient volume of the right people with the right education, training, and appropriate management skills. • framework: ce-htm capacity building model. 2. impact measurement • measurable impact on clinical outcomes. • framework: ce-htm theory of change (toc) model, utilizing who defined access, quality, safety, coverage, and efficiency. 3. credentialing • credentialing typically means ensuring minimum competencies and experience for the ce profession, expressed through registration and/or certification. 4. policy • ces show value to moh at national level • as a result, ces assist in writing national ht policy • ces educate healthcare decision-makers, both public and private healthcare leaders 5. ongoing who partnership • who medical devices unit primary focus, but other relevant units, eg, emergency response • who compendium of innovations for low-resource settings • who covid19 training – training in multiple languages over ht lifecycle of pandemic-specific devices during 2022, the ce community organized priority teams, ensuring perspectives from the following ht experts: 1. senior advisors – at least one highly experienced priority area expert to advise the team 2. champion/leaders – typically at least 2-3 experienced area leader/champions 3. hospital-based 4. health system-based 5. moh-based 6. academic-based 7. industry-based 8. regional understanding-perspective across a who region for a ce with multi-country experience 9. national ce society or institute-based other considerations for these teams was to ensure balanced input across the 6 defined who regions, from the ced-gcea network. these include the americas, africa, eastern mediterranean, europe, southeast asia, and western pacific, and utilizing ced-gcea board and collaborator members. figure 7. clinical engineering competencies figure 8. 4th icehtmc (international clinical engineering and health technology management congress), october 2021 https://www.who.int/health-topics/medical-devices#tab=tab_1 https://www.who.int/publications/i/item/9789240032507 https://www.who.int/publications/i/item/9789240032507 https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/management-use/trainings 33 j global clinical engineering vol.5 issue 2: 2022 judd, david, martinez, stavrianou : global clinical engineering status: post-covid19 review the teams met periodically and reported results at townhall sessions during 2022 global ce week, agreeing on next steps for 2023, focusing on sharing results from the capacity building (cb) / impact measurement townhall; the other priority areas are currently analyzed. post-covid19 global ce community next steps in determining the optimal process to follow, realizing that the body of practice (bop) had increased significantly during the pandemic, the teams decided upon the following primary data sources for examining progress and determining next steps: 2022 body of knowledge (bok) & body of practice (bop) survey , september-december 2022 current results of the bok-bop (capacity building-cb) survey, as of end of 2022 are shown on figure 9. a preliminary review of bok-bop data is shown in figures 9-12. figure 13 shows the resulting capacity building framework model. a quick summary follows: • ce practitioners as defined by who serve in a variety of roles shown on figure 11; the survey was particularly focused on those serving in the ce or bme role ‘at the point of care’ managing ht. • this is a young profession globally, well-educated, needing the recognition of skills that formal credentialing provides (as in most healthcare professions). • ces are undergoing rapid growth in digital healthrelated responsibilities. • an early comparison of global data with african region data shows important regional differences. • there was an outstanding response to the survey from 29 countries in africa, and a statistically significant response across all global regions. the 2022 survey provided over 4 times the input of the 2017 survey (35 countries, 199 responses) with its 865 responses so far from 124 countries. figure 9. global 2022 bok-bop survey j global clinical engineering vol.5 issue 2: 2022 34 judd, david, martinez, stavrianou : global clinical engineering status: post-covid19 review figure 11. global 2022 bok-bop survey results figure 10. global 2022 bok-bop survey results 35 j global clinical engineering vol.5 issue 2: 2022 judd, david, martinez, stavrianou : global clinical engineering status: post-covid19 review 2022 global theory of change (toc) / impact measurement survey current results of the toc (impact measurement-im) survey (toc explanation video): • number of responses: 34 • number of countries that sent specific case studies: 16 • the main focus was to ask about the areas of healthcare delivery or health systems generally where our global community of ce-bme felt they have had the most influence. • so far, the category that was noted in most instances as being an area of impact for health systems was patient safety (n=24 instances were noted of this type of impact), followed by improved diagnostics (n=17), and improved health access (n=16), cost savings (n=15), and hospital capacity (n=15). given the recent pandemic, there is also evidence that emergency preparedness is another area where impact has been achieved (n=12). figure 12. global 2022 bok-bop survey results figure 13. capacity building framework https://youtu.be/h49gpgcwrly j global clinical engineering vol.5 issue 2: 2022 36 judd, david, martinez, stavrianou : global clinical engineering status: post-covid19 review conclusions next steps: besides continuing to analyze the credentialing and policy townhalls and related next steps as well as assess our partnership with the world health organization, gcea and ced will begin to implement findings for capacity building and impact measurement. the pandemic has made our ce/bme profession highly visible globally, e.g., with who and with ministers of health and private health system leaders. how will we take advantage of this opportunity utilizing ce best practices? we have presented and published many strategies regarding how the profession can assist mohs and other health leaders to address their key national health priorities. the global ce community encouraged the development of individual professional society and country heroes during the pandemic. the community needs to continue to work with national ce/bme societies to raise up current and future leaders, as were recognized by ced-gcea in 2022 (fig. 14). the bok-bop survey, the capacity building framework, and toc survey: countries can begin to drill down on their practices they provide compared globally and the gaps they will need to address to continue to expand their role and services for healthcare delivery improvement. the accepted global ce role expanded during covid19, and the global community can help each country and practitioner with the skills necessary to meet this increased demand. ced-gcea can help prepare the messages and communication packages to assist this work. individual site and country clinical engineering status: the data sources identified share many country best practices for ce competencies and covid-19 cerelated solutions. the current five priority projects address the top global ce concerns and opportunities. consider first the ce capacity building framework. analyze how your country fits in this framework and to prioritize what gaps you want to pursue. work with the global ce community partners and your national ce society to determine next steps. we have many tools, networking within, and potential external alliances available; how will each practitioner and how will the ce global community use these to further grow in our profession? ce use of the social media tool has also been very helpful; how will these tools be incorporated into going forward? figure 15 describes the overall international track record of the utilization of these tools by ce between 2020-2022. the authors intend to conduct further analysis of the collected data and report their final findings in a future publication in the global clinical engineering journal. references 1. who health technology definition 2. who world health assembly 2020-2022 3. who priority medical devices list for the covid-19 response and associated technical specifications 4. ifmbe ced 5. gcea 6. ifmbe ced webinars, 2020-2022 7. gcea webinars, 2020-2022 figure 14. global ce community emerging leaders figure 15. track record of social media and educational platforms impact https://en.wikipedia.org/wiki/health_technology https://www.who.int/about/governance/world-health-assembly https://www.who.int/publications/i/item/who-2019-ncov-meddev-ts-o2t.v2 https://www.who.int/publications/i/item/who-2019-ncov-meddev-ts-o2t.v2 https://ced.ifmbe.org/ https://www.globalcea.org/home https://ced.ifmbe.org/courses-webinars https://www.globalcea.org/webinars 29 j global clinical engineering vol.5 issue 3: 2023 received june 20, 2023, accepted july 17, 2023, date of publication august 1, 2023 sustainable procurement of medical devices in an international context: part 1 background and definitions by valerio di virgilio1, alexia bouchard saindon2, francisco cesar gerardo becerra posada2 1 università degli studi la sapienza rome, italy 2 united nation office for project services abstract background and objectives: sustainability is a working principle included in the united nations (un) procurement processes with the adoption of the sustainable development goals (sdgs) in 2015. in the context of internationally funded projects in developing countries for procuring health-related goods during and following the covid-19 pandemic, this article further investigates what sustainable procurement means when applied to purchasing medical devices (mds), considering its impact on health services. it also proposes a reflection on the concepts of sustainability and quality assurance as guiding principles for technical teams during the process of md procurement. material and methods: this article aims to identify how sustainability can be implemented during the execution of a project based on the analysis of principles that guide procurement actions in the four un agencies with the highest volume of md procurement. the concept of sustainability is also explored from a macrosystemic point of view as the ratio between the impact of a procurement project on healthcare services and its investment. its implications for population health and wealth is also discussed. based on the experience of the authors in implementing purchasing processes of mds, a framework for the specific technical activity is then proposed. results: in the un system, sustainable procurement focuses on the social, economic, and environmental quality of the equipment and on the conditions of its production to guarantee that a sustainable good is procured. not being enough, the focus should also be on the benefit of a procurement project, not as the possession of a new md, but as the utility of the device: an instrument to provide healthcare services of the beneficiary country. procuring sustainable goods should include planning their future use as an essential component for a sustainable positive impact on the health and wealth of the beneficiary population. thus, the intended use of the procured devices should be defined, planned, and measured. in the proposed framework, sustainability is a ratio between an md’s social, economic, and environmental costs and the benefits of its use. when neglecting the essential factor of sustainable use of mds, the risk of purchasing equipment that will not be properly and efficiently used is relevant. to guarantee the sustainable use of a md, it is essential to assess the needs, the local conditions, and the conditions for its lifelong use. further evolution of the concept of sustainability is developed towards the possibility of modulating the project’s objective from procuring sustainable mds to improving the sustainability of the health services by procuring mds. conclusion: sustainable procurement of mds is a key factor in supporting the sustainable development of health services and health systems toward the sdgs. post-pandemic investments to strengthen the resilience of health services in developing countries shall consider sustainable procurement, including the essential quality assurance process. this process, led by an expert clinical engineer, shall be centered on the future use of the equipment and not be limited to its quality as a material good. keywords – medical device procurement, sustainable procurement, needs assessment, health services in developing countries, quality assurance, sustainability. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context: part 1 background and definitions j global clinical engineering vol.5 issue 3: 2023 30 introduction sustainability principles have recently been included in the un procurement processes.1 considering the opportunity to follow sdgs2 and reduce health inequities by focusing on project implementation, this article investigates further what sustainable procurement means when purchasing mds in a developing country and its impact on health services. quality in healthcare is a comprehensive and multifaceted concept, including technical competencies, effectiveness, efficiency, continuity, and safety. it is known that in developing countries, improving quality is not a luxury, and doing so often pays off.3 therefore, it is essential and possible to place sustainability and quality assurance (qa) at the center of the biomedical engineer’s efforts, aiming to improve quality healthcare services in developing countries. healthcare services save lives and increase the population’s well-being, but at the same time, they have a relevant impact on the environment, social and economic aspects of the communities involved. if not correctly managed, this impact can weaken communities and threaten their ability to guarantee healthy lives for future generations.4 as the pandemic of covid-19 progressed and the number of patients affected rose, the demand to procure materials and medical devices (md) to deliver healthcare increased, especially in developing countries, which were more vulnerable to the pandemic due to a historical lack of investment in the health sector.5 in this context, the quality of the procurement process to ensure the sustainable purchase of mds in developing countries becomes a key factor that goes beyond the technical characteristics of the device. more than ever, the procurement of mds needs to have a durable and positive effect on health services to improve patient care while reducing their environmental, social, and economic impacts according to the sdgs.6 this article presents the experience of the authors during the covid-19 pandemic when the requests for mds for developing countries exploded. following this increase, in 2021, unops has become the second largest health procurement agency within the un for mds and supply, with usd 500 million in purchases, after unicef, the number one procuring agency. application framework and methods the application framework can be depicted as an international procurement process where a funding source is donating or loaning money to a beneficiary, typically a public institution of a developing country, and the procurement is carried out by an implementing agency. in developing countries, the knowledge asymmetry between private suppliers and public purchasers is more evident: “public procurers perceive it hard to know what the available market offerings are resulting in the problem of finding the best available solution. they also lack enough insight into the operations, making it hard to understand the need of which the procurement is meant to fulfill. in extension this problem makes it hard to mediate the need to the market.”7 the rise of new technologies in the global market increases this knowledge gap, limiting the effort of public procurers toward a more sustainable procurement. it is essential to have public procurement institutions with enough technical capacities to challenge the market to reduce the dependence on information from manufacturers or suppliers that can be biased to their own advantage. to be able to take evidence-based decisions and choose only the innovative technologies that represent a real advantage, and finally to orient the market development toward sustainable innovations that are in the interest of developing countries. for these reasons, international implementing agencies are also responsible for bringing technical knowledge to strengthen local technical capacities. this article focuses on the procurement of mds, with particular attention on medical equipment that requires specific installation and safety measures. it also analyzes the main un procuring agencies perspectives on sustainability and where the focus should be placed. consequently, this framework’s target beneficiary of the procurement process will be part of secondary and tertiary care-level infrastructures. expert in mds, the 31 j global clinical engineering vol.5 issue 3: 2023 virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context: part 1 background and definitions technical lead of the project should be a biomedical or clinical engineer leading the technical part of the procurement process; thus, they are institutionally in charge of ensuring the quality of the purchase. within the described framework, the procurement of mds is a project limited in time, with a specific, welldefined schedule, budget, and expected quality. the project manager (pm) and their team will pursue these three dimensions simultaneously.8 if the pm is not an expert in mds, they will pursue a schedule and a budget while relying on the technical lead to ensure the quality/scope. firstly, this framework will explore the meaning of ‘sustainable’ and its definition in the context of a procurement project of mds. secondly, what sustainable procurement means from the technical perspective of the project within the agency will be investigated. finally, a discussion on quality and sustainability and their similarities and differences in the procurement of mds will be made. a macro approach to sustainable mds procurement in developing countries the health of a population is positively correlated with economic development.9 a healthier population is more active and productive, thus increasing the development process of a country. in return, the development of a country increases its capacity to offer better health services to its population. if the third sustainable development goal ‘good-health and well-being’10 and universal health coverage, are to be achieved, countries must invest at least 5% of their gdp.11 focused investment is needed and funding agencies can play a key role in their strengthening.12 health capital expenditures and assets maintenance and management have been historically underfinanced. the pandemic pointed out this fragility and lack of resilience of health systems. as a result, in 2020, governments’ increased health care expenditure to address the additional medical needs was observed.13 a procurement project of mds represents the injection of funds into a developing country’s health services, aiming to improve the population’s health and contribute to the country’s sustainable economic development. implementing an investment project in the health sector is part of a virtuous circle: direct investments or loans coming from present or future taxes are transformed into infrastructure and technologies that improve the population’s health. the healthier a population is, the better the economy. however, healthcare financial resources being limited, the high-quality (sustainable) or low-quality (unsustainable) of an md procurement project is thus a critical factor that will impact the health services performance and thus, the population’s health. this means that the work of the technical leads in md procurement projects has a potential impact on the lives of millions of people. therefore it is possible to define sustainability as a critical ‘gain factor’ (figure 1), which depends on how the project is implemented. a high-quality project will have a highly positive factor so that the investment will produce results that will exceed the loan reimbursement, thus increasing health services resilience. this factor is what makes a project sustainable for the convenience of the beneficiary country’s population. in light of this top-down definition of ‘sustainability’ it is possible to define the sustainability of a project with the ratio between the impact of the project on the sdgs and the amount of the investment. from this macro perspective, qa and sustainability assurance are synonymous, depending on the project’s impact. when the impact of the project is reduced, null, or worse, negative (when for example, there are high costs to maintain brand-new medical technologies that are seldom figure 1. the virtuous circle of investments in health technology. the procurement project’s sustainability is a critical factor in achieving the intended impact of a healthier population. virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context: part 1 background and definitions j global clinical engineering vol.5 issue 3: 2023 32 used), what will remain for the population is a debt that will be paid by their own taxes (figure 2). the population subsequently receives fewer benefits, and the economy doesn’t grow as expected based on social determinants of health studies. the lower the income, the worse the health.14 therefore, an md procurement project always impacts the wealth and the health of the population it aims to help. this impact depends on its sustainability. being aware of its impact during the project’s planning, design and implementation will improve its sustainability, in fact: ‘’...economic growth and increased health spending alone are not enough to scale-up healthcare coverage and achieve better health outcomes. these must be combined with accountability of results, transparent management of public funds, and multisectoral efforts with community involvement at implementation level.’’15 principles and definitions of sustainability applied by the united nations agencies in 2015, the united nations (un) adopted the sdgs to end poverty and hunger, ensure prosperity for all and protect the environment by 2030.16 these goals and their targets, especially the third one ‘good-health and wellbeing’,17 serve as a foundation to the mds sustainable procurement strategies of the un agencies working in the healthcare sector. un procurement of medical equipment and supplies amount has grown from $640 million (average 2013-2019) to $2.26 and $2.35 billion in 2020 and 2021.18 a group of these agencies, the un sustainable procurement in the health sector (sphs), whose objective is to contribute to more sustainable health services and greener economies through sustainable procurement in the health sector, has an estimated annual purchasing volume of $5 billion in health products which represents the largest market share in the health sector.19 therefore, un agencies are committed to lead by example and may also influence manufacturers and suppliers in the healthcare market toward more sustainable products concerning the sdgs.20 graph 1 presents the five un agencies that purchased the most medical equipment in the 2020-21 biennium. un agencies sustainable procurement approach the sustainable procurement of mds approach is slightly different depending on the specific mandate of each agency. however, the policies of who,22 unicef,23 undp24 and unops25 all have in common three dimensions figure 2. disruption of the virtuous circle of investments in health technology: when quality assurance/sustainability of the procurement project is lacking, sustainable growth of the population’s health and wealth associated with the project are not guaranteed and often negatively affect the population. graph 1. amount of medical equipment purchased by un agencies in 2020 and 2021 in $ million. wfp procures mainly food and clinical nutrition supplies that are out of the scope of this article.21 33 j global clinical engineering vol.5 issue 3: 2023 virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context: part 1 background and definitions of sustainability: economic, environmental and social which are applicable throughout the life cycle of the md. table 1 summarizes the sustainable procurement principles of the four mentioned un agencies working in the healthcare sector, and details the elements considered for a sustainable purchase. according to the un agencies’ policies, these three dimensions of sustainable procurement must be considered in all phases of the implementation project (program design, budgeting, implementation, and monitoring). the key to a successful project is to plan procurement collaboratively with the relevant stakeholders in the early phases of the project.26 the definitions of sustainable procurement of the un agencies include three dimensions: an environmental aspect which focuses on the quality of the md purchased its carbon footprint a social aspect which focuses on the quality of the manufacturing conditions of the md the condition of the labor force for its production and an economic aspect which focuses on the quality of the financial resources allocation its life cycle cost. all the un definitions of sustainability are centered on the quality of the device and the quality of its production and transportation. however, delivering a quality device to a beneficiary is insufficient to ensure sustainability. a sustainable device directly becomes unsustainable if not used because its environmental, social, and economic costs are compared with no benefits as discussed in the following paragraphs. table 1. summary of the sustainable procurement principles of who,22 unicef,23 undp,27 and unops.25 virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context: part 1 background and definitions j global clinical engineering vol.5 issue 3: 2023 34 unicef explicitly includes a “definition of need planning supplies with programme specifications” at the beginning of the procurement process and an “end-user utilization fit for purpose impact” at the end to measure the impact of the purchase.26 nonetheless, this does not directly link the use of the goods with their sustainability and the design of their requirements. sustainability levels in the implementation of a md procurement project as discussed previously, the sustainability principles depend on the project results and impact on the health services and can be summarized into different levels. the technical lead can pursue these levels according to their experience, awareness of sustainability principles, and role in the dialogue with the pm and the project stakeholders. it will also be linked to the policy and regulations of the purchasing agency. local regulations have to be considered as well. basic sustainability level: procurement of a sustainable device this level is the first level of sustainability to achieve and as depicted previously, most of the procurement policies within the un system are focused on this level to purchase goods produced sustainably. however, owning a sustainable md does not guarantee per-se a benefit for the health services and the population. moreover, an environmentally friendly md purchased at a low price and with high ethical standards that are not used at all, or not appropriately, or scarcely used during all its expected lifetime harms the environment since its environmental cost cannot be balanced with an adequate health and economic benefit. and therefore, it represents a low-quality unsustainable purchase that will damage the financial wealth and thus, the health of the population it intends to benefit. intermediate sustainability level: procurement centered on the sustainable use of an md reflecting on the procurement processes during the covid-19 pandemic, the authors present three pillars that guarantee sustainable use of the procured device and thus contribute to sustainable procurement. the lessons learned during the assessment of several hospitals in various developing countries show a significant percentage of medical equipment (estimated by the authors to up to 20%) that is not working or not efficiently used. it has been reported that about 40% of donated mds in developing countries are out of service.28 the main reasons for this situation are: the lack of patients and healthcare resources resulting from a weak needs assessment; inadequate installation of the equipment; absence of funds for consumables, maintenance, and spare parts; lack of experience and training of technicians and healthcare staff; delays in approvals/permissions as per local regulations. pictures like the ones shown in figures 3 and 4 are quite common in developing countries where a significant amount of mds is not used with high environmental, social, and economic costs. figure 3. photos of unused mds in three different hospitals, the first in the caribbean, the second in central asia and the third in central america. figure 4. pictures of stored new laboratory equipment. the boxes on the pictures were never opened several months after their delivery. the third picture shows equipment waiting for years to be completely installed. 35 j global clinical engineering vol.5 issue 3: 2023 virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context: part 1 background and definitions effective procurement is based on getting the correct goods to meet the functional needs of the beneficiary. that is to say that the planned use of the equipment has to provide planned benefits to the population. in fact, the entire procurement process is based on a needs assessment as its essential starting point. when a procurement process has been carried out transparently, efficiently, and coherently with the objectives, the reliability of the needs assessment is still to be confirmed to get quality results.29 to guarantee that the purchased mds will be correctly used, the project’s technical lead should investigate its intended use by discussing the pretended use of the md with the beneficiary. thus, the first pillar of sustainability should be: the needs assessment where the following aspects shall be investigated: 1. the demand design of the list of mds to be procured: is there an evidence-based health need that justifies the proposed md? 2. the intended use design of the technological level: when the intended use is clarified, it is possible to choose the appropriate technological level of the md and its accessories. 3. the expected quality/durability design of technical specifications: by balancing the available budget with the expected quality, the technical characteristics of the goods to be purchased can be designed. therefore, an adequate md will result from a procurement process that begins with a needs assessment strongly correlated to the population’s health needs through a constructive technical dialogue involving the beneficiary and the clinical end-user. the needs assessment and the preparation of the equipment list is usually a process carried out before the project starts to estimate the project budget and formalize the agreements between the beneficiary, the donor, and the implementing agency. nevertheless, it is recommended that this preliminary needs assessment is validated and strengthened by a deeper analysis at the project’s start, because the conditions may have changed, and the preliminary needs analysis is usually too quick and does not consider the intended use and the expected durability/quality. the second pillar of sustainability is the assessment of existing conditions. it is essential to focus on the context where the goods will be used. to this extent, the focus shall be on: (1) the sustainable and safe delivery of the equipment from the fabrication site to the installation site; (2) the infrastructure that will receive the mds and the design of the interface of the equipment within the existing environment; (3) the interaction of the equipment with other equipment or technologies; and (4) the capacities of the human resources that will use and maintain the mds. the result of the assessment of existing conditions is an adequate delivery and installation plan. the third pillar of sustainability is the assessment of the lifelong use conditions of the md. as mentioned before, it is not enough to purchase an adequate md and install it; a sustainable purchase should also include assessing its useful life conditions. to this extent, the focus shall be on: (1) the adjustment of the equipment’s life span based on the project’s conditions; (2) the warranty and post-warranty services; (3) the existence of organizational conditions such as trained resources for sustainable use and maintenance of the equipment; (4) the existence of funds for maintenance and consumables; and (5) the existence of a plan for disposal of the equipment. the result of the assessment of the conditions during the life expectancy of the mds is an adequate lifelong use plan. advanced sustainability level: purchasing an md with a sustainable impact on the health service when implementing an md project, it is possible to broaden the framework approach to the national health service level by considering a targeted population and the entire national system of secondary and tertiary care infrastructure. in this broader vision, it is possible to achieve a wider needs analysis during the planning and implementation of a project to adjust the list of the equipment and their characteristics. some international procurement processes can be designed to target the population of an entire country so that the needs assessment of the project is focused virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context: part 1 background and definitions j global clinical engineering vol.5 issue 3: 2023 36 on the national healthcare services. in contrast, others are limited to infrastructures of specific regions or sites such as the equipment of a new health infrastructure. in an ideal international procurement project, the technical lead can include considerations on the impact of the purchase of mds on the entire national health service. in this case, it is recommended for the technical lead to open a dialogue with the national ministry of health counterpart and request access to consolidated and updated health statistical data. this represents a challenge since during the implementation of a procurement project, the pressure to comply with the schedule and the budget may limit these kinds of actions and considerations. higher sustainability level: purchasing mds to increase the sustainability of the health service the final level of sustainability definition includes the case when an mds procurement project’s objective is to increase the health service’s sustainability. since we are focusing on secondary and tertiary care, this means a more efficient and environmentally friendly way to provide care to patients through innovative technology. targeting the improvement of health services quality through advancing technical competencies, effectiveness, efficiency, continuity, and safety can be the primary objective of an mds procurement project.30 new technologies and innovation in the health processes following their introduction in the health service is a major theoretical subject that includes health technology assessment (which is not the focus of this paper). nevertheless, at least one specific aspect of introducing new technologies is worth underlying: the integration of medical equipment with information technology (it) systems.31 this interface is an aspect that deserves to be further discussed since it has several well-known clinical benefits and improves workflow and efficiency. it systems produce a large amount of data that can be used for future needs assessment. therefore, as a valuable side effect, the digitization of health services in developing countries will bring the decision-makers the data needed for evidence-based strategic investment decisions. projects that want to strengthen the sustainability of health services through medical technology procurement cannot be considered pure mds procurement since other soft components such as “change management” are essential for their successful implementation, which usually is spread over several years and requires a joint effort of the beneficiaries with the implementing agencies. conclusion there are different definitions of sustainability in md procurement within the un system. the definitions used by the four main agencies in health procurement (unicef, unops, who, and undp) are centered on environmental, social and economic sustainability, in the sense of the environmentally friendly quality of the md, the socially acceptable conditions of its production and its economic impact on local communities. nevertheless, the attention to the long-term use of a md is essential to its sustainability and will be achieved by considering aspects related to environmental, social, and economic development in addition to its impact on health services. selecting equipment that meets the beneficiary needs, the human resources capacities, and the local infrastructure conditions while considering its lifelong use brings to the health services much more benefits and is more sustainable than focusing only on the quality of the equipment itself. the technical lead in a procurement project is responsible for introducing and strengthening the analysis of the needs, the local conditions, and the conditions that can guarantee optimal use of the equipment during its lifespan. these analyses are the foundation that will guarantee a sustainable and efficient design of the equipment list, the technical specifications, the installation and training requirements, and the post-sales services, all in line with local conditions and capacities. no solution fits all. each md procurement project should be tailored to the local situation and the project’s framework. in an internationally funded project, the technical lead working for the implementation agency must establish a technical dialogue with the beneficiary to understand local needs and peculiarities and propose tailored solutions based on international sustainable standards adapted to the context. this technical dialogue is also a key factor for 37 j global clinical engineering vol.5 issue 3: 2023 virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context: part 1 background and definitions knowledge transfer and will strengthen the local technical capacities to plan new projects. once the needs assessment is completed, the project’s objective will be defined; therefore, all the effort during the implementation phase should be spent on keeping coherence with the specified objective. once the project is completed, measuring the impact of the md purchase on health services by determining how much of the project’s aim has been achieved will provide lessons learned to guide future purchasing projects. examples of ‘’outcomes performance indicators include cost effectiveness, compliance level, and client satisfaction and service leadership.’’32 considering a project’s critical factor (correlation between the invested amount of money and the impact on the healthcare system) means investigating the needs, planning the objectives, and quantifying the outcome. therefore, evaluating the project’s sustainability as the gain produced by its implementation is possible. a critical factor with a positive impact can be achieved by ensuring that the project’s objectives are built on the available country’s evidence data to reach a planned outcome that can be measured at the end of the project. this implies a deep technical dialogue with the local beneficiary and will enrich the beneficiary’s technical capabilities and the knowledge of the implementing agency about the local situation. the sdgs can therefore be achieved by maintaining a strict coherence between any project’s objective (or intended outcome) and the activities during its implementation. careful planning addressing sustainability issues before the execution of the project is a fundamental recommendation. still, in practice it often conflicts with the schedule and pressure to implement the project within a specific timeframe linked to the loan and political conditions. on the other hand, investments in capacity building, health technology management and infrastructure could significantly improve existing medical equipment efficacy in a sustainable way, saving the costs of production and shipping of new equipment.33 according to undp, “in order to preserve a healthy environment and human well-being, there is a recognized need to move away from overconsumption, waste and ecological harm”34 which is especially true and applicable in the context of md sustainable procurement. conflict of interest the authors declare no conflict of interest regarding the publication of this paper. references 1. united nations. the 17 goals | sustainable development. united nations. retrieved april 8, 2023. available at: https://sdgs.un.org/goals. 2. rasanathan k, diaz t. research on health equity in the sdg era: the urgent need for greater focus on implementation. int j equity health. 2016 dec 9;15(1):202. available at: https://pubmed.ncbi.nlm. nih.gov/27938374/. 3. diprete brown l, miller franco l, rafeh n et al. quality assurance of health care in developing countries. quality assurance methodology refinement series.1-33. available at: 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perry l, malkin r. effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? medical and biological engineering and computing. 2011. 49(7):719-722. available at: https://doi.org/10.1007/ s11517-011-0786-3 29. kaufman r, guerra-lópez i. needs assessment for organizational success. alexandria(va): astd press; feb 2013. 30. diprete brown l, miller wordo l, rafeh n et al. quality assurance of health care in developing countries. quality assurance methodology refinement series.1-33. available at: https://pdf.usaid.gov/pdf_docs/pnabq044.pdf. 31. huang, e. (2021). a multi-platform information management system of total life cycle for medical equipment. global clinical engineering journal, 4(1), 5–13. https://doi.org/10.31354/globalce.v4i1.78. 32. david y, jahnke e. g. (2018). planning medical technology management in a hospital. global clinical engineering journal, (1), 23–32. available at: https:// doi.org/10.31354/globalce.v0i1.23 33. perry l, malkin r. effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? medical and biological engineering and computing. 2011. 49(7):719-722. available at: https://doi.org/10.1007/ s11517-011-0786-3 34. lindstrom a, coronado-garcia l. sustainable health procurement guidance note. undp. march 2020. 1-62. available at: https://www.undp.org/publications/ guidelines-sustainable-procurement-healthcarecommodities-and-services https://doi.org/10.1007/s11517-011-0786-3 https://doi.org/10.1007/s11517-011-0786-3 https://pdf.usaid.gov/pdf_docs/pnabq044.pdf https://doi.org/10.31354/globalce.v4i1.78 https://doi.org/10.31354/globalce.v0i1.23 https://doi.org/10.31354/globalce.v0i1.23 https://doi.org/10.1007/s11517-011-0786-3 https://doi.org/10.1007/s11517-011-0786-3 https://www.undp.org/publications/guidelines-sustainable-procurement-healthcare-commodities-and-services https://www.undp.org/publications/guidelines-sustainable-procurement-healthcare-commodities-and-services https://www.undp.org/publications/guidelines-sustainable-procurement-healthcare-commodities-and-services 15 j global clinical engineering vol.3 issue 2: 2020 first publication in bmj qual saf as 10.1136/bmjqs-2020-012149 on 27 october 2020, publication on globalce journal: 10 november 2020 editorial: unravelling the magic of latent safety threats by y. david forensic engineering section, biomedical engineering consultants llc, houston, tx, usa. sterile processing errors in medical and dental offices are ranked the third highest hazard according to the annual ecri ‘top 10 health technology hazards’ 2020 report.1 other experts have raised similar concerns with sterilisation processes. for example, the who and the clinical engineering division of international federation of medical and biological engineering (ifmbe) have partnered to provide a series of webinars with international experts exchanging knowledge on covid-19 related critical topics. a recent webinar addressed the critical challenge of decontamination and disinfection of covid-19 medical equipment in low-income and middleincome countries.2 during the webinar, participants asked about methodologies to assess whether the transmission of infection is borne by technological tools used to fight the disease. how can critical lifesaving breathing equipment be safely and quickly sterilised and moved from one patient to the next? the who/ifmbe webinar2 stated that ‘engineers and infection control professionals seem to be working in different silos’. such silos must be dismantled because medical technology is indispensable in the provisioning of healthcare services. disinfection and sterilisation of medical equipment are key concerns for healthcare organisations, and they require serious consideration of sociotechnical system interactions. the annual ‘top 10 health technology hazards report’ is based on retrospective studies, yet management of covid-19 safety requires capacity to process realtime data and the input of experts to predict where risks may occur and how to deploy plans to maintain a safe healthcare environment. alfred et al3 in this issue of bmj quality & safety describe the sterile processing department (spd) as ‘an example of a socio-technical system, where people, procedure, technology, environment, and organization interact to produce a range of proximal and distal outcomes’.3 the goal of their study was to ‘develop a comprehensive understanding of the spd assembly work system by uncovering key relationships between system components, and the sources of variance that might influence reliable assembly in instrument reprocessing’. they explain their findings as a function of a variety of contributing factors including: technological, labelling and human capacity issues. the authors’ analysis cogently points to interventions ‘beyond the hospital’s traditional focus on individual staff ’. their results show the necessity of identifying system components and the impact of their interactions, to reveal appropriate interventions to improve the quality and safety of care and to reduce delays. the emphasis on expanding beyond ‘tradition’ is particularly pertinent now. safety is a dynamic non-event the rapidly evolving covid-19 epidemic has stretched the capacity of healthcare systems worldwide; consequently shining a light on existing quality and safety processes that often go unnoticed because, as karl weick advanced, safety is a dynamic non-event.4,5 safety is dynamic because processes remain within acceptable limits due to moment-tomoment adjustments and compensations by the healthcare workers. it is a nonevent because safe outcomes are taken for granted and often go unrecognised. paradoxically, the public appreciates quality and safety more when the system is unsafe, because lack of safety is salient, whereas normalcy is not. you do not have to look far these days to see how much more appreciation the public has for the quality and safety of healthcare. however, this level of interest—concern, really—has the risk of isolating the responsibility for healthcare safety and quality to the (relatively) small group of professionals who actually deliver healthcare. it is further presumed to be http://www.globalce.org http://globalce.org http://globalce.org https://qualitysafety.bmj.com/content/qhc/early/2020/10/26/bmjqs-2020-012149.full.pdf david: unravelling the magic of latent safety threats 17 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 16 david: unravelling the magic of latent safety threats products of compromised quality, safety and efficacy, in terms of poisoning, inadequate or no treatment, contributions to drug resistance, the related economic burden, and erosion of public trust in the health system; … urgent action is needed by the international community, member states and relevant actors in health systems… to develop appropriate norms, standards and guidelines, including taking into account national, regional and international needs and initiatives,… to prioritize support for establishing and strengthening regional and subregional networks of regulatory authorities… to promote the greater participation of member states in existing international and regional initiatives for collaboration and cooperation… to support the building-up of effective national and regional regulatory bodies and networks… to raise awareness of the importance of effective regulatory systems within the health system context’.10 in other words, system safety is dependent on coordination of all levels, not each level in isolation, and is a shared responsibility. interventions to address disinfection and sterilisation risks are dependent on the coordination of all stakeholders, including the public. as we begin to transform from fragility to vitality, this is the moment to convert the present heightened awareness into a strategy of education. together, we should adopt guidelines for incorporating healthcare technology life cycle management beyond the focal point of products entry into the market and expand it to include consideration of the entire healthcare technology life cycles. from ideation to obsolescence, healthcare technology should be benchmarked at every stage based on indicators that every member including the public can understand, relate to and embrace as measure of minimum acceptable performance level for safety and quality. this will include the public, who for example may begin using home-based medical technology more than ever, in gaining participation to make care decisions. every segment of care providers will now have tools to assess the whole life cycle of medical products from installation, performance assurance, upgrades, reallocation and retirement from one market to another. regardless of the reasons that led to relegating the quality and safety role only to those professionals who were formally tasked with it, we must embrace the strategy to expand the responsibility to the public. instead of a single product mentality, let us challenge our ability to measure and embed predictive preventive measures of system performance. critical characteristics of safety and quality management can be used to measure and mitigate latent risks and can be used to rank healthcare delivery and provide a ‘report card’ that can enhance choices the public can make. i suggest, therefore, a call for action to establish national institutions and international cooperation that will promote and harmonise safety and quality indicators relating to technological tools being deployed in our healthcare delivery systems. no more magic show. funding the authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. competing interests none declared. patient consent for publication not required. provenance and peer review commissioned; internally peer reviewed. acknowledgement the globalce journal acknowledges the permission given from bmj quality and safety to post this editorial. references 1. emergency care research institute (ecri). top 10 health technology hazards for 2020. expert insights from health devices. special report, 2019. available: https://www. ecri.org/landing-2020-top-ten-healthtechnology-hazards [accessed sep 27]. 2. international federation of medical and biological engineering (ifmbe). online course 7. decontaminationdisinfection of critical covid-19 equipment, health workers, and patients. available: https://ced.ifmbe. org/covid19/guruprograms/16-covid19/16-covid19townhalls-decontamination.html [accessed sep 27]. 3. alfred m, catchpole k, huffer e, et al. work systems analysis of sterile processing: assembly. bmj qual saf 2020:bmjqs-2019-010740. 4. weick ke. organizational culture as a source of high reliability. calif manage rev 1987;29:112–27. 5. reason j. safety paradoxes and safety culture. inj control saf promot 2000;7:3–14. 6. zhang j, li j, wu z. the chinese experience fighting against covid-19, shanxi medical engineers. global clinical engineering journal 2020;2:35–8. 7. alfred m, catchpole k, huffer e, et al. work systems analysis of sterile processing: decontamination. bmj qual saf 2020;29:320–8. their job to teach and apply medical, engineering and other scientific knowledge to improve the quality and safety of everything related to the healthcare services. however, we now realise that these presump tions need to be examined. recent global conditions have demonstrated that national emergency response plans and the stocking of medical supplies fell short of expectations. yet with the inclusion of experts specifically trained in safety and quality, these plans are already better networked with the supply chain that is being designed to be patient ready when urgently needed. similarly, safety and clinical engineers were finally permitted to use ultraviolet radiation as sterilisation technology in patient care spaces. ultraviolet radiation is not a new tool, but it is now applied because of expert recommendations and consequently it now plays an important role in protecting medical personnel, patients and family members.6 all of this begs the question: why has covid-19 spurred recognition on the part of the public, and by medical professionals, of safety and quality controls in the delivery of healthcare? pandemics highlight the existing people and processes that keep our systems safe and the fact that these elements of our system are not failsafe. there are threats in the system that remain latent because people are dynamically adapting in real time, but when the system is stretched too far, the threats no longer remain dormant. deploying a predictive model of quality and safety, with professionals specifically trained in these areas, will be impactful to show in which scenarios such threats are likely to appear and can be timely mitigated. understanding what keeps our systems safe without sufficient knowledge of what protects us, the ambiguous methodology for optimal provisioning of staff and patient safety was initially like performing magic. starting with the elderly community and later with all ages, it has been like watching a houdini act—how did that illusion which we were watching just happen? will it happen again? as noted above, we need to re-examine the presumptions we hold about delivering safe and high-quality healthcare services. once we understand the latent threats in the system, these can become controllable features. what appears to be magic is anything but. there are many system factors at play—people, processes and technologies— that are keeping us safe, but they require further attention if they are to remain safe under unprecedented conditions. neither safety nor quality seems to have kept up in the rush to find an effective response to the pandemic. whose job is it to keep up? as pointed out by alfred et al3 regarding the instrument assembly process and a previous paper on the decontamination of instruments7 if we fail to identify all the system factors and their interactions, we fail to understand what keeps our systems safe. consequently, we make assumptions about the backbones of our system, and when the system reaches its breaking point, we jump to solutions that are not aligned with the true root cause of the problem because we do not understand the mechanisms that underlie the safe operating state. previous examples regarding problems with instrument reprocessing have already pointed to the lack of understanding on the systems factors at play that led to poor solutions. for instance, i participated in an investigation in 2005 following the exposure of patients during surgeries in duke university health system, to instruments that were processed between procedures in hydraulic fluid instead of cleaning detergent.8 the hospitals did not detect the problem for weeks, despite complaints from staff members that the instruments felt unusually slick. the mix-up occurred when an elevator company drained hydraulic fluid into empty detergent barrels and the detergent supplier mistakenly redistributed them. the covid-19 pandemic has emphasised the importance of decreasing instrument contamination risks9 as well as a general sense of urgency that may impose the risk of jumping to solutions too quickly. it is important to note that these latent safety threats have been there all along, but we are just noticing them more now than before because some of them are no longer latent. it was never magic; it was always the steady and adaptive coping of system factors—mostly people in the background—that never got recognised. people around the world are now more clearly recognising their own responsibility and the benefits of adopting a more safety-oriented culture in their personal lives as well as in the products they use. the respect of paying homage to safety reached such a high awareness that one must again wonder, why did it take a global devastating pandemic to bring us to this level? and can the same be stated about quality? urgent need to implement appropriate solutions for sociotechnical problems alfred et al3 in their analysis of sterile processing already pointed to the need ‘for a wider range of interventions to enhance system performance beyond the hospital’s traditional focus on individual staff behaviours and motivations’. system safety is thus dependent on the coordination of healthcare staff and management at the front line of service deliveries with the manufacturers who produce medical products, regulatory bodies and government who monitor its introduction into the market and clinical engineers who manage it over its life cycle use. this was acknowledged and highlighted by the 67th world health assembly when they issued a declaration in 2014 that states, in part, ‘[c]oncerned by the impact on patients of medical ecri.org/landing https://ced.ifmbe.org/covid19/guruprograms/16-covid19/16-covid19-townhalls-decontamination.html https://ced.ifmbe.org/covid19/guruprograms/16-covid19/16-covid19-townhalls-decontamination.html https://ced.ifmbe.org/covid19/guruprograms/16-covid19/16-covid19-townhalls-decontamination.html david: unravelling the magic of latent safety threats j global clinical engineering vol.3 issue 2: 2020 18 8. the new york times. surgical tools 'washed' in hydraulic fluid. available: https://www.nytimes. com/2005/06/13/us/ surgical-tools-washed-inhydraulic-fluid.html 9. aj b, brown c, abdelrahman t, et al. international surgical guidance for covid-19: validation using an international delphi process cross-sectional study. int j surg 2020;79:309–16. 10. world health organisation. regulatory system strengthening for medical products. sixty-seventy world health assembly, 2014. available: https://apps.who.int/gb/ ebwha/pdf_files/ wha67/a67_r20-en.pdf?ua=1 [accessed sep 27]. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. https://www.nytimes.com/2005/06/13/us https://www.nytimes.com/2005/06/13/us surgical-tools-washed-in-hydraulic-fluid.html surgical-tools-washed-in-hydraulic-fluid.html https://apps.who.int/gb/ebwha/pdf_files https://apps.who.int/gb/ebwha/pdf_files a67_r20-en.pdf https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.5 issue 1: 2022 8 received march 26, 2021, accepted april 21, 2022, date of publication may 16, 2022 comparison of automatic sleep stage classification methods for clinical use by alexei labrada, elsa santos febles, josé manuel antelo cuban neuroscience center (cneuro), cuba abstract sleep stage scoring is necessary for diagnosing several sleep disorders. however, it is an intensive and repetitive task and a vital automation candidate. this work seeks to evaluate different kinds of machine learning based classification algorithms available in the scientific literature to determine which one fits better the clinical practice requirements. the comparison is made with a predefined experimental design, using electroencephalography, electrooculography, and electromyography signals from the polysomnographic records of the sleep-edfx dataset. the comparison considers the accuracy and speed of algorithms based on linear discriminate analysis, support vector machines, random forests, and artificial neural networks. the latter group includes the deep neural networks deapfeaturenet, based on convolutional neural networks, and deepsleepnet, additionally based on recurrent neural networks. it is determined that several of the tested algorithms boast high accuracy levels (85%). from them, deepsleepnet is chosen as the fittest due to its considerable advantage in execution time. nevertheless, the final result should always be reviewed by the experts. keywords – polysomnography, sleep stage scoring, machine learning, deep learning, signal processing. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction sleep stage scoring is necessary for diagnosing several sleep disorders, including insomnia, sleep apnea, narcolepsy, and hypersomnia. according to the american academy of sleep medicine (aasm), this operation entails the division of a polysomnographic record (psg) in consecutive 30-second windows, called epochs. each epoch has to be classified as wakefulness (w), rem sleep (r), or one of three non-rem sleep stages: n1, n2, or n3. * additionally, aasm defines the rules that have to be followed to perform the scoring based on the visual examination of each epoch of the psg record. a psg record shows the behavior throughout the time of various electrophysiological signals. the three most http://www.globalce.org http://globalce.org http://globalce.org 9 j global clinical engineering vol.5 issue 1: 2022 labrada, febles, antelo : comparison of automatic sleep stage classification methods for clinical use important signals are (1) electrical activity in the cerebral cortex, measured using electroencephalography (eeg); (2) in the face muscles, using electromyography (emg); and (3) the eye movements, using electrooculography (eog). it may also include the cardiac activity or electrocardiogram (ecg), the respiratory activity, and the body movements. the scoring rules rely on identifying various patterns in the signals, including the alpha, beta, theta, and delta activity, k complexes, spindles, rem, and sem.** table 1 summarizes some of these patterns. table 1. common patterns in polysomnographic signals pattern stage signal frequency morphology alpha activity w, n1 eeg 8 13 hz beta activity w, n1, r eeg 14 30 hz theta activity nrem, r eeg 4 8 hz delta activity n3, r eeg 0.5 4 hz spindle n2, n3 eeg 12 14 hz k complex n2, n3 eeg 0.5 1.5 hz biphasic high amplitude peak slow waves n3 eeg 0.5 2 hz high amplitude waves eeg = electroencephalography. the psg records may last for 8 hours, so the number of epochs is close to a thousand. therefore, the scoring process is intensive, repetitive, and prone to errors. the scientific literature describes many algorithms that allow the automation of the process by using various machine learning techniques. however, the low inter-scorer agreement level,1,2 among other limitations, has limited the accuracy of the algorithms and, hence, the reach of the automation process. for instance, fraiwan et al. 3 use the continuous wavelet transform of the eeg signals as features and a linear discriminant analysis (lda) based classifier. as a result, they reach an 84% accuracy level with the mit-bih4,5 dataset records. susmakova & krakovska6 also use an lda-based classifier, but their algorithm extracts a wider variety of features from different signals. furthermore, they prove the importance of the information contained within the eog and emg signals to discriminate some of the stages. koley & dey7 evaluate the performance of a support vector machine (svm) based classifier with different combinations of features. their algorithm has an 89% accuracy on their own dataset, close to the inter-scorer agreement level. aboalayon et al.8 also use an svm classifier, reaching a 92.5% accuracy on records from the sleep-edf5,9 dataset. set et al. 10 compare the performance of different classifiers, including decision trees (dt), random forests (rf), svm, and artificial neural networks (ann). moreover, they employ various feature extraction techniques, counting the discrete wavelet transform (dwt). as a result, they determine that the rf obtains the best results, reaching a 97% accuracy with their own records. finally, aboalayon et al.11 compare the dt, svm, ann, k-nearest neighbors, naive bayes (nb), and lda classifiers. in their work, the dt classifier obtained the best results with a 93% accuracy on records from the sleep-edf dataset. finally, the deep learning techniques also have gained a foothold in sleep stage scoring. for example, zhang et al.12 propose using a recurrent neural network (rnn) as a classifier but using conventional feature extraction methods. their algorithm reaches 80.25% accuracy on the shhs5 dataset records. alternatively, yildirim et al.13 present a convolution neural network-based algorithm that uses convolutional layers for feature extraction, with a 91% accuracy on sleep-edf records. additionally, supratak et al.14 use a convolutional neural networks (cnn) combined with an rnn, reaching an 82% accuracy on the same records. the goal of this work is to select a sleep stage scoring algorithm to facilitate the work of the experts. furthermore, the algorithm should be included in a software system j global clinical engineering vol.5 issue 1: 2022 10 labrada, febles, antelo : comparison of automatic sleep stage classification methods for clinical use for the clinical analysis of polysomnographic records. therefore, the selection should be based on the accuracy of the predictions and consider execution time and the general availability of the input data. with that in mind, the performance of several algorithms from the scientific literature will be compared using the same records and in similar conditions. materials the work uses psg records from the sleep cassette dataset belonging to sleep-edfx.5,9 the dataset has 153 subjects between 25 and 101 years old and was scored by several experts following the rechtschaffen and kales (r & k)15 rules. the records include two eeg and one eog signal, samples at 100 hz, and one emg signal at 1 hz. both eog and emg signals are considered in this work, but only the fpz-cz channel is used from the eeg signals. that way, all the implemented algorithms depend only on the minimum parameters of any psg record.1 the dataset is split into two parts of approximately the same number of records. the first half contains the subjects with identifications 00 through 38 and is reserved for training the scoring algorithms. the second one, with subjects 40 through 82, is used to evaluate and compare the performance of said algorithms. methods the analyzed algorithms’ execution time can be split into three main phases: data preprocessing, feature extraction, and classification. the preprocessing and feature extraction phases are implemented in the python and c# programming languages. for the classification, the work additionally employs the weka software system16,17 from the university of waikato, new zealand. preprocessing the goal of the preprocessing phase is to prepare the data for the feature extraction phase. to achieve it, all signals are uniformly sampled at 100 hz, and no digital filtering is applied beyond what is already included in the dataset: 0.5 to 100 hz range for eeg and eog and 0.7 to 16 hz, for emg. the records are segmented in 30-second windows that match the epochs that will be classified later. also, the third and fourth non-rem sleep stages from r & k are combined into one slow wave sleep or n3 stage1,7 to fit better the aasm stages. additionally, the unknown or invalid sleep stages are excluded from consideration. the wake stages before the first and posterior to the last sleep stages are also excluded from the training dataset records. the latter operation reduces the disparities in the amounts of epochs classified with each sleep stage. besides, more importantly, for the rnn classifiers, it does not affect the continuity of a record’s epochs. feature extraction the feature extraction phase obtains descriptive values that reflect the information inside the relevant signals for the classification process. the values or features used in this work are obtained by analyzing the signals in each epoch in the time domain, frequency domain, time-frequency domain, and other nonlinear means. descriptive statistics these features are obtained by computing descriptive statistics from the signal’s samples. the mean, variance, kurtosis, skewness, and 75th percentile have been employed in this work. entropy entropy is a measure of the irregularity of a signal in the time domain.18 equation 1 shows the formula proposed by shannon for this measure: where p(x_i ) is the probability of a signal sample having the value x_i. other estimation methods, including the approximate entropy, are displayed in equation 2. the values of ϕ can be obtained using an algorithm that represents the signal in the phase domain xi={xi, x(i+1), ..., x(i+(m-1)) } and calculates the distance between those patterns using the l1 norm. then, (1) (2) 11 j global clinical engineering vol.5 issue 1: 2022 labrada, febles, antelo : comparison of automatic sleep stage classification methods for clinical use where is the amount of xj patterns that satisfy ∥xi-xj ∥1≤r. in this work, the pattern length (m) is 2 and r is the standard deviation of the signal in the epoch, multiplied by 0.1, as estimated in.18 largest lyapunov exponent the largest lyapunov exponent (lle) indicates how unpredictable a signal is. it has been demonstrated that it can help discriminate the n1 and n2 stages.7 the algorithm proposed by19 allows estimating lle by calculating the distances between the most similar trajectories, which are also distant in the time domain. equation 4 describes this distance, where τ is the threshold in time domain and xi={xi, x(i+j), ..., x(i+(m-1)j)} is a trajectory in phase domain. once the distances have been calculated, the lle can be obtained using linear regression with equation 5. in our work we use the values 10 and 7 for m and j, respectively, while τ is the mean period of the signal (mnf-1). fractal dimension the fractal dimension estimates the fractional dimensions of the geometric shape of a signal in the time domain.18 this measure is especially useful for recognizing the n3 stage.7 the higuchi algorithm calculates the fractal dimension as the slope of the mean squares fit of the values of log(l(k)) against log(1/k) for k between 1 and kmax. the values of l(k) are calculated using the equation 6: where lm(k) is the mean length of the sequence calculated with equation 7: in this work we use the value 40 for kmax, that was estimated in.18 discrete fourier transform the fast fourier transform (fft) algorithm efficiently estimates the frequency spectrum. the spectrum can be used to obtain the mean frequency of the signal, the spectral entropy, and the relative spectral density of the relevant frequency bands (table 1). the mean frequency can be calculated using equation 8: where m in the amount of frequency bins, fi are the frequency values and p is the normalized spectral frequency (∑pi=1).20 similarly, the spectral entropy of a frequency band can be obtained from equation 9: where fl and fh are the minimum and maximum frequencies, respectively and nf is the amount of frequency bins in the range [fl,fh].18 high order spectra the high order spectra analysis can extract features related to third-order statistics of a signal.21 before calculating the features, the bispectrum has to be estimated using equation 10, (3) (4) (5) (6) (7) (8) (9) j global clinical engineering vol.5 issue 1: 2022 12 labrada, febles, antelo : comparison of automatic sleep stage classification methods for clinical use where xi is the short-time fourier transform (stft) of the signal on the i-th window and w is the number of windows. the stft in a vicinity of xi is the fft of the product of the signal and a window function centered on xi. 22 in our work, we use 2 seconds long haan windows, with 1 second (50%) of overlap between consecutive windows. the bispectrum is symmetric in both axes, so its domain of interest is defined in the expression 11. once the bispectrum is calculated, it is possible to calculate its mean amplitude, the normalized bispectral entropy (equation 12), its logarithmic sum (equation 13) and its mean frequency (equation 14): wavelet transform the wavelet transforms translate a signal into the time-frequency domain. the transformation approximates the signal inside a time window by a wavelet base (ψ) using different time scales.22 the scale factors are inversely proportional to the frequency of the wavelet base, as stated in equation 15, where ts is the sampling period and fψ is the mean frequency of the wavelet base (3). the dwt decomposes the signal in two coefficient vectors with n/2 values, satisfying where hψ and gψ are dual filters with sub-sampling, related to the wavelet base.22 the a1 vector contains an approximation of the original signal in the frequency range [0,1/4 fs ], while d1 is a detail vector in the frequency range [1/4 fs,1/2 fs ], where fs is the sampling frequency.10 the dwt can be computed again from vector a1, in order to obtain the vectors a2 and d2 with frequency ranges [0,1/8 fs ] and [1/8 fs,1/4 fs ], respectively. thus, successively, the signal can be decomposed in l levels, after which the vectors d1,d2,...,dl,al belong to different frequency bands. the entropy of each relevant frequency band (table 1) along the epoch in question can be calculated from the transform. we use the daubechies function (db1) as the wavelet base for the eog signals and the reverse biorthogonal function (rbio3.3) for the eeg signals. given the 100 hz sampling frequency of the signals, once they are decomposed into 5 levels, the frequencies of the coefficient vectors approximately match the frequency bands in table 1. classification the classification phase is responsible for assigning a sleep stage to each epoch contingent on the features extracted from it. in our work, we use classifiers based on linear discriminate analysis,3 svms,23 rf,23,24 ann, and nb.23 several kinds of neural networks have been analyzed, including multilayer perceptrons (mlp),10,25 cnn, and rnn. specifically, we have tested the networks deepfeaturenet (dfn) and deepsleepnet (dsn),14 implemented on python using tensorflow. the former is a cnn, while the latter is a hybrid network combining a cnn and an rnn. both algorithms use cnn for feature extraction, so they do not require the methods described in section feature extraction. the implementation proposed for a single signal has been expanded to process the eog, emg, and eeg signals.14 this was achieved by taking advantage of the (10) (11) (12) (13) (14) (15) (16) 13 j global clinical engineering vol.5 issue 1: 2022 labrada, febles, antelo : comparison of automatic sleep stage classification methods for clinical use capacity of cnn layers to process several input channels and by increasing the size of the filters proportionally to the number of channels. the dfn network has been trained with 75 epochs, while dsn has required 25 more in fine-tuning. the source code is available at https:// github.com/alabrada/deepsleepnet. for the remaining classifiers, it has been used the implementations available in weka, using their respective default parameters. evaluation the performance of each algorithm has been analyzed, considering the accuracy (acc) and cohen’s kappa coefficient. additionally, the classification performance of the individual stages is considered using the precision (pr) and recall (re) metrics. results the classification algorithms have been trained with the first half of the psg records of the sleep cassette dataset. the set has 76 records that belong to 39 different subjects with identifiers 00 through 38. table 2 shows the distribution of the stages assigned by the experts to the 74354 epochs that have been used from those records. the 10-fold cross-validation technique has been used to estimate the hyper-parameters of the models and the validation error. table 3 shows the estimated errors. the trained classifiers have been tested using the second half of the sleep cassette dataset, and the results have been compared. the set has 77 records that belong to 39 subjects with identifiers 40 through 82. a total of 68.8% of the 208349 epochs belong to the wake stage. table 2. sleep stage distribution of the analyzed epochs stage training testing (partial) testing (full) count percent count percent count percent w 14884 20.0 33410 33.9 143265 68.8 n1 7536 10.1 14013 14.2 14013 6.7 n2 30143 40.5 33906 34.4 33906 16.3 n3 7954 10.7 5104 5.2 5104 2.4 r 13837 18.6 12062 12.2 12062 5.8 total 74354 100.0 98495 100.0 208349 100.0 table 3. validation error using the training records type acc kappa pr re w n1 n2 n3 r w n1 n2 n3 r lda 77.29 0.6882 0.902 0.438 0.775 0.817 0.785 0.804 0.398 0.869 0.843 0.695 nb 64.79 0.5324 0.748 0.320 0.738 0.507 0.659 0.689 0.249 0.668 0.925 0.619 rf 83.09 0.7674 0.868 0.623 0.830 0.896 0.822 0.904 0.365 0.906 0.863 0.825 svm 79.49 0.7155 0.858 0.501 0.788 0.872 0.787 0.867 0.286 0.894 0.848 0.745 mlp 80.60 0.7334 0.883 0.515 0.808 0.867 0.790 0.874 0.342 0.885 0.838 0.794 dfn 74.27 0.6630 0.969 0.287 0.883 0.652 0.822 0.789 0.692 0.721 0.912 0.658 dsn 78.10 0.7055 0.906 0.326 0.854 0.756 0.911 0.901 0.427 0.812 0.726 0.817 avg 76.80 0.6865 0.876 0.430 0.811 0.767 0.797 0.833 0.394 0.822 0.851 0.736 https://github.com/alabrada/deepsleepnet https://github.com/alabrada/deepsleepnet j global clinical engineering vol.5 issue 1: 2022 14 labrada, febles, antelo : comparison of automatic sleep stage classification methods for clinical use following the procedure that has been described in section preprocessing, the disparity between stages can be decreased by reducing this quantity to the 33.9%. table 4 shows a performance comparison between the algorithms using only the selected epochs, while table 5 shows the same comparison, but with all the epochs. finally, table 6 compares the execution time of the algorithms while classifying the whole test dataset. the execution time of the algorithms that use classifiers implemented in weka is further split into the feature extraction and classification phases. the data has been collected in a personal computer with an intel core i5-4570 processor (cpu), 16 gb of ddr3-1600 memory (ram), and executed in microsoft .net framework. discussion the results show that the test error is less than the validation error when using the full records, but it is greater when using the selected subset of the epochs. this apparent discrepancy can be explained due to the previously mentioned high proportion of epochs classified with wake stages. every one of the analyzed algorithms obtains relatively high precision and recall results classifying this stage. in contrast, all algorithms attain poor precision and recall results that classify the n1 stage in absolute and relative terms. this behavior is consistent with other studies from the scientific literature,24 especially those table 4. performance comparison of the classifiers using the partial test dataset type acc kappa pr re w n1 n2 n3 r w n1 n2 n3 r lda 69.43 0.5776 0.911 0.385 0.664 0.465 0.723 0.759 0.279 0.840 0.752 0.563 nb 55.09 0.4109 0.841 0.329 0.594 0.241 0.555 0.604 0.231 0.582 0.954 0.515 rf 73.98 0.6335 0.858 0.504 0.692 0.637 0.737 0.853 0.183 0.887 0.756 0.652 svm 72.93 0.6213 0.866 0.433 0.697 0.591 0.718 0.842 0.215 0.863 0.774 0.619 mlp 71.22 0.6009 0.817 0.399 0.724 0.558 0.682 0.856 0.244 0.784 0.770 0.634 dfn 67.78 0.5670 0.968 0.303 0.743 0.517 0.898 0.697 0.640 0.734 0.776 0.454 dsn 73.88 0.6308 0.864 0.347 0.772 0.812 0.959 0.894 0.419 0.744 0.553 0.675 avg 69.19 0.5774 0.875 0.386 0.698 0.546 0.753 0.786 0.316 0.776 0.762 0.587 table 5. performance comparison of the classifiers using the full test dataset type acc kappa pr re w n1 n2 n3 r w n1 n2 n3 r lda 83.45 0.6804 0.981 0.340 0.644 0.429 0.655 0.913 0.279 0.840 0.752 0.563 nb 69.02 0.4682 0.966 0.222 0.504 0.197 0.380 0.766 0.231 0.582 0.954 0.515 rf 86.43 0.7263 0.966 0.466 0.666 0.622 0.711 0.947 0.183 0.887 0.756 0.652 svm 85.73 0.7147 0.969 0.382 0.679 0.563 0.675 0.942 0.215 0.863 0.774 0.619 mlp 85.10 0.699 0.955 0.347 0.709 0.532 0.666 0.947 0.244 0.784 0.770 0.634 dfn 80.14 0.6366 0.991 0.270 0.687 0.415 0.879 0.862 0.579 0.774 0.772 0.432 dsn 85.30 0.6973 0.953 0.318 0.773 0.812 0.967 0.970 0.537 0.688 0.442 0.474 avg 82.17 0.6604 0.969 0.335 0.666 0.510 0.705 0.908 0.324 0.774 0.746 0.556 15 j global clinical engineering vol.5 issue 1: 2022 labrada, febles, antelo : comparison of automatic sleep stage classification methods for clinical use using the sleep-edfx dataset.13,14,26–28 the dfn and dsn algorithms reach around 20% higher recall measures for this stage, but its influence is mitigated by lower values in other stages. the low classification accuracy of the n1 stage can affect the result of the sleep quality analysis,29 which makes the algorithms unsuitable for standalone usage and, thus, require the intervention of the experts. from the first five algorithms, the ones using more conventional strategies, the rf-based classifier obtains the best results. this confirms the conclusions that were reached by previous studies.10,30 furthermore, svm, mlp, and lda also obtain satisfactory results according to both performance metrics. from the two last algorithms based on deep learning, dsn reaches superior results in all metrics other than dfn. however, during validation, our implementation of dsn is 4% lower in accuracy and 6% lower in kappa score than the one reported by supratak et al.14 with the same dataset, but using different hyper-parameters and half of the psg records. regarding the traditional algorithms, the accuracy of dsn classifying the test dataset is equivalent to the accuracy of rf within 1%. considering that several of the algorithms reach similar accuracy levels, their execution times are used as tie-breakers. the results in table 6 prove that, from the analyzed algorithms, the ones based on deep learning require a significantly lower amount of time to identify the sleep stages of a psg record. conclusions as part of our work, we have compared the performance of a wide range of sleep stage scoring algorithms available in the scientific literature to find the one that better matches clinical use requirements. with that in mind, accuracy and speed are used as the selection criteria for the comparison. the results prove that the rf, svm, mlp, and dsn algorithms reach the greater accuracy levels while classifying, exceeding 85% in this metric and 0.69 in cohen’s kappa. moreover, from them, dsn is significantly faster, requiring less than 30 seconds to score a record’s epochs on average. the combination of both criteria determines that dsn is the most appropriate sleep stage scoring algorithms for the context of the clinical practice, from the set of candidates taken into consideration. nevertheless, the algorithms are much less accurate in classifying the n1 stage, so the experts should review the sleep stage scoring performed by dsn. references 1. malhotra rk, avidan ay. atlas of sleep medicine. in: 2nd ed. elsevier; 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https://doi.org/10.1016/j.cmpb.2011.11.005 https://doi.org/10.1016/j.cmpb.2011.11.005 https://doi.org/10.1016/j.smrv.2011.06.003 https://doi.org/10.1109/tnsre.2017.2733220 https://doi.org/10.1109/tnsre.2017.2733220 http://arxiv.org/abs/1811.10111 http://dx.doi.org/10.1371/journal.pone.0216456 http://dx.doi.org/10.1371/journal.pone.0216456 https://doi.org/10.1109/access.2019.2900345 https://doi.org/10.1109/access.2019.2900345 https://doi.org/10.1016/j.cmpb.2016.12.004 j global clinical engineering vol.6 issue 1: 2023 46 received september 15, 2023, accepted november 28 2023, date of publication december 10, 2023 internet of things and digital twin technology-based management system of medical equipment by wanrong liu, bin li, zhiyong ji shanghai sixth people’s hospital affiliated to shanghai jiao tong university school of medicine, shanghai 201306, china abstract background: in recent years medical technology has progressed with the rapid development of medical services and required optimization of medical equipment. however, a lack of effective management methods has led to the inefficient use of medical equipment. therefore, an effective medical equipment management mode is urgently needed to address these problems and challenges. methods: the internet of things and digital twin technology are applied to intelligent medical equipment management as the current standard of medical equipment management. results: the intelligent perception terminal can realize the dynamic acquisition of real data, such as the location, process, and efficient use of medical equipment, and help carry out digital, networked, and intelligent monitoring and analysis. meanwhile, applications such as dynamic management software, real-time positioning software, and space-environment quality monitoring software are being developed. conclusion: automatic, intelligent, and visual management of medical equipment configurations, operations, and performance evaluation, combined with good management based on digital twinning, can improve collaborative management efficiency and operation resource support. keywords – internet of things, medical equipment, digital twin technology. copyright © 2023. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 47 j global clinical engineering vol.6 issue 1: 2023 wanrong liu, bin li, zhiyong ji: internet of things and digital twin technology-based management system of medical equipment introduction throughout the past, the history of human society is a history of struggle between human beings and diseases. from blood-letting therapy in ancient times to modern medicine based on scientific experiments, the health industry has gradually become an incredibly complex system with deep integration of multiple sectors. new technologies such as cloud computing, big data, artificial intelligence, 5g, biotechnology, and detection-based technology continue to develop and mature, and the intelligent modern health industry, based on new technologies, is booming with increasingly high requirements for rational allocation of medical equipment. at a time when the quality of information provided by medical device management is poor and facing many challenges, the internet of things (iot) improves the ability to transfer important healthcare data in the new century. however, most existing hospitals have adopted iot technology to track patients’ health status, and there is a lack of understanding of the use of iot technology for medical equipment management. secondly, a hospital’s nature determines that medical equipment use may change at any time, so an effective dynamic management mode for medical equipment use is urgently needed.1 medical equipment is the core component of medical resources and is very important to the quality of medical service and the health protection of the people. intelligent management of medical equipment resources plays a crucial role in the scientific and effective rational allocation of medical equipment resources.2 traditional medical equipment management has the following pain points and difficulties3: 1. the rapid development of technology has led to a wide range of equipment, clinical needs, users, supervisors, and management personnel involved in the equipment’s use and allocation; 2. the location and ownership of medical equipment are scattered, which leads to inconsistency between the physical object and their recorded use. 3. the overall level of medical equipment asset management in most hospitals is weak due to the monopoly of technical data of imported products, a lack of real-time management information, insufficient allocation of professional personnel, and an emphasis on procurement over maintenance; 4. the long product cycle of medical equipment and heterogeneous and complex types of information systems and data sources make it impossible to develop accurate and dynamic statistical analyses of medical equipment data configuration and use benefit, efficiency, and effect. some hospitals have affixed asset bar codes to medical equipment, reducing labor intensity to a certain extent and improving efficiency. however, problems, such as difficulty in accurately positioning equipment, the overallocation of equipment, and untimely deployment, lead to low work efficiency and high error rates. hospital managers face a difficult problem in breaking through the bottleneck of extensive traditional manual management. the development of 5g, iot, mobile internet, industrial internet, and other technologies has provided technical support for the refined management of medical equipment and new solutions for intelligent management.4-7 medical equipment exists as “things,” iot is a self-information expression and management method based on “things” itself. the earliest idea for the “digital twins” is an “information mirroring model,” named by michael grieves of the university of michigan, also known as digital mapping. in 2012, the national aeronautics and space administration gave the concept description of digital twinning: digital twinning refers to integrating multi-disciplinary and multi-scale simulation processes by fully using physical models, sensors, operation history, and other data. as the mirror image of the physical product in the virtual space, it reflects the “whole life cycle process” corresponding to the physical product. in 2021, pylianidis et al. pointed out that digital twins are being adopted by increasingly more industries, transforming them and bringing new opportunities.8 to summarize, a digital twin is a dynamic digital clone created for one or more devices or systems.9 it is possible to use iot and digital twin technology to help managers manage medical equipment. this paper discusses a medical equipment management system based on iot and digital twin technology. the overall technical design architecture includes 5g networking, cloud on medical equipment asset data, and wanrong liu, bin li, zhiyong ji: internet of things and digital twin technology-based management system of medical equipment j global clinical engineering vol.6 issue 1: 2023 48 medical operation support resource coordination management platform based on spatial digital twin. promote the development of medical equipment management in the direction of intelligence and automation. this management system has been tested in practice during the covid-19 pandemic, which has infected many people worldwide and overwhelmed healthcare systems. life support equipment is important as the “main force” of this outbreak. use the medical equipment management mode based on iot and digital twin technology to grasp the use of life support equipment in real time, including but not limited to airvo series respiratory humidifiers, ecg monitors, and other medical equipment. therefore, the life support equipment of clinical departments is coordinated and deployed, providing a sound decision-making basis for the rational allocation of medical equipment and greatly reducing equipment redundancy. methods to solve the problem of efficient hospital medical equipment management. we will fully use 5g and iot, combining mobile internet, big data, and cloud computing. a smart management platform for medical equipment in the iot has been built.10 the overall technical design architecture includes 5g networking, cloud on medical equipment asset data, and a medical operation support resource coordination management platform based on spatial digital twinning, as shown in figure 1. first, the equipment state perception terminals and space environment quality perception terminals are used to complete the field big data acquisition. then, equipment networking can be achieved through bluetooth, wifi, cable networks, and other hybrid networking technology. a communication connection is established with the cloud management platform through 5g technology to complete massive data interaction. different data acquisition models are considered for different types of medical equipment. the data acquisition model completes training and iterative optimization on the platform side and is dynamically delivered to the edge node. the edge node applies the acquisition model to complete data acquisition and upload. after that, it connects the management platform, the device management platform, and the data distribution, storage, and computing platform. it provides users with dynamic management software, real-time positioning software, space environment quality monitoring software, and other applications. realize the intellectualization of resources, information sharing, and interconnection. finally, the sharing and collaboration between the mobile and computer ends are realized through the innovative use of digital twin technology in hospital buildings, equipment, other physical and virtual processes, and mechanism modeling. the index system of multiple dimensions is integrated and presented allowing managers to make decisions. 5g networking scheme 5g combined network scheme as the primary support for application exploration. realize the operation data acquisition of hospital equipment assets with ultra-high frequency and large data volume. the algorithm system is trained on this basis. with the help of 5g technology, the application value in medical scenarios can be jumped. as shown in figure 2. it is deployed in band, protected band, and independent cellular network carriers with very small bandwidth. give full play to the mature technological advantages of narrowband iot, including strong flexibility and adaptability, low power consumption, wide coverage, multi-connection, and low cost. realize the dynamic management of hospital equipment assets, location, emergency management, and other applications. with edge computing, all data generated by the terminal need not be uploaded to the cloud data center. instead, edge nodes deployed at the network’s edge and process it quickly. dynamic recognition of equipment state is carried out by edge computing. intelligent status identification and data reporting are performed directly on the collection side. it can reduce computing delay, device power consumption, and cloud servers’ power consumption, thus significantly reducing application barriers and costs. it gives full play to mind evolutionary computation (mec), which is good at searching and solving.11 to realize the innovative integration of mec and industrial internet data application systems, and gradually realize intelligent algorithm optimization and online distribution. realize the solution of sensitive data in medical institutions, and realize the security isolation of data within the intranet. 49 j global clinical engineering vol.6 issue 1: 2023 wanrong liu, bin li, zhiyong ji: internet of things and digital twin technology-based management system of medical equipment figure 1. systematic structure. figure 2. 5g networking scheme. wanrong liu, bin li, zhiyong ji: internet of things and digital twin technology-based management system of medical equipment j global clinical engineering vol.6 issue 1: 2023 50 medical device asset data is stored in the cloud the key to implementing related applications based on iot is to realize the data collection of perception terminal and the data binding of object equipment assets. typical industrial internet identification of three terminals: 1. dynamic energy identification is a medical equipment running state dynamic monitoring terminal. a dynamic energy marker is deployed for each active medical device. after the device is powered on, its operating status can be collected and uploaded in real time as shown in figure 3; 2. dynamic environment identification is a monitoring terminal for the environmental quality of medical space. with low power consumption and wide area communication capability, a dynamic environment identifier is deployed in each medical space to collect and upload medical space environmental indicators in real time. as shown in figure 4; 3. proactively locating and marking the terminal completes the space master data binding and distribution. this combines with the medical device status dynamic monitoring iot terminal to achieve the room-level dynamic positioning of the equipment and links the data service to the hospital inventory equipment assets ledger information and the hospital’s existing equipment assets deployment for a professional dynamic two-dimensional code identification. this will build a cloud database of equipment assets with logos as links. the identification image information, location image information, original asset card image information, and other image information for medical equipment assets are collected. at the same time, based on the management norms of special medical equipment, an equipment assets benchmark database, in line with the latest management requirements, is established to complete the inventory equipment assets information. medical operation support resource coordination management platform based on spatial digital twin digital twinning is a digital method to establish a virtual model representing a physical entity. and through the simulation analysis to simulate the real activities of these physical entities. the master data model of the real physical space of medical institutions is established to complete the datatization of objects such as organizations, hospitals, buildings, floors, rooms, and spaces. as an effective solution, digital twin technology gives full play to timely, fast, and intelligent information services. the comprehensive use of virtual-real interaction, data fusion analysis, decision-making process iterative optimization, and other technical means helps realize the interactive integration and intelligent control from physical entity to the virtual digital model and intelligent management of support equipment location, inventory, environmental warnings, fault repairs, fault locations, and other applications. results fine management based on the iot and digital twin can be realized and refined to the room level, improving data acquisition and transmission coverage and improving the efficiency of collaborative management of operational resource support. environmental and location monitoring management iot terminals are deployed in every room to allow dynamic monitoring of the room or designated area for temperature, humidity, pressure, volatile organic compounds, harmful gasses, particulate matter, and other parameters. room-level real-time positioning of medical equipment can be realized, as shown in figure figure 3. dynamic energy identification. figure 4. dynamic environment identification. 51 j global clinical engineering vol.6 issue 1: 2023 wanrong liu, bin li, zhiyong ji: internet of things and digital twin technology-based management system of medical equipment 5. meanwhile, environmental warnings, electrical safety warnings, position change warnings, and overall building temperature information on medical equipment are also provided.12 equipment operation and maintenance monitoring in the medical equipment maintenance programme overview report, the who states that maintenance steps include identifying fault phenomena and causes, maintenance, post-maintenance testing, and completing maintenance reports. traditional equipment warranties are reported by telephone; however, maintenance reports are mainly on paper, which multiple departments must review and sign. maintenance information also needs to be counted manually monthly which is inefficient. traditional management methods have been unable to meet the needs of hospital refinement, digitization, and network management.13 the system can realize the whole process management from repair reporting to maintenance and evaluation through code scanning, quickly locate the repair reporting area, and objectively record the fault phenomenon, maintenance emergency, response time, process, and quality, which allows the development of an annual maintenance report. digital image visual management 3d visualization of medical equipment deployment service position and state was realized based on digital twin. digital twinning of hospital building appearance, hierarchical structure, and other factors is carried out to integrate medical equipment positioning, energy efficiency, and other iot data.14 as shown in figure 6, the user can monitor queries, viewpoint adjustments, and scene switches, strengthening closed-loop traceability management. improve the efficiency of collaborative management of operational resource support on december 5, 2022, the shanghai epidemic was lifted, and the number of patients with respiratory tract infections increased sharply. the utilization rate of life support equipment in hospitals, especially airvo series respiratory humidifiers, has grown rapidly. considering that the use status of medical equipment changes in real time, this paper takes the monitoring situation of a respiratory humidification therapy instrument in shanghai sixth people’s hospital at 10:00 a.m. from december 1, 2022 to december 30, 2022 as an example. the monitoring of equipment used in the system is shown in table 1. the system can not only display the use status of the device in real time, but also realize accurate positioning synchronously. this ensures the prompt deployment of the unused devices from department a to department b, shortening the deployment time from 30 minutes to about 10 minutes. it helps decision-makers realize online, networked, and intelligent medical equipment management, replacing traditional manual paper records. reduce the repeated purchase caused by unreasonable allocation of medical equipment, improve the efficiency of equipment use, and improve the efficiency of cooperative management of operational resources. figure 5. schematic diagram of room-level positioning of medical equipment. figure 6. the hospital-integrated management platform based on digital twin. wanrong liu, bin li, zhiyong ji: internet of things and digital twin technology-based management system of medical equipment j global clinical engineering vol.6 issue 1: 2023 52 conclusion the configuration and optimization of medical equipment, especially life support and other large medical equipment, is an important task of hospitals. the basis of good resource configuration management is to grasp the actual running status of the current device completely in real time. provide an objective basis for device configuration to support configuration decisions.15–16 this paper proposes a new medical equipment management mode. compared with traditional medical equipment management, this mode not only realizes the information of archives simply with the help of the iot and digital twin technology. it is important to ensure the real-time dynamic update and maintenance of medical equipment to improve the management efficiency of hospital medical equipment to boost the continuous development of hospital medical treatment, teaching, and scientific research. acknowledgments the authors thank and acknowledge the anonymous reviewers for their valuable comments. references 1. shamayleh a, awad m, farhat j. iot based predictive maintenance management of medical equipment. j med syst 2019; 44(4). 2. liu wr, li b, and ji zy. application of telemedicine technology in the prevention and treatment of respiratory infectious diseases. china med equip 2020,35(06):108-111,120. 3. liu tz, shen az, hu xj, et al. spd-based logistics management model of medical consumables in hospitals. iran j pub health 2016;45(10):1288-1299. 4. ranjbar e, sedehi rg, rashidi m, and et al. design of an iot-based system for smart maintenance of medical equipment. in 3rd international conference on internet of things and applications (iot), univ isfahan, isfahan, iran, apr 17-18, 2019. 5. akkaoui r. blockchain for the management of internet of things devices in the medical industry. ieee transact intell transport sys 2021;1-12. table 1. monitoring situation of airvo series respiratory humidifiers used in the whole hospital from december 1st to december 30th at 10:00 am sharp time actual quantity available quantity quantity in use usage rate december 1 37 36 10 27.78% december 2 37 36 11 30.55% december 3 37 37 10 27.02% december 4 37 37 12 32.43% december 5 37 36 28 77.77% december 6 37 37 28 75.67% december 7 37 36 33 91.67% december 8 37 37 35 94.59% december 9 46 46 40 86.96% december 10 46 46 44 95.65% december 11 46 44 36 81.82% december 12 46 45 43 95.56% december 13 46 46 44 95.65% december 14 46 43 43 100% december 15 46 46 45 97.83% december 16 46 44 40 90.91% december 17 46 46 42 91.30% december 18 46 46 39 84.78% december 19 46 43 40 93.02% december 20 46 46 37 80.43% december 21 46 46 39 84.78% december 22 46 45 40 88.89% december 23 46 46 42 91.30% december 24 46 45 42 93.33% december 25 46 46 36 78.26% december 26 46 44 38 86.36% december 27 46 45 40 88.89% december 28 46 46 34 73.91% december 29 46 46 35 76.08% december 30 46 46 39 84.78% 53 j global clinical engineering vol.6 issue 1: 2023 wanrong liu, bin li, zhiyong ji: internet of things and digital twin technology-based management system of medical equipment 6. zhang gd, navimipour nj. a comprehensive and systematic review of the iot-based medical management systems: applications, 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personalized health and medicine 2020;(270):103-107. 13. umbelino v, coutinho f, fonseca i, and et al. standards about medical equipment maintenance a survey, in 6th ieee portuguese meeting in bioengineering (enbeng), isel, lisbon, portugal, feb 22-23, 2019. 14. tao f, xiao b, qi ql, et al. digital twin modeling. j manufact sys 2022;(64):372-389. 15. chen lh. application of mathematical modeling in cost control of medical equipment procurement in public hospitals. computat mathemat methods med 2022;12. 16. wang zh, guo ht, gan mj, et al. progress analysis of medical equipment information management. biomed engineer clin 2020;24(01):87-90. j global clinical engineering vol.6 special issue 6: 2024 102 conference paper deciphering astroglial dynamics and interactions through multi-scale computational modeling in multiple sclerosis evolution chrysoula tsimperi1,*, konstantinos michmizos2 and leontios hadjileontiadis1 1 department of electrical and computer engineering, aristotle university of thessaloniki, thessaloniki, greece. 2 computational brain lab, department of computer science, rutgers university, piscataway, nj, united states. * corresponding author email: xrysa97.tsiberi@gmail.com abstract multiple sclerosis (ms) is a neurodegenerative disease affecting millions worldwide, highlighting the complex relationship between the immune system and the central nervous system. astrocytes are recognized as significant contributors to the disease’s pathogenesis. in this work, a biophysically realistic astrocytic model was created to investigate astrocytes' role in ms development, focusing on their impact on axonal conduction and enhanced sodium channel facilitation in demyelinated axons. through the advancement of comprehension about the involvement of astrocytes in the pathophysiology of ms, this study explores the processes underlying the disease. the study also examines the morphology of astrocytes and its influence on cellular activity, providing insights into cell instability drivers and the interaction between morphological changes and functional modifications. this approach aims to understand the complex connections between cellular characteristics and physiological attributes, enhancing our understanding of multiple sclerosis and potentially developing groundbreaking therapies. keywords—astrocytes, conduction velocity, in-silico, multiple sclerosis. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 103 j global clinical engineering vol.6 special issue 6: 2024 introduction astrocytes are key contributors to multiple sclerosis (ms) lesions, playing a crucial role in maintaining neural homeostasis and preventing neural tissue damage.1 they exhibit dual roles, responding adaptively or non-adaptively to the severity of injury.2,3 their intricate morphology and adaptive responses are central to ms lesion development.4,5 however, this dual nature, providing both protection and potential hindrance, makes them complex therapeutic targets.6 in this study, our primary objective is to delve into the role of astrocytes in the development of ms lesions, adopting a comprehensive approach through three distinct parts. the first part explores how astrocytes influence axonal conduction, with implications for msrelated functional deficits. the second part examines how astrocytes facilitate sodium channels in demyelinated axons, shedding light on potential ms pathophysiology mechanisms. the third part seeks to correlate the loss and recovery of astrocytes in the cerebral cortex with myelin loss due to conduction block in new ms lesions. our approach involves creating biologically realistic models of two distinct astrocytic states, one representing physiological conditions and the other mimicking pathological scenarios. these models serve as the foundation for our study, enabling us to expand our understanding of various factors, including demyelinated and remyelinated axon conductance, the role of ions as signaling molecules (such as ca2+, na+, and k+), and the impact of inflammatory cytokines like il1β/6 and tnfα . our overarching goal is to develop comprehensive computational representations of astrocytes that encompass both their physiological and pathological behaviors within the neocortex area. by developing biophysically realistic models and incorporating empirical data, we aim to accurately capture astrocyte morphology and functionality while exploring their behavior across different scales. methods in this study, we aimed to unravel the intricate machinery underlying astroglial pathophysiology in ms by addressing the challenge of their complex, sponge-like morphology. this work systematically assessed the multiscale morphology of astroglia to create a realistic multicompartment cell model for biophysical interrogation within the neuron computational environment. as a proof of concept, we simulated two neocortex astrocytes in a virtual environment, subjecting them to a series of imaging experiments. this allowed us to reveal crucial aspects of astroglial pathophysiology that are challenging to access through empirical methods. these findings encompassed spatiotemporal dynamics of intracellular k+ and na+ redistribution, essential ca2+ buffering properties, as well as the effects of demyelinated and remyelinated axon conductance and the influence of inflammatory cytokines such as il1β/6 and tnfα. we aimed to create a modeling approach that faithfully replicates the intricate morphology of astrocytes across multiple scales while retaining the full capabilities of biophysical simulations provided by neuron. a. significance of morphology in ms brain astroglia has a distinct morphology compared to nerve cells due to their complex system of nanoscopic processes that fill tissue volume between branches.3,7 they are often seen as a cloudy structure around thicker branches and do not overlap in tissue domains.8,9 in ms lesions, astroglia plays complex roles, influencing inflammation and neuronal repair. the nervous system influences the shapeshifting properties of reactive astrocytes, which can be influenced by damage severity. traumatic brain injuries can increase gfap levels, leading to cell-body hypertrophy and hot spots of cell proliferation (figure 1). the presence of astrocytes near focal lesions can lead to “palisades” and decreased astrogliosis hallmarks.3,10,11   to develop effective therapies targeting astrocytes, a deeper understanding of their subtypes and functions is essential. super-resolution imaging techniques hold promise in unraveling astrocyte behavior in ms.12 due to the varying cellular mechanisms and morphological features of astroglia, it is important to develop a model that can explore astroglial functions under pathological conditions. b. data selection in this study, we employed a multifaceted approach to investigate the role of cortical astrocytes in the context of neocortical lesions associated with ms. using datasets from mouse models, we harnessed advanced imaging http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 104 techniques to visualize the intricate morphological changes of astrocytes within the cortex when neocortical lesions are present. for this work, it was selected two datasets of astrocytes (physiology and pathophysiology) from the neocortex area from the neuromorpho database (tables 1 and 2) for the development of an interactive realistic model.13 figure 1. function of the astrocyte from homeostasis to pathology. table 1. measurements of physiology cell. measurements data soma surface 67.05 µm2 number of stems 13 number of bifurcations 742 number of branches* 1497 overall width 44.67 µm overall height 52.97 µm overall depth 51.07 µm average diameter 0.51 µm total length 8281.73 µm total surface** 11237.8 µm2 total volume** 2672.6 µm3 max euclidean distance 41.74 µm max path distance 63.29 µm max branch order 27 average contraction 0.87 total fragmentation 7466 partition asymmetry 0.65 average rall’s ratio 1.9 average bifurcation angle local 65.21° average bifurcation angle remote 77.33° fractal dimension 1.1 * rows highlighted in blue represent the number of branches. ** rows highlighted in red correspond to surface area and volume parameters, which are utilized in calculating the surface-to-volume ratio (svr). table 2. measurements of pathology cell. measurements data soma surface 126.98 µm2 number of stems 6 number of bifurcations 267 number of branches* 540 overall width 24.57 µm overall height 67.02 µm overall depth 51.54 µm average diameter 0.64 µm total length 3160.88 µm total surface** 5575.83 µm2 total volume** 2820.8 µm3 max euclidean distance 46.74 µm max path distance 62.2 µm max branch order 26 average contraction 0.83 total fragmentation 3764 partition asymmetry 0.62 average rall’s ratio 2.08 average bifurcation angle local 69.86° average bifurcation angle remote 75.01° fractal dimension 1.11 * rows highlighted in blue represent the number of branches. ** rows highlighted in red correspond to surface area and volume parameters, which are utilized in calculating the surface-to-volume ratio (svr). http://www.globalce.org http://globalce.org http://globalce.org 105 j global clinical engineering vol.6 special issue 6: 2024 c. incorporation of astrocyte mechanisms this section discusses the versatility of models built, emphasizing their ability to incorporate numerous neuron-enabled channel and transporter kinetic mechanisms validated through experiments and simulations. formal descriptions of these algorithms are accessible through the extensive neuron database, senselab. the model includes various channel current and diffusion-reaction mechanisms tailored to this study. these mechanisms encompass the kir4.1 potassium current, intracellular k+ and na+ diffusion, the demyelination and remyelination axon conductance mechanism, and k+/na+ extrusion.14, 15 gap junction mechanisms are also incorporated, offering options for current leakage or diffuse escape.8 also, we delve into the simulation algorithms that govern intracellular ca2+ dynamics in msastro, including the diffusion of ca2+ among compartments of different sizes. these algorithms draw from neuron book 24 and are adapted from the modified cadifus.mod file.16 d. generating complete astrocyte morphology the study’s methods involved setting up the neuron environment, generating astrocyte stem trees through various options, and simulating the nanoscopic processes within the msastro system.7 stem trees were selected from libraries, generated with endfoot structures, or loaded from reconstructed files. nanoscopic process geometry was determined using default statistics or built-in tools. parameters for membrane conductance and dendritic geometry were adjusted for accurate simulations. the resulting astrocyte models were compared to empirical data, and their morphology was refined to achieve alignment. computer simulations were used to analyze sodium uptake mechanisms, focusing on the electrochemical properties of astrocytes and the na+, k⁺-atpase (figure 2). high-affinity ca2+ indicators were employed to translate fluorescence signals into intracellular ca2+ dynamics, requiring in-silico modeling of ca2+ entry, diffusion, and buffering mechanisms. the clustering of ca2+ channels was studied to reveal spatial dynamics and the role of channel clusters in ca2+ signaling (figure 3). architectural characteristics of astroglia were investigated through the examination of tissue volume fraction figure 2. summed distribution of astrocyte intermediate forms binding na+ and k+ versus membrane potential. figure 3. the visualization of the internal dynamics of ca2+ in a cell is done through the use of dendrites. the black circle shows the area of interest, while the right shows the dendrites’ d1 and d2. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 106 (vf) and surface-to-volume ratios (svr), providing insights into morphology and interactions with the surrounding environment (figure 4). computational modeling of cytokine signaling was conducted, focusing on interactions between microglial cytokines and their effects on astroglial behavior. using an ordinary differential equation (ode) model (equation 1), the research explored the effects of autocrine/paracrine microglial cytokine interactions, particularly those involved ms, such as tnfα, il-1β, and il-6. we used a classic s-systems model formulation to simulate the expression dynamics of each cytokine (figure 5a). where cx = cx(t) is the expression of cytokine x (tnfα, il-1β, il-6) that is produced at rate kx upon activation by cytokine ci at time = t − τd,ix. thus the delay term τd,ix is time between the activation of ci and its subsequent activation of cx. the activation of cx depends on ci according to a hill function characterized by half-maximal activation constant kix and cooperativity coefficient nix. similarly, inhibitory cytokine cj reduces cx production with time delay τd,jx according to a decreasing sigmoidal function characterized by kjx and njx. the degradation of cx occurred with both concentration-dependent and concentration-independent components determined by rate constants γx and γss,x, respectively. the concentration-independent degradation term encompassed the initial value of cytokine x, which was set to css,x = 0.1 for all cytokines, and a degradation constant that was set to maintain a constant steady state 17 in the absence of stimulation. lastly, the study explored the requirements for effective conduction within astroglia particularly the influence of internodal distance on conduction velocity, and assessed the impact of parameters like na+ and k+ channel density (1) (4) (5) (2) (3) figure 4. neuron-based astrocyte model: determining volumetric quantities. figure 5. network model and mathematical simulation of complex signaling dynamics cytokines. (a) the literature-based network model depicts the activation and inhibition of cytokine production. (b) the results of our calibrated model are shown along with a saturating stimulus of lps = 1000 & t = 0. http://www.globalce.org http://globalce.org http://globalce.org 107 j global clinical engineering vol.6 special issue 6: 2024 on conduction. in astroglia, ion dynamics is a relatively slow process and the simulation trial normally requires needs at least 100 seconds. results and discussion the results showcased that the chosen rate coefficients for isolated astrocytes and the current-voltage (i-v) relation were consistent with the physiological implications of the electrogenic sodium pump. this provided a fundamental understanding of sodium dynamics in these cells (figure 2). no step involving binding or dissociation between na+ or k+ and the astrocytes is directly influenced by voltage. there is a considerable indirect effect of voltage on the binding of na+ or k+ to the astrocytes, owing to the voltage-dependent distribution of intermediates. moving beyond sodium uptake, the research delved into the intricate world of astroglial calcium waves. while traditionally, slow global calcium elevations were the primary indicators of astroglial activity, recent advancements in high-sensitivity ca2+ imaging revealed faster and more localized ca2+ signals prevalent in smaller processes (figure 3). the vf, which describes the proportion of local tissue occupied by astrocytes, was examined to provide insights into astrocyte morphology. similarly, the svr, a key biophysical determinant of a cell's function, was analyzed to evaluate how astrocyte morphology aligns with its surrounding environment. it is not known how svr ranges in neocortex astroglial cells. however, we decided to evaluate surface area-to-volume ratios, which can be considered a measure of how much the morphology of a cell is adapted to interact with its environment. (tables 1 and 2) (svrphysiology = 4.205 μm−1 & svrpathology = 1.977 μm−1). this provided quantitative data that shed light on the physical interact interactions between astrocytes and their surroundings (figure 4). the model provided insights into how these cytokines may influence astroglial responses under pathological conditions, paving the way for a deeper understanding of complex cellular interactions (figure 5). by focusing on incorporating relevant mechanisms into the model, the study aimed to explore the requirements for effective conduction within astroglia. notably, experimental evidence suggests a low na+ channel density within the internodal axolemma (2–6%), potentially acting as a mediator between demyelinated regions. several simulations were conducted to scrutinize this possibility. in constructing the model, a 12-node axon was designed, with each node divided into regions representing demyelinated or remyelinated phases. the presence of new ranvier nodes emerged in internodal regions during remyelination, creating short internodes. as the remyelination process progressed and the lamellae increased, the likelihood of successful ranvier conduction escalated rapidly, although the conduction velocity remained low. the relationship between internodal conduction time (ict) and velocity exhibited a linear trend for small and large internodal lengths (l), with the increase in velocity observed only for l below 2000 μm (figure 6). this study suggests the significance of internodal distance in conduction velocity and emphasizes the delicate balance between nodal and internodal currents for effective propagation. conclusion in summary, this study uses advanced computational modeling to explore astroglial physiology and interactions, providing insights into astrocyte function, calcium dynamics, tissue architecture, and cytokine signaling. it raises questions about how specific inflammatory stimuli influence disease outcomes and whether modulating figure 6. neuron-based astrocyte model: determining volumetric quantities. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 108 astrocyte responses could have therapeutic potential. the study emphasizes the need for comprehensive frameworks like s-systems to understand cytokine interactions and their impact on targets, offering a promising avenue for deeper understanding and potential intervention in neurological disorders. acknowledgment this work was based on astro by the department of clinical and experimental epilepsy, institute of neurology, university college of london. the authors thank dr. leonid savtchenko for his inspirational support. references 1. ravi, k., paidas, m.j., saad, a., et al. astrocytes in rare neurological conditions: morphological and functional considerations. j comp neurol. 2021;529(10):2676–2705. https://doi.org/10.1002/cne.25118. 2. kponath, g., park, c., pitt, d. the role of astrocytes in multiple sclerosis. front immunol. 2018;9:217. https:// doi.org/10.3389/fimmu.2018.00217. 3. henstridge, c.m., tzioras, m., paolicelli, r.c. glial contribution to excitatory and inhibitory synapse loss in neurodegeneration. front cell neurosci. 2019;13(63). https://doi.org/10.3389/fncel.2019.00063. 4. carlos, r., gustavo, s., gaston, k., et al. brain atrophy in multiple sclerosis. am j psychiatry neurosci. 2015;3(3):40–49. https://doi.org/10.11648/j. ajpn.20150303.11. 5. correale, j., and farez, m.f. the role of astrocytes in multiple sclerosis progression. front neurol. 2015; 6(180). https://doi.org/10.3389/fneur.2015.00180. 6. wheeler, m.a. and quintana, f.j. regulation of astrocyte functions in multiple sclerosis. cold spring harb perspect med. 2019;9(1):a029009. https://doi. org/10.1101/cshperspect.a029009. 7. savtchenko, l.p., bard, l., jensen, t.p., et al. disentangling astroglial physiology with a realistic cell model in silico. nat commun. 2018;9(1):3554. https://doi. org/10.1038/s41467-018-05896-w. erratum in: nat commun. 2019; 10(1):5062. https://doi.org/10.1038/ s41467-019-12712-6. 8. batiuk, m.y., martirosyan, a., wahis, j., et al. identification of region-specific astrocyte subtypes at single cell resolution. nat commun. 2020;11(1):1220. https:// doi.org/10.1038/s41467-019-14198-8. 9. rusakov, d.a., bard, l., stewart, m.g., et al. diversity of astroglial functions alludes to subcellular specialisation. trends neurosci. 2014;37(4):228-42. https://doi. org/10.1016/j.tins.2014.02.008. 10. savtchenko, l.p. and rusakov, d.a. regulation of rhythm genesis by volume-limited, astroglia-like signals in neural networks. philos trans r soc lond b biol sci. 2014; 369(1654):20130614. https://doi.org/10.1098/ rstb.2013.0614. 11. schiweck., j., eickholt, b.j., murk, k. important shapeshifter: mechanisms allowing astrocytes to respond to the changing nervous system during development, injury and disease. front cell neurosci. 2018;12(261). https://doi.org/10.3389/fncel.2018.00261. 12. zhou, b., zuo, y.x., jiang, r.t. astrocyte morphology: diversity, plasticity, and role in neurological diseases. cns neurosci ther. 2019;25(6):665–673. https://doi. org/10.1111/cns.13123. 13. clavreul, s., abdeladim, l., hernández-garzón, e., et al. cortical astrocytes develop in a plastic manner at both clonal and cellular levels. nat commun. 2019; 10(1):4884. https://doi.org/10.1038/s41467-019-12791-5. 14. fleidervish, i., lasser-ross, n., gutnick, m., et al. na+ imaging reveals little difference in action potential– evoked na+ influx between axon and soma. nat neurosci. 2010;13(7):852–860. https://doi.org/10.1038/ nn.2574. 15. hines, m. and shrager, p. a computational test of the requirements for conduction in demyelinated axons. restor neurol neurosci. 1991;3(2):81–93. https://doi. org/10.3233/rnn-1991-3205. 16. carnevale, n.t. and hines, m.l. the neuron book; cambridge up: cambridge, uk; 2006. 17. furchtgott, l.a., chow, c.c., periwal, v. a model of liver regeneration. biophys j. 2009;96(10):3926–3935. https://doi.org/10.1016/j.bpj.2009.01.061. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.1002/cne.25118 https://doi.org/10.3389/fimmu.2018.00217 https://doi.org/10.3389/fimmu.2018.00217 https://doi.org/10.3389/fncel.2019.00063 https://doi.org/10.11648/j.ajpn.20150303.11 https://doi.org/10.11648/j.ajpn.20150303.11 https://doi.org/10.3389/fneur.2015.00180 https://doi.org/10.1101/cshperspect.a029009 https://doi.org/10.1101/cshperspect.a029009 https://doi.org/10.1038/s41467-018-05896-w https://doi.org/10.1038/s41467-018-05896-w https://doi.org/10.1038/s41467-019-12712-6 https://doi.org/10.1038/s41467-019-12712-6 https://doi.org/10.1038/s41467-019-14198-8 https://doi.org/10.1038/s41467-019-14198-8 https://doi.org/10.1016/j.tins.2014.02.008 https://doi.org/10.1016/j.tins.2014.02.008 https://doi.org/10.1098/rstb.2013.0614 https://doi.org/10.1098/rstb.2013.0614 https://doi.org/10.3389/fncel.2018.00261 https://doi.org/10.1111/cns.13123 https://doi.org/10.1111/cns.13123 https://doi.org/10.1038/s41467-019-12791-5 https://doi.org/10.1038/nn.2574 https://doi.org/10.1038/nn.2574 https://doi.org/10.3233/rnn-1991-3205 https://doi.org/10.3233/rnn-1991-3205 https://doi.org/10.1016/j.bpj.2009.01.061 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 15 j global clinical engineering vol.4 issue 2: 2021 received january 16, 2021, accepted may 21, 2021, date of publication may 27, 2021 a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit by fabiola m. martinez-licona, sergio e. perez-ramos electrical engineering department, universidad autonoma metropolitana, mexico city abstract backgrounds and objective: the intensive care unit (icu) receives patients whose situation demands high complexity tasks. their recovery depends on medical care, their response to medications and clinical procedures, and the optimal functioning of the medical devices devoted to them. adverse events in the icu due to failures in the facilities, particularly medical devices, impact the patients, operators, and all involved in their care. the origins of the technological failures seem to be more oriented to the interaction between the equipment and the operator. once the medical equipment is functioning, we must guarantee its correct execution to meet both the clinical service’s objectives and the expectations of those involved in care, including the patients themselves. we present an approach to quality management based on failure analysis as the source of risk for medical devices’ functioning and operation in the icu. we decided to address it through a systematic approach by using elements from the failure mode and effects analysis (fmea) method and the ishikawa diagrams’ support to obtain the causes graphically. material and methods: we used the risk analysis framework as a basis of the methodology. by obtaining the causes and sub causes of technological failures in the icu for adult patients, we adapted some of the fmea method and applied the ishikawa diagrams to analyze the relationship between cause and failure. the icu devices came from the official mexican standard and the world health organization (who) information related to the icu operation and facilities. the data from the causes of failure came from specialized consultation and discussion forums on medical devices where these topics were addressed; we searched for over five years in spanish forums. we proposed a calculation of the risk priority number based on the information subtracted from the forums. then, we defined an indicator showing the priority level used to address the issue. results: in general, the results showed that most of the medical equipment failure causes have medium and high-risk priority levels and, in some cases, the cause presented as the most prevalent did not match with the reported in official documents such as technical or operation manuals. the most frequent causes found are related to electrical system issues and operation skills. we presented three study cases: defibrillator, vital sign monitor, and volumetric ventilator, to show the risk level designation. the conclusions inferred from these cases are oriented to training strategies and the development of support material in spanish. conclusion: the development of risk management methodologies to monitor and solve potential hazard situations in critical areas is valuable to the health technology management program. the fmea method showed a solid basis for the risk assessment processes, and its application to the icu medical technology allowed the creation of the evidence supporting the decision-making process concerning strategic solutions to guarantee patient safety. keywords – risk assessment, failure analysis, fmea, icu medical equipment, health technology management. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.4 issue 2: 2021 16 martinez-licona, perez-ramos : a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit introduction the patients in the intensive care unit (icu) are under unique circumstances. this situation is due to the requirement of specialized multi-organ support actions needed to restore their health, including medical devices.1 furthermore, the icu patients’ complexity makes them depend on medical care, their response to medications and clinical procedures, and the optimal functioning of the medical devices devoted to them. studies carried out in this regard have shown the impact of failures related to technology and its applications in the analysis of adverse events at icu,2 and the importance of safety improvement in using medical devices in this area to have greater control of incidents.3 technological failure is defined in the hospital environment as an event in which medical equipment has stopped working correctly, which is associated with a probability of harming the patient or the operator.4 the origin of technological failures can be approached from different perspectives; some of the most relevant has to do with the negative effect on the patient or the context of medical devices’ operation. some sources of failure that have been identified in this regard are5: • the wrong dynamic range of measurement • a lack of training in the operation of the equipment • a lack of quality control in measurements • a lack of quality control in pre-installations • the wrong design the origins of the technological failures mentioned are more oriented to the interaction between the equipment and the operator. once the equipment is in operation, we must guarantee its correct execution to meet both the clinical service’s objectives and the expectations of those involved in care, including the patients themselves. in this sense, technological failure becomes a reference point for developing plans and strategies that help improve quality. within this frame of reference, aspects related to the medical device’s operation will be taken as a quality feature so that the failure analysis approaches from a strictly technological perspective. furthermore, it implies that the factors associated with its operation and functioning, including infrastructure, device design, and human resources, will be analyzed around the medical device and not as independent causes. thus, we can design strategies for the containment and eventual elimination of the fault. as for the icu, analyzing the causes of medical devices’ failures will make it possible to develop plans for risk management and control of related incidents. this kind of management process is particularly relevant, given the vulnerable condition of the patients treated in icu demands actions that guarantee their safety and those who interact with them. we must address two considerations: a failure may be due to more than one factor, and in icu, the potential factors involved increase the difficulty of the analysis. we decided to address the issue through a systematic approach, so we chose to take the failure mode and effects analysis (fmea) method. fmea method is a systematic process that identifies the potential product or process design failures before they occur to eliminate them or minimize the associated risk.6 although this method has been used more frequently in the automotive industry; it can detect and contain potential failures in various natures’ products and processes. therefore, its application to the medical field has been growing.7 it includes improving patient safety,8 the analysis of risk points in the implementation of smart devices,9 its application in radiotherapy,10 or quality management in the clinical laboratory.11 fmea method integrates two stages for its implementation: identifying the failure and its evaluation.12 the identification stage includes the following: the process’ phases list to be analyzed, the potential failure modes, the identification of the effects, if the failure mode occurred, the causes that could have originated them, and the discovery of the controls that the process has to prevent failures from happening, that is, prevention and detection. the evaluation stage evaluates the severity, occurrence, and detection of the failure and identifies the points to apply corrective and improvement actions. finally, the stage is complemented by assigning risk through an indicator and prioritizing failure modes to take action. tools such as pareto diagrams or cause-effect diagrams are common to identify the causes of failures. in this case, we selected the ishikawa diagram because it facilitates analyzing problems and solutions in aspects such as quality of processes, products, and services. the ishikawa diagrams rely on a logical order to structure the information 17 j global clinical engineering vol.4 issue 2: 2021 martinez-licona, perez-ramos : a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit and take the form of a fishbone; the multiple cause and effect relationships of the variables that intervene in the processes are presented.13 we present an approach to quality management that starts from analyzing failures as sources of risk for medical devices’ functioning and operation in the icu. from the fmea, we used the first stage, identification of the failure. then, with the ishikawa diagrams’ support, we obtained graphic displays of its causes and origins where created, which, together with a numerical indicator, allowed determining the prioritization of corrective actions. methods the methodology we used was founded on the risk analysis framework. by considering the technological failures that occur in the icu for adult patients, we identified their causes and sub-causes. we adapted some elements from the fmea method with the support of ishikawa diagrams to analyze the relationship between cause and failure. we obtained the icu medical devices’ identification to be analyzed from the official mexican standard nom025-ssa3-2013 for the organization and operation of intensive care units14 and the central medical equipment section of the world health organization (who).15 then, for each piece of medical equipment, the causes of failure were classified into the following five categories13 and incorporated into an ishikawa diagram: • human resources that are involved in the operation • environment or conditions under which medical equipment operates • materials used for its operation • methods for the development of functions for its operation • machines or any equipment or tools required to perform the work we obtained the information to identify the possible causes of failures associated with using the equipment from the search in specialized consultation and discussion forums on medical devices where these topics were addressed; we searched for over five years in spanish forums. among the platforms consulted are yoreparo. com, ayudabiomedica.com, forumsdeelectronica.com, sefh. es, and elhospital.com. the information was completed by consulting the equipment’s technical and operation manuals. we identified the possible causes of a failure for each medical equipment and, based on the number of mentions found in the forums consulted, their priority level. we determined to evaluate the quality of operation of each piece of equipment by defining the following metric based on the risk priority number (rpn) that, according to the fmea evaluation stage, is defined by rpn= severity*occurrence*detection (1) each of the terms included in (1) were adapted to the forum information context, so: • severity is computed by taking the number of found mentions per specific cause divided by the highest value of mentions per any cause in the medical device. • occurrence is calculated by taking the number of mentions per specific cause divided by the total number of mentions in the medical device. • for detection we proposed to assign three levels of impact of the failure, 1 to low, 2 to medium, and 3 to high, according to the information reported in the equipment’s medical manuals. we carried out the assignment by searching the troubleshooting sections for the frequency of reported failures and solutions, assigning a higher level to the most frequent. then, we defined an indicator that shows a level of priority that can be used to address the issue. first, we normalized the rpn for each failure cause in the equipment (rpnn); then, we classified it into low, medium, and high categories based on the proportion of the rpnn failure cause within the related equipment. in general, high class was assigned to rpnn > 0.5, low priority to rpnn < 0.1, and medium priority to rpnn between these two values. following, we proposed a priority level percentage indicator that shows the general situation of the equipment as: %_priority_level = (number of mentions per rpn class/ number of total mentions per equipment)*100 we determined each medical equipment’s risk level based on the percentage of failures with high and medium priority levels obtained from the priority indicator. these http://yoreparo.com http://yoreparo.com http://ayudabiomedica.com http://forumsdeelectronica.com http://sefh.es http://sefh.es http://elhospital.com j global clinical engineering vol.4 issue 2: 2021 18 martinez-licona, perez-ramos : a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit results enabled us to focus on specific issues to develop action plans to address them. results the icu medical equipment included in the analysis were: • apnea monitor • central monitoring • defibrillator • hospitalization bed • infusion pump • portable x-ray system • vital sign monitor • volumetric ventilator the numbers of causes found, total mentions identified, and percentages of priority levels for each one are shown in table 1. table 1. causes, mentions, priority levels (pl) percentage found in icu medical devices medical device causes total mentions % high pl. % medium pl. % low pl. apnea monitor 11 24 50 33.33 16.67 central monitoring 10 24 62.50 25 12.50 defibrillator 14 39 53.85 33.33 12.82 hospitalization bed 13 34 26.47 44.12 29.41 infusion pump 14 55 49.09 21.82 29.09 portable x-ray 17 69 39.13 23.19 37.68 vital signs monitor 15 39 46.15 38.46 15.38 volumetric ventilator 13 38 28.95 44.74 26.32 we present below the defibrillator, vital signs monitor, and volumetric ventilator cases to illustrate the results. case 1: defibrillator. table 2 shows the causes found, the number of mentions, the values of severity, occurrence, and detection obtained, and the computed normalized rpn. the cause with the highest number of mentions was the suspension of the electrical system with 5. in contrast, the causes with the lowest number of mentions were related to the equipment’s documentation. the prioritization was carried out as follows: low priority: 0.01≤rpnn≤0.1 medium priority: 0.16≤rpnn≤0.24 high priority: 0.43≤rpnn≤1 the last column’s color corresponds to the priority class assigned, green to low, yellow to medium, and red to high priority level. to illustrate obtaining the severity, occurrence, detection and rpnn values, we will take the failure cause “insufficient battery charge” (ibc). then, we get the rpnn : 19 j global clinical engineering vol.4 issue 2: 2021 martinez-licona, perez-ramos : a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit figure 1. ishikawa diagram for the defibrillator failure analysis. table 2. causes, mentions, rpnn data, and priority classes found in the defibrillator cause found no. mentions severity occurrence detection rpnn emergency electrical system 5 1 0.128 3 1 suspension of electrical service 4 0.8 0.102 3 0.64 insufficient battery charge 4 0.8 0.102 3 0.64 difficulty using the defibrillator 4 0.8 0.102 3 0.64 broken electrode cables 4 0.8 0.102 2 0.43 transients caused by other loads with the same supply 3 0.6 0.076 2 0.24 voltage fluctuations 3 0.6 0.076 2 0.24 power cord 3 0.6 0.076 1 0.12 poor electrode cleaning or incorrect application 2 0.4 0.051 3 0.16 battery life 2 0.4 0.051 2 0.11 faulty electrodes 2 0.4 0.051 3 0.16 incorrect electrode placement 1 0.2 0.025 2 0.03 lack of manuals and/or guides 1 0.2 0.025 1 0.01 difficulty with the documents’ language 1 0.2 0.025 1 0.01 the max_rpndefibrillator was obtained from computing severity, occurrence, and detection of the failure cause with most mentions (emergency electrical system). since rpnn_ibc > 0.5, the priority for this failure cause is high, so it gets the red color. next, we elaborated the ishikawa diagram, shown in figure 1, where the causes of failures were located in the established categories based on their failure impact, the most significant impact near the fishbone. the colors indicate the assigned priority level: red-high, yellowmedium, and green-low. j global clinical engineering vol.4 issue 2: 2021 20 martinez-licona, perez-ramos : a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit case 2: vital signs monitor. table 3 shows the causes found, the number of mentions, the values of severity, occurrence, and detection obtained, and the computed normalized rpn. for example, the cause with the highest number of mentions was related to the emergency electrical system with 6. on the other hand, the causes with the lowest number of mentions included electrical supply and equipment documentation issues. in this case, the prioritization was carried out as follows: • low priority: 0.03≤rpnn≤0.06 • medium priority: 0.11≤rpnn≤0.25 • high priority: 0.35≤rpnn≤1 table 3. causes, mentions, rpn data and priority classes found in the vital signs monitor cause found no. mentions severity occurrence detection norm. rpn emergency electrical system 6 1 0.153 2 1 suspension of electrical service 5 0.833 0.128 1 0.35 power cord 4 0.666 0.102 3 0.67 difficulty using the monitor 3 0.5 0.076 3 0.38 insufficient backup batteries 3 0.5 0.076 2 0.25 communication with the non-invasive pressure module sensor 3 0.5 0.076 2 0.25 battery charge timeout 3 0.5 0.076 1 0.13 lack of knowledge of the use of the control console for calibration and adjustment (software) 2 0.333 0.051 3 0.17 communication with the heart rate module 2 0.333 0.051 3 0.17 communication with the pulse oximetry module 2 0.333 0.051 2 0.11 communication with the temperature module 2 0.333 0.051 1 0.06 voltage fluctuations 1 0.166 0.025 3 0.04 lack of manuals and / or guides 1 0.166 0.025 3 0.04 transients caused by other loads with the same supply 1 0.166 0.025 2 0.03 difficulty with the documents’ language 1 0.166 0.025 2 0.03 as in the previous case, the last column’s color corresponds to the priority class assigned, green to low, yellow to medium, and red to high priority. we elaborated the ishikawa diagram corresponding to this medical equipment, shown in figure 2, using the same settings for the previous case of the failure location and the color assigned according to the priority. we elaborated the ishikawa diagram corresponding to this medical equipment, shown in figure 2, using the same settings for the previous case of the failure location and the color assigned according to the priority. table 4 shows the causes found, the number of mentions, the values of severity, occurrence, and detection obtained, and the computed normalized rpn. in this equipment, the cause with the highest number of mentions was related to the power cord with 6. on the other hand, there were only two causes with the lowest number of mentions, including electrical transients and pneumatic systems. in this case, the prioritization was carried out as follows: • low priority: 0.01≤rpnn≤0.17 • medium priority: 0.22≤rpnn≤0.38 • high priority: 0.69≤rpnn≤1 21 j global clinical engineering vol.4 issue 2: 2021 martinez-licona, perez-ramos : a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit the last column shows the priority class assigned: green to low, yellow to medium, and red to high priority level following the color agreement. in the same way, we elaborated the ishikawa diagram corresponding to this medical equipment, shown in figure 3, using the same priority color assignment of the other cases. figure 2. volumetric ventilator table 4. causes, mentions, rpnn data and priority classes found in the volumetric ventilator cause found no. mentions severity occurrence detection norm. rpn power cord 6 1 0.157 2 1 bad filter placement 5 0.833 0.131 2 0.69 bad connection to nebulizer 4 0.666 0.105 1 0.22 emergency electrical system 4 0.666 0.105 1 0.22 bad installation of traps or collectors of excess water 3 0.5 0.078 3 0.38 gas supply system 3 0.5 0.078 3 0.38 electronic system 3 0.5 0.078 2 0.25 bad installation of the humidification system 2 0.333 0.052 3 0.17 improper battery charging 2 0.333 0.052 3 0.17 voltage fluctuations 2 0.333 0.052 2 0.11 difficulty using the ventilator 2 0.333 0.052 2 0.11 transients caused by other loads with the same power 1 0.166 0.026 3 0.04 pneumatic system 1 0.166 0.026 1 0.01 j global clinical engineering vol.4 issue 2: 2021 22 martinez-licona, perez-ramos : a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit table 5 shows the failures that occurred most frequently in the remaining icu medical equipment’s consultation forums and table 6 shows the risk level assigned after considering the priority levels obtained from the analysis. the performance of each piece of equipment was obtained from considering the high and medium priority levels. accordingly, we established the following risk levels: • high: 75≤pl≤100. the equipment’s operation presents failures that must be addressed immediately since its impact directly affects the patient’s condition. the actions to be taken must be a priority so that the failure does not cause a significant problem. • medium: 51≤pl≤74. the equipment generally works as expected, but some elements indicate that a failure could compromise the performance and have consequences for patient care. • low: 0≤pl≤50. the equipment works ideally or closely. care measures should focus on maintaining and improving its functioning to have the level of risk under control. figure 3. ishikawa diagram for the volumetric ventilator failure analysis. modified from 19 table 5. most frequent failure causes in the icu medical equipment failure medical equipment suspension of electrical service apnea monitor emergency electrical system apnea monitor suspension of electrical service central monitoring emergency electrical system central monitoring wear of controls, handles and knobs hospitalization bed connections box hospitalization bed difficulty using the hospitalization bed hospitalization bed lack of knowledge in the use of the control, calibration and adjustment system (software) infusion pump emergency electrical system infusion pump voltage fluctuations infusion pump hold alarm infusion pump emergency electrical system portable x-ray system overheating portable x-ray system inactivity portable x-ray system suspension of electrical service portable x-ray system inefficient equipment placement portable x-ray system 23 j global clinical engineering vol.4 issue 2: 2021 martinez-licona, perez-ramos : a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit discussion risk management is a crucial element for the efficient management of medical technology. unfortunately, its principles and applications in this area have not yet reached a desired level of consolidation, so work on this issue should be promoted. in a critical area, the risk management repercussions impact both the patient and the operator, even reaching the infrastructure due to the complicated relationship these components have for functioning. failure analysis is an approach to risk management that allows evaluating quality, in this case, reflected in operation, and provides elements that can be integrated with those used to manage medical equipment, such as schedules and maintenance reports, preventive or corrective maintenance documents. these components provide relevant information, but it is their systematic and well-documented integration that adds value for the development of action plans to control these failures. the fmea method has proven to be a practical analytical element in different settings. at icu, it has been applied to evaluate clinical aspects such as pressure injury due to critical illness combined with interventions and therapies.16 when adapting some of the fmea components to the information obtained from the icu’s equipment, it is possible to analyze the interaction between the different natures of the causes that generate failures. the ishikawa diagrams complemented the analysis by contrasting the practical occurrence of the failures reported in the forums, with which they report the technical and operation manuals, which we would consider as more formal and official documentation. the consultation and discussion forums are a source that may not offer high reliability compared to the information obtained from more official and formal documentation such as technical or operating manuals. however, their presence in the community shows a practical reality of the failures that appear in the engineers’ and technicians’ daily actions and technicians in charge of attending to the equipment considered; it also represents a need to share and communicate problems and solutions at a higher level of specificity. the quality of this source depends on the seriousness with which the community presents the cases and their responses; we assume this requirement is met given these forums’ purpose. the results show that in practice, icu medical equipment requires constant and detailed care. none of the equipment was considered obtained at a low-risk level; this implies a constant presence of risk that may come from different sources. portable x-ray is the device with the lowest risk level; although it is not continuously used, its most prevalent causes are related to infrastructure and operating conditions. in contrast, the monitoring devices are the ones that obtained a higher score in the level of risk; problems associated with the quality of the electrical system are more prevalent as causes of failure. in the case of the vital signs monitor (case 2), it is striking that the difficulty in its use has a high priority. the lack of knowledge of the control console’s use for calibration and adjustment (software) has medium priority, and the lack of manuals and documentation has low priority. the location of these causes in the ishikawa diagram indicates that they have a high impact on the occurrence of potential equipment failure. with this information, a latent training need and the development of support material in spanish for staff can be inferred. the defibrillator is another device that scored high risk, and both the level assigned to the high and medium priority causes generally match its location on the ishikawa diagram. this situation indicates that it is clear what actions must be taken to control this equipment’s risk, those related to the electrical supply, its use, the battery’s charge, and electrodes. in the case of the volumetric ventilator, the highest priority causes are related to the operator’s handling of equipment components, particularly the filter and the power cable. when complementing the ishikawa diagram analysis, a situation similar to the one presented table 6. risk level assigned to the icu medical equipment medical device pl high+ medium risk level apnea monitor 83.33 high central monitoring 87.5 high defibrillator 87.18 high hospitalization bed 70.59 medium infusion pump 70.91 medium portable x-ray 62.32 medium vital signs monitor 84.61 high volumetric ventilator 73.69 medium j global clinical engineering vol.4 issue 2: 2021 24 martinez-licona, perez-ramos : a risk assessment method based on the failure analysis of medical devices in the adult intensive care unit in the vital signs monitor can be seen, a training and support material problem is detected. in general, the found results contrast with those of other studies that used the fmea method in the icu, where the failures with the highest priority related to alarms of the ventilation device17 or increased rates of internal infection due to the inadequate operation of the medical equipment18 are reported. it is important to note that the fmea method’s application in each case depends on the quantity and quality of the information collected and that the value of the results will be maintained in direct relation to its updating. the limitations of this article are oriented to the data and its scope. information from general and non-formal sources was used instead of a specific source such as an icu of a particular hospital or a health system. consequently, the results show generalized trends in the community regarding the causes of failures. therefore, the information obtained from the analysis can be a starting point to develop action plans that can be improved by providing feedback with the particular icu’s specific data under consideration. the fmea method is a comprehensive tool for developing risk management programs; what is proposed is to use some of its components to build support elements for these programs, focusing on specific aspects, such as the operation of the medical device. in a previous approach, information was considered to assign priorities related to functioning.19 then, using the concepts of severity, occurrence, and detection, an analysis of failures is complemented, attending to the causes and giving them a complete management approach. in this case, we used these concepts as a basis and adapted them by defining them in the context of the information presented in the forums. more advanced work in this field, incorporating information derived from tools such as orders or service logs, is in process. conclusions the development of risk management methodologies that aim to monitor and solve potential hazard situations in critical areas is valuable to the health technology management program. the fmea method showed a solid basis for the risk assessment processes, and its application to the icu medical technology allowed the creation of the evidence supporting the decision-making process concerning strategic solutions to guarantee patient safety. conflict of interest the authors declare that they have no conflict of interest. references 1. raffin ta. ethical concerns in managing critically ill patients. in critical care medicine: principles of diagnosis and management in the adult, 2dn edition. st. louis (mo): mosby; 2002:1447-1464. 2. da silva g, da silva r, ferreira m. technologies in intensive care: causes of adverse events an implications to nursing. rev bras enferm. 2016;69(5):915-923. http://dx.doi.org/10.1590/0034-7167.2016690505 3. thomas a, galvin i. patient safety incidents associated with equipment in critical care: a review of reports in the uk national patient safety agency. anaesthesia 2008;63(11):1193-1197. https://doi. org/10.1111/j.1365-2044.2008.05607.x 4. vincent c, taylor-adams s, stanhope n. framework for analyzing risk and safety in clinical medicine bmj 1998;316(7138):1154-1157. https://doi.org/10.1136/ bmj.316.7138.1154 5. martinez-licona f, azpiroz-leehan j, cadena-méndez m, coronel j, rechy e. hospital technological failure classification. in iii cong. colombiano de bioing. ing. biomédica, pereira, colombia, 2008:1-4 (in 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press; 2009. 13. luca l. a new model of ishikawa diagram for quality assessment. in iop conf. ser. :mater. sci., kozani, grecia; 2016:1-6. https://doi.org/10.1088/1757-899x/161/1/012099 14. norma oficial mexicana nom-025-ssa3-2013, para la organización y funcionamiento de las unidades de cuidados intensivos on diario oficial de la federación; 2013. available at: https://www.gob.mx/cms/uploads/ attachment/file/35891/nom-025-ssa32013.pdf 15. core medical equipment. on world health organization; 2011. available at: https://apps.who.int/iris/ handle/10665/95788 16. wåhlin i, ek ac, lindgren m, geijer s, årestedt k. development and validation of an icu-specific pressure injury risk assessment scale. scandinavian journal of caring sciences 2020. https://doi.org/10.1111/ scs.12891 17. asefzadeh s, yarmohammadian m, atighechian g. clinical risk assessment in intensive care unit. international journal of preventive medicine 2013;4(5): 592-598. https://www.ncbi.nlm.nih.gov/pmc/articles/ pmc3733191/ 18. homauni a, zargar s, hazrati e, markazi n. intensive care unit risk assessment: a systematic review. iranian journal of public health 2020;49(8):1422-1431. https://doi.org/10.18502/ijph.v49i8.3865 19. perez-ramos s, martinez-licona f. failure analysis to evaluate the functioning quality of medical devices: case of the volumetric ventilator in the adult intensive care area. in proceedings of the nacional congress of biomedical engineering, mexico 2020;7(1):351-358, 2020 (in spanish). http://memorias.somib.org.mx/ index.php/memorias/article/view/783 https://doi.org/10.1017/s0266462314000051 https://doi.org/10.1017/s0266462314000051 https://doi.org/10.1002/hfm.20302 https://doi.org/10.1002/hfm.20302 https://doi.org/10.1016/j.cca.2015.06.016 https://doi.org/10.1016/j.cca.2015.06.016 https://doi.org/10.1088/1757-899x/161/1/012099 https://www.gob.mx/cms/uploads/attachment/file/35891/nom-025-ssa3https://www.gob.mx/cms/uploads/attachment/file/35891/nom-025-ssa3https://apps.who.int/iris/handle/10665/95788 https://apps.who.int/iris/handle/10665/95788 https://doi.org/10.1111/scs.12891 https://doi.org/10.1111/scs.12891 https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3733191/ https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3733191/ https://doi.org/10.18502/ijph.v49i8.3865 http://memorias.somib.org.mx/index.php/memorias/article/view/783 http://memorias.somib.org.mx/index.php/memorias/article/view/783 33 j global clinical engineering vol.6 issue 4: 2024 received june 19, 2024, accepted december 13, 2024, date of publication december 20, 2024. original research article a decision support system for rational deployment of medical equipment based on real-world data dingding jia1, haowei zhang1, yang you1, yiming li2, shunxin qian3, qilin tao4, qi su5 and heqing lu5,* 1 school of health science and engineering, university of shanghai for science and technology, shanghai, china. 2 procurement center, xinhua hospital affiliated to shanghai jiao tong university school of medicine, shanghai, china. 3 equipment department, north campus of huashan hospital affiliated to fudan university, shanghai, china. 4 department of medical equipment, children’s hospital of fudan university, shanghai, china. 5 department of medical equipment, shanghai first maternity and infant hospital, school of medicine, tongji university, shanghai, china. * corresponding author email: luheqing0811@126.com abstract objectives: to inform judgments about the efficient and rational deployment of medical equipment in hospitals and give decision support. methods: the information system for rational deployment of medical equipment (merdis) is based on asp.net mvc framework and designed with sql server database and c# language. the analysis methods are based on clinical pathway demand and multiple regression data statistics. it uses big data collected from hospitals, including current equipment deployment, clinical pathways, and other basic information, to calculate and provide each hospital with a recommended equipment deployment. results: by analyzing the data of 52 hospitals through the merdis system, it is convenient, accurate, and intuitive to get the rational deployment plan, and suggestions of different types of hospitals affected by different factors can be given conveniently, accurately, and intuitively. conclusions: the merdis system’s design provides the basis for the subsequent development of medical equipment macro data management. in the process of continuous improvement and supplementing of data, the software model will become more and more accurate and reliable. keywords—rational deployment of medical equipment, big data, decision support, asp.net. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.6 issue 4: 2024 34 jia, zhang, you, li, qian, tao, su, lu: a decision support system for rational deployment of medical equipment based on real-world data introduction at present, medical and health resources are still scarce resources in china.1–3 the problem of inappropriate deployment of medical equipment in hospitals is a significant issue. irrational and excessive purchase or insufficient deployment of large-scale medical equipment is widespread. however, there are limited studies on deploying and utilizing large-scale medical equipment.4–15 this paper aims to design a system that can enter the general information to provide a rational recommendation for the rational deployment of medical equipment in hospitals. there are multiple advantages to addressing and solving the problem of irrational deployment of medical equipment in hospitals. such benefits include, among others, an increase in the utilization efficiency of medical equipment resources, improving the care and health of patients, reducing medical appointment waiting lists for diagnosis and treatment, and ensuring that newly established hospitals are adequately and efficiently equipped. as such, many benefits arise for patients, health practitioners, and hospital management in establishing an effective medical equipment deployment planning system. this is particularly important in public hospitals where resources are limited, and capital expenditure needs to be carefully managed. the deployment of medical equipment is typically the remit of the hospital equipment department. indeed, there is a body of domestic literature on the methods of medical equipment deployment. however, such literature tends to be limited to a certain hospital and does not consider the hospital as a unit.4,5 furthermore, foreign research explicitly focuses on emergency medical equipment control methods.3 either for the special situation of medical resources allocation analysis7,8, to solve this problem ethically9, or for the allocation of scarce medical resources research. there are many domestic pieces of research on the purchase decision analysis of medical equipment10–13, but they are not based on much actual data research. there is a gap in the literature as it has not yet considered the potential role of detailed and complex statistical investigation in equipment deployment. the information system for rational deployment of medical equipment, or merdis for short, is developed with c# language, and the main framework is asp.net mvc. this study investigated the basic information of 52 hospitals in shanghai and other provinces to provide a data basis. the investigated hospitals include various types. the merdis analyses the above data in the database and gives the corresponding deployment plan recording to the hospital parameters. methods functional requirements analysis the deployment quantity of medical equipment should be directly affected by the frequency of such equipment, and the frequency of equipment is directly affected by the frequency of surgeries and visits in the hospital. at the same time, the hospital’s level, built-up area, and physical resources cause differences in the frequency of surgeries and visits. the annual income of the hospital directly reflects the differences in the frequency of operations and visits among hospitals. therefore, the deployment method can be designed based on the above information. the different influence factors were analyzed and processed by collecting the above data. then, a rational deployment plan of medical equipment in different hospitals is provided to ensure the rational deployment plan of medical equipment in the hospital. the main users of merdis are the hospital equipment managers or the relevant personnel of the hospital procurement center. ordinary users have the authority to log in, register, enter information, query the deployment plan, and other functions. based on the functions of ordinary users, administrators have the authority to manage user information, hospital information, information check, and modification. the information users enter includes the hospital’s basic influencing factors, the deployment information of medical equipment, and the clinical pathway information. figure 1 is a usage case diagram of the merdis. system design ideas and architecture the key technology on which the system is based is the asp.net mvc framework. asp.net mvc is a framework for building scalable, standards-based web applications using well-established design patterns and the power 35 j global clinical engineering vol.6 issue 4: 2024 jia, zhang, you, li, qian, tao, su, lu: a decision support system for rational deployment of medical equipment based on real-world data of asp.net and the .net framework. the mvc-based framework is divided into model, view, and controller. this framework divides data and view independently and loses the coupling between modules. the browser sends the client request to the front-end controller in this framework. the controller forwards the request according to the configuration file, and the back-end controller interacts with the processor mapper. after determining the view corresponding to the request, the data model is extracted from the database through the data interaction layer and processed. finally, the model and view of the execution result are rendered, and the interface view with data is returned to the user. this mode fully applies each component in the whole operation process and realizes the traits of dynamic modular update of the system.14–21 take data transmission, the deployment information of the hospital medical equipment used for various analyses in the system is stored in the database, the client requests the deployment recommendation from the system in the browser, the controller receives the operation instruction, and sends the data output command to the database. the corresponding part of the data in the database is taken out through the data model and then calculated by a series of algorithms in the controller. finally, the recommended or theoretical minimum deployment quantity should be fed back to the user through the view (display layer). figure 2 is the diagram of mvc parts. function module design the main application objects of merdis are medical equipment, and the main users are hospital staff. the target aim is to recommend and evaluate the deployment of medical equipment. for ordinary users, they should register before logging into the system. as the hospital data is highly confidential, for information security, the registration information should be checked by the administrator first, and then the users can log in to the system. after logging in, users can query deployment recommendations, query deployment evaluation, and upload hospital information, medical equipment information, and clinical pathway information. administrator users can process user and hospital information in the database based on the functions that ordinary users can achieve. at the same time, the information check function is added to check and approve the newly uploaded user information and hospital information. the abnormal information of users and hospitals is rejected or deleted, and only the normal data can be input into the database. figure 3 shows the functional flowchart of merdis. figure 1. usage case diagram of the merdis. figure 2. relationship of mvc parts. j global clinical engineering vol.6 issue 4: 2024 36 jia, zhang, you, li, qian, tao, su, lu: a decision support system for rational deployment of medical equipment based on real-world data database design the main entities of merdis include users, hospitals, equipment, and diseases. each entity is a table in the database. the relational table between the hospital and medical equipment is the “deployment” table, and the relational table between “disease type” and “hospital” is the “dinfo” table, which is used to represent the frequency of diagnosis and treatment of hospital diseases. for disease types, equipment, and hospitals, the relationship between the three became a table “cp”, which stores clinical pathway information. what’s more, to facilitate the representation and save storage space, a “hospital-categories” table was set up for hospital classification, an “equipment-categories” table was set up for equipment classification, and a “daily work” table to record the daily workload of different types of hospitals to different kinds of equipment, a “variables” table was set up to store calculation information. figure 4 is the database class diagram of merdis, through which we can intuitively understand the logical relationship between various table items in the database. deployment method based on clinical pathway the basic information of the 52 hospitals surveyed includes the attributes of the hospital, category, number of beds, the annual number of surgeries, the number of doctors, the annual medical income, and the building area of the hospital. the information on the clinical pathway includes the disease type, the medical equipment used in each pathway, the usage times of the equipment in each pathway, and the annual implementation times of each pathway. the annual demand of the clinical pathway is calculated first. based on the clinical pathway data of a hospital in the database, according to the capacity of the equipment, the annual clinical pathway demand for each kind of medical equipment in each hospital can be analyzed. because the clinical pathway on file in the hospital cannot cover all kinds of diseases, the proportion of the operational volume of the clinical pathway in the total operation quantity can be calculated according to the hospital’s annual operation quantity. the actual operation quantity of the hospital is approximately replaced figure 3. the functional flowchart of merdis. figure 4. database diagram of merdis. 37 j global clinical engineering vol.6 issue 4: 2024 jia, zhang, you, li, qian, tao, su, lu: a decision support system for rational deployment of medical equipment based on real-world data by the total number of clinical pathways used divided by this proportion to improve the accuracy of the theoretical minimum deployment value. the formula is as follows: where, “r”, “m”, “n”, “h”, “p”, “q”, and “k” are integers greater than or equal to 1. and “m” is the annual usage times of the clinical pathway, “h” is the annual operation quantity of the hospital, “n” is the usage times of a certain kind of equipment to be studied in the clinical pathway (calculated according to the theoretical times of examinations), “k” is the total quantity of clinical pathways in the hospital, “rp,q” is the annual clinical pathway demand of equipment “q” in the hospital “p”. next, the equipment capacity of each kind of equipment is estimated. due to the influence of the environment, work process, service life, maintenance times, and other factors, the working capacity of medical equipment in the hospital is different. this method, according to clinical experience, estimates the average usage capacity of a certain type of equipment—“annual saturated working capacity” (calculated as “daily saturated workload (times) × annual start-up days”) in the form of “s”. it is worth noting that the daily saturated workload here refers to the maximum workload of the equipment under moderate working conditions rather than the continuous working capacity. finally, the theoretical minimum deployment quantity of the equipment is estimated. for the equipment to be studied, the minimum theoretical deployment of the equipment can be obtained by dividing the annual clinical pathway demand “r” by the annual saturated working capacity “s”. as: where tp,q is the theoretical minimum deployment quantity of equipment “q” in the hospital “p”. here, the value of t refers to the minimum number of deployment quantities to meet the normal completion of the hospital’s in-patient operation, rather than the most rational number of the deployment. deployment method based on big data big data analysis refers to advanced and efficient data mining and machine learning techniques applied to a large amount of data. research work and results in big data analysis are continuously rising, and more and more new and efficient architectures, programming models, systems, and data mining algorithms are proposed.21–23 in addition to the clinical pathway, this study also investigated the deployment of medical equipment in hospitals, including the quantity, grade, annual frequency of tests, annual income, service time, and maintenance cycle of certain medical equipment in each hospital. at the same time, nine independent variables such as the attribute of these hospitals, annual operation quantity, medical income, number of beds, and built-up area were also investigated as the influencing factors of medical equipment deployment. based on the big data of these hospitals, the recommended deployment plan of medical equipment in a hospital can be given on the premise that the medical equipment of all the hospitals investigated is rationally deployed. the least square method is used to calculate the multiple regression equation in the following format: where ai is the coefficient, xi is the basic parameter value, n is the number of impact factors, and t is the recommended deployment quantity based on big data. after each calculation, the regression coefficient is stored in the database to facilitate the next calculation. this deployment method mainly applies to newly established hospitals or hospitals preparing for consultation. other influencing factors in this study, we can potentially enhance the deployment of medical equipment by integrating three key factors: average length of stay (alos), outpatient visits, and diagnosis procedure numbers. these factors have been shown to significantly influence the demand for medical resources.24–28 (1) (2) (3) j global clinical engineering vol.6 issue 4: 2024 38 jia, zhang, you, li, qian, tao, su, lu: a decision support system for rational deployment of medical equipment based on real-world data calculation of alos: alos is a critical indicator that reflects the hospital’s capacity usage and helps predict the demand for in-patient-related medical equipment. the formula used is as follows: where losi is the length of stay for patient i, and n is the total number of patients. according to studies, alos directly correlates with the equipment needs of hospitals with longer in-patient stays.24,25,28 prediction of outpatient visits: outpatient visits are essential for predicting the demand for outpatient medical equipment. we use regression analysis to forecast future outpatient visits based on historical data: where is the predicted outpatient visits, α is the intercept, β is the trend coefficient, and ∈t represents the error term. this model was influenced by previous studies that emphasize the importance of outpatient volume in medical resource allocation. diagnosis procedure numbers: diagnosis-related procedures require different types and quantities of medical equipment. we model this as a linear programming optimization problem, considering the demand for each procedure type and the available hospital resources. the optimization model is as follows: where cij is the cost associated with assigning equipment j to procedure i, and xij is the number of equipment units assigned to each procedure. this method is derived from existing models that allocate medical resources efficiently based on diagnostic needs.25–28 the final optimization model combines alos, outpatient visits, and diagnosis procedure numbers to allocate (5) resources dynamically. the goal is to minimize costs while satisfying the demand for each hospital’s medical equipment based on real-time data. results after the user logs into merdis, the system will obtain the corresponding user’s information, including the name, the hospital where they work, and the user type, and then display the user information under the function bar of the home page, as shown in figure 5 (taking the administrator home page as an example). at the top of the home page is the function bar. for ordinary users, there are new hospital information imports, new equipment information imports, contact information, and logouts. on this basis, administrator users have user information management, hospital information management, and information check. the homepage has three main functions: deployment recommendation, evaluation, and settings. the deployment recommendation is to query the newly established hospital’s medical equipment deployment plan by giving this hospital’s basic information. deployment evaluation evaluates the current deployment of medical equipment in the hospital, analyzes whether the deployment plan is rational, and offers suggestions. users can click “home page” to return to the main interface during use. take the deployment of ct (64 detectors) and mr (1.5t) in a first-class hospital of obstetrics and gynecology as an example. the basic information and deployment of the two medical devices in the hospital are shown in tables 1 and 2. according to the data in tables 1 and 2, formula (1) can be used to calculate the theoretical annual clinical pathway demand of ct (64 detectors) and mri (1.5t), and then formula (2) can be used to calculate the theoretical minimum deployment number based on the clinical pathway. for example, the theoretical minimum deployment number of ct (64 detectors): (4) (6) 39 j global clinical engineering vol.6 issue 4: 2024 jia, zhang, you, li, qian, tao, su, lu: a decision support system for rational deployment of medical equipment based on real-world data the data in table 3 shows that the number of ct (64 detectors) deployments in the studied hospitals meets the demand of clinical pathways, and the deployment is more appropriate. the number of mr (1.5t) deployments is lower than the theoretical demand, which cannot meet the medical needs of patients in this hospital. each hospital can get its own deployment plan recommendation and evaluation by filling in the relevant information. at the same time, the information in the database is becoming more and more complete in the user operation. table 1. clinical data statistics of shanghai first maternity and infant hospital in 2019. hospital level hospital type operation quantity (times) annual clinical pathway usage (times) first-class maternity hospital 65108 11881 figure 5. deployment evaluation page. table 2. usage of ct (64 detectors) and mri (1.5t). equipment name total number of clinical pathways used annual start-up days daily saturated workload (times) ct* (64 detectors) 2714 250 120 mr** (1.5t) 4182 250 40 *ct = computed tomography; **mr = magnetic resonance. table 3. comparison of actual equipment deployment quantity and calculation results. equipment name r s actual equipment deployment quantity theoretical minimum deployment quantity recommended deployment quantity ct* (64 detectors) 14873 30000 1 0.4958 1.3384 mr** (1.5t) 22918 10000 1 2.2918 2.3146 *ct = computed tomography; **mr = magnetic resonance. j global clinical engineering vol.6 issue 4: 2024 40 jia, zhang, you, li, qian, tao, su, lu: a decision support system for rational deployment of medical equipment based on real-world data including alos, outpatient visits, and diagnosis procedure numbers in the medical equipment deployment model has significantly improved the efficiency of resource allocation. alos, in the decision-making process for allocating medical equipment, hospitals with longer average lengths of stay may require increased medical equipment resources or optimization of their treatment processes. our system can effectively reduce hospital stays and improve hospital efficiency through the rational use of medical devices and resource allocation. outpatient visits: hospitals with high outpatient volumes require more equipment to meet patient needs effectively. this is consistent with other literature, emphasizing the importance of forecasting outpatient visits for better resource planning. when deploying medical equipment, the quantity or type of equipment should be allocated based on the hospital’s outpatient visit volume, such as increasing outpatient equipment in high-volume hospitals or updating equipment. number of diagnostic procedures by type: diagnostic procedures directly influence the type and quantity of medical equipment required. by incorporating the demand for specific procedures into the optimization model, we can ensure that resources are allocated according to the varying needs of different procedures. this approach ensures that hospitals are better prepared for both routine and complex procedures. for example, some hospitals may specialize in cardiology or orthopedics, and the equipment needs of these departments may differ significantly from others. the allocation strategy can be adjusted based on the hospital’s specific needs. in conclusion, this study highlights the importance of integrating multiple real-world data factors—alos, outpatient visits, and diagnosis procedure numbers—into a decision support system for medical equipment deployment. the model improves resource utilization, helps reduce wastage, and ensures that hospitals are better equipped to handle fluctuating demands. to validate the practicality and reliability of our system, a satisfaction survey was conducted among doctors and patients at the shanghai first maternity and infant health hospital. the survey assessed various aspects including the rationality of equipment layout, user convenience, and user satisfaction, with each aspect rated on a scale of 1 to 5, where 5 indicates very satisfied and 1 indicates very dissatisfied. it can be observed from the table that our system has provided a certain level of assistance in the rational placement of medical equipment. physicians, as professionals, tend to rate the rationality and convenience of equipment layout more highly, while patients, as recipients of services, focus more on the convenience and comfort of the medical process. consequently, there is a certain degree of variation in these ratings, which also suggests that as medical institutions, we need to pay attention to the needs of patients, improve the layout of equipment, enhance patient convenience, and thereby increase overall user satisfaction. discussion the merdis system makes it convenient, accurate, and intuitive to get a rational deployment plan and suggestions for medical equipment in the hospital. according to the frequency of clinical pathways on medical equipment and the working ability of the equipment, the theoretical minimum number of medical equipment deployments in different influencing factors can be calculated by the formula, and the recommended deployment quantity of medical equipment can be obtained through the calculation method of big data. due to the difficulty of data research, the current data of 52 hospitals is not complete enough, and the deployment of medical equipment is only limited to large medical equipment. in the case of continuous data input and enrichment, the calculation model will become more accurate and expand the scope of medical equipment covered. table 4. survey results. interviewee rationality of equipment layout user convenience user satisfaction (%) physicians 4.6 4.7 95.2 patients 3.8 3.2 82.1 41 j global clinical engineering vol.6 issue 4: 2024 jia, zhang, you, li, qian, tao, su, lu: a decision support system for rational deployment of medical equipment based on real-world data when the data tends to be complete and the number of statistical years increases, the function of forecasting the purchased quantity of equipment can be added to the later system version. by the annual average growth rate method, the annual growth rate of equipment deployment can be analyzed, and the annual deployment quantity of the next year or even several years can be estimated according to the equipment deployment base at the end of the previous year.5 the formula is as follows: where y0 represents the initial number of devices configured in the starting year of recording, yn denotes the number of devices configured in the most recent year, n is the number of years for which statistics are compiled, and r represents the annual average growth rate of device configuration. the working capacity of different equipment is also different, and the same kind of equipment is used in different models and working environments. later research can be closer to the direction of full-cycle management of medical equipment, real-time monitoring of the use of medical equipment, and increase the accuracy of statistics. conclusion the merdis system represents a groundbreaking advancement in medical equipment management, providing a solid foundation for the future development of macro data management in this sector. its ability to analyze vast amounts of hospital data, encompassing equipment deployment and clinical practices, offers significant insights and improvements in the field. the system’s intuitive interface and analytical capabilities enable healthcare institutions to conveniently and accurately devise rational deployment plans tailored to their specific needs and influenced by various factors. this technology-driven approach promises to streamline the decision-making process for medical equipment resource allocation, leading to more efficient and effective utilization of medical assets. as the merdis system progresses, with ongoing refinements and the accumulation of more data, its predictive models are expected to become increasingly accurate and dependable. this evolution will further empower healthcare decision-makers, enhancing their ability to allocate resources optimally. the success of the merdis system is also a credit to the collaborative efforts of participating hospitals, individuals, and various supporting organizations, including the shanghai municipal health commission’s policy research project, the national natural science foundation of china, and the shdc clinical research plan. their contributions have been pivotal in realizing this innovative project, which exemplifies the power of integrating technology with practical data to revolutionize hospital resource management. acknowledgment the authors wish to thank the study participants for their contribution to the research and current and former investigators and staff. the authors would specifically like to thank north hospital of huashan hospital-fudan university, north hospital of ruijin hospital-shanghai jiaotong university school of medicine, shanghai municipal hospital of traditional chinese medicine, and international peace maternity & child health hospital of china for their research and administrative assistance. funding this work was supported by the planning project of shanghai science and technology [21s31902100], the national natural science foundation of china [82073474], the management project of shanghai hospital development center [2024skmr-27], and the national institute of hospital administration [2022meb108]. references 1. yuan, l., cao, j., wang, d., et al. regional disparities and influencing factors of high quality medical resources distribution in china. int j equity 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https://doi.org/10.1186/s40537-021-00555-2 https://doi.org/10.1108/mrr-09-2021-0648 https://doi.org/10.1186/s12962-021-00322-3 j global clinical engineering vol.6 issue 1: 2023 36 received august 16, 2023, accepted november 18 2023, date of publication december 6, 2023 clinical engineering and health policies in venezuela: challenges and achievements in a changing political context by rodrigo mijares simón bolívar university, research and development foundation, health technology management unit (ugts-usb), caracas, venezuela abstract this article summarizes the evolution of clinical engineering in venezuela and its interaction with the political environment and health policies. method: the study consists of a comprehensive review of publications from the health technologies management unit of simón bolívar university throughout 1992-2023, organized into three thematic areas: technological and environmental; relationship with public health policies; and influence of the political system. conclusions: the early history of clinical engineering in venezuela stands out for its impact on training and technological management to ensure quality and efficiency in the venezuelan healthcare system. in the first area, it demonstrated the potential for improvement in medical technologies, generating high expectations. the second area focuses on the relationship between technologies and health policies, emphasizing the need to align public policies and technological management. however, challenges identified include the lack of evaluation and selection of appropriate medical technologies and political influence in acquisitions. the third area addresses political influence on the quality of medical care, emphasizing the importance of considering political and technological aspects in decision-making. keywords – clinical engineering, health technology, public policies, political systems. copyright © 2023. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 37 j global clinical engineering vol.6 issue 1: 2023 rodrigo mijares: clinical engineering and health policies in venezuela: challenges and achievements in a changing political context introduction venezuela’s humanitarian crisis, the resurgence of vector-borne diseases, and the implications of contagion in the region are well known [1]. what is little known is the struggle of the health management unit to improve medical technologies. health technologies are attached to the research and development foundation of the simón bolívar university (ugts-usb). for the last 30 years, ugts-usb has conducted clinical engineering research. in this article, we will share how these investigations have been enriched thanks to the interaction with other areas of knowledge in a context marked by the political situation in venezuela, like many latin american countries. however, we want to point out that this experience is in venezuela. the desire is to make known a little-known reality. our contribution in this field is especially relevant due to the challenges we have faced when researching in a country that has gone from a fragile democracy (19921999), authoritarianism (1999-2018), and finally, a dictatorship (2019 to the present). initially, our focus focused exclusively on technology and the environment, aiming to develop technical capabilities and solve problems around clinical engineering. however, we soon realized that it was crucial to understand and consider the country’s political system to have any impact on society. therefore, we broadened our perspective and understood that technologies originate through public health policy. in this way, our research took a new direction, incorporating health policy study, evaluation, and analysis. this more holistic understanding allowed us to generate greater value in our research and, most importantly, better understand the results obtained for the national and international organizations requesting our work. by considering the country’s political context, we were able to interpret the results of our contributions more accurately and how these may or may not be accepted to contribute to improving the health system in a challenging environment, as is often the case in countries of latin america. methodology the study consists of an exhaustive review of ugts-usb publications covering the period 1992-2023, categorizing them into three thematic areas: a) technological and environmental approach: we focus on advancing technical capabilities in the field of clinical engineering. we explore how these capabilities have delivered tangible results, particularly in a democratic context. b) intersection of technologies and public health policies: this area delves into the integration of health technologies into public policies. examines how this integration can influence the application and utilization of technologies, especially in a politically authoritarian system. c) influence of the political system: the third area focuses on analyzing how the political system, particularly a dictatorship, impacts the performance of public policies. since the article is a narrative, table number 1 is presented to analyze the essential elements that characterize it. characters protagonist the health technologies management unit (ugts-usb), affiliated with the research and development foundation of simón bolívar university, is the central figure in this narrative. antagonists during the research period, governments emerged as the primary antagonists. in secondary roles, national institutions, private companies, organized social entities, and nongovernmental and international organizations that commissioned the research also feature, each playing a role that adds complexity to the narrative. setting place venezuela, located in south america. table 1. fundamental elements of the article narrative. rodrigo mijares: clinical engineering and health policies in venezuela: challenges and achievements in a changing political context j global clinical engineering vol.6 issue 1: 2023 38 historical period 1992-2023 political conditions fragile democracy (1992-1999), authoritarianism (1999-2018) and finally a dictatorship (2019 to present). social conditions of the protagonists the decrease in university salaries in the last 22 years in venezuela reaches historic levels. at the end of 2001, a full-time professor had a salary equivalent to about $2,440. for january 2023, the salary of a top-level and dedicated teacher is $26.14, calculated at the official rate of the central bank of venezuela (bcv). mood during the democratic period, hope, optimism, and confidence defined our days, even facing challenges. the transition to authoritarianism plunged us into a sense of “amazement” as we witnessed foreign professionals taking precedence over venezuelans. in the dictatorship phase, tension gripped us. regime sympathizers closely monitored the execution of projects with international organizations within hospitals. aware that we could face disappearances or imprisonment upon completing our tasks, we lived under constant pressure. however, we keep the hope alive for a return to democracy in venezuela and eagerly anticipate contributing to improving our healthcare system. theme this article summarizes the evolution of clinical engineering in venezuela and its interaction with the political environment and health policies. point of view we opt for the first person, identifying ourselves with the acronym ugts-usb. this approach immerses us in an intimate perspective, allowing us to explore the thoughts and emotions of the management unit throughout its research journey. conflicts inside the ugts-usb during the democratic era, internal harmony prevailed as we all belonged to the engineering field. however, resistance surfaced within the group with the onset of authoritarianism and the incorporation of areas related to public policies and knowledge of political systems. this juncture evolved into a phase of discussion and analysis, highlighting the imperative to address conflicts and integrate specialists in those areas. external in the democratic period, access to information was relatively straightforward. yet, during authoritarianism, although we could gain entry to health institutions, formal requests for information often went unanswered. the challenge escalated during the dictatorship when we lacked access to public institutions and information. when access was finally secured during the dictatorship, it came through international organizations, with the commitment to maintaining information confidentiality—no direct or indirect disclosure to third parties without the prior written consent of the contracting party. the possession of sensitive information directly impacting the health of venezuelans, coupled with the inability to disclose it, poses an ethical and moral conflict. nevertheless, we maintain hope that these highly esteemed organizations will carry out effective work. style we adopt a realistic approach reflected in the faithful and detailed representation of reality over time, as depicted in our published research. our narrative authentically portrays everyday life and organizational dynamics. before publication, many of our investigations underwent public discussions, hoping they would be subject to contradictions and debates, fostering a broadening of perspectives. however, our resource constraints and the necessity to meet established deadlines added an additional challenge to this process. source: table prepared by the researcher. information on social conditions can be detailed in: human rights observatory (2023), on its website. historical background the early history of clinical engineering in venezuela is characterized by three fundamental milestones that have shaped its evolution. in the 1970s, a technical health training program known as “hipólito unanue” was established, which impacted not only venezuela but throughout latin america, laying the foundations for the training of personnel in the management of technologies. in 1993, a survey conducted among engineers from the foundation for the maintenance of medical assistance infrastructure https://www.uladdhh.org.ve/index.php/2023/01/18/sueldo-de-profesores-universitarios-en-venezuela-representa-el-1-de-lo-que-ganaban-en-2001/ 39 j global clinical engineering vol.6 issue 1: 2023 rodrigo mijares: clinical engineering and health policies in venezuela: challenges and achievements in a changing political context (fima) revealed the pressing need for training in medical devices, underscoring the importance of continuous training in this constantly evolving field.2 however, the highlight was the introduction of clinical engineering in venezuela in 1992 under the visionary guidance of professor luis lara estrella. his focus on technological management as an integral part of health care led to the creation of the health technology management unit (ugts), which became a fundamental pillar in optimizing technological aspects in health institutions. his definition of clinical engineering as integrating various engineering and management processes, seeking efficient and effective technological management with high availability and satisfaction, reflected the holistic vision necessary to ensure quality and efficiency in medical care.3 these historical milestones marked the beginning of clinical engineering in venezuela and underlined the crucial relevance of technical training in health. the combination of technical training and sound technological management became the cornerstone to ensure the quality, availability, and efficiency of medical infrastructure and devices used in the country’s health system. results a) the first area was technological and environmental. in the first area, which spanned since 1996, the venezuelan health system observed a push toward technological and environmental modernization. a notable milestone was the transformation of the jm de los ríos children’s hospital into an autonomous service as part of the decentralization of the health system. the newly assumed administration decided to work with the ugts-usb to improve the hospital’s technological capacity, which resulted in a significant increase in the hospital’s operational level, rising from 26% to 64% in just one year.4 the operational level refers to recovering installed technologies, which require corrective maintenance. the fundamental points that generated this positive and encouraging result have to do with a) financing; b) political decentralization; c) transparency, by having scrutiny by the press or any interested organization; and d) the link between the hospital authorities (public world), the university (knowledge), and the private world. on the other hand, the european community generously offered financing to continue the modernization process. however, the political dynamics changed under the new administration led by mr. hugo chávez. the proposal to involve the cuban government in the project caused disagreements and tensions, ultimately preventing this opportunity from materializing. this disruption negatively impacted the hospital’s ability to provide quality care to patients by limiting their access to technology and resources that would have significantly improved medical services. to understand the decision of president hugo chávez, to create a new healthcare model in venezuela, directed and inspired by cuba; an investigation was carried out with another group of colleagues from the usb. one of the most important conclusions was that the quantitative data found did not allow for measuring the impact of the cuban mission, expressed in the population’s improvements in health conditions and the prevention of diseases.5 in 2001, an evaluation of the ministry of health’s main hospitals revealed a common deficiency in their technological management, highlighting recurring problems in key areas such as the electrical system, elevators, and air conditioning systems. this lack of adequate technology management posed significant challenges to providing an optimal healthcare environment.6 in 2019, evaluations were carried out in two hospitals in caracas by the ugts-usb, under the observation of international organizations. although the results were not published due to confidentiality requests, it can be noted that the hospital infrastructure experienced a deterioration concerning the evaluation narrated in the previous paragraph. this decline was exacerbated by a drinking water shortage and environmental sanitation deficiencies resulting from inadequate cleaning practices. additionally, a worrying 23% rate of healthcare-associated infections was recorded. the work was presented to the country’s health authorities and international organizations. rodrigo mijares: clinical engineering and health policies in venezuela: challenges and achievements in a changing political context j global clinical engineering vol.6 issue 1: 2023 40 in 2001, the essential public health functions (fesp) of the ministry of health of venezuela were evaluated. “guarantee and improvement of the quality of individual and collective health services” obtained the lowest score.7 these results highlighted the importance of addressing technology management in health policy planning. these results prioritized our future work. the ugts-usb prioritized the creation of a protocol for the evaluation of medical devices, which, after its development, obtained approval from the ministry of health as official policy. however, despite these established regulations, devices purchased by public entities do not undergo evaluations before use, raising concerns about the effective implementation of such a policy.8 likewise, it should be noted that the medical devices used and acquired by cuba were not subjected to evaluation either. the ugts-usb included the incorporation of the environmental aspect in the studies. the disposal of hospital waste and mercury by dental personnel were evaluated. the findings pointed out deficiencies in waste management and potential health risks in the hospital environment, underlining the importance of addressing environmental aspects in the management of technologies.9-10 in 2013, a study carried out in collaboration with an oil company exposed the relationship between technological management and health infrastructure by identifying damage to medical equipment due to fluctuations in the electrical supply. this example highlighted the systemic challenges in technology management and its impact on public service delivery.11 finally, with the emergence of the covid-19 pandemic in 2020, the capacity for collaboration between health organizations (private clinics), private companies, and universities in creating essential medical devices was demonstrated. the response to the crisis led to the development of mechanical ventilators and protective equipment prototypes, evidencing the importance of clinical engineering in critical moments of public health. although the work was presented to the red cross and communication was maintained with government entities, the expected viability was not achieved, highlighting possible challenges in promoting and accepting innovations in the health system.12-13 these episodes highlight the evolution of clinical engineering in venezuela over the decades, marked by technological advances, political challenges, and the importance of technical training and effective management to ensure quality and efficiency in medical care. b) the second phase includes the relationship between technologies and public health policies. research and health policies adopted by developed nations significantly influence public health strategies in developing nations. typically, this process involves adaptation, collaboration, and consideration of local needs. effective public policies in health must be based on scientific evidence, local context, and international collaboration. our first work on this topic took place in 2003, in collaboration with the venezuelan society of cardiology, when the institutional performance of a cardiology service was evaluated from 1990 to 2000. this analysis found that the service complied with 73% of the guidelines established by the american college of cardiology and the american heart association (aha).14 it should be noted that technological considerations were not addressed in this study. in 2004, we developed a conceptual and methodological proposal in the context of a medical technology management project sponsored by the ministry of health. the main objective was to establish coherence between public health policy and medical technology management.15 subsequently, after a year of studying the health system in france at the university of nancy, we wrote an article in 2005 to conceive a political-management model, supported by two specific experiences: a) the execution of projects in various health institutions in venezuela and b) an in-depth analysis of the european health system, particularly the french system.16 our approach is built on a series of crucial steps that allow for a more effective and sustainable intervention: defining objective morbidity and mortality, analyzing the 41 j global clinical engineering vol.6 issue 1: 2023 rodrigo mijares: clinical engineering and health policies in venezuela: challenges and achievements in a changing political context if we focus on the technological aspect in the health area, although venezuela has its own human resources, as a financial provider, it could be expected that its personnel would have a dominant position in the relationship. however, it is totally passive. currently, due to the economic situation that venezuela is going through, experts warn of a notable technological lag in the field of medical technologies. more than 60% of medical equipment is estimated to be obsolete.20 no other situation could be expected because, in both authoritarian and dictatorial periods, the positions of the venezuelan specialists who had decision-making were postulated, not because of their capacity but because of their ideological affinity. other specialists think that the venezuelan government found in cuba great support to develop its regional political project, involving the military sphere to remain in power, avoid uprisings, and fight against internal opposition and international pressure that advocates for a regime change in venezuela.21 c) the third area will analyze how the political system influences the quality of medical care. we are fully aware of the importance of considering political and technological aspects when making sound decisions. for a broader understanding, it is enriching to examine the work of togerson.22 an illustrative example is evident in evaluating the quality of cardiology services in a hospital during the study period (1990-2009). in the first stage (1990-1999), a decline in the quality of care is observed, decreasing from 73% to 58% in the second stage (1999-2009), influenced by two contrasting political systems.23 in the second stage, despite implementing improvements in the environmental setting and acquiring medical devices (unfortunately, we lacked information on the entity responsible for these acquisitions and on the evaluation of the quality of these devices, in compliance with health oversight), a decrease in the quality of medical care was observed. the increase in coverage by 75%, without conducting fundamental studies to structure the local care offering [16] effectively, resulted in a decline in quality. the results were shared with authorities and patients. in determinants of health, evaluating current public health policies, delimiting the geographic and local context, and selecting the relevant technologies. without a doubt, it is imperative to have the participation of all the actors involved to carry out this work. delimiting the geographical and local context is essential due to the great differences in venezuela. our study considers data from various sources and finds relevant differences between territorial entities when designing national public policies based on evidence.17 throughout our work in public health policies related to the cardiovascular system, we have observed a lack of evaluation and even less in selecting appropriate medical technologies. in this sense, it has been identified that the acquisitions of technologies after 1999 have been carried out through agreements with ideologically related allied nations. in many cases, they are selected by another country without due evaluation of their quality and relevance. an example of acquisitions from ideologically related countries was observed in the adoption of radiotherapy and nuclear medicine rooms in 19 public centers through a bilateral agreement with argentina in 2011. this agreement revealed that numerous pieces of equipment lost their five-year maintenance guarantees because they were at customs. in addition, several regulations related to radiotherapy and those of the health comptroller’s office were not complied with. unfortunately, the clause relating to the training of human resources was not adhered to.18 in october 2000, the cuba-venezuela comprehensive cooperation agreement was established, a strategic mechanism that would impact both countries’ health, economy, education, sports, and culture. the relationship between them is determined by two fundamental variables: politics and economics. in the political sphere, both nations share a socialist ideology. however, economically they seek progress through cooperative advantages, through the exchange of goods and services according to their respective capabilities. venezuela provides oil, while cuba provides its human capital.19 rodrigo mijares: clinical engineering and health policies in venezuela: challenges and achievements in a changing political context j global clinical engineering vol.6 issue 1: 2023 42 2014, hospital authorities decided to revert to the same coverage they had in 1999, indicating a lack of preparedness to manage a 75% increase in the population served in the second stage. likewise, we conducted a comparative analysis of the management status of the jm de los ríos children’s hospital about its situation two decades ago (1996-2016). in 1996, a significant improvement in operational capacity was evident, increasing from 26% to 64%. however, by 2016, a reduction in operability was observed, falling below 25%. additionally, unsanitary conditions were identified, such as contamination of freshwater sources.24 it is worth mentioning that, in 1999, despite the european community seeking collaboration on the technological improvement project alongside the usb, this initiative did not receive government approval.4 these unsanitary conditions, among other pieces of evidence, were used by the non-governmental organization “prepara familia” to request the adoption of measures to protect the rights to life and personal integrity of the children hospitalized at the jm de los ríos hospital. consequently, in february 2018, the inter-american commission on human rights (iachr-oas), in its resolution 8/2018, issued precautionary measure no. 1039-17, which was expanded in resolution 43/2019 dated august 21, 2019.25-26 in 2018, we shared our first experience with an organized civil society that had the desire to collaborate in improving the healthcare system in their municipality. ugts-usb gathered information and transformed it into a “social agenda” aligned with the constitution. subsequently, this agenda was discussed with various regional social and political stakeholders.27 the regime rejected the support. later, with the support of an international agency (which we are prohibited from identifying), we managed to secure adequate funding to improve the living conditions of healthcare professionals in the locality. subsequently, the civil association took the initiative to create its own spaces to provide medical care to the region’s citizens. in 2021, two international organizations hired ugtsusb to conduct research to assess the situation of hospitals. however, restrictions limiting the disclosure of the resulting information made it impossible to make the obtained results public. we do not want to speculate on the reasons for this limitation. nevertheless, it is important to note that censorship impacts the discussion of issues concerning the problems in venezuela in the context of a dictatorial government situation. finally, based on our experiences, we propose conducting “longitudinal analysis of the intersection between the political system, public policies and technological management in the context of health”, abbreviated as “policy-tech.” however, the challenges we face in this type of research are notable, especially regarding information acquisition. describing a political system seems like a relatively accessible task. when it comes to public policy, a review of medical records (when possible) reveals a loss of 47% of such records. however, collecting technological information in a longitudinal analysis is the real challenge. critical data such as annual inventory, operational status of the equipment, life history of the equipment, operation and maintenance manuals, experience evaluations of technical personnel, selection procedures, and contracting of service companies, among other fundamental aspects, are non-existent. the absence of this data represents a substantial obstacle to achieving a complete and accurate evaluation. exploring the works cited in our bibliography provides suggestions for addressing these challenges. for example, in public policy, we seek guidance from statistical experts. regarding technological management, we condense our strategies into the following activities: identify colleagues or companies with experience in the institution, carry out systematic literature reviews, and establish dialogues with doctors, nurses, and technicians who manage these technologies. notably, many of these institutions had been previously evaluated by the ugtsusb, which allowed comparisons to be made that would facilitate decision-making. 43 j global clinical engineering vol.6 issue 1: 2023 rodrigo mijares: clinical engineering and health policies in venezuela: challenges and achievements in a changing political context conclusion the health system is suffering degradation as a dictatorship consolidates, resulting in a currently complex humanitarian crisis. while the general situation is widely recognized, the clinical engineering narrative is poorly understood. clinical engineering in venezuela is characterized by three fundamental milestones: the establishment of the “hipólito unanue” technical health training program in the 1970s, laying the foundation for medical technology training throughout latin america; the introduction of clinical engineering in 1992 under the visionary direction of professor luis lara estrella, focused on comprehensive technological management in health; and the evolution towards technological and environmental modernization of venezuelan hospitals, although hindered by political challenges and inadequate management. in the first realm, clinical engineering in venezuela experienced notable technological advancements, political challenges, and the constant need to adapt to ensure quality healthcare. collaboration between the public and private sectors and efficient management emerge as crucial elements to overcome these challenges. the second domain underscores the importance of coherence between health policies and technological management, the necessity of considering the local context in policy formulation, and the challenges associated with technology acquisitions lacking proper evaluations. additionally, the strategic relationship with cuba has significantly influenced the landscape of clinical engineering in venezuela. the third domain highlights how political changes can directly impact healthcare quality. instances such as the decline in the quality of cardiology services, the management of jm de los ríos children’s hospital, and collaboration with civil society emphasize the complexity and challenges associated with the interaction between the political system and public health. the presence of censorship in a dictatorial context underscores the limitations in discussing and evaluating the healthcare situation in venezuela. finally, the narrative underscores the imperative of overcoming challenges in the “policy-tech” research. however, the lack of essential data poses a substantial obstacle. nevertheless, it is recommended that these challenges be addressed by exploring cited works in the bibliography. in the realm of public policies, seeking the expertise of statistical experts is suggested to overcome the loss of records. for technological management, concrete strategies are proposed, including locating colleagues or companies with experience in the healthcare institution, conducting systematic literature reviews, and engaging in direct dialogues with healthcare professionals. the mention of previous evaluations by ugts-usb provides valuable insights to facilitate future decisions. a proactive and collaborative approach 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(2012). cáncer en los equipos. https://transparenciave.org/project/ cancer-en-los-equipos/ 19. tapias l. (2010). análisis de las relaciones bilaterales entre cuba y venezuela en materia política y económica. período de estudio 2000-2008. monografía de grado presentada como requisito para optar al título de internacionalista. universidad colegio mayor de nuestra señora del rosario. https://repository.urosario.edu.co/server/api/core/ bitstreams/56195b19-a92c-4d82-b4a3-c7070362681e/ content 20. urbina h. (octubre 2023). alertan sobre atraso tecnológico, más del 60% de equipos médicos en el país “estarían obsoletos”. prensa la caraota digital. https:// www.caraotadigital.net/venezuela/alertan-sobreatraso-tecnologico-mas-del-60-de-equipos-medicosen-venezuela-estarian-obsoletos/ 21. ledesma l (2010). las relaciones económico-comerciales entre cuba y venezuela. trabajo de grado presentada como requisito para optar al título de internacionalista. universidad pontificia de madrid, españa. https://repositorio.comillas.edu/xmlui/bitstream/handle/11531/41122/tfg-%20munoz%20 ledesma%2c%20laura.pdf?sequence=1 22. togerson douglas. “between knowledge and politics: three faces of policy anatysis”, en policy sciences, number 19, 1986, pp. 33-59. https://www.jstor.org/ stable/4532067 23. mijares r, gonzález m, rincón e y oropeza a. (enerojunio 2012). sistema político, políticas públicas, y calidad de la atención médica a las enfermedades cardiovasculares: caso de estudio en caracas-venezuela. revista gerencia y políticas de salud, 11 (22): pp. 107-122. file:///c:/users/rebeca/downloads/ adminpujojs,+3306-11914-1-ce%20(7).pdf 24. mijares r, utrera n, castro n, lugo r, y méndez (2018). evaluación tecnológica del hospital de niños josé manuel de los ríos. rev hisp cienc salud, 4(2): 78-83. https:// dialnet.unirioja.es/servlet/articulo?codigo=6786507 25. prepara familia (2019). el estado debe garantizar a los niños el derecho a la vida. boletín reto país. disponible en: https://retopaisvenezuela.org/prepara-familia-elestado-debe-garantizar-a-los-ninos-al-derecho-a-la-vida/ 26. comisión interamericana de derechos humanos. (2019). resolución 43/19, mc 1039/17 niños, niñas y adolescentes pacientes en trece servicios del hospital josé manuel de los ríos, venezuela, ampliación. disponible en: http://www.oas.org/es/cidh/decisiones/ pdf/2019/43-19mc1039-17-ve-ampliacion.pdf 27. mijares, rodrigo, utrera, nestor, castro, noel, lugo, rubén, sierra, zaida, rincón, elena, azpurua, luís, garcía, beatriz, & mijares, alfredo. (2018). agenda social para mejorar el desempeño de un sistema de salud: caso de estudio. revista de salud pública, 20(4), 430-437. https://www.redalyc.org/articulo. oa?id=42258472005 https://transparenciave.org/project/cancer-en-los-equipos/ https://transparenciave.org/project/cancer-en-los-equipos/ https://repository.urosario.edu.co/server/api/core/bitstreams/56195b19-a92c-4d82-b4a3-c7070362681e/content https://repository.urosario.edu.co/server/api/core/bitstreams/56195b19-a92c-4d82-b4a3-c7070362681e/content https://repository.urosario.edu.co/server/api/core/bitstreams/56195b19-a92c-4d82-b4a3-c7070362681e/content https://www.caraotadigital.net/venezuela/alertan-sobre-atraso-tecnologico-mas-del-60-de-equipos-medicos-en-venezuela-estarian-obsoletos/ https://www.caraotadigital.net/venezuela/alertan-sobre-atraso-tecnologico-mas-del-60-de-equipos-medicos-en-venezuela-estarian-obsoletos/ https://www.caraotadigital.net/venezuela/alertan-sobre-atraso-tecnologico-mas-del-60-de-equipos-medicos-en-venezuela-estarian-obsoletos/ https://www.caraotadigital.net/venezuela/alertan-sobre-atraso-tecnologico-mas-del-60-de-equipos-medicos-en-venezuela-estarian-obsoletos/ https://repositorio.comillas.edu/xmlui/bitstream/handle/11531/41122/tfg-%20munoz%20ledesma%2c%20laura.pdf?sequence=1 https://repositorio.comillas.edu/xmlui/bitstream/handle/11531/41122/tfg-%20munoz%20ledesma%2c%20laura.pdf?sequence=1 https://repositorio.comillas.edu/xmlui/bitstream/handle/11531/41122/tfg-%20munoz%20ledesma%2c%20laura.pdf?sequence=1 https://www.jstor.org/stable/4532067 https://www.jstor.org/stable/4532067 https://dialnet.unirioja.es/servlet/articulo?codigo=6786507 https://dialnet.unirioja.es/servlet/articulo?codigo=6786507 https://retopaisvenezuela.org/prepara-familia-el-estado-debe-garantizar-a-los-ninos-al-derecho-a-la-vida/ https://retopaisvenezuela.org/prepara-familia-el-estado-debe-garantizar-a-los-ninos-al-derecho-a-la-vida/ http://www.oas.org/es/cidh/decisiones/pdf/2019/43-19mc1039-17-ve-ampliacion.pdf http://www.oas.org/es/cidh/decisiones/pdf/2019/43-19mc1039-17-ve-ampliacion.pdf https://www.redalyc.org/articulo.oa?id=42258472005 https://www.redalyc.org/articulo.oa?id=42258472005 5 j global clinical engineering vol.6 issue 1: 2023 received may 5, 2023, accepted october 3, 2023, date of publication november 28, 2023 an analysis of adverse event reports in fda’s maude database by spilios zisimopoulos, nicolas pallikarakis institute of biomedical technology (inbit), greece abstract background and objectives: medical devices (mds) are pivotal in the modern healthcare environment. adverse events are an expected part of an md’s lifecycle. various vigilance systems have been established worldwide to prevent such events' recurrence. the manufacturer and user facility device experience (maude) database of the us food and drug administration (fda) is a publicly accessible database that contains data on medical device reports (mdrs) submitted to fda since 1991. this study aims to examine the evolution of md adverse event reports and analyze several characteristic parameters as they evolved during the last three decades. material and methods: an analysis of maude data was performed to examine the outcomes and device characteristics of adverse event reports from 1991 up to 11/2022. these outcomes included the event type, remedial action, report source, reporter occupation and device evaluation by manufacturer. specific md groups were analyzed separately to examine their effect on the event outcomes. segregated files of the database that contain different types of information on adverse event reports were combined to investigate the various aspects of these reports. results: event outcomes are presented as annual histograms. an overall of about 15 million reports have been submitted to maude during the 30 years examined with more than 2.5 million of them during the first 10 months of 2022. this number is growing at an increasing rate. most of the events (63.5%) have resulted in simple device malfunctions without serious implications to the patient. depending on the device type, however, the health risks may be higher (98.4% injuries from specific dental implants and 3.2% deaths from implantable defibrillators). about 20% of the reports have led to recalls or corrective actions. most of the reports (96%) are submitted by manufacturers, and over 70% of the devices returned to them are evaluated, following the requirements of fda 21 cfr, 803. finally, the average device age was found to be 5.4 years, with an increasing tendency observed over the years, while 43% of the events that occur are associated with devices during their first year of operation. conclusion: a medical device adverse event reporting system is a critical component of safety in the use of medical technology in modern healthcare. the information available in maude and its use continues to grow at an accelerated rate and allows critical improvements of mds, especially in terms of risk prevention, as it gives perception about their safety issues. fda has taken various steps to encourage and facilitate adverse event reporting and make the data available to the public. keywords – maude, fda, adverse events reports, medical devices, vigilance. copyright © 2023. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database j global clinical engineering vol.6 issue 1: 2023 6 introduction in today's world, medical devices (mds) have become a fundamental component of modern healthcare systems. mds range from simple face masks and syringes to complex implantable devices and medical imaging systems and are used to diagnose, treat, and manage various medical conditions. however, like any other medical procedure, mds are not without risks. adverse events can occur due to various factors like device malfunction or misuse, resulting in serious patient harm. to prevent and mitigate these risks, it is essential to have a robust md vigilance system involving health competent authorities1 and md manufacturers that investigate and eventually perform necessary remedial actions following adverse events with mds. in most developed countries md vigilance systems have been implemented for more than 30 years, aiming to reduce the likelihood of similar adverse events happening again in another place and time. the cornerstone of the md vigilance systems is adverse event reporting. a medical device adverse event reporting system is a mechanism that enables healthcare facilities, patients, and manufacturers to report incidents associated with mds. these systems provide standardized processes for reporting such events and allow the collecting and analysis of information related to md safety. such a system is of the utmost importance, as it is critical in ensuring patient safety and improving healthcare quality. one of the primary benefits of an md adverse event reporting system is that it enables healthcare providers and manufacturers to identify and address safety concerns related to medical devices. the report of adverse events by healthcare facilities helps manufacturers gain insight into the performance and safety of their devices. the information provided can then be used to identify design flaws, manufacturing defects, software problems, or other issues that may contribute to adverse events and take appropriate action to address these issues, such as modifying the device design or implementing new quality control processes. on the other hand, when information about the risks associated with specific devices is publically available, healthcare providers can investigate whether an event they faced has also been manifested in a different facility, and, in that case, follow the instructions that the manufacturer has proposed. a medical device adverse event reporting system also enables better communication between healthcare providers, regulatory agencies, and competent authorities. when adverse events are reported, the authorities can use this information to take appropriate action when necessary. for example, if a particular device is associated with a high rate of adverse events, regulatory agencies may require additional testing or labeling changes from the manufacturer to improve safety. finally, a medical device adverse event reporting system can promote transparency and accountability in the healthcare industry.(a) by publicly making information about adverse events, the system can help hold manufacturers, distributors, and healthcare providers accountable for their actions. this can help with the trust-building process between patients and healthcare providers and ensure that the healthcare industry is held to the highest safety and quality standards. the aim of this study is to examine the evolution of medical device adverse event reports, available at the manufacturer and user facility device experience (maude) database of the us food and drug administration (fda) and analyze several characteristic parameters of these reports as they evolved during the last three decades. adverse events reporting systems there are several mds adverse event reporting systems worldwide, aiming to address safety issues that arise from the use of medical devices. the reports can be generally made by manufacturers, healthcare professionals and volunteers. fda's maude database, designed to collect reports of adverse events associated with mds is the most well known, it is available to the public and can be accessed online, allowing the analysis of the available data.2 maude contains the reports submitted through the medical device reporting (mdr) system, which are used by manufacturers, a the competent authorities for medical devices (camd) facilitate implementing and enforcing the regulations on medical devices and on in vitro diagnostic medical devices in the eu. https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview_en#competent-authorities-for-medical-devices---camd https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview_en#competent-authorities-for-medical-devices---camd 7 j global clinical engineering vol.6 issue 1: 2023 zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database importers and users of mds. the mdr system is a mandatory reporting system, and manufacturers must report any adverse event that involves their device.3 the european databank on medical devices (eudamed) is maintained by the european union (eu) and is designed to provide a living picture of the lifecycle of mds, including modules related to device registration, notified bodied and certificates among others. the database has been established in the 2000s according to the mds directives: 90/385/eec for the active implantable medical devices (aimd), 93/42/eec (md) for the medical devices and 98/79/ec for the in vitro diagnostics. the eu vigilance system is based on the meddev 2.12/1 rev.8 series of guidelines of 2012(b) on post-market surveillance and vigilance system adopted in 2019.(c) the eu's new 2017/745 and 2017/746 mdrs, reshaped the structure and use of eudamed to improve the safety and performance requirements of medical devices bearing a ce mark.4 however, access to eudamed is restricted only to competent authorities and partially to notified bodies for devices that are involved, and the information on mds related incident reports is not yet available to other parties, despite the explicit reference in the regulations. various other adverse event reporting systems are being used at the national level. some well known examples are the australian therapeutic goods administration (tga) adverse event reporting system,5 health canada's medical device adverse event reporting (mdaers),6 uk’s medicines and healthcare products regulatory agency (mhra)7 and germany’s federal institute for drugs and medical devices (bfarm).8 these systems are used to report or access adverse events associated with mds and are open to healthcare professionals, patients and manufacturers, while they can also be accessed online. many other countries have also similar systems in place, and many manufacturers have their own reporting systems for post-market surveillance purposes. relevant work using maude a search was performed in the pubmed database on papers published from 2000 to date, with the term “maude database” included in the title or abstract of the paper (maude database [title/abstract]). this was done to include only papers whose content was focused on the analysis of maude’s data, and the search yielded 303 results. next, another query was performed, adding the terms “maude” and “fda” in the title or abstract of the journal papers (maude database [title/abstract] or (maude[title/abstract] and fda [title/abstract])). the latter broader search was performed to find articles that may have been eluded from the initial query, while keeping their content mainly based on data from maude and excluding ones with simple references and various irrelevant synonyms. the final search yielded 308 results up to 2022 (figure 1), with 31 additional articles been published during the first quarter of 2023. most of these studies analyze adverse events for specific medical device groups.9 recent years examples involve mds like injectable fillers, deep brain stimulators, middle ear prostheses, ossicular prostheses and catheters.10–14 during the last years, a couple of studies analyzed maude data taking into consideration the full spectrum of medical device groups.15–17 however, they were focused on limited aspects of the available data, like reporting source and reporter occupation, and they were published before the boom of reports submitted to maude after 2019 (figure 2). the number of studies mining the information used from maude are constantly increasing during the last ten years and provide very valuable insights on safety b https://ec.europa.eu/docsroom/documents/32305 c ttps://ec.europa.eu/docsroom/documents/32305 figure 1. pubmed articles with relevant maude terms in title/abstract. https://ec.europa.eu/docsroom/documents/32305 ttps://ec.europa.eu/docsroom/documents/32305 zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database j global clinical engineering vol.6 issue 1: 2023 8 issues concerning mds. this trend was reported in a study by p. malataras and n. pallikarakis, regarding the use of maude’s data in research between the years 2005 and 2014,9 where a linear increase of papers published each year was showcased. to add into that, a sharp increase of publications has been observed in the last couple of years, highlighting the developing interest in utilizing fda’s maude data as shown in figure 2. materials & methods the maude database was used for the analysis performed in this study. of all the afore-mentioned adverse event report databases, maude is the best structured and most complete, with data ranging from 1991 to date. furthermore, it can be easily accessed and has been used in other studies in the past. data processing and analysis was performed using the jupyter notebook web application, along with the python data analysis (pandas) and numerical python (numpy) libraries. data acquisition and pre-processing all data used in this study are publicly available on fda’s maude page.2 data available in maude span from 1991 up to 2022 (user facility reports since 1991, distributor and voluntary reports since 1993 and manufacturer reports since 1996). for the remainder of this work, data referring to the year 1997 will consist of events reported between 1991 up to 1997, according to maude’s “foidevthru1997” file. data regarding 2022 contains reports that were available on maude until 4/11/2022, due to the time of research. for the remainder of the work, data up to 4/11/2022 will be referred to as data for the year 2022. device information associated with an event was taken from the available “foidevxxxx” and “devicexxxx” files, were xxxx annotates the year. information about the adverse event was found in the files named “mdrfoithru2021”, which contains data from inception up to 2021 and “mdrfoi”, which contains data of the present year (i.e., 2022). the device and mdrfoi files were joined together using the “mdr_report_key” field as primary key. data pre-processing a total mdrfoi dataframe was created by merging the “mdrfoithru2021” and “mdrfoi” files. after data cleaning by deleting rows with wrong field format, wrong delimiter, unreadable characters, duplicate key values etc. 15,387,348 lines of data remained. the same process was carried out for all “devicexxxx” files, and a total device dataframe was created containing 15,386,069 lines of data. after merging these mdrfoi and device dataframes, using the mdr report key value as primary key, a final dataframe with 15,343,314 lines of data was created, upon which the analysis of adverse event reports was carried out. event outcomes all adverse event reports available on maude were analyzed under the scope of various event outcomes. using the various outcome codes presented below as queries, the data are organized and presented as histograms of number of reports for each year until 2022. outcomes included whether the device was evaluated by the manufacturer, event type, remedial action, problem code, and device age (year of report minus year of manufacture). event type the event type (h1 field on the 3500a form) is used to describe the impact of adverse events. it is only considered relevant by the fda when the reporter of the event is a manufacturer and makes use of the following codes: figure 2. annual maude adverse event reports. data until 4/11/2022 9 j global clinical engineering vol.6 issue 1: 2023 zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database d = death, {in, il, ij} = injury, m = malfunction, o = other, {blank}= no answer provided. only one code may be used for each event. a malfunction refers to an adverse event where the device demonstrated an unexpected behavior, without any further implications to the patient or the user. one should keep in mind that the submission of an mdr itself is not evidence that the device caused or contributed to the adverse outcome or event. moreover, the event type field is not available on the form for voluntary reporting of adverse events. remedial actions a remedial action (h7 field on the 3500a form) corresponds to any actions outside the scope of routine maintenance of a device, when necessary to prevent an adverse event from recurring that could pose safety issues. the following codes and their interpretations are being used by the maude database at this point: rc = recall, rp = repair, rl = replace, rb = relabeling, ot = other, no = notification, in = inspection, pm = patient monitoring, ma = modification/adjustment, {blank}= invalid data/ nan. according to 21 cfr part 7, recall means a firm's removal or correction of a marketed product that the fda considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.(d) a recall can be initiated by the manufacturer, the fda, or both, and may be required when a device poses a significant risk of harm to patients or users. replacement, on the other hand, is the process of providing a new, corrected or modified device to replace a defective or unsafe device that has already been distributed to patients or healthcare facilities. a replacement may be initiated by the manufacturer as a proactive measure to address a safety issue or may be required by the fda as part of a recall. in some cases, the manufacturer may offer a replacement device to patients as a voluntary corrective action, even if the device has not been recalled by the fda. apart from the removal of the unsafe device from the market and the notification, healthcare providers and patients may be requested to return the device for corrective action to address the safety issue. correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. as a result, an adverse event report may be associated with one or more remedial action codes, for example rc, rp. report source the reporting source refers to the official submitter of the report to fda. the available codes are p= voluntary report, u = user facility report, d = distributor report and m = manufacturer report. the initial reporter of the event can be any person. for example, an affected patient may choose to submit the report himself (using the 3500 form), which will then be classified as voluntary report, or send it to the manufacturer who is obligated to submit it (using the 3500a form). in the latter case, the code m will be used. track is also kept of the initial reporter. initial reporter occupation regardless of the formal submitter of an event to fda (i.e., a user or a manufacturer), the occupation of the initial reporter is recorded separately (e3 field on the 3500a form). the classification codes for the initial reporter occupation consist of three digits and can be found on the maude database site.(e) the available occupations range from physician and patient to biomedical engineer or attorney. device evaluated by manufacturer according to cfr 21, 803, §50, manufacturers are responsible for conducting an investigation of each event and evaluating the cause of the event. in case the device was returned to them and information in a report is not complete, they must provide an explanation on why, as well as the steps taken to obtain it. to this end, the “device evaluated by manufacturer” (h3 field on the 3500a form) is being used. the acceptable values are: y = yes, n = no, r = device not returned to manufacturer and {blank}= no answer provided. these values are mutually exclusive. d https://www.ecfr.gov/current/title-21/chapter-i/subchapter-a/part-7 e https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/ about-manufacturer-and-user-facility-device-experience-maude https://www.ecfr.gov/current/title-21/chapter-i/subchapter-a/part-7 https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database j global clinical engineering vol.6 issue 1: 2023 10 device age the associated device age for the adverse events was calculated by subtracting the year of the device manufacture date (h4 field on the 3500a form), as filled in by the manufacturer of the device, from the year in which the report was submitted to the fda. device groups event outcomes such as event type and remedial action were analyzed separately for various device groups. this was done to investigate the differences an adverse event may have regarding the involved device. the md groups chosen were ones with a notable percentage of each year’s total reports and are presented in table 1. results number of reports the histogram of the annual number of submitted reports to fda from 1997 to 2022 is presented in figure 1. about 15 million reports have been submitted to maude until the end of 2022 and over 2.5 million of them occurred during the last year. a big increase in the number of reports can be observed over the last few years. event types table 2 presents the distribution of event types for 6 different examples of prominent md groups, as well as all the average values for all available fda device groups that exist in maude. from the grand total of the reports in table 2, we can see that most of the events result in simple device malfunction, without further implications to the patient (63.5%). about 1% of the total reported events is associated with patient death. table 2. event type distribution for various md groups event type malfunction injury death other n/a glucose monitors ['mds', 'oyc', 'pqf'] 89.1 10.7 0.2 ≈ 0.0 glucose test ['cfr', 'lfr', 'nbw'] 90.2 9.0 ≈ 0.0 0.8 pump, infusion 98.3 1.4 ≈ 0.1 ≈ 0.2 implantable cardioverter defibrillator (non-crt) 36.3 60.0 3.2 ≈ 0.5 prosthesis, hip, semiconstrained (metal uncemented acetabular component) 2.7 95.0 0.3 ≈ 0.0 implant, endosseous, root-form 1.6 98.4 ≈ 0.0 ≈ 0.0 average for all device groups 63.5 34.3 1.2 1.0 the average numbers derived from all the available device types can vary significantly across different device groups. as observed in the trend (figure 3), there is a steady decline in the ratio of adverse events that result in deaths, from 2.5% up until 1997 to 0.3% in 2022 (r2 = 0.66). similarly, events with outcome categorized as “other” or without applicable information (n/a) decreased from 7.5% in 1997 to almost 0% in 2022 (r2 = 0.85), showing table 1. medical device groups with frequently presented adverse events fda group code group name cfr hexokinase, glucose lfr glucose dehydrogenase, glucose nbw system, test, blood glucose, over the counter mds sensor, glucose, invasive oyc pump, infusion, insulin, to be used with invasive glucose sensor pqf sensor, glucose, invasive, non-adjunctive lws implantable cardioverter defibrillator (non-crt) dze implant, endosseous, root-form frn pump, infusion kwa prosthesis, hip, semi-constrained (metal uncemented acetabular component) 11 j global clinical engineering vol.6 issue 1: 2023 zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database the increased completeness of the information provided to the fda over the years. subsequently, more incidents are manifested as device malfunctions, with 73% reported as such in 2022, compared to only 40% up to 1997 (r2 = 38%). although injury reports dropped from 49.2% in the period 1991 1997 to 26.6% in 2022, their fluctuations seem to be independent of the time (r2 ≈ 0). according to table 2, more than 90% of events related to glucose test groups have been about device malfunctions, with the rest (about 10%) being associated with injuries. in contrast, about 95% of the reported incidents of metal uncemented acetabular component hip prostheses (kwa) resulted in patient injury. similarly with implantable defibrillators, the majority of dental implant event types were categorized as injuries (98.4%). implantable defibrillators adverse events have the highest probability of death (3.2%) compared to the rest of the examined device groups, due to their crucial role in physiological heart function. finally, most of the reports regarding infusion pumps (over 98%) were about simple device malfunctions. figure 4 shows that most reports have no remedial action connected with them (80%). nevertheless, for the remaining 20%, where information is available, the most common action happens to be a recall, which is associated with three-quarters of adverse events (table 3). repair of the affected devices was a common action during 2011, 2013 and 2014 and may depend on the types of affected devices. actions categorized as “other” were more common until the mid ‘10s, while being the most common remedial action during the older years. recently, the “other” category stopped being used so frequently (7% of total reports). remedial actions different md groups are associated with different remedial actions (table 3). for example, reports involving continuous glucose monitoring devices and infusion pumps resulted in a recall action by the manufacturer or fda 9 out of 10 times. on the other hand, dental implants resulted in almost no recalls, and the main action taken by the manufacturers was either an inspection (69.7%) or replacement of the implant (26.0%). finally, about 1 out of 10 reports about glucose test device groups led to a recall, as devices like test strips are not so crucial to patient safety compared to previously referred devices. replacement (38.0%), notification (28.6%) and other (23.3%) were the most frequent remedial actions for dealing with issues such as incorrect measurements. figure 3. adverse event types. number of reports(top) and percentage evolution(bottom). zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database j global clinical engineering vol.6 issue 1: 2023 12 report source the majority of the total reports (96%) were filed by the device manufacturers, as shown in figure 5. this concerns the stricter requirements about adverse event reporting imposed on manufacturers. in the last 4 years there has been an increase in distributor reports. during these years, dental implants and implantable defibrillators were the main types of devices reported. initial reporter occupation figure 6 presents the occupation of the initial adverse event reporter. the initial reporter may be different than the one that submits the final report to fda, like in the case when a user of a medical device notifies an event to its manufacturer, who is then obligated to file an official report to the fda. physicians and other health care professionals have a constant rate of reporting adverse events. in the years 2012 and 2013, a considerable number of events were reported by attorneys. this was the period of lawsuits filed against metal-on-metal hip prosthetics manufacturers.18,19 between 2013 and 2018 about 15% of reports (peaking at 21% in 2016) were made by the patients themselves. during this period, insulin pumps and glucose sensor events were predominant, so it makes sense that home users initially made a lot of the reports. an increase in the percentage of reports initially submitted by dentists can be observed after 2019. deeper analysis showed figure 4. adverse event remedial actions. table 3. adverse event remedial action distribution for various md groupss remedial action (%) recall repair replace relabeling other notification inspection patient monitoring modification/ adjustment glucose monitoring ['mds', 'oyc', 'pqf'] 93.58 0.01 4.27 0.01 0.12 1.99 0.01 0.01 ≈ 0.0 glucose test ['cfr', 'lfr', 'nbw'] 9.55 0.10 38.03 0.02 23.27 28.60 0.02 ≈ 0.0 0.40 pump, infusion 89.86 9.53 0.05 ≈ 0.0 0.42 0.10 0.02 ≈ 0.0 0.03 implant, endosseous, root-form 0.36 0.03 26.04 0.02 3.76 0.06 69.66 0.06 0.01 average for all device groups 74.0 7.0 5.5 ≈0.1 7.0 3.6 2.1 0.2 0.5 13 j global clinical engineering vol.6 issue 1: 2023 zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database that many of the events were caused by dental implants (peaking at 24% of the total reports in 2021) during the last 4 years. finally, more events have been reported in the previous five years, especially in 2022 (35%), by other non-healthcare professionals than in the past. device evaluated by manufacturer figure 7 shows the status of reports as far as the device evaluation by the manufacturer is concerned. more than half of the devices reported (52.3%) are sent to the manufacturer, and most of them are evaluated (70.8% of sent devices). 2022 was an exception, with 55% of the devices sent to the manufacturer not being evaluated. device age the mean age of the devices involved in all adverse events of the maude database is 5.4 years. however, this result is strongly influenced by the impact of the last couple of years’ reports, as shown in figure 8. up until 2019, the average device age was 2.8 years. the seeming rise in the device's age might be related to the reported devices' types. most of the events (43%) are associated with devices during their first year of operation. figure 5. adverse events report source. figure 6. adverse event initial reporter occupation. figure 7. device evaluation by manufacturers. zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database j global clinical engineering vol.6 issue 1: 2023 14 discussion there has been an obvious increase in the number of reports over the last years (see figure 1), which can be attributed to several factors. one reason is the increased awareness and reporting of adverse events by healthcare professionals and patients due to improved access to information and reporting systems. another reason is the growing number and complexity of mds, which increases the likelihood of adverse events. in addition, the fda has expanded the types of adverse events that must be reported by manufacturers and healthcare facilities, which has led to an increase in the number of reports submitted to maude. other changes included updated reporting requirements for specific devices and improved clarity on using the fda forms 3500/ 3500a for reporting. these requirements are outlined in the code of federal regulations (cfr) title 21, part 803,(f) which establishes the mandatory medical device reporting criteria. this rule was published in 2014 and implemented in 2015. under its requirements, manufacturers and importers of mds are required to report to the fda any serious injuries or deaths associated with their devices within 30 calendar days of becoming aware of the incident. additionally, manufacturers must report any malfunctions that could result in a serious injury or death within 5 workdays of becoming aware of the issue. moreover, healthcare facilities, such as hospitals, nursing homes, and outpatient clinics, must report certain adverse events related to mds to the fda within 10 days. these events include incidents that result in serious injury or death or require intervention to prevent serious injury or death. finally, in 2014, the fda published a final rule on electronic medical device reporting (emdr), effective from 2015, that requires manufacturers and importers to submit mdrs to the fda in an electronic format that the fda can process, review, and archive(20). last but not least, in the previous two decades, there has been observed an increasing number of mds that have received a 510(k) clearance compared to a premarket approval (pma). safety issues are raised as the clearance provision pathway does not require clinical trials and is less rigorous than the pma process (21,22). considering the number of total reports in maude and the death event type percentage of these reports presented in table 2, it means that more than 180,000 adverse events are historically related to patient death. however, this number can be used only as an approximation due to the limitations of the database (i.e., multiple reports on the same incident, underreporting, incomplete figure 8. device age distribution. annual mean age of reported devices (top) and total device age histogram (bottom). f https://www.ecfr.gov/current/title-21/chapter-i/subchapter-h/part-803. medical device reporting: electronic submission requirements. a rule by the health and human services department, and the food and drug administration. published 2014. effective after 2015. https://www.ecfr.gov/current/title-21/chapter-i/subchapter-h/part-803 15 j global clinical engineering vol.6 issue 1: 2023 zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database information, etc.). although the decrease in deaths and increase in malfunctions reported in figure 3, although possible, does not explicitly indicate an increase in device safety, as it could also mean the intensified reporting of less severe adverse events compared to the past years. some intuition can be gained about the event types for each examined device group. glucose testing devices, such as test strips, are associated mainly with a less serious malfunction (see table 2). an example of such a malfunction could be wrong glucose test results. although not crucial as an adverse event itself, such a malfunction could pose more serious consequences for the patient in the long term. this may be why these devices have a very high rate of recalls (table 3). in contrast to glucose testing devices, most of the reported incidents of hip prostheses (kwa) resulted in serious patient injury, with a probability of patients having to undergo revision surgery. patient injury was almost universal (98.4%) for dental implant adverse events. a factor that may be of importance is the absence of implant dentistry from the recognized dental specialties of the american dental association.(g) although the fda monitors and regulates mds, it does not act toward healthcare practice regulations. the fact that implantable defibrillators adverse events showcase the highest probability of death (3.2%) compared to the rest of the examined device groups is expected, due to their crucial role in physiological heart function. finally, the fact that almost all the reports regarding infusion pumps were about simple device malfunctions, without further serious implications to the patients, may indicate an increased awareness regarding adverse event reporting of crucial devices. however, it should be noted that infusion pumps malfunctions have a high potential for patient injury and must be treated as near-miss adverse events. these events are incidents that can potentially cause harm to a patient but are caught or mitigated before any actual harm occurs. examples of reported infusion pump problems that could lead to such incidents include lack of warning when inappropriate data is entered or failure to generate audible alarms for critical problems such as an occlusion in the tubing.23 and adverse events are often avoided due to luck or vigilant healthcare professionals. remedial action codes were found to be often omitted from the adverse event reports. it is unclear whether this is because the event resulted in no action to be taken by the manufacturer or the information was not correctly updated in the database. as a silver lining, the rate of existing remedial actions has risen in the last year. moreover, the “other” category is used less frequently, which may indicate that the report form became more user friendly and awareness toward adverse event reporting has risen. the fact that the device manufacturers have filed 96% of the reports, while the trend is continuously rising (figure 5), is related to the stricter requirements imposed on manufacturers by cfr 21, 803. this is also the reason behind the high device evaluation percentage by the manufacturers (figure 7). adding to this, many users from facilities or homecare prefer to file a report to the manufacturer, who then submits it to fda. this is the reason why the initial reporter occupation is analyzed separately. data for 1997 consists of all data available from 1991 to that year. according to maude, user facility reports have been submitted since 1991, distributor and voluntary reports since 1993 and manufacturer reports since 1996. for this reason, the report rates by manufacturers are quite low until 1996, compared to the next years. according to cfr 21, 803, §50, manufacturers are responsible for conducting an investigation on each event and evaluating the cause of the event. if the device was returned to them and information in a report is incomplete, they must explain why and the steps taken to obtain it. this is why most devices returned to the manufacturer by the user facility or the distributors are evaluated (70.8% on average). the last year was an exception, and the reason could be further investigated. regarding the maude database, several issues were discovered. first, there are some instances of unintuitive or straight up incorrect information on the use or description of the files. as an example, the “deviceproblemcodes” file should contain the mdr report keys with the corresponding device problem code, while the “foidevproblem” file should contain a list of device problem codes with their matching code description, according to the site’s g https://ncrdscb.ada.org/recognized-dental-specialties https://ncrdscb.ada.org/recognized-dental-specialties zisimopoulos, pallikarakis: an analysis of adverse event reports in fda’s maude database j global clinical engineering vol.6 issue 1: 2023 16 description. however, the data contained in these files are interchanged. additionally, “mdrfoi” file’s description was not updated for the current year, at the time of this work. though it contained data from 2023, it read “maude base records received for 2022”. the mdrfoithruxxxx file also contains a vast amount of information of 5 gb, making it difficult for casual users to access it. splitting it as is the case with device files would facilitate further database usage. other shortcomings of maude derive from adverse event reporting system issues. a common problem for all vigilance systems worldwide is underreporting adverse events. though events seem to be reported more frequently during the last years, it is still plausible that more adverse events occur than those finally reported to the fda. the rate of medical device adverse events underreporting is difficult to determine, as the number of incidents is unknown accurately. non-reporting can be attributed to many factors, such as fear of blame, lack of time, complexity of the reporting system, or even perceived ineffectiveness. adding to this, in cases of human error, underreporting is expected to be even more prevalent.24,25 other issues may be the symptoms of underutilizing the mdr system’s potential. for example, although more than one remedial action code can be assigned to an adverse event, in practice reports in maude, use a single code. as a result, when an event is marked with a corrective action (i.e. replacement of the device), the recall code is omitted and vice versa. therefore, it becomes unclear whether the corrective action was part of a recall, or a voluntary preventive manufacturer action. finally, it is important to note that an increase in adverse event reports does not necessarily mean that the number of adverse events has increased, but rather that reporting systems have become more effective in capturing and documenting these events. conclusions it is obvious that the fda encourages reporting adverse events and maude plays an essential role in identifying potential safety issues and facilitating corrective actions that protect public health. it also provides an essential source of data for review studies in this area, as demonstrated by the increasing number of related publications mentioned in the introduction. in europe, despite the explicit reference in the md regulations on the availability of the vigilance data in the eudamed, this part of the database is still not accessible. this fact restricts the utilization of this critical data for advancing safety in medical technology in europe and worldwide. in conclusion, using an adverse event reporting system efficiently facilitates communication between regulatory agencies and healthcare providers and promotes transparency and accountability in the healthcare industry. ensuring that mds are safe and effective will improve patient outcomes, with clear benefits for the healthcare sector that remains a cornerstone of our society. references 1. wiig s, aase k, bourrier m, roise o.transparency in health care: disclosing adverse events to the public | springerlink [internet]. 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o’meley p, carter p. the need for greater reporting of medical device incidents. emj. 2019 oct 1;3(1):56–63. 25. 2knisely bm, levine c, kharod kc, vaughn-cooke m. an analysis of fda adverse event reporting data for trends in medical device use error. proceedings of the international symposium on human factors and ergonomics in health care. 2020 sep 1;9(1):130–4. http://canada.ca https://recalls-rappels.canada.ca/en https://recalls-rappels.canada.ca/en http://mhra.gov.uk https://www.gov.uk/drug-device-alerts https://www.bfarm.de/en/medical-devices/tasks/risk-assessment-and-research/field-corrective-actions/_node.html https://www.bfarm.de/en/medical-devices/tasks/risk-assessment-and-research/field-corrective-actions/_node.html https://www.bfarm.de/en/medical-devices/tasks/risk-assessment-and-research/field-corrective-actions/_node.html http://drugwatch.com https://www.drugwatch.com/hip-replacement/recalls/ https://www.drugwatch.com/hip-replacement/recalls/ https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements https://www.federalregister.gov/documents/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements https://www.fda.gov/medical-devices/infusion-pumps/examples-reported-infusion-pump-problems https://www.fda.gov/medical-devices/infusion-pumps/examples-reported-infusion-pump-problems 33 j global clinical engineering vol.3 issue 1: 2020 received may 18, 2020, accepted july 1, 2020, date of publication july 14, 2020 submissions style guide for the global clinical engineering journal by j.s. schultz1 and y. david2 1 department of biomedical engineering, university of houston, houston, texas, usa. 2 biomedical engineering consultants, llc, houston, texas, usa. abstract this paper provides guidelines for writing an effective manuscript that complies with the general scientific writing style. in particular, these guidelines are used by the editors and reviewers of the global clinical engineering journal (www. globalce.org) when they evaluate submitted manuscripts. readers of this paper will gain an understanding of the preferred writing format for each of the manuscript’s individual sections. examples are provided that illustrate their purpose and presentation style for each section. we expect the guidance provided in this paper to improve the quality of writing in general but especially by young clinical engineers so that their published work will attract the interest of the general scientific community. keywords – clinical engineering, paper, manuscript, scientific paper, submission, journal, global ce, global, write, technical writing, abstrcat, conclusion, methodology, results, methods, review, guide, conclusions. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction publications and distribution of research work and of best practices in the field of clinical engineering remain highly limited. this is particularly the case for young beginning researchers in the healthcare technology management area. yet, writing a scientific manuscript is arguably the most important step in the development and preservation of knowledge.1 nevertheless, few authors have been taught how to effectively communicate and to professionally write manuscripts. in addition, they struggle with selecting the most suitable writing style and the best way to present their data.2 writing styles vary according to the purpose of the paper and the intended audience. for example, the format for a newspaper article is vastly different than for a scientific journal. even within the scientific journal domain, there are different styles for research accounts, review papers, editorials, and letters to the editor. because readers are accustomed to a certain style in the different domains, using the conversation-like style of a letter in a scientific paper can put off the reader. clinical engineering authors may be challenged to identify and use the optimal visual medium to use to report on their work results and processes. for example, finding the optimal way to share data that lends itself more to a presentation using graphical or tabulated formats.3 methods aside from some minor variations, the structure and organization of most scientific manuscripts follow a simple format: introduction, methods, results, discussion, conclusions, and references.4 writing a manuscript, http://www.globalce.org http://globalce.org http://globalce.org globalce.org schultz, david: submissions style guide for the global clinical engineering journal j global clinical engineering vol.3 issue 1: 2020 34 especially for a peer-reviewed journal like global clinical engineering journal (http://www.globalce.org/downloads/ guidelines%20to%20authors_final.pdf) demands work that may seem like a burden within the clinical engineering community. but there are good reasons to persevere. knowledge grows and advances through sharing, supporting, and challenging information. it also contributes to the author’s expertise and career advancement. basically, authors are expected to write accurately, clearly, and succinctly. here, we provide some guidelines for submitting research articles in this journal. the basic format for manuscripts submitted for consideration by the reviewers for this journal is outlined below: 1. title section 2. authors and their affiliations 3. abstract section 4. introduction section 5. methods section 6. results section 7. discussion and conclusions section 8. references section in this paper, we will provide some guidance and suggestions for successfully getting your message to your audience. 1. title section the choice of words for the title of the paper is quite important. the title is the first piece of information that can catch the attention of reviewers as well as prospective readers. the title should be concise and should reflect the content and impact of your study. title example 1. “progressing toward the application of artificial intelligence for medical equipment replacement in canadian hospitals —an idea from the biomedical engineering department at northern health”5 this title might be better stated as: “artificial intelligence methods for medical equipment replacement decisions” title example 2. “benchmarking comparison between beijing and american hospitals”6 this title might be better stated as: “comparison of beijing and american hospitals in operations, finance, and staffing/productivity” title example 3. “pulse spectrophotometric determination of plasma bilirubin in newborns”7 might be better stated as: “plasma bilirubin determination in newborns by plus spectrophotometry” lang1 gives the following list of items to consider for titles of public health type articles: (i) the study setting, location, or both; (ii) the patients, organism, event, or relationship studied; (iii) the intervention, treatment, or exposure; (iv) the comparator or control group(s); (v) the outcomes or end points; (vi) the study design, and sometimes; (vii) the time period or duration of the study. for example, suppose an investigation has the following characteristics. any of them can impact the selection of an appropriate title: a long title might be: “effectiveness of ‘smart toilets’ using ultraviolet germicidal irradiation vs. regular cleaning for reducing escherichia coli infections in refugee settlements in jordan: a randomized trial” study characteristics potential impact of title selection the setting and location: refugee settlements in jordan the patients or subjects: residents using public toilets the intervention: self-disinfecting “smart toilets” using ultraviolet irradiation to kill bacteria the control condition: regular manual toilet cleaning the end point: escherichia coli infections the study design: randomized trial the time period (probably not a factor in this study) http://www.globalce.org/downloads/guidelines http://www.globalce.org/downloads/guidelines 20authors_final.pdf 35 j global clinical engineering vol.3 issue 1: 2020 schultz, david: submissions style guide for the global clinical engineering journal a short title instead might be: “effectiveness of self-disinfecting toilets for reducing escherichia coli infections” 2. authors and their affiliations the author’s names will be published exactly as they appear in the accepted article. it should not include titles such as dr., or professor, or ph.d. one of the early considerations by readers of the published articles is reviewing the author or authors and their affiliations. each author usually will have at least one or more affiliations. affiliation means the association of the author with an organization or a group. noted affiliations usually suggest a relationship between the article work and the location where the work conducted, support was provided, or the tools used were located. affiliations will be published as they appear in the accepted manuscript. include each component of the affiliation information in order of small to large (department, division, section, institution, city, state, country). do not include zip or postal codes, street addresses, or building/office numbers. there is also no need to list positions within an institution (e.g., department chair, professor, etc.). consider the designation of the corresponding author for future communications, but do not include physical addresses; only an e-mail address is required. you can list the corresponding author’s initials in parentheses following the email address. the corresponding author should be indicated with the placement of an asterisk after the name, and be written corresponding with the author's e-mail below the first page of the manuscript. the asterisk shall be omitted if there is only one author. you are, as an author, expected to review this carefully as names and affiliations may be automatically corrected and modified with various editing apps. 3. abstract section the abstract section is one of the most important parts of a published article. after the title, it is the section that an individual reads or scans to decide whether to look at the full paper. it is essential that authors be very careful that the abstract is consistent with the rest of the manuscript. studies have shown that many abstracts do not reflect the content of the report in the methods, results, or conclusions.8,9 the abstract should contain the following information.10 highlights of an abstract include: a. an introduction of the topic b. a brief mention of the important methods or techniques that were used in the report c. the most significant results of the report d. a succinct summary of the conclusions the following is an example of an abstract with too much detail (about 425 words).6 “the first clinical engineering (ce) benchmarking between chinese and american hospitals was performed in 2014. at that time, only data from zhejiang province were available. a new comparison was completed in 2018 with data collected from 11 hospitals from the capital city of beijing. these data were compared with those from 270 acute care hospitals in the united states. first, comparisons were made with hospital data such as patient discharges, patient days, equipment quantity and cost, and operating costs. the ce benchmarking comparison was made in 3 categories: (a) operations, (b) finance, and (c) staffing/productivity. within the operations category, the following metrics were compared: equipment amount/operating beds, annual repairs/equipment amount, and annual scheduled maintenance/equipment amount. within the finance category, the following metrics were compared: total ce expense/total hospital operating expense, total ce expense/operating beds, and total ce expense/equipment cost. within the staffing/productivity category, the following metrics were compared: total ce fulltime equivalent (fte)/equipment amount, total ce fte/operating beds, and total ce fte/total hospital operating expense. these comparisons showed the following: (1) although still a bit lower than the united states, beijing hospitals have more equipment than zhejiang but a slightly lower amount of repairs and scheduled maintenance per equipment; (2) the total ce expense/total hospital operating expense ratio is around 1% in both beijing and the united states, but slightly greater than in zhejiang; however, the total ce expense/operating beds and total ce expense/ equipment cost are still lower in beijing and zhejiang than in the united states; and (3) the ce fte amount is lower in beijing than in zhejiang and closer to the schultz, david: submissions style guide for the global clinical engineering journal j global clinical engineering vol.3 issue 1: 2020 36 united states relative to both equipment amount and total hospital operating expense, but still a bit lower than the united states relative to the number of operating beds. some of the differences detected are likely caused by the same factors found in the previous study of zhejiang hospitals, namely, higher length of stay in china than in the united states, lower wages and living costs in china, and different healthcare delivery methods in these countries. the differences found between beijing and zhejiang cannot be explained solely by inflation (~2%/year) or even higher cost of living in the capital but likely because of more equipmentintensive medical practice. overall, these results confirm the outstanding progress and level of excellence of ce in china. the original abstract includes information concerning zhejiang province, but the main focus of the paper is the comparison between beijing and the united states. so, references to zhejiang were removed from the abstract.” the abstract should follow the journal author’s guidelines. the guidelines for the global ce journal can be found on the journal website (http://www.globalce.org/downloads/ guidelines%20to%20authors_final.pdf). using the above abstract as an example, the revised abstract shown below serves as a clear summary containing objectives, results, and a brief conclusion. it is now shorter and contains about 200 words. in this suggested revision, we deleted comments related to zhejiang since the main point of the study was a comparison of clinical engineering practice between beijing and the united states. we report a new clinical engineering (ce) benchmarking comparison between beijing (11 hospitals) and the united states (270 acute care hospitals) that was completed in 2018. first, comparisons were made with hospital data such as patient discharges, patient days, equipment quantity and cost, and operating costs. the ce benchmarking comparison was made in 3 categories: (a) operations, (b) finance, and (c) staffing/productivity. these comparisons showed the following: (1) beijing hospitals have a bit lower equipment than the united states; (2) the total ce expense/ total hospital operating expense ratio is around 1% in both beijing and the united states; however, the total ce expense/operating beds and total ce expense/ equipment cost are still lower in beijing than in the united states; and (3) the ce full time equivalents amount relative to both equipment amount and total hospital operating expense is similar in beijing and the united states. some of the differences detected are likely caused higher length of stay in china than in the united states, lower wages and living costs in china, and different healthcare delivery methods in these countries. overall, these results confirm the outstanding progress and level of excellence of ce in china. the abstract should be composed at the very end of your writing since it includes a summary of the elements of your work such as the research problem and objectives, the methods, key results, and the main conclusion. 4. introduction section the primary purpose of the introduction section of a research paper or report is to provide background and place the specific context of the work from the perspective of a more general issue or problem. a common mistake in writing an introduction is to provide too much detail in reference or methods.1,11 elements of the introduction section are: • background • importance of the problem • what the objectives of the study • what is the existing state of knowledge of this topic – mini-review that traces the development of the problem and summarizes its current state • how was the study conducted and why • a preliminary indication of the outcome or conclusion of the report here we provide an introduction section from two articles that discuss issues related to alarms in intensive care units. the presentation in example a is very thorough, but perhaps over extensive in the literature review citations. the presentation in example b is more descriptive, does not provide literature citations, and is perhaps more suitable for a magazine rather than a scientific journal. example a12 “with the development of medical technology, clinical alarms from diverse medical devices, which are explosively increasing, are becoming a new issue in intensive care units (icus). medical device (clinical) http://www.globalce.org/downloads/guidelines http://www.globalce.org/downloads/guidelines 20authors_final.pdf 37 j global clinical engineering vol.3 issue 1: 2020 schultz, david: submissions style guide for the global clinical engineering journal alarms, which were designed to draw medical staff's attention when a patient's conditions goes beyond the proper range, are causing a new alarm hazard problem.1 according to previous studies, there were no more than 6 types of alarms from one critically ill patient in 1983; however, there were at least 40 types of clinical alarms in 2011.1 excessive clinical alarms may cause an alarm hazard, which includes inappropriate application of alarms, alarm fatigue, and the application of a uniform alarm range to every patient.2 while defects of devices threatened patient safety in the past, alarms indiscriminately generated by the explosive increase in the number of medical devices now threaten their safety. reports on safety accidents related to the diversity of medical device alarms have raised awareness of the clinical alarm hazard. in 2002, 65% of 23 sentinel events were related to dysfunction and disuse of alarm devices and inappropriate alarm setting.3 five-hundred sixty-six deaths related to the monitoring of device alarms4, severe burns due to neglect of alarms from hyperthermic machines5 and hypoxic brain damage6 were also reported. in 2012, alarm hazard was ranked first among ten types of medical technology hazards in the united states.2 ambient noises, including clinical alarms in icus were estimated to be more than 80 db, which is close to the noise level generated by a pneumatic drill in an operating room.7 in addition to the noise problem caused by alarms, icu nurses may have difficulty in distinguishing alarms for urgent intervention from others since different device manufacturers use different types of alarms. for example, they need to differentiate alarms for replacing the syringe of an infusion pump from those for a life-threatening emergency when they hear both types of alarms.8 icu nurses were found to have difficulty in differentiating more than 6 different alarms1,9 and could differentiate no more than 9–14 out of 23 alarms on average.10 in one study, medical staff members were repeatedly exposed to an average of 771 patient monitor alarms per patient per day.11 medical staff overexposed to alarms may experience a decrease in concentration, become careless, and commit mistakes. moreover, overexposure may make medical staff less sensitive to alarms and may cause them to cope improperly with significant alarms that can affect patients' safety.12 the literature suggests that excessive medical device alarms may cause nurses to feel alarm fatigue.7,13,14 alarm fatigue occurs when medical staff are overwhelmed by excessive clinical alarms2; in particular, false (positive) alarms, inappropriate alarms-setting ranges, and the overuse of patient monitors act as principal factors that cause alarm fatigue.7,14 of these, the most problematic factor is false alarms: frequent false alarms may produce the 'cry wolf' effect and may cause nurses to regard significant alarms as false and thus fail to respond properly. it may also make an alarm system less reliable and may cause nurses not to use alarm devices.14,15 it is therefore essential to effectively manage medical device alarms and develop good interventions that can reduce false alarms. since 2010, standardized prevention has been suggested on the basis of various studies on how to conceptualize and reduce alarm fatigue16,17,18,19 and basic research on nurses' recognition of clinical alarms and on the obstacles to their alarm management16,17 in the united states. on the contrary, in korea, little research has been conducted on medical device alarms. medical device alarm hazard and alarm fatigue are novel concepts, and the korean society for patient safety established in 2013 has just posted a foreign article introducing the concept of clinical alarms.20 this study aimed to investigate the current status of medical device alarms in icus, where medical devices equipped with an alarm function are most frequently used, to determine nurses' recognition of and fatigue in relation to alarms, and to identify obstacles to alarm management. this information will provide basic data that could help create a safe hospital environment.” example b13 “more and more medical devices are being used throughout healthcare institutions with an increasing variety of alarm-related features. alarms are used to warn of disconnected monitoring electrodes and ventilator breathing circuits. they can alert clinical staff when important measurements like oxygen saturation exceed safe limits or when a dangerous situation occurs like air entering the iv line for an infusion pump. most of the time, clinical alarms work well and serve, literally, schultz, david: submissions style guide for the global clinical engineering journal j global clinical engineering vol.3 issue 1: 2020 38 as a life-saving technology. however, for many devices, alarms can be confusing or can create confusion, for example from false positive events. for some devices, alarm settings can be adjusted outside of safe limits or the alarms can be completely defeated. as a result of these and other problems, deadly and life-threatening alarm-related incidents continue to occur. while the development of broad systematic improvements for how clinical alarms are designed and used are necessary to achieve the ultimate goal of reliable clinical alarm performance, the results are years away. this article focuses on ways that clinical engineers can have a much more direct and immediate impact on minimizing clinical alarm risk in their institutions. these include establishing safety criteria for alarms during the device selection process, performing alarmrelated safety audits to identify specific areas of risk with existing alarms and systems, helping to establish alarm setting and response protocols, and supporting the training of clinical staff on the proper operation and use of medical devices with clinical alarms.” 5. methods section11 the methods section is where the procedures used in the study are described and a description of how data were collected is given. in providing information on the methods used, one doesn’t need to give a detailed recipe of every detail but sufficient information for those who are “skilled in the art”14 to understand and evaluate the procedures. where possible, a method used that was described elsewhere in the literature should also be indicated and cited by reference. the format of a methods section depends somewhat on the type of investigation. for an article that is primarily of a survey nature, such as the performance evaluation of a system such as “alarms in intensive care” as mentioned above, the methods section would include how survey data were obtained. for articles that are experimental in nature the methods section usually describes materials and procedures. the example below15 illustrates a thorough description of a methods section for an experimental research paper. it provides adequate information on describing the source and characterization of materials used in the study (materials). then a clear description of how the data were collected and analyzed (assessment of aerosol output and image analysis of aerosol plumes). then a thorough explanation of the evaluation of the reliability of the data (statistical analysis of results). materials this study was performed using the following pharmaceutical preparations: (1) the cfc-free mdi airomir." this preparation contains albuterol sulfate as the active ingredient and nominally releases 200 χ 100-pg doses of albuterol. it also contains the propellant hfa-134a and oleic acid and ethanol as inactive ingredients. (2) the multidose dpi terbasmin turbuhaler,b which nominally contains 200 χ 500-pg doses of terbutaline sulfate. (3) the cfc-propelled mdi terbasmin inhalacion,c which nominally contains 400 χ 250-pg doses of terbutaline; it also contains a mixture of three cfc propellants (1:2:1 of cfc 11:12:114 mixture) and other inactive ingredients. the two pharmaceutical preparations of terbutaline were obtained from commercial sources. assessment of aerosol output experiments were conducted in industrial thermostated (2oc) chambers" at room (22 oc), cool (0 °c), or cold (-10 °c) temperatures. three groups of fully assembled hfa-134a inhaler devices (canister, mouthpiece) with different initial contents (full, onehalf full, and one-fifth full, titrated by 0, 100, or 160 actuations, respectively) were stored in the thermostated chambers hours before the standardized set of nebulizations. the assembled containers were then shaken for approximately 30 seconds, and the valve was actuated at intervals of 10 seconds in an inverted position. dpi devices were inserted via a mouthpiece adapter into an inhalation simulation machine formed by a glass bulb and tube connected to a vacuum pump. the inhalation flow rate necessary to activate the dpi was provided by turning the pump on for five seconds and adjusting the suction pressure to obtain a flow rate of 60 l/mhv1, which is appropriate for the turbuhaler system. forty actuations were performed with each pharmaceutical preparation to reduce potential minor variabilities between individual measures. to avoid the thermal influence of the operators' hands 39 j global clinical engineering vol.3 issue 1: 2020 schultz, david: submissions style guide for the global clinical engineering journal during actuation, the operators wore thick latex gloves stocked with the inhalation devices inside the chambers. the canisters were weighed at 25 °c using a mettler precision balance (readability 10g, accuracy defined as 100 [displayed weight true weight]/true weight ranged from 3% to 5%). each container was weighed before and after its particular set of actuations, and the net amount of aerosol emitted was determined by subtracting final weights from the initial weights of the canisters; the results were expressed in grams or milligrams. results are also expressed as a percentage of the amount of aerosol discharged in cool or cold conditions with respect to that expelled under control conditions (22 °c). image analysis of the aerosol plume the propelled aerosols from hfa-134a and cfccontaining mdis were visualized by a sequence of highspeed dark-field photographs taken of three actuations at 22 °c and -10 °c. representative pictures of a fully formed aerosol plume were digitized by scanning analysis; the captured image was then improved, transferred to the appropriate format,' and processed using image analysis software.' isodensity lines were defined with this software in the digitized image of the aerosol cloud (i.e., lines connecting points of equal gray intensities [from 0 to 220 arbitrary units]). the aerosol plume formed after activation of a dpi in the inhalation simulation machine was observed only by visual inspection, since the quality of photographs was poor due to light reflecting brightly from the glass of the apparatus. statistical analysis of results data are expressed as mean sem. the data on experimental groups passed the kolmogorov-smirnov normality test; hence, statistical analysis was performed using anova, followed by the bonferroni multiple comparison test. k linear regression analysis was conducted using the same software. significance was defined as ρ less than 0.05. 6. results section typically, the results section provides information that was gathered during the study. of course, not all the data would be selected for publication, but the studies that are pertinent to the thrust of the project. some comments, explanation, or discussion should be provided with each element of the results. the text in the results section should act as a tour guide, leading your reader from item to item (every figure or graph must be cited in the text and in numerical order), and drawing attention to the highlights, especially to those that will be important in making conclusions. there are several keys to writing a good results section. these include: (1) presentation of the results in an orderly sequence, following the sequence of the methods section when feasible. (2) if tables and figures will be used to summarize your data, then construct these first and use them as a basis for writing the results sections. make sure the main points of explanation and interpretation are given prominence in the first sentence of each paragraph. (4) avoid redundancy in the text and only cite representative data from the tables and figures. do not repeat but summarize the information in tables and figures. (5) avoid vague references to tables and figures in the text. example: bad: results of the survey of nurses are shown in table 1. good: a high percent of alarm notifications were ignored by nurses in the icu setting, see table 1.15 (6) avoid repeating a description of the methods in the results section. (7) avoid discussion of conclusions in the results section. in other words, present the facts but save interpretation of the significance of the results for the discussion/ conclusion section. table 1. an example of medical equipment management plan (memp) inventory inclusion criteria using patient risks and mission criticality for planning preventive maintenance (pm) and safety and performance inspection (spi) activities. schultz, david: submissions style guide for the global clinical engineering journal j global clinical engineering vol.3 issue 1: 2020 40 whenever appropriate, the results of the study should be summarized in tables and/or graphs. readers may look at tables or graphs even before reading the text and would like to understand these without searching back and forth to the body of the text. the design of tables and graphs are quite critical to helping the reader fully understand the quality of the data and how the data supports the conclusion of the report.12 some good and bad examples and suggestions for best practices for tables and graphs are given in a pdf from mit.16 a recent article from the british journal of dermatology8 illustrates excellent examples of tables and graphs. above is an example of a well-organized table 1. the title is a concise sentence. the column headings and subheadings are clear enough to make the data understandable without having to look at the text. the footnote gives enough detail to make the data understandable without going into experimental detail.18 graphs are used to present data in an organized way, not to dress it up. one should not use both graphs and tables for the same data. line graphs are best for data that show pronounced trends, while bar and dot charts are better to show items with different values. consider the impact from the use of colors versus black and white especially if the publication cannot accommodate the use of color. in most of the on-line publications like the global clinical engineering journal this is not a problem. one should provide textual context for graphs, indicating how the graph advances, summarizes your discussion, and supports and clarifies your conclusions. graphs should be as self-explanatory as possible. this allows the reader to scan through the article and get the key messages without needing to read the text in detail. fig.3 (next column) is an example of a poor graph.17 the symbols ae, av, ee, and ep are not defined in the legend of the graph, nor is the meaning of the term microprocess explained. fig.5 (next column) is an example of a good graph. the lettering is large enough to withstand photographic reduction. the caption is concise and provides information pertinent to the discussion, tolerance of error bars are provided.20 often data can be presented in either a graph or a table. the choice depends on which better informs the reader. in the example below, data are provided for the comparison of an implanted glucose monitor (freestyle libre) with blood-sample technique (ysi). trends across different levels of blood glucose are much clearer in the bar graphs than in the published table below.19 http://web.mit.edu/7.021/www/lectures/tablesgraphs_mo.pdf https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2133.2006.07705.x https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2133.2006.07705.x 41 j global clinical engineering vol.3 issue 1: 2020 schultz, david: submissions style guide for the global clinical engineering journal 7. discussion and conclusion section the main purpose of this section is draw conclusions from the data gathered in the study and perhaps to compare the results to previous similar studies. here you provide an interpretation of your results and answers the study question. you can suggest further work to be done and review the literature again as it now can shed more insight on the subject of the paper.21 here are some guidelines for structuring this section. 1. summarize key findings and interpret the results 2. compare with other studies 3. generalize results if appropriate 4. speculate on implications of the study 5. point out any limitations of the study 6. suggest possible follow-up studies 7. succinctly list your conclusions the table below summarizes the elements and suggestions for submitting a paper to the global clinical engineering journal: title concise & descriptive all words capitalized except articles and prepositions abstract describes problem & states objectives/hypotheses describes technique(s) used & avoids experimental detail reports most significant results concluding statement introduction demonstrates good clinical engineering insight, understanding, & accuracy reviews & interrelates relevant scientific literature cites literature correctly using name-year or citation-sequence convention flow of ideas – starts broadly, then leads to a specific topic ends with clearly & concisely stated 1–3 hypotheses/objectives methods written in the third person and past tense concise but complete accurately describes what was done, without giving instruction statistics and quantitative methods are explained literature cited (if appropriate) results results clearly and accurately explained statistical output appropriately noted all relevant tables and figures cited appropriately discussion and conclusions clearly addresses each hypothesis/objective – supported or rejected? demonstrates good insight and mastery of relevant ideas compares results to previous studies (cite relevant literature) explains unexpected results (e.g., provides alternative hypotheses) describes or suggests future experiments list your conclusions and possible impact from the results schultz, david: submissions style guide for the global clinical engineering journal j global clinical engineering vol.3 issue 1: 2020 42 acknowledgments be professional (avoid being "gushy" or overly flippant) literature cited precisely and consistently follows style of global ce journal all citations noted in the manuscript are included in the literature cited list each reference listed has been cited at least once in the manuscript tables tables appear after literature cited section tables are numbered consecutively, starting with table 1 titles are sufficiently clear and concise double-spacing used throughout the table columns of numbers aligned by decimal point using decimal tabs figures horizontal axis = independent variable, vertical axis = dependent variable axes clearly labeled submission to global clinical engineering journal manuscripts submitted to the global clinical engineering journal are subjected to the initial review by the editorin-chief for the purpose of identifying overlap between the manuscript and the mission of the journal and for identifying the most appropriate editors to be assigned for the double-blind review process. the complete publication process is posted on the journal website (http:// www.globalce.org/downloads/flowchart_globalce.pdf) and is presented below. this process provides for a quality review that is fair and timely. it helps the authors receive constructive feedback on how to improve their submission. it also facilitates the posting of individual accepted manuscripts immediately or even prior to the scheduled publishing of the next issue of the journal. now, we encourage you to begin working on your manuscript and gain recognition for your work. conflicts of interest statement the authors declare that there is no conflict of interest. references 1. lang ta. writing a better research article. j pub health emergency. december 2017;1. available at: http://jphe. amegroups.com/article/view/4265/5102. 2. king l. preparing better graphs. j pub health emergency. january 2018;2(1). available at: http://jphe.amegroups. com/article/view/4288/5126. http://www.globalce.org/downloads/flowchart_globalce.pdf http://www.globalce.org/downloads/flowchart_globalce.pdf http://jphe.amegroups.com/article/view/4265/5102 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[internet]. available at: http://web.mit.edu/7.021/www/ lectures/tablesgraphs_mo.pdf. 17. bassani jwm, rocha ls, luders ml, and bizinotto wj. micro-process based management of medical equipment maintenance. proceedings of the second joint 24th annual conference and the annual fall meeting of the biomedical engineering society, engineering in medicine and biology, houston, tx, usa, october 2002, pp. 1942–1943 vol.3. available at: https://ieeexplore.ieee.org/abstract/ document/1053105 18. binseng wang, emanuel furst, ted cohen, ode r. keil, malcolm ridgway, and robert stiefel: medical equipment management strategies. biomedical instrumentation & technology, aami, may 2006, vol. 40, issue 3, pp. 233-237, https://www.aami-bit.org/doi/full/10.2345/i0899-820540-3-233.1, (last visited march 23, 2020). 19. karinka sa, bailey ts, brazg rl, et al: clinical diabetes/ therapeutics, 910-p: improved accuracy of 14-day factorycalibrated freestyle libre system with new glucose algorithm. diabet j, am diabet assoc june 2019;68 (supplement 1), poster presentations. available at: https://diabetes. diabetesjournals.org/content/68/supplement_1/910-p 20. yang y, bajaj n, xu p, et al. development of highly porous large plga microparticles for pulmonary drug delivery. j biomaterials april 2009;30(10):1947–53. available at: https://www.sciencedirect.com/science/article/pii/ s0142961208010181?via%3dihub, 21. bates college, department of biology. how to write a paper in scientific journal style and format. [internet]. available at: https://www.bates.edu/biology/files/2010/06/howto-write-guide-v10-2014.pdf. http://jphe.amegroups.com/article/view/4327/5152 http://jphe.amegroups.com/article/view/4327/5152 https://spie.org/samples/9781510619142.pdf https://www.researchgate.net/publication/340053463_progressing_toward_the_application_of_artificial_intelligence_for_medical_equipment_replacement_in_canadian_hospitals_ https://www.researchgate.net/publication/340053463_progressing_toward_the_application_of_artificial_intelligence_for_medical_equipment_replacement_in_canadian_hospitals_ https://www.researchgate.net/publication/340053463_progressing_toward_the_application_of_artificial_intelligence_for_medical_equipment_replacement_in_canadian_hospitals_ https://www.researchgate.net/publication/340053463_progressing_toward_the_application_of_artificial_intelligence_for_medical_equipment_replacement_in_canadian_hospitals_ https://insights.ovid.com/clinical-engineering/jceng/2020/01/000/benchmarking-comparison-beijing-american-hospitals/11/00004669 https://insights.ovid.com/clinical-engineering/jceng/2020/01/000/benchmarking-comparison-beijing-american-hospitals/11/00004669 https://insights.ovid.com/clinical-engineering/jceng/2020/01/000/benchmarking-comparison-beijing-american-hospitals/11/00004669 https://www.igi-global.com/gateway/article/145164 http://websites.uwlax.edu/biology/researchmanuscripts.html http://websites.uwlax.edu/biology/researchmanuscripts.html http://www.usask.ca/biology/kaminskyj/342/lab/biol342_04lab/ap18_lab_rept.pdf http://www.usask.ca/biology/kaminskyj/342/lab/biol342_04lab/ap18_lab_rept.pdf https://www.aami-bit.org/doi/full/10.2345/0899 https://www.aami-bit.org/doi/full/10.2345/0899 5d2.0.co https://www.upcounsel.com/person https://www.upcounsel.com/person https://journals.sagepub.com/doi/10.1177/875512250001600105 https://journals.sagepub.com/doi/10.1177/875512250001600105 mit.edu http://web.mit.edu/7.021/www/lectures/tablesgraphs_mo.pdf http://web.mit.edu/7.021/www/lectures/tablesgraphs_mo.pdf https://ieeexplore.ieee.org/abstract/document/1053105 https://ieeexplore.ieee.org/abstract/document/1053105 https://www.aami-bit.org/doi/full/10.2345/i0899 https://diabetes.diabetesjournals.org/content/68/supplement_1/910 https://diabetes.diabetesjournals.org/content/68/supplement_1/910 https://www.sciencedirect.com/science/article/pii/s0142961208010181?via%3dihub, https://www.sciencedirect.com/science/article/pii/s0142961208010181?via%3dihub, https://www.bates.edu/biology/files/2010/06/how-to-write-guide-v10-2014.pdf https://www.bates.edu/biology/files/2010/06/how-to-write-guide-v10-2014.pdf 37 j global clinical engineering vol.4 issue 1, 2021 in our continuous efforts to encourage sharing of knowledge and publication of engineering and scientific work related to the clinical engineering field, we have initiated a new section of our global clinical engineering journal www.globalce.org named book review. we hope that you will find it helpful to your career and at the same time promote the submission of other books for our review serving the benefit of all our readers. introduction to clinical engineering samantha jacques & barbara christe isbn 978-0-12-818103-4 academic press, elsevier published 2020 this book review is about the elsevier academic press newly published introduction to clinical engineering by two authors samantha jacques, ph.d., fache, and barbara christe, ph.d. with foreword by lawrence (larry) w. hertzler, c.c.e., faami. in addition to the forward, the book contains six chapters, an appendix, and an index for a total of 270 pages. dr. jacques (or “sam” as her colleagues call her) has served as director/vp of clinical engineering program in several healthcare systems, and her writings express her expertise in healthcare technology management from the applied side. this style adequately complements dr. christe’s writing that draws from her academic background and pedagogical experience. together, the two styles combine into a single book that both practitioners and students will find interesting. true to its title, the book provides a concise introduction to the conventional clinical engineering field that sometimes struggles with identity and recognition. the authors clarify this issue straight up in chapter 1, the profession. it starts with an introduction to healthcare technology management (htm) and argues that clinical engineers are part of htm. it is an exciting proposition that falls short of the notion that the clinical engineering profession as a learned life science engineering discipline contains a broader scope where htm is one of its competencies, including consulting, design, informatics, and marketing. in their attempt to clarify a conventional clinical engineering practice, the authors partially achieve their goal; however, they left some confusion with readers, suggesting that technicians and technologists who specifically support medical equipment often function in a biomedical engineer position. chapter 1 suggests that aami in 1973 developed a certification program for clinical engineers but neglected to recognize that this program was discontinued by aami and re-initiated through the america college of clinical engineering as correctly described few pages later. the book generally describes the structure of a healthcare system and clinical engineering’s role within it from a us point of view. for example, according to japan’s clinical engineering association, over 20,000 certified clinical engineers are licensed to service and to operate complex heart-lung bypass machines as well as dialysis systems. chapter 2, healthcare technology basics, provides an overview of how medical products enter into commerce and the roles of regulations and fda function in protecting public safety. i found the scenarios described in section devices throughout the healthcare system and relationship to patient care a good topic and practical reference for educating readers about the intersection between care processes and medical technology. chapter 3 on healthcare technology management introduces the crucial concepts of system book review by y. david editor-in-chief, globalce journal http://www.globalce.org http://www.globalce.org www.globalce.org j global clinical engineering vol.4 issue 1, 2021 38 thinking and system engineering. the chapter then follows a short cover of human factors issues and jumps into computerized maintenance management systems (cmms). it provides an excellent introduction to cmms with well-organized material. chapter 4 on safety and systems safety effectively covers a wide range of subjects that include regulations, standards, safety, risk management, quality, and adverse event investigation. the material is a well organized, easy read; however, the subjects on industry standards and infection control provide limited education for the readers about related international standards bodies and infection control. this is especially notable regarding care areas airway infection management where chapter 6 adds to this content but neglects to connect the readers to it. furthermore, new air disinfecting tools, which became an increasingly vital component of patient care, both for patients and staff, lacked cover yet are essential during this pandemic era, we all are fighting. chapter 5 on information technology delivers a useful description of the closer relationship between clinical engineering and the health it field with an effective comparison between life cycle management that the engineers/technicians follow and the itil practice that the it practitioners do. further description of the data flow between medical devices and the ehr is written with clarity and includes content about cybersecurity’s evolving importance. this chapter, in my opinion, is one of the best in this book. the final two chapters, chapter 6 on facilities management and chapter 7 on human resources management, cover areas that will be most helpful for hospital-based practitioners who were not exposed to these topics previously. finally, the most extensive section of the book, almost 100 pages, appendix: additional readings provides, as its name suggests, additional reading that incorporates throughout the various subjects of the appendix an interesting section of questions to consider, acronyms, and abbreviations. it would have been helpful for the readers to add a table of content. readers will be able to satisfy their curiosity by continuing further reading in the appendix subjects related to chapters of the book they are reading at that moment. the book accomplishes its purpose of providing readers with a clear introduction to the body of knowledge that all novices to the field of clinical engineering must understand. it delivers the reader an appreciation for the vast knowledge one should be competent in and the benefit from realizing how to prepare for their next step in their career. you can find the handbook at https://www.elsevier. com/books/introduction-to-clinical-engineering/ jacques/978-0-12-818103-4?countrycode=us&format=print&utm_source=google_ads&utm_medium=paid_ search&utm_campaign=usashoppinglr&gclid=cj0kcqiaujb_ brdjarisakkycukc0l0wdks5fayxfoap78e0kx1hqgbbolt32tbemuo-ltxkn_kqityaak_pealw_wcb&gclsrc=aw. ds where it is sold, after discount, for us $74.96. in this field, recently published books were more extensive in scope, suffering format variation due to their multiple contributors, and were more expensive. as this book is aimed at students, novices, and practitioners ready to advance in their career, it will be very useful to this community and anyone else who explores and is curious about clinical engineering as a future career. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://www.elsevier.com/books/introduction-to-clinical-engineering/jacques/978-0-12-818103-4?countrycode=us&format=print&utm_source=google_ads&utm_medium=paid_search&utm_campaign=usashoppinglr&gclid=cj0kcqiaujb_brdjarisakkycukc0l0wdks5fayxfoap78e0kx1hqgb https://www.elsevier.com/books/introduction-to-clinical-engineering/jacques/978-0-12-818103-4?countrycode=us&format=print&utm_source=google_ads&utm_medium=paid_search&utm_campaign=usashoppinglr&gclid=cj0kcqiaujb_brdjarisakkycukc0l0wdks5fayxfoap78e0kx1hqgb https://www.elsevier.com/books/introduction-to-clinical-engineering/jacques/978-0-12-818103-4?countrycode=us&format=print&utm_source=google_ads&utm_medium=paid_search&utm_campaign=usashoppinglr&gclid=cj0kcqiaujb_brdjarisakkycukc0l0wdks5fayxfoap78e0kx1hqgb https://www.elsevier.com/books/introduction-to-clinical-engineering/jacques/978-0-12-818103-4?countrycode=us&format=print&utm_source=google_ads&utm_medium=paid_search&utm_campaign=usashoppinglr&gclid=cj0kcqiaujb_brdjarisakkycukc0l0wdks5fayxfoap78e0kx1hqgb https://www.elsevier.com/books/introduction-to-clinical-engineering/jacques/978-0-12-818103-4?countrycode=us&format=print&utm_source=google_ads&utm_medium=paid_search&utm_campaign=usashoppinglr&gclid=cj0kcqiaujb_brdjarisakkycukc0l0wdks5fayxfoap78e0kx1hqgb https://www.elsevier.com/books/introduction-to-clinical-engineering/jacques/978-0-12-818103-4?countrycode=us&format=print&utm_source=google_ads&utm_medium=paid_search&utm_campaign=usashoppinglr&gclid=cj0kcqiaujb_brdjarisakkycukc0l0wdks5fayxfoap78e0kx1hqgb https://www.elsevier.com/books/introduction-to-clinical-engineering/jacques/978-0-12-818103-4?countrycode=us&format=print&utm_source=google_ads&utm_medium=paid_search&utm_campaign=usashoppinglr&gclid=cj0kcqiaujb_brdjarisakkycukc0l0wdks5fayxfoap78e0kx1hqgb aw.ds aw.ds https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.4 issue 3, 2021 2 editor’s corner who owns the right to repair? i recently participated in an effort led by members of the health technology management community in north america about what is becoming to be known as “the right to repair” movement. this is not just a healthcare equipment issue but rather it origin is from outside the healthcare industry and spread throughout many industries including information technology (computers), consumer electronics (phones), agricultural products, appliances, automotive and more. the debate is about the principal question: why do consumers not have the right to access parts, tools, or guides (service manuals) for the equipment that they own? holding back information or placing replacement parts as inaccessible to consumers/owners or an independent equipment service providers takes away the owner’s property rights. the right to repair coalition maintains programs aimed to change that by raising awareness including within the healthcare technology management field. the coalition’s website post a quotation, under their medical technology tab1, that “in some developing countries, up to 50% of the medical equipment is unusable at any given time. in some hospitals, up to 80% of their medical equipment is inoperative …” world health organization. to access service information, you and many others are probably familiar with, and perhaps even used, the frank’s hospital workshop site2 to find needed information not otherwise provided for repairing your medical equipment. this coalition’s website posts frank’s story as follows: “frank weithoener is a well-regarded biomedical repair technician in tanzania. he identifies five major barriers to medical device repair in developing countries: 1. no spare parts for repairs and maintenance 2. no technical manuals 3. poorly trained biomedical technicians 4. no technical support from the manufacturers 5. lack of awareness of the advantages of preventive maintenance since manufacturers weren’t supporting the repair of their products, frank decided to do it himself. he runs a website2, dedicated to training technicians. unfortunately, weyer, general electric, and other manufacturers regularly send him legal threats and take-down notices demanding that he stop teaching people to repair life-critical medical equipment.” the us fda issued a report on the topic in may 20183 summarizing, in part, that “the objective evidence indicates that many oems and third party entities provide high quality, safe, and effective servicing of medical devices” and that “the continued availability of third party entities to service and repair medical devices is critical to the functioning of the u.s. healthcare system.” however, this did not address the questionable access to manuals and spare parts. others, including an apple inc. co-founder, steve wozniak, stated during an interview with one of the supporters of this movement in part4 “if you know what you’re doing and you’re doing certain steps that other solved…why stop the self-repair community?” even politicians engage with this debate, like us senator mr. ron wyden and us representative y. d. clarke who together introduced a bill in the senate of the us tilted ‘‘critical medical infrastructure right-to-repair act of 2020”5 attempting to alleviate medical equipment repairs during covid-19 crisis. however, as medical equipment is used at times in life critical conditions, we must ask the question: who is competent to service such important technology. this led me to search for an answer to the question what is a competent clinical engineer? i visited variety of sources and came across an article a day in the life of a clinical engineer system supervisor6 where “this sophisticated technology requires constant assessment, management and maintenance to deliver on that promise” points to the public expectations that the equipment will improve http://www.globalce.org http://www.globalce.org 3 j global clinical engineering vol.4 issue 3, 2021 providers’ ability to manage their patient’s conditions and raise their care outcomes. during my search i used terms such as how to become an engineer where the quora website that states its mission is “to share and grow the world’s knowledge”, showed as a response one of the titles that asked: can anyone become an engineer, or do you have to be born into it with natural skills?7. an interesting angle that i wonder if it suggests that it is possible that engineers’ dna set us apart? hopefully, they are not serious about that. another source adds the suggestion that soft and interprofessional skills must be part of clinical engineering education program8,9. so, while i believe in the principal of right to repair, i also strongly recommend that clinical engineers should seek demonstration of their competency through credentialing program. in a recent article is clinical engineering an occupation or profession?10, where i am included as one on the list of international authors, it states in part: “clinical engineers also need to recognize, like other professions that when establishing defined requirements to enter the professional practice, there needs to be consensus about and adopting clinical engineering practice criteria. this includes domain boundaries, establishing a minimum qualifications criterion for entering clinical engineering practice in healthcare, a commitment for compliance with life-long continuing education, adherence to ethical behavior, service stewardship to their communities, and rules for self-governing. adoption of these cannons will gain wider recognition and elevate the professional standing they desire.” did you experience any of the obstacles when looking for service manuals or access to replacement parts or software keys to equipment apps? would you agree with me that, since we are concerned with patients’ lives, the right to repair movement should modify their poster to reflect that it’s argument should be about the right to repair by competent workers. let me know your opinion. references 1. https://www.repair.org/medical 2. http://www.frankshospitalworkshop.com/ 3. fdara 710 3rd party servicing report, https://www. fda.gov/media/113431/download?mod=article_inline 4. steve wozniak speaks on right to repair, https://www. youtube.com/watch?v=cn1djpmoovy 5. wyden and clarke introduce bill to eliminate barriers to fixing critical medical equipment during the pandemic | u.s. senator ron wyden of oregon (senate.gov) 6. https://www.chop.edu/news/ day-life-clinical-engineer-system-supervisor 7. https://www.quora.com/can-anyone-become-anengineer-or-do-you-have-to-be-born-into-it-withnatural-skills 8. https://www.careercloud.com/news/2017/4/24/ the-most-important-soft-skills-engineers-need 9. https://www.researchgate.net/publication/228592803_ developing_interprofessional_skills_in_a_clinical_engineering_program 10. https://www.globalce.org/index.php/globalce/ article/view/131/74 together we are making it better! dr. yadin david copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://www.repair.org/medical http://www.frankshospitalworkshop.com/ https://www.youtube.com/watch?v=cn1djpmoovy https://www.youtube.com/watch?v=cn1djpmoovy http://senate.gov https://www.chop.edu/news/day-life-clinical-engineer-system-supervisor https://www.chop.edu/news/day-life-clinical-engineer-system-supervisor https://www.quora.com/can-anyone-become-an-engineer-or-do-you-have-to-be-born-into-it-with-natural-skills https://www.quora.com/can-anyone-become-an-engineer-or-do-you-have-to-be-born-into-it-with-natural-skills https://www.quora.com/can-anyone-become-an-engineer-or-do-you-have-to-be-born-into-it-with-natural-skills https://www.careercloud.com/news/2017/4/24/the-most-important-soft-skills-engineers-need https://www.careercloud.com/news/2017/4/24/the-most-important-soft-skills-engineers-need https://www.researchgate.net/publication/228592803_developing_interprofessional_skills_in_a_clinical_engineering_program https://www.researchgate.net/publication/228592803_developing_interprofessional_skills_in_a_clinical_engineering_program https://www.researchgate.net/publication/228592803_developing_interprofessional_skills_in_a_clinical_engineering_program https://www.globalce.org/index.php/globalce/article/view/131/74 https://www.globalce.org/index.php/globalce/article/view/131/74 j global clinical engineering vol.5 issue 1: 2022 22 received august 12, 2021, accepted may 5, 2022, date of publication may 24, 2022 covid-19, a blessing in disguise: the experience of a nigerian radiotherapy engineer by oluwasegun o. adio, iyobosa b. uwadiae, alaba o. adewumi department of radiation oncology, university college hospital, ibadan, nigeria abstract the health technology sector of lowand middle-income countries (lmics) is bedeviled by performance failures that make it a significant obstacle to effective patient healthcare interventions. the predominant factors behind the sector’s poor performance have been identified as (a) inadequately trained technical personnel and (b) the unserviceable condition of medical equipment. past studies show that after adequate training, there is an increase in the proficiency of in-hospital biomedical engineers, but the studies have been limited to the maintenance job description of the engineers. we present a case study of the successful installation of sophisticated medical equipment by an in-hospital engineer to demonstrate that comprehensive training can also develop the installation expertise of local engineers. the installation, which is usually accomplished by the equipment manufacturer, was delegated to the trained in-hospital engineer due to the covid-19 pandemic. furthermore, the bulk of medical equipment in lmics is imported, which has led to an over-dependence of their health sectors on non-indigenous technology to the detriment of local alternatives and know-how. the world health organization estimates that 7 out of 10 sophisticated medical equipment imported by lmics are unserviceable due to the issue of compatibility and adaptability with the setting. previous research focuses on equipment subsidy, frugal innovation, and health technology management to better adapt foreign equipment to the environment. still, this paper explores the option of indigenous technology and expertise to provide in-country development of suitable and sustainable medical equipment. keywords – covid-19, medical equipment, engineer, lmic, training, installation, local production. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org 23 j global clinical engineering vol.5 issue 1: 2022 adio, uwadiae, adewumi : covid-19, a blessing in disguise: the experience of a nigerian radiotherapy engineer introduction as the world’s nations grappled with the covid-19 pandemic, several unprecedented measures were adopted to limit the spread of the disease. social distancing, quarantines, flight restrictions, lockdowns, and other routine-disrupting changes were imposed by governments at all levels. on the 21st of march 2020, nigeria went into lockdown, and restrictions were introduced on travel by land and air.1 this, however, had only a partial impact on hospital activities because health workers, as essential service providers, were exempted from the restrictions. doctors, nurses, and other hospital personnel kept working to provide medical care and manage the increasing patient volume due to coronavirus. treatment of the disease required many types of lifesaving medical equipment, especially in intensive care units; therefore, more than ever, clinical engineers were needed to ensure the uninterrupted operation of medical devices.2 the job function of clinical engineers includes equipment maintenance, acceptance testing, user training and education, clinical research and development, quality assurance, and productivity assessment.3 it is important to note that clinical engineering began in the late 1960s to address patient-safety concerns as increasing numbers of medical devices deployed in teaching hospitals. not long after that, a preponderance of electrical safety failures brought the maintenance job description of in-house engineers to the fore.4 clinical engineers develop their maintenance and troubleshooting skills through a combination of a handson learning experience, in-service training, and short courses designed to equip them with the skills to handle a wide range of medical devices. however, when hospitals acquire new or sophisticated technology with maintenance requirements beyond the engineer’s general skills, maintenance contracts are signed, or equipment-specific training is sought. hospitals typically opt for maintenance contracts with the original equipment manufacturers (oems) or their agents in high-income countries. on the other hand, hospitals in lowand middle-income countries (lmics) opt for training because of the long distance between them and the oems.5 unfortunately, the equipment-specific training is adequate on most occasions, and the hospitals are forced to resort to high-priced maintenance programs that still involve the oems or their third-party agents.3,6 the local engineers are authorized to carry out only run-of-the-mill repairs while the heavy-duty maintenance is performed by the oems, usually after long waiting periods with a likelihood of poor treatment outcomes for the patient.7 delay in cancer treatment leads to increased patient distress, increased risk of local recurrence, and reduced patient survival over time.8,9 in lmics, where delayed treatment is common, it can be attributed to late presentation in patients, inadequate radiation therapy facilities, insufficient trained manpower, and machine downtime.10,11 therefore, the goal of the in-house engineer is to minimize downtime so that patients can avail themselves of the already limited therapy units. a previous paper has shown that with adequate training, in-house radiotherapy engineers (re) could develop improvisation skills to reduce machine downtime in a nigerian radiotherapy center.12 this paper is a case study that shows that in-house re can go beyond the usual maintenance tasks to installing sophisticated equipment that preserves oems and their agents with comprehensive training. however, it is worthy of note that the case study could not have arisen but for the advent of covid-19. a success story before the covid-19 lockdown, high dose rate (hdr) brachytherapy equipment was set for installation in four radiotherapy centers across nigeria. the equipment, a 25-channel saginova hdr after loader brachytherapy system (figure 1) manufactured by eckert & ziegler bebig gmbh germany, had been shipped in, and engineers from the company were scheduled to follow for the installation work when the pandemic struck, and a restriction was placed on traveling. as travel restrictions lingered, the situation became worse because, at the time, the country had only one functional brachytherapy center for its growing number of oncology patients. moreover, the delay grew costlier with each passing day as the cancer cases worsened from lack of treatment and the radioactive decay of the j global clinical engineering vol.5 issue 1: 2022 24 adio, uwadiae, adewumi : covid-19, a blessing in disguise: the experience of a nigerian radiotherapy engineer expensive co-60 sources.13,14 it was therefore imperative to find a quick solution. the equipment manufacturer reached out to an re in the radiation oncology department, university college hospital ibadan (uch), who had undergone training at their company factory (figure 2). the training was sponsored by uch after installing the same brachytherapy equipment in the hospital by the manufacturer in 2019. the training the five-day course gave the trained technical specialists level a and level a+ proficiencies. for example, the level a certification authorized them to carry out standard maintenance and basic interventions on the equipment as advised by the manufacturer, while the level a+ certification authorized them to load and unload radioactive sources. each trainee was provided with a full-color illustrated manual containing step-by-step information on how to unpack the equipment, install it, test it while inactive, load the co-60 source, test it while active, and adjust the equipment settings. it also included schematic and circuit diagrams and layout diagrams of the standard control and treatment rooms. the teaching method employed was hands-on learning, where trainees first observed the instructors and then practiced the lessons. common real-life faults were simulated, and the trainees were instructed on how to solve them. each training module ended with a q and a and a quiz to test for mastery of the module. the trained and authorized engineers were then awarded certificates of training. the installation the re successfully installed the equipment, loaded the co-60 source, and conducted acceptance testing in the four radiotherapy centers (figure 3). barring the occasional logistic problems, the installation was uneventful and did not lead to problems the german engineers would not have encountered, such as broken cables and a damaged safelogic compact arising from inadequate packaging. the oem provided remote guidance throughout the installation process, and the equipment was installed and handed over to the centers in good time. the re also worked with the resident medical physicists to ensure that all technical parameters of the equipment were within acceptable limits. the trainee becomes a trainer. before embarking on the training, the goal of the re was to be reasonably proficient in maintaining the equipment in his center and other centers in the country that may require his service. in addition, having witnessed the long waiting periods that lmic hospitals are subjected to when working with oems and agents, he planned to become an alternative service engineer with the least response time. this desire was made known to the trainers, and they provided as much instruction as possible within the limited training period. figure 1. a 25-channel saginova hdr afterloader brachytherapy unit installed by the local engineer. figure 2. the radiotherapy engineer at the training facility in germany. 25 j global clinical engineering vol.5 issue 1: 2022 adio, uwadiae, adewumi : covid-19, a blessing in disguise: the experience of a nigerian radiotherapy engineer however, the engineer’s goal was flawed because it took up to two days to arrive at some centers, and if he were their service engineer, the equipment would be out of order for that long. consequently, he rethought his plan and decided to train the centers’ in-house engineers as much as possible so that they could independently maintain their equipment. one center sponsored their engineer to join in installing the equipment of another center after participating in the installation at his center. the aim was to use the opportunity to further hone the expertise of their engineer. benefits enjoyed from the successful installation asides from the obvious benefits of timely brachytherapy treatment for cancer patients and obtaining value from the expensive co-60 source, installing the equipment by a local re had significant economic benefits for the hospitals. the two-way airfares for oem engineers were eliminated, and the per diem was considerably reduced, saving the government some foreign exchange earnings. in addition, the experience boosted morale and increased the technical skills of the re and his colleagues. it also gave him the expertise for guiding the prepurchase and procurement planning process of medical equipment in his department. finally, the trip to other radiotherapy centers helped develop a strong collaborative relationship between the re and the in-house engineers of the centers. looking ahead the healthcare needs in lmics are tremendous, as is the quantity of medical equipment required to meet them. however, the bulk of medical equipment in these regions is imported or supplied by foreign donors. for example, a survey of 1,242 equipment in ten indonesian hospitals revealed that only 4.2% were manufactured in that country.15 the figures for nigeria show the country is dependent on importation for about 99% of its medical equipment needs, and the small local production in the country is limited to simple devices like syringes. regrettably, the impact of the country’s $170m medical equipment market on patient care is still underwhelming as large numbers of imported medical equipment are unusable.16 up to 70% of sophisticated medical equipment imported into lmics is nonfunctional because of a mismatch between the equipment design and the setting where they are used. these “off-the-shelf” products fail to meet the environmental profile needs of lmics already suffering from an unstable power supply, lack of clean water, an abundance of dust, and a hot and humid climate.17 even figure 3. setting up a treatment console (left). a fully installed treatment console (right). j global clinical engineering vol.5 issue 1: 2022 26 adio, uwadiae, adewumi : covid-19, a blessing in disguise: the experience of a nigerian radiotherapy engineer when the equipment is stripped down, they are still not explicitly designed to meet the 4 as for preventing equipment mismatch to a market: availability, accessibility, appropriateness, and affordability.18 in view of the above, lmics should begin exploring the local production of low-resource medical equipment, starting with non-complex ones. such equipment would be designed with the environmental profile in mind and consider practitioner/end-user input to meet the appropriateness factors. it would be made from locally available raw materials and stripped of nonessential features to solve availability and affordability problems.19 however, this option remains only an aspiration until the many barriers facing local production are surmounted. one of the principals but unintended barriers is the influx of donated foreign medical equipment. low cost or donated medical equipment leads to aid dependency in lmics and a stifling of the country’s development.20 another barrier is the absence of an atmosphere conducive to r&d and innovation in lmics.18 r&d is funded mainly by industries in high-income countries, but in lmics it is publicly funded through academic institutions. however, in nigeria, for example, the better part of the time and activity of universities is devoted to teaching and assessing students, while research work is a secondary activity. reasons like poor funding, insufficient research personnel, extraneousness of research focus on societal needs, and a delink between the academia and productive sectors have been attributed to the situation.21 to reverse this trend, the government needs to reappraise its allocations to the education sector, where the 2021 expenditure on salaries and overhead is 429% of the capital budget of the federal ministry of education.22 it also needs to double the funding for the federal ministry of health to meet its 2011 abuja declaration of committing at least 15% of the annual budget to the health sector.23 the two ministries and the federal ministry of science and technology must also work together to midwife the all-important collaboration among academic institutes, medical practitioners, and industries to kick off the production of domestically-designed medical equipment from locally-sourced raw materials for use in the nation’s hospitals. other challenges that must be addressed before local production can begin in lmics include establishing a regulatory framework for health technology assessment, harmonization of device classification, standardization for product safety and quality, and creating an enabling business environment. 23 in-house hospital engineers can also contribute their quota to the local production of medical equipment in lmics through additive manufacturing. a few hospitals have pioneered 3d printing laboratories for the fabrication of person-specific needs that are not on the market. these so-called hospital factories use additive manufacturing to make products like individualized prosthesis for patients and anatomo-functional models used for surgical planning and patient education.24 other areas where 3-d medical printing is used include the production of microfluidic devices for laboratory test, meal assistance devices for spinal cord injury patients, immobilization devices for radiotherapy and fixation plates implanted by orthopaedics surgeons.25-27 hospitals in lmics can equip their biomedical engineering departments with 3-d printing labs to fabricate some of these personalized medical products. the essence of locating the laboratory in the hospital is to foster collaboration between medical practitioners, patients (end users), and the engineers from the designing to production stages. while setting up the lab may be initially cost-intensive, hospitals can recoup their investments with a good business model, and patients can get apropos service at a fraction of the cost of getting it from oems. conclusion achieving adequate health technology in lmics is long and fraught with many difficulties. progress in the sector has come in fits and starts and has barely made a dent in providing healthcare facilities with the resources they need to provide patients with the care they need. but with a strategic plan to develop the local ‘man and machine’ and an unflinching determination to commit time and financial resources to the plan, lmics too can begin the journey towards self-sufficiency in their practice of medicine. 27 j global clinical engineering vol.5 issue 1: 2022 adio, uwadiae, adewumi : covid-19, a blessing in disguise: the experience of a nigerian radiotherapy engineer references 1. federal ministry of information and culture. #covid19: what president buhari has done, and is doing, by presidency. abuja, nigeria: tunji oyeyemi; 2020. available at: https://fmic.gov.ng/covid19-what-president-buhari-has-done-and-is-doing-by-presidency/ 2. world health organization. disease commodity package novel coronavirus (covid-19) 2021. available at: https://www.who.int/publications/i/item/ disease-commodity-package---novel-coronavirus-(ncov) 3. mullaly s. survey of clinical engineering effectiveness in developing world hospitals: equipment resources, procurement and donations. annu int conf ieee eng med biol soc. 2008; 2008:4499-502. 4. david y, maltzahn w, neuman m, et al. clinical engineering, principles and applications in engineering series. boca raton (fl): crc press; 2003. 5. de maria c, mazzei d, ahluwalia a. improving african healthcare through open-source biomedical engineering. int. j. adv. life sci 2015; 7(1):10-19. 6. reichenvater h, matias ls. is africa a ‘graveyard’ for linear accelerators? clin oncol. 2016; 28(12):179-83 7. hossain a, rashid m, islam r, et al. current status of skilled clinical engineer in developing countries. procedia soc behav sci 2015; 195:1688-93. 8. khorana a, tullio k, elson p, et al. time to initial cancer treatment in the united states and association with survival over time: an observational study. plos one 2019; 14(3): e0213209 9. mackillop w, o’sullivan b, withers h. the effect of delay in treatment on local control by radiotherapy. int. j. radiation oncology biol. phys. 1996; 34(1):243-50 10. ayoade b, salami b, agboola a, et al. beliefs and practices associated with late presentation in patients with breast cancer; an observational study of patient presenting in a tertiary care facility in southwest nigeria. j afr cancer 2015; 7:178-185. 11. tumba n, adewuyi s, eguzo k, et al. radiotherapy waiting time in northern nigeria: experience from a resource-limited setting. ecancer 2020; 14:1097 12. adio o, uwadiae i, madu c, et al. necessity is the mother of improvisation: how radiotherapy engineers in nigeria rise to the challenge. pmj 2019; 2(1): 71-8. 13. hanna t, king w, thibodeau s, et al. mortality due to cancer treatment delay: systematic review and metaanalysis. bmj 2020;371:m4087 14. huang j, barbera l, brouwers m, et al. does delay in starting treatment affect the outcomes of radiotherapy? a systematic review. j. clin. oncol. 2003; 21(3): 555-63 15. perry l, malkin r. effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? med biol eng comput. 2011; 49:719–22 16. international trade administration. healthcare resource guide: nigeria. washington dc: 2019. available at: https://2016.export.gov/industry/health/ eg_main_130219.asp. 17. world health organization. medical devices: managing the mismatch: an outcome of the priority medical devices project. 2010. available at: https://apps.who. int/iris/handle/10665/44407 18. world health organization. local production and technology transfer to increase access to medical devices: addressing the barriers and challenges in lowand middle-income countries. 2012. available at: https:// apps.who.int/iris/handle/10665/336774 19. james t, jaiswal a. medical devices industry in india local manufacturing and trade. research and information system for developing countries; 2020 available at: http://www.ris.org.in 20. neighbour r, eltringham r. the reality of designing appropriate ‘low cost’ medical products for developing countries and their unintended consequences. aht 2014. iet conference. 2014 available at http:// digital-library.theiet.org/content/conferences/10.1049/ cp.2014.0792 21. bako s. universities, research and development in nigeria: time for a paradigmatic shift. published proceedings of the 11th general assembly of codesria, on rethinking african development: beyond impasse: https://fmic.gov.ng/covid19-what-president-buhari-has-done-and-is-doing-by-presidency/ https://fmic.gov.ng/covid19-what-president-buhari-has-done-and-is-doing-by-presidency/ https://www.who.int/publications/i/item/disease-commodity-package---novel-coronavirus-(ncov https://www.who.int/publications/i/item/disease-commodity-package---novel-coronavirus-(ncov http://export.gov/industry/health/eg_main_130219.asp http://export.gov/industry/health/eg_main_130219.asp https://apps.who.int/iris/handle/10665/44407 https://apps.who.int/iris/handle/10665/44407 https://apps.who.int/iris/handle/10665/336774 https://apps.who.int/iris/handle/10665/336774 http://www.ris.org.in http://digital-library.theiet.org/content/conferences/10.1049/cp.2014.0792 http://digital-library.theiet.org/content/conferences/10.1049/cp.2014.0792 http://digital-library.theiet.org/content/conferences/10.1049/cp.2014.0792 j global clinical engineering vol.5 issue 1: 2022 28 adio, uwadiae, adewumi : covid-19, a blessing in disguise: the experience of a nigerian radiotherapy engineer towards alternatives; 2005, maputo, mozambique. available at: https://www.codesria.org/ 22. buhari m. 2021 budget speech: budget of economic recovery and resilience. joint session of the national assembly; 2020 abuja, nigeria. available at: https:// pwcnigeria.typepad.com/ 23. world health organization. the abuja declaration: ten years on. 2011. available at: https://www.who.int/ healthsystems/publications/abuja_declaration/en/ 24. lanzarone e, marconi s, conti m, et al. hospital factory for manufacturing customised, patient-specific 3d anatomo-functional models and prostheses: in: tullio t, giacomo c, walter t, eds. factories of the future: the italian flagship initiative. new york: springer; 2019:233-54. 25. lee w, kwon d, choi w, et al. 3d-printed microfluidic device for the detection of pathogenic bacteria using size-based separation in helical channel with trapezoid cross-section. sci rep 2015; 5(7) 26. nozaki t, murakami t, shimono t, et al. development of meal assistance device for patients with spinal cord injury. ieee 14th international workshop on advanced motion control (amc), auckland, new zealand; 2016: 388-93. available at: https://ieeexplore.ieee.org/ abstract/document/7496381 27. asfia a, novak j, mohammed m, et al. a review of 3d printed patient specific immobilisation devices in radiotherapy. phiro 2020; 13: 30-5 https://www.codesria.org/ https://pwcnigeria.typepad.com/ https://pwcnigeria.typepad.com/ https://www.who.int/healthsystems/publications/abuja_declaration/en/ https://www.who.int/healthsystems/publications/abuja_declaration/en/ https://ieeexplore.ieee.org/abstract/document/7496381 https://ieeexplore.ieee.org/abstract/document/7496381 51 j global clinical engineering vol.6 special issue 6: 2024 conference paper leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 1 biomedical technology unit, department of medical physics, school of medicine, university of patras, patras, greece. 2 institute of biomedical technology, patras, greece. * corresponding author email: liontou.kon@gmail.com abstract accurate identification and management of medical devices is of particular importance to ensure patient safety and regulatory compliance within healthcare systems. this paper presents a comprehensive exploration of medical device data retrieval, focusing on the integration of web scraping and application programming interface (api) technologies. the utilization of unique device identifiers (udis) and the global medical device nomenclature (gmdn) system is emphasized to enhance device authentication, attribute verification, and accurate categorization. this paper introduces a state-of-the-art code implementation that combines web scraping techniques and api integration to address the challenges of retrieving and verifying device information. the code facilitates both access to data and healthcare professionals and stakeholders to make informed decisions based on reliable and up-to-date information. this is a significant and defining advance in the field, offering a powerful solution that is innovative as well as vital. the paper concludes by discussing the potential impact of these developments on patient safety, regulatory compliance, and the overall advancement of healthcare technology. in addition, the importance of accurate device identification, the role of udis and gmdn, and the significance of the provided cutting-edge code are highlighted, providing valuable insights into the field of medical device data retrieval. keywords—web scraping, medical device data management, api integration. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:liontou.kon@gmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.6 special issue 6: 2024 52 introduction in today’s data-driven landscape, the demand for effective data extraction techniques is critical. patient safety, regulatory compliance, and informed decision-making hinge on the acquisition of accurate and up-to-date information about medical devices. however, obtaining this information can be a daunting task, given the disparate origins and formats of available data. this paper examines the challenges associated with medical device data management and introduces a comprehensive methodology, proposing a combination of web scraping methods with the integration of application programming interfaces (apis), with a particular focus on two key elements: unique device identifiers (udis) and global medical device nomenclature (gmdn) terms, pivotal for the identification and categorization of medical devices. our objective is to present an integrated approach for gathering, validating, and employing medical device data from the accessgudid (global unique device identification database), which acts as the authoritative source of device information, laying the foundation for our methodology. in addition, our methodology relies on the web-praxis medical equipment management software (mems), developed by the institute of biomedical technology (inbit)1, whose data can be accessed by appropriate healthcare unit users. a dataset of medical device information was provided for the purpose of this study. accessgudid database on the other hand is freely accessible. the significance of swift medical equipment (me) identification in today’s fast-paced healthcare environment cannot be overstated. particularly in the context of recalls and field safety notices (fsns) issued by manufacturers, which contain vital information about affected device types, rapid identification plays a crucial role. clinical engineers are entrusted with the immediate and appropriate response to these notices, ensuring the correct course of corrective actions or equipment withdrawals to prevent adverse events. to address this pressing need, our developed software serves a dual purpose. it aids in the validation of me within a hospital’s inventory, ensuring precise matching with the corresponding udi codes. udi serves as a standardized system for identifying and tracing medical devices additionally, it facilitates the accurate classification of me into gmdn groups, a critical facet of the udi system. gmdn serves as a standardized system for classifying medical devices worldwide. it is noteworthy that recalls and fsns frequently include udis for affected devices, emphasizing the growing importance of udi-based traceability. moreover, according to mdr 2017/7452, the traceability of devices by means of a udi system should significantly enhance the effectiveness of the post-market safety-related activities for devices. to address the complexities of gathering and verifying device-related data, this paper discloses an innovative code implementation. we combine web scraping techniques with accessgudid (global unique device identification database) api integration, presenting a powerful solution. our code adeptly extracts imperative device details from the accessgudid website and validates this information with data provided by web-praxis. additionally, our code integrates seamlessly with the accessgudid api, simplifying the retrieval of device-specific information dependent on udis, ensuring compliance with data usage regulations, and increasing the reliability and accuracy of the retrieved data. in summary, this paper delves into the intricate realm of medical device data management, leveraging advanced techniques for data extraction and integration. our integrated approach not only promises to enhance patient safety and regulatory compliance but also equips healthcare professionals with the tools needed for informed decisionmaking in an increasingly dynamic healthcare landscape. background in the modern era, accurate and timely management of medical device data is essential for various stakeholders in the healthcare industry. in this section, we talk about the background of the key elements of this paper’s methodology: unique device identifiers (udis) and global medical device nomenclature (gmdn), in addition to an overview of web scraping and application programming interface (api) integration. http://www.globalce.org http://globalce.org http://globalce.org 53 j global clinical engineering vol.6 special issue 6: 2024 apis, on the other hand, serve as intermediaries between software applications, enabling seamless communication and data exchange. web scraping vs. api web scraping, with its capability to access data from multiple web pages and repositories, excels in collecting large volumes of heterogeneous data efficiently. it offers flexibility in data collection and analysis, making it a valuable tool in domains such as computer vision and natural language processing. apis, on the other hand, provide a structured and controlled means of accessing specific data from applications or software. while they offer advantages such as standardized interfaces and faster data extraction, they also come with limitations in terms of functionality and access to a single website or predefined functions.5, 7, 8 methods and materials python for web scraping python is a highly favored choice for web scraping due to several key reasons. firstly, python is a very popular programming language because of its simplicity and learnability, facts that make it accessible even to those with little programming experience. its extensive community support ensures readily available assistance for overcoming coding challenges. furthermore, python excels in web scraping because of the readability of the code. python code is designed for easy understanding, promoting clear and concise programming practices. this readability not only enhances productivity during development but also facilitates code understanding, even when revisiting it after some time has passed. this attribute promotes more efficient code maintenance and facilitates code reuse.8 for these reasons, python is used in all the software we developed. our code we present an integrated code solution that combines web scraping via beautiful soup (version 4, python library for html and xml parsing, crummy, cambridge, ma, usa) with accessgudid api integration. tailored unique device identifiers (udis) unique device identifiers or udis, are alphanumeric codes for medical devices, offering a standardized global means of identification. they enable precise tracking from manufacturing to post-market surveillance. udis encode key device information like manufacturer, model, and production date. their implementation has significantly advanced healthcare, enhancing patient safety, regulatory compliance, and supply chain management. udis empower healthcare professionals to quickly access device data, identify recalls, and respond to adverse events effectively. 3 global medical device nomenclature (gmdn) the global medical device nomenclature (gmdn) is an internationally recognized system for naming and categorizing medical devices. it offers a structured classification system that facilitates global communication in healthcare. gmdn codes categorize devices based on their purpose, structure, and operation, enabling precise comparisons. gmdn adoption has streamlined regulations, research, and product development in the medical device industry. it promotes consistency in terminology and categorization, as well as seamless compatibility and cooperation among healthcare stakeholders for sharing accurate device information.4 web scraping and api integration in the contemporary era, extracting data from various web sources has become essential for various domains, including healthcare. in this section, a foundational understanding of the main data extraction methods: web scraping and application programming interfaces (apis), is provided. web scraping, also known as web extraction or harvesting, involves the automated extraction of data from websites and their subsequent storage for analysis or retrieval. this method, widely recognized for its efficiency and accuracy, has evolved significantly over the years. modern web scraping tools have become versatile, capable of parsing markup languages, integrating with computer vision and natural language processing techniques, and simulating human browsing behavior.5,6 http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 54 for healthcare professionals, this tool simplifies access, validation, and analysis of device data based on udis and gmdn names while ensuring data compliance. a key aspect of our methodology involves cross-referencing data derived from web scraping with information from praxis, our primary data source. this information is structured in an excel file and has been collected by humans, checked, and entered into the praxis database. this quality control step identifies disparities in device attributes, improving data accuracy. for example, discrepancies in gmdn names trigger further investigation to address updates or errors. our comprehensive validation process involves verifying gmdn names, selecting the most prevalent name when multiple names exist, and aligning device attributes across sources, ultimately enhancing the reliability of medical device data. data import to begin data retrieval, the code begins by importing data from an excel file provided by web praxis. this file includes critical information about medical devices and the specific columns of interest include general group, specific group, manufacturer, model, and comments, where unique device identifiers (udis) are often found. the initial excel file includes 279 records, representing distinct medical devices. udi extraction next, the code extracts the 14-digit udis from the appropriate field (if any because not all records have a registered udi). this step is crucial for subsequent operations as udis serve as the primary key for accessing device information. web scraping and api integration the heart of the methodology lies in its ability to combine web scraping and api integration for comprehensive data collection. web scraping extracts data based on udis, while api calls are made to the accessgudid database to retrieve detailed device information. this hybrid approach ensures that even devices without readily available udis can be identified and analyzed. data validation and presentation as data is retrieved, the code simultaneously validates and cross-references it to ensure accuracy and reliability. the data are then organized and presented in a structured format for further analysis and reporting. data cross-referencing for enhancing data reliability, the code employs crossreferencing. it verifies device attributes like gmdn terms by comparing data from praxis with data obtained through web scraping or api integration. this process ensures consistency across multiple sources and is a vital quality control step. the aforementioned accomplishments were realized through the utilization of the following libraries: requests for making http requests to interact with web services and retrieve data from web servers, pandas for data manipulation, tkinter for creating a gui, re for regular expressions, time for time-related operations, and beautiful soup for web scraping purposes to pull the data out of html and xml files, as it helps in navigating, searching, and modifying the parse tree. beautiful soup creates a parse tree from page source code that can be used to extract data easily. results the results were quite satisfactory. out of the 279 records initially provided, we found udi matches for 193 records (69% success rate). by implementing a complex search based on the company name and brand name (this was done because there were cases that we did not have a udi—device type match a priori), we were able to identify 14 more records which means 207 records in total (74% success rate). the output generated by the code is presented in a structured excel format (figure 1), providing a comprehensive overview of matched udis, associated company names, brand names, gmdn names, cross references, and definitions. http://www.globalce.org http://globalce.org http://globalce.org 55 j global clinical engineering vol.6 special issue 6: 2024 demonstrate a fairly accurate recording of medical equipment, with correct udis, gmdn names, and definitions. matching all 279 medical records cannot be possible due to inaccuracies inherent in the databases. this creates issues for our model, often leading to many closely related outcomes. even for a human observer, distinguishing between these outcomes is extremely challenging. so, reaching a perfect 100% match rate is impossible and would demand a lot of human effort from an experienced eye, potentially even reviewing unrelated results. hence, a 74% match rate is considered satisfactory under these circumstances. overall, the output provides a comprehensive overview of the matched udis, associated company names, brand names, gmdn names, cross-references, and definitions, allowing for further analysis and verification of the recorded medical equipment data. in general, the implemented code combining web scraping techniques and integration with the accessgudid api has proven to be an essential tool for retrieving, validating, and analyzing medical device data based on udis and global medical device nomenclature (gmdn) names. the need for web scraping arises from the vast amount of device information available on websites like accessgudid. web scraping enables the efficient extraction of specific data elements, such as company names, brand names, gmdn names, cross-references, and definitions, from complex html structures. by automating the data retrieval process, this method provides instant access to the most up-to-date device information, ensuring accuracy and timeliness. integrating an api (in this case, the accessgudid api) further enhances the code’s functionality and reliability. by leveraging the api, the code establishes a secure connection to the comprehensive device database provided by accessgudid, ensuring compliance with data usage policies, facilitating seamless data retrieval, and enhancing the reliability and accuracy of the obtained device information. moreover, the use of udis plays a crucial role in device identification and traceability. udis provide a standardized system for the unique identification of medical devices, ensuring many benefits for both patient and equipment safety. the code’s ability to cross-check device data with where: 1st column: udi, udis are listed. it includes both the udis that were initially matched and the “n/a” symbol for equipment that had no udi in the initial data and required an advanced search. 2nd column: company name as registered on the website. 3rd column: brand name as registered on the website. 4th column: gmdn name as registered on the website. 5th column: gmdn cross reference. the term “same” is displayed for records that have the same gmdn name on both the website and the initial excel data. for records that are not the same, a different description is provided. this description was obtained from the initial data. 6th column: gmdn definition as registered on the website for the devices that were “identified” by the udi. for the devices that we did not know the udi beforehand, and we made an advanced search, we had many results. so, the gmdn definition was obtained by examining the first page of search results on the website generated by the advanced search. we identified all the gmdn names and applied a sorting algorithm to select the names that appeared most frequently. figure 1. format of the output excel file. discussion the high success rates in both types of searches indicated that the data provided by web-praxis, although challenging to manage due to its unstructured format, http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 56 udis and gmdn names ensures the authenticity of devices, verifies their attributes, and allows for accurate categorization. this cross-checking process allows healthcare professionals to identify and address potential discrepancies, ultimately ensuring patient safety and improving informed decision-making. conclusion in conclusion, the combination of web scraping, api integration, and the use of udis addresses the challenges of accessing, validating, and analyzing medical device data. the implemented code streamlines these processes, enabling users to efficiently retrieve reliable device information, verify device characteristics, and eventually make informed decisions. the code can be periodically used to ensure the fidelity of udi codes and gmdn group classification of me in a medical equipment inventory, to address the dynamic nature of the above systems, and to update the information for new me types added to the inventory. as technology evolves, more and more advancements in web scraping and api integration will contribute to even more efficient and accurate device data management and analysis in the healthcare industry. μany suggestions can be taken into account for even greater effectiveness of the solution we proposed. firstly, validating and cleaning the input data is significant for ensuring data quality in general. additionally, automating code execution as well as batch processing capabilities can improve efficiency, especially when dealing with large volumes of data. moreover, integration with healthcare or inventory management systems is significant, in order to synchronize data and improve decision-making capabilities. collaborations and partnerships with regulatory bodies, healthcare institutions, or manufacturers can facilitate data sharing and drive industry-wide improvements in device identification and data management practices. moreover, continuous data monitoring is recommended both to periodically retrieve and update device information from reliable sources so as to maintain data accuracy and relevance. finally, comprehensive documentation and user support materials is necessary to be provided, as they would help users to use the code effectively and maximize its potential. acknowledgments we would like to acknowledge the invaluable contribution of the web-praxis software, as a primary data source for this research. references 1. inbit. available online: https://www.inbit.gr/en/. 2. official journal of the european union. the european parliament and the council of the european union; 2024. available online: https://eur-lex.europa.eu/ legal-content/en/txt/?uri=celex%3a32017r0745. 3. unique device identification system (udi system), fda. available online: https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance/ unique-device-identification-system-udi-system. 4. gmdn. available online: https://www.gmdnagency.org/. 5. sathya, a.c., rao, p. mastan, babu, s. development of a covid-19 information dashboard to access the health care resources and requirements online. in 2022 3rd international conference on computing, analytics and networks (ican), rajpura, punjab, india; ieee; 2022; pp. 1–8. https://doi.org/10.1109/ ican56228.2022.10007167. 6. zhao, b. web scraping. in encyclopedia of big data. laurie a. s., connie l. m. springer: cham, switzerland; 2017;pp. 1–3. 7. web scraping vs api: what’s the difference and similarity. 2023 available online: https://www.scrapingdog. com/blog/web-scraping-vs-api/. 8. khder, m.a. web scraping or web crawling: state of art, techniques, approaches and application. int j adv soft computing appl. 2021;13(3):144–168. https:// doi.org/10.15849/ijasca.211128.11. http://www.globalce.org http://globalce.org http://globalce.org https://www.inbit.gr/en/ https://eur-lex.europa.eu/legal-content/en/txt/?uri=celex%3a32017r0745 https://eur-lex.europa.eu/legal-content/en/txt/?uri=celex%3a32017r0745 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system https://www.gmdnagency.org/ https://doi.org/10.1109/ican56228.2022.10007167. https://doi.org/10.1109/ican56228.2022.10007167. https://www.scrapingdog.com/blog/web-scraping-vs-api/ https://www.scrapingdog.com/blog/web-scraping-vs-api/ https://doi.org/10.15849/ijasca.211128.11 https://doi.org/10.15849/ijasca.211128.11 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 j global clinical engineering vol.6 issue 2, 2023 2 editor’s corner a call for competence-driven healthcare technology: the right to repair and clinical engineering competency the debate surrounding “right-to-repair” has reached clinical engineering, sparking a crucial discussion about technical expertise and patient safety. on one hand, healthcare providers question why they cannot choose service providers for their medical equipment, obtain replacement parts, and manuals given their investment in acquiring and maintaining its performance. on the other hand, the industry raises concerns about the specialized training and qualifications necessary for safe and effective maintenance of sophisticated devices.. this debate hinges on the concept of competency: the ability to perform a task effectively. in healthcare, where lives hang in the balance, ensuring competency should be paramount. unlike a simple household appliance, medical equipment demands intricate knowledge, experience, specialized tools, and a deep understanding of its intricacies. therefore, simply owning the device should not grant automatic repair rights. as you can see on the cover page of this issue, we encourage further understandings of professional stewardship characteristics especially as it refers here to engineering competency. the foundation of competency lies in education, discipline boundary, skills sustainability, and compliance with professional credentialing. from the wisdom of the book of proverbs, the biblical anthology of saying and instructions, (“discretion will watch over you, understanding will guard you...”) to the latin root “competere”, which is a combination of “com” (“together” or “with”) and “petere” (“to seek” or “go towards”). therefore, the literal meaning is seeking or suitable to go together, having competence. over time, the term evolved generally to represent the ability, capacity, or fitness to perform tasks or function effectively. it is commonly used now to describe a set of skills, knowledge, and attributes that make an individual a capable and qualified practician in a particular field, role, or task. in healthcare, ensuring patient safety necessitates demonstrable competent stewardship, including from the professionals who ensure that patient care medical technology is safe and effective. as healthcare grows ever more technology-intensive and its reliance on that technology increases, the clinical engineering profession competency becomes ever so more vital. patient who enters the healthcare system for the treatment of their disease or abnormal condition may be unable to understand and to make decisions about the technology that is about to be used during the treatment or management of their condition. furthermore, patients may be unable to fend for him/herself due to receiving medications or anesthetic drugs that render them unconscious, unable to make decisions. in such situations patients are appropriately expect that members of the healthcare team will ensure that the technology used on them is safe and effective. the care team includes clinical engineering practitioners. while physicians are taking the historical oath of ethics known as “hippocratic oath”, engineers are also bound by the “first do no harm” (in latin primum non nocere) and by the engineer’s creed contained in professional engineer ethical oath.1 assessing and maintaining competency requires a multi-pronged approach: • technical knowledge: examining expertise in relevant systems, protocols, and troubleshooting. • risk management: evaluating the ability to identify and mitigate potential risks associated with equipment operations and maintenance. • problem-solving skills: assessing the capacity to diagnose and resolve technical issues effectively. • communication skills: ensuring clear and concise communication with stakeholders, including healthcare professionals and patients. http://www.globalce.org http://www.globalce.org 3 j global clinical engineering vol.6 issue 2, 2023 • project management: evaluating the ability to manage equipment maintenance projects efficiently and effectively. • ethics and professionalism: assessing adherence to ethical principles and professional standards. • continuous learning: evaluating commitment to ongoing learning and knowledge acquisition. the methods for measuring competency range from performance assessments and technical examinations to peer reviews and self-assessments. ideally, the approach should be tailored to the specific context and goals of the organization and the engineering discipline. however, a global baseline of competency is essential to ensure safe patient outcomes. the debate around “right-to-repair” ultimately boils down to who should determine competency: the industry or the healthcare provider? we, as clinical engineers, must advocate for competency-based access, demonstrating our value through education, professional credentialing, and ethical practice. this will pave the way for a future where clinical engineering is recognized as a “free” profession2, empowered to make decisions based on expertise and not external constraints. join the conversation! share your thoughts on the “right-to-repair” debate and how we can achieve competency-driven healthcare technology management programs. if you’re not yet accredited, let us know how we can help you on your journey towards professional recognition. global clinical engineering alliance and the global clinical engineering journal will look forward to your response. we can ensure that patient safety remains the cornerstone of our discipline, and that means, that together we can make it better. references 1. the professional clinical engineer, y. david, journal of clinical engineering, sept/oct 1988. 2. is clinical engineering an occupation or profession?, y. david et al, global clinical engineering journal, vol. 4, issue 2, 2021. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. have a wonderful and productive 2024! dr. yadin david http://www.globalce.org http://www.globalce.org j global clinical engineering vol.6 issue 3, 2023 2 editor’s corner building better healthcare: the vital role of clinical engineering in hospital construction in the meticulous construction of a new hospital, every detail counts. from needs assessment and architectural design to the implementation of state-of-the-art medical technology, each element plays a crucial role in the hospital’s functionality, efficiency, and ultimately, the quality of patient care delivered. among these critical components are somewhat less appreciated (especially when functioned as expected) fixtures, fittings, and equipment (ffe), which require careful management to ensure seamless operation and optimal utilisation within the healthcare environment. below are some of the benefits accrued by ensuring that ffe is holistically considered from conception through to the operational phase of the new hospital. enhancing patient care and safety: properly considered fixtures, fittings, and equipment contribute significantly to the delivery of high-quality patient care. functional equipment and well-designed fixtures create a conducive environment for healthcare professionals to perform their duties efficiently, leading to better outcomes for patients. conducting comprehensive risk assessments throughout the hospital development process helps identify potential hazards, including ergonomic challenges, equipment issues such as connectivity, electrical hazards, and infection control vulnerabilities. proactive mitigation measures such as ergonomic design principles, equipment safety protocols, and infection prevention strategies minimise the likelihood of accidents and adverse events. knowledge of and adherence to regulatory requirements and industry standards, along with comprehensive staff training and education, ensures compliance and promotes a culture of safety awareness. integrating safety principles and universal design concepts into the architectural layout and ffe selection enhances overall safety and accessibility, while continuous monitoring and improvement processes foster a culture of transparency and accountability. by addressing safety risks proactively, future-ready hospitals uphold the highest benchmarks of safety and quality, positioning themselves as trusted providers of healthcare services now and in the years to come. comprehensive planning: comprehensive planning stands as the cornerstone of successful hospital construction endeavours, necessitating meticulous attention to detail from inception to fruition. during the initial stages, prioritising thorough planning and coordination ensures the seamless integration of fixtures, fittings, and equipment (ffe) into the building design. this entails engaging a diverse array of stakeholders, including architects, engineers, clinicians, facilities managers, medical device managers, and importantly, patients and the public, to assess ffe requirements comprehensively. operational efficiency: efficient ffe selection entails considering factors like reliability, ease of maintenance, and compatibility with existing infrastructure, ensuring uninterrupted care delivery. strategically placing equipment within the hospital environment optimises workflow patterns and minimises unnecessary steps, enhancing efficiency. for instance, proximity between diagnostic equipment and treatment areas streamlines processes and reduces patient wait times. proactive maintenance schedules, including calibration and preventive repairs, sustain equipment functionality and mitigate unplanned downtime, optimising resource utilisation and operational efficiency. embedding technological advancements such as smart sensors and predictive analytics augments operational efficiency by enabling proactive decision-making, monitoring, and maintenance interventions. leveraging http://www.globalce.org http://www.globalce.org 3 j global clinical engineering vol.6 issue 3, 2023 real-time data insights facilitates early detection of inefficiencies and potential equipment shortfalls, empowering healthcare facilities to optimise resource allocation and enhance patient care delivery. by integrating efficient ffe selection, strategic placement, proactive maintenance, and technological innovation, hospitals can cultivate environments that prioritise operational excellence and elevate the standard of patient care. anticipating technological advancements: one of the key aspects of future readiness is anticipating technological advancements in medical equipment and healthcare delivery. by staying abreast of emerging technologies such as telemedicine platforms, artificial intelligence (ai) diagnostics, and robotic-assisted surgery systems, hospital planners can design infrastructure that accommodates these innovations. this may include incorporating flexible room layouts, modular equipment configurations, and advanced it infrastructure to support interoperability, new diagnostic and treatment modalities, and data exchange. adapting to changing patient demands: as patient preferences and expectations evolve, hospitals must adapt their facilities to meet shifting demands for convenience, accessibility, and personalised care. future-ready hospitals may incorporate amenities such as patient-controlled environments, decentralised care hubs, and integrated telehealth services to enhance the patient experience. flexible ffe solutions that allow for rapid reconfiguration and scalability enable hospitals to respond dynamically to fluctuations in patient volumes and care delivery models. furthermore, by incorporating the patient and public voice into the planning process, hospitals gain invaluable insights into the practical needs and preferences of those who will ultimately utilise the facility. this collaborative approach fosters a sense of ownership and trust among stakeholders, ensuring that the hospital environment is designed with the end-users’ perspectives in mind, ultimately enhancing patient satisfaction and overall experience. embedding patient and public voices into the early stages of planning promotes needs identification, transparency and accountability, empowering communities to actively participate in shaping their healthcare infrastructure. by soliciting feedback on design elements, wayfinding systems, and accessibility features, hospitals can create environments that are inclusive and responsive to diverse needs. moreover, involving patients and the public in decision-making processes fosters a sense of shared responsibility for healthcare outcomes, promoting community engagement and social cohesion. ultimately this not only enhances the functionality and efficiency of hospital facilities but also strengthens trust, collaboration, and resilience within the healthcare system. sustainability and resilience: in light of environmental concerns and resource constraints, future-ready hospitals prioritise sustainability and resilience in their design and operations. energy-efficient fixtures, renewable energy sources, and green building materials reduce carbon footprint and operational costs while promoting environmental stewardship. additionally, resilient infrastructure designs, such as backup power systems and disaster preparedness measures, cybersecurity and data privacy, enhance the hospital’s ability to withstand and recover from unforeseen events, ensuring continuity of care in times of crisis. clinical engineering professionals should be engaged in addressing these concerns. collaboration and innovation ecosystems: future-ready hospitals embrace collaboration and innovation ecosystems that foster partnerships with industry stakeholders, research institutions, and technology providers. this further facilitates continuum of care that includes the home. by actively engaging with these networks, hospitals can access cutting-edge technologies, research findings, and best practices that inform http://www.globalce.org http://www.globalce.org j global clinical engineering vol.6 issue 3, 2023 4 decision-making and drive continuous improvement. this collaborative approach enables hospitals to remain at the forefront of innovation and deliver state-of-the-art care to their patients. in the dynamic landscape of healthcare delivery, the correct management of fixtures, fittings, and equipment is indispensable for ensuring the seamless operation of a new hospital build. by prioritising patient care, operational efficiency and safety, healthcare institutions can create an environment conducive to healing and innovation. through meticulous planning, diligent execution, and ongoing maintenance, hospitals can uphold the highest standards of quality and excellence in healthcare delivery for the benefit of patients and healthcare professionals alike. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. indeed, the essence of a hospital transcends its architectural beauty; it lies in its ability to provide comprehensive healthcare services supported by the right equipment and infrastructure. a tent equipped with essential medical supplies, diagnostic tools, and skilled healthcare professionals can function as a makeshift hospital in times of crisis, delivering life-saving interventions where they are most needed. conversely, a visually stunning building devoid of essential medical equipment serves merely as a hollow shell, unable to fulfil its purpose of healing and caring for the sick. therefore, while architectural aesthetics are undeniably important, it is the integration of appropriate fixtures, fittings, and equipment that truly defines a hospital’s capacity to deliver effective healthcare services and positively impact the lives of its patients. nata zaman secretary general of global clinical engineering alliance and equipping advisor for the new hospital programme, nhs england, uk http://www.globalce.org http://www.globalce.org j global clinical engineering vol.7 issue 3: 2025 60 received september 18, 2024, accepted june 23, 2025, date of publication september 16, 2025. review application of usability techniques in medical devices in health technology management: a rapid review mariana brandão†,* and renato garcia† institute of biomedical engineering (ieb-ufsc), federal university of santa catarina, florianópolis, santa catarina, brazil. † these authors contributed equally to this work. * corresponding author email: marianaribeirobrandao@gmail.com abstract the role of clinical engineering in health technology management (htm), incorporating human factors engineering tools, such as usability techniques, allow for improvements in the development of safer, more effective, and quality use of technological solutions. this work resulted in a rapid review of the application of usability techniques to contribute to the development and use of technological solutions for health, so that the occurrence of adverse events can be mitigated. as a consequence, information can be provided for improvements in health technology processes, in order to stimulate and highlight the importance of human factors in health. in order to understand the application of usability techniques in clinical engineering throughout the life cycle of htm, an exploratory study was done on the literature involving medical devices. this work reinforces the importance of applying techniques to identify the problems faced in the use of technologies and thereby contribute to the activities of clinical engineering so as to reduce errors and failures. the integration and consideration of human factors in the life cycle of htm is essential for the further advancement of clinical engineering in technology management throughout the healthcare ecosystem, and also in the discussion, construction, and validation of strategies that will help in preventing adverse events. keywords—clinical engineering, human factors engineering, usability techniques, health technology management, health technology assessment. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:marianaribeirobrandao@gmail.com mailto:mulugetamideksa@gmail.com mailto:mulugetamideksa@gmail.com mailto:mulugetamideksa@gmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 61 j global clinical engineering vol.7 issue 3: 2025 brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review introduction technological advances have enabled a rapid increase in the use of medical equipment in healthcare facilities.1 as a result of this growth in the frequency of use of health technologies, it has become necessary to incorporate processes that help with technological management throughout the life cycle, from the development and manufacturing stages to incorporation and use in health services. health technology management (htm), in order to make patient care more effective and with greater safety and quality, must encompass and consider the entire context in which the technology is incorporated, and is essential to make its use more appropriate and reliable. the institute of biomedical engineering at the federal university of santa catarina (ieb-ufsc) has a management model based on three main pillars: infrastructure, human resources, and technology, thus providing a systemic assessment of the technological resource2. health technologies are essential for monitoring, therapy, and diagnosis of diseases, but their use can cause adverse events for users. the main problems that could lead to adverse events are differences in functionality between technologies from different manufacturers; lack of standardization3; inefficient maintenance services; inadequate planning for incorporation; inefficient technology design; problems arising from hidden flaws; inadequate use; failure to take human factors and user ergonomics principles into account when developing technological solutions4; unsatisfactory instructions or training; improper storage and/or improper use; inadequately structured management procedures5,6; incorrectly used accessories; displays showing results that are difficult to read; and incorrectly changed alarm settings.7 studies that address technology–user interaction often neglect the human factors’ perspective, but because of an increase in technological complexity in healthcare, the need to implement research in this area has also grown proportionally.8 usability and user experience is essential in healthcare8, and can solve usage problems, increase safety, reduce incidents that cause harm to patients, and provide greater reliability in the use of technology in healthcare environments.7,9 applying usability techniques at different stages of the life cycle makes it possible to contribute to technological development more safely. in addition, they can be applied to different types of technology and help to improve use and mitigate likely risks to users in htm.10 one of the requirements to be considered in the process of evaluating and developing new technological solutions in healthcare is usability, which establishes a relationship between the characteristics of human factors with ease of use, efficiency, and user satisfaction during the use of technology.8,11,12 when considering human factors in clinical engineering, the ability of users to use technological resources in a safer and more effective way is considered, according to the real contexts of healthcare environments.13 the area of study of human interaction with other elements of a system to achieve adequate usability is called human factors engineering (hfe), which is fundamental for analyzing human behavior in the face of new technologies and establishing improvements in protocols for use in health services.7,11,14 investigating human behavior, considering their limitations, abilities, and interactions with the environment, helps to improve safety, efficacy, and quality in htm.9,15 hfe the area responsible for applying knowledge about the characteristics and limitations of people with technologies, processes, and environments is called hfe.7,9 the focus of hfe is to understand how people interact with technology and to study how design affects the interactions that people have with technology.9 it is therefore a strategic tool to be incorporated into the activities of clinical engineering in htm. the tool used to evaluate human interaction with a product is usability, and its consideration in healthcare is fundamental.8 most researchers agree that usability is a useful tool for evaluating the user experience,8 which consists of an approach that goes beyond the design of the interface, and encompasses the system, the user and their characteristics, and the context of use of the technologies or system.16 usability, as defined by the nbr iso 9241-11:2011 and nbr iec 62366:2016 standards, is a metric used to measure how well a product can be used by certain users and achieve specific objectives, by considering parameters such as effectiveness, efficiency, and satisfaction in a given context of use.11,12 the interaction between the brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review j global clinical engineering vol.7 issue 3: 2025 62 components involved in establishing a usability metric describes the integration between the user, task, and equipment to achieve a common goal, by measuring the metrics of effectiveness, efficiency, and satisfaction.12 there are five attributes that are involved: learnability, efficiency of use, ease of memorization, low error rate, and user satisfaction.17 usability is attributed to effectiveness, efficiency, satisfaction, usefulness, learnability, and accessibility.18 the different usability attributes are described on table 1. there are several international standards and regulations, presented in table 2, which can be used to initiate a usability approach in htm,5,8,9 and are important for demonstrating compliance with safety requirements.5 hfe has a series of techniques that aim to study the interactions between devices and their users, facilitating identification of problems and dangers related to use.9,10 by incorporating usability evaluation methods into cyclical human-centered design processes in an iterative way, it is possible to develop designs that involve users, making products, systems, and/or services more usable.17 in this way, usability techniques enable users to understand the problems they face and thus contribute to the development of technological solutions. usability techniques in order to assess usability, qualitative and/or quantitative techniques can be applied,8 in the pre-commercialization stages, in the processes of innovation, exploration, experimentation, and evaluation of prototypes,20 as well as in post-commercialization, when technologies are already incorporated in their environment of use. therefore, taking usability into account beyond development and use is essential for safety and reliability,21 which is why the methods can be applied throughout the life cycle.22 usability techniques aim to assist in testing and evaluation with users,7 enabling the construction of a collaborative and interdisciplinary ecosystem, in which the actors involved with technological health resources interact with each other, enhancing the implementation of solutions and user-centered technological incorporation.23 the application of usability techniques is an additional tool for analyzing human factors in htm.10 there are various ways of obtaining information regarding technology–user interaction: information and opinions related to usability can be collected with the aim of understanding users and the environment of use; observing people performing certain tasks associated with the product; discussing aspects of the project in user groups with the aim of obtaining new ideas; conducting structured studies with users using the technology in their own real environment or in simulated locations; including in a risk management plan for hazard identification; as well as using tools to model interfaces at different levels of reliability in the course of developing healthcare solutions.7,11 table 1. description of usability attributes. usability attributes description effectiveness accuracy with which users have achieved certain established objectives,12 and thus consists of an important metric for measuring the risk of error during use and ensuring patient safety.19 efficiency accuracy in relation to the resources spent by users to achieve a given objective.12 the system must be efficient and have the lowest possible error rate.17 satisfaction absence of discomfort and positive attitudes toward the use of a product12 refer to perceptions, feelings, and opinions.17 the system must be pleasant from the user’s perspective.19 usefulness checks whether the product or service achieves its use objectives.17 learning learning measures the ability of users to recall the system after a period of training or time without performing a particular task.17 the system must be easy to use from the user’s perspective.19 accessibility easy access to the products needed to complete the objective by people with the widest range of abilities.12,17 considering accessibility enables clarity and simplicity in design for people who may temporarily have some limitation or those who have it permanently.17 63 j global clinical engineering vol.7 issue 3: 2025 brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review there are various techniques specified in regulations,11,24 international guidelines and guidance materials,5,9 and books and scientific publications, some of the main ones being, but not limited to, observational analysis, interviews, focus groups, task analysis, questionnaires, the delphi method, heuristic evaluation, usability testing, and user error analysis. figure 1 shows a comparative illustrative proposal for usability techniques, based on the classification between qualitative, quantitative, and mixed-method analysis, whether the application of the technique depends on direct contact with the technology, table 2. standards involving in the usability of medical devices. standard title main objective abnt nbr iec 62366:2016 healthcare products—application of usability engineering to healthcare products. to specify the process for analysis, specification, development, verification, and validation of the safety-related usability of healthcare products. abnt nbr iso 14971:2020 medical devices—application of risk management to medical devices. to specify the principles of the process for risk management of health products, including aspects of usability. abnt iso/tr 16982:2014 ergonomics of human-system interaction—usability methods that support user-centered design. to provide information about usability methods, advantages, disadvantages, and other factors relevant to the use of each usability method. abnt nbr iec 60601-1-6:2020 medical electrical equipment part 1-6: general requirements for basic safety and essential performance. collateral standard: usability to specify the minimum usability requirements for medical electrical equipment. abnt nbr iec 60601-1-11:2012 medical electrical equipment part 1-11: general requirements for basic safety and essential performance. requirements for medical electrical equipment and medical electrical systems used in domestic health care environments. specifies requirements for electromedical equipment used in domestic environments, including usability aspects. abnt nbr iso 13485:2016 health products quality management systems requirements for regulatory purposes specifies minimum requirements for quality management systems in healthcare products, considers usability aspects. abnt nbr iso 9241-210:2011 ergonomics of human–system interaction part 210: human-centered design for interactive systems. specifying requirements and recommendations for humancentered design for the entire life cycle. abnt nbr iso 9241-11:2011 ergonomic requirements for working with visual interaction devices. part 11: usability guidelines specifies minimum requirements to identify the necessary information to be considered in the specification or evaluation of usability. aami/ansi he75 human factors engineering—design of medical devices. reference covering general principles, managing the risk of use errors, design elements. each technique has specific principles and characteristics that need to be known to ensure that the analysis of medical technologies is objective and with valid results.7,10 no technique is best in all situations.11,24 usability techniques can be divided according to the type of data to be extracted from the research: quantitative, when the evaluation of parameters has a numerical perspective; qualitative, to extract choices and feelings from the user’s point of view8; as well as mixed methods, containing qualitative and quantitative data. brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review j global clinical engineering vol.7 issue 3: 2025 64 and whether the user’s perspective on the product or the researcher’s view when observing the technology–user interaction is considered predominantly. usability techniques have been used at various stages of the life cycle of health technologies, from pre-commercialization to post-commercialization processes,10 and are strategic hfe tools to support htm. the choice of the usability technique depends on the information you want to extract.8 in addition, its results are only reliable when the participants are people who are representative of the population and who perform a certain task of interest.11 primary knowledge of usability techniques, including an understanding of the differences and basic principles of application, is essential to choose the one that best meets the needs.24 in order to understand the application of usability techniques in clinical engineering throughout the life cycle of htm, an exploratory study was done on the literature involving medical devices. materials and methods this research was conducted through a rapid review, which consists of a reliable and systematized methodology for synthesizing knowledge. this approach is used when steps in the process of a systematic review are simplified, or omitted, to produce information from the selection of research that is available in the literature, and that is of relevance to a topic of study.25 the rapid review was developed to ensure that decisions influencing the application of usability techniques in medical equipment can be informed by an up-to-date and reliable account of the scientific evidence that is relevant in the context of the research. this rapid review research was based on the ministry of health’s methodological guideline for the preparation of systematic reviews26 as well as the university of oxford’s prisma methodology, which consists of a set of evidence-based items that aim to assist in the presentation of research results.27 the guiding question of the rapid review research proposed for this case study was: “what are the usability techniques that are applied to medical equipment over the course of the technological life cycle?” to determine the choice of articles, inclusion and exclusion criteria were established, which included population parameters of the desired technology, the type of intervention used, the availability of the work, the date of publication, and the type of evaluation of the results, as presented in table 3. to answer this question, a search strategy used was to define keywords to identify publications that respond to this theme: usability; human factor; medical device; and medical equipment. the search was carried out in the following electronic databases: ieee, pubmed, and scielo, which were used systematically, and scopus, scielo, lilacs, sage, and jmir, in which searches were carried out independently. in order to determine the choice of articles, inclusion and exclusion criteria were established, which included the population parameters of the intended technology, the type of intervention used, the availability of the work, the date of publication, and the type of evaluation of the results. the use of the logical operators “and” and “or” helped in the literature search. the databases were searched using a combination of keywords: (usability or “human factor*”) and (“medical equipment*” or “medical device*”). figure 1. comparison of the usability technique. 65 j global clinical engineering vol.7 issue 3: 2025 brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review after the initial search, a publication date filter was applied, excluding articles with a publication date greater than 10 years ago. the titles and abstracts were read, and a total of 189 publications were selected. reading these studies in full resulted in the exclusion of 124 articles that did not meet the established inclusion criteria. thus, 65 articles were eligible to compose the rapid review, which present the application of usability techniques in medical equipment. the studies were classified according to the techniques used, the type of medical equipment in which the evaluation was carried out, the stage of the technology life cycle in which the methods were applied, and whether or not there was a conflict of interest in the research. the usability techniques presented in the articles were applied by the researchers to observe user interaction with the medical equipment or to identify problems by observing and transcribing the opinions of the users of the technologies. results the results of the review showed a variety of possibilities for applying usability techniques to medical equipment, from higher risk class devices, such as computed tomography,28 to even less complex equipment for home use.29 of the 65 studies, the medical equipment with the most research was the infusion pump, with sixteen in total,30–35 followed by pulmonary ventilator with five,36,37 defibrillator with five,38,39 and vital signs monitor, referenced in five studies.40–43 in addition to those already mentioned, usability techniques have also been applied to: glucometer,44–46 pulse oximeter,29 anesthesia machine,47,48 electrosurgical unit,49 endoscope,50 insulin infusion pump,51 operating table,52 ultrasound,53 among others, demonstrating the diversity in the application of usability techniques. in some selected studies, human factors methods were applied to more than one piece of table 3. rapid review inclusion and exclusion criteria. parameters 1. exclusion criteria 2. inclusion criteria population 1.1 equipment/devices other than medical devices. accessories and isolated parts will not be considered. screening applications, medical records, and medical software will also not be considered. studies that do not specify the technology will be disregarded. 2.1 medical equipment used for diagnosis, monitoring, and/ or therapy of diseases. intervention 1.2 does not apply usability engineering techniques and/ or does not describe the technique. 2.2 studies that show results of the application of usability engineering techniques. availability of the work 1.3 incomplete and/or unavailable texts. 2.3 full texts available publication date 1.4 works more than 10 years old from the date of publication. 2.4 works up to 10 years old from the date of publication. assessment 1.5 they do not present results of the application of usability techniques in medical equipment. they do not show the assessment of usability and the interference of human factors with technology. 2.5 they present results of the application of usability techniques in medical equipment to evaluate the usability of technology and the interference of human factors. type of work 1.6 nonprimary studies (such as reviews, meta-analyses) and/or works from the same research project. 2.6 primary studies and works not part of the same research project. brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review j global clinical engineering vol.7 issue 3: 2025 66 equipment, who applied the methodology to blood pressure monitors and pulse oximeters.38 the results show that usability techniques are being used for a variety of purposes, from design validation in the early stages of product development, to assisting in the processes of incorporating technology into a facility; to assessing the ergonomics of medical equipment; to analyzing usability problems through adverse event analysis; investigating product design problems; analyzing the instructions for use of a piece of equipment; and assisting in identifying hazards and minimizing risks to the patient, even at the level of comparing usability between different types of make/model of a technology. an analysis of the selected papers showed that usability techniques are being applied at different stages of the technology life cycle, from pre-commercialization to post-commercialization. usability techniques were applied both individually and integrated with one or more other methods, with the integration of techniques being the most widely used methodology in the selected studies. the studies that applied more than one technique reinforce the importance of integrating different methods to extract information from different perspectives, as each technique has its advantages and limitations. an example of the presence of integrating techniques is the usability test, which was the method with the highest number of applications among the selected works, and which was generally accompanied by the implementation of questionnaires in the pre-test, to analyze the profile of the participants, and in the post-test, to quantify user satisfaction regarding the usability of the technology. in the post-test questionnaire, most of the time, the sus scale, a tool used to extract relevant information about how satisfied the user feels when interacting with the technology, was applied. a complementary tool, also applied in some of the selected studies, was the use of eye tracking used to analyze the user’s eye movement when interacting with the product interface, to help assess the usability of users when using technologies.47,54 another validated tool used in the selected studies was the nasa-tlx scale, used to measure people’s mental workload. this scale was applied in all the studies in which this usability technique was used, and was applied through integration with other methods.28,36,37 reducing the physical and mental workload is one of the recommendations, in which the authors cite the importance of manufacturers considering these scenarios for users and providing customizable options to meet the needs of the end operator.28 discussion human factors in health must be involved throughout the entire life cycle of the technology in the technology management processes of clinical engineering activities, from the pre-commercialization stages, based on a useroriented development of health technologies, to the postcommercialization stages, involving the clinical staff in the processes of technological incorporation, investigation of problems in the use of technology to minimize harm to the patient, among many other activities that involve clinical engineering.7,10,13 interdisciplinary interaction in health technology processes is essential for identifying potential problems in the use of medical equipment in establishments, and thus establishing and implementing improvement actions. the implementation of a collaborative and interdisciplinary living lab ecosystem has the potential to contribute to htm, through the application of usability techniques with different actors involved with medical devices, including clinical engineering, end users, health professionals, industry, and government, among others. usability techniques can be applied at different stages of the life cycle of health technologies, helping to identify user needs in order to develop and/or improve technological solutions. a program proposal was developed to cover the main activities considering human factors, as shown in table 3. the objective to apply usability techniques for the consideration of the human factor in each life cycle stage is presented in table 4. 67 j global clinical engineering vol.7 issue 3: 2025 brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review table 4. objective to apply usability techniques for the consideration of the human factor in each life cycle stage. life cycle stage main activities objective to apply usability techniques for the consideration of the human factor design and development innovation ideation. design, prototyping, and development. compliance with regulations. regulations, good manufacturing practices, and certification. production, distribution, storage, and marketing. establishing project goals and requirements based on the problems identified by users when using the technologies. collecting data on user needs. developing solutions centered on user needs. testing solutions with the user for validation, risk, usability analysis, and project adjustments. planning and selection market analysis health technology assessment (hta) sizing up the establishment’s profile by analyzing the technologies, infrastructure, and human resources to understand the need for incorporation. checking that the technology has been regularized with the health agency and complies with regulations, ordinances... carrying out economic analyses of the total cost of ownership. specifying and selecting the technology. purchasing process (bidding if necessary) meeting user needs, combining clinical interest with the technologies available on the market. consider usability aspects when specifying technology, check that technological development is user-centered and based on standards. consider usability in technology selection. consider human factors engineering principles and usability techniques to incorporate into hta. receipt, verification, and acceptance ensure that all equipment incorporated complies with what has been requested. ensure that they are evaluated before first use through acceptance tests that attest the safety and performance of the technology. document and implement criteria for supplier qualification. test the incorporated technologies with users for final acceptability, checking that they meet the need. inventory carry out the inventory (survey, registration, and identification) of the entire technology park with all the necessary information to ensure the accuracy and traceability of the data. the entire inventory process must be documented and conducted periodically. involve the user who operates the technology in the inventory of the technology park, to understand the importance of identification and traceability for management. identify possible flaws in the processes of incorrect and/or incomplete identification of the inventory, thereby hindering traceability. installation install the equipment in compliance with the manufacturer’s regulations and recommendations. show users the impact of the infrastructure on performance and security with the technology. evaluate the infrastructure to check the implications for users’ use of the technologies. understand the difficulties faced by users when interacting with the infrastructure. training ongoing and periodic training program to ensure that operators are able to carry out their activities. drawing up and implementing good practice guidelines for the proper use of health technologies. train users to operate the technology properly. carry this out immediately after installation and inventory and periodically on an ongoing basis with the entire team. develop training focused on solving problems faced by users. develop good practice materials for proper use. brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review j global clinical engineering vol.7 issue 3: 2025 68 analysis of the application of usability techniques in pre-commercialization in processes involving the development of technological solutions, it is essential to include the user in the gathering of data on the need and validation of the product, enabling the prior identification of usability problems that the technology may pose.10 therefore, user-centered design encompasses the active involvement of people during technological development, with a clear understanding between user requirements and tasks, providing solutions through continuous interactions with users in an interdisciplinary team.15 the pre-commercialization stage is the time when the technology is under development, and it is essential to include the user in gathering data on the need and validating the idea or product. this stage makes it possible to reduce future complications by anticipating possible usability problems that the technology may pose. the studies in which usability techniques were applied in the pre-commercialization stages demonstrate the need to include users throughout the technological development process to ensure better usability results and greater patient safety,55,56 as well as making it possible to reduce costs.57 the application of usability techniques in the technological development process reduces the need for design modifications and more costly upgrades post-market introduction, which becomes a competitive advantage. in addition, there are considerable improvements in safety, which minimize the likelihood of medical device recalls. when hfe approaches are used during the technology–user interface development process, especially taking into account the user’s perspective, there are considerable improvements in ease of use.9 analysis of the application of post-marketing usability techniques usability techniques applied in post-marketing demonstrate the relevance of studies considering human factors during the use of technologies, and thus assist manufacturers, researchers, among other actors, who wish to explore ergonomic studies after incorporation of technology into the market.58 the application of usability techniques in the process of incorporation in health establishments can obtain life cycle stage main activities objective to apply usability techniques for the consideration of the human factor use risk management draw up and implement standardized procedures and protocols for the use of technologies. develop methodologies to ensure technological traceability. analyze the history of failures and analyze the probable causes. investigate the adverse events involved. understand the problems of using the technology and understand the impact of human factors on the occurrence of failures and adverse events. analyze the cause of failures incorporated into risk management in order to establish improvement strategies. analyze usability problems in order to establish specific strategies and improvements in new technological solutions. technical interventions define and implement procedures to ensure the metrological traceability and safety of technologies. develop and implement procedures for inspection, testing, calibration, preventive and corrective maintenance, electrical safety tests, and qualification. involve the user in the importance of carrying out calibration, maintenance, and other technical interventions for the safety and performance of the technologies. analyze the impact of human factors on technical interventions in technologies. obsolescence, decommissioning, and final disposal developing and implementing procedures describing the criteria for decommissioning technology, taking into account the technical, operational, financial, or strategic aspects of the establishment. execution of the activity by issuing a decommissioning report. analyze the effectiveness of using the technology. evaluate the needs of the clinical staff to ascertain the need for technological replacement. researching technological advances that consider humancentered aspects for technologies with better usability. 69 j global clinical engineering vol.7 issue 3: 2025 brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review include the difficulties faced by users in order to mitigate the occurrence of user errors. therefore, a continuing education program should consider the problems faced by users in their day-to-day use of the technology, both when it is first introduced and throughout its life cycle. usability techniques can be applied to analyze the impact of training to investigate its effectiveness and thus establish actions that can improve the use of the technology. throughout the use of technology in healthcare environments, usability techniques can be applied continuously to analyze the users’ perspective on interaction with the technological resource. in this way, it is a strategy for identifying possible problems and planning preventative actions. drawing up and monitoring indicators involving technologies is a clinical engineering activity that must also take human factors into account when critically analyzing the results of the metrics. incorporating user evaluations of user satisfaction, error rate, effectiveness, and efficiency in performing certain tasks are important usability metrics to be considered in clinical engineering. clinical engineering must incorporate the monitoring and analysis of adverse events in its activities. analysis of failures and adverse events also requires attention to probable human errors, and applying usability techniques can help to investigate the probable causes, and thus establish strategies more assertively. clinical engineering should also stimulate the environment for reporting adverse events, by implementing actions that minimize the main barriers that influence the deficiency in the reporting process by operators, which are fear of guilt, lack of time, nonperception of effectiveness when reporting, lack of knowledge of the reporting system, lack of feedback, and a complicated and time-consuming platform for reporting. metrology in health is a strategic tool for identifying adverse events and hidden failures involving health technologies. metrological problems can be associated with inaccurate diagnoses and inadequate treatment, as these factors are directly related to the prevalence of adverse events. when assessing obsolescence, applying usability techniques can provide data to help clinical engineering make decisions on whether or not to discard technology, by understanding the problems faced and clinical needs, satisfactory results, as the use of technologies in environments directly impacts the experience of staff and patients, and the selected equipment will normally be used for several years.59 inadequate incorporation that does not meet local and operator needs can lead to disuse of the technology, as well as operating errors, resulting in problems for patient safety. in addition to the impacts on the establishment, considering usability in the process of incorporation also provides manufacturers with information on users’ needs, and thus helps with feedback for the development of new products.59 liu et al. also presented a usability evaluation methodology through the integration of techniques that can provide evidence to support the selection of more appropriate equipment, by considering the context of use of the technology.60 by applying usability methods, it is possible to recommend improvements to the technology–user interface and increase safety61; identify how the context of use can affect the usability of technology55; as well as understand educational needs60 and improve training strategies39 and instructions for use.19 studies have shown that the application of usability techniques through the analysis of adverse events makes it possible to identify sources of hazards and investigate the causes of these incidents associated with the use of medical devices,62 and thus assist in both the pre-marketing and post-marketing of technologies. through the evaluation and analysis of adverse events in databases, it is possible to optimize risk control solutions in the use of medical equipment and achieve satisfactory results in usability to contribute to the development of public health and better user experiences.32 another approach, little explored in other studies, is the use of technology by individuals with physical/sensory disabilities, demonstrating in their research that medical devices are often not designed to meet the needs of specific users.63 clinical engineering needs to work toward managing health technologies that are more accessible to everyone. usability techniques can also be applied in the design and implementation of training programs, which are a stage in the technology’s life cycle, and should be carried out periodically and continuously. training should brandão and garcia: application of usability techniques in medical devices in health technology management: a rapid review j global clinical engineering vol.7 issue 3: 2025 70 author contributions conceptualization, m.b. and r.g.; methodology, m.b. and r.g.; formal analysis, m.b.; writing–original draft preparation, m.b.; writing–review & editing, m.b. and r.g.; supervision, r.g. acknowledgments not applicable. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare they have no competing interests. ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure not applicable. references 1. shukla, s., gupta, m., pandit, s., et al. implementation of adverse event reporting for medical devices, india. bull world health organ. 2019;98(3):206–211. https://doi. org/10.2471/blt.19.232785. 2. signori, m.r. and garcia, r. clinical engineering incorporating human factors engineering into risk management. in proceedings of world congress on medical physics and biomedical engineering, munich, germany. september 7–12, 2009:449– 452. http://doi.org/10.1007/978-3-642-03885-3_125. as well as assessing the availability of new technologies on the market. human factors must also be taken into account in the stages of technological substitution, so that the transition and incorporation of a new technology has minimal impact on the healthcare environment. conclusion this work demonstrated that the application of usability techniques can assist clinical engineering in the development and use of technological solutions that integrate the user in the processes throughout the life cycle, and that provide data with a more systemic view of the problem. some of the actions of clinical engineering highlighted and discussed in these usability techniques consist of: development of technologies with better usability for users; process of incorporation of new technologies in establishments that meet clinical needs; preparation and implementation of training and qualifications in technologies; development of good practice materials for appropriate use; identification and monitoring of the occurrence of failures and adverse events to propose improvement actions; and performance evaluation as a metrological tool to preventively identify adverse events and hidden failures, as well as in the evaluation of technological obsolescence considering the users in these processes. therefore, human factors must be considered throughout the life cycle, integrating a feedback system of information for continuous improvements. the integration and consideration of human factors must be encouraged for the further advancement of clinical engineering throughout the healthcare ecosystem, in the discussion, construction, and validation of strategies that may assist in the prevention of adverse events. incorporating usability techniques must be a tool applied throughout the life cycle of technologies as a strategic methodology to ensure safety, regulatory compliance, and cost reduction in healthcare environments. with these integrated and collaborative actions, the aim is to achieve an increasingly humanized, inclusive, collaborative, sustainable management of health technologies, focused on the best user experience 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2023, accepted july 3, 2023, date of publication july 11, 2023 analysis of 2022 chinese clinical engineering body of knowledge and body of practice survey by jing tong1, kun zheng2, bin li3 1 shanghai ocean university, china 2 children's hospital zhejiang university school of medicine, china 3 shanghai sixth people's hospital affiliated to shanghai jiaotong university school of medicine, china abstract background and purpose: clinical engineers (ces) face greater demands for their professional knowledge as healthcare technology, especially life support equipment, including ventilators and artificial heart-lung machines, becomes increasingly important and complex. however, there are significant differences in clinical engineering majors around the world, and independent research on the body of knowledge and practice in clinical engineering is lacking in china. materials and methods: this study is an initial investigation into the body of knowledge and body of practice in the field of clinical engineering in china, conducted through a questionnaire-based survey. the aim of the survey is to collect important data from chinese ces. results: the investigators' background highlights that chinese ces are predominantly young, highly educated, and have limited work experience. ongoing education and training will be needed to keep up with technological advancements. however, the future of clinical engineering in china looks positive. the survey of knowledge and work activities in the clinical engineering industry in china indicates that the main focus is maintaining the normal operation of hospitals. after that, according to the future development trend of the hospital, new knowledge and practical activities are continuously expanded. conclusions: although the survey provides insight into the knowledge and activities that are most relevant to clinical engineering in china, further research is necessary to establish a reliable body of knowledge and practice. keywords – chinese clinical engineering, body of knowledge, body of practice, clinical engineering survey. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction clinical engineering is a multidisciplinary field that combines knowledge from several disciplines such as engineering, medicine, and computer science. the work of ces involves the application of technology to improve patient care, safety, and outcomes in a healthcare setting. their work is highly practical and requires continuous learning and experience to keep up with the rapidly evolving technology and medical practices. as a result, the body of knowledge and practice in clinical engineering has quickly grown over the years. however, this growth in knowledge has led to challenges in education and personnel training. on the one http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 21 j global clinical engineering vol.5 issue 3: 2023 tong, zheng, li: analysis of 2022 chinese clinical engineering body of knowledge and body of practice survey hand, the content taught in schools may not meet the knowledge needs of actual work, and different colleges and universities have different majors and curriculum settings, resulting in differences in knowledge structure and stock.1 conversely, due to differences in working environments, medical treatment focus, and existing hospital technology, ces' knowledge and experience may gradually differ. these differences and deficiencies in knowledge and practical experience are common in the industry and pose a bottleneck for industry development and personnel training. therefore, it is necessary to establish a correct knowledge framework in clinical engineering. recently, the global clinical engineering alliance (gcea) and ifmbe-ced jointly conducted a clinical engineering survey. this time, it is important to understand the type of knowledge that ces need to develop their work (body of knowledge) and identify the activities that ces carry out globally (body of practice). the ultimate goal is to define a set of disciplines to help any teaching unit revise and develop its academic program to train ces. in the past, similar studies have been conducted from a global perspective.2 however, this article only focuses on china, and aims to gain a preliminary understanding of the knowledge and practice system in clinical engineering through large-scale surveys. the remainder of this paper is organized as follows. the research materials and methods are described in section ii. the third section is the research results, and then the fourth section analyzes according to the research results. the fifth section is the conclusion. materials and methods the purpose of this questionnaire is to collect different relevant types of information from respondents to better understand the current knowledge system and practice system in the field of clinical engineering. the questionnaire is divided into four parts, each focusing on a specific aspect of the respondent's background and work experience. the first part, titled "basic information," requests the respondent's name, gender, location, age, and contact information. this section is important for establishing basic demographic information about the respondents and their location. the second part, titled "occupational background," is designed to gather information about the educational and work backgrounds of the respondents. in this section, respondents are asked to provide information on their degrees, professional fields, working years, nature of work, and whether there is a clinical engineering (ce) registration and certification process in china. this section will help to provide a clearer picture of the educational and professional backgrounds of ces in china. the third part, titled "knowledge," is focused on identifying the importance of 40 different knowledge areas in the respondents' work. respondents are asked to evaluate the level of importance of each area according to their own situation, rating them as minor, moderate, high, or not important. this section will provide insight into the specific areas of knowledge that ces find most relevant to their work. the fourth part, titled "work activities," lists 8 categories of work activities that ces commonly engage in, such as health technology management, service delivery management, and information technology/digital health. respondents are asked to evaluate the percentage of time they spend on each category and provide choices for supplementary descriptions of other categories. this section will help to identify the specific work activities that ces in china engage in and the relative amounts of time they devote to each one. it is worth mentioning that this questionnaire utilizes an online questionnaire to collect data, benefiting from various advantages. the online format facilitates quick and easy questionnaire distribution to many potential respondents, increasing response rates. the online format eliminates the need for manual data entry, thereby reducing the potential for errors and enabling more efficient data analysis. additionally, the online questionnaire allows for the inclusion of skip patterns and branching logic to ensure that each respondent only answers questions relevant to their specific background and experience. therefore, the online questionnaire is a practical and effective method to collect knowledge and work activity data of ces in this study. tong, zheng, li: analysis of 2022 chinese clinical engineering body of knowledge and body of practice survey j global clinical engineering vol.5 issue 3: 2023 22 results basic information the survey received strong support from ces in 21 provinces across china, with 178 valid responses received. among them, 67 were from zhejiang, 21 from shanghai, 17 from sichuan, and none of the other provinces reached 10 (figure 1). the age structure of the respondents is an important factor in assessing the long-term development potential of ces. as shown in figure 2, 32.58% of the respondents are aged 20 to 30, 28.65% are aged 31 to 40, 23.03% are aged 41 to 50, and 15.73% are aged 51 to 60. of the respondents, 60% are under 40, indicating that young and middle-aged people have become the backbone of china's clinical engineering talent pool. among the 178 respondents, it is worth noting that women accounted for only 27% (figure 3). encouraging more women to join the clinical engineering talent team is a long way to go. occupational background the working years of ces are an important factor in determining their level of professionalism, knowledge, and experience. in this survey, the distribution of respondents based on their working years is quite diverse. more specifically, 23.03% of the respondents have 1 to 3 years of work experience, indicating many early-career ces in the workforce. 10.11% have 3 to 5 years of work experience, while 14.61% have 5 to 10 years of work experience. these respondents can be considered to be in the mid-career stage and are likely to have more experience and expertise in the field. moreover, the survey results reveal that there are also many ces with extensive work experience. specifically, 17.42% have 10 to 15 years of work experience, 10.11% have 15 to 20 years of work experience, and 24.72% have more than 20 years of work experience. this indicates that a significant number of senior ces have accumulated a wealth of experience and knowledge throughout their careers. overall, the diverse distribution of working years among respondents in this survey suggests that the clinical engineering field has both experienced and novice professionals. figure 1. geographical distribution of respondents. figure 2. age distribution of respondents. figure 3. gender distribution of respondents. 23 j global clinical engineering vol.5 issue 3: 2023 tong, zheng, li: analysis of 2022 chinese clinical engineering body of knowledge and body of practice survey older age is associated with more work experience (figure 5), which seems to align with the objective law, but the trend of older practitioners with more work experience means that opportunities for professional development in clinical engineering are limited. with the continuous and rapid progress of medical technology and the increasing integration of modern medical equipment into hospitals, the responsibilities of medical engineering departments in china have evolved from focusing on the maintenance of a single piece of medical equipment in the 20th century to covering a series of tasks such as preventive maintenance of medical equipment, regular repair and maintenance, quality control, metrological testing, technical evaluation, clinical evaluation, innovation, and improvement. this has led to an increase in the number of practitioners, and the level of education of personnel is gradually increasing to meet the needs of the role.3 the survey also included questions about the educational backgrounds of the respondents. the results showed that the majority of the respondents had an undergraduate degree in an engineering area (46.07%), and a significant number of them had a master's degree in engineering area (28.65%). however, there were also respondents with educational backgrounds in non-engineering areas, such as undergraduate degrees in other areas (9.55%), master's degrees in other areas (6.74%), and phds in both engineering and non-engineering areas (3.93% and 2.25%, respectively). there was also one respondent who had a degree in another area not covered by the survey options. figure 6 compares the educational background of respondents from the china clinical engineering survey in 2021 and 2022. the results show a clear trend towards higher levels of education among ces. when asked about the main nature of their current position, above-average respondents chose clinical/ biomedical engineer (58.99%), followed by healthcare technology managers (12.36%), medical equipment planners (6.74%), technologists (5.06%), technicians (10.67%), professors/educators/researchers (1.12%), consultants (1.12%), and others (3.93%). however, this question reveals an interesting finding: chinese ces focus more on healthcare technology planning, assessment, management, analysis, education, and support (table 1). finally, the survey led to a consensus among ces in china that there is a registration and certification process in place for ces in the country. figure 4. working years distribution of respondents. figure 5. working years of respondents in different age groups. figure 6. educational background distribution of respondents in 2021 and 2022. tong, zheng, li: analysis of 2022 chinese clinical engineering body of knowledge and body of practice survey j global clinical engineering vol.5 issue 3: 2023 24 knowledge the knowledge domains were classified based on clinical engineering background knowledge. respondents were asked to rate the importance of 40 items related to their daily duties and responsibilities, using a 4-point scale: 1 for not important, 2 for minor important, 3 for moderate important, and 4 for high important. the average score for each item was calculated, and the detailed results of the investigation are presented in table 2. table 1. occupational nature of respondents options count percentage clinical/biomedical engineer 105 58.99% healthcare technology manager 22 12.36% medical equipment planner 12 6.74% technologist 9 5.06% technician 19 10.67% professor/educator/researcher 2 1.12% consultant 2 1.12% other 7 3.93% table 2. the importance of each background knowledge category\options not importance minor importance moderate importance high importance average medical device regulation 3 4 42 129 3.67 maintenance management 2 6 53 117 3.6 quality management 1 7 63 107 3.55 computers, networking, information technology 1 12 61 104 3.51 data management 2 10 66 100 3.48 risk management 2 16 56 104 3.47 electronics (theory, design, analysis, etc.) 5 17 59 97 3.39 facilities management 1 22 64 91 3.38 surgical instruments & devices 4 23 59 92 3.34 medical device innovation 4 17 74 83 3.33 interoperability of devices and/or systems 5 17 72 84 3.32 procurement strategies 5 18 72 83 3.31 engineering asset management 2 24 74 78 3.28 project management 5 20 77 76 3.26 respiratory equipment 4 33 54 87 3.26 hospital engineering 7 23 67 81 3.25 digital health 4 23 81 70 3.22 medical imaging 0 35 73 70 3.2 health technology assessment 7 25 73 73 3.19 leadership or executive skills coaching 9 25 74 70 3.15 systems engineering 5 32 76 65 3.13 25 j global clinical engineering vol.5 issue 3: 2023 tong, zheng, li: analysis of 2022 chinese clinical engineering body of knowledge and body of practice survey category\options not importance minor importance moderate importance high importance average patient safety user/patient training 14 33 56 75 3.08 health facility planning and design 9 37 65 67 3.07 statistics 3 43 71 61 3.07 consumables 9 39 72 58 3.01 management (area/s other than those listed) 13 27 83 55 3.01 sterilization 10 42 65 61 2.99 physiological monitoring 17 40 57 64 2.94 telemedicine / telehealth 13 40 72 53 2.93 hemodialysis 19 43 54 62 2.89 presentation skills 10 48 75 45 2.87 airborne infection control 16 47 61 54 2.86 clinical laboratory 14 53 57 54 2.85 human factors engineering 19 47 56 56 2.84 simulation and modelling 21 51 60 46 2.74 home care/virtual care (remote patient monitoring) 23 46 67 42 2.72 accounting and finance 15 61 65 37 2.7 radiation oncology 28 58 45 47 2.62 neonatal and/or pediatric care 33 52 45 48 2.61 anesthesia 35 62 35 46 2.52 table 3. overall time spent in each group of activities activity\percentage 0 1~25 26~50 51~90 91~100 health technology management 2.81% 23.03% 29.78% 30.34% 14.04% service delivery management 5.62% 16.85% 22.47% 32.58% 22.47% development,testing,evaluation and modification of products 16.29% 38.76% 26.4% 12.36% 6.18% information technology / digital health 9.55% 39.33% 24.16% 18.54% 8.43% education of others 8.99% 39.89% 29.21% 16.85% 5.06% facilities management / infrastructure 8.99% 25.28% 29.21% 27.53% 8.99% risk management / security 0.56% 27.53% 28.09% 29.78% 14.04% general management 0.56% 17.98% 29.21% 37.08% 15.17% tong, zheng, li: analysis of 2022 chinese clinical engineering body of knowledge and body of practice survey j global clinical engineering vol.5 issue 3: 2023 26 work activities table 3 displays respondents' estimated percentage of time in eight job categories. these categories include health technology management, service delivery management, development, testing, evaluation and modification of products, information technology/digital health, education of others, facilities management/infrastructure, risk management/security, and general management. besides these predefined categories, respondents were also allowed to provide information about other job categories they worked in. table 3 data is a valuable resource for gaining insight into the work activities of ces. this information can inform workforce development and training programs in the field, ultimately leading to better-prepared clinical engineering professionals. discussion although the survey had a broad geographic scope, with respondents from multiple provinces in china, the fact that a large proportion of the responses (67 out of 178) came from a single province, zhejiang, could potentially introduce bias to the data. given that zhejiang is a relatively affluent province and is home to many wellknown medical device manufacturers, the experiences and knowledge of ces in this region may not fully represent the wider population of ces in china. therefore, it is important to interpret the survey results with caution and avoid overgeneralizing based on the experiences of ces in zhejiang alone. the survey results indicate that the clinical engineering community in china is relatively young, with limited work experience. however, it is encouraging to note that practitioners with more than 20 years of experience are still active in similar numbers as young practitioners. this balance between new and experienced professionals bodes well for the future of clinical engineering in china, with promising human resource reserves and team-building prospects for the younger generation. the survey results also indicate that the vast majority of respondents, 97.75%, held at least an undergraduate degree, with many pursuing engineering-related studies. this finding highlights chinese clinical engineering practitioners' solid professional knowledge base. it is worth noting that this trend of increasing education among domestic ces in china is not unique, as global survey results suggest that china is among the countries with the highest percentage of highly educated ces. in fact, while 80% of ces worldwide have a bachelor's degree or higher, the figure for china is 97%. however, the low representation of women in the field, accounting for only 27% of the total, is a cause for concern. efforts to encourage more women to pursue careers in clinical engineering must be made. in addition to the issue of job diversity, there is also a concern about limited opportunities for professional development within clinical engineering, especially for older practitioners with more experience. china has a well-established registration and certification process for ces, indicating the profession's maturity. however, in situations with limited avenues for professional development or lateral transitions, experienced practitioners may face the challenge of stagnation, potentially hindering their ability to bring novel ideas and unique perspectives to their work. to address this issue, it is crucial to promote continuing education and training opportunities for ces. establishing a body of knowledge (bok) and a body of practice (bop) in clinical engineering can also facilitate their continuing professional development, allowing them to expand their knowledge and expertise and stay up-to-date with the latest developments in the field. providing opportunities for continuing education and interdisciplinary collaboration can help experienced practitioners maintain their effectiveness and innovation, ultimately leading to a more dynamic and effective clinical engineering profession. the issue of the main nature of work in clinical engineering sheds light on the various roles that practitioners play in the healthcare industry. in china, most ces identify as clinical/biomedical engineers, focusing on planning, evaluation, management, analysis, education, and medical technology support. the position also includes functions such as healthcare technology managers, medical equipment planners, clinical engineering technologist, clinical engineering/biomedical equipment technician and others. practitioners must possess diverse skills and knowledge to effectively carry out their responsibilities. additionally, 27 j global clinical engineering vol.5 issue 3: 2023 tong, zheng, li: analysis of 2022 chinese clinical engineering body of knowledge and body of practice survey many respondents were identified as healthcare technology managers and medical equipment planners. as time progresses, the work of ces is no longer limited to the maintenance and repair of medical equipment. by combining their understanding of clinical needs, they can effectively provide hospitals with beneficial and appropriate configurations, management, and medical equipment planning.4 the diversity of reported positions also reflects the wide range of expertise required in clinical engineering, from technical proficiency to leadership and management skills. regarding the importance of knowledge, three parts can be roughly divided. medical device regulation, maintenance management, quality management, data management, risk management, facilities management, and implementation methods such as computers, networking, and information technology rank highly in the clinical engineering industry. among them, medical device regulations are considered to be the most important as a factual basis. this highlights the significance of regulatory compliance and the proper management of medical devices in clinical engineering. clinical engineering work in china is mainly focused on managing and maintaining hospital operations, which is also reflected in the main nature of the work of ces. today's medical activities development in china greatly depends on medical devices' safety, reliability, and stability. ces effectively ensure the normal operation of medical devices through evaluation, maintenance, quality control, measurement, etc., to ensure the normal development of medical activities.5 china promulgated the "regulations on the supervision and administration of medical devices" on january 4, 2000.6 after two revisions, the latest version was implemented on june 1, 2021. it shows that medical devices must follow risk management principles, whole process control, scientific supervision, and social governance. this is a guide for all ces in china. the important knowledge areas that follow are some of the more specialized and precise subdivisions of dayto-day management work, such as surgical instruments & devices, procurement strategies, engineering asset management, project management, hospital engineering, statistics and health technology assessment, etc. mastery of these areas can help bridge the knowledge gap for chinese ces, allowing them to ensure high-quality, safe, and efficient healthcare operations. knowledge of surgical instruments and equipment is crucial for ensuring the safety and success of medical procedures, while a procurement strategy is necessary to obtain the necessary resources while maximizing the budget. engineering asset management involves the management of complex systems, requiring expertise in monitoring, maintaining, and optimizing equipment. project management is critical to coordinating resources, managing timelines, and communicating effectively with stakeholders. moreover, hospital engineering encompasses various technical disciplines, including electrical, mechanical, and structural engineering. effective ces must be able to design, maintain, and optimize complex systems to ensure healthcare facilities' safe and efficient operation is another essential knowledge area for ces. a solid understanding of statistical analysis is crucial for evaluating the performance of healthcare systems, identifying areas for improvement, and measuring the impact of interventions. health technology assessment (hta) is an emerging field that is becoming increasingly important in healthcare. it systematically evaluates health technologies' safety, efficacy, cost-effectiveness, and social impact, including medical devices and equipment. hta provides valuable information for healthcare decision-makers, helping them make informed decisions about which technologies to invest in and how to allocate resources effectively. finally, the knowledge categories in the lower part share a common feature: they overlap with the expertise of other occupations in the hospital. for example, sterilization is generally responsible for nurses, anesthesia is generally for anesthesiologists, and accounting and finance are generally responsible for professional accountants. this rule also continues in the survey results of time spent on practical activities. activities related to the clinical engineer's primary task—ensuring clinical applications for the medical device business (e.g., service delivery management, general management)—are more timeconsuming and therefore ranked high.7 conversely, less relevant activities (such as education of others, development, testing, evaluation and modification of products) take up less time and therefore ranked lower. this shows that chinese ces may be more inclined to the direction of traditional clinical engineer functions. however, ces tong, zheng, li: analysis of 2022 chinese clinical engineering body of knowledge and body of practice survey j global clinical engineering vol.5 issue 3: 2023 28 play a bridge role in developing medical device products. they are integrators of medical technology, guardians of equipment safety, evaluators of instrument applications, and communicators between hospital construction and industrial development. to promote the further development of china's clinical engineering field, it is necessary to attach importance to industry-university-research-medical cooperation and knowledge sharing, and incorporate it into the strategic career development plan. conclusion under the new requirements of hospital-refined management and modern medical technology, the development of clinical engineering in china is facing new challenges. strengthening the construction of the bok and the bop is an important measure for adapting to environmental changes and improving comprehensive strength. this survey may not cover the scope of all clinical engineering personnel and may not fully reflect the knowledge needed for clinical engineering in china, but the research results have predicted a set of knowledge required for clinical engineering in china. the bok and bop in clinical engineering still require indepth research, and determining key knowledge requires the consensus of numerous authoritative experts and stakeholders. unless the bok defined, relevant practices, research, and scholarly teaching information are collected, and consensus is reached, the clinical engineering knowledge system framework will be incomplete. it should be noted that the systemic nature of the knowledge system must be established based on verified evidence. references 1. xie m, lin x, zhao h, et al. a preliminary study on the construction of clinical engineering technology professional knowledge system and curriculum system [j]. health vocat edu 2022;40(17):38-40. 2. nascimento l, calil s, judd t, et al. analysis of ifmbeced 2017 worldwide clinical engineering survey[j]. global cin engineer j 2019;2(1):15-22. 3. xiong w, pan y, wang z, et al. clinical medical engineering helps people's health [j]. chinese hosp architect equip 2022;23(10):30-34. 4. lu m, lu p, jiang x, et al. establishment of medical equipment life cycle quality control system based on information management platform [j]. china med equip 2019;34(11):120-124. 5. chen z. discussion on the functions and tasks of clinical medical engineers in the full life cycle management of magnetic resonance equipment [j]. china med equip 2020;35(11):5-8. 6. national medical products administration. regulations on the supervision and administration of medical devices [eb]//baidu encyclopedia. [2023-02-22]. 7. liu y, lyu j. demand and cultivation of professional talents in clinical engineering at home and abroad based on the analytical theory[c]//proceedings of the 2018 2nd international conference on management, education and social science (icmess 2018). qingdao, china: atlantis press, 2018[2023-02-22]. 9 j global clinical engineering vol.5 issue 2: 2022 received february 28, 2022, accepted july 7, 2022, date of publication july 22, 2022 earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region by jean marie vianney nkurunziza, jean claude udahemuka, francine umutesi, jean baptiste dusenge medical technology division, rwanda biomedical center, kigali, rwanda abstract the desire for earthquake hazard mitigation has been the focus of many researchers and governments for decades. this is paramount because an earthquake disaster can quickly cause many injuries, fatalities, and damages. the global database of the 21,000 most devastating disasters (earthquakes included) since 1900 indicates that 50% of them with the most significant number of injuries occurred only during the past 20 years. in human history, the xaanxi earthquake is ranked third among the disasters that claimed more lives. in addition, earthquakes contributed to six of the most deadly disasters of the past two decades and 21% of the economic losses. in the same period, the earthquakes due to the virunga volcanic activity were responsible for more than 100 deaths and extensive material and infrastructure damage. the referenced information and statistical data about the earthquake occurrence process, adverse effects, economic losses, and the current technological success in reducing its risks through warning systems are the basis for developing this paper. the authors aim to raise awareness and recommend that the virunga region countries (democratic republic of the congo, rwanda, and uganda) be a good place for an earthquake early warning system and earthquake management plan. an earthquake early warning system even caught the attention of the united nations, where the endorsed sendai framework for disaster risk reduction (unisdr, 2015) specified that early warning must be a priority and has to be substantially evolved by 2030. keywords – earthquake, early warning, rwanda, virunga region, health facilities, disaster, seismic activity. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.5 issue 2: 2022 10 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region background an earthquake is a weak to violent ground shaking produced by the sudden movement of rock materials below the earth’s surface.1 over the past 40 years, natural disaster effects have drastically increased in terms of reported number, total deaths, total people affected, and economic loss (figure 1).2 earthquakes are the most destructive natural hazards throughout human history. hundreds of thousands of people lost their lives, and the loss of billions of dollars of properties occurred in these disasters.3 earthquakes occur naturally (i.e., tectonic and volcanic) or as a result of human activity (i.e., explosion, mine collapse, or reservoir-induced).4 the earth is made of different layers classified rheologically or chemically. rheologically speaking (classification based on the liquid state of rocks under tremendous pressure and temperature), the earth is divided into five layers: lithosphere, asthenosphere, mesosphere, outer core, and inner core.5 chemically speaking, the earth’s geological structure comprises four layers: the crust, the mantle, the outer core, and the inner core, though researchers of the australian national university have, in 2021, uncovered a fifth layer within the earth’s inner core.6 the different earth layers and corresponding thicknesses are shown in figure 2.7 an earthquake happens when two blocks (tectonic plates) of the earth’s lithosphere or upper mantle suddenly slip past one another. the surface where they slip is called the fault or fault plane. the location below the earth’s surface where the earthquake starts is called the hypocenter, and the location directly above it on the surface of the earth is called the epicenter.8 diverging and converging tectonic plates’ action in the earth’s crust is responsible for the creation of volcanoes. the volcanic activity is rooted in molten rock called magma, which is squeezed onto the earth’s surface.9 a key control on the eruptive processes is the tectonic setting, which determines how magma is generated, the pathways by which it reaches the earth’s surface, and the characteristics of eruptions.10 a volcano may be active, dormant, or extinct.9 the activity of the tectonic plates responsible for the volcanic eruption can have divergent boundaries (when tectonic plates move apart) (figure 3).11 or convergent boundaries (two tectonic plates are moving toward each other, often causing one plate to slide below the other in a process known as subduction) (figure 4).12 figure 1. disaster impact 1980-2019, showing that in the last two decades, disasters have significantly increased. figure 2. a cut-away of the earth’s layers. figure 3. diverging tectonic boundaries. 11 j global clinical engineering vol.5 issue 2: 2022 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region convergent plate boundaries are often the sites of earthquakes, volcanoes, and other significant geological activity.12 the earth’s crust is divided into six continental-size plates (african, american, antarctic, australia-indian, eurasian, and pacific) and about 14 of sub-continental size (caribbean, philippine, etc.) as per 2014, about 1,900 volcanoes on eartare considered active, meaning they show some occasional activity and are likely to erupt again.9 earthquakes are measured by their magnitude, energy release, and intensity. from 1935 to 1970, the richter scale was the method for measuring earthquake magnitude. measurements on the moment magnitude scale are determined using a complex mathematical formula to convert motion recorded with a seismometer into a magnitude number that represents the amount of energy released during an earthquake.13 this method suffered from being only used in california and measuring earthquakes within only 370 miles from seismometers. today, the moment magnitude scale method is used and it works by measuring the movement of the rock along the fault.14 the classes of earthquake magnitude are presented in figure 5.14 the second way of earthquake measurement is by intensity, whereby measurement is an on-the-ground description. earthquake intensity is very different from earthquake magnitude. earthquake intensity is a ranking based on the observed effects of an earthquake in each particular place. therefore, each earthquake produces a range of intensity values, ranging from the highest in the epicenter area to zero at a distance from the epicenter. earthquake intensity values follow either the modified mercalli intensity scale (1 to 12) or the rossi-forel scale (1 to 10).14 however, the modified mercalli intensity (mmi) is now dominantly used worldwide (figure 6).13,15 worldwide, more than one million earthquakes occur yearly, an average of about two every minute.16 a database including the 21,000 most devastating disasters worldwide since 1900 indicates that 50% of disasters, including earthquakes, with the most injuries, occurred only during the last 20 years.17 in 2000-2019, earthquakes affect few people but are responsible for claiming more lives than floods, droughts, and storms (3% and about 59% of total disasters).2 between 1998-2017, according to who, earthquakes caused nearly 750 000 deaths globally. the extent of destruction and harm caused by an earthquake depends on the magnitude, intensity, and duration, local geology, time of the day, building design and materials, and the risk management measures put in place.18 in 2021, the worst magnitutde earthquake (8.2) occurred in alaska, usa. figure 4. converging tectonic boundaries. figure 5. earthquake magnitude classes. j global clinical engineering vol.5 issue 2: 2022 12 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region the earthquake prompted a tsunami warning (lifted within 1 hour) and residents in towns and cities took protective cover.19 this earthquake resulted in minimal damage, and no big wave was recorded.20 according to usgs data, this quake was the seventh-largest recorded in us history, tied with another alaskan quake from 1938.21 on august 14 2021, a 7.2 magnitude earthquake hit haiti’s southwestern departments of south, grand’ anse, and nippes. over 2,200 people died, 12,700 people were injured, and 137,000 homes were destroyed, putting thousands of people in urgent need of assistance.22 the countries with the greatest number of earthquakes were mexico (9572), indonesia (5484), and new zealand (3544).23 the indian ocean earthquake and tsunami caused the most casualties of all earthquakes that have taken place in the 21st century thus far. in the same period, top 15 deadliest earthquakes killed 558340 persons.24 earthquakes contributed to six of the top deadliest disasters of the last two decades, contributing 21% of the economic losses. figure 6. comparison of intensity and magnitude methods of earthquake measurement. figure 7. the proportion of various types of impacts by disaster sub-group (2000-2019).2 figure 8. top 10 deadliest disasters (2000-2019).2 13 j global clinical engineering vol.5 issue 2: 2022 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region hospital systems play a critical role in treating injuries and preventing additional deaths during earthquakes and other disasters. hospital systems are at the core of disaster resilience because they must provide timely essential healthcare services to communities during and after an emergency response.17 however, like other types of infrastructures, hospitals are not invulnerable to an earthquake. earthquakes can significantly damage and disrupt a community’s interdependent infrastructure, including residential and commercial buildings; utilities (e.g., water and sewage); dams; levees; fires, tsunamis, flash floods, communications technology; healthcare facilities; chemical plants; industrial storage tanks; nuclear power plants and other hazardous materials storage locations; and bridges, tunnels, airports, roads, sea ports, and/or rail lines. in addition, outages may lead to secondary radiological or other hazardous materials incidents, transportation and supply chain disruption (including those used to transport food and medicines); and significant financial losses.25 though natural disasters kill over 100,000 people and affect more than 150 million, the deadliest disaster is reported to be the 1931 yangtze river floods which claimed over million deaths.26 ranked third globally among other natural disasters to have claimed more lives, the worst humanitarian earthquake disaster in history is recorded in xaanxi, china. an earthquake of magnitude 8 occurred in 1556 and resulted in 830,000 deaths, and reports indicated that all 97 counties were affected. for some counties, 60% of the population died.27 it was seconded by an earthquake in latin america and the caribbean, where an earthquake struck haiti on january 12, 2010. this quake killed an estimated 220,000 people and displaced 1.5 million; damages included but were not limited to housing, agriculture, water and sanitation, education, transport, health, and energy, valued at us$7.8 billion.28 according to the haitian government.27 316000 people were reported to have lost their lives in the disaster. volcanic activity of the virunga mountains the east african rift system is one of the most outstanding and significant rift systems on earth and transects the high-elevation ethiopian and east african plateau.39 the african rift valley extends over almost one-fifth of the earth and is one of few active rifts on the earth’s land surface.40 it is often mentioned as the modern archetype for rifting and continental break-up showing the complex interaction between rift faults, magmatism, and preexisting structures of the basement.41 the east african rift system (ears) (figure 11) forms a narrow (50–150 km wide), elongated system of normal faults that stretch some 3,500 km in a sub-meridian direction.40 ears results from continental extension and thinning of the crust.39 figure 9. breakdown of recorded economic losses (2000-2019).2 figure 10. earthquakes and critical infrastructure disruption.25 j global clinical engineering vol.5 issue 2: 2022 14 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region tectonic activity in east africa is often attributed to mantle upwellings at various scales.10 the virunga mountains, which make up part of the ears range north of lake kivu in east-central africa, extend about 50 miles (80 km) along the borders of the democratic republic of the congo, rwanda, and uganda.42 the volcanic mountain range features eight major volcanoes, namely nyiragongo (3470 meters), nyamuragira (3058 meters), mikeno (4437 meters), kalisimbi (4507 meters), gahinga (3473 meters), sabyinyo (3671meters), muhabura (4127 meters), bisoke (3711 meters). only two (nyiragongo and nyamuragira) of these volcanoes are active, while the others are dormant.43 the most earthquake-affected areas of the virunga volcanic regions are the northern and western provinces of rwanda and the north-kivu province on the drc side. the two provinces of rwanda have a population of 4,206,869 (data from the websites of both provinces) spread over 9175 km2 in which 20 hospitals were constructed, while the north kivu province has a population of 6 000,000 as per the 2015 census, over a surface area of 59,483 km2.44 the active mountains/volcanoes are responsible for different earthquakes which ravaged the virunga region (especially drc and rwanda). to mention some, two earthquakes of magnitude 6.0 and 5.0 struck the great lakes region on february 3 2008, the first in the drc and the second in rwanda. it was reported that 34 died, 434 were wounded, and considerable damage in the two countries.45 in 2002, nyiragongo erupted, and the lava lake drained from fissures on its western flanks. the city center of table 1. examples of health facilities damaged by earthquakes medical facilities destroyed by earthquake country year olive view medical center29 usa 1981 kumamoto hospital30 japan 2016 loma prieta31 usa 1989 1059 health facilities destroyed, 401 completely damaged32 nepal 2015 in 2 minutes, 97% of city hospital beds were destroyed in pisco city earthquake33 peru 2007 50% of health facilities destroyed in pakistan earthquake pakistan 2005 bhuj hospital, 150deads inside hospitals and 20000 overall died34 india 2001 10 hospitals destroyed to relacarion, and 50000 persons killed17 turkey 1999 maternité solidarité hospital, a 75bed emergency obstetrics facility damaged,35 also 22% of hospitals were destroyed36 haiti 2010 bushenge hospital, 80% of its structure damaged37 rwanda 2008 mexico city earthquake,13 hospitals collapsed, 866 people died and 100 were health personnel38 mexico 1985 bam earthquake, 3500 people injured, many health facilities destroyed38 iran 2003 maule and bio-bio earthquake, 20% of the hospitals in the region suffered, and 484 people died36 chile 2010 figure 11. tectonic plate boundaries for east africa rift valley, including the virunga mountains. 15 j global clinical engineering vol.5 issue 2: 2022 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region goma town, the capital of the east virunga province, had been destroyed by voluminous lava flows. over 200,000 people were left homeless, adding to the pre-existing human disaster caused by frequent civil wars. from 1882 to 2021, nyiragongo erupted at least46 35 times.47 between 2002-2008, 85 people died, and several infrastructure damages were recorded in rwanda due to earthquakes.48 table 2. natural methods of an earthquake early warning system49 earthquake detection method explanation unusual animal behavior some animal (birds, dogs, swans, cats, deers, snakes, insects, worms, fishes, horses, donkeys, geese, fowls, ducks, pigeons etc) are endowed with sensory perception denied to human beings, upon which their change of behavior informs the public about the earthquake occurrence nearby. before the earthquakes in haichang (1975), bahai (1969), chile (1835), ryakya (1896), yogoslavia (1963), san andreas (1906), japan (1896), tango 1927, kanto 1923, eddo (1855), india (1892), uttarkashi (1991), latur (1993), jabalpur (1997), chamoli (1999) and bhuj (2001), different animals had already shown unusual behavior hydrochemical precursors concentration levels of dissolved minerals and gaseous components. temperature change there seems to be a relation between temperature and earthquake. for example, a considerable rise of temperature by 10°c and 15°c was reported before earthquakes in lunglin in china (1976) and przhevalsk in russia (1970). water level drastic changes in water level occurs before major earthquakes. the rise of water level by 3 and 15 cm was reported before lunglin (china) and przhevalsk (russia) earthquakes. also, the decrease in water level before the nankai earthquake in japan (1946). similarly, water level rose by 3 cm a few hours before the earthquake in meckering in australia (1968). in china rise in water level in wells was observed before earthquakes of haicheng (1975), tangshan (1976), liuquiao and shanyin (1979). radon gas it is a radioactive gas which is discharged from rock masses prior to earthquake. it is dissolved in the well water and its concentration in the water increases. this happened before earthquakes of tashkent (1972), tangshan (1976), luhuo (1973), and uttarkashi earthquake (1991) oil wells large scale fluctuation rate of oil flow from oil wells are observed before earthquakes. for example, such cases were observed in israel, china, northern caucasus before 1969, 1971 and 1972 earthquakes. foreshocks foreshocks provide valuable dues to the occurrence of a strong earthquake. haichang earthquake in china (february 4, 1975), oaxaca, mexico earthquake of november 1978anantnag (1967), dharmasala (1968), kashmir (1973), kinnaur (1975) were forecast by studying the foreshocks changes in seismic wave velocity: the lead time (time difference between primary and shear waves) and a longer period of abnormality in wave velocity presaged a larger quake. in 2016, the combined effect of disasters in rwanda were forecast to cost the country a massive rwf 100 billion, earthquakes contributing rwf 21.6.51 in may 2021, following the eruption of congo’s mount nyiragongo volcano, a 5.3 earthquake struck the border of congo and rwanda, resulting in the demolition of 17 villages and damaging infrastructure including roads and hospitals. in addition, about 1,000 houses were destroyed, and more than 5,000 people were displaced by the eruption, killing at least 32 people.52,53 reports indicate that 21,000 congo residents cross into rwanda for refuge.54 according to unhcr, the eruption led to the displacement of over 500,000 individuals to the surrounding areas of goma, sake, minova, kiwanja in rutshuru, bukavu, and rwanda.55 the total recovery of rubavu will cost a whopping rwf 91,430,692,000, according to officials.54 j global clinical engineering vol.5 issue 2: 2022 16 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region weak shaking might have been felt in ruhengeri, located 28 km from the epicenter, sake 40 km away, gitarama 66 km away, and kigali 83 km away.56 during the same disaster of nyiragongo eruption and consequent earthquakes, there were 92 earthquakes and tremors of which only 4 were felt by humans. the rest were only picked up by instruments.57 considering the human and material losses caused by earthquake, an early warning system and management plan would contribute to saving lives. the technological advances have made it practical to design and implement earthquake early warning system based on internet of thing.58 traditionally, before the invention and development of recent advanced technologies for earthquake detection and warning, other methods were used to detect the occurrence of the earthquake in the near future, as presented in table 2. earthquake early warning system (eews) the immediate resilience after the earthquake is becoming an important aspect worth being investigated.59 an earthquake early warning system (eews) is both a scientific and a societal challenge. it would be wonderful to see eew save many lives and reduce societal losses in future earthquakes.60 the success of eews will be attributed to advances in communications, digital seismology, and automatic processing.61,62 the first successful eews were developed by japan and proved useful before the 1975 haicheng, china earthquake. shortly after receiving the warnings, the government urged the residents to evacuate to a safe place, and on february 4, an m7.3 earthquake struck the region.63 japan invested $600 million in such a system after the 1995 kobe earthquake killed 6,400 people. today, japan’s system allows every citizen to receive an advance alert of an earthquake ground shaking from the japan meteorological agency. thanks to this system, no trains table 3. challenges in disaster management, earthquakes included38 challenge category examples lack of preparedness no previous training of personnel and lack of training programs, lack of prior planning for disaster situations, lack of attention to the experiences and lessons of previous disasters logistics challenges inappropriate places for providing services to the injured, management of donations, no emergency fund, security management, human resources management technical challenges evacuation of hospitals, patient security, admission, entry and exit management and discharging of injured, triage and prioritization of patients communication and information management contact with the media, communication within the hospital, out-of-hospital communications, management of very important people and visitors lack of coordination coordination problems with volunteers who were referred to help, lack of coordination among hospital officials, lack of coordination among the authorities in different hospitals, no incident command system, disobeying the orders of officials by personnel, intractable performance of tasks by staff, absence of command unity and single commander, frequent examinations of some injured, bewilderment of personnel and officials, fragmentation and repetition, inappropriate interventions of unrelated individuals figure 12. the technical principles of an earthquake early warning system.50 17 j global clinical engineering vol.5 issue 2: 2022 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region derailed in the magnitude 9.0 2011 tohoku earthquake, and according to a poll in japan, 90% of the citizens think the system is worth the investment.64 today, the technology exists to detect earthquakes so quickly that an alert can reach people before strong shaking arrives. eews entail detecting initial earthquake shaking and rapid estimation and notification to users before imminent, stronger shaking.60 eews are beneficial as they allow organizations to take either automated or procedural actions to counter the impacts of the shaking. examples of organizational actions include slowing trains, halting surgeries, elevators, and traffic, evacuating hospitalized patients, securing sensitive machinery, and turning off dangerous or essential equipment (figure 13).65,66 the emerging computing technologies such as mobile computing and internet-of-things (iot) systems are equipped with various mems (micro electro mechanical systems) sensors (e.g., accelerometers, gyroscopes, gpss), wi-fi, bluetooth, making it possible to build and operationalize earthquakes early warning stations. however, the project is not only expensive but also difficult to realize a countrywide network.67 the idea of using early warning for earthquakes was first considered by j.d. cooper in november 1868; he proposed the installation figure 13. examples of eews applications categorized in terms of procedure complexity and potential action cost.66 of seismic sensors near hollister, california, that would send an electric signal via telegraph to san francisco once an earthquake was detected.68 however, the first practical eews was uredas installed in japan for railway systems in 1988.66 today, eews are used to deliver public warnings in japan, mexico, south korea, romania, turkey, china, italy, switzerland, canada, india, taiwan, and along the west coast of the united states of america.63,66,69,70 for example, following the 2008 wenchuan earthquake, china’s central government encouraged the establishment of a national eews. it resulted in a high-quality national seismological network with 15 000 stations, 1928 seismic stations (equipped with collocated broadband seismometers and force-balanced accelerometers), and 3114 strong-motion stations (equipped with force-balanced accelerometers), and 10 349 sensors based on low-cost mems.71 postearthquake engineering reconnaissance missions play an important role in learning about the performance of structures and infrastructure under seismic loading, the social impacts of disasters, disaster management processes, and the science of seismic events.72 the complete scope of the eew problem can be summarized in four steps (figure 14).66 seismic waves detection and transmission when an earthquake occurs, energy is released due to tectonic plates moving relative to one another. the energy generated from the collisions propagates through and around the surface of the earth as seismic waves. seismic waves are not generated by earthquakes only because explosions, volcanic eruptions, wind, supersonic planes, figure 14. scope of earthquake early warning system problems. j global clinical engineering vol.5 issue 2: 2022 18 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region people’s footsteps, vehicles, and bikes can generate them. seismic waves can be divided into surface waves that travel on earth’s surface and body waves that travel through earth. there are two types of body seismic waves.15 • primary waves, compression waves, or dilatation waves (p-waves) are waves that reach the earth’s surface first. they can travel through all mediums of liquid, solid, and gases. they possess high velocity (4-8 km/sec) with low destructive power and move radially from the focus of the earthquake.50 • secondary waves (s-waves, also called shear waves) reach the earth’s surface following primary waves. such waves travel only through solid media and get aborted in liquid media. they are characterized by lower speed (2-4 km/s) compared to primary waves and scatter in all directions from the earthquake focus point (they displace material at right angles to their path). these waves are more damaging, causing maximum destruction during an earthquake.50 the s wave carries the major destructive energy, and the smaller amplitude p wave precedes the s wave by the time equal to 70% of the p-wave travel time to the station.61 when measuring seismic waves, the time difference between the pand s-waves tells us the distance the earthquake is from the seismograph. data from a seismometer, also called a seismogram, shows velocity on the y-axis and time on the x-axis (table 4).73 the fundamental observations used in seismology are seismograms , a record of the ground motion at a specific location. seismograms come in many forms, on smoked paper, photographic paper, common ink recordings on standard paper, and digital format (on computers, tapes, cd roms). the strength of shaking can practically be represented by peak ground acceleration (pga), peak ground velocity (pgv), and peak ground displacement (pgd).61 the ground vibration measurements by seismograms are used for estimation earthquake source parameters (origin of the earthquake and rupture duration, earthquake location including epicenter and depth, sie of the earthquake expressed in magnitude), getting seismic wave travel path information (seismic velocity model, attenuation model).74 different instruments are used to detect and measure the seismic magnitude, and their difference depends on the parameter to measure, types of sensing transducers, bandwidth, and signal intensity. they detect the seismic waves created by subsurface ruptures and convert ground motions into electronic signals suitable for transmission. generally, seismometers, accelerometers, and gyrophones are standard for measuring earthquake magnitude. • geophones: these are electricity-powered devices that have been used for measuring seismic data.75 they are ingenious devices with active elements hanging over a spring, amplifier, and magnet, as shown in figure 15.76 the magnet moves up and down around the mass when the earth moves. the magnetic field of this moving magnet produces an electrical voltage in the wire. this voltage can be amplified and recorded by a simple voltmeter.76 table 4. various minerals and their p and s wave velocities mineral p-wave velocity (m/s) s-wave velocity (m/s) soil 300-700 100-300 dry sand 400-1200 100-500 limestone 3500-6000 2000-3300 granite 4500-6000 2500-3300 basalt 5000-6000 2800-3400 figure 15. basic principle of a gyrophone. 19 j global clinical engineering vol.5 issue 2: 2022 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region an important feature of geophones is that they can only monitor frequencies above their natural frequency, up to a specified spurious frequency (10hz-250hz).77 • seismometers are instruments used to identify vibrations brought about by the plates’ movement. the device measures the velocity of a point on the ground during an earthquake. a seismometer, a clock or time-signal receiver, and a recording system constitute a seismograph. the basic seismometer is presented in figure16. the output of the seismometer is usually measured in volts/rnrn/s. the damping is typically measured as a ratio of critical damping, and is normally set to a value of about 0.7 critical. the natural frequency of the seismometer is measured in hertz and for local earthquakes normally has a value less than 2 hz, with 1 hz often used. each seismometer can measure motion in one direction, either vertical or horizontal.74 seismometers are classified into broadband (capable of sensing ground motions over a wide range of frequencies) and short period types (cover the frequency band from 1 hz to 100 hz). seismometers are classified by type (tele seismometers, strong-motion seismometer, strain-beam seismometer), range (50 to 750 v/m, 1500 v/m, and 20,000 v/m), and varieties (short period, long period, and broadband).78 • accelerometers: accelerometers give information about forces that a subject experiences during a seismic activity.79 they measure the acceleration of the shaking ground and are designed to measure the large-amplitude, high-frequency seismic waves typical of large local earthquakes. in addition, the double integration of the accelerometer output gives the distance function, which can detect the distance from the epicenter. nowadays, there has been considerable interest in the seismic exploration industry in mems microchips as acceleration-measuring sensors.75 though accelerometers and geophones are used in seismometry, attention to seismometer and its market up to 2022 was shown to grow in recent applications (figure 17).78 according to the configuration of the networks/sensors, an eew system can be conceptually classified as a regional or an onsite system. a regional eew system is based on a dense sensor network covering a geographical area of high seismicity, and when an earthquake occurs, the relevant source parameters are estimated from the early portion of recorded signals at sensors close to the rupture. regional eew systems typically require many stations triggered on the arrival of the p-wave signal to provide stable early estimates of earthquake location.50,80 the regional eews takes 10-15 secs to detect an earthquake, and by the time the damaging s-waves reach some locations close to the epicenter, a warning is not possible. the areas without warning are termed blind zones and may range around 40–60 km from the epicenter, depending upon how quickly an earthquake is located. the problem of the blind zone can be overcome by the onsite eew system, under which a single station installed in the target area will immediately sense the earthquake and issue a warning.80 figure 16. basic seismometer [image from iris website] figure 17. seismometers market growth from 2016 to 2022. j global clinical engineering vol.5 issue 2: 2022 20 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region site-specific or onsite eew systems consist of an array of sensors or a single sensor located in the vicinity of a single target site or structure /infrastructure of interest. site-specific systems provide estimates of peak-groundmotion ims [e.g., pga, or pgv] based directly on the amplitude and/or predominant period of the initial recorded p-wave signal (figure 18).50 generally an eews consists of: • remote station: the remote station is generally located in the neighborhood of the earthquake source. it contains different sensors for seismic waves detection, the data acquisition and processing system, the power supply, and the data transmission system. the remote station monitors and detects earthquakes based on seismic networks. the station processes can estimate the earthquake location, magnitude, maximum seismic intensity, earliest arrival time, and alert notification decisions.36 • communication network: the rapid development in communication technologies, especially in satellite communication, has impacted the evolution of the seismic network. communication technologies used in seismometry help exchange seismic data between stations and warn the target users. each communication network has five elements for the successful transmission of information. data, sending, receiving, channel, and communication protocol are elements.81 communication technologies can be wired, wireless, or satellite-based. there are different topologies used in seismic networks, which differ based on the distance at which data are to be transmitted, data rates, efficiency, and robustness (table 5).82 the communication system is entitled to strong computer algorithms to quickly estimate an earthquake’s location, magnitude, and fault rupture length and to map the resulting intensity. it should also be capable of delivering quick and reliable mass notifications, and end-users must be educated on how to use the alerts.64 figure 18. the two possible approaches to earthquake early warning. figure 19. earthquake communication network for maryland geological survey.83 21 j global clinical engineering vol.5 issue 2: 2022 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region the different earthquake prediction methods include support vector regressor, elarms or epic, machine learning algorithm models, deep neural networks, or vs models.29 • base station: the base station is generally located at the site whose warning is addressed. the base station is composed of mast/tower, sectorial antennas, pdh & sdh microwave, waveguide cables, rectifier, generator, radio base station, duplexers, data distribution frame rack, transceiver unit (tru), trunking, tx cabinet & shelter a short-haul modem, and a computer for data processing, display, storage and internet distribution of data.83,84 the base station is meant to give alarms to the region to be warned. currently, there are successful eews in the world, but most of them were initiated and installed after the concerned countries were seriously struck by earthquakes. successful eews implementations include uredas for japan, shakealert for usa, and sasmex for mexico. japan has the most widespread network for earthquake warnings worldwide, and china is currently building a nationwide eews which will be completed in june 2023. the seismic network can be broadband, short period, or mems-based.85 the global seismographic network (gsn) is a permanent, digital network of more than 150 modern stations in over 80 countries. it is composed of a globally distributed, state-of-the-art digital seismic network that provides free, real-time, open-access data through the iris dmc.86 since its operation, the gsn has produced high-quality digital data from widely distributed, similarly equipped, and well-calibrated stations.87 gsn instrumentation is capable of measuring and recording with high fidelity all of earth’s vibrations, from high-frequency, strong ground motions near an earthquake, to the slowest free oscillations of the earth. as a result, gsn seismometers have recorded the greatest earthquakes on scale (for example, the 1994 mw-8.2 bolivia earthquake at 660 km depth) and the nano-earthquakes (m < 0) near the sea floor at the hawaii-2 observatory. in addition, gsn sensors are accurately calibrated, and timing is based on gps clocks.88 the gsn, together with the usgs national earthquake information center (neic), are the principal global sources of data and information for earthquake locations, earthquake hazard mitigation, and earthquake emergency response. the real-time seismograms provided by neic for different regions update every 30 minutes. to achieve this telemetry coverage, a wide range of solutions—geosynchronous satellites employing antennas in the 1 to 4 m range, inmarsat, iridium, landlines, local table 5. seismic network topologies: nodes represent stations and lines the communication links topology characteristics short distance, different data on each link, data exchange passes through other nodes, not robust because link outage can affect different nodes short distance, different data rates, data exchange passes through other nodes, not robust because link outage can affect different nodes large distance, same data on links, data exchange travels through central node, robust because link outage only effects one node large distance, same data on links, rate in links can differ, robust because link outage only affects one node j global clinical engineering vol.5 issue 2: 2022 22 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region internet service providers, submarine cable, etc.—has been implemented, in cooperation with nasa/jet propulsion laboratory the us national imaging and mapping agency, the us. national weather service, japan’s national research institute for earth science and disaster prevention, and the comprehensive nuclear test ban treaty organization (ctbto) (figure 21 and 22).88-90 conclusion in conclusion, this paper highlighted the natural process behind volcanic activity and the role of eews in mitigating earthquake risks. in addition, this paper presented the historical statistics of earthquakes in fatalities, infrastructure damages and economic losses caused, and the stand of earthquakes among other disasters. the eews came to the attention of researchers as a solution to reduce the adversity of earthquake risks. though the conceptual idea about eews started many decades ago, today, technological advancements have transformed the dream into reality. across the world, many operational seismic stations and networks are used to monitor and provide real-time information about seismic activity. even if, in many cases, the public is warned a few seconds before destructive seismic waves, the alert can enable immediate actions that protect people and property. the activities which must be urgently performed include halting delicate medical procedures and moving patients to safe assembly points, pausing airplane landings, students exiting classrooms, turning off household appliances, and safely stopping and exiting vehicles. also, automated responses must be addressed, such as opening elevator doors, shutting down production lines, securing chemicals, stopping trains, and protecting power stations and grid facilities. figure 20. per-country distribution of disasters with the highest number of injuries since 1900.17 it is observed that earthquakes dominated the disasters which ravaged and shocked mankind. 23 j global clinical engineering vol.5 issue 2: 2022 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region figure 21. distribution of stations pertaining to global seismographic network. figure 22. components of global seismographic network system. j global clinical engineering vol.5 issue 2: 2022 24 nkurunziza, udahemuka, umutesi, dusenge : earthquake early warning system: a solution for life rescue in health facilities and risks mitigation for the population of the virunga region although there is no eews for the earthquakes occurring in the virunga volcanic region, hospitals in rwanda have safe assembly points where people can gather in case of an emergency or disaster. however, this good initiative is not enough compared to the technological progress of the current generation of eews, and the development achievement of other countries with the same earthquake challenges. in 2005, at the 2nd world conference for disaster reduction in kobe, japan, 168 countries ap¬proved the hyogo framework for action and they agreed to: promote the goal of ‘hospitals safe from disasters’ by ensuring that all new hospitals are built to a level of safety that will allow them to function in disaster situations and implement mitigation measures to reinforce existing health facilities, particularly those providing primary health care. in addition, in 2015, the member states of the united nations endorsed the sendai framework for disaster risk reduction (unisdr, 2015), where it is specified that early warning must be a priority and early warning systems have to be substantially evolved by 2030. therefore countries affected by the virunga volcanic activity are first recommended to join efforts to exchange how the eews can be implemented to warn the residents about the likelihood of earthquake occurrence in the near future. furthermore, the eews should also send a warning to healthcare care facilities for better preparation before the occurrence of destructive seismic waves. since the residents are warned, congestion at a health facility can be reduced, and the 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medical devices in an international context part 3 assessment of local and lifelong use conditions by valerio di virgilio1, alexia bouchard saindon2, francisco becerra posada2 1 università degli studi la sapienza, roma 2 united nations office for project services (unops) abstract background and objectives: this article is the third in a series of three manuscripts published in this journal. it aims to describe how sustainable procurement of medical devices (mds) can be implemented in operational projects in the context of developing countries. it also further details how the biomedical/clinical engineer lead (bcel) in charge of technical support during the md procurement process can apply sustainability principles and concepts of value-based procurement. material and methods: based on the authors’ experience of more than 20 years in procurement projects and implementation of mds, the role of the bcel will be developed from a theoretical point of view with the description of the second and third pillars of a sustainable purchase following the needs assessment: the assessment of existing conditions along with local capacities and the evaluation of the use conditions during the lifetime of the medical equipment. the application of these principles in operational projects will be further discussed by analyzing literature and lessons learned from projects implemented in developing countries. results/proposal: the bcel has a key role in the sustainable procurement of mds to design the technical specifications of the goods, related services, and post-sales conditions to maximize the benefit of the investment. as the specialist can analyze the local existing conditions and capacities while ensuring efficient use of the mds during their lifespan, they can contribute to a sustainable implementation of mds in developing countries. the bcel shall also be able to analyze the local and international markets to find all possible technological solutions that meet the needs, local conditions, and capacities and ensure quality use during the lifespan of the purchased md. the bcel shall have competencies in identifying all the risks related to the use of the md from the safety risks linked to its installation, use, and maintenance to the sustainability risks linked to obtaining the conditions that guarantee the use of the device and maintaining them as long as possible. examples of these conditions include the presence of qualified and trained users, availability of maintenance and consumable budgets, availability and maintenance of infrastructure conditions (access, electrical power, water, drainage, medical gasses, etc.), and last but not least, presence of patients requiring a diagnosis or treatment using the purchased md who were identified during the evaluation of the first pillar: a sound needs assessment. conclusion: as an evolution of the bcel’s traditional biomedical and clinical engineering work, he/she shall assume the responsibility to guarantee the sustainability of the md purchase. this quality assurance and control role is achieved by a sound theoretical background knowledge based on the three sustainable procurement pillars: the needs, existing and lifetime use conditions assessments, the analysis of the local and international markets, and a broad understanding of sustainability risks. keywords – medical device procurement, sustainable procurement, technical specifications, local conditions, local capacities, lifetime use of mds, total cost of ownership, health services in developing countries, quality assurance, sustainability, clinical engineer role, international health procurement, value-based procurement. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. 17 j global clinical engineering vol.6 issue 2: 2024 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 introduction in a previous article,1 sustainability principles and their importance in md procurement projects, especially in developing countries, has been described. a theoretical concept with three fundamental pillars was proposed to improve the sustainability in md procurement projects and address the risk of purchasing mds that will not be used by local clinical personnel. this concept suggests focusing the technical work of the bcel on three assessments: (1) the needs, (2) the local conditions and capacities, and (3) the conditions for the lifetime use of the md. all actions performed during the project are recommended to be coherent with the results of these three assessments linked to the project’s objective to facilitate the sustainable outcome of the purchased mds. without specific attention to the sustainable conditions of use, an investment in health technology, including md purchases, has a high risk of becoming a burden for the local health system. this article aims to further detail how these pillars for sustainability can be implemented in md procurement projects within the environment of developing countries. this article will focus on assessing the mds’ local and lifetime use conditions since the needs assessment was already developed in a previous article.2 the responsibility and recommended actions that the bcel can take to perform these assessments are discussed and analyzed using examples from implemented projects. in this framework, a convenient approach is to focus on value-based procurement, a novel approach to purchasing that evaluates potential new mds to maximize overall value for money (including their economy, effectiveness, efficiency, equity, and sustainability), rather than focusing only on the lowest purchase price will also be explored.3,4 the assessment of existing conditions and capacities the second pillar of sustainability is the assessment of existing conditions and capacities where the md will be used. this includes the analysis of the following conditions: • the delivery logistics required to get to the installation site and the installation room from the nearest port/airport and the manufacturing site; • the customs rules and regulations; • the installation site infrastructure and installation conditions according to the technical requirements of the mds to be implemented; • the local and international rules and regulations on mds, construction, electrical, fire prevention, health and safety, etc. • the local capacities are clinical, technical, logistics, financial, etc. • the availability of the mds, services, and consumables on the local and international markets is needed to guarantee sustainability. the result of these analyses is the development of detailed technical specifications for the mds to be procured, starting from the technological level defined in the needs assessment in line with the analysis of the intended use of the md, together with an adequate delivery and installation plan translated into requirements to be included in the tender documents. the technical specifications of the mds shall be tailored to consider local clinical and technical capacities as well as their working method, standards, and cultural environment. therefore, a dialogue with the mds’ clinical and technical beneficiaries is essential during assessing the existing conditions and capacities for defining the technical specifications. eg1 mds required to equip a delivery room can be selected in very different ways depending on cultural aspects, including delivery positions and the presence of accompanying relatives. depending on the local culture, the use of birthing balls, stools, supports from the ceilings together or instead of the classical delivery bed have to be discussed and considered when designing the equipment list and their technical specifications.5,6 linked to the incoterms used in the tender and purchasing contract, shipment conditions shall consider the logistics and safety of the sites. sometimes, due to urgency or specific logistic complexity, the delivery costs may become higher than the costs of the goods. to minimize the carbon footprint and reduce costs, local suppliers shall be encouraged to participate in the tender processes since ‘’goods sourced locally have a positive sustainability di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 j global clinical engineering vol.6 issue 2: 2024 18 impact, e.g., eliminating transportation costs.’’7 in most cases, the national regulatory authority certification is mandatory to import the goods, and relevant customs bureaucracy shall be managed. the design of pre-installation requirements represents, for complex equipment, a critical issue since the installation shall comply with the manufacturer’s recommendations and local rules and regulations. in most cases, international practices and safety standards for the installation shall be added to local rules and regulations depending on the maturity level of the beneficiary country. the result of the assessment of the existing conditions are: 1. detailed technical specification of the mds; 2. complete delivery conditions and specifications; 3. exhaustive organization of the pre-installation responsibilities; 4. pre-installation requirements; 5. training requirements for the tender process; 6. installation requirements for the tender process. the role of bcel in the assessment of existing local conditions and capacities based on the assessment of the existing conditions: infrastructure, electromechanical installations, clinical and technical capacities, installed and available technologies, local market, intranet-internet connections, etc. the bcel along with the local stakeholders and within the scope of the project agreement, will design, as summarized in figure 1: 1. the technical specifications are the detailed requirements for the md; in this process, the bcel shall consider the technological level8 and the clinical objectives defined in the needs assessment as well as the installation conditions and, most notably, the local clinical and technical capacities, as well as the lessons learned in previous projects and the local and international market. this process implies a consistent workload depending on how the market analysis can be performed depending on the availability of lessons learned from previous projects. if an up-to-date database of previous successful projects with the same specific technology required for the project is available, the market analysis can be reduced. suppose a new technology has to be purchased. in that case, the market analysis may require a larger technical effort and contact with potential suppliers and manufacturers, requiring several additional weeks for the specifications design of a single technology. typically, this process is outsourced by the bcel to other biomedical engineers who can work remotely while the bcel focuses on the next steps. according to the united nations office for project services (unops)9 and the united nations international children’s emergency fund (unicef),10 the bcel could also perform additional sustainability considerations in the planning phase of the project: ○ plan a market analysis to understand and determine: • sustainable solutions that might already exist in the local market; • sustainable solutions that have been implemented internationally; • the economic, social and environmental risks/ opportunities related to that specific md; • standards and regulations requirements available for the md. ○ assess the sustainability risks of the md and adjust the procurement strategy consequently. 2. the delivery requirements, including temporary storage and transport conditions, safety rules for manipulation and transportation, possibly considering, during tender evaluation, the carbon footprint. for larger equipment, these requirements shall include the access pathway inside the beneficiary’s infrastructure to the final installation site, considering the size and weight of the good’s packages: the rigging plan. this includes onsite transportation that can become relevant for heavy or large equipment requiring a detailed plan, including health and safety considerations for the workers. also, the disposal, recycling, or storage of equipment packaging can also be an important aspect to integrate into the technical specification preparation. 3. the pre-installation responsibilities are linked to the installation site and md’s specific chosen brand and model. the bcel shall design how to organize the contractual 19 j global clinical engineering vol.6 issue 2: 2024 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 responsibilities between the beneficiary hospital, the supplier, and the international purchasing organization, including, when relevant, the hospital’s constructor. the exchange and approval of progressively more detailed technical drawings and the definition of responsibilities for the pre-installation work between all the stakeholders is essential to the success of the implementation. this process shall consider the standards and regulations applicable to the different installation aspects, such as structural capacities, radiation protection, hazardous material management, waste management, etc. 4. the pre-installation requirements which include all technical requirements for a safe installation and use of mds that need to be specified by the bcel to support hospital architects and engineers in designing new infrastructures or renovating existing sites3; they can be organized as shown in table 1. these requirements are specified when the equipment type is defined and adjusted with the manufacturer’s documentation when the specific brand and model is awarded. 5. human resources (clinical and technical) training requirements. the design of the training requirements is a critical issue, and the bcel shall consider all available options from simple written instruction of use and maintenance to online training and tutorials or even in-person training by the manufacturer’s certified instructor. the bcel can also consider the possibility of longer training when introducing new technology. for example, the clinical and technical personnel could travel to a clinical or training center where the same equipment model is installed for several weeks of hands-on training. a good practice is to identify the trained personnel and restrict the use and maintenance of the md only to trained staff. another recommended strategy is training local technicians to maintain essential mds, such as hospital furniture and simple equipment commonly found in primary care institutions that benefit a larger population.11 6. detailed installation requirements in charge of the supplier to be included in the tender document. as the last step of the installation design, the bcel will prepare the final installation requirements to be tendered with the equipment. these requirements shall match the onsite conditions, and the pre-installation works that the beneficiary or a third party eventually takes care of. it is a good practice to include the specific installation requirements in a framework considering environmental protection, health and safety of the installers, as well as human rights and gender equality policies. after installation completion, the supplier may be required to implement a communication plan to enhance the visibility of the project. if so, this activity shall be implemented under the strict supervision of the beneficiary. the bcel shall consider the impact of pre-installation works and installation activities on the hospital’s clinical workflow and discuss it with the beneficiary before starting the purchasing process. in some instances, the impact can be so unacceptable for the beneficiary that the purchase of the new equipment is rejected, and a different technological solution shall be pursued. to improve the quality of procurement processes, a standard template of technical specifications for the procurement of mds with standards, regulations, and sustainability principles is recommended to be available for bcels within an implementation agency. a peer-review mechanism of technical specifications, delivery, installation, and lifetime use plan by bcels is also recommended to be incorporated into the procurement processes of mds. the outcome of the project’s implementation can be monitored, and lessons learned can be gathered to benefit future projects. eg2 a purchasing project for a few computed tomography (ct) scanners installed in specific hospitals where the clinical engineer has also designed their sustainable use can be further investigated and improved if analyzed nationally. the national distribution of imaging equipment in a network scheme that minimizes the distance to the electrical supply temperature and humidity water hot/cold weight drainage radiation shielding medical gasses magnetic shielding other gasses biohazards containment network connections table 1 pre-installation requirements, which include all technical requirements for the safe installation and use of mds di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 j global clinical engineering vol.6 issue 2: 2024 20 nearest ct scanner for the population, their connections, and their interactions through local and national pacs/ris systems allows a broader assessment that can suggest some adjustments to the technical specifications for purchasing the ct scanner in the benefit of its future optimized use. figure 1. the role of bcel in assessing existing local conditions and capacities. the sustainability risks of a weak assessment of existing conditions a incomplete or absent assessment of the local conditions is, together with a weak needs assessment, the main cause for an unsuccessful project: the equipment is delivered but not used. the opportunity to improve the health system’s quality and the investment are lost, 21 j global clinical engineering vol.6 issue 2: 2024 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 and the equipment becomes a burden to be removed and disposed of. the world health organization states, “according to one estimate, only 10–30% of donated equipment becomes operational in developing countries. reasons for unused equipment include mismanagement in the technology acquisition process, lack of user training, and lack of effective technical support.’’12 other risks associated with a poor assessment of existing conditions can include the following examples. • an impossibility to deliver, install, test the equipment or train personnel due to poor road conditions, war zones, etc.; • a lack of services for the safe and effective use of the device: absence of a reliable electrical power source, unavailability of medical gasses, inadequate water quality, insufficient mechanical structure, no protection against radiation or bio risks exposure, lack of information technology, etc.; • a lack or absence of training and qualified clinical and technical resources to use and maintain the md; • a lack or absence of proper accessories and consumables to make effective use of the device; • non-compliance of the device to local standards and regulations.3 the bcel shall avoid additional examples of frequent pitfalls and derived lessons learned during the design phase: 1. absent, insufficient, or wrong pre-installation conditions when the installation works are supposed to start. to prevent this situation, it is possible and useful in some cases to delegate the pre-installation works to the beneficiary hospital even when the beneficiary has a weak technical capacity. in these cases, the supervision of the works and the final approval shall be assumed by the bcel and the equipment supplier. only a close follow up of the execution of the pre-installation works can guarantee that the proper pre-installation conditions will meet the requirements. 2. a lack of personnel to be trained: the bcel shall ensure that the beneficiary users are available and prepared to receive the appropriate training at the planned time. the final users and the final responsibility for maintenance shall be formally designated by the beneficiary authority to receive the training and be available during the training days. furthermore, recording the training sessions to guide new users and creating a formal document to register who has been trained and is habilitated to use and maintain the equipment correctly is advisable. 3. a lack of specific tools and consumables on the local market. the bcel shall verify in advance and search for alternatives when a particular tool or consumable is unavailable on the local market. 4. the local supplier representative lacks capacities for installation and post-sales services delivery. the bcel shall confirm that the local representative of the supplier/manufacturer has been properly trained to install the equipment. the bcel shall require appropriate certification of local technical people delegated for equipment installation from the manufacturer. in past projects, situations where local representatives could not install the equipment properly and damaged the new equipment during the installation attempt happened. the presence of the bcel and close supervision of the installation process is recommended, especially for sensitive and high-technology equipment. in case of doubt, a video record of the installation can be useful. 5. during the installation planning, especially in large projects with tens or hundreds of installations, the climate factor has to be considered. the bcel shall know the difference between the dry and wet seasons in the beneficiary country since some critical delivery operations of managing important loads from trucks to rural sites may be affected by heavy rains. working in a developing country environment requires additional flexibility and problem-solving capacities to face some unforeseen issues that arise during the installation. these issues can also be much more complex in a fragile environment. eg3 during the installation of a md in a remote hospital in haiti, a broken specialized tool represented an issue: the nearest market in the capital was far away, and most probably the specific tool was not available there. an overseas purchase was needed, adding a delay of at least 3-5 days on the overall installation. di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 j global clinical engineering vol.6 issue 2: 2024 22 however, it’s not all about risks, many opportunities can be analyzed and pursued during the project’s design and implementation. a relevant approach recommended to the bcel is to constantly seek opportunities to improve the sustainability of the health system through the introduction of technologies. eg4 in jamaica, nurses use most of their work time to manually measure patient vital signs and copy them on paper registers. they report that up to 90% of their time is used to perform similar paperwork. a simple device to monitor and record vital signs in a database can abruptly reduce nurse routine work and help nurses spend more time attending to patient’s needs. examples of local conditions assessments figure 2 shows the workflow for the pre-installation requirements responsibilities as designed by the bcel in charge of the procurement project of 32 ct scanners in 2022 in the philippines. four main actors were involved: unops organization, the philippines department of health at a national level, the supplier, and the beneficiary hospitals. constraints at the beginning of this project were that installation site plans were not all available for every hospital, and it was urgent to implement the project according to certain emergency response programs. based on the decision that each hospital had to be responsible for complying with the pre-installation requirements, the following operational workflow was designed by the bcel in charge during the project launch. in 2008, during a project in uruguay, a communication plan was proposed by the bcel and implemented by the project team to inform the recipient health units and the general population of the equipment to be delivered and of their schedule so that the units were prepared for the immediate inclusion of the new technologies in the clinical activities.13 the ministry of health (msp) implemented a component of the plan through radio messages and local newspaper advertisements. each supplier implemented figure 2. workflow of 32 cts installation process: from the analysis of local conditions to the definition of the requirements, implementation and use (klappenbach f. with the permission of the author) 23 j global clinical engineering vol.6 issue 2: 2024 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 a second component under the strict supervision of the msp. tender requirements detailed the services required to the suppliers: national television advertisements, national written press advertisements, and labels while establishing that the ministry of health will keep the rights to all information managed by the supplier, being the supplier forbidden to use it without written authorization. in many cases, citizens, after a communication campaign on local radios and newspapers, went to the health units to see the new technologies. this process of local conditions assessment to implement the italian loan for mds purchase was successfully presented by the ministry of health to the health commission of the uruguayan parliament on february 26th, 2008. assessment of the lifetime use conditions the third pillar of sustainability is the assessment of the lifetime use conditions of the md. the result of this analysis is an adequate lifetime use plan. a key factor is to plan the duration of the useful life of the md. the manufacturers are not used to expose the planned life duration of their goods, but this might change since “manufacturers are required to provide definite expected lifetime for the certification of their product under the new eu medical device regulations (eu mdr 2017/745).’’14 however, the us food and drug administration does not require manufacturers to establish an expected life for a device.15 the expected minimal life duration of the equipment is an essential element of any purchase since it is relevant to evaluate the total cost of ownership and is the basis of any asset management plan for existing and future technologies. the role of bcel in the assessment of lifetime use conditions while considering the project’s constraints such as the available budget, the local conditions, and resources, the bcel shall explore their awareness and interest with the stakeholders on the purchase’s midand long-term benefits. the bcel shall also promote all the actions needed to maintain the equipment during its lifespan and keep the benefits and positive impact of the investment as long as possible. the bcel in accordance with the beneficiary, will design and propose, as summarized in figure 3: 1. the planned lifetime use duration of the equipment. one of the impacts of the life expectancy definition is in the specifications for the materials of the goods. certain kinds of steel or plastic can increase or reduce the life expectancy of medical furniture or a medical device while simultaneously increasing or reducing its value and purchasing cost. once the expected duration of the equipment is determined, the bcel shall revise the technical specifications of the md to adjust and adapt them consequently to the available technologies on the market. 2. the post-sale services requirements, including warranties, maintenance, consumables contracts, and documentation, are to be provided with the md. 3. for certain types of equipment, it is recommended to use the financial planning of the total cost of ownership. this costing methodology considers the total cost of a product over its lifetime. in addition to the initial procurement costs, transportation, maintenance, operations, utilities, training, consumables, and waste management costs are also evaluated based on the expected lifetime of the purchased equipment.16 if the cost of post-sales services or consumables is substantial compared to the cost of the equipment, it is recommended to consider the total cost of ownership during the financial analysis of the purchasing process. 4. when the consumable and maintenance costs are comparable with the equipment cost, other options besides the purchase can be considered by the bcel such as leasing or renting the equipment by purchasing a certain amount of consumables. these types of contracts may represent a valid strategy alternative to the purchase depending on the market and on the contracting rules of the beneficiary and donors.17 5. how to manage the technical documentation accompanying the equipment from the commissioning to the disposal, including all user and maintenance manuals, training and maintenance actions, measures and tests, calibrations etc., shall be planned by the bcel. 6. designing the maintenance requirements, including the in-warranty and post-warranty preventive and corrective maintenance requirements according to the complexity of di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 j global clinical engineering vol.6 issue 2: 2024 24 the sustainability risks of a weak assessment of lifetime use conditions the risks associated with a poor or absent assessment of the lifetime use conditions may render the md unusable after some time and thus threaten the sustainability of the project: • insufficient planning or lack of financial resources needed to purchase consumables and spare parts to maintain the md throughout its life expectancy; • a lack of properly trained clinical and technical staff during the lifetime of the md; • an absence of the equipment documentation: contractual warranty, user and service manuals, etc. probably caused by the lack of hand-over of the project’s contractual documents regarding warranty and post-sales services to the beneficiary; • absent, inadequate, or inappropriate warranty requirements in the tender documents. the manufacturer’s default warranty conditions may require to send the equipment to the production site in case of malfunctioning or to demonstrate that the malfunctioning is not due to improper use; • a lack of managerial capacities to follow up with the supplier regarding maintenance, repairs, and upgrades included in the warranty; • unavailability of consumables or spare parts on the local market, which does not allow or makes the use or the repair of the equipment too expensive; • a premature failure of the purchased md due to materials inappropriate to the hospital environment where aggressive cleaning agents are frequently used; • a lack or insufficient program of continuous training on how to use the md for new users; sustainable risk assessment the recommended approach to sustainability is to start the project with a proper risk analysis involving the different project’s stakeholders. sustainable risk assessment is performed at the start of the purchasing projects, in the evaluation of the three pillars -needs, existing and lifetime use conditions, and capacities allows the bcel to identify the challenges and evaluate the potential risks the equipment and the local needs, is an essential duty of the bcel. indeed, procuring mds without a maintenance plan can be wasteful and reduce the device’s lifetime.18 it is also advisable to include the software updates in the maintenance requirements. 7. it is part of the bcel role to analyze the availability of spare parts and consumables on the local market and to include appropriate requirements in the purchasing tender conditions to encourage the availability of such goods. the bcel also needs to confirm with the beneficiaries the availability of a budget for these consumables and their capacity to manage efficiently the purchase of spare parts and consumables. 8. ideally, when a bcel plans the lifetime use of the mds, he/she shall include a plan for its decommissioning and consider the expenses associated when calculating the total cost of ownership.19 all the requirements mentioned above, excluding decommissioning, will be included by the bcel in the tender documents and act as relevant contractual conditions once the device has been received, installed, and commissioned properly. figure 3. the role of bcel in the assessment of lifetime use conditions. 25 j global clinical engineering vol.6 issue 2: 2024 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 related to sustainability that could have an impact on the outcome of the project. once the sustainable risk assessment is performed and the specific risks of the procurement project have been identified, a mitigation plan can be prepared. different risk mitigation strategies to ensure sustainable procurement practices of md implementation can be applied to different projects, including: 1. openly discuss the sustainability risk of scarce or improper use of the purchased mds with the different project stakeholders. 2. openly discuss sustainability challenges with manufacturers or distributors of mds during the market analysis. 3. center the procurement process on the added value of the intended use of the mds rather than on their possession. 4. give relevance to the requirements on the supporting services of the goods that can guarantee proper and long-term use of the device. 5. when applicable, choose a procurement process that allows an evaluation of the quality and performance of the md during the selection phase, discarding the minimum price approach and considering alternatives to the purchase. 6. ask for a list of reference centers during the selection phase to validate the quality and performance of the bided md in the mid and long term. 7. discuss and share experiences with other health technology assessment experts from un agencies or international institutions on evidence-based procurement of md. 8. build within the implementation organization a record of the performances of the mds and suppliers to build a knowledge database. conclusion sustainable procurement of mds, especially in developing countries, is of utmost importance.1 the bcel has a key role and responsibility in assuring the implemented mds’ quality and sustainability. this article further detailed the proposed theoretical background of two fundamental pillars besides assessing the needs2: local and lifetime use conditions and capacities analyzes that the bcel can follow as a guideline to achieve sustainable projects. it also emphasizes the role of the bcel as the technical expert conscious of the project’s sustainability and responsible for the quality assurance process, raising awareness on the possible issues and discussing solutions with the rest of the team, the beneficiary, and the project’s stakeholders to minimize the risks. since the bcel has to work in a multidisciplinary team20 and be able to dialogue with different stakeholders from various backgrounds, they require expertise to cover all the aspects of the project, from public health to project management, while also considering clinical aspects, hospital design, infrastructure, installation, mds design and technology.21 the assessment of the local capacities and conditions is a key element in the work of the bcel to: • ensure that the technology level is adequate to the site conditions which in developing countries may be challenging because of the lack of adequate infrastructure, stable electrical power supply, controlled working temperature and humidity, accessibility, and • ensure that the md is adequate to the local capacities of use and of maintenance since, in most developing countries those capacities are scarce. expert professionals, when available, have a high turnover because they are constantly searching for better conditions. once the bcel confirms that the technology design is fit for purpose and adequate to local conditions and capacities, including the design of the support services for delivery, installation, and training, they have to ensure that these sustainable conditions will last during the device’s lifetime. this can be done by planning the intended lifespan of the md and verifying that the main conditions will remain stable: availability of trained personnel, planned maintenance by trained technical personnel, availability of consumables, adequate electrical supply, etc. the focus on the lifespan of the md will bring the total cost of ownership criteria in the evaluation and add the analysis of alternative ways of procuring the goods, such di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 j global clinical engineering vol.6 issue 2: 2024 26 conflict of interest the authors declare no conflict of interest regarding the publication of this paper. acknowledgments the authors would like to thank federico klappenbach and oscar marenco for contributing to the examples and figures presented in this article and for the constructive technical discussions during project implementation. references 1. di virgilio, v., bouchard saindon, a., & becerra posada, f. c. g. (2023). sustainable procurement of medical devices in an international context: part 1 background and definitions. global clinical engineering journal, 5(3), 29–39. https://doi.org/10.31354/ globalce.v5i3.159 2. di virgilio, v., bouchard saindon, a., & becerra posada, f. (2023). sustainable procurement of medical devices in an international context part 2. global clinical engineering journal, 6(1), 18–28. https:// doi.org/10.31354/globalce.v6i1.165 3. access and delivery partnership. path. value-based procurement of medical equipment. june 2020. available at: https://adphealth.org/upload/resource/ vbp_guide_en_june2020.pdf 4. boccato c, cerutti s, vienken j, research for development. medical devices improving health care through a multidisciplinary approach. springer. 5. unicef. semana mundial del parto respetado. available at: https://www.youtube.com/watch?v=bdjk5o5g3zs 6. sutcliffe kl, dahlen hg, newnham e, levett k.“you are either with me on this or not”: a meta-ethnography of the influence birth partners and care-providers have on coping strategies learned in childbirth education and used by women during labour. women and birth. available at: https://doi.org/10.1016/j. wombi.2023.02.001 7. united nations office for project services. procurement manual. revision 7. 2021, july 1. available at: https://content.unops.org/service-line-documents/ procurement/unops-procurement-manual-2021_en.pdf as renting or lending the equipment with a consumable contract. the benefit procured by using the purchased md should be the central matter of the procurement process rather than the ownership of the md. additionally, to communicate efficiently and integrate the different collaborators’ viewpoints, perceived risks, and suggested mitigation measures, the bcel must know all these aspects to understand and use the appropriate language. when the bcel is entrusted with an international procurement project, professional preparation, progressive exposure to complex projects, and a peer-review mechanism are recommended. the bcel can contribute to accomplishing the desired outcome by first confirming that the project objectives are built on evidence-based data and that the purchase of the md will indeed improve the health services of the beneficiary country. then, they must keep a high coherence of all their actions with the desired objectives and outcomes. this coherence needs to be maintained throughout the project, be it during the preparation of the purchasing list and the technologies’ specifications or the installation and design of the post-sales services. all these actions must be consistent with the desired outcome, and the local situation, resources, and capacities available on the field must always be considered. finally, monitoring the results of a procurement project by visiting the installation sites and recording the use of the mds within 6 months or one or several years after their commissioning will allow us to understand the impact of the project and learn lessons on the choices made by the bcel along the way. the public procurement process has the weakness that most, if not all, of the choices have to be made at the very beginning when the requirements of the tender documents are prepared. how these choices will positively impact the use of the md in the specific local context is a vision that the bcel can achieve with experience and guidance from peer-review processes and senior experts. preparing tender requirements is thus equivalent to designing an infrastructure where everything is to be forecasted in advance, giving the bcel freedom to express their imagination, creativity, and experience during the process. 27 j global clinical engineering vol.6 issue 2: 2024 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 3 8. who, user guide: who technical specification for medical devices. version 1.1. 2014. available at: https://cdn.who.int/media/docs/default-source/ medical-devices/technical-specifications/user-guide. pdf?sfvrsn=2c161505_5&download=true 9. united nations office for project services procurement group. sustainable procurement framework annex 1 to the procurement manual. unops. 2021, july 1. available at: https://content. unops.org/service-line-documents/procurement/ unops-procurement-manual-annex-1-2021_en.pdf 10. unicef. unicef implements sustainable procurement. unicef supply division; september 2018. available at: https://www.unicef.org/supply/sites/unicef.org. supply/files/2019-06/sustainable-procurementinformation-note.pdf 11. cheng m. a strategy to maintain essential medical equipment in developing countries. in: dyro j. the clinical engineering handbook. setauket, ny: the biomedical engineering series, elsevier academic press. chapter 38, pp. 108-113. 12. who. medical device donations: considerations for solicitation and provision. who medical device technical series. available at: https://iris.who.int/ bitstream/handle/10665/44568/9789241501408eng.pdf?sequence=1 13. di virgilio v, ambrois g. clinical engineering development in the uruguayan public health system. annu int conf ieee eng med biol soc. 2010. available at: thttps://pubmed.ncbi.nlm.nih.gov/21097119/. 14. medical device and diagnostic industry. expected medical device lifetime at a glance. available at: https://www.mddionline.com/regulatory-quality/ expected-medical-device-lifetime-glance 15. us food and drug administration. medical device reporting for manufacturers. november 2016. available at: https://www.fda.gov/files/medical%20 devices/published/medical-device-reporting-formanufacturers---guidance-for-industry-and-foodand-drug-administration-staff.pdf 16. unicef. unicef implements sustainable procurement. unicef supply division; september 2018. available at: https://www.unicef.org/supply/sites/unicef.org. supply/files/2019-06/sustainable-procurementinformation-note.pdf 17. adp health. path. value-based procurement of medical equipment. june 2020. available at: https://adphealth. org/upload/resource/vbp_guide_en_june2020.pdf 18. mol cr, thet. final report of the medical equipment (me) uptime project. march 2018. available at: https:// www.thet.org/wp-content/uploads/2018/05/180329final-report-me-uptime-project.pdf 19. world health organization. decommissioning medical devices. who medical device technical series. february 2019. available at: https://www.who.int/ publications/i/item/9789241517041 20. hinrichs-krapels s, ditewig b, boulding h, et al. purchasing high-cost medical devices and equipment in hospitals: a systematic review. bmj open 2022. available at: https://bmjopen.bmj.com/content/12/9/e057516 21. david y, jahnke eg. planning medical technology management in a hospital. global clinical engineering journal 2018;(1), 23–32. available at: https://doi. org/10.31354/globalce.v0i1.23 j global clinical engineering vol.7 issue 3: 2025 36 received january 3 2024, accepted june 9 2025, date of publication september 2 2025. original research article characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics joanie b. houinsou*, roland c. houessouvo, kokou m. assogba and daton medenou ecole doctorale des sciences de l’ingénieur (ed-sdi)/laboratoire letia/epac, université d’abomey calavi (uac), abomey calavi, 01 bp 2009 cotonou, bénin. * corresponding author email: jobhouinsou04@gmail.com abstract background and objective: this study investigates the characterization of body odor signatures for early disease detection, aiming to demonstrate the feasibility of using simulated olfactory profiles within a computational diagnostic framework. the motivation arises from the growing interest in non-invasive diagnostic alternatives based on volatile organic compounds (vocs) emitted by the human body. materials and methods: a simulation-based approach was implemented using validated voc datasets to construct binary odor profiles. these profiles were encoded as binary vectors, with each bit indicating the presence or absence of a specific compound. a simplified binary matching algorithm, excluding mutation and crossover operations, was employed to simulate pattern matching. the hamming distance was used as the fitness function to quantify the similarity between profiles. results and discussion: the results indicate that the simplified binary matching algorithm reliably identified pathological odor profiles, producing high similarity scores with reference signatures. despite the absence of conventional genetic operators, the method consistently converged to optimal or near-optimal matches. these findings emphasize the potential of binary odor encoding for distinguishing between healthy and pathological states, underscoring the robustness of the simplified computational framework. conclusion: this work presents a novel and interpretable computational model for olfactory-based disease detection using simulated binary voc patterns. it supports the development of low-cost, non-invasive diagnostic tools in medical contexts. future research should explore extending the method by incorporating continuous voc encoding, integrating evolutionary operators, and validating the results with semi-experimental or clinical data. keywords—body odors, diseases, early detection, computational diagnostics, simplified binary matching algorithm, volatile organic compounds (vocs). copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:jobhouinsou04@gmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 37 j global clinical engineering vol.7 issue 3 2025 houinsou, houessouvo, assogba, medenou: characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics introduction the improvement of early disease detection methods is of crucial importance for public health.1 traditional approaches to medical diagnosis may be limited by cost, accessibility, and reliability. in this context, research is increasingly focusing on innovative methods based on artificial intelligence to enhance disease detection and prevention.2 the genetic algorithm, an artificial intelligence technique inspired by the principles of natural evolution, holds promising potential in the field of early disease detection. by leveraging the adaptive and evolutionary capabilities of living organisms, this algorithm optimizes solutions for complex problems.3 in this context, this article examines the application of the genetic algorithm for early disease detection, with a specific focus on analyzing body odors composed of volatile organic compounds (vocs). recent research suggests that certain diseases can alter specific odor profiles of the human body,4 providing an opportunity to use olfactory information as an early indicator of health issues. the objective of this article is to present a methodology based on a simplified pattern-matching algorithm, inspired by the principles of genetic algorithms, for analyzing body odors and detecting diseases at an early stage. unlike conventional genetic algorithms that incorporate selection, crossover, and mutation operations, the method implemented here deliberately omits these evolutionary components. instead, it evaluates binary-encoded odor profiles using hamming distance to identify the closest match to a target profile. this simplification aims to enhance interpretability, reproducibility, and computational efficiency within a purely simulation-based framework. by integrating expertise in genetics, artificial intelligence, and medicine, this approach could contribute to revolutionizing medical diagnostic methods by enabling faster, more accurate, and less invasive disease detection. literature review body odors volatile organic compounds (vocs) are chemical substances released by the human body, playing a significant role in body odor.5,6 in ancient societies, body odors were more prevalent and accepted, regarded as part of individual and social identity. over time, attitudes toward body odor have evolved alongside scientific advances and social norms.7 in medieval europe, body odor was associated with notions of sin and decadence due to religious beliefs, and perfumes were commonly used to mask undesirable odors. in the modern era, hygiene and cleanliness became priorities, leading to the development of personal care products to control body odor. however, these products may alter natural odors by adding fragrances.8 recently, certain movements have advocated for the acceptance of natural body odor, and challenged social norms that aim to eliminate it. body odors vary among individuals due to various factors, and perceptions of body odor differ across cultures.9 early detection of diseases the early detection of diseases plays a crucial role in preserving health and well-being. it enables prompt intervention by identifying early signs and symptoms, leading to more favorable outcomes in terms of treatment, management, and even cure.10 numerous benefits are associated with the early detection of diseases.11 firstly, it allows for rapid medical intervention, helping prevent disease progression and reduce potential complications.12 secondly, it increases the likelihood of treatment success, as interventions are often more effective when administered at an early stage of the disease. additionally, it helps reduce long-term healthcare costs, as early treatments are typically less invasive and less expensive than those required at an advanced stage of the disease.13 to detect diseases early, various methods are employed. regular screenings and health examinations are essential for identifying early signs of common diseases such as breast, cervical, and colon cancers. technological advancements have led to the development of sophisticated blood tests and medical imaging techniques, which can aid in detecting diseases at an early stage, even in the absence of apparent symptoms.14 furthermore, genetics and personalized medicine have opened new possibilities by identifying genetic markers associated with certain conditions.15 http://framework.by http://framework.by houinsou, houessouvo, assogba, medenou: characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics j global clinical engineering vol.7 issue 3: 2025 38 early disease detection helps limit potential complications, improve patients’ quality of life, and reduce the burden on healthcare systems.12,16 genetic algorithm genetic algorithms (gas) were first described by john holland in the 1960s and later developed by him, his students, and colleagues at the university of michigan during the 1960s and 1970s. holland’s objective was to understand the phenomenon of adaptation as it occurs in nature and to develop methods for incorporating the mechanisms of natural adaptation into computer systems.17 the genetic algorithm (figure 1) is a computational approach inspired by the process of biological evolution. it is a search and optimization method based on the principles of natural selection and genetics. genetic algorithms are widely applied to solve complex problems in various fields, including engineering, optimization, artificial intelligence, and bioinformatics.18,19 the genetic algorithm operates by simulating an artificial evolution process, in which an initial population of individuals (often represented by bit strings) is randomly generated. each individual in the population is evaluated based on its performance relative to a specific goal defined by an evaluation function.20 the crucial step in the genetic algorithm is selection. the fittest individuals, i.e., those with the best performance, are chosen to reproduce and produce offspring. this selection is typically based on a method called “fitness-proportional selection”, in which the probability of selection is proportional to the fitness value of each individual.17,21,22 once selection is complete, genetic operations are applied to the offspring. these operations include recombination (crossover) and mutation. recombination involves combining the genetic information of two selected individuals to create new individuals, while mutation introduces random changes in individuals to explore new potential solutions.17,21,22 this process of selection, recombination, and mutation is repeated over several generations, allowing the population to gradually converge toward increasingly optimal solutions. the genetic algorithm may also incorporate techniques such as elitism, which involves retaining the best individuals from one generation to the next to ensure faster convergence.17,21,22 materials and methods materials we utilized the human metabolome database (hmdb) to obtain detailed information on small-molecule metabolites present in the human body. the objective was to apply this information for biomarker discovery applications.24,25 figure 1. general workflow of a canonical genetic algorithm.23 39 j global clinical engineering vol.7 issue 3 2025 houinsou, houessouvo, assogba, medenou: characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics additionally, we relied on the work of reference26, which cataloged over 1,800 volatile organic compounds emitted by the body of a healthy individual. we also consulted the cancer odor database (cod), an online resource documenting known volatile organic metabolites of cancer (vomc), commonly referred to as “cancer odors”.27 finally, broza et al. 28 highlights the increasing importance of developing new diagnostic and detection technologies to address growing clinical challenges. it emphasizes a new diagnostic frontier based on detecting disease-associated volatile organic compounds (vocs) using sensors that employ nanomaterials. population dataset construction to construct the initial population used in our simulations, we compiled a comprehensive dataset of 2,571 volatile organic compounds (vocs) from authoritative sources, including the human metabolome database (hmdb), the cancer odor database (cod), and peerreviewed literature, such as the catalog published by.26 each voc was annotated with a unique cas number and labeled according to its known association with physiological or pathological states, including various cancer types and healthy conditions. this dataset served as the basis for generating 25 distinct binary vectors, each representing a specific simulated odor signature associated with a defined condition. the encoding process involved mapping the presence (1) or absence (0) of each of the 2,571 vocs for every condition, resulting in uniform-length binary chromosomes. these chromosomes were stored and processed as the initial population from which the algorithm searched for the best match to a given target. the structured nature and dimensional richness of this population enabled meaningful comparison and pattern recognition through hamming distance evaluation. importantly, the dataset was constructed to balance diversity (in terms of represented conditions) and consistency (in binary structure), ensuring that the algorithm operated within a representative yet tractable search space. methods the method employed for disease detection is the simplified binary matching algorithm, which encompasses five phases. phase 1: individual representation each individual, denoted by equation 1, is symbolically characterized by a chromosome—a structured sequence of fixed-length binary digits that corresponds to the quantity of volatile organic compounds (vocs) defining the olfactory profile. the chromosome is mathematically expressed as: [ ]1 2, , ,i i i inchromosome v v v= … (1) within the confines of this representation (equation 1), each element vij (equation 2) is discretized into a binary bit, serving as an indicator of the presence or absence of a specific voc. this binary encoding is represented by the formula: 0, 1, ij if the voc is not present v if the voc is present  =   (2) where vi1, vi2,..., vin, represent the elements of the chromosome for sample i, vij denotes the presence (1) or absence (0) of the j—th voc, n is the total number of vocs considered, and i=1,2, ..., n indexes the sample. consequently, the collective exposition of equations (equation 1) and (equation 2) coherently explicates the chromosome's nature as a combination of binary units, delineating the presence or absence of vocs within the context of individual representation. vij is the binary variable indicating the state of the j—th voc in the i—th chromosome. phase 2: evaluation function an evaluation function assigns a value, or fitness score, to each chromosome based on its ability to solve the given problem. in this study, the hamming function serves as the objective function (equation 3), calculating the distance between the desired solution and the candidate solution within the population. houinsou, houessouvo, assogba, medenou: characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics j global clinical engineering vol.7 issue 3: 2025 40 ( ) 1 0 , ( ) i s n ij sj j f chromosome chromosome abs chromosome chromosome − = = − −∑ (3) where schromosome denotes the binary vector representing the i—th individual (candidate solution) in the population, chromosomes the target chromosome corresponding to the reference (disease) profile, and f (chromosomes, chromosomes) the fitness function measuring their similarity. the term abs(chromosomeij, chromosomesj)defines the absolute difference between the candidate and the target at the position j , while the summation counts 1 0 ( ) n ij sj j abs chromosome chromosome − = −∑ the total number of mismatches between the two binary vectors. in our implementation, the fitness score is defined as the negative hamming distance between the target profile and each candidate in the population. this transformation (multiplication by −1) enables the interpretation of higher scores—values closer to zero—as better matches, while preserving the relative ranking of similarity. a score of 0 represents a perfect match, whereas increasingly negative scores indicate greater dissimilarity. phase 3: population initialization we initialized the population with binary data imported from a specially prepared excel file, following the methodology described in previous studies.24–26,28 these data define the search space for disease identification, representing the presence or absence of volatile organic compounds (vocs) associated with specific conditions phase 4: main loop of the algorithm the main loop of the algorithm concluded when the predefined termination criterion was met, which in our case was a fixed number of iterations equal to the population size. phase 5: results analysis this phase involves examining the individuals to identify those that correspond to the best solution found and extracting relevant information from them to address our problem. figure 2 illustrates the workflow of a simplified pattern-matching algorithm that identifies the binary individual within a given population that best matches a predefined target profile. the procedure begins by initializing variables to store the best-known match, then iteratively evaluates the hamming distance between each candidate chromosome and the target. whenever a closer match is identified, the best candidate is updated. the algorithm concludes by returning the individual with the smallest distance to the target. this approach is deterministic, easily interpretable, and does not employ stochastic genetic operators such as crossover or mutation. this flowchart (figure 2) illustrates the sequence of steps in the proposed deterministic algorithm: 1. initialization of the binary-encoded population based on voc presence/absence; 2. comparison of each individual with a target profile using the hamming distance; figure 2. workflow of the simplified binary matching algorithm. 41 j global clinical engineering vol.7 issue 3 2025 houinsou, houessouvo, assogba, medenou: characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics 3. selection of the profile with the minimum distance as the optimal match. the algorithm bypasses traditional genetic operations—such as selection, mutation, and crossover—and relies exclusively on distance-based evaluation. figure 3 presents the pseudocode for a simplified computational procedure designed to identify the individual within a binary population that most closely matches a given target profile. the method iteratively computes the hamming distance between each chromosome and the target, updating the best match whenever a smaller distance is encountered. this approach enables efficient nearest-neighbor selection in discrete binary spaces while eliminating the need for evolutionary operators such as crossover or mutation. results and discussion results the simplified binary matching algorithm, applied to early disease detection through body odor analysis, produced the following results: presentation of data in binary form we obtained data encoded in binary form, as illustrated in figure 4, representing our search space. figure 3. pseudocode for a simplified matching algorithm based on hamming distance. figure 4. binary encoding of vocs related to body odor. houinsou, houessouvo, assogba, medenou: characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics j global clinical engineering vol.7 issue 3: 2025 42 figure 5. algorithm trace for a random healthy chromosome. figure 6. fitness scores generated by a random healthy chromosome. figure 7. algorithm trace for a random diseased chromosome. in our search space, this chromosome corresponds to an individual with neck cancer (figure 10). regardless of the target chromosome, the simplified binary matching algorithm converges toward an optimal solution with an associated score. a score of 0 (figure 1) indicates that the target chromosome is present in the solution space; otherwise, the algorithm identifies the chromosome in the space that is closer to the target than any other (figure 2). the chromosome in the best individual and fitness score the code outputs the best individual identified within the population of potential solutions—namely, the body odor sequence achieving the highest fitness score. this score, derived from the hamming distance between the individual and the target sequence, facilitates the identification of the most effective profiles for disease detection based on body odor. execution traces of the algorithm are presented in figures 5–12. processing by our simplified binary matching algorithm on a randomly generated chromosome classified it as healthy, with a fitness score of −1,257 (figure 5), indicating a high similarity to the healthy reference profile. the corresponding fitness scores for this case are shown in figure 6. processing by the same algorithm on another randomly generated chromosome classified it as diseased, with a fitness score of −1,241 (figure 7), indicating slightly lower similarity to the healthy reference profile. the corresponding fitness scores are presented in figure 8. within our search space, this chromosome is associated with breast cancer. a diseased chromosome from the search space was processed using our simplified binary matching algorithm, which identified it with a fitness score of 0 (figure 9). 43 j global clinical engineering vol.7 issue 3 2025 houinsou, houessouvo, assogba, medenou: characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics figure 8. fitness scores generated by a random diseased chromosome. figure 9. algorithm trace for a selected diseased chromosome in the search space. figure 10. fitness scores generated by a selected diseased chromosome with neck cancer in the search space. space that is closer to the target than any other (figure 2).regardless of the target chromosome, the simplified binary matching algorithm converges toward an optimal solution with an associated score. a score of 0 (figure 1) indicates that the target chromosome is present in the solution space; otherwise, the algorithm identifies the chromosome in the space that is closer to the target than any other (figure 2). index of the nearest data point the code identifies the index of the nearest data point in the fitness score sequence. this index is then used to associate the corresponding data with additional information for results analysis. in our case, it links to detailed information about the volatile organic compounds associated with either a diseased or a healthy individual, as determined by their unique cas identification number. fitness scores the code outputs the list of fitness scores for each individual in the population at every generation. this enables visualization of score evolution over time and facilitates tracking of the algorithm’s progress in identifying the best individual. as the search space becomes more enriched, these scores are expected to improve. houinsou, houessouvo, assogba, medenou: characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics j global clinical engineering vol.7 issue 3: 2025 44 nearest line the code retrieves information associated with the nearest data point from the excel file used to generate the initial population. this allows for examining the specific details of that data and analyzing them in relation to the results of the simplified binary matching algorithm. algorithm convergence regardless of the target chromosome, the algorithm converges towards an optimal solution. discussion by deliberately omitting evolutionary components such as selection, crossover, mutation, and replacement, the algorithmic procedure in this study deviates from conventional genetic algorithms, adopting instead a deterministic, pattern-matching framework. the resulting model functions solely through the initialization and evaluation of a predefined population of binary voc profiles. each individual in the population represents a potential solution encoded as a fixed-length binary vector, with evaluation performed using the hamming distance as the fitness metric. this simplified configuration enhances interpretability and reproducibility by avoiding the stochastic variability and convergence dynamics inherent in evolutionary systems. although this design sacrifices the exploratory capabilities of classical genetic algorithms, it is well-suited for simulation scenarios in which the search space is predefined and fully enumerable. to ensure that the dataset retained discriminatory power despite the absence of evolutionary mechanisms, we conducted a distributional analysis using the hamming distance metric. this analysis assessed profile diversity and spatial separability within the binary encoding space. the results confirmed that the initial population preserved sufficient structural variability to support meaningful pattern recognition. conclusion in conclusion, the simplified binary matching algorithm demonstrates significant potential for early disease detection based on body odors within medical diagnostics. analysis of volatile organic compounds present in body odor offers valuable insights into an individual’s health status. the study’s results indicate a strong correlation between body odor profiles, volatile organic compounds, and disease presence, thereby opening new avenues for non-invasive and cost-effective diagnostic methods. however, further studies and the establishment of standardized protocols are essential to validate this approach and ensure its clinical reliability. while the results figure 11. convergence to zero of the algorithm for a target chromosome present in the search space. figure 12. convergence to a finite score of the algorithm for a target chromosome absent in the search space. 45 j global clinical engineering vol.7 issue 3 2025 houinsou, houessouvo, assogba, medenou: characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics demonstrate the feasibility of body odor analysis for early detection of various diseases, additional research is necessary to improve the specificity and sensitivity of the method. integrating the simplified binary matching algorithm into body odor analysis offers the potential to optimize early disease detection, enabling faster and more effective medical intervention. additionally, this non-invasive approach may enhance patient acceptance and participation. although inspired by the genetic algorithm paradigm, the implemented model diverges from traditional evolutionary computation by adopting a deterministic, non-stochastic structure. for clarity, the term “simplified binary matching algorithm” is used to reflect both its origins and methodological constraints. overall, the use of the simplified binary matching algorithm for early disease detection based on body odors presents promising new prospects in the medical field. this approach has the potential to improve treatment success rates by enabling early and accurate disease diagnosis. author contributions conceptualization, j.h. and k.a.; methodology, j.h.; software, j.h.; hardware, j.h. and r.h.; validation, j.h., r.h., and d.m.; formal analysis, j.h.; investigation, j.h.; resources, j.h.; data curation, j.h.; writing–original draft preparation, j.h.; writing–review & editing, r.h. and d.m.; visualization, j.h.; supervision, k.a.; project administration, k.a.; funding acquisition, d.m. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare they have no competing interest. ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure not applicable. references 1. srivastava, s. and gopal-srivastava, r. biomarkers in cancer screening: a public health perspective. j nutr. 2002;132(8 suppl):2471s–2475s. https://doi.org/10.1093/ jn/132.8.2471s. 2. maselli, g., bertamino, e., capalbo, c., et al. hierarchical convolutional models for automatic pneumonia diagnosis based on x-ray images: new strategies in public health. ann ig med prev e comunità. 2021;(6):644–655. https://doi. org/10.7416/ai.2021.2467. 3. gen, m. and cheng, r.w. genetic algorithms and engineering optimization. john wiley & sons: hoboken, 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https://doi.org/10.1093/database/bax055 https://doi.org/10.2217/nnm.13.64 https://doi.org/10.2217/nnm.13.64 39 j global clinical engineering vol.3 issue 2: 2020j global clinical engineering vol.3 issue 2: 2020 38 received september 12, 2020, replied october 24, 2020, date of publication october 27, 2020 commentary/letter to the editor of the global ce journal by b. m. gamble1, francoise mailhot2, r. rivas3, s. rabbani4, m. secca5, m. cheng6 1 alumni of toronto university, and longtime follower of the theories of chris argyris and w. edwards deming. several time presenter at the deming institute annual conference, canada 2 international development. specialist in national and international program evaluations, canada. 3 clinical engineering head, biomedical engineering undergraduate program, universidad peruana cayetano heredia, peru. 4 department of biomedical physics and technology, university of dhaka, bangladesh 5 mozambique 6 ottawa creative thinking group, canada. dear editor, it is clear that potential covid pandemics will be recurring events and the use of ppe is basic and vital. everyone will need such simple devices to protect themselves and others. the consequence of no ppe protection could be disastrous for global health! stockpiling ppe is not for everyone. healthcare facilities in low-resources countries have limited ppe supplies. furthermore, transportation and distribution across the country can be problematic in rural areas. home-made ppe is the most practical solution but this needs effective global efforts to educate and guide global populations. in the past 3 months, the ifmbe/ced, in collaboration with who and other professionals, has conducted an excellent series of webinars to inform the world about medical devices in combating the covid-19 pandemic bringing invaluable information for global healthcare. we wonder if ifmbe/ced would pioneer another important initiative with who to advocate and co-ordinate the resources from different organizations and individual professionals to create a manual on home-made ppes and basic knowledge on cleaning and sterilization so that laypersons can make ppe to protect themselves and others. a highly successful public health education publication where there is no doctors1 is an example. preventing sars and other related diseases are a global problem that currently relies mainly on isolated and scattered national solutions. it is urgent that international organizations such as ifmbe and who provide trusted advice to countries worldwide to create a global protection-sensitive culture against pandemics. reference 1. burma/myanmar library. where there is no doctor. author: 2011. available at: https://www.burmalibrary.org/ docs12/where_there_is_no_doctor-2011(en)-red.pdf this letter is dedicated to brian gamble, deceased on july 31st at the age of 88. brian was a most well informed and open-minded internationalist i have known. michael cheng editor’s answer: dear dr. cheng, thank you for deciding to address your concerns and the proposed initiative to the global clinical engineering journal. although it does not comply the typical material that we have published, after reviewing your letter to the editor carefully, we have decided to publish it due to its international scope and the offering of potential involvement for clinical engineers from around the world. while you are making specific conclusions (i.e., pandemic will be recurring events, ppe in limited supply, the success of public health education via a book) no support has been offered to substantiate these. nevertheless, we would like to encourage you to further explore the optimal route to assemble expert authors and to write your proposed manual. we see value in such collaboration especially if it will be sensitive to local availability of resources and in a format that accommodates worldwide access such as through internet tools. we encourage you to pursue this idea. respectfully, dr. yadin david copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 29 j global clinical engineering vol.5 issue 1: 2022 first published in national academy of engineering perspectives, may 27, 2022, date of re-publication in globalce journal, june 1, 2022 copyright and credit belong to national academy of sciences (all rights reserved). the growing role of clinical engineering: merging technology at the point of care by thomas judd1 and yadin david2 1 international federation for medical and biological engineering’s clinical engineering division, usa 2 biomedical engineering consultants llc, usa keywords – healthcare, technology, clinical engineering, patient care, health systems, global collaboration, nursing, policy copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. fiza shaukat is a native of pakistan living in the united states. as a biomedical engineer, she was eager to improve her country’s medical devices and digital health strategies. she approached us in 2018 seeking expertise in clinical engineering, which focuses on the point-of-care intersection between the use of health technology and the expertise needed for optimal support and resource management. pakistan, like many countries, has faced myriad systemic challenges, which were amplified by the covid-19 pandemic; these challenges include a fragmented delivery system and a lack of interoperability between medical devices, electronic health records, and other recent health technologies. we worked with fiza on a health technology asset management method. later, during the pandemic, we pointed her and her in-country colleague http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.5 issue 1: 2022 30 judd, david : the growing role of clinical engineering: merging technology at the point of care tazeen bukhari to the covid-19 inventory tool, offered by the world health organization (who), to assess national gaps in the availability of medical devices and oxygen; the information was used to inform the pakistani ministry of health’s plan for confronting the pandemic. meanwhile, fiza faced the premature loss of her grandmother due to cardiac complications—she had not received care in a timely manner because patient data and test results could not be shared quickly between providers. fiza took initiative so that her loss would not be repeated for other families. she brought a technical solution to the point of care, using clinical engineering and emerging health information technologies.1 as clinical engineers (ces), we have encountered variations of fiza’s story in several countries. clinical engineers support and advance patient care outcomes by applying engineering, life sciences, and managerial skills to optimize healthcare technology during its life cycle deployments. they are sought for their systems thinking expertise, to conduct an independent validation of healthcare products, identify support requirements, and ensure that medical device users’ needs are met and that products are accessible and ready for patients. they assess and manage the use of health technologies, which who defines as “the application of organized knowledge and skills in the form of (medical) devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of care and/or life,” including both traditional medical devices and emerging digital health tools.2 to illustrate the range of ce contributions, we offer two examples.3 the first is in device innovation. in remote desert-like regions of western and south australia treatment for trauma victims requires long-distance and space-limited transportation. the patients are often in shock and require a blood/fluid transfusion. but these fluids are kept at a very low temperature, and rapid infusion of cold fluids can worsen a patient’s condition or even induce hypothermia. two clinical engineers developed a fluid/blood warmer that does not require electrical power but uses the latent heat principle to warm intravenous fluids at accident sites, overcoming the lack of suitable portable fluid warmers that are not dependent on main electrical or battery power. the second example involves risk reduction and safety of medical devices at the point of care. a clinical engineer and his team in mexico’s national center of health technology excellence investigated national management of medical equipment in public hospitals. they concluded that, among the country’s 32 states, health technology management was effectively coordinated by trained ce practitioners.4 clinical engineers are trained to identify challenges and opportunities to improve healthcare delivery through the adoption of effective and safe technological solutions. for example, “alarm fatigue” can be eliminated in icus with smart medical device alarms that triage the urgency of attention needed, distinguishing life-threatening events from those less urgent. and remote care for patients isolated due to infection concerns can reduce the time and cumbersome logistics involved for care providers to monitor and tend to their patients. clinical engineers recognize the need for both systems expertise in healthcare partnerships and the development and implementation of national policies to reduce fragmentation and inefficiencies in healthcare delivery.5 the case for such expertise and partnerships has been made in classic consensus reports of the national academy of medicine—to err is human: building a safer health system (2000), crossing the quality chasm: a new health system for the 21st century (2001)—and in a joint publication with the nae, building a better delivery system: a new engineering/health care partnership (2005). the latter report notably described “opportunities and challenges to using systems engineering, information technologies, and other tools to advance a twenty-first century system capable of delivering safe, effective, timely, patient-centered, efficient, equitable health care” (p. vii). we are encouraged to see recent evidence of engineering partnership improving healthcare delivery, in the may 2021 nae perspective, ers rise to the covid-19 challenge: teamwork between engineers and healthcare providers cuts er waiting time, and in a johns hopkins university january 2020 article, enter the surgineer. but the vision, alas, is yet to be fully realized. since 2020 the us healthcare delivery sector has lost over 300,000 workers,6 exacerbating a staffing shortage https://pubmed.ncbi.nlm.nih.gov/25077248/ https://pubmed.ncbi.nlm.nih.gov/25057539/ https://pubmed.ncbi.nlm.nih.gov/25057539/ http://nap.edu/11378 http://nap.edu/11378 https://www.bme.jhu.edu/news-events/news/enter-the-surgineer/#:~:text=%e2%80%9cit%20is%20to%20'bury%20the,member%20of%20the%20clinical%20workforce. 31 j global clinical engineering vol.5 issue 1: 2022 judd, david : the growing role of clinical engineering: merging technology at the point of care that existed before the pandemic. nurses are among the most impacted group.7 a new approach that includes shared interprofessional training can help alleviate the situation by training clinical engineers for engagement at the point of care. we envision broader systems responsibilities for all care delivery team members, to overcome the segmented and increasingly specialized healthcare workforce and thus ensure higher quality and safety through a new collaborative approach. the intersection of technology and healthcare delivery clinical engineers have the expertise to facilitate a systems approach to health, where technological tools are needed to measure health system inputs and outputs. tools for monitoring and reporting clinical parameters and laboratory results enhance the identification of early trends in large populations and can support better health and wellness. the use of health technologies must be strategically guided, with coordination of local, national, and international resources, optimal resource management, policies that guide technology-related outcomes,8 and plans for life cycle stages. to that end, a healthcare model is needed that integrates the delivery of care to improve both care outcomes and patient experience.9 such integration requires adequate knowledge of the technology life cycle, from innovation to application; academic programs that keep up with changes to point-of-care technologies; and participation in technological innovations such as robotics, artificial intelligence, and implantables. clinical engineers have a foundational role in this integration, with their unique knowledge related to the management of health technology systems and validation at the point of care. in coordination with clinicians and other stakeholders, ces are demonstrating the benefits of their inclusion as equal members of the healthcare delivery team, particularly during the global pandemic, at both the point of care and population health levels.10 global need as the sales of global medical products are predicted to reach $658 billion by 2028,11 it is clear that, for optimal return on investment and sustainability, the implementation of such products should be managed and supported by trained professionals such as clinical engineers. during the first 2 years of the covid-19 pandemic, who’s world health assembly focused on the need for intensive care ventilators (2020) and medical oxygen (2021).12 who has specifically recognized clinical engineers for optimally managing assets such as medical devices, personal protective equipment, oxygen, and digital health tools, particularly in low-resource settings.13 two ce organizations, the international federation of medical and biological engineering chemical engineering division (ifmbe ced) and the global clinical engineering alliance (gcea), grew tremendously during the pandemic with a surge in the need for their members’ expertise. in partnership with who, these organizations are now connected to colleagues in nearly 200 countries, sharing best practices and solutions to complex challenges. the next step is to build the right systems capabilities for improving global healthcare delivery. a call for action for clinical engineering to transition from localized point of care to population health, certain systems competencies must be in place: 1. education of the workforce to create greater collaboration and resiliency. collaborative interdisciplinary educational training14 will ensure the systems skills needed to maximize the benefits of health technologies. with demonstrated competencies and internationally coordinated professional credentialing, ces will be prepared to be equal partners with the other members of a healthcare team, participating in new clinical roles and workflows to free physicians and nurses for direct patient care. 2. national health technology policy to address priority national challenges. pandemic-related impacts necessitated rapid implementation of national health technology policy in many countries.15 this and experiences with other disasters (e.g., floods, wildfires, earthquakes, power outages) clearly show the need for international coordination of new national guidelines to sustain access to, availability of, and the transfer of https://ced.ifmbe.org/ https://www.globalcea.org/home?hslang=en j global clinical engineering vol.5 issue 1: 2022 32 judd, david : the growing role of clinical engineering: merging technology at the point of care critical healthcare technology tools. clinical engineers can play an important role in informing and implementing such policy. 3. national and international alliances and partnerships to share expertise and lessons learned. such alliances will coordinate meetings of healthcare stakeholders (e.g., clinicians, administrators, and ministry of health personnel with clinical engineers) to examine areas of concern where ces can make a difference. for example, the global clinical engineering alliance has offered webinars, a virtual international congress, and a global ce summit to identify and rank common global challenges. such alliances can help those in the health sector, industry, academia, and ngos drive cost-effective and high-quality innovations in healthcare delivery, and manage the performance of the technology used at both point of care and in regional and global populations. as healthcare delivery systems around the world increasingly depend on technology for access to the best care, the expertise of clinical engineers in the use and management of this technology is critical for achieving best outcomes. for both point-of-care and population health, a systems approach can improve the delivery of health services through education, workforce collaboration, policy development, and partnerships. clinical engineers are indispensable partners in achieving this mission. just as fiza was driven to overcome challenges, the approach described here shows a pathway to achieve the outcomes we all need. references 1. see “women shaping the health tech world 2021” (https://www.youtube.com/watch?v=dhv5hnqnei4). 2. who compendium of innovative health technologies for low-resource settings 2021: covid-19 and other health priorities. geneva. p. vii. 3. for further evidence of the scope of ce contributions, see clinical engineering success stories and patient outcomes based on evidence from 125 countries (chapter 3, clinical engineering handbook, 2nd ed., 2020, academic press). 4. ayala r, orencio e. 2019. identification of health technology management departments in mexico’s state health services. global clinical engineering journal 1(2):17–21. in their article ces are referred to as biomedical engineers. 5. many ce success stories are reported in our 2020 article, “evidence-based impact by clinical engineers on global patients’ outcomes” (health & technology 10(2):517–35). 6. us bureau of labor statistics. 2022. the employment situation – april 2022. 7. kreimer s. 2022. nursing shortage looms large and projected to intensify in next 18 months: report. fierce healthcare, apr 5. 8. for an introductory resource on development of appropriate health technology–related policies and legislation, see ifmbe ced 2020 webinar on healthcare policy. 9. such impacts are demonstrated in the projects recognized by the healthcare information and management systems society (himss) davies awards. 10. see the presentation by claudio meirovich on “covid case studies” (track f3) at the ifmbe ced-gcea october 2021 global virtual congress. 11. fortune business insights. 2021. medical devices market…2021-2028. 12. who priority medical devices list for the covid-19 response and associated technical specifications 13. who. 2017. human resources for medical devices. geneva. see pp. 24 (table 1) and 40. 14. institute of medicine. 2015. measuring the impact of interprofessional education on collaborative practice and patient outcomes. washington: national academies press. 15. sharma j, bunders j. 2020. a model for priority setting in health technology innovation policy. global clinical engineering journal 2(3):24–34. http://www.globalcea.org/ https://ced.ifmbe.org/covid19/gurupcategs/16-covid19/view.htmlhyperlink%20%22https:/www.globalcea.org/webinars%22 https://www.globalcea.org/icehtmc https://www.youtube.com/watch?v=dhv5hnqnei4 https://www.who.int/publications/i/item/9789240032507 https://www.who.int/publications/i/item/9789240032507 https://www.who.int/publications/i/item/9789240032507 https://www.sciencedirect.com/science/article/pii/b9780128134672000031 https://www.sciencedirect.com/science/article/pii/b9780128134672000031 https://www.globalce.org/index.php/globalce/article/view/51/22 https://www.globalce.org/index.php/globalce/article/view/51/22 https://www.globalce.org/index.php/globalce/article/view/51/22 https://www.bls.gov/news.release/pdf/empsit.pdf https://www.bls.gov/news.release/pdf/empsit.pdf https://www.fiercehealthcare.com/providers/nursing-shortage-looms-large-and-projected-intensify-next-year-and-half-report https://www.fiercehealthcare.com/providers/nursing-shortage-looms-large-and-projected-intensify-next-year-and-half-report https://ced.ifmbe.org/ce-leadership-competencies-webinars/guruprograms/14-ce-leadership-competencies-webinars/51-policy-legislation.html https://ced.ifmbe.org/ce-leadership-competencies-webinars/guruprograms/14-ce-leadership-competencies-webinars/51-policy-legislation.html https://www.himss.org/resources-all?f%5b0%5d=resource_center_resources%3a29766 https://www.globalcea.org/icehtmc2021-materials-2?hslang=en https://www.globalcea.org/icehtmc2021-materials-2?hslang=en https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085 https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085 https://www.who.int/publications/i/item/who-2019-ncov-meddev-ts-o2t.v2 https://www.who.int/publications/i/item/who-2019-ncov-meddev-ts-o2t.v2 https://www.who.int/publications/i/item/9789241565479 https://doi.org/10.17226/21726 https://doi.org/10.17226/21726 https://doi.org/10.17226/21726 57 j global clinical engineering vol.6 special issue 6: 2024 conference paper human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2 and panagiotis d. bamidis1 1 lab of medical physics & digital innovation, school of medicine, faculty of health sciences, aristotle university of thessaloniki (auth), thessaloniki, greece. 2 laboratory of fluid mechanics and turbomachinery, department of mechanical engineering, aristotle university of thessaloniki (auth), thessaloniki, greece. * corresponding author email: georgios.lyssas@gmail.com abstract this research aims to create a tool that can recognize the state of the human skeletal muscle from surface electromyography (semg) signals. the goal of this muscle state machine is for use in the functional rehabilitation of people suffering from spinal cord injury and for stroke survivors who have lost mobility in their upper body limbs. the use of machine learning techniques for the classification of these muscle states brought forth the need for database creation to train the generated ml model. for the data collection process, an experimental protocol was proposed, and tests were conducted in healthy individuals with a nexus mkii medical device. following the data collection, a signal analysis procedure was performed to extract features from the semg signals that directly relate to the muscle state. in addition to the signal analysis, a machine learning classification model was created to recognize and classify the semg signals in different states of the muscle. this classification had a high enough accuracy of producing the correct result, given that the training and sampling size of the database was considerably small provided that in similar cases of ml classifying models the size of the databases includes way more samples than the one in this research. the future steps for this research are the creation of a more extensive and diverse database and using this model in real-time situations. keywords—electromyography, machine learning, signal classification. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:georgios.lyssas@gmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.6 special issue 6: 2024 58 introduction people who suffer from spinal cord injury or are stroke survivors experience a loss in their mobility as an aftereffect of their condition.1 to combat these aftereffects, functional rehabilitation is used. in cases of movement loss, the activation of the muscles is not visible in most cases, this is a problem that is impacting rehabilitation practitioners and a solution needs to be proposed. in this research, a solution to this problem was explored with the creation of a machine learning model that is trained to recognize and categorize the electromyography signals that are produced from the activation of the skeletal muscles. this model simulates a state machine of the human skeletal muscle and the states recognized were the state of no activation, the activation state, and the muscle fatigue state. these states were selected due to their high importance in the procedure of patient rehabilitation. to train the model for recognizing the muscle states an extensive database of electromyography signals must be produced.2 materials and methods in this research there were no open-source databases that were relevant to the recognition of the muscle states, therefore the creation of such a database was imminent. for the creation of a database, a measurement protocol was made and introduced in this research with the scope of measuring the states of the human skeletal muscle. this protocol targeted the muscles of the upper extremities specifically the bicep and triceps muscles of both arms as it is illustrated in figures 1 and 2. the exercises introduced were a set of 10 isometric contractions of the muscle without any external weight for measuring the baseline activation of the muscle, a continuous maximum contraction of the muscle that was held for 10 seconds so that the maximum contraction signal could be measured and lastly, a set of isometric contractions with an external weight of 5 kg until the subject was unable to continue, which was the start of muscle fatigue. in the last set of exercises, the goal was to have an electromyography signal that included all the muscle states and the transition between those states. those exercises were performed for both the bicep and tricep muscles of both arms of the subjects. the number of subjects that participated in this procedure was 20. 13 of which were male and 7 were female with a mean age of 27, and the subjects that were a part of this research were selected. the measurements were recorded by a nexus mkii medical device, and the files of the measurements were later extracted for a signal processing sequence that created the final database for training the machine learning model.3 after the extraction of the files of the measurements the procedure followed is shown in figure 3, the timeline of the signal is in the form of a raw-emg signal, this form includes noise from the recording and measuring process and it is imminent to denoise the signal, for the features and the information of the signal to be clear and readable, the creation of the envelope of the signal was the result of figure 1. measurement protocol. figure 2. example of measurement. http://www.globalce.org http://globalce.org http://globalce.org 59 j global clinical engineering vol.6 special issue 6: 2024 the denoising procedure. having completed the denoising procedure the signal was later separated into parts that contained an event in the timeline of the signal; those parts are referred to as epochs and are the data points of the database that was created. from the epochs created features of high importance to the classification of muscle states were extracted, those features were based on the time and frequency domain and parameters of the signal shape. those parameters were the mean and median frequency, the mean amplitude, the hjorth parameters (activity, mobility, complexity), the skewness and kurtosis of the signal, and also the continuous wavelet transform of the epochs.4–6 the features underwent a power analysis the results of which can be seen in figure 4. all those features were later introduced to the machine learning model for the creation of the classifier (figure 4). after the creation of the database three machine learning techniques were implemented and compared. the techniques used were a random forest classifier7 model (a representation of a tree can be seen in figure 5), an svm model, and a shallow neural network, which were created with python programming language and with the use of the scikit learn and tensorflow keras libraries. those models were trained with the created database and their speed and reliability in their results were measured so that the optimal between the three models could be chosen as the muscle state machine.8 results and discussion for the comparison between the efficiency and reliability of the machine learning models the use of metrics is the discerning factor between those models. the metrics that were used can be seen in figure 6 where it is apparent that the random forest classifier model achieved the highest score among the other models. discussion in conclusion, the reliability and the adaptability of the random forest model is the best choice for the recognition and classification of emg signals to muscle states, in this application with a small sample size. although these results show that the random forest model is the best choice among the other models the effective database for the training of these models was quite limited and the accuracy with which those models recognize the muscle states is certainly influenced. this leads to the need for the creation of a completed and reliable electromyography signals database to further encourage the use of ml in biomedical applications. figure 3. signal analysis procedure. figure 4. signal features power analysis. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 60 acknowledgments this study was conducted as a part of the research program “neurosuitup: neurorehabilitation through synergistic man-machine interfaces promoting dormant neuroplasticity in spinal cord injury” (mis 5047840) and will be implemented and clinically validated in the context of the project “heroes: human extremity robotic rehabilitation and outcome enhancement for stroke funded by h.f.r.i.” special thanks to dr. alkinoos athanasiou, alexander astaras, athanasios arvanitidis, niki pandria, and vasileia petronikolou. references 1. athanasiou, a., mitsopoulos, k., praftsiotis, a., et al. neurorehabilitation through synergistic man machine interfaces promoting dormant neuroplasticity in spinal cord injury: protocol for a nonrandomized controlled trial. jmir res protoc. 2022;11(9):e41152. https://doi.org/10.2196/41152. 2. let, a.m., filip, v., let, d., et al. a review in biomechanics modeling. in proceedings of the international conference of mechatronics and cyber—mixmechatronics—2020. gheorghe g.i., eds. springer international publishing: figure 5. visualization example of a random forest tree. figure 6. result of comparison with metrics (closer to 100% is better). http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.2196/41152 61 j global clinical engineering vol.6 special issue 6: 2024 zurich, switzerland; 10–11 september 2020; pp.156–164. https://doi.org/10.1007/978-3-030-53973-3_17. 3. briouza, s., gritli, h., khraief, n., et al. classification of semg biomedical signals for upper-limb rehabilitation using the random forest method. in 2022 5th international conference on advanced systems and emergent technologies (ic_aset). ieee xplore: 22–25 march 2022; pp. 161–166. https://doi.org/10.1109/ ic_aset53395.2022.9765871. 4. cifrek, m., medved, v., tonković, s., et al. surface emg based muscle fatigue evaluation in biomechanics. clin biomech. 2009;24(4):327–340. https://doi. org/10.1016/j.clinbiomech.2009.01.010. 5. karthick, p.a. and ramakrishnan, s. analysis of fatigue conditions in biceps brachii muscles using surface electromyography signals and strip spectral correlation. in 2014 19th international conference on digital signal processing. ieee xplore: 20–23 august 2014; pp. 190–194. https://doi.org/10.1109/ icdsp.2014.6900826. 6. rangayyan, r.m. biomedical signal analysis. 2nd ed. wiley-ieee press: hoboken, nj, usa; 2015. 7. gokgoz, e. and subasi, a. comparison of decision tree algorithms for emg signal classification using dwt. biomed signal process control. 2015;18:138–144. https://doi.org/10.1016/j.bspc.2014.12.005. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.1007/978-3-030-53973-3_17 https://doi.org/10.1109/ic_aset53395.2022.9765871 https://doi.org/10.1109/ic_aset53395.2022.9765871 https://doi.org/10.1016/j.clinbiomech.2009.01.010 https://doi.org/10.1016/j.clinbiomech.2009.01.010 https://doi.org/10.1109/icdsp.2014.6900826 https://doi.org/10.1109/icdsp.2014.6900826 https://doi.org/10.1016/j.bspc.2014.12.005 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 5 j global clinical engineering vol.7 issue 1: 2025 received november 7, 2024, accepted january 6, 2025, date of publication january 15, 2025. review balancing innovation and safety in digital healthcare shalini sharma1, maninder singh2,* and keerti bhusan pradhan1 1 chitkara business school, chitkara university punjab, chandigarh-patiala national highway, punjab-140401, india. 2 t a pai management institute, manipal academy of higher education, manipal-576104, india. * corresponding author email: maninder.singh@manipal.edu abstract in an era of rapid digital transformation, patient safety is increasingly intertwined with technological advancements in healthcare. this article explores the dual nature of these innovations, where tools like telemedicine, artificial intelligence (ai), and electronic health records (ehrs) offer significant potential to enhance care delivery and introduce new risks such as algorithmic bias, cybersecurity threats, and challenges in minimizing patient risks. a balanced approach focusing on robust safety protocols and continuous learning is required to ensure technology enhancement without undermining patient safety. the paper aims to advance the discourse on integrating technology with patient-centric care, proposing future research and policy development strategies to sustain a high safety standard in an increasingly digital healthcare environment. keywords—digital health, artificial intelligence, telemedicine, cybersecurity, healthcare innovation, patient safety. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. sharma, singh, pradhan: balancing innovation and safety in digital healthcare j global clinical engineering vol.7 issue 1: 2025 6 introduction integrating digital technologies into healthcare supports enhancing patient outcomes, streamlining workflows, and making healthcare more accessible. digital tools such as electronic health records (ehrs), telemedicine, and artificial intelligence (ai) offer unprecedented opportunities to enhance patient care.1,2 while these innovations have the potential to revolutionize patient care, they also pose significant risks if their implementation outpaces patient safety protocols.3,4 this intersection of technological innovation and patient safety has emerged as a critical area of focus. as the healthcare sector embraces digitalization and health systems become increasingly complex, these advancements hold the potential for both groundbreaking improvements and unintended risks. the challenge lies in ensuring that these technologies are implemented in ways that prevent inadvertent harm to patients.4 digitized healthcare systems must prioritize identifying and mitigating risks associated with new technologies.2 the adoption of digital tools like ai and telemedicine should be viewed through a lens of sustainability, where the focus should be on developing resilient healthcare systems that can adapt to and mitigate emerging risks.1 a proactive stance in technology integration could ensure patient safety is not compromised in pursuing technological progress.4 the challenges associated with new technological advancement in the healthcare sector are even more complex compared to other sectors. the nature of healthcare demands is different in different geographical regions. further, there are disparities in how technology is implemented and accessed across different regions, particularly in lowand middle-income countries. these areas often face significant challenges in adopting advanced technologies due to resource limitations, which can exacerbate existing inequalities in patient safety outcomes.5 therefore, the benefits of digital tools that can enhance care delivery, are not universally experienced. technological advancements must ensure equitable distribution and safe implementation across diverse healthcare settings and geographies.6 to address these disparities effectively, it is essential to integrate policy and organizational culture into the safe adoption of technology within healthcare systems. policies must be adaptable and forward-thinking, balancing the promotion of technological advancements with the imperative to safeguard patient safety.7 equally important is fostering an organizational culture that prioritizes safety, encourages transparency, and supports continuous learning. such a culture not only mitigates risks associated with new technologies but also empowers healthcare professionals to engage in proactive safety practices, thereby enhancing the overall resilience of the healthcare system.8 a balanced approach that prioritizes both innovation and safety is essential to harness the full potential of digital health. this requires a comprehensive understanding of how technologies influence various aspects of healthcare, along with a commitment to continuous learning and adaptation. ensuring safety protocols keep pace with technological advancements is critical to mitigating risks and maximizing benefits.2,4 by fostering a culture of safety, we can navigate the complexities of digital health and towards the future of robust healthcare systems. this paper aims to contribute to the ongoing discourse by offering insights that will help shape the future of patient safety in the digital age.1,9 the paper explores the dualities, emphasizing the need for a balanced approach that maximizes the benefits of technology while safeguarding the fundamental principles of patient safety.10 methods this study utilized a systematic literature review methodology to identify, evaluate, and synthesize peerreviewed articles relevant to the intersection of patient safety and healthcare technologies, ai, telemedicine, and cybersecurity. the selection process was guided by the expertise of two highly qualified reviewers. one reviewer from the field of patient safety has extensive experience in identifying key issues in this field. the second reviewer specializes in quality control, focusing on integrating safety principles into healthcare systems. this dual expertise ensured a high evaluation standard, significantly enhancing the quality and reliability 7 j global clinical engineering vol.7 issue 1: 2025 sharma, singh, pradhan: balancing innovation and safety in digital healthcare of the selected studies for this review. the review process began with a comprehensive search across four major academic databases: scopus, web of science, pubmed, and google scholar, spanning publications from january 2014 to october 2024. a carefully curated search strategy was employed, utilizing thematic keywords designed to capture diverse terminologies and contexts associated with the study’s themes. terms such as “artificial intelligence”, “machine learning”, “telemedicine”, “digital health”, “healthcare cybersecurity”, “health disparities”, and “patient safety” were included. synonyms and alternative terms were explicitly incorporated to account for variability in terminology, such as “telehealth” alongside “telemedicine” and “electronic medical records (emr)” alongside “electronic health records (ehr)”. boolean operators (e.g., and, or) and phrase searching were used to refine the search, while database-specific subject headings (e.g., mesh terms in pubmed) further enhanced precision. this approach resulted in the retrieval of 234 articles, which were subsequently imported into reference management software for de-duplication. after removing 28 duplicate records, 206 unique articles remained for title and abstract screening. reviewers independently evaluated the articles based on predefined inclusion and exclusion criteria during this phase. articles were included if they were empirical, peer-reviewed studies addressing healthcare technology, ai, telemedicine, or cybersecurity, published in english, and indexed in scopus, web of science, or pubmed. articles not meeting these criteria such as theoretical papers, non-peer-reviewed studies, or those unrelated to healthcare were excluded, leaving 87 articles for full-text review. the full-text review phase, conducted by the same domain experts, excluded an additional 45 studies due to methodological limitations, irrelevance, or insufficient indexing. this process culminated in the selection of 42 articles for inclusion in the final review. these articles represented a diverse array of topics in the context of patient safety, including ai in healthcare (12 articles), telemedicine and digital health (10 articles), cybersecurity in healthcare systems (9 articles), digital divide (8 articles), and health disparities (3 articles). geographically, the articles spanned studies conducted in north america, europe, asia, and africa, providing a global perspective on the intersection of technology and healthcare. the quality of the selected articles was validated through their indexing in major academic databases. of the 42 articles, 38 (90.5%) were indexed in scopus, 34 (81%) in web of science, and 30 (71%) in pubmed. notably, 28 articles (66.7%) were indexed across all three databases, underscoring their multidisciplinary relevance and high scholarly standards. this systematic review methodology, characterized by a robust search strategy, precise selection criteria, and expert oversight, ensured the inclusion of high-quality, globally relevant studies. the synthesis focused on a qualitative narrative rather than a quantitative meta-analysis due to study heterogeneity. literature review the key challenges persistence of medical errors despite advances in medical technology, medical errors continue to plague healthcare systems worldwide, with around 33% of patients experiencing harm during healthcare delivery.11 studies have shown that the incidence of adverse events among hospitalized patients remains high globally despite increased digitalization in healthcare delivery.12–14 this trend raises concerns about the effectiveness of current patient safety strategies and the disparity in resource allocation to safety initiatives compared to other medical priorities such as technology adoption.15,16 health inequities and the digital divide while technology has the potential to reduce healthcare disparities, the digital divide continues to exacerbate health inequities, particularly for vulnerable populations,17–19 underprivileged communities may lack access to the necessary devices or internet connectivity to utilize telemedicine and remote monitoring technologies effectively.20,21 these gaps in access further highlight the need for comprehensive policies and investment in digital infrastructure to ensure that advancements in sharma, singh, pradhan: balancing innovation and safety in digital healthcare j global clinical engineering vol.7 issue 1: 2025 8 healthcare technology benefit all patients, regardless of socioeconomic status.22,23 challenges of telemedicine the advent of telemedicine, particularly accelerated during the covid-19 pandemic, presents both opportunities and challenges in healthcare delivery. while telemedicine enhances accessibility, it also increases the risk of miscommunication and missed diagnoses due to the lack of comprehensive physical examinations.24–26 moreover, technological illiteracy and inadequate access to digital devices exacerbate health disparities, especially in low-resource healthcare settings.27–29 this highlights the importance of ensuring equitable access to telehealth services and addressing the underlying social determinants that hinder the effective use of such technologies. remote monitoring remote monitoring technologies, particularly in managing chronic illnesses, have gained traction due to their ability to provide continuous data on patient health. however, these technologies are not without risks. delays in healthcare provider responses or misinterpretation of remote data can lead to adverse patient outcomes.30,31 moreover, the effectiveness of remote monitoring depends on the accuracy and timeliness of the data collected. underscoring the need for healthcare providers to carefully evaluate these technologies before implementation.3,31,32 algorithmic bias in ai ai in healthcare holds the potential to improve diagnostic accuracy and optimize treatment plans. however, algorithmic bias remains a significant concern, particularly when ai models are trained on datasets that lack diversity.33–35 such biases can lead to inaccurate diagnoses and treatment recommendations that disproportionately affect marginalized populations.36 for example, biased ai systems have been found to suggest less aggressive treatments for black patients compared to white patients, perpetuating health inequities.37,38 addressing this requires both, technological advancements and ethical considerations during the development and deployment of ai in healthcare. risks of overreliance on automation the increasing automation of healthcare processes, while reducing human error in some cases, also poses risks. overreliance on automated systems can lead to complacency among caregivers, diminishing their clinical judgment and decision-making capabilities.39–41 ensuring that healthcare professionals maintain their skills and remain critical of automated recommendations is essential for patient safety.42 the balance between automation and clinical expertise is crucial to protect the medical proficiency of healthcare providers. cybersecurity vulnerabilities in healthcare systems the digitalization of healthcare has also introduced cybersecurity risks, which, if not properly addressed, can jeopardize patient safety.43–45 cyberattacks, including ransomware, disrupt healthcare services and compromise sensitive patient data.46 the wannacry ransomware attack, which targeted the uk's national health service (nhs), highlighted the potential for widespread disruption caused by inadequate cybersecurity measures.47–49 as healthcare organizations increasingly adopt digital tools, governments and healthcare providers must prioritize cybersecurity investments and training to protect patient data and maintain uninterrupted care delivery.50,51 thus, the extant literature highlights that digital technologies in healthcare hold promise but they also come with significant risks to patient safety, particularly in vulnerable populations and low-resource settings. to fully harness these technologies’ potential, addressing issues such as cybersecurity, algorithmic bias, access disparities, and overreliance on automation is imperative. ensuring patient safety in a digitalized healthcare environment requires a coordinated effort between healthcare providers, policymakers, and technology developers to mitigate these risks while advancing the quality of care. recommendations solutions to these challenges the solution to these challenges lies in the need for a balanced approach that embraces technological advancements and addresses the associated risks. 9 j global clinical engineering vol.7 issue 1: 2025 sharma, singh, pradhan: balancing innovation and safety in digital healthcare treatment, emphasizing the importance of critical thinking and human oversight in automated processes.64–66 continuous professional development ensures that healthcare providers remain competent and confident in the face of rapidly changing technology. implementing rigorous evaluation and feedback mechanisms to ensure that new technologies are safe and effective, healthcare systems should implement rigorous evaluation and feedback mechanisms. these mechanisms should involve continuous monitoring of technology performance, patient outcomes, and user experiences. feedback from healthcare providers and patients should be systematically collected and used to refine and improve technologies.67,68 suggestions for policy and regulatory framework the successful integration of digital technologies in healthcare requires robust policy and regulatory support. policy makers and regulatory bodies should develop comprehensive frameworks that promote innovation while ensuring patient safety. setting clear guidelines for the ethical use of ai, mandating regular safety audits of ehr systems, and establishing protocols for responding to cybersecurity threats. these policies should be flexible enough to adapt to the fast-paced evolution of digital health technologies while maintaining stringent safety standards.69,70 policymakers must create a comprehensive regulatory framework providing clear guidelines to healthcare institutions regarding the use of ai algorithms in healthcare, and must undergo rigorous testing and validation to prevent biases that could lead to unequal treatment outcomes.66,71 stringent cybersecurity standards for all healthcare institutions, including mandatory encryption protocols, regular software updates, and comprehensive training for healthcare professionals on recognizing and responding to cyber threats. additionally, there should be a legal requirement for healthcare organizations to report cyberattacks promptly, enabling a coordinated response and minimizing the impact on patient care.62 integrating technology with a patient-centric approach to mitigate the risks associated with digital technologies in healthcare, a patient-centric approach must be prioritized. this approach involves designing and implementing technologies that enhance patient safety while maintaining human oversight. for instance, ai algorithms should be developed with diverse datasets to avoid biases and ensure equity in healthcare outcomes.52–54 additionally, involving healthcare professionals in designing and deploying these technologies can bridge the gap between technological innovation and practical and safe application.55–57 enhancing interoperability of ehr systems one of the significant challenges with ehrs is the lack of interoperability between different systems, which leads to incomplete patient records and potential safety risks. to address this, healthcare organizations should adopt standardized data sharing and integration protocols across platforms.58,59 this can be supported by government policies that mandate interoperability standards, ensuring that patient data can be accurately and securely accessed regardless of the system in use. the adoption of open-source solutions has shown promise in creating more adaptable and interoperable systems.60 developing robust cybersecurity frameworks given the increasing threats of cyberattacks on healthcare systems, developing and implementing robust cybersecurity frameworks is imperative. these should include regular updates to software systems, training for healthcare staff on recognizing and responding to cyber threats, and the adoption of advanced encryption methods to protect patient data. by investing in robust security systems, healthcare organizations can protect their patient’s safety and operational integrity.61 continuous education and training for healthcare providers as digital technologies evolve, continuous education and training for healthcare providers are essential. this training should focus on using new technologies effectively and understanding their limitations and potential risks.62,63 for example, training programs could include modules on the ethical implications of ai in diagnosis and sharma, singh, pradhan: balancing innovation and safety in digital healthcare j global clinical engineering vol.7 issue 1: 2025 10 government policies should also incentivize healthcare institutions especially in lowand middle-income regions to invest in advanced cybersecurity measures, such as aibased threat detection systems, to protect patient data and ensure operational continuity.72 setting national standards for data sharing and integration, ensuring that patient information can be seamlessly transferred across healthcare providers without compromising safety. interoperability standards should be designed to support patient privacy while allowing healthcare professionals access to comprehensive patient histories, thus reducing the likelihood of medical errors.73 policies should encourage the development of opensource ehr platforms that can be easily adapted to different healthcare settings, particularly in resource-limited environments.74 establishing quality assurance programs to monitor and evaluate the effectiveness of remote healthcare services. these programs should include protocols for ensuring that telemedicine consultations are conducted with the same level of care as in-person visits. this could involve the development of standardized telemedicine practices, including guidelines for when physical examinations are necessary and protocols for ensuring accurate patient assessments.75 scope for future research future research could focus on understanding and mitigating the biases inherent in ai systems used in healthcare. researchers should explore the ethical implications of ai in healthcare, examining how these technologies can be designed to promote equity in treatment outcomes across different demographic groups. there is a critical need for longitudinal studies assessing ehr systems’ long-term impact on patient safety and healthcare outcomes. future research could investigate how ehr-related issues, such as alert fatigue and data entry errors, evolve and what their implications are for patient safety. future research could focus on developing innovative cybersecurity solutions tailored to the healthcare sector. this includes exploring the use of ai for real-time threat detection and response and investigating new encryption technologies that can protect patient data without hindering legitimate users’ access. studies could evaluate the effectiveness of telemedicine across different patient populations, particularly in rural and underserved areas. this includes studying the impact of telemedicine on healthcare access, patient outcomes, and satisfaction, as well as identifying barriers to effective telemedicine use. discussion the review illustrates that digital health technologies hold tremendous potential to improve patient care but also pose substantial risks that require ongoing evaluation, ethical considerations, and regulatory oversight. ensuring patient safety in the digital age demands a multi-faceted approach involving continuous education, developing robust safety protocols, and establishing policies that foster both technological innovation and equity in healthcare delivery. this discussion reaffirms the need for healthcare systems to prioritize patient safety at every stage of technological integration, ensuring that digital health’s benefits are realized without compromising care quality or exacerbating disparities. the critical examination of the intersection of technological advancements and patient safety, offering insights into both the promise and perils of digital transformation in healthcare. while digital tools such as electronic health records (ehrs), telemedicine, and ai have the potential to enhance care delivery, they also introduce significant risks that must be addressed proactively. despite advancements in digital health, the persistence of medical errors underscores the complexity of ensuring patient safety in an increasingly digitized healthcare environment. the rise of telemedicine, accelerated by the covid-19 pandemic, represents a paradigm shift in healthcare delivery. however, its success is contingent upon equitable access and resolving inherent limitations, such as the absence of comprehensive physical examinations and technological illiteracy among vulnerable populations. these challenges illustrate that telemedicine can exacerbate existing health inequities rather than alleviate them without careful attention to implementation and infrastructure. therefore, 11 j global clinical engineering vol.7 issue 1: 2025 sharma, singh, pradhan: balancing innovation and safety in digital healthcare policymakers must ensure that digital health solutions are accessible, effective, and tailored to diverse populations. the review also highlighted the significant risks posed by algorithmic bias in ai systems, which can perpetuate health disparities if not properly addressed. ai’s reliance on non-representative datasets can result in biased diagnoses and treatment plans, disproportionately affecting marginalized communities. addressing this issue requires both technological advancements and ethical oversight to ensure that ai systems are trained on diverse and inclusive datasets. furthermore, the risks of overreliance on automation, suggest the need for healthcare providers to maintain critical thinking and clinical judgment when interacting with digital tools. in terms of cybersecurity, the digitalization of healthcare has made systems more vulnerable to cyberattacks, which can jeopardize both patient safety and data privacy. robust cybersecurity frameworks and regular updates to software systems are essential to safeguarding patient data and ensuring the continuity of care. additionally, training healthcare personnel to recognize and respond to cyber threats is critical in preventing disruptions in care delivery. the analysis of remote monitoring technologies has revealed both the advantages and challenges of these tools in managing chronic illnesses. while remote monitoring offers the ability to continuously track patient health, the reliability of the data and the timeliness of healthcare responses are critical to ensuring positive patient outcomes. delays in addressing essential health changes can result in adverse outcomes, underscoring the importance of healthcare providers carefully evaluating these technologies before widespread implementation. conclusion while advancements like ai, ehrs, and telemedicine offer significant potential to improve healthcare, they must be deployed with strong safety protocols, attention to equity, and comprehensive regulatory oversight. there is an urgent need for a global, future-focused commitment to patient safety in the digital era. without these safeguards, the risks—such as algorithmic bias, cybersecurity threats, and unequal access—can undermine the very goals of improving patient outcomes. this paper suggests a cohesive, patient-centric strategy that continuously evaluates emerging technologies to ensure they enhance, rather than compromise, the quality and safety of care. author contributions conceptualization, s.s.; methodology, s.s.; investigation, s.s.; writing–original draft preparation, s.s.; writing– review & editing, m.s. and k.b.p.; visualization, m.s. and k.b.p.; supervision, m.s. and k.b.p.; project administration, 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principles, strategies, applications, and new directions; latifi, r., doarn, c.r., merrell, r.c., eds. springer: cham, switzerland; 2021; pp. 97–113. https://doi. org/10.1007/978-3-030-56917-4_7. j global clinical engineering vol.6 special issue 6: 2024 96 conference paper design of a normative semg database for biometric comparison in rehabilitation research athanasios arvanitidis*, konstantinos mitsopoulos, vasiliki fiska, alkinoos athanasiou and panagiotis d. bamidis aristotle university of thessaloniki, school of medicine, lab of medical physics and digital innovation, thessaloniki, greece. * corresponding author email: thanosarv99@gmail.com abstract electromyography (emg) is used in a wide range of research fields, such as physiotherapy, ergonomics, and neurorehabilitation. normative emg databases play a crucial and significant role in the efficient diagnosis and treatment of neuromuscular disorders. they can rapidly provide information that, although not necessarily diagnostic, can efficiently and effectively guide further diagnostic studies. quantitative electromyography (qemg) in the upper extremities is an effective diagnostic tool, but there are currently few normative databases available. the absence of fundamental guidelines and established methods for creating normative databases contributes to a significant obstacle in the field of rehabilitation research. this study aims to bridge this gap by designing a dynamic, scalable, consistent, available, and partition-tolerant nosql database (db), in alignment with the consistency, availability, and partition tolerance (cap) theorem, to house normative surface electromyography (semg) values for upper body muscles, primarily for biometric comparison in rehabilitation. the db encompasses diverse emg features, both in the time and frequency domains, as well as anthropometric variables, extracted by healthy participants and post-stroke or spinal cord injury patients. the participant selection is based on greece’s average demographic statistics and specific inclusion and exclusion criteria from existing clinical trials. the proposed db is particularly designed to be continuously updated offering real-time insights, allowing the db to be an even more valuable resource for researchers and practitioners working in the field. keywords—quantitative electromyography, rehabilitation, biomedical database, nosql. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 97 j global clinical engineering vol.6 special issue 6: 2024 introduction the electrochemical and mechanical activities that occur during the biological events of the human body frequently generate measurable signals, known as biosignals, that can be analyzed. these signals offer valuable insights into not only the intrinsic physiological and pathophysiological states of the body, but also into an individual’s affective, attentional, and other cognitive states. such information is fundamental in understanding the underlying mechanisms of specific biological systems or events and holds significant potential for medical diagnosis.1 emg is a specific biosignal generated from electrophysiological changes in muscle fiber membrane conductivity and quantifies the electrical currents produced during muscle contractions.2,3 emg sensors can generate information relevant to muscular activity and are widely used in clinical settings for diagnosing conditions and diseases of the central and peripheral nervous systems that involve the sensorimotor and somatosensory pathways. quantitative electromyography (qemg), offers a valuable approach to diagnostics, shedding light on neural and muscular disorders. however, a solemn omission in the current landscape is the lack of a comprehensive normative database (db) that can serve as a standard for biometric comparison.4 this deficiency has far-reaching implications, particularly in rehabilitation research, where effective diagnosis and treatment are contingent upon comparative analyses. surface electromyography (semg) offers a non-invasive yet robust way to acquire useful information about the human body’s physiological and pathophysiological states. given its non-invasive nature, semg has been considered an invaluable tool for studying a myriad of conditions, ranging from genetic neuromuscular disorders to spinal cord injury.5 in recent years, advancements in semg technologies have positioned them as a complement or even a potential alternative to needle electromyography (nemg) and nerve conduction studies (ncs). however, this technological leap is undermined by several limitations.6 this study aims to tackle the lack of standardized dbs for semg data, which restricts their comparability and, as a result, hampers their clinical utility.4,7–9 the current study aims to fill this void, by creating a nosql db with normative semg values of the upper body. the cap theorem has been more known in recent years as a crucial framework for understanding the limitations and potential trade-offs in developing distributed dbs.10 the theorem states that only two of the following three properties—consistency, which ensures that all data replicas are synchronized, high availability, which ensures uninterrupted access to data for updates, and partition tolerance, which allows for continued operation in the face of network failures—can be maintained by such a system at an optimal level.11 leveraging the capabilities of mongodb, the db is designed to be dynamic, scalable, and in alignment with the cap theorem, ensuring consistency, and partition-tolerance. moreover, it aims to incorporate a wide spectrum of emg features, both in the time and frequency domains. these features are extracted from a diverse participant pool that includes healthy individuals as well as those with spinal cord injuries and stroke. additionally, the db integrates anthropometric variables such as gender, age, and body mass index (bmi), with the participant selection based on greece’s average demographic statistics and specific inclusion and exclusion criteria from existing clinical trials from the neurosuitup and heroes projects.12,13 the db not only offers normative semg values but also hosts raw semg signals, enhancing its utility for researchers and practitioners alike. methods and materials database design & schema the staggering volume of data generated and processed every day is a defining feature of the modern era. particularly in biomedical research, where data serve as both input and feedback for useful insights, this “data deluge” poses a unique mix of obstacles and opportunities. the management of such enormous datasets requires dbs that are not only robust but also flexible enough to deal with the peculiarities of the data they are designed to http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 98 handle. to handle divergent storage challenges, different dbs must be designed depending on the situation.14,15 traditional sql dbs are well-suited for handling structured data and offer robust query capabilities. these dbs have excelled in storage efficiency and data retrieval speeds when compared to rudimentary flat file systems. however, they often fall short when tasked with handling non-uniform or unstructured data, a characteristic that is increasingly prevalent in today’s data-rich environment. nosql dbs have emerged as the tool of choice for managing these extensive, heterogeneous, and ever-evolving data sets, leading to the rise of nosql dbs, particularly those of a document-oriented nature.14–16 studies indicate that nosql architectures outperform their sql counterparts in almost all performance metrics, including the speed of data storage, indexing, and query retrieval.16 in this study, mongodb—a document-based nosql db—is selected as it is well-equipped to manage such inconsistencies. mongodb resides on the cp side of the cap theorem (figure 1), meaning it prioritizes consistency and partition-tolerance over availability. figure 1. mongodb—cap theorem. though nosql dbs like mongodb are typically schema-less, this study utilizes a conceptual schema to clarify its architectural structure. the schema (figure 2) consists of multiple tables and each table possesses unique primary keys and defined attributes suitable for storing a variety of data types. the architecture allows for straightforward referencing between tables. this interconnection enhances the db’s robustness, making it adaptable to different query requirements and enhances its scalability to manage dynamic and multi-dimensional data. moreover, the incorporation of json-like documents with dynamic schemas not only simplifies data integration but also offers greater flexibility, thus exemplifying modern db requirements. figure 2. database schema. sample size in this study, stratified sampling is employed. the population is going to be divided into homogeneous subpopulations, or strata, based on gender.17 analyses have suggested that a minimum of 50 subjects per stratum is needed to ensure clinically useful confidence intervals; therefore, a sample size of 100 participants is selected, with 50 participants in each gender-based cell. previous studies have shown that the inclusion of fewer than 50 subjects per stratum results in confidence intervals that lack clinical utility, while studies with more than 75 subjects per group do not significantly refine these intervals.18 the focus on gender as a stratifying variable was predicated on previous research indicating significant gender differences in patterns of muscle fatigue and neuromuscular activation during isometric contractions.17 this supported the inclusion of gender as a critical stratifying variable to gain insights into muscle fatigability and endurance capacity, which are influenced differently in men and women, in the pursuit of developing a db with normative data.17 http://www.globalce.org http://globalce.org http://globalce.org 99 j global clinical engineering vol.6 special issue 6: 2024 it is worth mentioning that the selected sample size takes also into consideration the influence of data skewness on measures of central tendency and variance. for normally distributed data, a stable measure can be obtained with a sample size of approximately 70; however, the requirement may vary between 30 and 80 depending on the skewness of the data. provision of skewness as a descriptive statistic is highly recommended for future studies, in order to enable clinicians to make more informed decisions.19 database validation a multi-step approach is used to validate the db, ensuring its robustness and clinical applicability. of the data stored. initially, data are acquired from the main cohort of healthy participants. following this, semg processing and feature extraction techniques are applied to the collected data, leading to time and frequency domain analyses. subsequently, statistical metrics such as means, standard deviations, and skewness are calculated. transforms are applied to these metrics to approximate gaussian distributions if the initial data deviate from a gaussian pattern. z-scores for each subject are then computed. leave-one-out gaussian validation is executed to ensure optimum sensitivity in the gaussian cross-validation. this method is chosen for its efficacy, despite being less rigorous than completely independent cross-validation, which is often more resource-intensive.20 clinical correlations and validity are conducted with a second cohort comprising patients with spinal cord injuries (sci) or stroke conditions, evaluated by experienced clinicians. parametric and non-parametric statistical methods are applied throughout the validation process (figure 3). the feedback mechanisms between gaussian cross-validation and statistical metrics, as well as between clinical validation and semg processing and feature extraction, are used to fine-tune the db’s performance and relevance, closely aligning it with clinical requirements.21 figure 3. database validation. future perspectives workflow an integrated methodology is suggested to strengthen the reliability and clinical relevance of our normative emg db in advance of future research trajectories. the workflow starts with a per-person profile that considers anthropometric data such as laterality, gender, and age. the semg myoware 2.0 muscle sensor (advancer technologies, llc, version 2.0, raleigh, nc, usa) is used for semg signal acquisition to record raw semg data, which is then stored in the db. a two-tiered computational analysis follows; for the main cohort, an emg processing and feature extraction process is executed, and the resulting data are then stored in the db. it’s crucial to note that a validation cohort is employed for clinical correlations, as validated by experienced clinicians. these correlations serve to ascertain the relevance of the db in practical, clinical settings. the validation process for the db, as outlined in the previous section, follows as the next step of the workflow adding an extra layer of credibility. this workflow, illustrated in figure 4, seeks to provide a normative semg db. figure 4. study workflow. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 100 discussion the current study addressed the lack of availability of normative dbs for qemg by designing a nosql db for normative semg values of upper body muscles. the absence of such dbs poses a significant obstacle in fields such as physiotherapy and neurorehabilitation, thereby hindering precise diagnostics and effective treatment strategies. in alignment with the cap theorem, mongodb is chosen for its ability to manage large and heterogeneous data and a conceptual schema is implemented to clarify the architectural structure and guide the data storage and retrieval processes. the db’s applicability is enhanced by a stratified sampling method focused on gender. a multi-step validation approach is undertaken to ensure the db’s clinical applicability. however, the study has its limitations, primarily the focus on upper body muscles and the restricted sample size. although the db is designed to handle a diverse range of semg data, it has the potential to be more comprehensive. furthermore, stratification can be further expanded, contingent upon an increase in sample size, offering opportunities for future refinement and increasing the level of representation. it is disconcertingly revealed through the study that a contemporary, universal methodology for generating a reliable normative emg db is lacking, and that frameworks for qemg normative dbs are similarly deficient. conclusion this study addresses the notable absence of normative dbs neurorehabilitation research. capitalizing on the flexibility and scalability of mongodb, a nosql db is developed, which integrates semg data and anthropometric variables from a demographically representative participant pool in greece, including both healthy participants and post stroke or spinal cord injury patients. the db is designed to be scalable, enhancing its long-term utility for clinical diagnostics and rehabilitation research. validation protocols and clinical correlations further refine its 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http://doi.org/10.1109/icaca.2016.7887957 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 j global clinical engineering vol.6 issue 1: 2023 18 received october 10, 2023, accepted november 21, 2023, date of publication december 1, 2023 sustainable procurement of medical devices in an international context part 2 needs assessment by valerio di virgilio1, alexia bouchard saindon2, francisco becerra posada2 1 università degli studi la sapienza, roma 2 united nations office for project services (unops) abstract background and objectives: this article describes how sustainable procurement of medical devices (mds) can be implemented in operational projects in developing countries. it also further details how sustainability principles and the needs assessment can be applied by the biomedical/clinical engineer lead (bcel) responsible for the technical and quality aspects of the procurement process of mds. it also emphasizes the importance of the bcel considering the country’s or region’s specific healthcare context when working on md procurement projects in developing countries. material and methods: based on the author’s experience of more than 20 years in procurement projects and implementation of mds in developing countries, the role of the bcel will be analyzed from a theoretical point of view with the description of the first pillar of a sustainable purchase, the needs assessment, to how it can be operationally applied through the analysis of relevant literature, case studies and lessons learned from past projects. results: the bcel has a key role in the sustainable procurement of mds as an integrator able to understand clinical needs and translate them into requirements while being aware of the sustainability and safety risks linked to technology implemented in the fragile environment of a developing country with limited resources. this context also creates additional challenges that can be managed if the bcel is conscious of the country’s health expenditure, geopolitical, healthcare, model of care, regulatory, infrastructure, and logistical conditions in which the mds will be installed. many equipment may remain unused if the technology implementation is not in line with the needs of the beneficiaries. therefore, a thorough needs assessment performed by the bcel to obtain the detailed list of mds, their technological level and estimated budget is of utmost importance to increase the project’s sustainability and mitigate the risk of unused mds. conclusion: besides traditional disciplines in biomedical and clinical engineering, the bcel shall also learn at least basic principles in public health, healthcare planning, project management, health infrastructure, and development aid to facilitate the dialogue with stakeholders based on knowledge, flexibility, and capacity to anticipate and solve practical issues on the ground. to this extent, it is advisable for a bcel new to the environment of developing countries to have progressive exposure to more complex projects and to extensively use the peer review mechanism to assure sustainability and quality during project implementation. a theoretical background based on sustainable procurement principles, analysis of the local and national health context and regulations, and knowledge of lessons learned from past projects should guide the bcel’s approach to performing the needs assessment while implementing a new project. keywords – medical device procurement, sustainable procurement, needs assessment, health services in developing countries, quality assurance, sustainability, biomedical/clinical engineer role, international health procurement. copyright © 2023. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 19 j global clinical engineering vol.6 issue 1: 2023 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 introduction in a previous article,1 the concept of sustainable procurement of mds has been discussed, and its importance regarding health services of developing countries emphasized. public investments in mds aim to improve health services and, thus the population’s health. this creates a virtuous circle where a healthier population improves the economy, which translates into a better investment return. in this framework, the sustainability aspect in md procurement projects has been defined as the critical factor that transforms financial resources into results: improved population health and wealth. this is particularly important in low-income countries (lic) where healthcare financial resources are often scarce, and deciding where to invest them is paramount. an unsuccessful project, where for example, funds are spent to purchase equipment that is not needed or not efficiently used, can disrupt the virtuous circle by creating a major financial debt, which brings more poverty and, thus the population to a more fragile status.1 the sustainability of md purchasing projects is therefore intimately linked to their resulting impact on the population as well as the economy of the country. therefore, the appropriate and efficient use of the purchased devices should be at the center of the efforts of the bcel. the concept of the three essential pillars to achieve sustainable procurement of mds has been proposed as central to preventing the risk of purchasing equipment that will not be properly and efficiently used. this concept outlines the importance of concentrating the technical effort in assessing (1) the needs, (2) the local conditions, and (3) the conditions for the lifelong use of the md. consequently, technical decisions along the project should be strictly coherent with the results of these three assessments and the resulting planned project impact and objectives to guarantee the sustainable use of the purchased devices. the objective of this article is to detail further how the first pillar for sustainability, the needs assessment, can be implemented in procurement projects within the environment of developing countries. the context of lic creates additional challenges regarding md procurement such as limited clinical, technical, and financial resources which need to be considered, especially during the introduction of complex mds. the bcel has a key role in facing these challenges and ensuring the project’s sustainability. the responsibility and recommended actions that the bcel can take in these circumstances are discussed and analyzed using examples from implemented projects. definition and context of sustainable procurement of mds the concept of the three pillars to achieve sustainable procurement of mds1 is an addition to the social, economic, and environmental considerations that are widely included in the policies of the four un agencies mainly responsible for md purchase: who,2 unicef,3 undp.4 and unops.5 the sustainability concept of a purchase shall be primarily linked to the use of the md and only secondarily to its social, economic, and environmental impact. in fact, if the purchased mds are unfit for purpose or wrongly installed and unused, they shall not be considered sustainable even if they are compliant to certain social, economic and/or environmental sustainability standards. a low environmental impact is unacceptable if the md is not fit-for-purpose and brings no benefits (eg1 and figure 1). figure 1. the refrigerator, is too large to be used by a small aids prevention laboratory in a central asian country. di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 j global clinical engineering vol.6 issue 1: 2023 20 eg1 the purchase of a medical refrigerator meeting certain sustainability criteria such as durable material composition without ozone contaminants, high energy efficiency, reduced and recyclable packaging, iso 13485 certification, and purchased at the best price available on the international market, faces risks to be unsustainable if the needs assessment was not correctly carried out. the refrigerator is not really needed or is too large for the needs of the beneficiary unit creating a problem of space and utilization that is solved with its early disposal. the context in developing countries creates additional challenges in the procurement of mds. according to who: “in the sub-saharan africa region, a large proportion (up to 70%) of equipment lies idle due to mismanagement of the technology, acquisition process, lack of user-training and lack of effective technical support.’’6 another study reported an average of 38.3% of out-of-service medical devices (md) in developing countries due to a lack of training, health technology management, and infrastructure.7 eg2 in an important procurement process managed by the honduras social security institute in 2011 and revised in 2014, it was found that about 20% of the purchased goods had not been used within 3 years from their installation while an additional 10% was seldom used. developing countries conditions the main conditions that a bcel shall consider during the assessment of a new project in a developing country are: 1. health expenditure conditions; 2. geopolitical conditions; 3. pre-existing healthcare conditions; 4. model of care; 5. infrastructure and logistical conditions; 6. regulatory conditions. health expenditure conditions: the per-capita health expenditure (figures 2 and 3) linked to the availability of human and material resources gives an overview of the economic conditions of each developing country. low health expenditure is associated with few or limited trained medical and technical resources that might impact the technological level of the mds to be purchased. it can also limit the availability of consumables and spare parts on the local market and cause a lack of tools and knowledge to repair the mds. a bcel shall, therefore, consider that even when a budget is available for the purchase of mds, funds for their consumables or maintenance might not be available in the long run and might compromise their efficient use. the huge gaps in per-capita health expenditure between the different regions of the world also hide important gaps inside a particular region. for example, in the latin america and caribbean region, the health expenditure has a mean value of 594 usd. still, when countries of this region are taken individually, there is a great variance between the bahamas which has an expenditure figure 2. worldwide health expenditure per-capita (us$).8 figure 3. health expenditure per-capita (us$) in latin america and the caribbean region.8 21 j global clinical engineering vol.6 issue 1: 2023 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 similar to europe & central asia, and haiti, which has an expenditure similar to the poorest countries of africa and south asia, (figure 2). while per-capita and public health expenditure can estimate a country’s effort to manage healthcare and improve universal health coverage, life expectancy is to be considered as a parameter that can roughly summarize the results of this effort, not considering other factors like lifestyle, socioeconomic, and genetics. it can be observed that the higher the health expenditure per-capita the higher the life expectancy of the country (figure 4) with some interesting exceptions like the us where the health expenditure is mainly out of pocket, leading to less efficient use of the expenditures and the countries where per-capita annual expenditures go below $400. over time, as countries invest more money in healthcare, the life expectancy of their population increases (figure 5): “on average, a 10% increase in health spending per-capita is associated with a gain of 3.5 months of life expectancy.”9 geopolitical conditions: tense geopolitical conditions in countries affected by war zones, territories controlled by rebel or criminal groups, and high criminality zones might complicate the delivery of equipment or the travel of technicians to perform the installation or the repair of mds. in those cases, the delivery of the equipment or the maintenance technicians’ access may require a police or military escort and pose additional challenges to the project. pre-existing healthcare conditions: available information on the local healthcare system, such as mortality/morbidity rates as well as health statistics on the population published by who11 and data on the present workload and activity of the beneficiary center(s) supporting the assessment of the context in which the mds will be implemented. model of care: different countries have different organizations and operationalization of health services, including different referral systems, processes of care, providers’ organization and services management. these differences directly impact the distribution of technologies in the health infrastructures according to their complexities. it is recommended that the bcel adopts the vision of a supply chain: a patient with a specific disease can be progressively attended to in infrastructures of different levels according to the diagnosis of the severity of the illness, and thus, the complexity of the technology shall be planned accordingly. infrastructure and logistical conditions: delivery of mds in remote areas can be difficult due to poor road conditions or accessibility by boat only. remote areas might also have limited or no access to reliable electrical or water resources, which might affect the utilization of mds.12 regulatory conditions: the bcel working in developed countries is usually part of a multidisciplinary team including medical planners, clinical experts, architects, and engineers with an exhaustive background of norms, regulations, and guidelines. in opposition, the bcel working in developing countries has to cope with a multidisciplinary team that is significantly reduced or sometimes absent in a context of international rules and regulations that may not apply to fragile contexts. the presence of a local national regulatory authority (nra) in the country and its level of maturity as defined by who facilitates the understanding and implementation figure 4. life expectancy versus health expenditure percapita in 2019.10 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 j global clinical engineering vol.6 issue 1: 2023 22 of national regulations and the acceptance (or not) of international standards in mds procurement projects. the efforts of who and the pan american health organization (paho)13 to improve the capacities of nras in developing countries shall also be considered and monitored as part of the bcel action in mds procurement projects. the bcel shall also be aware of the who listed authority,14 which will assess and classify the maturity level of nras based on a transparent and objective set of indicators established in the who global benchmarking tool.15 the role of the bcel when a procurement project of mds for an lic is assigned to the bcel, he should always consider the beneficiary country’s conditions during all project steps. in fact, the knowledge and consideration of the local health realities is essential to ensure a sustainable result of the procurement process and, finally the purchase of sustainable mds that will meet the needs of the local beneficiaries in the long term. the role and expertise of the bcel are crucial in addressing the challenges related to the implementation of mds and the promotion of sustainable procurement practices in developing countries. bcels with adequate experience should participate right from the start of the planning phase of an md procurement project to ensure that sustainability criteria will be considered. the needs assessment the first pillar of sustainability is the needs assessment, which involves investigating the demand and the intended use of the md requested by the beneficiary. considering the user’s needs is a central concept in the procurement process definitions of the 4 main un agencies procuring mds. who states that the benefits of good procurement include: “the most economically advantageous terms for the equipment acquired – not necessarily the lowest price obtained through tender, but the best deal for the organization’s needs” and defines the needs assessment as the “quantification of gaps between desired health service provision and the current situation”.16 unicef and undp also include the importance of meeting the needs of the end-user and the “fit-for-purpose” concept17 in their procurement processes: “the selected offers from a competitive tender should display the optimum combination of quality, whole life cost, effectiveness, and other factors such as social, environmental and other strategic objectives, to meet end-user needs.”18 unops also mentions to “re-consider the needs, i.e. consider specifically whether those goods or services need to be purchased.”19 according to the clinical engineering handbook,20 the first step in the planning phase of mds acquisition projects is “demonstrated needs and benefits”. effective and sustainable procurement is thus based on getting the right goods to respond to the needs. in fact, the whole procurement process is based on a needs assessment as its essential starting point. public investment in mds through the implementation of an international purchasing process is a long journey, and as “most journeys we take are considered successful if we arrive at the right place, at the right time, and in good condition. the “right place” is vital. identifying where you should head and justifying why you should get there will provide you with the critical data upon which to do planning, design, development, implementation, and monitoring and evaluation.”21 the objective of the needs assessment the final objective of an md procurement project is the intended impact on population health. thus, the needs assessment’s objective has to align with this intended impact on patient care. figure 5. life expectancy versus healthcare expenditure percapita from 2000 to 2019 in latin america and the caribbean region.10 23 j global clinical engineering vol.6 issue 1: 2023 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 it is important to clarify that the objectives and impact of an md procurement project shall be designed and measured by clinical variables such as the number of patients treated or the reduction of waiting lists, rather than by the amount of equipment or money spent during the project. therefore, performing a thorough needs assessment to define the project’s objectives and identify the clinical variables upon which the project’s success will be measured is essential. the project’s objectives and clinical variables shall also be defined based on the country’s health policy and statistics22 as well as on the analysis of the context as developed in chapter 2.1. when possible, it is recommended to involve, right from this initial step of the project, the beneficiary country’s health personnel that has, at different levels, a deep knowledge of the local technical capacities, conditions, and needs. the role of the bcel in the needs assessment a medical planner usually carries out the analysis of the clinical needs along with the establishment of the project’s clinical objective. the bcel has to understand the clinical objectives and the process that has been carried out to define them by dialoguing with the medical planner. therefore, the bcel should deeply understand healthcare systems in developing countries and their dynamics. profound knowledge of the healthcare needs and the locally and internationally available commercial solutions are essential for the bcel to evaluate and propose technological solutions for the assessed clinical needs and objectives. starting from this essential dialogue with the medical planner, the bcel can complete the needs assessment by defining the objectives of the procurement process in terms of technologies. based on the planned clinical activities and workloads, the bcel can determine the equipment list. in fact, an equipment type that may be included in the list corresponds to an equipment class that requires a technological-level definition to associate the expected clinical throughput with its estimated value and technical requirements in terms of space, installation, electricity, etc. eg3 a 20l tabletop autoclave used to sterilize laboratory equipment performing a few analyses per day is technologically much different and less complex than a 500l pass-through autoclave of a surgery center, requiring more complicated installation steps. still, often they are simply referred to as autoclaves in the purchasing lists provided to the bcel. to define the project objectives, the needs assessment should be analyzed, validated, and updated in the planning phase of the procurement process. all stakeholders must be involved in the needs analysis, which must be as detailed and complete as possible. the scope of this assessment should also include present and future needs in a 5 to 10-year projection. by focusing on the specific use of the device, the procurement process can be tailored to meet the needs of the beneficiaries and select the most adequate equipment. the quality of the md procurement process can be maximized when all the actions of the bcel are coherent with the project’s objectives. in the planning phase of a procurement project, the bcel should also consider the following conditions as recommended by the clinical engineering handbook: ‘’1. demonstrated needs and benefits of the mds 2. available qualified users 3. approved and reassured source of recurrent operating budget 4. confirmed maintenance services and support 5. adequate environment support 6. regulatory compliance’’20 analyzing these conditions before purchasing the equipment allows the bcel to prevent potential issues related to the use of the md. these conditions are also included as part of the three pillars of sustainability. this process results in adequate equipment that meets the beneficiary’s needs and thus is more likely to be used by the clinical personnel (figure 6). to perform a proper needs assessment, the bcel should always involve the clinical end-user as stakeholders and purchase mds and services from local manufacturers whenever possible. the sustainability risks related to a weak needs assessment a reliable needs assessment conducted under the responsibility of the bcel is, therefore, the central point of an effective health procurement process. it also helps di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 j global clinical engineering vol.6 issue 1: 2023 24 minimize sustainability risks, such as insufficient adequacy between the clinical personnel’s needs and the purchased md’s characteristics, compromising its usage. however, this analysis can sometimes be difficult to achieve due to the following pitfalls: • inadequate involvement of the relevant stakeholders in the project is caused either by the difficulty of implicating all the necessary stakeholders in the needs analysis, deficient identification of the clinical beneficiaries, or lack of consideration of the position of the beneficiaries in the health system network. • an outdated needs analysis caused by a significant delay between the completion of the analysis and the official launch of the project or by a change of the actors or some of their characteristics (evolution of the private sector, new government, new strategies in the distribution of health services, change in the clinical team, etc.). • a short-term needs assessment does not consider future needs caused by an analysis that considers only the current necessities and lacks to foresee future perspectives for at least the next 5-10 years related to the new etiologies of diseases and the emergence of new diagnostic and therapeutic needs. depending on the project’s starting point when the bcel begins to be involved, the needs assessment may be included or not in the project scope. the projects that start from a list of mds and technical specifications already defined are considered “purely transactional.” they can be considered high-risk projects since the procurement project is separated from the needs analysis and the evaluation of the impact of the purchase on the local healthcare system. implementing these transactional projects represents a high risk to the sustainable impact of the procurement project because no one in the project team is responsible for ensuring that the mds to be purchased are genuinely needed and that the local conditions allow for their efficient use. the clinical needs are unknown to the project team, and the coherence of the implementation is jeopardized. other types of projects, such as those where the dialogue between the bcel and the medical planner who defined the clinical objectives is impossible, and has moderate risks. these risks shall be mitigated by the bcel, which can revise and validate the medical planner’s analysis when possible or at least the clinical objectives, focusing on the purchase of mds. case studies in the following discussion, 2 case studies of projects implemented in the latin america and caribbean region, one in uruguay and the other in haiti, representing extremes in terms of per-capita health expenditure differences in the region, will be presented. uruguay has a high health expenditure and a mature public health system with established capacities to understand and properly use the funding for capital investment in mds. on the other hand, haiti has minimal health planning capacities and lacks technical experts. in 2008, in uruguay, as part of a project funded by a soft loan from italian corporations, 34 types of mds were purchased and destined for more than 300 health centers nationwide.23 the needs assessment process carried out before the beginning of the project has been an example of good practice of sustainability (figure 7). the project’s agreement stated the general objective: “sustain the capacity of the uruguayan public health system to meet the population’s needs while prioritizing the most vulnerable groups.” figure 6. description of the three main activities for each needs assessment deliverables that the bcel shall focus on. 25 j global clinical engineering vol.6 issue 1: 2023 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 this process, carried out transparently with an outstanding maturity by the central office of the ministry of health in contact with the regional directors, has produced the expected results: each center was aware and prepared to receive the equipment from the loan investment. the bcel validated the needs assessment carried out by the beneficiary and assured coherence of the purchase with the needs assessed. in 2012, in haiti, during the design phase of the construction and medical equipment procurement project of the gonaives hospital, no local medical counterpart was involved (baio a. gonaives hospital project raising from destruction the challenge of building in haiti international federation of hospital engineering. buenos aires, october 15th, 2014). the only person from the haitian ministry of health participating in the technical dialogue was the recently appointed, but not yet contracted, director of the new hospital. in this case, the bcel had to plan a methodology to define the list of equipment since no dialogue with the clinical beneficiary could plan medical equipment adequate to the intended level of care and size of the hospital (a regional hospital with a 200-bed capacity). to mitigate this risk, a workshop was organized involving all the stakeholders working on mds in the country. this workshop resulted in a scheme to follow for the definition of the equipment list, primarily oriented towards implementing simple technologies to facilitate local maintenance (figure 8). for example, manual operation tables rather than electrical ones were chosen to allow for ease of use and maintenance. figure 7. methodology of the needs assessment of the project “italian loan to support uruguayan health services” implemented in 2008, starting from the project’s objectives definition and ending with the types of equipment included, the list of equipment requested by the beneficiary centers and its adjustment to meet the available budget. figure 8. health technology management scheme (nunziata e. technical workshop on mds towards health technology management in haiti. haiti, june 15th 2012). di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 j global clinical engineering vol.6 issue 1: 2023 26 the demand for local maintenance support was solved during the tender process by asking the suppliers to establish a maintenance center in the country (at that time, no maintenance capacity private or public were present in the country). to help suppliers comply with this challenging requirement, the contracting authority included a financial incentive: an important advanced payment during the procurement process. eight local technicians were also hired and trained under the guidance of international technical experts to open packages, assemble, and install all the hospital furniture purchased. at the end of the project, the hospital could recruit trained technicians as maintenance employees. this also reduced the costs for suppliers since they did not have to travel to haiti to assemble the purchased furniture. in both case studies, a component of the procurement project was focused on strengthening local technical capacities in terms of equipment maintenance to improve the project’s sustainability. in uruguay, maintenance tools were purchased and provided to regional hospitals where biomedical engineers trained during the project execution could use them to maintain and repair mds.23 in haiti, training and tools for medical furniture repair was provided to local technicians, and an incentive for international suppliers to establish local maintenance centers was added to the procurement project. as a lesson learned, improving and strengthening local technical capacities is strongly recommended as an objective of md procurement projects in developing countries to enhance sustainability. conclusion sustainability is essential in implementing an internationally funded project in a developing country to procure mds. this factor determines if the project will improve the population’s health conditions or the country’s impoverishment.1 sustainable procurement of medical devices shall be driven by the bcel using the framework of the three pillars: assessing (1) the needs, (2) the local conditions, and (3) the conditions for the lifelong use of the md. the bcel is responsible for ensuring the quality of the project’s results and, thus, its sustainability. this article presented the theoretical background of the first pillar, the needs assessment, that the bcel can follow as a guideline in the project’s planning phase. in this way, he can assume the responsibility for the quality assurance processes and the project’s sustainability while raising awareness of the possible issues and discussing solutions with the rest of the team, the beneficiary, and the stakeholders to minimize the project’s risks. an international procurement project of mds requires high technical specialties in a multidisciplinary team, including project management. the needs assessment step requires competencies and knowledge in public health, clinical aspects, hospital design, infrastructure, mds, project planning, and market and technology analysis. the bcel has to dialogue with several stakeholders and, therefore, understand and use their languages to integrate their points of view, perceived risks, and suggested mitigation measures. a good approach for the bcel is to begin the project from a risk analysis perspective. while different stakeholders can raise any risk, the bcel shall focus on quality risks, which in the light of the previous discussion means sustainability risks: the main risk being the investment of money in the purchase of mds that are not or scarcely used because they do not respond to the needs of the beneficiary. during the analysis, the bcel can integrate different viewpoints and brainstorm possible prevention and mitigation measures. considering sustainability as the center of their activity and responsibility, the bcel’s role in a project is much more important than simply writing technical specifications or performing technical evaluations. therefore, the bcel needs thorough professional preparation and progressive exposure to the complexity and the issues specific to the context of developing countries. in this sense, the peer review mechanism is a tool commonly used in organizational processes to assure higher quality in project implementation and the continuing education and professional growth of bcels interested in leading international procurement projects. when implementing a specific project, balancing the impact of time and budget constraints with quality assurance actions is the main goal that any bcel has to focus on. the needs assessment should be included in the planning phase of the procurement project and coordinated by the bcel, which can integrate the different stakeholders’ points of view. the assessment of sustainability risks performed 27 j global clinical engineering vol.6 issue 1: 2023 di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 during the project’s planning phase allows the bcel to identify the challenges and evaluate the potential risks that could impact the project’s outcome. conflict of interest the authors declare no conflict of interest regarding the publication of this paper. acknowledgments the authors would like to thank antonio baio, enrico nunziata, cristina nocetti and federico klappenbach for contributing to the examples and figures presented in this article and for the constructive technical discussions during project implementation. references 1. di virgilio, v., bouchard saindon, a., & becerra posada, f. c. g. (2023). sustainable procurement of medical devices in an international context : part 1 background and definitions. global clinical engineering journal, 5(3), 29–39. https://doi.org/10.31354/globalce.v5i3.159 2. who. sustainable procurement. who; april 2022. available at: https://apps.who.int/gb/mspi/pdf_ files/2022/04/item5_11-04.pdf. 3. unicef. unicef implements sustainable procurement. unicef supply division; september 2018. available at: https://www.unicef.org/supply/sites/unicef.org. supply/files/2019-06/sustainable-procurementinformation-note.pdf. 4. undp. practitioner’s guide to sustainable procurement. available at: https://popp.undp.org/undp_popp_document_library/public/psu_procurement%20overview_ sustainable%20procurement.docx#:~:text=several%20 of%20factors%20influence%20sustainable,line%20 with%20good%20financial%20management. 5. united nations office for project services procurement group. sustainable procurement framework annex 1 to the procurement manual. unops. 2021, july 1. available at: https://content. unops.org/service-line-documents/procurement/ unops-procurement-manual-annex-1-2021_en.pdf. 6. who. guidelines for healthcare equipment donations. organization of health services delivery. march 2000. available at: https://apps.who.int/iris/bitstream/handle/10665/70806/who_ara_97.3_eng. pdf?sequence=1&isallowed=y. 7. perry l, malkin r. effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? med biol engineer comput 2011;49(7):719-722. available at: https://doi.org/10.1007/s11517-011-0786-3. 8. the world bank. current health expenditure per capita. april 7th, 2023. available at: https://data.worldbank. org/indicator/sh.xpd.chex.pc.cd. 9. oecd. health at a glance 2017. oecd indicators. available at: https://www.oecd-ilibrary.org/docserver/ health_glance-2017-5-en.pdf?expires=1695829119 &id=id&accname=guest&checksum=eef8cb0c0ea d898f03d1bb9bd984b28a. 10. ortiz-ospina e, roser m. healthcare spending. 2017. available at: https://ourworldindata.org/ financing-healthcare. 11. who. world health statistics. 2023. available at: https://www.who.int/data/gho/publications/ world-health-statistics. 12. malkin r. barriers for medical devices for the developing world. expert rev med devices. 2007. available at: https://pubmed.ncbi.nlm.nih.gov/18035940/. 13. paho. paho and national regulatory authorities of regional reference seek to strengthen regulation of medical products in the americas. july 11, 2023. available at: https://www.paho.org/en/news/117-2023-paho-and-national-regulatory-authoritiesregional-reference-seek-strengthen. 14. who. who-listed authority (wla). a framework for evaluating and publicly designating regulatory authorities as who listed authorities (wla). available at: https://www.who.int/initiatives/ who-listed-authority-reg-authorities. 15. who. who global benchmarking tool (gbt) for evaluation of national regulatory systems. available at: https://www.who.int/tools/global-benchmarking-tools. https://doi.org/10.31354/globalce.v5i3.159 https://apps.who.int/gb/mspi/pdf_files/2022/04/item5_11-04.pdf https://apps.who.int/gb/mspi/pdf_files/2022/04/item5_11-04.pdf https://www.unicef.org/supply/sites/unicef.org.supply/files/2019-06/sustainable-procurement-information-note.pdf https://www.unicef.org/supply/sites/unicef.org.supply/files/2019-06/sustainable-procurement-information-note.pdf https://www.unicef.org/supply/sites/unicef.org.supply/files/2019-06/sustainable-procurement-information-note.pdf https://popp.undp.org/undp_popp_document_library/public/psu_procurement%20overview_sustainable%20procurement.docx# https://popp.undp.org/undp_popp_document_library/public/psu_procurement%20overview_sustainable%20procurement.docx# https://popp.undp.org/undp_popp_document_library/public/psu_procurement%20overview_sustainable%20procurement.docx# https://content.unops.org/service-line-documents/procurement/unops-procurement-manual-annex-1-2021_en.pdf https://content.unops.org/service-line-documents/procurement/unops-procurement-manual-annex-1-2021_en.pdf https://content.unops.org/service-line-documents/procurement/unops-procurement-manual-annex-1-2021_en.pdf https://apps.who.int/iris/bitstream/handle/10665/70806/who_ara_97.3_eng.pdf?sequence=1&isallowed=y https://apps.who.int/iris/bitstream/handle/10665/70806/who_ara_97.3_eng.pdf?sequence=1&isallowed=y https://apps.who.int/iris/bitstream/handle/10665/70806/who_ara_97.3_eng.pdf?sequence=1&isallowed=y https://doi.org/10.1007/s11517-011-0786-3 https://data.worldbank.org/indicator/sh.xpd.chex.pc.cd https://data.worldbank.org/indicator/sh.xpd.chex.pc.cd https://www.oecd-ilibrary.org/docserver/health_glance-2017-5-en.pdf?expires=1695829119&id=id&accname=guest&checksum=eef8cb0c0ead898f03d1bb9bd984b28a https://www.oecd-ilibrary.org/docserver/health_glance-2017-5-en.pdf?expires=1695829119&id=id&accname=guest&checksum=eef8cb0c0ead898f03d1bb9bd984b28a https://www.oecd-ilibrary.org/docserver/health_glance-2017-5-en.pdf?expires=1695829119&id=id&accname=guest&checksum=eef8cb0c0ead898f03d1bb9bd984b28a https://www.oecd-ilibrary.org/docserver/health_glance-2017-5-en.pdf?expires=1695829119&id=id&accname=guest&checksum=eef8cb0c0ead898f03d1bb9bd984b28a https://ourworldindata.org/financing-healthcare https://ourworldindata.org/financing-healthcare https://www.who.int/data/gho/publications/world-health-statistics https://www.who.int/data/gho/publications/world-health-statistics https://pubmed.ncbi.nlm.nih.gov/18035940/ https://www.paho.org/en/news/11-7-2023-paho-and-national-regulatory-authorities-regional-reference-seek-strengthen https://www.paho.org/en/news/11-7-2023-paho-and-national-regulatory-authorities-regional-reference-seek-strengthen https://www.paho.org/en/news/11-7-2023-paho-and-national-regulatory-authorities-regional-reference-seek-strengthen https://www.who.int/initiatives/who-listed-authority-reg-authorities https://www.who.int/initiatives/who-listed-authority-reg-authorities https://www.who.int/tools/global-benchmarking-tools di virgilio, bouchard saindon, becerra posada: sustainable procurement of medical devices in an international context part 2 j global clinical engineering vol.6 issue 1: 2023 28 16. who. procurement process resource guide who medical device technical series available at: https:// www.who.int/publications/i/item/9789241501378. 17. undp. procurement for sustainable development strategy 2022-2025. available at: https://www.undp. org/procurement/strategy#:~:text=undp%20procurement%20for%20sustainable%20development,one%20 behind%2c%20and%20building%20resilience. 18. unicef. sustainable procurement information note. available at: https://www.unicef.org/supply/reports/ sustainable-procurement-information-note. 19. united nations office for project services procurement group. sustainable procurement framework annex 1 to the procurement manual. unops. 2021, july 1. available at: https://content. unops.org/service-line-documents/procurement/ unops-procurement-manual-annex-1-2021_en.pdf. 20. dyro j, cheng m. good management practice for medical equipment. in: dyro j. the clinical engineering handbook. setauket, ny: the biomedical engineering series, elsevier academic press. 31;108-113. 21. kaufman r, guerra-lópez i. needs assessment for organizational success. alexandria(va): astd press; feb 2013. 22. oecd. health policy in your country. available at: https://www.oecd.org/health/health-systems/healthpolicy-in-your-country.htm 23. v. di virgilio, g. ambroise; “clinical engineering development in the uruguayan public health system”; proc. ieee engineering in medicine and biology society, buenos aires, argentina 31/08-4/09 2010. https://www.who.int/publications/i/item/9789241501378 https://www.who.int/publications/i/item/9789241501378 https://www.undp.org/procurement/strategy# https://www.undp.org/procurement/strategy# https://www.unicef.org/supply/reports/sustainable-procurement-information-note https://www.unicef.org/supply/reports/sustainable-procurement-information-note https://content.unops.org/service-line-documents/procurement/unops-procurement-manual-annex-1-2021_en.pdf https://content.unops.org/service-line-documents/procurement/unops-procurement-manual-annex-1-2021_en.pdf https://content.unops.org/service-line-documents/procurement/unops-procurement-manual-annex-1-2021_en.pdf https://www.oecd.org/health/health-systems/health-policy-in-your-country.htm https://www.oecd.org/health/health-systems/health-policy-in-your-country.htm j global clinical engineering vol.6 issue 4: 2024 6 received april 30, 2024, accepted july 24 2024, date of publication october 28 2024. original research article dose verification for linac-based stereotactic radiosurgery planned at different prescription isodose levels using delta4 phantom+ emmanuel fiagbedzi*, francis hasford and samuel nii tagoe department of medical physics, university of ghana, ghana. * corresponding author email: emmanuel2g4@gmail.com abstract background: linear accelerator (linac)-based stereotactic radiosurgery (srs) plans and their treatment are complex techniques that require a comprehensive quality assurance program before they are clinically implemented. to cope with this intricacy, clinics must comprehensively validate treatment plans to deliver precise doses and assure patients. the study aimed to verify the treatment planning dose to the dose delivered at the linac during the srs treatment planned at different prescription isodoses with the new wireless delta4 phantom+. materials and methods: clinically accepted volumetric modulated arc therapy (vmat) srs plans made with the stereotactic end-to-end verification (steev) anthropomorphic phantom were created with six different prescription isodose level using 6 mv flattening filter free (fff) beam. all these vmat srs plans were replicated on the delta4 phantom+ and delivered with varian truebeam linac. the planned and delivered dose showed excellent correlation, and this was evaluated using distance to agreement (2 mm), dose deviation (2%), and gamma-index passing rate. results: the results showed that the calculated treatment planning system (tps) dose and the measurement with the delta4 phantom+were in excellent accord. the minimum gamma pass rate was 99.6% and the maximum 100%. the gamma passing rate above 95% for all plans and dose goals were achieved. conclusion: the verification with the delta4 phantom+ measurement depicted an excellent correlation with the dose of the srs treatment plans for the different prescription isodose levels. the wireless delta4 phantom+ device is precise and consistent. it is a quickly set-up device, suitable for srs treatment verification and allows for real-time measurement. however, we do recommend a stricter passing rate for vmat srs plans. keywords—stereotactic radiosurgery, prescription isodose, treatment plans, delta4 phantom+, gamma-index. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:emmanuel2g4@gmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 7 j global clinical engineering vol.6 issue 4: 2024 introduction stereotactic radiosurgery is minimally invasive or non-invasive type of external beam radiation therapy that operates behind the principle of using focal technique to deliver high radiation doses in one or few fractions by the help of multiple convergent beams of high energy photons to distinct small target volumes while sparing healthy surrounding tissues.1,2 these treatments can be delivered using the cyberknife, gamma knife, novalis, proton and linac-based systems.3 linac-based systems for srs are increasing and gaining ground in many centers. nonetheless, the prescription isodose levels differ among different institutions.4 utilizing flattening filter-free (fff) beams and volumetric modulated arc therapy (vmat), linear accelerator (linac)-based srs enables the delivery of intricate dose distributions within a shorter timeframe. with only a few fractions, any slight deviation from the target could majorly affect tumour control. thus, the accurate localization of targets and adherence to strict mechanical and dosimetric tolerances are crucial for precisely delivering linac-based srs plans.5,6 the quality assurance (qa) of this linac-based srs system is important for fully implementing this advanced technique. mistakes committed in any of the stages in the radiotherapy chain may pose detrimental effects to patients. while some mistakes can be found through pre-treatment dose verification, called patient-specific quality assurance (psqa), others during the acceptance and commission stage.7,8 pre-treatment verification confirms that the treatment dose, position, and volume are as planned. in a broader sense, verification assures the quality of treatment implementation. stereotactic radiosurgery (srs) is a well-established technique that delivers larger doses of radiation to small intracranial targets, usually in a single session. this therapy has stood the test of time and has evolved with technological advances.9 initially developed within a fixed frame system with point-based measurements of target coordinates, srs has progressed to frameless systems with image-guided target localization. dynamic modulated arc therapy with the linac has also increasingly gained ground in delivering srs. considering this, it is undoubtedly true that technological advances have reduced set-up inaccuracies and uncontrolled errors in delivering srs. however, these innovations have made treatment delivery an increasingly complex process, and there is an ultimate need for assurance that the exact dose is delivered to the right target and that maximal sparing of the adjacent normal critical organs is held.3,10 nowadays, a couple of methods are used for psqa. these include point or transmission dose verification, 3d dose reconstruction methods, and other dedicated phantoms.11 dosimeters such as diodes, ionization chambers, and radiochromic films are widely used but their area of functioning differs. some may not be ideal for smaller fields because of large sensitive volumes.12 film dosimetry is commonly used for pre-treatment verifications. however, mistakes can occur during the calibration and reading process.13 while a diode detector is appropriate for small field measurements as mostly used in srs, in big fields, it over-response due to high z material.14,15 a recent study found that synthetic diamond detectors performed well when measuring point doses in stereotactic radiation beams. however, single-element detectors also offer limited information regarding the dose distribution.13 in this study, the authors aimed to establish congruence between linac-based srs vmat plans at different prescription isodose levels to measurement done with the delta4 phantom+ and to validate the use and appropriateness of this phantom for pre-treatment verification. materials and methods all treatment planning and phantom measurements were performed at the centro riferimento di oncologico (cro), aviano-italy. the measurements were done on varian truebeam linac and with the new wireless delta4 phantom+ (figure 1). the treatment plans were generated using the varian eclipse 15.0 treatment planning system (tps). clinically accepted vmat srs plans made with computed tomography (ct) images of the stereotactic end-to-end verification (steev) anthropomorphic phantom with six different prescription isodose levels (50, 55, 60, 65, 70, and 80), http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 issue 4: 2024 8 a prescribed dose of 18 gy in a single fraction and using 6 mv fff beam were created. the treatment plans were done with five arcs and three different planning target volume margins (0 mm, 1 mm, 2 mm). the delta4 phantom+ is a new wireless system that allows highly accurate patient-specific qa of advanced radiotherapy techniques like imrt, vmat, srs, halcyon, and tomotherapy. it uses a three-dimensional (3d) detector array with 1069 detectors to assess the full dose distribution in the isocentric region, rather than just a single planar measurement.16 this comprehensive 3d verification ensures the treatment is given as exactly planned. the delta4 phantom+ comprises two planar circuit boards built in an orthogonal crossed array pattern. these boards feature radiation-detecting elements of p-type and si diodes, with a 0.5 cm spacing in the central high-resolution region and a 1 cm spacing elsewhere (figure 2). the high-resolution region of the boards is located in the central 6 cm × 6 cm area, while the overall detector plane region measures 20 cm × 20 cm. the cylindrical phantom is 22 cm in diameter and 4 cm in length. the material is composed of pmma and has a 1.19 g/cm3 of mass density. the delta4 phantom+ has a dose resolution of 0.1 mgy, allowing for precise measurements. it can detect doses as low as 1 mgy, without any upper limit. the phantom is entirely wireless, without any cable connections. it effortlessly transfers data using wi-fi and operates on battery power, ensuring a seamless and convenient setup and usage experience.17 the varian truebeam linac is a modern medical linear accelerator that revolutionizes radiotherapy treatment. it has photon energies of 6, 10, and 15 mv, 6 and 10 fff, and electron energies of 6, 9, 12, 15, and 18 mev. it has a round edge, millennium multi-leaf collimator (mlc) with middle 20 pairs of width 0.5 cm, peripheral 20 pairs of width 1 cm, and an enhanced dynamic wedge. mv imaging has 2.5 mv photon energy; in addition, it has kv cbct and a-si 1200 portal imaging. this allows for image-guided radiotherapy and various high-end treatments like srs and stereotactic body radiotherapy (sbrt).18 the treatment plans were modelled onto the delta4 phantom+ ct scan within the tps for dose calculation. the dose distribution was recalculated, and the planning data, including the original plan’s beam parameters, were the same. these plans were then transferred to the true beam linac and delivered (figure 3). the delta4 phantom+ software is an integral component of the delta4 phantom+ system. the software provides an intuitive and easy-to-navigate interface, allowing users to quickly set up and perform measurements. it supports dicom structure import functions, allowing for seamless integration with existing treatment planning systems (tps). the delta4 software enables real-time acquisition of dose distribution data during treatment delivery, providing instant feedback on treatment accuracy. it offers a range of tools to analyze the disparities between measurement and calculated tps dose effectively. 17 an analysis utilized the key parameters distance to agreement (dta), dose agreement (da), and the gamma pass rate. the concept of gamma analysis was initially proposed by low et al.19 figure 1. the set-up position of the delta4 phantom+ on the couch of the truebeam linac. figure 2. the operation of the delta4 phantom+ showing the interior of the radiation-detecting elements.16 http://www.globalce.org http://globalce.org http://globalce.org 9 j global clinical engineering vol.6 issue 4: 2024 as a means to compare dose distributions that have been calculated and measured quantitatively. this utilizes the physical distance and dose difference, then normalizes them based on the acceptability criteria.20 the dta, dose deviation (dd), and gamma-index passing rates were all calculated by the software.19 the criteria for acceptance used in this center was dta of 3 mm, dose difference of 3%, and the gamma-index passing rate of 95% and 90% for imrt and vmat srs, respectively based on the aapm tg-218 action limit8 but in this study a 2% dose difference, 2 mm dta and the gamma-index passing rate of 95% were used. isocenteric set-up position was used for the delta4 phantom+ in measurement. a fourfield box technique measuring 10 × 10 cm2 was measured for the correction factor.16 results the analysis of all plans included using the three most suitable parameters: the da (with a limit of 2%), dta (with a limit of 2 mm), and gamma passing rate. table 1 summarizes the results of the gamma passing rate, distance to an agreement, and dd of all plans with the different prescription isodose levels. overall, in all cases, excellent agreement was seen between the measurement and calculation of tps doses. the minimum gamma passing rate was 99.6% and the maximum was 100%. the gamma passing rate for all plans was higher than 95% using 2%/2 mm dd/dta. our criteria of 95% for the gamma-index was met for all plans with all the different prescription isodose levels used. the correction factor was found to be 1.01. figure 3. truebeam linac monitor interface during measurement. table 1. kappa values for qualitative variables showing good agreement between two devices. assessment parameters margin used prescription isodose level 50 55 60 65 70 80 gammaindex passing rate 2%/2 mm 0 mm 99.7% 99.8% 99.9% 99.9% 100% 100% 1 mm 99.6% 99.7% 99.9% 99.7% 99.8% 100% 2 mm 99.9% 100% 100% 100% 99.8% 99.8% dose deviation (dd) 0 mm 76.0% 76.0% 79.1% 80.3% 81.1% 83.4% 1 mm 76.1% 76.1% 79.5% 80.7% 81.5% 83.7% 2 mm 76.2% 76.2% 79.9% 80.9% 81.7% 83.9% dose to time agreement 0 mm 100% 100% 100% 100% 100% 100% 1 mm 100% 100% 100% 100% 100% 100% 2 mm 100% 100% 100% 100% 100% 100% http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 issue 4: 2024 10 discussion in this study, the use and suitability of the wireless delta4 phantom+ were assessed for treatment verification of linac-based srs plans made with different prescription isodose levels. we compared measurements made with phantom and treatment planning dose. we found the wireless delta4 phantom+ as an easily set-up device with minimal positional errors that provides consistent and comprehensive qa suitable for srs plans. its functionality is identical to the plug-in delta4 phantom+ with a few exceptions.21 the wireless system, real-time results, waterproof construction, and ease of use make it wellsuited to measuring small fields and composite srs plans. delta4’s first calibration and commissioning procedure must be completed with rigorous and precise measurements to assure patient-specific qa testing accuracy. it enables complete analysis of data and a quicker approach to conduct measurements without the need for additional qa systems. measurements are taken on the phantom’s two planes, and the software generates a 3d dose distribution using an interpolation approach16 (figure 4). there is documented evidence of the use of other detectors in srs, such as ionization chambers, alanine pellets, plastic scintillators, sun nuclear corporation (snc) arccheck, snc srs mapcheck, iba matrixx resolution, electronic portal imaging device (epid) and iba myqa srs but their scope of operation varies.6,22 the gamma-index is a valuable tool in dosimetric verification analysis, allowing for a comparison between the tps plan and the measurement (figure 5). figure 4. the delta4 phantom+ software displaying the result. the absolute dosage is shown in two diode arrays in three dimensions on the top panel, with color coding used to indicate the dose (yellow arrow). http://www.globalce.org http://globalce.org http://globalce.org 11 j global clinical engineering vol.6 issue 4: 2024 it provides a metric to assess the level of agreement in dose. it is commonly utilized for psqa. the minimum gamma pass rate was 99.6%, and the maximum was 100%. the gamma passing rate was above 95% for all plans as seen in table 1. dose goals were also achieved. developing a center-specific protocol is crucial, as the treatment planning and set-up influence the gamma-index. various factors can impact the final result, such as the detector’s type and sensitivity, tps algorithm, linac output, and clinical judgment of dose tolerance level.23 it is important to mention that the dta and dd criteria utilized for gamma analysis are not entirely independent. they have a connection to the dose gradient factor. it is widely accepted that a passing rate of 90% with a 3 mm/3% clinical significance is commonly used for most highly advanced treatment techniques.24 this study used a different gamma passing rate of 95% with a 2 mm/2% due to the sharp dose gradient in srs. however, should our gamma-index passing rate be less than 95%, further verification would be necessary with any of the other detectors such as gafchromic film. according to nelms et al., gamma passing rates using the criterion of 3mm/3% are insensitive to clinically meaningful patient dose mistakes on a field-by-field basis.25 sadagopan et al. validated the accuracy and reproducibility of the delta4 device by comparing its results to measurement with film and an ion chamber.26 similarly, bedford et al. found that delta4 demonstrated a slightly stronger correlation between calculated and measured doses than the film.27 this may be due to the absolute figure 5. the delta4 phantom+ software displaying three histograms: distance to agreement, dose deviation, and gamma-index. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 issue 4: 2024 12 nature of delta4 measurements in contrast to the relative nature of film dosimetry. our measured pass rates were comparable with those of other detectors using the same pass criteria when used for treatment verification for vmat plans. the minimum gamma passing rate in our study was higher when compared to ebt-xd film 96.70%, epid 95.93%, srsmapcheck 96.76%, and myqa srs 97.91% using the same passing criteria 2%/2mm.6 furthermore, in a study by desai et al.,the delta4 phantom+’s performance was evaluated by measuring 36 clinical cases using a viewray mridian linac.28 the findings were identical to those obtained utilizing a sun nuclear arccheck. both devices met the institution’s 95% pass rate for a 3%/3 mm gamma requirement. still, the use of 2%/2 mm gamma passing rates revealed subtle variances among the devices, with the delta4+ being a little superior in terms of the results.28 applying 2%/2 mm as a gamma parameter provided excellent sensitivity and minimum fluctuation. the detector’s resolution allows for good visualization of the gamma distribution graphically on the software. this is a precious visual tool for identifying regions of overdose and underdose.29 our final measured gamma pass rates may be influenced by some factors such as the truebeam linac output variability, user configuration, and detector settings. however, it is challenging to separate these factors from the final findings. moreover, selecting an srs qa detector is contingent upon several elements that vary between institutions. these considerations include prior expertise, financial resources, user-friendliness, and the sensitivity and specificity requirements that align with the institution’s unique srs qa criteria.2,6 hence, it is important to interpret the gamma pass rates presented in this study as a validation of the delta4 phantom+ as suitable for srs treatment verifications rather than as a direct method for comparing it with the other detectors. furthermore, although we recommend using 2%/2 mm because of the great degree of agreement our investigation was able to attain, other tight gamma parameters such as 2%/1 mm or 1%/1 mm could be explored due to the high dosimetric accuracy of stereotactic treatments.8 conclusion the delta4 phantom+ and software system provide efficient set-up, precise real-time measurement, and comprehensive three-dimensional analysis, making it well-suited for the intricate nature of modulated irradiation such as vmat srs on the linac. the findings suggest that good agreement between measurement and tps was achieved irrespective of the prescription isodose and planning target volume margins used. the use of delta4 phantom+ demonstrates efficacy and efficiency in psqa. accuracy is crucial in every aspect of treatment delivery for srs plans; however, despite meeting the gamma-index rate used, we recommend a stricter passing rate for vmat srs plans. the comparison of delta4 phantom+ with other qa verification systems was not conducted due to time constraints and the unavailability of different qa systems in the department. there is potential for further expansion of the work. conflicts of interest statement the authors declare that they have no conflicts of interest. acknowledgment we want to express our sincere gratitude to all staff at the medical physics department of centro riferimento di oncology (cro) in aviano-italy who supported data collection and made my research visit fruitful. references 1. fiagbedzi, e., hasford, f., tagoe, s.n., et al. radiotherapy infrastructure for brain metastasis treatment in africa: practical guidelines for implementation of a stereotactic radiosurgery (srs) program. health technol. 2023;13:893–904. https://doi.org/10.1007/ s12553-023-00799-3. 2. korreman, s., medin, j., 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http://globalce.org https://doi.org/10.1016/j.rpor.2020.07.004 https://doi.org/10.7759/cureus.30885 https://doi.org/10.1118/1.3659707 https://doi.org/10.1118/1.3659707 https://doi.org/10.1118/1.3544657 https://doi.org/10.1120/jacmp. v10i2.2928 https://doi.org/10.1120/jacmp. v10i2.2928 https://doi.org/10.1088/0031-9155/54/9/n04 https://doi.org/10.1002/acm2.13216. https://doi.org/10.1002/acm2.13216. https://doi.org/10.1002/acm2.12285 https://doi.org/10.1002/acm2.12285 original research article dose verification for linac-based stereotactic radiosurgery planned at different prescription isodose levels using delta4 phantom+ emmanuel fiagbedzi*, francis hasford and samuel nii tagoe original research article application and innovation of 3d printing in medical equipment maintenance lei jiang original research article assessment and capital planning of a regional clinical engineering department test equipment inventory samantha puin avila*, marie-ange janvier and andrew a.m. ibey original research article a decision support system for rational deployment of medical equipment based on real-world data dingding jia1, haowei zhang1, yang you1, yiming li2, shunxin qian3, qilin tao4, qi su5, heqing lu5,* j global clinical engineering vol.7 issue 1: 2025 32 received july 5, 2024, accepted december 13, 2024, date of publication feburary 27, 2025. review protocol for a systematic review on the application of robotics in orthodontic treatments guillermo cano-verdugo1, myriam angélica de la garza-ramos1*, omosebi temitope olabisi2, yinli liu3, georgina mayela núñez-rocha4, maría natividad ávila-ortíz4 and karina janett hernández-ruiz4 1 universidad autónoma de nuevo león, facultad de odontología, monterrey, nuevo león, méxico. 2 lagos state university teaching hospital: ikeja, lagos state, nigeria. 3 department of orthodontics, academic centre for dentistry amsterdam (acta), university of amsterdam and vrije universiteit amsterdam, the netherlands. 4 universidad autónoma de nuevo león, facultad de salud pública y nutrición, monterrey, nuevo león, méxico. * corresponding author email: myriam.garzarm@uanl.edu.mx abstract background and objective: robotics have multiple uses in dentistry, especially within the field of orthodontics, though the possible applications of these innovative systems are still not well defined. the objective of this systematic review protocol will focus on describing the steps to outline the role of robotics in orthodontic treatments and define its functionality and range within clinical applications. methods: to achieve this, peer-reviewed studies focusing on the employment of robotic systems in various aspects of orthodontic treatment will be incorporated, while literature reviews will be not considered. data will be explored through scopus, pubmed, google scholar and doaj. potential for bias will be established using the robins-e and certainty assessment with grade guidelines. results: the main results of the articles included will be tabulated in an excel spreadsheet, and a detailed narrative summary and interpretation of the data will be produced and displayed based on its use in surgical and non-surgical orthodontic treatments. conclusion: this systematic review protocol aims to offer important perspectives on the application of robotic systems in orthodontic procedures, contributing to advancement in clinical practices and technological integration. the results may assist practitioners in adopting robotic systems to enhance treatment precision, efficiency, and overall patient care. the literature search will encompass studies from various regions worldwide. this study is self-funded and has been registered on the prospero database under the registration number crd42023463531. keywords—robotics, orthodontics, clinical application, surgical orthodontics, orthodontic wire bending, systematic review, dental technology, innovative orthodontics. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 33 j global clinical engineering vol.7 issue 1: 2025 cano-verdugo, de la garza-ramos, omosebi, liu, núñez-rocha, ávila-ortíz, hernández-ruiz: protocol for a systematic review on the application of robotics in orthodontics treatments introduction the term “robot” originated in 1920 from czech novelist karel čapek, while “robotics” represents an intelligent fusion of perception and action, spanning multiple fields like engineering and computer science.1,2 in recent years, robotics has profoundly impacted various facets of modern life, from industrial manufacturing to healthcare, including significant advancements in dentistry. emerging literature highlights robotics’ capability to engage, investigate, and work alongside humans, transforming oral health services and assistance.3,4 the robotics industry has increasingly focused on autonomous technologies, enabling minimally invasive procedures in dental operations. a notable milestone occurred in 2017 with a robot’s successful completion of full dental treatment, marking robotics' integration into diverse dental specialties.5 while relatively new in orthodontics, robots are poised to streamline routine tasks, thereby enhancing orthodontists’ workflow.6 exploring the role of robotics in orthodontics is essential for redefining how treatments are conducted. integrating robotic technology has the potential to enhance patient outcomes by optimizing treatment duration, reducing human error, and improving precision in procedures such as wire bending.7,8 additionally, incorporating robotics into orthodontic practice could help streamline workflows by addressing challenges related to efficiency and standardization. by automating repetitive and labor-intensive tasks, orthodontists may be able to dedicate more time to diagnosis and personalized patient care.9,10 moreover, robotics could contribute to expanding access to orthodontic treatment and improving its overall quality. in regions with limited orthodontic specialists, robotic systems might help increase treatment capacity, ensuring faster and more precise care. recognizing the significance of robotics in this field is fundamental to enhancing clinical efficiency and optimizing patient outcomes, ultimately reducing complications and expediting recovery. currently, four primary categories of medical robots have been documented—robotic surgical systems, wearable robotic devices, assistive robots, and medical robots—highlighting their growing influence in healthcare services.11,12 to clarify the methods to be employed, a protocol for systematic review will be conducted to offer the scientific community accurate data on the implementation of robotics in orthodontics. this protocol addresses the current scarcity of literature by summarizing the role and scope of robotics in clinical practice within the orthodontics field. methods statement adherence the prisma recommendations13 will be followed in the elaboration of this review and this protocol is registered at the prospero site with record number crd42023463531, accessible at https://www.crd.york. ac.uk/prospero/display_record.php?recordid=463531. research question what are the steps for developing a systematic review on the role and scope of robotics in clinical orthodontic practice? inclusion criteria, data variables, and data sources an exhaustive search will be conducted in scopus, doaj, pubmed, google scholar, researchgate: academic networking platform and proquest dissertations & theses global, excluding searches for unpublished or non-peerreviewed literature. no restrictions based on age or language will be imposed for the publications. eligibility criteria and data items will be stablished according the pico tool14; detailed information will be displayed in table 1, while table 2 outlines the search strategy according to the data source. data collection process the selection of documents will be carried out through a multi-step screening process, starting with the title, followed by the abstract, and ultimately the full text. additionally, a manual search will be conducted by reviewing the reference lists of relevant manuscripts and documents that meet the inclusion criteria. during the review, several challenges may arise, such as inconsistencies in applying the inclusion and exclusion criteria, differing interpretations of data, or issues with retrieving relevant articles from certain databases. to address these challenges, the https://www.crd.york.ac.uk/prospero/display_record.php?recordid=463531 https://www.crd.york.ac.uk/prospero/display_record.php?recordid=463531 cano-verdugo, de la garza-ramos, omosebi, liu, núñez-rocha, ávila-ortíz, hernández-ruiz: protocol for a systematic review on the application of robotics in orthodontics treatments j global clinical engineering vol.7 issue 1: 2025 34 search process will be performed concurrently by two independent authors, each reviewing the same data source. in case of disagreements, a third unbiased reviewer will be consulted to resolve discrepancies and reach a final consensus. data collection will be carried out by the researcher who will search the database and will be validated by o.t.o. and m.a.g.r. for consensus. data collected by the authors will be arranged in an excel worksheet and divided into the following sections: origin and journal impact level, authors, publication year, and country of study, type or name of the robotic technology, use in orthodontics (surgical or non-surgical), purpose of the study, study results, conclusions drawn, strength and drawbacks (table 3).15 table 1. eligibility criteria and data variables included within the study. pico element inclusion and exclusion criteria data variables p (problem) inclusion: all activity related to orthodontic practice exclusion: activities unrelated to orthodontics pertains to the dental specialty that the study concentrates on i (intervention) inclusion: implementation of devices for functional purposes in orthodontics exclusion: original articles focused on artificial intelligence applications in orthodontics focuses on the utilization of automated systems that support orthodontic procedures practitioners o (outcome) inclusion: benefits and drawbacks of utilizing robotics in orthodontics exclusion: studies that do not show practical outcomes on the implementation of robotic technology in orthodontics results in employing innovative technological tools to aid orthodontic treatments s (study type) inclusion: research studies, including published and unpublished original articles, doctoral dissertations, and master’s theses exclusion: any documents not falling within the defined inclusion criteria studies considered to be included within results synthesis table 2. search strategy. source search strategy pubmed: u.s. national library of medicine (“robot technology” or “robot-assisted” or “robotic systems” or “automation in robotics” or “robotization” or “robotic applications”) and (“orthodontics” or “orthodontic treatments” or “dental alignment” or “braces therapy” or “orthodontic procedures”) google scholar search engine “robot-assisted” and “orthodontics” and “dentistry” scopus: abstract and citation database “robot-assisted” and “orthodontic procedures” doaj directory of open access journals “robotic systems” and “dental orthodontics” researchgate: academic networking platform “robot-assisted technology” and “orthodontic treatments” proquest dissertations & theses global: global database of academic theses and dissertations “robotics applications” and “orthodontic care” 35 j global clinical engineering vol.7 issue 1: 2025 cano-verdugo, de la garza-ramos, omosebi, liu, núñez-rocha, ávila-ortíz, hernández-ruiz: protocol for a systematic review on the application of robotics in orthodontics treatments evaluation of potential bias in the study and assessment of the reliability of the evidence to avoid potential issues with missing data or lowquality studies, the potential risk for bias will be established trough the robins-e tool, and individual and overall analyses will be performed. in the absence of data, the decision for article inclusion will be determined through collective agreement. for the certainty assessment, the grade approach will be applied to evaluate the quality of the evidence both individually and collectively.16,17 figure 1. prisma flow selection diagram. table 3. table format that will be employed for data extraction. origin and journal impact level authors, publication year, and country of study type or name of the robotic technology use in orthodontics (either surgical or non-surgical) purpose of the study study results conclusions drawn strengths drawbacks 1st included manuscript 2nd included manuscript # included manuscript cano-verdugo, de la garza-ramos, omosebi, liu, núñez-rocha, ávila-ortíz, hernández-ruiz: protocol for a systematic review on the application of robotics in orthodontics treatments j global clinical engineering vol.7 issue 1: 2025 36 approaches for data synthesis a descriptive synthesis of the data will be carried out, organizing the information according to the use of robots in surgical and non-surgical orthodontic treatments. heterogeneity will be assessed based on design of study and the specific application of robotics in orthodontics.9 results this section will present the results after data collection and analysis. the flow selection will be represented with prisma flow diagram (2020 version)18 for new systematic reviews, which include searches of databases, registers, and other sources, where identification, screening, and included manuscripts will be presented (figure 1). the findings will be based on the use of robotics in surgical and non-surgical orthodontics. tables and figures will summarize key metrics and outcomes to facilitate comparison and interpretation. the risk of bias and certainty of evidence for each included study will be detailed. discussion this study aimed to summarize the methods employed for a systematic review of robotics applications in orthodontics. as a results, we obtained a comprehensive overview of the current methods and techniques used in orthodontics that incorporate robotics. the systematic review is expected to review how robotic technology is applied in orthodontic procedures, potentially providing insights into its effectiveness, precision, and impact on treatment outcomes. additionally, it may highlight the challenges, benefits, and prospects of robotics in orthodontics, helping guide further research or development in this field. this approach aligns with other researchers who have developed protocols for systematic reviews, aiming to clarify the methods used in emerging fields. by establishing clear and structured methodologies, these protocols help ensure that systematic reviews provide solid, reliable, and complementary research. this approach strengthens the evidence base and enhances the understanding of robotics applications in orthodontics, supporting future advancements in the field. such systematic frameworks contribute to a more rigorous and standardized assessment of the technologies and techniques employed, ultimately benefiting clinical practice and ongoing research.19–21 while this review primarily focuses on robotics in orthodontics, it is important to consider complementary technologies that may synergistically enhance robotic applications. artificial intelligence (ai), for instance, has the potential to revolutionize orthodontic treatments by improving diagnostic accuracy, treatment planning, and patient monitoring. ai can work in tandem with robotic systems, enabling more precise movements and personalized treatment strategies based on patient data. additionally, 4d printing, a technology that adds a temporal dimension to traditional 3d printing, could significantly impact orthodontic care by creating dynamic, self-adjusting devices that respond to the patient’s anatomical changes over time. integrating robotics with ai and 4d printing can provide a more holistic and futureproof approach to orthodontic treatments, enhancing both treatment outcomes and efficiency. we will interpret the results in the context of existing literature, highlighting the implications for clinical practice in orthodontics. the advantages and limitations of using robotics in orthodontics will be critically evaluated. additionally, this section will address the study’s strengths and weaknesses, potential biases, and the generalizability of the findings. conclusion this protocol is expected to contribute to elucidating a systematic review detailing robotics applications in orthodontics. it is anticipated that this protocol has been scientifically grounded, aiming to yield generalizable and valuable results to the scientific community. author contributions conceptualization: g.c.-v. and m.a.g.-r., methodology: g.c.-v., o.t.o. and y.l.l., software: o.t.o. and y.l.l., validation: g.m.n.-r. and m.n. á.-o., formal analysis: g.c.-v. 37 j global clinical engineering vol.7 issue 1: 2025 cano-verdugo, de la garza-ramos, omosebi, liu, núñez-rocha, ávila-ortíz, hernández-ruiz: protocol for a systematic review on the application of robotics in orthodontics treatments and k.j. h.-r., investigation: g.c.-v., m.a.g.-r. and k.j.h.-r., resources: m.n.á.-o. and g.m.n.-r., data curation: o.t.o. and y.l.l., writing—original draft preparation: g.c.-v. and m.a.g.-r., writing—review & editing: g.c.-v., m.n.á.-o. and g.m.n.-r., visualization: y.l.l. and k.j.h.-r., supervision: m.a.g.-r. and m.n.á.-o., project administration: g.c.-v., funding acquisition: m.n.á.-o. and g.m.n.-r. acknowledgments the authors would like to express their gratitude to frida priscilla bañuelos-ruiz, dds., and maría josé mora-reyna, dds., for their support in the development of this protocol. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare they have no competing interests ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure a section of the present manuscript has been uploaded to the open science framework (osf) portal and is available for access at the following link: https://osf.io/ tn6s2/?view_only=ac2622dc1b934089906da26d435 2aa49. this repository 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https://doi.org/10.1016/j. jclinepi.2018.01.012. 18. rethlefsen, m.l. and page, m.j. prisma 2020 and prisma-s: common questions on tracking records and the flow diagram. j med libr assoc. 2022;110(2):253–257. https://doi.org/10.5195/jmla.2022.1449. 19. flores-garcía, b.d., núñez-rocha, g.m., ávila-ortíz, m.n., et al. protocol for a systematic review of the health impact of urban farming interventions. eco cities. 2024;5(2):2786. https://doi.org/10.54517/ec2786. 20. muhl, c., wadge, s., hussein, t. social prescribing and students: a scoping review protocol. plos one. 202;18(8):e0289981. https://doi.org/10.1371/journal. pone.0289981. 21. bratti, v.f., wilson, b.e., fazelzad, r., et al. scoping review protocol on the impact of antimicrobial resistance on cancer management and outcomes. bmj open. 2023;13(2):e068122. https://doi.org/10.1136/ bmjopen-2022-068122. https://doi.org/10.4103/jioh.jioh_80_24 https://doi.org/10.4103/jioh.jioh_80_24 https://doi.org/10.1109/icma57826.2023.10215842 https://doi.org/10.1109/icma57826.2023.10215842 https://doi.org/10.1016/j.amjsurg.2024.116057 https://doi.org/10.1136/bmj.n71 https://doi.org/10.1136/bmj.n71 https://doi.org/10.1016/j.jclinepi.2020.07.005 https://doi.org/10.1016/j.jclinepi.2020.07.005 https://doi.org/10.1093/pubmed/fdae056 https://doi.org/10.1136/bmj.328.7454.1490 https://doi.org/10.1136/bmj.328.7454.1490 https://doi.org/10.1016/j.jclinepi.2018.01.012 https://doi.org/10.1016/j.jclinepi.2018.01.012 https://doi.org/10.5195/jmla.2022.1449 https://doi.org/10.54517/ec2786 https://doi.org/10.1371/journal.pone.0289981 https://doi.org/10.1371/journal.pone.0289981 https://doi.org/10.1136/bmjopen-2022-068122 https://doi.org/10.1136/bmjopen-2022-068122 109 j global clinical engineering vol.6 special issue 6: 2024 conference paper revolutionizing healthcare education: mobile virtual patients for digital problem-based learning ioanna dratsiou, evangelia romanopoulou, annita varella, eleni dafli and panagiotis d. bamidis* medical physics and digital innovation laboratory, school of medicine, faculty of health sciences, aristotle university of thessaloniki (auth), thessaloniki, greece * corresponding author email: pdbamidis@gmail.com abstract the move to a student-centered medical curriculum places greater emphasis on active learning and the development of clinical reasoning skills. virtual patients, defined as computer-based programs that simulate real-life clinical scenarios, have become increasingly popular as an enhancement to medical training. this study explores the usability and effectiveness of mobile virtual patients (mvps) in supporting healthcare professionals and medical students in developing skills related to symptom management, diagnosis, and treatment in the context of the h2020 shapes project for older adults. fourteen participants, divided into two groups of seven each from the university of nicosia and aristotle university of thessaloniki, respectively, participated in pbl sessions using mvps. these cases encompassed various conditions, from neurodegenerative diseases to chronic conditions, focusing on participants active engagement and inquiry-based learning. the system usability scale (sus) and the electronic virtual patients (evip) toolkit were applied, which brought usability, technology acceptance, and clinical reasoning into perspective. results showed high usability, with healthcare professionals giving an sus of 86.2, compared to 77.5 for medical students. both groups reported positive experiences, but medical students rated the learning effect and coaching higher than healthcare professionals. this suggests that mvps are valuable instruments in enhancing clinical reasoning and knowledge acquisition. it further emphasizes the customization of mvps for the various needs of a medical student and a healthcare professional to realize optimized educational outcomes. future studies should address scalability, infrastructure needs, and inclusion in broader medical curricula to further advance the spread within healthcare education. keywords—mobile virtual patients (mvps), problem-based learning, clinical reasoning, usability, healthcare education. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.6 special issue 6: 2024 110 introduction medical education has shifted towards a student-centered approach, placing greater importance on active learning and the development of clinical reasoning skills rather than relying solely on passive information absorption and unproductive memorization.1,2 several studies have demonstrated the efficiency of simulation for knowledge acquisition and for technical3 and nontechnical4,5 skills training in healthcare. indeed, the rapid advancement of dependable information technologies has made it possible to develop contemporary learning activities that were previously unattainable. these innovations now have the potential to significantly enhance medical education and training in healthcare.6 under this perspective, virtual patients (vps) are often defined as “specific types of computer-based programs that simulate real-life clinical scenarios where learners emulate the roles of health care providers to obtain a history, conduct a physical exam, and make diagnostic and therapeutic decisions”7, have seen a growing adoption as educational tools in numerous medical institutions.8 one of the fundamental features inherent to vps is their capacity to furnish a secure and risk-free environment for medical practice and also offer clinical skills learners the invaluable opportunity for repeated utilization, completely unhindered by the constraints of time and place. this multifaceted functionality not only ensures a safe learning environment but also promotes accessibility and convenience.9 there has certainly been a noticeable trend toward vps creation and use among academic institutions as a result of the opportunities that they offer in contemporary medical education.10 in fact, the encouraging evaluation results of studies showed that vps are highly accepted by both medical teachers and students, and also may improve cognitive and behavioral skills more effectively than traditional approaches do.2,10 in recent years, the school of medicine of the aristotle university of thessaloniki (auth) has undertaken significant initiatives to enhance medical education by embracing contemporary educational approaches and modernizing the curriculum.11 as a result of these efforts, a comprehensive and accessible vps repository has been established.12 this accomplishment has been further strengthened with more vps, resulting from the sustainable exploitation of the outcomes of medical-oriented research projects, to support students and healthcare professionals in developing practical knowledge, clinical reasoning skills, and professional behavior. all these vps have also been adapted and seamlessly integrated into a mobile environment functioning as mobile virtual patients (mvps).13 furthermore, these educational resources have been fully incorporated into problem-based learning (pbl) sessions within the medical curriculum, serving both undergraduate and postgraduate students2 and supporting healthcare professionals’ innovative learning. rationale of this study mpvs were utilized within the context of the h2020 shapes project14 aimed to establish a european open ecosystem enabling the deployment of a large-scale, eu standardized open platform for supporting and extending healthy and independent living for older adults. the shapes pan-european piloting campaign was launched in fifteen pilot sites, including six european innovation partnership on active and healthy ageing (eip on aha) reference sites, and involved hundreds of key stakeholders, such as older adults, their families, caregivers, and healthcare professionals.15 the deployment of mvps served a specific purpose within this broader project. they were employed to support healthcare professionals and medical students in enhancing their skills related to older adults’ symptoms management, diagnosis, and treatment as well as refining their reasoning and decision-making capabilities, contributing to improved healthcare practices for older individuals. in the context of our broader project, we deployed mvps to assist healthcare professionals and medical students in enhancing their skills related to older adults’ symptom management, diagnosis, and treatment, while improving their reasoning and decision-making capabilities. within this framework, the present study endeavors to address the following research question: how do healthcare professionals and medical students experience pbl with mvps, while considering factors http://www.globalce.org http://globalce.org http://globalce.org 111 j global clinical engineering vol.6 special issue 6: 2024 such as usability, technology acceptance, and their clinical reasoning perspectives on mvps? methods and materials participants participants’ recruitment and pilot activities were supported by the thessaloniki action for health & wellbeing living lab (thessaloniki active and healthy ageing living labs, thess-ahall)16, which operated since 2014 under the auspices of the lab of medical physics and digital innovation, school of medicine, auth. multifaceted recruitment strategies have been implemented within the thess-ahall ecosystem (municipalities and public entities, hospitals, rehabilitation centers, and nursing homes, as well as a great number of individuals/beneficiaries) to approach and recruit eligible participants. a total of fourteen participants were recruited for the pilot activities, and divided into two distinct groups. one group consisted of medical students at the university of nicosia research foundation (unrf) (n = 7) and the pilot activity was conducted in cyprus, while the other group comprised healthcare professionals (n = 7) and took place at auth in greece (table 1). the sample size was regarded as appropriate given the iterative approach guiding this preliminary investigation. table 1. participants’ demographics. groups healthcare professionals (n = 7) medical students (n = 7) age m = 29.9 ± 10.9 m = 22.2 ± 2.3 gender 85.7% female 14.3% male 71.4% female 28.6% male level of education 57.1% bachelor’s degree 28.6% master’s degree 14.3% ph.d. or higher 71.4% lower secondary school certificate 28.6% bachelor’s degree level of digital literacy 42.8% basic 14.4% intermediate 42.8% advanced 28.5% basic 28.5% intermediate 43% advanced intervention during their engagement with the scenarios, participants were exposed to interactive computer simulations replicating real-life healthcare and medical training scenarios, primarily designed for educational assessment and training purposes. within this context, participants were provided with the opportunity to interact with a diverse array of virtual cases through the mobile virtual patients app (figure 1), allowing them to gain familiarity with a spectrum of neurodegenerative diseases, such as alzheimer’s, parkinson’s, dementia, and stroke, alongside other chronic diseases like diabetes and heart diseases. this interactive approach facilitated an inquiry-based learning methodology, fostering a deeper understanding of these medical conditions. in particular, both two groups interacted autonomously with virtual scenarios divided into four categories: • diagnosis & treatment scenarios (55 scenarios) aimed to simulate various medical conditions and their corresponding treatment plans. • educational scenarios (7 scenarios) focused on providing educational content to learners about new medical techniques, procedures, or guidelines. • symptoms management (3 scenarios) is designed to simulate patients' symptoms and enable learners to practice managing and treating them effectively. figure 1. mobile virtual patients app interface. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 112 • empowerment category (4 scenarios) aimed to help learners familiarize themselves with patient empowerment and active participation in their healthcare. overall, the study adhered to general data protection regulation (gdpr) regulations, obtaining the necessary bioethics approval from the aristotle university of thessaloniki bioethics committee. informed consent was obtained from all participants, ensuring their understanding of the study’s scope and their rights as participants. measures system usability scale score (sus score)17 was used to measure the level of usability along with the electronic virtual patient evaluation toolkit (evip toolkit) to explore participants’ learning and clinical reasoning experiences with mpvs as well as their overall pbl experience. the evip toolkit is an assessment tool for virtual patients created by the largest european program for virtual patients18 serving as an evaluation tool for the achievement of educational outcomes resulting from the use of digital virtual patients. it is based on a set of likert-type statement responses grouped clustered into five subsets: 1) authenticity of the patient encounter and the consultation, 2) professional approach in the consultation, 3) coaching during consultation, 4) learning effect of the consultation, and 5) overall, judgment of case workup. dimensions of perceived usefulness (pu), perceived ease-of-use (peu), and intention of use (iu) were also measured to explore the technology acceptance of mvps. results findings from the clinical reasoning tool analysis illuminated slight distinctions in the manner in which the two groups perceived their progress in achieving educational outcomes when utilizing mvps. the analysis indicates that the coaching provided during consultation exhibits the most notable disparity, with medical students achieving significantly higher scores than healthcare professionals. in addition, the axis of learning effect within the consultation further underscores that medical students consistently achieve superior scores highlighting a clear difference in how they acquire knowledge. however, it is important to note that both groups’ participants’ overall evaluation of whether working through mpvs was a worthwhile learning experience remains favorable, as the scores in both groups exceed the m = 4 (see figure 2). the exceptionally high sus score of m = 86.2 ± 11.1 obtained from healthcare professionals undoubtedly validates the outstanding usability of the mvps. this remarkable score underscores the system’s user-friendliness and effectiveness in meeting the specific needs and demands of healthcare professionals, further enhancing its practical significance in the healthcare context. the sus score derived from medical students’ feedback (m = 77.5 ± 6.6), suggests a good level of usability for the proposed mvps among participants. when comparing these results with those of healthcare professionals, it’s notable that both groups reported above-average usability scores. while medical students’ scores are slightly lower than those of healthcare professionals, the overall trend indicates a consistent perception of the system’s usability across these different user groups, affirming its broad applicability within the healthcare domain (table 2). table 2. usability, technology acceptance, and clinical reasoning results. healthcare professionals (n = 7) medical students (n = 7) sus m = 86.2 ± 11.1 m = 77.5 ± 6.6 figure 2. the e-vip clinical reasoning results. http://www.globalce.org http://globalce.org http://globalce.org 113 j global clinical engineering vol.6 special issue 6: 2024 acknowledgments we would like to express our sincere appreciation to the participants and collaborators whose involvement and contributions were essential to the successful completion of this study, especially andreas andreou and prof. constandinos mavromoustakis from unrf and iraklis tsoupouroglou from auth. references 1. hege, i., kononowicz, a.a., berman, n.b., et al. advancing clinical reasoning in virtual patients–development and application of a conceptual framework. gms j med educ. 2018;35(1). doi: 10.3205/zma001159. 2. dafli, e., fountoukidis, i., hatzisevastou-loukidou, c., et al. curricular integration of virtual patients: a unifying perspective of medical teachers and 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(2007). effective use of educational technology in medical education--colloquium on educational technology: healthcare professionals (n = 7) medical students (n = 7) pu m = 4.57 ± 0.53 m = 4.29 ± 0.76 peu m = 4.71 ± 0.49 m = 4.43 ± 0.53 iu m = 4.57 ± 0.79 m = 4.29 ± 0.76 discussion this study sought to assess the level of usability and technology acceptance concerning the mvps between medical students and healthcare professionals as well as discern potential different viewpoints between these two distinct participant groups. across healthcare professionals and medical students, the mvps demonstrated favorable ratings, demonstrating their effectiveness in facilitating learning experiences. the high sus score suggests that the digital solution was user-friendly, while positive assessments in dimensions like pu, peu, and iu emphasize its value and accessibility. although subtle variations in perceptions exist, both groups viewed the mvps as valuable resources for supporting clinical reasoning skills. these different perspectives emphasize the importance of tailoring mvps to align with the distinct needs and expectations of each group, thereby optimizing their educational value and clinical reasoning development. conclusions and future work overall, the results collectively underline the digital solution’s potential to enhance healthcare education, catering to the needs of healthcare professionals and aspiring medical students alike. future research could focus deeper on understanding the specific preferences and expectations of each group to tailor the mvps cases accordingly. exploring their scalability of implementation on a larger scale within healthcare education institutions could provide valuable insights into their practicality and sustainability for widespread adoption. this research could involve assessing infrastructure requirements, training needs, and the financial implications of integrating the mvps into the curriculum. http://www.globalce.org 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adults. technologies. 2022;10(1):8. https://doi.org/10.3390/ technologies10010008. 16. thessaloniki action for health & wellbeing living lab (thess-ahall). available online: https://aha livinglabs.com/. 17. lewis, j.r. and sauro, j. the factor structure of the system usability scale. in human centered design: first international conference, hcd 2009, held as part of hci international 2009, san diego, ca, usa, july 19–24, 2009. springer: berlin, germany. https://doi. org/10.1007/978-3-642-02806-9_12. 18. electronic virtual patient project (evip). available online: http://virtualpatients.eu/. http://www.globalce.org http://globalce.org http://globalce.org https://designformeded.com/wp-content/uploads/2013/05/effective-use-of-educational-technology-in-medical-education.pdf. https://designformeded.com/wp-content/uploads/2013/05/effective-use-of-educational-technology-in-medical-education.pdf. https://designformeded.com/wp-content/uploads/2013/05/effective-use-of-educational-technology-in-medical-education.pdf. https://doi.org/10.1186/s12909-015-0296-3 https://doi.org/10.1186/s12909-015-0296-3 https://doi.org/10.1002/9781119061656.ch10 https://doi.org/10.1002/9781119061656.ch10 https://aristotlemedical.edu.gr/ https://vp.med.auth.gr/ariadne https://vp.med.auth.gr/ariadne https://shapes-26bd2.web.app/ https://shapes2020.eu/ https://shapes2020.eu/ https://doi.org/10.3390/technologies10010008 https://doi.org/10.3390/technologies10010008 https://aha livinglabs.com/ https://aha livinglabs.com/ https://doi.org/10.1007/978-3-642-02806-9_12 https://doi.org/10.1007/978-3-642-02806-9_12 http://virtualpatients.eu/ editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 j global clinical engineering vol.4 issue 3: 2022 16 received january 31, 2022, accepted february 9, 2022, date of publication march 1, 2022 overview of trending medical technologies by jean marie vianney nkurunziza, jean claude udahemuka, jean baptiste dusenge, francine umutesi medical technology division, rwanda biomedical center, kigali, rwanda abstract healthy population is regarded as the most valuable asset of any country. unfortunately, the health challenges that hinder mankind's wellbeing are enormously increasing. examples include but are not limited to: the diversity of emerging diseases afflicting the global population, the projected demographic growth of elderly people who need consistent monitoring, the deficiency in medical staff, the lower density of physicians, and the challenging geographical location of the population from healthcare providers. the mitigation of such health challenges calls for novel technologies to improve patient outcomes. in this article, seven emerging technologies, namely: wearable devices and internet of things, artificial intelligence, blockchain technology or distributed ledger technology, robotics technology, telehealth and telemedicine, big data technology and nanomedicine have been highlighted. for each discussed technology, its historical background, development drivers, market status and trends, significance to healthcare, key player companies, and associated challenges have been presented. the information contained in this paper was collected from different journal articles, websites, reports, conference proceedings, and books. it was observed that though the technologies discussed in this article show growth at different rates, healthcare technology development and implementation are very promising in revolutionizing the health sector and improving the health of the population. therefore, healthcare providers and countries are recommended to put in place healthcare technology assessment programs to help them collect data regarding the technology efficacy, relevance, safety, outcomes, and alternative technologies towards better planning for healthcare services improvement. keywords – wearable devices, internet of things, blockchain, telehealth and telemedicine, artificial intelligence, big data, nanomedicine, market, drivers, challenges and companies. copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction the triumph of modern medicine is axed to the emerging technological innovations, and there is no doubt that the medical expenditures and life expectancy are variables driven by technological progress.1-2 medical technology uses scientific knowledge to improve healthcare by new and improved equipment to make work easier, pleasant, quick, and productive.3 the management and treatment of diseases have become largely dependent on innovation and discoveries in newer drugs, surgical techniques, diagnostic and therapeutic equipment.3 medical doctors themselves are becoming more reliant on technology to diagnose and carry out treatments.4 the scope of medical technology is vast; it covers consumables (bandage, syringes, hearing aids, wheelchairs, etc.), implants (hips http://www.globalce.org http://globalce.org http://globalce.org 17 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies and knees, stents, pacemakers, etc.), medical equipment (imaging machinery, dialysis equipment, etc.), and in-vitro diagnosis.5 technological innovations are appreciated by the general population because they enable a 4p-model for medicine (predictive, preventive, personalized, and participatory).6 the factors that reinforce the market for medical technology include advances in science and engineering, patent protection, increasing prevalence of chronic diseases, aging population, emerging pathogens, financial incentives of technology companies, mass media reports, public demand driven by direct-to-consumer advertising, consumer awareness and advocacy, rising prices of physician and hospital services, off-label use of drugs and devices, malpractice avoidance, strong and growing economies.7-8 the maintainability of high quality of life in the aging population is probably the most significant underlying global which requires requiring technological mindset.9 for example, japan has the longest life expectancy, and its aging population ratio is still increasing. this has called for rising expenditures, giving concerns about the future inflation of health costs.10 in 2050, 16% (1.5 billion) of the world’s population will be above 65 years old.11 in china, 2.4 young people will have to support 7.9 old people in 2050.11 the physical nature, purpose, and stage of diffusion constitute the three ways to describe a healthcare technology.7 according to the stage of diffusion, medical technologies classification is presented in table 1. today the actual figures for medical technologies are not available, but it is estimated that 500,000 different types of medical devices are in service.12 from 1960 to 2007, health care expenditure in oecd countries increased, on average, from 3.8–9.0% of gdp.1 in 2020 it was forecast that the global market for medical technology would achieve a volume of 490 billion euros.11 in 2025, global turnover for medical devices is estimated at approx. 615 billion dollars.11 the main categories of healthcare technology include but are not limited to: drugs, biologics, devices/equipment and supplies, medical and surgical procedures, public health program, support systems, organization, and managerial systems. however, not all technologies fall neatly into the category, and certain hybrid technologies combine drugs and devices.7 in the past decade, the medical technology revenues have increased by 44.7% (usd 352.9 billion to usd 510.9 billion for 2011 and 2021, respectively), and the forecast is to reach usd 594.5 billion in 2024.13 in 2022, the strongest medical technologies segments will be in cardiology, imaging diagnostics, orthopedics, and surgery. these technologies will account for 50% of the market.11 although there are giant companies in medical technology, 95% of all medical technologies businesses are small and medium-sized companies (sme), with the majority having fewer than 50 employees.11 as of 2020, medtronic inc. was the leading medical technology company with a revenue of 30.12 billion usd. it was seconded by johnson&johnson with total revenue of 23 billion usd. in a survey conducted about medical technology in belgium,5 106 companies participated, and the results are that 67.9% were active in medical devices-consumables, 15.1 % in in-vitro diagnosis, 12.7% in pharmaceutical products, 6.6% in para-pharmaceutical products, 43.4% in medical software, 40.6 % in implants and 45.3% in medical equipment and systems. medical technologies are classified into preventive, screening, diagnosis, rehabilitation, palliation, and treatment types.7 the technological acceptance and use expansion vary from society cultures. the technology acceptance model developed by davis, theory of planned behavior, and unified theory of acceptance and use of technology 2 (utaut2) developed by venkatesh showed that perceived table 1. classification of medical technologies according to the stage of diffusion7 medical technology class explanation future in a conceptual stage, anticipated, or in the earliest stages of development experimental undergoing bench or laboratory testing using animals or other models investigational undergoing initial clinical (i.e., in humans) evaluation for a particular condition or indication established considered by clinicians to be a standard approach to a particular condition or indication and diffused into general use obsolete/ outmoded/ abandoned superseded by other technologies or demonstrated to be ineffective or harmful j global clinical engineering vol.4 issue 3: 2022 18 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies usefulness, perceived ease of use, price value, and habit are the key factors that determine the application and market expansion of a particular technology in a certain region.14,15 in addition to those factors, commercial-grade, durability, reliability, sustainability, technical support, disinfection, alarm management, network, and device security also advocate adopting a particular technology.16,17 literature review it is not easy to cover all details of the medical technologies available in a single paper due to their diversity. in this paper, the following trending technologies are looked at: health wearables and internet of things, artificial intelligence (ai), blockchain technology (bct) or distributed ledger technology (dlt), robotics technology, nanomedical technology, telemedicine and telehealth, big data health wearables and internet of things environmental, psychological, behavioral, and physiological domains that adversely impact the quality of life are recognized by the world health organization.19 wearables as medical technologies are becoming part of personal analytics, measuring physical status, recording physiological parameters, or informing schedules for medication.20 the journey of wearables started with the invention of spectacles around the 13th century by english friar roger bacon.21 growth in wearables was slow until the 20th century, when in 1907, the first portable camera was put on the market. since then, the pace of developing new devices never ceased to increase until 2014, when android wearables were commercialized. the whole evolution of wearable technology is picturesquely presented in the chronological sequence in figure 1. from a monetary perspective, the market of wearable devices is anticipated to grow exponentially at a rate of 20% and is expected to reach 150 billion eur by 2028, as presented in figure 2. figure 1. evolutional milestones in wearable devices.21 figure 2. wearable market growth forecast.21 19 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies in the third quarter of 2021, the chinese market shipped 35.28 million units across the globe,22 and the market was dominated by huawei.23 from a technological point of view, wearables are self-contained devices with embedded sensors worn by the user to detect, diagnose, monitor, and communicate the health and performance data of the user.24 wearable technologies include smartwatches, wristbands, hearing aids, electronic/optical tattoos, head-mounted displays, subcutaneous sensors, smart belts, electronic footwear (smart shoes and socks), and smart textiles (smart pants, smart shirts).20,25 generally, wearables devices are composed of five components: sensors, connectivity, battery, interface, materials/algorithm.25 from the design and manufacturing consideration, wearable devices contains microprocessors, interface including data communication, different types of sensors: inertial measurement units (gyroscopes, accelerometers, barometers, and magnetometers), optical sensors (complementary metal-oxide-semiconductor [cmos]) sensors, spectrophotometers, cameras, temperature sensors, chemical probes, electrodes, microphones, shock detectors, strain gauges.20 these days, when the world is dealing with covid-19, vital-sign wearable solutions were implemented in different countries. wearables can provide a key early-warning system about the likelihood of covid-19 infection and its surveillance.26 for example, in singapore, visi mobile developed by sotera was used as a wearable device on patients in mild illness to monitor heart bit rate, respiratory rate, body temperature, and oxygen saturation.16 wearable devices find different application in biomedical and clinical services, as shown in figure 3. apart from measuring vital signs, aggregate data taken from wearables can also contribute to the research by detecting general patterns and trends within a population, contributing to improved public health responses.26 wearables are positioned to different body parts depending on the parameter to be measured, as shown in figure 4. wearable devices come into 4 main classes25: • lifestyle and fitness devices. this includes fitness trackers, sport and activity trackers (e.g., moov now, misfit shine, fitbit charge2). • diagnostics and monitoring devices. these noninvasive devices provide valuable health information (e.g., dexcomg4, quardio core). • therapeutic devices. these devices monitor disease states, track activity, store data, and deliver feedback therapy (e.g., quell, minimed530ginsulin pump). injury prevention and rehabilitation devices. this includes body motion monitoring devices, wearable sensing garments, fall detection devices (e.g., philips lifeline, sprouting baby monitor). the international electro-technical committee standardization management board strategic group10 distinguishes wearable technologies into near-body electronics, on-body electronics, in-body electronics, and electronic textiles.17,21 wrist-worn and handheld wearables are the most widely adopted and market-filled niche covering figure 3. some biomedical applications of medical wearables.27 figure 4. wearables based on on-body location.26 j global clinical engineering vol.4 issue 3: 2022 20 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies smart rings, wrist bands, smartwatches, and gesture control devices.21 unlike conventional testing in a clinical setting, which may occur a few (or less) times a year, wearables offer continuous access to real-time physiological data.28 in their use, wearable devices are applications of the internet of things, a concept used by devices for sending and receiving data via the internet.18 embedded intelligence connectivity offers a unique opportunity for condition monitoring, localization, identification, personal contextual notifications, information display, and virtual assistance.21 the wearables data processing cycle follows 6 stages, as presented in figure 5. the wearable market is growing faster in patients with specific conditions like epilepsy, chronic obstructive pulmonary disease, asthma, heart arrhythmia, chronic pain, and breast cancer.17 today, many wearable devices are commercially available, such as rings, headsets, sleep masks, wearable patches, arm straps, finger clips, chest straps, fitness bracelets, fitness bands, and flex garments. specific products include google glasses, gow pack, lumoback, metria wearable sensor technology, necg platform, peeko monitor, persmobile, numetrex heart sensing racer tank, re-timer, sleepshirt, t. jacket, 360 kids guardian, and vega.15,24,29 significant growth in purchased wearable devices has been recorded in north america, western europe, and the asia pacific region, while in the rest of the world, the market growth is lower. reports about the future of wearable technologies predict that the market volume will be 27.8 billion dollars in 2022 and 93.19 billion dollars in 2027.18 some of the challenges of wearable devices include the feeling of constant surveillance, inefficient data analytics, lack of appropriate data labeling, insufficient computing capabilities, inefficient switching among resources in hybrid networks, lack of modern energy harvesting figure 5. wearables data processing cycle.21 table 2. wearable wireless technologies, operating frequency, and range.21 communication technology frequency range range short-range rfid 125–134 khz, 13.56 mhz, 860–960 mhz up to 100 m nfc ble (ieee 802.15.1) 13.56 mhz 2.4–2.48 ghz <0.2 m up to 100 m zigbee zigbee (ieee 802.15.4) 868–868.6 mhz, 902–928 mhz, 2.4–2.49 ghz up to 100 m wi-fi (ieee 802.11a/b/g/n) 2.4–2.48 ghz, 4.9–5.8 ghz 20-250 m wi-fi 5 (ieee 802.11ac) 4.9–5.8 ghz up to 70 m wi-fi 6 (ieee 802.11ax) 1–6 ghz up to 120 m wigig (ieee 802.11ad/ay) 57–70 ghz 10–100 m vlc (ieee 802.15.7) 400–800 thz up to 100 m vlc (ieee 802.15.7) lte frequency bands up to 15 km long-range lte-m lte frequency bands up to 10 km lora 867–869 mhz up to 50 km sigfox 868–878.6 mhz up to 50 km 21 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies opportunities, low data resolution.21 the major market players in wearable medical technologies are: apple, fitbit, jawbone, misfit, mykronoz, samsung, garmin ltd, xiaomi technology co. ltd, qualcomm technologies, inc; adidas group, sony corporation, lifesense group.18 the details on many body-worn devices are presented in figure 6. artificial intelligence (ai) ai is rapidly evolving in clinical practice in dealing with a significant amount of data provided by smart wearables, smartphones, and other monitoring systems in medical services.6 the concept of ai was first conceived in 1950 by alan turing in his book entitled computers and intelligence in what was called turing test when he was trying to determine whether computers were capable of human intelligence. in 1956, john mccarthy described “artificial intelligence” as the science and engineering of making intelligent machines.30 the systematic evolution of ai is presented in figure 8. today, ai is defined as using computers and technology to simulate intelligent behavior and critical thinking comparable to a human being or the science and engineering of making intelligent machines.31-34 the evolution of ai is presented in figure 3. ai is not one type of machine or robot but a series of approaches, methods, and technologies that display intelligent behavior by analyzing their environments and taking actions—with some degree of autonomy—to achieve specific targets that can improve health services.35,36 studies about ai have exponentially increased from 826 in 2012 to 12563 in 2019.37 by 2019, there were 279,145 ai patent applications in the us, with the global market expected to reach 190.61 billion dollars in 2025. ai can add about $15.7 trillion to the world economy by 2030,38 with china leading the global market in 2030 with a share of 26.1%.39 these assertions are justified by the research article published by chinese universities from 2015 to 2019, as seen in figure 7. with ai, patients will receive more rapid, accurate diagnoses and reduced adverse events. the top applications of ai include robot-assisted surgery, virtual nursing assistant, administrative workflow assistance, fraud detection, dosage error reduction, clinical trial participant identification, preliminary diagnosis, automated image diagnosis, cybersecurity, health research, and drug discovery and development.41 ai also finds application in diagnosis and case identification and prognosis and prediction. the ai umbrella encompasses the following subfields30: • machine learning (ml): machine learning involves training an algorithm to perform tasks by learning from figure 6. wearable devices worn on various body parts and the parameters they can monitor.27 figure 7. top 10 institutions with the most ai-related publications (2015-2019).40 j global clinical engineering vol.4 issue 3: 2022 22 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies patterns in data rather than performing an explicitly programmed job.42 machine learning algorithms can automatically learn and improve from experience without explicitly programming. the most common algorithms of ml are: supervised learning (used when we can precisely define the task we want the algorithm to learn based on data that we already have), unsupervised learning (it is like learning without a teacher. we have a group of patients with different sets of data, but we do not know their individual diagnoses. we build a model, then try to cluster patients based on similar attributes such as the symptoms they presented with, their lab markers or age and gender), reinforcement learning (this allows the algorithm to learn how to complete the tasks with a sequence of decisions by itself without being told how to do it).35,37 • deep learning (dl): it is a subset of ml with similar functions but with different capabilities.37 this method of ai allows a machine to be fed with large quantities of raw data and to discover the representations necessary for detection or classification.43 dl uses chips called graphics processing units to rapidly perform required calculations, a single card of which can potentially process hundreds of millions of images a day.42 dl mammography is used for breast cancer detection, in computed tomography (ct) for column cancer diagnosis, in chest radiographs, for the detection of pulmonary nodules.41 • natural language processing: this branch of ai is concerned with the use of computational methods in understanding and interpreting human language.35,42 artificial neural networks (ann) or simulated neural networks (snn): ann are considered the heart of dl. ann is technology based on a human neural network.44 examples of ann include handwriting recognition, speech-to-text transcription, weather prediction, and facial recognition.45 an snn contains a node layer, one or more hidden layers, and an output layer. each node, or artificial neuron, connects to another and has an associated weight and threshold. if the output of any individual node is above the specified threshold value, that node is activated, sending data to the next layer of the network.46 ann are used in economics, ecology, environment, biology. in medicine, the most widely used family is the multilayer perceptron (pmc) in therapeutic decisions to process data for anthropology.47 • computer vision (cv): cv allows the building of artificial systems capable of retrieving any information from an image previously obtained. cv involves different stages, namely: image acquisition (image capture with a sensor and transformation of visual information into digital information), pre-processing (preparing the image for the next level handling), feature extraction (detection of some objects to be analyzed), segmentation (separation of images into cohesive regions), noise reduction and high-level processing.48 today, there are many practical applications where ai was successfully useful. the key challenges of ai are their computing power, trust deficit, data privacy and security, data scarcity,38 ethical regulations, high resource and research cost, shortage of transparency, poor governance and accountability, notability of data annotation.49 globally, the ai companies are nvidia corporation, amazon.com, inc., meta platforms, inc., deepmind, openai, affectiva, datarobot, ubiquity6 cloudminds.50,51 to ensure appropriate utilization of ai, companies need to embrace techniques that help them achieve fairness, security, and explainability.49 table 3. examples of success of artificial intelligence.37 company application babylon health software application for online consultation where the system gives medication based on the symptoms entered in the system sensely (developed molly app) a virtual nurse that was designed to have a smiling face coupled with a pleasant voice to assist patients with monitoring their health deep genomics (developed oncecompass medecine app) to match genetic mutations found in patients’ tumor samples with ongoing clinical trials worldwide ibm watson software that provides evidence-based treatment options for oncologists atomwise uses supercomputers to root out treatments from a database of molecular structures http://amazon.com 23 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies table 4. applications of artificial intelligence in diagnosis and prediction.43 diagnosis and case identification prognosis and prediction function clinical area applications waveform analysis obstetrics intrapartum monitoring cardiovascular risk prediction, prediction of breast cancer survival. prediction of outcomes in colorectal cancer, predicting of survival in non-small cell lung cancer. prediction of hospitalization due to heart disease. prediction of sepsis in the intensive care unit, emergency department, and hospital floor prediction of treatment outcome in social anxiety. prediction of psychiatric readmission from discharge summaries neurology remote monitoring of gait image processing pathology detection of lymph node metastases in breast cancer dermatology identification of benign and malignant tumors, identification of fungal infection, classification of skin cancer ophthalmology identification of diabetic retinopathy, grading of macular degeneration cardiology diagnosis of acute coronary syndrome, identification of heart failure status through remote patient monitoring radiology mammography, diagnosis of pneumonia from chest x-ray electronic health records analysis identification of sepsis in the emergency department, identification of breast cancer symptoms, heart failure case identification, identification of patient phenotype from analysis of intensive care unit data, identification of medical subdomains in clinical notes figure 8. historical evolution of artificial intelligence.30 j global clinical engineering vol.4 issue 3: 2022 24 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies bct or dlt patients and healthcare practitioners are faced with the challenge of accessing, managing, integrating, and sharing health records securely.52 in many countries data are recorded on legacy papers and numerous disconnected electronic systems. in the us, 90% of physicians use unconnected computerized systems. patients must recount their history multiple times, which may be done incompletely. medical errors are estimated to be the third leading cause of death for americans. in 2015, 140 million patient records were breached according to protenus breach barometer report.53 the who estimates that many countries in africa and parts of asia and latin america have areas where more than 30% of the medicines on sale can be counterfeit.54 in 2018, the healthcare industry continued to be plagued by data breaches involving sensitive patient information. according to the breach barometer 2019 report, more than 15 million patient records were breached in 2018. such incidents allow blockchain vendors to launch new solutions.54 to alleviate the associated adverse effects, an interconnected system is needed. in the uk, the nhs planned to interconnect all computerizing health network records by 2018; however, this target was delayed first to 2020 and again to 2023.55 nevertheless, during covid-19, which is ravaging the globe, blockchain technology was used by two uk hospitals to keep tabs on the storage and supply of temperature-sensitive covid-19 vaccines.56 in march 2021, moderna, a biotechnology and pharmaceutical company based in the united states, signed a new agreement with ibm to use blockchain technology to manage its covid-19 vaccines. additionally, 3m pharmaceuticals, another american pharmaceutical giant, uses blockchain technology to curb counterfeit pharmaceuticals. recently, it has started using blockchain technology to identify and stop counterfeit face masks.57 bct, though initially designed for the financial market, its inherent characteristics make it suitable for the health sector, insurance, pharmacy, iot, food science, industries, e-voting, tourism, energy, and legal contract.58-60 bct helps streamline business processes by establishing trust, accountability, and transparency.58 in medical applications, the ideal blockchain model would be scalable with high security and data privacy. in finance, bitcoin and ethereum are examples of cryptocurrencies that use blockchain technology.61 in medical and clinical services, by using bct, patients become the platform, owning and controlling access to their healthcare data. the data are stored in the private blockchain cloud, where they cannot be changed by anybody, including physicians and patients themselves internally and natively. because data is stored on a decentralized network, there is no single institution that can be robbed or hacked to obtain a large number of patient records. data is encrypted in the blockchain and can only be decrypted with the patient’s private key. even if a malicious party infiltrates the network, there is no practical way to read patient data.62,63 in terms of patients’ full control of their health record history, there are three major aspects of privacy that need to be considered: (a) data ownership; (b) fine-grained access control; (c) data transparency, integrity, and auditability.53 in healthcare services, the key enablers of blockchain are the need for patient data security, desire to reduce medical errors and mistakes, breakthroughs in genomics, drug traceability and safety, government partnerships, removal of unscrupulous attacks, reduction of cost in medical transactions, and improved confidentiality in healthcare business operations.63 a blockchain is a ledger of transactions where an identical copy of the ledger is visible to all the members of a computer network. it is a digital healthcare system management from which authorized users, such as providers and patients, have access.62 bct is a permanent record of online transactions distributed, shared, and maintained by multiple parties. the first blockchain was developed by satoshi nakamoto in 2009. the technology brought breakthroughs until 2021 when dubai hosts all government operations and record-keeping operations on blockchain as part of the smart dubai 2021 initiative.64 25 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies the data-sharing practice is essential to enable clinical practitioners to transfer their patients' clinical data to the concerned authority for a quick follow-up.60 bct differs from a personal ledger in the number of security checks, whereby a blockchain makes many security checks.61 this technology is interpreted as blocks linked together to form a chain to offer patients and caregivers the ability to securely share the patient identity and healthcare information across platforms. today, the market for blockchain technology is very promising because it is forecast to save $100 billion per year since 2025. the saving will be realized in a reduction in data-breaching related costs, operations costs, information technology (it) costs, counterfeit-related fraud, and insurance fraud.52 in healthcare, the blockchain market in healthcare was valued at usd 2.12 billion in 2020 and is expected to reach usd 3.49 billion by 2026 and usd 4.7 billion in 2027 with a cagr of 8.7% during the forecast period, 2021–2026, with north america as the fastestgrowing market.54 regarding research, the number of scientific publications about blockchain technology shifted from 5 in 2016 to 64 in 2018. this was another indicator that this market was rapidly attracting researchers.65 in its structure, the components of blockchain technology are listed below. • blocks are the base of a blockchain and contain records linked lists, chains, genesis blocks, and consensus protocol.66 blocks contain records of the past transactions and have segments reserved to save the data for future transactions. a block on a blockchain network consists of hash codes, root hash of merkle tree, and nonce.61 • chains are blocks inside a blockchain network that are connected to each other. multiple blocks that are joined together form a chain of blocks. • nodes contain the entire history of a blockchain network. nodes are the devices that store these vast amounts of data. computers, laptops, and big servers function as nodes. all the nodes in a blockchain network are linked together. nodes verify the signatures, double-check the answer of the hash code after authenticating the details, and add a new block to the blockchain network. nodes can stay both online and offline.61 • master nodes. selective blockchain networks have master nodes which are are more capable than normal nodes.61 • peer-to-peer networks (p2p) are networks designed for linking two nodes. there are four types of blockchains: • public blockchains are permissionless blockchains that allow anyone to join. all nodes of the blockchain have equal rights to access the blockchain, create new blocks of data, and validate blocks of data.58,67 • private or managed blockchains are permissioned blockchains controlled by a single organization. in a private blockchain, the central authority determines who can be a node. the central authority also does not necessarily grant each node with equal rights to perform functions.67 figure 9. theoretical schematic of blockchain technology in healthcare.59 j global clinical engineering vol.4 issue 3: 2022 26 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies • consortium blockchains are permissioned blockchains governed by a group of organizations, rather than one entity. however, setting up consortiums can be a fraught process as it requires cooperation between several organizations presenting logistical challenges and potential antitrust risks.67 • hybrid blockchains are controlled by a single organization, but with a level of oversight performed by the public blockchain, which is required to perform specific transaction validations.67 some key players in the blockchain market are ibm corporation, microsoft corporation, gem, patientory inc., guardtime federal, isolve, and factom57 robotics technology technological advancement has revolutionized how medical procedures take place, including surgical operations. credits go not only to the development of actuators, sensors, control systems, and materials but also to the growth of imaging systems for medical applications such as higher resolutions and magnetic imaging.71 apart from the industrial robot (a word originating from the czech word “robota” meaning compulsory labor) first developed 50 years ago, today’s medical and healthcare robots are used in tremendous clinical work.72, 73 according to the robotic institute of america, a robot is a machine in the form of a human being that performs the mechanical functions of a human being but lacks sensitivity. the first robot was developed by leonardo da vinci in 1495, purposed at amusing royalty. it was followed the creation of the first operational robot by joseph marie jacquard in 1801, in which an automated loom, controlled by punch cards, created a reproducible pattern woven into cloth.73 in medicine, robotic systems were first introduced in the mid-80s, and today they make an impact in various medical disciplines, including general surgery, research, therapy, rehabilitation, neurosurgery, orthopedic surgery,74 and medical transport (for example, tug robot able to carry around more than 400 kilograms of medication).75 as per 2017, 20% of the world population experience difficulties with physical, cognitive, or sensory functioning mental and behavioral health, which can be solved with robotics technology application.76 the very first mechanical robot to be used in surgery was the puma 560 in 1985 for the precise positioning of the cannula for brain biopsies.77 statistics show that 1in every 25 patients will contract hospital-acquired infection (hais) in the usa, and 1 in 9 will die.75 that is why next-generation smart hospitals have robotics that can help reduce infections, viruses, and bacteria.78 for example, xenex robot allows for fast and effective systematic disinfection of any space within a healthcare facility by destroying deadly microorganisms causing hais using special ultraviolet (uv) disinfection methodology.75 data from the usa show that surgery costs annually are estimated to be $170 billion, with an estimated $41 billion us spent on readmission due to complications. in europe. over half (52%) of all surgeries were due to unexpected complications. consequently, robotics can lower the readmission rate by up to 50%, resulting in a saving of $10 billion annually.79 the global landscape of robotics application in healthcare and wellbeing are presented in table 7. table 5. challenges of blockchain technology59,62,60 technology blockchain software is still in its infancy, continually being developed and refined integration must initially be co-existent with current technologies, must be integrated overtime cost adoption of new technologies will incur initial greater costs to institutions regulation government institutions have yet to settle regulatory concerns over blockchain technology culture adoption of the technology will require significant buy-in from the global community energy maintaining the blockchain requires a network of nodes, and resulting substantial computing power privacy emerging cyber security concerns must be addressed before individuals will entrust data to a public blockchain 27 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies figure 10. blockchain structure in hospital applications.68 figure 11. properties of blockchain technology.69 j global clinical engineering vol.4 issue 3: 2022 28 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies in their general design and construction, medical robots consist of a central processing unit (the robot's brain for coordinating all its activities) and sensors (acting as the powerhouse of the robot feedback mechanism). these include light sensors, sound sensors, temperature sensors, contact sensors, proximity sensors, distance sensors, pressure sensors, positioning sensors, etc.). also included are actuators (the robot's hydraulic, pneumatic, or electric muscles), end-effectors (the tools that perform the actual work and interact with the environment or a workpiece), the power supply (energy required for robot operation), and the program (for providing the logic that drives the robot behaviors and activities).81 robotics applications in medicine involve different stakeholders, including primary stakeholders (direct robot user, clinicians, and caregivers), secondary stakeholders (robot makers, environmental service workers, health administrators), and tertiary stakeholders (policy makers, insurers, advocacy groups).76 among robotics applications, surgical robots have a high revenue growth market segment, are highly competitive with established players, well-defined market entry routes, and a good product innovation pipeline.80 in 2020, the leading global company in medical robotics was intuitive surgical, with a market cap of $121 billion, 6335 robots in service,78 with more than 1.2 million procedures performed globally, and with a growth of 18% per year.80 table 6. blockchain potentials for healthcare and life science52,59,70 category potential use key benefits patients patient empowerment. patients can keep track of their medical background. patients can check their latest medical prescriptions, patients can share their data securely across their providers increases patient trust. improves patient access to trusted data. facilitates better collaboration, increases transparency. improves and personalizes the patient experience. increases efficiency and reduces operations costs, enables patient access to their health records anywhere in the world. enables patient access to their latest prescriptions regulation and compliance compliance tracking, smart contract-based check establishes a trusted audit trail verifiable in real-time. establishes a platform to enforce privacy regulations automatically. enables monitoring of who has shared data and with whom, without revealing the data itself inter-company processes transfer of funds. medical devices supply chain. temperature-controlled supply chains, services facilitates automated payments through smart contracts. increases speed for payments. provides full transparency of assets across the supply chain to the patient. enables certified & private messaging between medical devices and service providers. brings all transactions into a single platform administration and back offices revenue management improves efficiencies in tracking and tracing areas where leakage occurs. reduces admin costs, increases reliability and auditability. speeds up financial transactions process pharmaceuticals verifies drug provenance. creates an industrywide, single source of aggregate information tracks and traces pharmaceuticals, proof of authenticity for anti-counterfeiting techniques. helps prevent the transport and sale of counterfeit products. makes it is possible to detect the full spectrum of complications related to pharmaceutical treatment research and development securing clinical trials prevents theft of intellectual property. enables users to authenticate any document and ensuring proof of the existence. enables access to a huge anonymous and authenticated database of patients 29 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies other companies in service include boston dynamics, stryker, accuracy, vicarious surgical, medtronic, ge healthcare, myomo, stereotaxis, ottava77,78 neocis.inc, medtronics, brainlab, smith & nephew plc, corindus vascular robotics, inc., riverfield co., ltd, auris health, inc., etc.80 between 2015-2020, china emerged as a leader for next-generation surgical robotic systems’ innovations with 237 (36.5%) patents published in this area from 2015 to 2020 (figure 12).80 table 7. medical robotics market potential assessment summary80 healthcare robotics technology readiness level breadth of application current adoption growth potential medical robots surgical robots diagnostics robots healthcare service robots medication delivery and dispensing cleaning and disinfecting telepresence and remote monitoring autonomous vehicles care robots personal assistant/ companion robots assistive robots figure 12. medical robotics patent filings from 2015 to 2020.80 j global clinical engineering vol.4 issue 3: 2022 30 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies the global medical robot market is expected to reach usd 12.7 billion by 2025 from an estimated usd 5.9 billion in 2020 at a cagr of 16.5% during the forecast period. on the other hand,82 medical robotics market is forecast to account for $43.22 billion in 2028 with a compound annual growth rate of 22.3% from 2021 to 2022 (figure 13).82 the key drivers of medical robotics market evolution include demand for minimally invasive procedures for diagnosis, improved precision in diagnosis and treatment, technological advancement in ai, management of surge capacity during peak demand, and improvement of the overall efficiency of logistics. also, there is a desire to increase the automation of pharmacy operations, large population living with chronical illnesses, hospitals’ will to maintain hygiene protocols and standards, especially as it directly impacts hospital accreditation, reduces manual labor, improves efficiency and cost savings for cleaning and disinfection. increasing prevalence of stroke, multiple sclerosis, parkinson's disease, cerebral palsy, rise of the elderly population, and shortage of caregivers.80 nowadays, since 2019 when the whole world experienced the covid-19 outbreak, robotics has been finding applications in undertaking human-like activities.83 in rwanda, robots were deployed to minimize contact time with confirmed cases and reduce the risk of contamination of health professionals in covid-19 treatment centers. the 5 human-size robots are programmed to perform temperature screening, take vitals readings, deliver video messages, detect people not wearing masks, and then instruct them to wear masks properly. one robot called urumuli deployed at kigali international airport had the capacity of screening 50 to 150 people per minute and reporting abnormalities to officers on duty.84 later, on 9 february 2021, in partnership with the united nations development programme, the government deployed another set of three thor uvc robots to nyarugenge district hospital to strengthen the national response to covid-19 pandemic.85 robots were also used to store patients’ data during diagnosis and treatment, reduce the workload of healthcare providers, ease the diagnosis procedures, and assist the physicians and students in learning more about the new disease in a short time.86 in south korea, a self-driving robot with cameras and an led screen was used to greet clients at the country’s biggest mobile operator, check their temperatures, dispense hand sanitizers, and disinfect the floor. other robots were used to disinfect 33 square meters in 10min using ultraviolet radiation. in addition, they could detect people's gatherings, advise them to disperse, and wear face masks.87 in china, wuhan city, where the pandemic was first detected, constructed a fully robot-staffed hospital where patients entering were screened by connected 5g thermometers to alert staff for feverish. in addition, patients wore smart bracelets and rings that synced with cloud minds’ ai platform so their vital signs, including temperature, heart rate, and blood oxygen levels, could be monitored. doctors and nurses also wore the devices to catch any early signs of infection.88 regarding the future of medical robotics, up to 2013, nanorobotics was still the largely hypothetical technology of creating machines or robots at or close to the scale of a nanometer.73 though the growth of the medical robotics industry is promising, it is humped by the following challenges: high establishment cost, fewer trained professionals to administer the tests, technical complexities leading to operational issues, the high running cost for disadvantaged people.80 figure 13. market growth for medical robotics.82 31 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies nanomedical technology it is a technology for diagnosing, treating, and preventing disease and traumatic injury, relieving pain, preserving and improving human health using molecular tools and molecular knowledge of the human body.89 nanotechnology classically refers to the matter in a size range of 1–100 nm but can be extended to include materials below 1 μm in size.90 nanomedicine is also defined as the application of nanobiotechnologies to medicine.91,92 though the concept of nanotechnology dates to 1959, the optimistic expectation of nanoparticles and nanoscale tools to improve the diagnosis and pharmacological treatment of several diseases was first established in 1990.93 the basis of this new science derives from the development of an array of ultramicroscopic devices and the studies of cellular, molecular, and finally atomsized structures in biology, chemistry, and physics in the 20th century. nanotechnology is not in itself a single emerging scientific discipline, but rather a meeting of different traditional sciences linking physics, chemistry, biology, medicine, electronics, and it.94 nanotechnology in medicine was recently focused on because there is a diversity of diseases originating from the alteration in biologic processes at the molecular level like mutated genes, misfolded proteins, and infections caused by viruses or bacteria (figure 14).95 the three main subsections of nanomedicine are: nanobiotechnology, nanotechnology, and nanobiomimetics.96 currently, in medicine, nanotechnology is used in antibacterial treatment, wound treatment, cardiovascular diseases, ophthalmology, cancer-fighting, cell repair, imaging, probing of dna structure, tissue engineering, tumor detection, separation and purification of biological molecules and cells, mri contrast enhancement and phagokinetic studies, company directory and to deliver drugs, heat, light or other substances to specific types of cells (such as cancer cells).91,97 its use in diagnostics is at the development stage. the use of nanoparticles will reduce damage to healthy cells in the body and contribute to the early detection of diseases.91 the global nanomedicine market size is projected to reach usd 232 million by 2026, from usd 150 million in 2019, at a cagr of 6.4% during 2021-2026.98 the nanomedicine market segmentation by type includes: • quantum dots (qd): qd are semiconductor nanocrystals that have a reactive core (made of cadmium selenide cdse, cadmium telluride [cdte], indium phosphide [inp], or zinc selenide [znse]), for controlling their optical properties. qd are used in medical real-time tissue imaging,99 biological probes, for live cells labelling,100 drug delivery vehicles, in vivo imaging, therapeutic delivery,101 blood cancer assay, and cancer detection and treatment, in vivo animal targeting, tracking different particles, forecasting of disease stage.102 • nanoparticles: a considerable fraction of the solid matter on earth can be found in the size range of colloids and nanoparticles, and in the last 2 decades, scientists have shown that colloids and nanoparticles are present everywhere in the environment.103 nps are categorized into three types: natural nanoparticles, incidental nanoparticles, and engineered nanoparticles (figure 15).104 from a chemical point of view, nanoparticles are classified into inorganic and organic types. inorganic nanoparticles are used as antimicrobial agent against bacteria, fungi, parasites, and viruses.104 organic nanoparticles prepared from various materials, including polymers and lipids, have found exciting therapeutic delivery and imaging applications.105 figure 14. relationship of nanobiotechnology to nanomedicine and other biotechnologies.91 j global clinical engineering vol.4 issue 3: 2022 32 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies the choice of material impacts various properties, including drug encapsulation, immunogenicity, and targeting. at the same time, the design of nanoparticles, such as size, shape, flexibility, and compartmentalization, will also impact nanoparticle performance. these two attributes (choice of material and nanoparticle design) collectively determine the therapeutic outcome (figure 16).105 other applications of nanoparticles within medicine include tissue engineering, bio-micromechanical systems (biomems), biosensors, anticancer drugs, microfluidics, and diagnostics.106 • nanoshells: the discovery of nanoshells was made by professor naomi j. halas and her team at rice university in 2003.107 these are a special class of nanomaterials that consist of concentric particles.108 a nanoshell is a type of nanoparticle with a dielectric (e.g., silica) core and a thin metal coating (usually gold).109 nanoparticles find a place in medicine because of their safety, biocompatibility, stability, bioavailability, optically tunable, and photo-luminescent ability as well as high ability to attach to many therapeutic materials. nanoshells (and especially gold nanoshells) show promise application in biomedical imaging, target therapy, gene delivery, tissue welding, drug delivery systems, therapeutic applications in general, and cancer imaging and treatment (figure 17).110 gold nanoshells exhibit unique optical properties because their interaction with the electromagnetic field is greatly intensified by a phenomenon known as localized surface plasmon resonance. they are designed to absorb radiation at various frequencies absorb certain types of radiation. once the nanoshells are attached to the cancerous cells, only laser light is needed to treat cancer. near-infrared (nir) light passes through the body figure 15. types of nanoparticles.104 figure 16. design parameters for nanoparticles.105 figure 17. use of nanoshells for cancer treatment (source: national cancer institute). 33 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies and reaches the gold nanoshell. the tuned gold nanoshell receives the nir light and converts the light energy into heat, killing the cancer cells.107 • nanotubes: nanotubes, usually made in carbon (cnts), consist of carbon atoms arranged in a series of condensed benzene rings rolled up into a tubular structure.111 carbon nanotubes (cnts) are cylindrical molecules that consist of rolled-up sheets of single-layer carbon atoms (graphene). they can be single-walled (swcnt) with a diameter of less than 1 nanometer (nm) or multi-walled (mwcnt), consisting of several concentrically interlinked nanotubes, with diameters reaching more than 100 nm. their length can reach several micrometers or even millimeters (figure 18).112 their impressive structural, mechanical, and electronic properties are due to their small size and mass, incredible mechanical strength, and high electrical and thermal conductivity. in medicine, nanotubes are used in pharmaceuticals, drug delivery systems, gene delivery and therapy, tissue engineering, bio-imaging, biosensor applications, lab-on-chip devices, photo-thermal therapy, diagnostics, and high-performance composites for implants.113,114 although there are advantages of nanotubes (like biocompatibility, rigidity, mimicking of natural tissue nanofibers, stimulating the adhesion and proliferation of cells and ability to form strong 3-d architectures, high surface area, high photo-stability and absence of quenching, special optical, mechanical, and electronic properties),114 concerns related to their toxicity, biosafety, and biodegradation still remain.113 examples of nanotechnology equipment in medicine include atom probes, atomic absorption spectrometer, profilometers, raman microscopes, calorimeters, cryogenic probe stations, scratch testers, flow chemistry reactors, graphene, surface analyzers, spectroscopic ellipsometer, wafer bonders, x-ray detectors, x-ray diffractometer, etc.106 the challenges faced by nanotechnology include high manufacturing costs, technical challenges, raised skeptical opinions within the scientific community about the clinical relevance of nanomedicine.93 the competitive landscape of the industry has also been examined along with the profiles of the key players who include abbott laboratories, arrowhead pharmaceuticals inc., general electric company, luminex corporation, merck & co. inc., nanobiotix, novartis ag, pfizer inc., sanofi sa, starpharma holdings limited.115 telemedicine and telehealth the provision of primary healthcare has been challenging during the recent and current periods of covid-19 due to overcrowding of medical services seekers to different health facilities.116 it is evident to many that covid-19 accelerated the adoption of telemedicine globally.117 telemedicine uses electronic communications and information technologies to provide clinical services when participants are at different locations.118,119 some writers prefer to use the term “telehealth” interchangeably with “telemedicine,” but telehealth is broader because it also considers even non-clinical services. telehealth refers to ‘the use of telecommunications and it to provide access to health assessment, diagnosis, intervention, consultation, supervision and information across distance.120 telemedicine is traced back many centuries, starting from ancient hieroglyphs and scrolls to share information about health-related events such as outbreaks or epidemics. this was followed by using smoke signals to warn nearby cities of sickness.120 in contemporary times, telemedicine through telephone and video technology has been used since the 1960s in the military and space sectors.121 apart from military services, telehealth was first used in 1972 when murphy and bird conducted 500 figure 18. conceptual diagrams of single-walled carbon nanotubes (a) and multiple-walled carbon nanotubes (b).111 j global clinical engineering vol.4 issue 3: 2022 34 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies patient consultations via interactive television.122 today, telemedicine is applied in radiology, dermatology, surgical peer monitoring, medication management, mental health, diagnosis, patient monitoring, etc.123 the drivers of telemedicine include: enhancement of care coordination, patients and doctors are fascinated by the services offered by telemedicine, society, and healthcare tendency to digital life (in oecd countries, nearly 65% of people aged 65 to 84 years are estimated to have more than one chronic condition, a prevalence that reaches 89% for those aged 85 and over), bridging of the rural gap, continuous innovation in the consumer technology market, projected shortages in the health professional workforce, growth of consumerism in health care cost-effectiveness, quick access to medical services,123,124 improved quality, medication management, changes in care models.125,126 the services offered by telemedicine include specialist referral services (assisting a general practitioner in rendering a diagnosis), direct patient care (sharing audio, video, and medical data between a patient and a health professional for use in generating a diagnosis, treatment plan, prescription or advice), remote patient monitoring (devices to remotely collect and send data to a monitoring station for interpretation), medical education and mentoring, consumer medical and health information, patient support service (reminders to take medication, supervision, scheduling of appointments and similar applications which are not implicitly medical).118 there are four key elements needed for a successful telemedicine program. 1. collaboration tools are devices that help patients to connect with healthcare service providers. they include smartphones, laptops, tablets, etc.127 2. medical peripherals are the diagnostic tools used in telemedicine, such as otoscopes, ultrasound machines, or digital stethoscopes.127 3. workflow represents adequate software to manage the complete process of connecting patients to medical professionals and to integrate telemedicine with their existing it resources.127 4. cloud-based services: cloud computing delivers different services through the internet. these resources include tools and applications like data storage, servers, databases, networking, and software. when using cloud computing, the user is not required to be in a specific place to access it, allowing the user to work remotely.128 in telemedicine, cloud-based services help user-friendly access to medical records for both clinicians and patients from anywhere they can access the internet.129 when the world experienced covid-19 pandemic, social distancing measures were put in place to fight its sustainability. moreover, the rapid global spread of covid-19 has increased the volume of data generated from various sources.130 the cloud technology had a major role in fighting the epidemic; it became a salvation for governments and organizations in numerous fields of life, education, health, industry, communication, remote surveillance, and more information (figure 19).131 figure 19. use of telemedicine by doctors and patient benefits.123 35 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies generally, the lines of action of the telehealth program are based on three components, as presented in figure 20. from 2010 to 2017 the world experience growth in the use of telemedicine, with three diseases dominating the growth rate. those are diabetes, congestive heart failure (chf), and chronic obstructive pulmonary disease (figure 21). since 2018, the quarterly investment in telehealth has experienced peaks and bottoms, but when who officially declared covid-19 as a pandemic on 13 march 2020, the investment in telehealth has drastically increased compared to previous years, as presented in figure 22. generally, the global telemedicine market was valued at $50 billion in 2019, with forecast potential growth to increase to $460 billion by 2030.135 there are three types of telemedicine: • store and forward telemedicine or asynchronous telemedicine. in this type of telemedicine, patient information such as medical images or bio-signals can be sent to the specialist as needed when it has been acquired from the patient.136 it is regarded as the acquisition and storing of clinical information such as lab reports, data, images, sound, and videos that are then forwarded to (or retrieved by) another site for clinical evaluation.122 • real-time video or synchronous telemedicine. in this type of telemedicine, consultations use video conferencing to connect the patient with the physician. patients from their homes can use smartphones, tablets, or computers to interact with physicians. this method enables the physician to conduct a medical consultation as they would in person.122 • remote monitoring telemedicine. this uses a range of technological devices to remotely monitor a patient's health and clinical signs. this is extensively used in the management of chronic diseases such as cardiovascular disease, diabetes mellitus, and asthma.136 the key challenges hindering the growth of telemedicine are system development costs, digital literacy, digital technology acceptance, less accurate diagnosis for specific images transmitted with telemedicine concerning the original images, aspects linked to security and confidentiality in the doctor-patient relationship through figure 20. general lines of action of telehealth.132 figure 21. world telehealth patients (thousand) per disease.133 figure 22. quarterly global telehealth funding (2018-2021) in $m.134 j global clinical engineering vol.4 issue 3: 2022 36 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies appropriate interfaces, and system implementation by the involvement of different parties.132,137 although telemedicine has many challenges to overcome, there are also opportunities to sustain its development. they include gap service coverage (for example, in the usa, teleradiology predominates other services), urgent service coverage (a case of a mobile telemedicine system for consulting acute stroke even remotely by employing a wireless lan or a mobile phone network), and videoenabled multisite group chart rounds (model of medical education liked to clinical care).138,139 big data the healthcare landscape is saturated with a large, diversified amount of data. big data in healthcare is overwhelming because of its volume and the diversity of data types, and the speed at which it must be managed.140 those data could be an enabling resource for deriving insights for improving care delivery and reducing waste.141 over more than a decade, as in other industries, the medical industry has experienced rapid digitization due to an increase in electronic medical records (emr).142 driven by mandatory requirements and the potential to improve the quality of healthcare delivery and obtain the best healthcare services meanwhile reducing the costs, requires a significant diversified quantity of electronic health records to help in clinical decision support, disease surveillance, and population health management.140,143 big data should be collected and used to ensure agreements between patients, healthcare service providers, and policy and research. today, there is no common definition to explain what big data is. however, some researchers tried to formulate the meaning of big data. according to mckinsey the term “big data” refers to “datasets whose size is beyond the ability of typical database software tools to capture, store, manage, and analyze.”144 big data is unmanageable using traditional software. we need technically advanced applications and software to employ fast and cost-efficient high-end computational power to utilize it properly. the term big data is described by the following characteristics: value, volume, velocity, variety, veracity, and variability, denoted as the 6 “vs”.143 according to some studies have shown that 93% of healthcare organizations have experienced a data breach because personal data is extremely valuable and profitable on the black markets, and this pushed organizations to start using data analytics to help them prevent security threats by identifying changes in network traffic, or any other behavior that reflects a cyber-attack.146 big data help to identify individual and community trends and develop better treatment plans or predict at-risk patients, forecast patient admissions trends and schedule the correct number of staff, drive innovation, compare chronic disease and population growth in neighborhoods, streamline insurance claims processes, easy detection of fraud and inventory tracking.147 the global health data in 2013 only was estimated to be 153 exabytes, with forecast potential growth to 2,314 exabytes in 2020 alone.135 big data analytics are divided into four categories: • descriptive analytics. this consists in decrying the current situation and reporting on it. • diagnostic analytics aim to explain why certain events occurred and what factors triggered them. • predictive analytics. this reflects the ability to predict future events; it also helps identify trends and determine probabilities of uncertain outcomes. • prescriptive analytics. this proposes suitable actions leading to optimal decision-making.148 the global big data analytics in healthcare market size was valued at $16.87 billion in 2017 and is projected to reach $67.82 billion by 2025, growing at a cagr of 19.1% from 2018 to 2025.149 the nine stages that make analyzed data useful are shown in figure 23. big data come from clinical practices and research, patient-generated data, medical claims, electronic healthcare records, social media, patient summaries, genomic and pharmaceutical data, clinical trials, telemedicine, mobile apps, sensors, and information on wellbeing, behavior, and socio-economic indicators.142,144 big data are used in medical services to gain advantages as shown in figure 24, and big data architecture for healthcare is presented in figure 25. 37 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies the big data analysis ensures that the health facility manager sees a big picture of the hospital, the attendance, its nature, the costs incurred, etc., which will help run it smoothly. an example of a dynamic dashboard for patient care is shown in figure 26.146 the challenges facing big data technology are: segmentation of data in healthcare providers (clinical data, financial data, administrative data, patient data are not linked and shared), protection of patient’s privacy,151 data capturing, cleaning and storage, stewarding and querying.152,153 there are several challenges in adopting big data technology: data in many health care providers are often segmented or siloed, complicated use big data is complicated, long system response time.151,154 the key players in healthcare data analytics include ibm, cerner, health catalyst, mckesson, oracle.155 conclusion in conclusion, driven by needed increases in medical productivity, the growing prevalence of chronicling diseases, the increasing aging population, and the increasing emphasis by healthcare agencies towards early diagnosis and treatment, many countries and healthcare providers are struggling to scale-up technology level to provide adequate services to patients. in addition, physicians themselves believe in introducing new technologies to help them prevent, diagnose, treat, monitor, and care for patients. technology advancement has proven effective in providing access to information, facilitating remote care, improving efficiency by connecting the patients with physicians, cost-effective and time-saving solutions. medical technologies encompass data centers, medical devices, software, drugs, it services, public clouds, cybersecurity, communication services, surgical procedures, and internet of things. the medical technology market is growing fast in asia, with different and bulky products available on almost all global markets. as a result, the global market for medical devices only is projected to grow from usd 455.34 billion in 2021 to usd 657.98 billion in 2028. the key challenges humping the development of medical technology are biomedical complexity, standardization, figure 23. the nine stages of the big data analytics lifecycle.150 figure 24. application areas of big data technology in medicine.146 j global clinical engineering vol.4 issue 3: 2022 38 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies figure 25. big data architecture for health system.148 figure 25. big data architecture for health system.148 39 j global clinical engineering vol.4 issue 3: 2022 nkurunziza, judahemuka, dusenge, umutesi : overview of trending medical technologies cybersecurity and data privacy, higher starting costs, and regulatory and environmental consideration. the revolution of healthcare technology applications in medical services requires knowledge and skills in assessment, planning, procurement, inventory management, installation, and maintenance. therefore, healthcare providers need to be watchful about healthcare technology assessment (hta) to ensure evidence about safety, effectiveness, relevance, technology outcomes, and alternative technologies when running a particular technology. hta is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to using health technology systematically, transparent, unbiased, and robustly. according to world health organization, only 70 countries worldwide have a national agency or committee 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https://healthitanalytics.com/news/top-10-challenges-of-big-data-analytics-in-healthcare https://www.rtinsights.com/5-challenges-of-big-data-analytics-in-2021/ https://www.rtinsights.com/5-challenges-of-big-data-analytics-in-2021/ 15 j global clinical engineering vol.6 issue 4: 2024 received january 2, 2024, accepted november 8 2024, date of publication november 20 2024. original research article application and innovation of 3d printing in medical equipment maintenance lei jiang department of medical devices, deyang luojiang people’s hospital, deyang, sichuan province, china. * corresponding author email: ljxrmyy@163.com abstract with the continuous progress of technology, 3d printing technology is setting off a revolution in medical equipment maintenance. the traditional supply chain and manufacturing process often lead to long maintenance times and high medical equipment costs. however, after the introduction of 3d printing technology, medical equipment maintenance will usher in a brand-new solution. through 3d printing, medical institutions can manufacture the required parts independently, without relying on suppliers’ delivery, thus greatly shortening the maintenance time. in addition, 3d printing can also be customized and optimized according to specific needs, improving the functionality and performance of medical equipment. therefore, the application innovation of 3d printing in medical equipment maintenance will bring great potential and opportunities to the medical industry and provide better medical services for patients. this innovation will make medical equipment maintenance faster, more economical, and efficient, and meet individual needs, bringing unprecedented development opportunities for the medical industry. keywords—3d printing, medical equipment, maintenance, innovate. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.6 issue 4: 2024 16 jiang: application and innovation of 3d printing in medical equipment maintenance introduction 3d printing plays an important role in medical equipment, providing a cost-effective solution for hospitals and medical institutions to replace some special structural plastic parts.1 by using 3d printing technology, we quickly created high-quality customized alternatives to suit the specific needs of medical devices, resulting in cost savings for hospitals. 3d printing has many advantages over conventional manufacturing methods. first, it enables complex structures to be printed in an integrated manner without additional assembly work. this not only reduces the manufacturing time but also improves the reliability and stability of the product. second, 3d printing also offers a more flexible material selection. we can select different kinds of plastic materials to print according to medical device use environment and functional requirements. by doing so, we can ensure that medical devices have the durability, corrosion resistance, and high-temperature resistance to meet various complex medical needs.2 therefore, the application innovation of 3d printing in medical equipment maintenance was further analyzed in this study. technology development and application status of 3d printing in the medical industry principle and development of 3d printing technology 3d printing (three-dimensional printing) is a technology for manufacturing three-dimensional objects by stacking specific materials layer by layer. compared with the traditional “subtractive manufacturing process”, 3d printing is an “additive manufacturing process”. its working principle is based on the core concept of “layerby-layer stacking.” it can be understood that the digital model is divided into a series of ordered two-dimensional sections (slices) according to the z axis (perpendicular to the horizontal plane), and these sections are stacked layer by layer using specific materials, finally forming a three-dimensional entity. 3d printing process (1) three-dimensional model design stage: first, a three-dimensional digital model must be created or scanned using cad-computer aided design software or other 3d modeling tools. (2) model data optimization stage: no matter in the process of scanning entities to obtain 3d point cloud reprocessing modeling or direct entity modeling, certain supporting structures can be added to maintain the shape and stability of printed objects and the supporting structures can be removed after printing. (3) section processing stage: the three-dimensional model is imported into the 3d printing software, which will segment the model into extremely thin two-dimensional sections, commonly known as “sections”, which will guide the 3d printer to build objects layer by layer. (4) layer-by-layer stacking stage: the 3d printer uses specific materials (such as plastic, metal powder, and ceramic) to stack layer by layer according to the slice information. after each layer is stacked, the printhead moves to the next layer and repeats the stacking process until the entire object is built. key technologies material selection. 3d printing uses various materials, including plastic (such as abs, pla), metal powder, ceramic, glass, etc., and different materials have different physical and chemical properties suitable for different application scenarios. in the maintenance of medical equipment, it is very important to select the appropriate materials, which need to have the characteristics of durability, biocompatibility, and mechanical properties to ensure that the equipment, after maintenance, can run normally and meet the medical standards. first, medical institutions can work with professional material suppliers to jointly evaluate and test the performance of different materials to find materials suitable for medical equipment maintenance. second, medical institutions can conduct laboratory tests and clinical trials to assess different materials’ durability, biocompatibility, and mechanical properties. through independent research development and testing, medical 17 j global clinical engineering vol.6 issue 4: 2024 jiang: application and innovation of 3d printing in medical equipment maintenance institutions can ensure that the selected materials meet the medical industry’ s requirements and maintenance equipment needs. third, medical institutions should establish strict quality control procedures, including material procurement, inspection, and verification.3 fourthly, a feedback mechanism is established to timely collect and analyze the performance data of the equipment after maintenance and make adjustments and improvements according to the data results, to promote medical institutions to continuously optimize the material selection and quality control procedures and improve the effectiveness and reliability of the equipment maintenance. printing accuracy. the accuracy of 3d printing depends on several factors, including the printer's design, the slicing process’ s accuracy, the material's nature, and so on. in the 3d printing process, medical institutions can take measures to establish an effective quality control process and improve the quality and reliability of printed parts. first of all, medical institutions can determine the optimal printing temperature, printing speed, height, and other parameters through experiments and tests. the printing parameters of different materials and parts may differ, so they must be adjusted and optimized according to the specific situation. optimizing the printing parameters can improve the surface quality, dimensional accuracy, and strength of parts. secondly, before printing, medical institutions can use 3d modeling software to check the design documents to ensure no error in geometry and size and conduct finite element stress analysis under certain conditions. the printed parts are divided into a limited number of smaller elements. the analysis module applies each element’ s appropriate physical conditions (such as load and boundary conditions). the analysis results can be reported, including information about the product stress distribution, safety factors, and shape variables, to ensure the intensity reliability of the printed parts. thirdly, medical institutions can also track and trace the quality control process of each printed part by establishing detailed documents and records and reviewing and analyzing them when necessary. finally, medical institutions should ensure that 3d printing equipment is in good working order, maintained, and calibrated according to the manufacturer's recommendations. periodic maintenance and calibration can ensure the equipment’ s stability and consistency and improve the printed parts’ quality and reliability. application status of 3d printing in the medical industry implant printing dental implants: 3d printing technology is introduced in dental restorations such as reseeding and the application in digital processing of dentures, thus obtaining the final product manufacturing materials with medical certification. orthopedic implants: 3d printing technology can produce more advanced and qualified implants and prostheses, which also increases the delivery speed of customized implants. from design to manufacturing a customized implant, it can be completed within 24h at the earliest. adjuvant therapy rehabilitation devices: the us team of mak-er worked with stratasys, a 3d printing company, to make prosthetic limbs for a child for as little as $350, while conventional prosthetic limbs cost as much as $40,000. artificial limbs need to be replaced many times during children’ s growth. if traditional artificial limbs are purchased, it will burden families heavily.4 teaching of anatomical model: when 2d images formed by x-ray films, mri, and ct scans are used to study and simulate surgical anatomical structures, the guiding significance is low, while 3d printed models can provide more detailed, intuitive, and stereoscopic anatomical information due to the characteristics of high fidelity.5 drug research conventional manufacturing methods are unsuitable for producing individualized drugs and complex geometries, limiting the ability to produce customized dosage forms. the advantages of 3d printing of drugs include accurate drug size and dose control, high repeatability, and the ability to produce dosage forms with complex drug release characteristics. according to patients’ age, weight, and disease severity, the development of personalized drugs j global clinical engineering vol.6 issue 4: 2024 18 jiang: application and innovation of 3d printing in medical equipment maintenance through 3d printing can improve efficacy and reduce adverse reactions.6, 7 biological printing a multidisciplinary research team from the university of minnesota, virginia tech, the university of maryland, princeton university, and johns hopkins university has designed a custom-made nerve guide tube with 3d printing, which is filled with biochemical signals that can cause the growth of motor and sensory nerves to help the recovery of the sensory and motor functions of the damaged nerves.8 maintenance of medical equipment xu et al.9 conducted reverse modeling on the fractured syringe pump fitting through parametric modeling, conducted stress analysis and strengthening on the model, and finally made the replacement using the fdm process. shen et al. 10 used the 3d scanner to obtain three-dimensional information on the damaged parts of the washing and disinfection machine and processed repair through software, finally making the available parts through a 3d printer. visual teaching and training by presenting the internal structure and working principle of medical equipment in the form of the physical model, we can provide medical staff with a more intuitive and visual tool to help them better understand the use of equipment and maintenance procedures. first, through the 3d printing technology, we can make the physical models of medical equipment. these models can accurately display the internal structure and components of the equipment so that medical staff can understand the working principle of the equipment more clearly. compared with traditional teaching methods, this visual approach is more vivid and intuitive, which helps to improve the learning effect. by observing and operating these models, medical staff can better understand the use of the equipment and operating procedures.11 secondly, 3d printing technology can also make a detachable model so that medical staff can understand the internal structure of the equipment in depth. they can disassemble the model and observe the position and function of each component better to understand the equipment's working principle and maintenance process. this hands-on participation can enhance medical staff's learning interest and participation and improve their understanding and mastery of the equipment. finally, the models produced by 3d printing technology can also be used to simulate the actual operation. medical staff can use these models to practice and be familiar with equipment and maintenance processes. this practical teaching method can help them master the skills and improve work efficiency and accuracy.12 development opportunities and challenges of 3d printing development opportunities for 3d printing (1) technological innovation and integration, combining 3d printing technology with advanced technologies such as artificial intelligence and big data will push it towards intelligence and automation and improve production efficiency and quality. the development of material science will promote the diversification of 3d printing materials so that more materials (such as metal, plastic, ceramic, etc.) can be used to make superior performance products. (2) growth of market demand. with the wide application of 3d printing technology in aerospace, automotive, medical, and other fields, the market demand will continue to grow. the advantages of 3d printing technology in personalized customization and complex structure manufacturing will promote its popularity in the consumer goods market. (3) policy support and promotion. various governments have issued policies to support the development of 3d printing technology, including providing funds and establishing an innovation platform. 3d printing technology has been included in the national strategic emerging industry development plan, becoming an important force in promoting the transformation and upgrading of the manufacturing industry. challenges for 3d printing (1) large-scale production cost. although 3d printing technology has advantages in prototyping and small-scale production, it still faces the challenge of high cost in largescale production. the high price of industrial-grade 3d 19 j global clinical engineering vol.6 issue 4: 2024 jiang: application and innovation of 3d printing in medical equipment maintenance printing equipment and materials used and the limitations of processing methods and processing efficiency make it difficult to reduce the cost of large-scale production. (2) print quality and consistency. minor errors that may occur during 3d printing, such as excessive or insufficient extrusion, can cause problems such as porosity, cracks, or deformation in the finished product. these defects not only waste resources but also increase the unpredictability of traditional manufacturing methods. (3) intellectual property protection. the popularity of 3d printing technology makes copying products easier and puts higher requirements for intellectual property protection. how to effectively protect the intellectual property rights of designers and manufacturers has become an urgent problem to be solved in the development of 3d printing technology. (4) technology and standard system. currently, the scale of the 3d printing industry is limited, the degree of marketization is relatively limited, and the application cases of mass manufacturing are few. the corresponding application standard system still needs to be established and improved to promote the standardization and development of 3d printing technology. advantages of 3d printing in medical equipment maintenance rapid manufacturing and customization capabilities in the traditional maintenance process, we often need to wait for the supplier's delivery, which costs a lot of time. with 3d printing technology, medical institutions can immediately manufacture the required parts without waiting.13 at the same time, 3d printing can also be customized according to the specific needs of the design to meet the personalized requirements of different devices. cost and resource savings the traditional supply chain and manufacturing process need many intermediate links, which wastes time and a lot of resources. 3d printing technology can directly convert design into physical products, reducing the intermediate links, thus saving costs and resources. improve equipment maintenance efficiency and reduce downtime 3d printing can improve equipment maintenance efficiency and reduce downtime. in the traditional maintenance process, we often need to wait for the supply or transportation of parts, which leads to prolonged equipment downtime.14 however, with 3d printing technology, medical institutions can immediately manufacture the needed parts, dramatically reducing repair time and improving equipment availability. application innovation of 3d printing in medical equipment maintenance the existing modeling techniques can be divided into wireframe, surface, solid, assembly, parametric, feature, and other types according to their different usages.15 in this study, autodesk inventor professional 2019 was used to conduct solid modeling for the patient to monitor the protective shell (with handle). solid modeling establishes a 3d solid model using basic voxel combination through collection operation and basic deformation operation. the generated solid model consists of a series of straight lines, arcs, points, and free curves, which describe the outline of the product.16 modeling using vernier calipers to physically measure the exterior dimensions of the patient’ s monitor and then use 3d modeling software to combine the measured dimensions with the parameters to design the protective shell of the monitor, taking into account the thermal expansion and contraction of the print material, the tolerance of the design is controlled at ± 0.03 mm (fdm fused deposition), and the modeling of the part is completed. the part is assembled in the inventor software. see figures 1–3. inventor stress analysis (finite element analysis) stress analysis, i.e., finite element analysis, converts an engineering system from a continuous system to a finite element system (discrete system) for solving and calculating engineering problems: the stress analysis environment in inventor is dedicated to isotropic materials, such as metals, plastics, and glass; stress analysis j global clinical engineering vol.6 issue 4: 2024 20 jiang: application and innovation of 3d printing in medical equipment maintenance can find out the dangerous points, i.e., the parts with stress concentration or strain concentration, which are often the potential positions of part failure. optimization design, according to the results of the stress analysis, can be part or component design optimization, for example, by adjusting the thickness of the material, shape, or the layout of the reinforcement to reduce stress concentration and improve the structure strength; validation design, in the product design stage, you can use stress analysis to verify the rationality of the design, through the simulation of the actual working environment of the force, you can predict the performance and life of the product. (1) specify the part as abs material, as shown in figure 4: (2) according to the actual use of parts, set constraints, as shown in figure 5: figure 1. model of protective case part 1 of monitor. figure 2. model of protective shell part 2 of monitor. figure 3. assembly model of protective shell parts of monitor. figure 4. specified part material. figure 5. setting constraints. 21 j global clinical engineering vol.6 issue 4: 2024 jiang: application and innovation of 3d printing in medical equipment maintenance (3) based on the actual use of the parts, set the load situation. the net weight of the monitor is about 4 kg, and the corresponding load is about 40 newton (n), as shown in figure 6: (4) set the finite element analysis grid, the average element size is set to 0.05, as shown in figure 7: (5) running results, the maximum displacement of 0.1609 mm, as shown in figure 8: (6) the minimum safety factor is 15, as shown in figure 9: according to the autodesk support website,17 the safety factor is the ratio of the allowable stress to the actual stress. a safety factor of 1 indicates that the stress is within the allowable limit, a safety factor of less than 1 indicates a possible failure and a safety factor greater than 1 indicates that the stress is within the allowable limit. the minimum safety factor in this design is 15, and a safety factor greater than 1 indicates that the design is reasonable. part printing slicing software use slicing software to load the model file with the .stl format and conduct slicing operation. slicing is to cut the 3d model into a series of slices, and each slice represents the part that the printer needs to print layer by layer during the printing process. set print parameters in the slicing software, you need to set the printing parameters, such as printing temperature, filling density, layer thickness, shell, etc. the settings of these parameters need to be adjusted according to the printer model, printing materials, and printing requirements. figure 6. setting load. figure 7. setting finite element analysis grid. figure 8. maximum displacement. figure 9. minimum safety factor. j global clinical engineering vol.6 issue 4: 2024 22 jiang: application and innovation of 3d printing in medical equipment maintenance export print file after setting the parameters, export the sliced file to a format that the printer recognizes. start printing transfer the exported print file to the 3d printer, prepare the print material, and start the printer, and the printer will print the model layer by layer according to the parameters and paths set in the slicing software. aftertreatment the surface of the printed model may be rough and needs to be ground and polished. you can use sandpaper, polishing paste, and other grinding tools to make the model surface smoother, as shown in figure 10. conclusion in actual maintenance, the original cost of spare parts is much higher than 3d printing, and the purchase of original spare parts costs about 300 yuan, while the cost of 3d printing is under 50 yuan; parts usually take one week to arrive, while 3d printing can be done in one day, saving maintenance costs and reducing maintenance time. in this study, the significant advantages of 3d printing technology in terms of speed, precision, and cost control are demonstrated through the manufacturing example of the protective shell of the monitor, which is especially suitable for the rapid manufacturing of single spare parts required for the maintenance and later improvement of medical devices. currently, 3d printing technology is still in the preliminary application stage in hospital equipment maintenance. this research aims to deeply explore this technology, optimize the design of 3d models, improve production efficiency, and ensure that it can quickly respond to the needs of clinical departments to maximize the social benefits of medical equipment. references 1. cai, r.q., zhu, y.n., wu, q. the 3d printing practice of 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image technology based on 3d printing technology. new gen info technol. 2021;4(2):20–25. https://doi.org/10.3969/j. issn.2096-6091.2021.02.003. 13. el magri, a., vanel, s., vaudreuil, s. an overview on the influence of process parameters through the characteristic of 3d-printed peek and pei parts. high perform. polym. 2021;33(8):862–880. https://doi. org/10.1177/09540083211009961. 14. li, y.l., yang, y.k., chen, x.l. using 3d printing technology to repair glidescope ranger video laryngoscope. chinese med equip j. 2019;10(40):107–108. https:// doi.org/10.19745/j.1003-8868.2019260. 15. bi, b.s., zhang, j.g., hou, r.t., et al. comparing research on 3d modeling technology & its implement methods. j wuhan uni technol. 2010;(16):26–30. https://doi. org/10.3963/j.issn.1671-4431.2010.16.007. 16. ge, q., xu, d.w., zhao, r.p., et al. research on the application of 3d printing technology in clinical engineering. china med equip. 2017;14(5):3. https://doi. org/10.3969/j. issn.1672-8270.2017.05.001. 17. how to determine the safety factor. available online: https://www.autodesk.com/support/technical/article/ caas/sfdcarticles/sfdcarticles/how-to-determine-thefactor-of-safety-s.html. https://doi.org/10.19551/j.cnki.issn1672-9129.2017.07.052 https://doi.org/10.19551/j.cnki.issn1672-9129.2017.07.052 https://doi.org/10.3969/j.issn.1674-1633.2021.11.038 https://doi.org/10.3969/j.issn.1674-1633.2021.11.038 https://doi.org/10.3969/j.issn.2096-6091.2021.02.003 https://doi.org/10.3969/j.issn.2096-6091.2021.02.003 https://doi.org/10.1177/09540083211009961 https://doi.org/10.1177/09540083211009961 https://doi.org/10.19745/j.1003-8868.2019260 https://doi.org/10.19745/j.1003-8868.2019260 https://doi.org/10.3963/j.issn.1671-4431.2010.16.007 https://doi.org/10.3963/j.issn.1671-4431.2010.16.007 https://doi.org/10.3969/j. issn.1672-8270.2017.05.001 https://doi.org/10.3969/j. issn.1672-8270.2017.05.001 https://www.autodesk.com/support/technical/article/caas/sfdcarticles/sfdcarticles/how-to-determine-the-factor-of-safety-s.html https://www.autodesk.com/support/technical/article/caas/sfdcarticles/sfdcarticles/how-to-determine-the-factor-of-safety-s.html https://www.autodesk.com/support/technical/article/caas/sfdcarticles/sfdcarticles/how-to-determine-the-factor-of-safety-s.html j global clinical engineering vol.6 issue 4: 2024 24 received april 23, 2024, accepted november 13 2024, date of publication december 18 2024. original research article assessment and capital planning of a regional clinical engineering department test equipment inventory samantha puin avila*, marie-ange janvier and andrew a.m. ibey the clinical engineering department, the children’s hospital of eastern ontario (cheo), eastern ontario, canada. * corresponding author email: spuin020@uottawa.ca abstract the clinical engineering department at the children’s hospital of eastern ontario (cheo) in eastern ontario, canada has 9 distinct regional locations. cheo’s regional program faces a challenge managing a fleet of 345 pieces of test equipment, mainly due to a lack of standardization. distant regional sites share equipment, making coordination essential. this article presents three unique themes: (1) the introduction of technologist standard kits (e.g., multimeters, electrical safety analyzers, etc.) and site-based kits (e.g., ventilator, electrosurgical unit testers, etc.); (2) the optimization of kit allocation; and (3) a novel test equipment replacement strategy using reliability, frequency of use, life expectancy, and usage classification criteria. this needs assessment for new equipment, and the replacement of aged equipment will ensure standardized and up-to-date test equipment that will, in turn, minimize equipment-related disruptions and improve technologist productivity. keywords—cmms, test equipment, maintenance, weighting factor, reliability, life expectancy, usage classification, frequency of use, inventory assessment. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:spuin020@uottawa.ca https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 25 j global clinical engineering vol.6 issue 4: 2024 avila, janvier, ibey: assessment and capital planning of a regional clinical engineering department test equipment inventory introduction the children’s hospital of eastern ontario (cheo) is an academic tertiary pediatric hospital in ottawa, ontario, canada. this specialized hospital provides high-quality, standardized, coordinated pediatric health care to approximately 500,000 children and youth annually.1 cheo operates a large regional clinical engineering department with over 50 staff members covering 15,000 km2. this demands a highly organized team and extensive coordination to keep all the medical equipment up to date. currently, cheo oversees a fleet of 345 test equipment devices, valued at approximately cad 900,000, distributed across nine regional sites, making proper inventory management crucial for ensuring compliance and directly impacting the quality of patient care.1 biomedical engineering technologists (bmets) are the primary test equipment users, as they support medical device technology. they serve as clinicians’ first point of contact, spending substantial time on clinical floors to provide general device support advice. they adhere to rigorous maintenance schedules for medical devices and document their activities in the computerized maintenance management system (cmms) e-automate (eci software solutions, tx, usa).2 to optimize resources and reduce costs, cheo uses a hub and spoke model, where smaller hospitals such as brockville, pembroke, and hawkesbury share specialized test equipment and reserve certain tools from cheo, the main site, for preventive maintenance tasks on devices requiring annual or semi-annual servicing. however, the shared approach introduces challenges for technologists, particularly delayed work order completion in the cmms due to scheduling and waiting for particular test equipment. an example of a shared device would be the waste anesthetic gas analyzer. additionally, borrowing test equipment from other sites increases the challenge, as technologists must specify the maintenance duration on an ad-hoc basis. this practice affects equipment availability and disrupts workflows when devices are not consistently returned to their original site, returned broken, or disappear. it can also reduce the equipment’s lifespan due to greater wear and tear and an increased risk of physical damage from handling, transportation, and potential rough treatment. the use of older test equipment also affects cheo technologists’ confidence in these aged, outdated, and out-ofsupport devices, leading them to carry backup equipment as a precaution. this lack of reliance complicates their tasks and slows down workflow. in contrast, modern devices provide greater confidence in performance, improved technical support, and regular updates, contributing to smoother operations and timely completion of work. to address these issues, this paper introduces an inventory assessment system with a scoring criterion as the foundation for developing a strategic replacement plan. a needs analysis was also conducted to evaluate specific equipment requirements, challenges, and preferences for new devices. this combined approach aims to alleviate equipment-related problems, allowing staff to focus more on patient care, ultimately improving productivity and job satisfaction. methodology this project was developed in four phases: data collection an inventory assessment system was implemented using excel (microsoft corporation, wa, usa), using a scoring criterion and data sourced from the cmms. all regional cheo sites were systematically organized and color-coded to enable easy differentiation (table 1). figure 1. test equipment distribution across regional sites. j global clinical engineering vol.6 issue 4: 2024 26 avila, janvier, ibey: assessment and capital planning of a regional clinical engineering department test equipment inventory table 1. eastern ontario cheo sites. sites column a m montfort sv saint vincent hospital ch cheo biomedical engineering p pembroke b brockville general hospital q queensway carleton c clinics groups br bruyere h hawkesbury data validation after extracting cmms data, a physical inventory was conducted, recording each device’s serial number, make, and model. discrepancies between the physical inventory and cmms were identified, and equipment was classified into three categories: physically found and recorded in the cmms, physically not found and in the cmms, and physically found and not recorded in the cmms. a meeting with bmets and the clinical engineering manager validated the inventory against cmms records, assessed equipment needs, and reviewed last year’s calibration list to ensure accuracy. standardizing cmms names and adopting the emergency care research institute ecrirecommended nomenclature improved search efficiency, consistency, and categorization, providing clearer access to equipment details in healthcare settings (table 2). data analysis a new scoring system was introduced, incorporating four key categories to calculate the capital planning of test equipment: frequency of use, usage classification, reliability, and life expectancy. frequency of use the frequency of use definition indicates how often an individual utilizes a specific supply, categorized as daily, weekly, or monthly based on relevance.3 for medical devices and test equipment, it specifically refers to their usage by healthcare professionals or biomed technologists, which should be documented in the cmms. to enhance database accuracy, a microsoft forms survey was conducted across regional sites to assess the usage frequency of test equipment, categorizing it as regular (daily to weekly), occasional (monthly to bi-monthly), or rare (semi-annual to yearly). table 3 summarizes the survey results, classifying equipment based on the highest number of responses, with ties resolved by recording the highest usage level. usage classification the term usage classification refers to categorizing test equipment based on its functionality, risk of use, or compatibility with medical devices. in canada, medical devices are classified into four categories based on the risk level they possess to health and safety.4 • class ⅰ: lowest risk (e.g., thermometers). • class ⅱ: moderate risk (e.g., diagnostic imaging equipment). • class ⅲ: high risk (e.g., implantable devices). • class ⅳ: highest risk (e.g., pacemakers). the alignment between health canada’s system and test equipment usage is determined by evaluating how often test equipment is used with various classes of medical devices. to accurately reflect the risk level of devices with which the test equipment is associated, a survey was conducted with technologists to identify the medical device class most frequently associated with each piece of test equipment. equipment used primarily with high-risk devices, such as class ⅲ medical devices, is assigned a higher weight than priority ⅲ equipment. if the device is used equally across different classes, it is classified according to the higher risk category as shown in table 4. reliability medical device reliability is the probability that devices will perform their intended function without failure for a specified period.5 in this context, test equipment reliability similarly refers to consistent operation over time, ensuring accurate assessments of medical devices. 27 j global clinical engineering vol.6 issue 4: 2024 avila, janvier, ibey: assessment and capital planning of a regional clinical engineering department test equipment inventory to evaluate reliability, an equation was developed that inversely relates device age (a) to the frequency of corrective maintenance, using cmms data. the formula includes a “+1” factor to account for the incoming inspection of the device. reliability is calculated using the formula: • r=reliability • a=age of the device • m=number of corrective maintenances reliability thresholds were established and points were assigned (table 5): life expectancy the fda defines life expectancy broadly as the time a device remains functional with activities such as upgrades, maintenance, and repairs.6 in contrast, the biomedical engineering advisory group offers a more concise list of 16 factors that might affect useful life, such as user profile and business risks as well with an extense list of the recommended life expectancy of medical devices.7 despite these guidelines, deciding when to retire or continue using a device remains complex due to the absence of a universal standard for determining device lifespan. in ontario, medical equipment management is decentralized, with hospitals making independent decisions. table 2. example of equipment descriptions and ecri standardized nomenclature. equip id description ecri ecri device code maker model serial number bm/1007 test equip testers 11-399 bcgro sa-2010s 13381 table 3. frequency of use categorization method. test equipment name regular use occasional use rare use results test equip temperature meter 3 3 0 regular use test equip humidity meter 3 2 1 regular use table 4. usage classification categorization method. test equipment name priority ⅰ priority ⅱ priority ⅲ priority ⅳ results test equip meter pressure 1 1 3 1 priority ⅲ test equip humidity meter 2 2 1 1 priority ⅱ table 5. reliability scale criteria. classification reliability score points assigned r > 4 reliable 1 4 ≤ r ≥ 2 medium 2 r < 2 unreliable 3 j global clinical engineering vol.6 issue 4: 2024 28 avila, janvier, ibey: assessment and capital planning of a regional clinical engineering department test equipment inventory cheo, a regional program, evaluates the replacement of medical devices based on long-term organizational goals, technological obsolescence, productivity impact, patient experience, and the adoption of new technologies and best practices. while these guidelines are designed for medical devices, they can be used as a proxy for test equipment. the criteria for evaluating test equipment lacks detailed literature or guidelines from recognized biomedical and clinical engineering organizations, complicating the management of its lifespan and replacement. the average life expectancy data for medical devices from the biomedical engineering advisory group’s recommended list and the cheo database was utilized to estimate the life expectancy of test equipment. since no specific guidelines exist for test equipment, these averages were applied to ensure consistency with the medical devices they support, enabling a practical approach to managing the lifespan of test equipment. as more precise methodologies are developed, opportunities to further refine these estimates will arise. weighting factor a weighting factor for each test equipment was developed based on: • reliability 25% • frequency of use 20% • life expectancy 35% • usage classification 20% table 6 is an example of the database of the test equipment. these criteria are grouped according to their importance, incorporating factors such as the age of the equipment, corrective maintenance records, and authorization status from the clinical engineering manager for retirement. a request for a quotation was made to segment test equipment by price. devices over $5,000 were classified as major capital, while those under $5,000 were considered minor capital, each following different procurement pathways (table 6). standard kit a standard kit was developed, incorporating a literature review and technologist input, to group essential test equipment into three categories: items for each technologist, items for each site, and optional site-specific items. to maintain its relevance, periodic reviews based on database weight and usage are recommended. (a.) technologists: each individual should possess: • electrical safety analyzer • patient simulator • multimeter • basic toolkit (b.) each site should be equipped with: • oscilloscope • pressure meter • temperature probe/calibrator • vent tester high flow (optional) (c.) each site should have if applicable: • defibrillator analyzer • gas flow analyzer • esu unit (if there is a surgical unit) • ultrasound power meter table 6. weighting factor. age years cm life expectancy 35% reliability 20% frequency of use 20% usage classification 20% price weight 2009 14 8 2 3 3 3 $2,300 2.65 2011 12 7 2 3 3 3 $6,000 2.65 29 j global clinical engineering vol.6 issue 4: 2024 avila, janvier, ibey: assessment and capital planning of a regional clinical engineering department test equipment inventory results data analysis the survey results indicate a high frequency of test equipment use among technologists, with over half of the fleet utilized weekly or monthly: 60.8% used regularly, 29.6% occasionally, and only 9.6% rarely (table 7). table 7. cheo test equipment frequency of use. quantity of devices frequency of use % 210 regular use 60.8% 102 occasional use 29.6% 33 rare use 9.6% approximately half of the test equipment is centralized at cheo, while the rest is distributed across eight other sites. notably, pembroke regional hospital (1.4% of total equipment), hawkesbury & district general hospital (1.7%), and brockville general hospital emergency (8.4%) are significantly distant from cheo, located 151 km away, respectively (see figure 2 for a map). to mitigate these geographical challenges, it is recommended that each site be equipped with dedicated test equipment to minimize the need for sharing. to optimize resource distribution, the following equipment relocations are proposed: • laser auto magnetic: relocate to hawkesbury. • defibrillator testers: allocate to brockville and hawkesbury. • test equipment gauge force: assign to pembroke, hawkesbury, and saint vincent hospital. • temperature modules: relocate to pembroke and hawkesbury. in terms of usage classification, 60.8% of test equipment is primarily associated with high-risk medical devices classified as priority ⅳ, highlighting the critical importance of maintaining their accuracy. additionally, 25.2% of the equipment is mainly used with priority ⅲ devices, 10.5% with priority ⅱ devices, and 3.5% with priority ⅰ devices. this classification helps in optimizing resource allocation, ensuring that the most critical equipment receives the necessary attention (table 8). table 8. cheo test equipment usage classification. quantity of devices usage classification % 210 priority ⅳ 60.8% 87 priority ⅲ 25.2% 36 priority ⅱ 10.5% 12 priority ⅰ 3.5% the life expectancy (table 9) evaluation reveals that 12.2% of the test equipment is over 15 years old, indicating that these devices are nearing the end of their operational life. furthermore, 30.7% of the equipment falls within the 8 to 15 year range, meaning that more than half of the fleet is approaching the end of its life cycle. in contrast, 57.1% of the test equipment at cheo is under 8 years old, demonstrating the hospital’s proactive efforts in acquiring new equipment over the years. table 9. cheo test equipment usage classification. quantity of devices years % 42 r > 15 years old 12.2% 106 8 < r < 15 years old 30.7% 197 r < 8 years old 57.1% table 10 summarizes the reliability of test equipment at cheo, indicating strong performance consistency. notably, 76.2% of the devices score at the minimum level on the reliability scale, while only 10.0% of the fleet demonstrates significant functional inconsistency. these results reflect cheo’s strategic focus on acquiring test equipment that supports long-term workflows. j global clinical engineering vol.6 issue 4: 2024 30 avila, janvier, ibey: assessment and capital planning of a regional clinical engineering department test equipment inventory table 10. cheo test quipment reliability. quantity of devices assigned points % 37 3 10.8% 45 2 13.0% 263 1 76.2% the weighting factor quantitatively reflects the health system’s priorities, assigning the highest weight of 35.0% to the age factor, highlighting the critical need for a replacement plan. reliability follows with a weight of 25.0%, showing the importance of acquiring devices that maintain their functions over time to ensure patient safety. the total cost of the test equipment fleet at cheo is approximately cad 863,025, with a calibration cost of $20,602 for 46 pieces of equipment in 2023 showing the hospital’s commitment to maintaining high operational efficiency and safety (tables 11 and 12). figure 2. cheo sites distance. table 11. test equipment above $5,000 (capital). test equipment name quantity price test equip esu unit 6 $6,000 gas flow analyzer 1 $7,700 test equip, test lung 1 $5,000 test equip defib/pacemaker 2 $6,500 test equip, simulator patient multiparameter 8 $9,000 test equip, ventilator, high flow 2 $7,700 total 20 $149,100 31 j global clinical engineering vol.6 issue 4: 2024 avila, janvier, ibey: assessment and capital planning of a regional clinical engineering department test equipment inventory conclusion implementing organized data collection and validation processes improved cheo’s test equipment management. the structured data collection and validation approach has resulted in a fully up-to-date database that reflects the physical inventory, synchronized with the cmms system. the test equipment is now standardized using the ecri-recommended nomenclature, ensuring consistency across all sites. additionally, the color-coded system by site allows for easy filtering and quick location of devices. this organization reduces errors in test equipment location and enhances overall workflow efficiency, minimizing disruptions to hospital operations. the data on test equipment usage emphasizes the need for a well-distributed inventory to support high-demand devices. with over 60% of the equipment used regularly, there is an increased risk of wear and tear and potential physical damage from frequent handling and transport due to the long distance between the hospitals. strategically redistributing these frequently used devices will enhance resource management and help ensure their longevity. the life expectancy criteria demonstrate the hospital’s proactive approach to acquiring new technology, highlighting that over half of the test equipment is regularly used with high-risk medical devices. while life expectancy accounts for 35% of the replacement decision, the remaining 65% is spread across other critical categories, ensuring a balanced evaluation of equipment prioritization for replacement. while there are precise methodologies for calculating medical device life expectancy, limited literature on test equipment highlights the novelty of this article’s scoring system for capital planning in the field. this innovative approach provides valuable insights into managing resources and lays the groundwork for future methodologies to enhance evaluation processes. as the field evolves, we expect to integrate factors like wear and tear and calibration, along with more accurate reliability calculations, to improve our assessment and prioritization of test equipment in healthcare settings. conflicts of interest the authors declare they have no competing interests. ethics approval not applicable. consent for publication not applicable. references 1. children’s hospital of eastern ontario (cheo). available online: https://www.cheo.on.ca/en/about-us/ about-cheo.aspx. 2. greenwood, k., janvier, m., zhang, y. r., et al. the dividends of an effective clinical technology management program. j clin eng. 2014;39(1):28–32. https://doi. org/10.1097/jce.0000000000000010. table 12. test equipment under $5,000 (minor). test equipment name quantity price test equip safety analyzer 6 $2,300 test equip, nibp 2 $3,200 test equip simulator spo2 3 $1,000 multimeter 5 $500 test equip meter, pressure 1 $2,100 test equip tachometer contact 1 $450 optical power/energy meter 1 $1,250 test equip, simulator, patient multiparameter 1 $800 total 20 $30,300 https://www.cheo.on.ca/en/about-us/about-cheo.aspx https://www.cheo.on.ca/en/about-us/about-cheo.aspx https://doi.org/10.1097/jce.0000000000000010 https://doi.org/10.1097/jce.0000000000000010 j global clinical engineering vol.6 issue 4: 2024 32 avila, janvier, ibey: assessment and capital planning of a regional clinical engineering department test equipment inventory 3. griffin, z.m. frequency of meaning use for ambiguous and unambiguous words. behav res methods instrum comput.1999;31(3):520–530. https://doi.org/10.3758/ bf03200731. 4. health canada. guidance on the risk-based classification system for non-in vitro diagnostic devices (non-ivdds). available online: https://www.canada. ca/en/health-canada/services/drugs-health-products/ medical-devices/application-information/guidancedocuments/guidance-document-guidance-risk-basedclassification-system-non-vitro-diagnostic.html. 5. abd rahman, n.h., ibrahim, a.k., hasikin,k. et al. critical device reliability assessment in healthcare services. j healthc eng. 2023;2023:3136511. https:// doi.org/10.1155/2023/3136511. 6. food and drug administration. guidance document: medical device tracking guidance for industry and fda staff. available online: https://www.fda.gov/ medicaldevices/deviceregulationandguidance/ postmarketrequirements/medicaldevicetracking/ default.htm. 7. biomedical engineering advisory group. life span of medical devices guidance paper. available online: https://www.academia.edu/10481813/biomedical_engineering_advisory_group_guidance_paper_ life_span_of_biomedical_devices_background. https://doi.org/10.3758/bf03200731 https://doi.org/10.3758/bf03200731 https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html https://doi.org/10.1155/2023/3136511 https://doi.org/10.1155/2023/3136511 https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/medicaldevicetracking/default.htm https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/medicaldevicetracking/default.htm https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/medicaldevicetracking/default.htm https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/medicaldevicetracking/default.htm https://www.academia.edu/10481813/biomedical_engineering_advisory_group_guidance_paper_life_span_of_biomedical_devices_background https://www.academia.edu/10481813/biomedical_engineering_advisory_group_guidance_paper_life_span_of_biomedical_devices_background https://www.academia.edu/10481813/biomedical_engineering_advisory_group_guidance_paper_life_span_of_biomedical_devices_background j global clinical engineering vol.6 special issue 6: 2024 78 conference paper improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis and anestis kalfas* aristotle university of thessaloniki, polytechnic school, department of mechanical engineering, thessaloniki, greece. * corresponding author email: akalfas@auth.gr abstract aortic valve stenosis (as) is a common and severe valvular disease where accurate assessment is essential for determining prognosis and treatment. current echocardiographic methods mostly rely on the simplified bernoulli (sb) equation, which approximates the peak pressure drop (δp), risking poor stratification, especially for low-flow low gradient patients. this study examines the capabilities of combining computational fluid dynamics (cfd) and imaging techniques for better stratification of as patients. patient-specific geometries of the aortic valve, ascending aorta, and left ventricular outflow tract were reconstructed from ct and echocardiography data during peak systole. inlet velocity boundary conditions based on ultrasound data enabled transient flow simulations. blood flow was modeled as laminar and newtonian, with the geometry discretized for computational efficiency without loss of accuracy. validation against echocardiography data showed a 4% deviation in velocity predictions. results indicated that δp and maximum velocity (vmax) are strongly influenced by aortic valve area size, while leaflet geometry affects flow jet location. the cfd model revealed that sb overestimates δp in non-severe as, potentially leading to misclassification. by combining cfd with precise imaging, detailed hemodynamic insights can be achieved, addressing the limitations of conventional methods and improving patient stratification for treatment. keywords—aortic valve stenosis, patient-specific modeling, stenosis categorization, leaflet effects, pressure drop, maximum velocity, hemodynamic flow field, computational fluid dynamics. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:akalfas@auth.gr mailto:achat@uom.edu.gr https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 79 j global clinical engineering vol.6 special issue 6: 2024 introduction cardiovascular diseases are the leading cause of death worldwide (32% in 2019)1, and among them, aortic valve stenosis (as) is one of the most serious. initially, the aortic valve (av) is one of the four valves of the heart, situated between the left ventricle (lv) and the ascending aorta (aa). this valve typically consists of three leaflets2, which open and close during the cardiac cycle due to the pressure difference between the lv and aa, ensuring the unidirectional flow of blood towards the aa. as is typically attributed to the calcification of its leaflets, resulting in an increased workload on the lv. specifically, due to the constriction of the cross-sectional area of the aortic valve area (ava), the lv is required to generate higher pressure, thereby ensuring the appropriate pressure drop between the lv and the aa to maintain the flow of mass at normal levels. the primary method used for categorizing, i.e., assessing, the severity of as is the non-invasive echocardiography. the key parameters utilized in this measurement include the maximum measured velocity, calculated ava and pressure drop.2 specifically, the pressure drop is estimated using the simplified bernoulli equation (sb, δpsb = 4 × vvc 2 mmhg, where vvc represents the velocity at the vena contracta, i.e., the maximum velocity). furthermore, it has been demonstrated that this equation tends to overestimate the actual pressure drop3, which could potentially impact patient assessment. the direct measurement of pressure drop can be achieved through invasive catheterization; however, this procedure carries inherent risks. accurate patient categorization is of vital importance, as from the moment as symptoms appear, the annual survival rate decreases by 25%.4 therefore, in recent years, there has been an increased demand for more effective assessment of individuals with as and a deeper understanding of the flow field along the aortic valve. in this context, the goal of this research is to construct a computational fluid dynamics (cfd) model for simulating the flow along the aortic valve, utilizing real patient data. additionally, another objective is to conduct a comprehensive analysis of the impact of aortic valve stenosis on the flow field. in this manner, this research aims to analyze the flow along the aortic valve for various constriction configurations, thereby enhancing our understanding of the phenomenon and facilitating future investigations in the quest for an additional index that will serve as a supportive tool in patient categorization. materials and methods data from computed tomography (ct) and echocardiography (echo) of a patient were acquired. from the ct data, the corresponding three-dimensional geometry was constructed for maximum diastole and systole using discretization software (retomo, 2024, beta cae systems international ag, d4 business village luzern platz 4, 6039 root, switzerland) (figure 1 (a)→(b)). subsequently, different software (ansa, beta) was used for processing and the improvement of the mesh (figure 1 (b)→(c)). additionally, the open av’s geometry was not discernible in the ct data at peak systole, likely due to the rapid nature of systole and the thinness of the leaflets. in contrast, the closed av was distinguishable at maximum diastole. for this reason, the geometry of the open av was constructed after processing the closed av, and the geometric dimensions were validated using the echo data (figure 1 (c)). specifically, the ava crosssection was nearly identical between the model and the echo (310 mm2). subsequently, the enhanced geometries obtained at both maximum diastole and systole were integrated within the left ventricular outflow tract (lvot) to facilitate the prescribed motion of the lv (figure 1 (d)). however, it was found in the literature that this motion does not significantly affect pressure drop.5. therefore, the prescribed left ventricle motion was chosen to be removed in order to reduce computational costs, and a conduit was placed in its position. additionally, a second conduit was added to the ascending aorta to minimize the effect of boundary conditions on the results. the total dimensions of the two conduits are shown in figure 1 (d), measured from the ava. to investigate the influence of as and its valve leaflets on flow dynamics, a python code was developed. this code, in conjunction with ansa, facilitates the creation of various aortic valve geometries. specifically, this code utilizes some basic geometric characteristics of the original valve and a user-defined percentage step. in this way, the desired ava profiles are automatically generated in the http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 80 form of curves. figure 2 depicts the geometries of the av constructed with different ava values. the flow simulation was conducted using computational fluid dynamics software (ansys fluent, r3, 2019). the simulation was time-varying (transient), and the valvewas in the fully open position during systole. the time step chosen was 10−3 seconds (it was found that variations between 10−3 seconds and 10−4 seconds result in a 0.03% deviation, while exponentially increasing computational cost). incompressible fluid with a density of 1060 kg/m3 and newtonian fluid with a dynamic viscosity of 0.004 kg·m/s) were considered. the boundary condition for the inlet referred to mass flow, for which it was assumed to follow a sin waveform, generating 90 ml (stroke volume, sv) during systole, which had a duration of 0.35 seconds (both values were derived from the echo data). the outlet boundary condition corresponded to a pressure, which was assumed to remain constant at 120 mmhg.6 an investigation was conducted to assess the impact of inflation layers and turbulence model on the relevant parameters, pressure drop (δp), and maximum velocity (vmax) at peak systole. the pressure drop was calculated based on the difference in static pressure between the level 45 mm before the ava and 90 mm after the ava. it was observed that the inflation layers introduced a deviation of 7.8% and 3.8% in δp and vmax, respectively. for the investigation of the turbulence model, the low reynolds sst model was chosen based on the literature.7 this model was used in conjunction with the volume mesh containing the inflation layers and produced ymax + (t) < 1.7 < 5. comparing the results between the laminar and turbulent flow models, differences of less than 0.8% were observed for both δp and vmax. therefore, the impact of the turbulence model appears to be minimal. additionally, the accuracy provided by the introduction of inflation layers, relative to the additional computational cost, is considered negligible. for these reasons, and to reduce computational costs, the laminar flow model and the volume mesh without inflation layers were chosen. additionally, before employing the two-volume meshes (one with inflation layers and one without), independent studies of the mesh were conducted. specifically, for the volume mesh that was chosen for the simulations (without inflation layers), five different volume mesh sizes were examined: 0.4, 0.8, 1.6, 3, 9.6 × 105. between the 4th and 5th volume meshes, there was a difference of 1.53% in δp and 0.98% in vmax, while between the 3rd and 4th volume meshes, the differences were 3.34% and 0.96% for δp and vmax, respectively. the 4th volume mesh size was selected to reduce computational costs. the assumptions made regarding the mesh size, the choice of a volume mesh without inflation layers, and the use of laminar flow reduced the computational time for simulating the entire systolic cycle for one case from approximately 24 hours to 5 hours. the simulations were conducted on a laboratory computer with 32 gb ram, a 512 gb ssd, and an 11th gen intel(r) core™ i7-1165g7 processor. figure 1. representation of the methodology followed for the construction of the computational model. (daa diameter of the ascending aorta) figure 2. different ava cross-sections. http://www.globalce.org http://globalce.org http://globalce.org 81 j global clinical engineering vol.6 special issue 6: 2024 results for the validation of the model, initially, a comparison of the results with the measurements from the examined individual’s echo was performed. the maximum velocity in the echo at the lvot ranges from 1.13 to 1.22 m/s, while the corresponding velocity in the model is 1.27 m/s. therefore, a 4% deviation in velocity is observed. furthermore, at the peak of systole, the pressure drops and the maximum velocity calculated from the model are 2.79 mmhg and 1.63 m/s, respectively. figure 3 presents the results of the ava’s impact on δp and vmax, as derived using the av from figure 2 and connected with spline curves. in the same diagram, the estimated pressure drop from sb is also depicted. the dashed lines indicate the thresholds for severe aortic stenosis condition.3 to investigate the effect of each valve’s geometry on the flow field, four different models with different avas were created (figure 4). the first model represents the patient’s initial ava and serves as the baseline for comparison with the other three, which sequentially incorporate a dysfunctional valve. these dysfunctional valves were intentionally designed to achieve nearly identical ava cross-sectional areas in all three cases. simulation results showed that all three different aortic valves did not significantly differ in terms of the increase in δp and vmax. specifically, the three dysfunctional avs exhibited an average increase of +215% in δp and +125% in vmax. discussion the comparison made between the results and the echo data indicates that the model adequately predicts the flow field. moreover, for a more comprehensive comparison, a comparison was conducted with patients from the literature5,8 who exhibited similar geometric and hemodynamic characteristics, including comparable ava and stroke volume. from the comparison, deviations were observed, which can be attributed to the slight differences in these characteristics. for instance, vmax literature = 1.33 m/s, whereas vmax model = 1.63 m/s. the higher value in the model can be attributed to the smaller ava and the greater maximum flow volume. based on this analysis, the methodology utilized for constructing the three-dimensional model has demonstrated its effectiveness in calculating the maximum velocity and pressure drop at peak systole. in figure 3, the high values of δp for severe as are attributed to the constant stroke volume of 90 ml, whereas this volume is affected in cases of as. figure 3. effect of ava cross-sections on flow characteristics. figure 4. models and flow patterns for assessing the impact of leaflets on the flow field. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 82 was revealed that in the patient’s initial model, the inflation layers have a more pronounced effect on δp and vmax compared to the turbulence model, while the layers themselves are considered to provide negligible additional accuracy compared to the computational cost they introduced. moreover, it was observed that all three leaflets exhibited a similar impact on δp and vmax, emphasizing that these parameters are predominantly influenced by the size of the ava, rather than the specific valve geometry. however, the valve’s geometry, specifically the leaflets, influences the flow pattern of the jet. references 1. world health organization, cardiovascular diseases (cvds). available online: https://www.who.int/news-room/ fact-sheets/detail/cardiovascular-diseases-(cvds). 2. ring, l., shah, b.n., bhattacharyya, s., et al. echocardiographic assessment of aortic stenosis: a practical guideline from the british society of echocardiography. echo res practi. 2021;8(1):g19–g59. https://doi. org/10.1530/erp-20-0035. 3. baumgartner, h., stefenelli, t., niederberger, j., et al. “overestimation” of catheter gradients by doppler ultrasound in patients with aortic stenosis: a predictable manifestation of pressure recovery. j american coll cardiol. 1999;33(6):1655–1661. https://doi. org/10.1016/s0735-1097(99)00066-2. 4. carabello, b.a. and paulus, w.j. aortic stenosis. lancet. 2009;373(9667):956–966. https://doi.org/10.1016/ s0140-6736(09)60211-7. 5. hoeijmakers, m.j.m.m., silva soto, d.a., waechter-stehle, i., et al. estimation of valvular resistance of segmented aortic valves using computational fluid dynamics. j biomech. 2019;94:49–58. https://doi.org/10.1016/j. jbiomech.2019.07.010. 6. weese, j., lungu, a., peters, j., et al. cfd-and bernoullibased pressure drop estimates: a comparison using patient anatomies from heart and aortic valve segmentation of ct images. med phys. 2017;44(6):2281–2292. https://doi.org/10.1002/mp.12203. therefore, the illustrated δp values correspond to the complete preservation of flow (sv = const) in the case of as. similar observations apply to vmax. additionally, in the same figure, a pronounced overestimation of sb is observed in individuals with non-severe as.3 overall, based on the chart in figure 3, clinical researchers could be able to assess the severity of stenosis in the specific patient for whom the model was created. additionally, they could examine potential stenosis cases that may arise in the future. therefore, by applying the methodology presented for constructing the cfd model and valves, clinical researchers could create corresponding diagrams for each patient under examination. this would lead to a more comprehensive understanding of each examined individual by medical researchers. however, for this analysis to be applicable in clinical research, it is imperative to utilize supercomputers to minimize computational costs. additionally, this methodology should be fully automated and thoroughly validated for accuracy across hundreds of patients. based on the results obtained from the investigation of the leaflets, it was found that all three leaflets affect δp and vmax to a similar extent. therefore, this leads to the additional conclusion that δp and vmax are not as strongly dependent on the geometry of the aortic valve as they are on the size of the ava. however, the geometry of the av affects the flow field, as depicted in figure 4, where the flow jet location is different in the four cases. hence, the valve’s leaflets impact the location where the flow jet impinges on the aa, potentially contributing to the development of an aortic root aneurysm, as the impingement point in the ascending aorta can influence the wall shear stresses. conclusion in this research, a methodology was presented for constructing a patient-specific computational fluid dynamics model for simulating blood flow along the aortic valve. it was found that the model construction methodology is sufficient for calculating δp and vmax. additionally, the code developed for automating the process of constructing various valves from the initial valve proved to be highly useful, as it can yield significant insights for future cases of more severe as in the same patient. furthermore, it http://www.globalce.org http://globalce.org http://globalce.org https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds) https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds) https://doi.org/10.1530/erp-20-0035 https://doi.org/10.1530/erp-20-0035 https://doi.org/10.1016/s0735-1097(99)00066-2 https://doi.org/10.1016/s0735-1097(99)00066-2 https://doi.org/10.1016/s0140-6736(09)60211-7 https://doi.org/10.1016/s0140-6736(09)60211-7 https://doi.org/10.1016/j.jbiomech.2019.07.010 https://doi.org/10.1016/j.jbiomech.2019.07.010 https://doi.org/10.1002/mp.12203 83 j global clinical engineering vol.6 special issue 6: 2024 7. stewart, s.f.c., paterson, e.g., burgreen, g.w. et al. assessment of cfd performance in simulations of an idealized medical device: results of fda’s first computational interlaboratory study. cardiovasc eng tech. 2012;3:139–160. https://doi.org/10.1007/ s13239-012-0087-5. 8. yang, c.s., marshall, e.s., fanari, z., et al. discrepancies between direct catheter and echocardiography-based values in aortic stenosis. catheter cardiovasc interv. 2016;87(3):488–97. https://doi.org/10.1002/ccd.26033. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.1007/s13239-012-0087-5 https://doi.org/10.1007/s13239-012-0087-5 https://doi.org/10.1002/ccd.26033 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 j global clinical engineering vol.6 special issue 6: 2024 12 original research article digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli and evangelia stalika international hellenic university, thessaloniki, greece. * corresponding author email: thtanis1@gmail.com abstract background and objectives: the explosion of new digital technologies is fundamentally disrupting the world as it has been perceived until now, transforming it multilevel and at an unprecedented speed. at the same time, with traditional ways of providing health services, their quality and scale cannot meet user’s needs and expectations. within this context of constant search for improved quality, the path of health services towards a digital and value-based transformation is now a one-way street, with drastic and immediate effects that are capable of disrupting the sector and making it sustainable. the most defining issue is how an organization adapts its organizational culture, strategy, and leadership and mostly prepares the staff to operate effectively in a digital world, adding value to users and sustaining prosperity. the main goal of this study is to investigate the perceptions of health professionals regarding the usability and ease of use of digital transformation applications. material and methods: to investigate the aim of the study, the use questionnaire was used. it was distributed completely paperless, exclusively through google forms. for better common understanding, we edited an auxiliary video and embedded it in the google form, to be watched before starting answering it. our sample was healthcare professionals who worked in various hospitals and health providers in northern greece. results: age appears to have a greater influence on health professional self-efficacy. regardless of specialty, they show positive perceptions of both the usefulness and ease of use and learning of digital applications. those with a lower level of education showed a higher perceived ease of use and learning, as well as their usefulness, than expected. conclusion: the acceptance of digital transformation in healthcare professionals is based on understanding the concerns and feelings of insecurity that overwhelm healthcare professionals. our findings can help us better understand the factors that influence their adoption of new digital technologies. likely, this will help us to reduce the time required to make all the structural changes that are necessary, but also to guide us properly for the best use of our already limited available resources. as people accept change at different rates, there is no time for delay and their preparation should begin immediately. keywords—digital transformation, health service management, healthcare services, healthcare professional’s perceptions, implementation factors. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto: thtanis1@gmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 13 j global clinical engineering vol.6 special issue 6: 2024 introduction people adopt new technologies quickly and completely, regardless of whether they are intermediate or end users. they are more experienced in the use of technology, and how organizations take advantage of it, and are becoming increasingly selective and demanding about what they are going to use.1 many, mistakenly believe it will be a seamless experience, powerful and adaptable, allowing healthcare professionals to function as they have already embraced the digital world in their lives.2 as this is complex and the existing structures and cultures of healthcare organizations are not sufficient to promote and harmoniously integrate innovative functions, the simple appearance of new digital technologies does not yield the expected service improvement.3 health services are inherently high-risk and have complex structures that strongly resist any change.3,4 it therefore seems to make no sense to invest in cutting-edge technology if there is not the right workforce with the right roles and skills to fully exploit its potential for the benefit of patients.4 we fully understand that people are the real key to digital transformation.5,6 this transition is essentially slowed down by strict regulations, the reluctance and resistance to change shown by all healthcare stakeholders, thus ignoring the importance of changes in the organization’s culture and the human factor in an increasingly broad technological ecosystem taking shape.7–9 the coronavirus disease has forced many healthcare-related processes to move online, almost overnight. however, it will take some time to fully understand the multiple impacts of the recent digital changes that have occurred in response to the current pandemic.10 professionals have different interests, perceptions, and beliefs. change management programs focus on trying to convince people why they need to change. these reasons are usually not in line with their individual interests and beliefs. people don’t change unless they want to. they have very little confidence in the new environment being formed mainly because of all these changing elements such as skills, processes, organizational structure, and hierarchy.11 however, changing working methods in health services is not an easy task for whoever undertakes it. the complex organization and high degree of complexity created by the variety of professional groups and regulatory systems complicates and often precludes the application of successful management techniques that perform exceptionally well in other forms of organizations. deep-rooted perceptions, organizational norms, and established culture complicate and hinder efforts to introduce new systems in healthcare.12,13 a primary task of management when starting a change process remains to increase the degree of emotional attachment of employees, because this not only affects their satisfaction, but also the performance of each one individually. the effect of an emotional denial from disengaged employees is manifold. without an emotional bond, they are much more likely to simply be absent from this endeavor.14 the purpose of this paper deals with the overall context of the management practice, during the process of digital transformation in health services. the main goal was the systematic investigation of the factors that influence health professionals in order to be committed and get involved in its implementation. for this purpose, the perceptions of health professionals regarding the usability of digital transformation applications were investigated. our findings can likely contribute to a broader understanding of the factors influencing the adoption of new digital technologies by healthcare professionals. in this way, it will be possible to reduce the time of carrying out all the structural changes that are imposed and also to make the most of our already limited available resources. methods research design to investigate the aim of the study, the use questionnaire15 was used. the use questionnaire (usefulness, satisfaction, ease of use) has been proposed by lund 2001 as a tool to categorize user responses into the 4 dimensions of usefulness (8 questions), ease of use (11 questions), ease of learning (4 questions) and satisfaction (7 questions). it includes a total of 30 questions, to be answered on a 7-level likert scale. the questionnaire was distributed completely paperless, exclusively through google forms. the questionnaire also http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 14 recorded demographic data regarding gender, age with a range of ten years, level of education, the directorate they belong to, the hospital they work for, the health region to which the hospital belongs, and whether they hold a position of responsibility. it was possible to answer from any pc, or smart device regardless of operating system. each participant had the possibility of a single answer. for a better understanding of how everyday work is changing through digital transformation applications and to explore the perceptions of different categories of professionals, we had to create an auxiliary video of 3 min 16 sec duration. the video was embedded in the google form, before the start of the questionnaire and immediately after the introductory informational notes. each participant needed to watch it in order to continue with the questionnaire answers to participate in the research. at the end of the survey, there was the possibility to consent and to state his email in order to be informed early of the results of the survey. sample–data collection the research lasted 2.5 months and ended a little prematurely due to the special conditions created for health professionals due to the covid-19 pandemic. it was divided into two parts. the first part, which lasted two weeks, concerns a weighted sample in terms of the composition of professionals according to the departments to which they belong. the composition of the directorates of the papageorgiou hospital was used as a standard sample. so initially the questionnaires were sent in digital form to 323 health professionals who had the following composition: 47 employees of the administrative department, 87 doctors of the medical department, 169 employees of the nursing department, 7 employees of the financial department, 4 employees of the it department and 9 employees of other directorates. these professionals worked in various hospitals and health providers in northern greece. seven days after sending the questionnaire a reminder message was sent to complete it. data analysis for statistical analysis, chronbach’s alpha test was used to check the reliability of the questions of each dimension of the questionnaire.16 independent samples t-tests were also used to investigate the variables of gender, hospital of service, and position of responsibility17, while to investigate the variables of age, level of education, department, and the hr owned by health professionals, one-way anova was used.18,19 to further investigate differences between samples hochberg’s gt2 test was used as the sample sizes were dissimilar.20 results descriptive statistics our sample (figure 1) consisted of 224 health professionals, 63 men (28.1%) and 161 women (71.9%). of these, 40 (17.9%) were aged 25–35, 85 (37.9%) 36–45, 88 (39.3%) 46–55 and 11 (4.9%) from 55+ years. 21 (9.4%) health professionals belonged to the basic education level, 103 (46%) to the technological (te) level, while 30 (13.4%) to the university (ue) level, 58 (25.9%) were holders of an msc degree and 12 (5.4%) phd holders. 127 (56.6%) of them worked at papageorgiou hospital, while the remaining 97 (43.4%) worked at other hospitals in northern greece. at the same time, 151 (67.4%) belonged to the potential of the 3rd health region, 65 (29%) to the 4th health region and 8 (3.6%) to the 6th health region. 51 (22.8%) held positions of responsibility while the remaining 173 (77.2%) did not hold any position of responsibility. participants’ overall responses to the use questionnaire showed a mean value (m = 5.56, sd = 0.89) (figure 2). 107 (47.8%) seemed to strongly agree (m > 5.5), while 200 (89.2%) agreed (m > 4.5). in the usefulness dimension, figure 1. the profile of the average participant. http://www.globalce.org http://globalce.org http://globalce.org 15 j global clinical engineering vol.6 special issue 6: 2024 they showed a mean value (m = 5.76, sd = 0.95), and 158 (70.5%) seemed to strongly agree (m > 5.5), while 204 (91%) agreed (m > 4.5). in the dimension of ease of use, they showed a mean value (m = 5.42, sd = 0.96), and 115 (51.3%) seemed to strongly agree (m > 5.5), while 191 (85.2%) agreed (m > 4.5). in the dimension of ease of learning, they showed a mean value (m = 5.61, sd = 1.00), and 139 (62%) seemed to strongly agree (m > 5.5), while 192 (85.7%) agreed (m > 4.5). in the dimension of satisfaction, they showed an average value (m = 5.45, sd = 1.06), and 112 (50%) seemed to strongly agree (m > 5.5), while 188 (89.2%) agreed (m > 4.5) (figure 3). reliability all dimensions were tested for and found to have acceptable limits for reliability using chronbach’s alpha test. for the dimension of usefulness, it was found that a = 0.94, for the dimension of ease of use it was found that a = 0.95, for the dimension of ease of learning it was found that a = 0.95, while for the dimension of satisfaction it was found that a = 0.96 (figure4). inductive statistics use independent samples t-tests (table 1) were conducted to compare gender, hospital of service, and position of responsibility with usability and usability of digital applications. there appeared to be no significant difference in the overall evaluation of usability and ease of use of digital applications between men (m = 5.58, sd = 0.87) and women (m = 5.55, sd = 0.90), t(222)= 0.20, p > 0.05, between health professionals working at the papageorgiou hospital (m = 5.52, sd = 0.90) and at the other hospitals (m = 5.61, sd = 0.88), t(222) = 0.73, p > 0.05, as and between health professionals who hold a position of responsibility (m = 5.65, sd = 0.76) and those who do not (m = 5.53, sd = 0.92), t(222) = 0.81, p > 0.05. a one-way anova of the populations was performed in order to investigate the effect of age on the usability of digital applications (table 2). the level of significance was set at p < 0.05 for all levels. age appeared to have a figure 4. reliability levels of the use questionnaire. figure 2. radar diagram of the 4 dimensions of the use questionnaire. figure 3. levels of agreement by dimension and overall in the use questionnaire. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 16 significant effect on the overall evaluation of usability and ease of use of digital applications f(3.220) = 3.05, p = 0.029. post hoc comparisons using hochberg’s gt2 test indicated that the mean value of age 36–45 (m = 5.33, sd = 0.95) (figure 5) differed significantly from that of age 46–55 (m = 5.70, sd = 0.90). however, the mean value of ages 25–35 (m = 5.66, sd = 0.72) and 55+ (m = 5.82, sd = 0.57) did not differ significantly from the other ages (table 3). the level of education appeared to have no significant effect on the overall evaluation of the usability and ease of use of digital applications f(4.219) = 0.82, p > 0.05. accordingly, the address to which the health professionals belong appeared to have no significant effect on the overall evaluation of the usability and ease of use of the digital applications f(4.219) = 1.22, p > 0.05, as well as the ministry of health to which the health professionals belong f(2.221) = 0.38, p > 0.05. table 1. results of independent samples t-tests for the effect of gender, hospital & position of responsibility on the dimensions of the use questionnaire. levene’s test for equality of variances t-test for equality of means 95% confidence interval of the difference f value significance t value degrees of freedom sig. (2-tailed) mean difference std. error difference lower upper gender use 0.901 0.344 0.199 222 0.843 0.02634 0.13247 −0.23472 0.28740 usefulness 0.358 0.550 0.096 222 0.924 0.01354 0.14162 −0.26555 0.29264 ease of use 2.165 0.143 0.275 222 0.784 0.03915 0.14235 −0.24138 0.31968 ease of learning 0.107 0.744 0.691 222 0.490 0.10266 0.14860 −0.19020 0.39551 satisfaction 0.412 0.521 −0.317 222 0.751 −0.04999 0.15751 −0.36039 0.26042 hospital use 0.009 0.923 −0.728 222 0.467 −0.08743 0.12007 −0.32405 0.14920 usefulness 0.246 0.620 −1.426 222 0.155 −0.18237 0.12793 −0.43448 0.06974 ease of use 1.176 0.279 −0.379 222 0.705 −0.04900 0.12915 −0.30351 0.20551 ease of learning 0.036 0.849 −0.110 222 0.913 −0.01483 0.13498 −0.28085 0.25118 satisfaction 0.107 0.744 −0.725 222 0.469 −0.10350 0.14278 −0.38489 0.17789 responsibility use 1.149 0.285 0.812 222 0.418 0.11519 0.14184 −0.16433 0.39471 usefulness 3.583 0.060 1.778 222 0.077 0.26815 0.15078 −0.02900 0.56529 ease of use 0.842 0.360 0.912 222 0.363 0.13898 0.15237 −0.16130 0.43925 ease of learning 0.287 0.593 −0.438 222 0.662 −0.06979 0.15944 −0.38399 0.24441 satisfaction 3.479 0.063 0.732 222 0.465 0.12343 0.16871 −0.20906 0.45591 http://www.globalce.org http://globalce.org http://globalce.org 17 j global clinical engineering vol.6 special issue 6: 2024 ease of use age appeared to have a significant effect on the ease of use dimension of digital applications f(3.220) = 3.26, p = 0.022. post hoc comparisons using hochberg’s gt2 test indicated that the mean value of age 36–45 (m = 5.18, sd = 1.04) differed significantly from that of age 46–55 (m = 5.58, sd = 0.94) (table 4). however, the mean value of the ages 25–35 (m = 5.50, sd = 0.78) and 55+ (m = 5.76, sd = 0.64) did not differ significantly from the other ages (figure 6). table 2. results of the one-way anova for the effect of age, address, grade & hse on the dimensions of the use questionnaire. sum of squares degrees of freedom mean square f value significance between groups directorate use 3.842 4 0.961 1.219 0.304 usefulness 5.839 4 1.460 1.633 0.167 ease of use 4.013 4 1.003 1.100 0.358 ease of learning 1.064 4 0.266 0.263 0.901 satisfaction 10.547 4 2.637 2.417 0.050 age use 7051 3 2.350 3.053 0.029 usefulness 5917 3 1.972 2.217 0.087 ease of use 8679 3 2.893 3.263 0.022 ease of learning 10.569 3 3.523 3.658 0.013 satisfaction 5.534 3 1.845 1.664 0.176 education use 2.592 4 0.648 0.816 0.516 usefulness 2.408 4 0.602 0.662 0.619 ease of use 2.246 4 0.562 0.610 0.656 ease of learning 4.754 4 1.188 1.195 0.314 satisfaction 4.317 4 1.079 0.964 0.428 health region use 0.610 2 0.305 0.383 0.682 usefulness 2.192 2 1.096 1.214 0.299 ease of use 0.487 2 0.244 0.265 0.768 ease of learning 0.557 2 0.278 0.277 0.758 satisfaction 0.931 2 0.466 0.414 0.662 figure 5. results of the mean of usability and ease of use by age. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 18 table 3. results of hochberg’s gt2 test for the effect of age on the usability of digital applications. age mean difference standard error significance 95% confidence interval lower bound upper bound 25–35 36–45 0.32622 0.16825 0.281 −0.1203 0.7727 46–55 −0.03373 0.16732 1.000 −0.4778 0.4103 55+ −0.15750 0.29873 0.996 −0.9503 0.6353 36–45 25–35 −0.32622 0.16825 0.281 −0.7727 0.1203 46–55 −0.35995 0.13344 0.044 −0.7141 −0.0058 55+ −0.48372 0.28116 0.418 −1.2299 0.2624 46–55 25–35 0.03373 0.16732 1.000 −0.4103 0.4778 36–45 −0.35995 0.13344 0.044 0.0058 0.7141 55+ −0.12377 0.28061 0.998 −0.8685 0.6209 55+ 25–35 0.15750 0.29873 0.996 −0.6353 0.9503 36–45 0.48372 0.28116 0.418 −0.2624 1.2299 46–55 0.12377 0.28061 0.998 −0.6209 0.8685 table 4. results of hochberg’s gt2 test for the effect of age on ease of use of digital applications. age mean difference standard error significance 95% confidence interval lower bound upper bound 25–35 36–45 0.31578 0.18056 0.398 −0.1634 0.7950 46–55 −0.08512 0.17957 0.998 −0.5617 0.3914 55+ −0.26488 0.32060 0.957 −1.1157 0.5859 36–45 25–35 −0.31578 0.18056 0.398 −0.7950 0.1634 46–55 −0.40090 0.14321 0.033 −0.7810 −0.0208 55+ −0.58065 0.30174 0.289 −1.3814 0.2201 46–55 25–35 008512 0.17957 0.998 −0.3914 0.5617 36–45 0.40090 0.14321 0.033 0.0208 0.7810 55+ −0.17975 0.30115 0.992 −0.9790 0.6195 55+ 25–35 0.26488 0.32060 0.957 −0.5859 1.1157 36–45 0.58065 0.30174 0.289 −0.2201 1.3814 46–55 0.17975 0.30115 0.992 −0.6195 0.9790 http://www.globalce.org http://globalce.org http://globalce.org 19 j global clinical engineering vol.6 special issue 6: 2024 ease of learning age appeared to have a significant effect on the ease of learning dimension of digital applications f(3.220) = 3.66, p = 0.013. post hoc comparisons using hochberg’s gt2 test indicated that the mean value of age 25–35 (m = 5.86, sd = 0.83) differed significantly from that of age 36–45 (m = 5.34, sd = 1.05) (table 5). however, the mean values of ages 46–55 (m = 5.72, sd = 1.02) and 55+ (m = 5.90, sd = 0.50) did not differ significantly from the other ages (figure 7). however, the level of education did not seem to have a significant effect on the dimension of ease of learning of digital applications f(4.219) = 1.19, p > 0.05, as well as the address to which the health professionals belong f(4.219) = 0.26, p > 0.05 and the hse to which they belong f(2.221) = 0.28, p > 0.05. the level of education did not appear to have a significant effect on the dimension of ease of use of digital applications f(4.219)= 0.61, p > 0.05, as well as the directorate to which the health professionals belong f(4.219) = 1.10, p > 0.05 and the hr to which health professionals belong f(2.221) = 0.26, p > 0.05. figure 6. results of the mean of ease of use dimension by age. table 5. results of hochber’s gt2 test for the effect of age on the ease of learning digital applications. age mean difference standard error significance 95% confidence interval lower bound upper bound 25–35 36–45 0.51213 0.18818 0.041 0.0127 1.0115 46–55 0.13182 0.18715 0.980 −0.3648 0.6285 55+ −0.05284 0.33413 1.000 −0.9396 0.8339 36–45 25–35 −0.51213 0.18818 0.041 −1.0115 −0.0127 46-55 −0.38031 0.14925 0.067 −0.7764 0.0158 55+ −0.56497 0.31447 0.367 −1.3995 0.2696 46–55 25–35 −0.13182 0.18715 0.980 −0.6285 0.3648 36–45 0.38031 0.14925 0.067 −0.0158 0.7764 55+ −0.18466 0.31386 0.992 −1.0176 0.6483 55+ 25–35 0.05284 0.33413 1.000 −0.8339 0.9396 36–45 0.56497 0.31447 0.367 −0.2696 1.3995 46–55 0.18466 0.31386 0.992 −0.6483 1.0176 http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 20 satisfaction age appeared to have no significant effect on the dimension of satisfaction using digital applications f(3.220) = 1.66, p > 0.05. accordingly, the level of education did not seem to have a significant effect on the dimension of satisfaction with the use of digital applications f(4.219) = 0.96, p > 0.05, as well as the hr to which the health professionals belong f(2.221) = 0.41, p > 0.05. the directorate to which the health professionals belong, however, appeared to have a marginally significant effect on the dimension of satisfaction with the use of digital applications f(4.219) = 2.41, p = 0.05 (table 3). post hoc comparisons using hochberg’s gt2 test, however (table 6), did not indicate that the mean value of the nursing division (m = 5.54, sd = 1.02) differed significantly from that of the administrative division (m = 5.13, sd = 1.14), the medical division (m = 5.15, sd = 1.12) of the it department (m = 5.64, sd = 0.92) and the other departments (m = 5.90, sd = 0.91). discussion the digital maturation of healthcare professionals is a natural process, but it will not happen automatically and without appropriate guidance.21,22 the adoption of new digital technologies is a complex process with many factors influencing at the individual level, such as perceptions of ease of use and learning, usefulness, and satisfaction of use. many negative and positive emotions are stimulated by them and affect this process.23 figure 7. results of the mean of the dimension of ease of learning by age. it appears that the effort they are expected to put into learning and properly using digital technologies is often cited as a key factor affecting the motivation of health workers to adopt them.24 healthcare workers can be empowered, adopt and use new digital technologies in environments where they align with their needs, workload, training, and skills. in turn, new digital technologies can empower health workers and equip them with skills and the necessary confidence when they are perceived as useful and easy to use and learn, in environments that enhance end-user recognition.25 while other professionals may decide to engage with new technologies or at least experiment with them more easily, healthcare professionals are more likely to demand greater levels of utility and ease of use to increase the appropriateness of their care, as they appear particularly wary of streamlining. of their use.26 generally, in the hospital setting user acceptance theories do not represent the ultimate explanations for individual behaviors. the core features of professional functioning require both institutional compliance and a requirement for autonomous decision-making.27 various organizational, cultural, and technological factors influence how people perceive the concept of usefulness and ease of use. but when individual decision-making is largely shaped by them, professionals embedded in the same institutional framework should exhibit isomorphic perceptions of the usefulness and ease of use of new practices or technologies, which may have also appeared in our results. after all, the existence of heterogeneous perceptions in a very strictly institutionalized environment such as that of health services would constitute, as it is traditionally considered, a paradox.27 in this regard, a form of dominantly imitative (and not coercive or normative) isomorphism seems to appear28, probably also as a result of the informative video. despite the fact that professionals use the distinctness of their role and their knowledge as resistance to institutional pressures and make individual decisions about new technology, it seems that they are not completely unaffected by them.27 new digital technologies are promoted by early adopters in the workforce predominantly as significant advances in clinical suitability, and in particular in quality of service, stability, and reliability. at the same time, however, they are promoted by managers and policymakers as sources http://www.globalce.org http://globalce.org http://globalce.org 21 j global clinical engineering vol.6 special issue 6: 2024 otherwise, healthcare professionals who have considerable power and resistance to managers and other professional groups, and are variously shielded from other social pressures and obligations outside their group, will not commit to and adopt the effort to digital transformation or they may even sabotage it. as a consequence, even the managers and promoters of the new technologies, who carry the institutional idea of spreading their use, will distance themselves as is usually the case or will be completely subordinated by the intermediate users (health professionals) in order to avoid ruptures and table 6. results of hochberg’s gt2 test for the effect of management on the satisfaction of using digital applications. directorate directorate mean difference standard error significance 95% confidence interval lower bound upper bound medicine nursing −0.39403 0.18579 0.298 −0.9192 0.1312 admin 0.01539 0.26847 1.000 −0.7435 0.7743 it −0.49652 0.45658 0.960 −1.7872 0.7941 other −0.74890 0.31520 0.168 −1.6399 0.1421 nursing medicine 0.39403 0.18579 0.298 −0.1312 0.9192 admin 0.40942 0.23102 0.550 −0.2436 1.0625 it −0.10248 0.43561 1.000 −1.3339 1.1289 other −0.35487 0.28398 0.905 −1.1576 0.4479 admin medicine −0.01539 0.26847 1.000 −0.7743 0.7435 nursing −0.40942 0.23102 0.550 −1.0625 0.2436 it −0.51190 0.47678 0.963 −1.8596 0.8358 other −0.76429 0.34381 0.239 −1.7361 0.2076 it medicine 0.49652 0.45658 0.960 −0.7941 1.7872 nursing 0.10248 0.43561 1.000 −1.1289 1.3339 admin 0.51190 0.47678 0.963 −0.8358 1.8596 other −0.25238 0.50457 1.000 −1.6787 1.1739 other medicine 0.74890 0.31520 0.168 −0.1421 1.6399 nursing 0.35487 0.28398 0.905 −0.4479 1.1576 admin 0.76429 0.34381 0.239 −0.2076 1.7361 it 0.25238 0.50457 1.000 −1.1739 1.6787 of efficiency, standardization, and continuous monitoring. these rationales are often perceived as a managerial intrusion into the unaffected exercise of professional practice and are met with suspicion and skepticism.27 essentially, therefore, employees should be given a sense of control over how the digital transformation will take place, demonstrating that new technologies are introduced as a means of enhancing rather than canceling them, in order to do much better and more easily what they already do exceptionally well. 29 http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 22 confrontations.27 this can be fatal not only for the quality but also for the sustainability of the health services of the future. age appears to influence health professionals’ selfefficacy. usually, the aging workforce will bring about adverse effects for the near future of the health services provided, as their physical capabilities begin to decline and they will be constantly called upon to apply new digital technologies for which they will have little or zero knowledge.23,30 of particular concern is the fact that the older workforce typically holds positions of responsibility. equally worrying in our findings is the fact that the 36–45 age group appears to have the least positive perceptions of ease of use and learning, with potential interest in their disengagement from the digital transformation project, despite the fact that they will inevitably be the dominant group that will be called upon to implement and manage it. gender, knowledge, and position of responsibility despite the fact that they are determining factors of the relative readiness and utilization of new digital technologies, did not seem to influence the perception of usefulness and ease of use and learning and indirectly the degree of their adoption. however, increasing the awareness, knowledge, and skills of health professionals in these technologies before their implementation is necessary to increase their adoption.31 our findings also showed that professionals with a lower level of knowledge of new digital technologies show a higher perceived ease of use and learning as well as their usefulness, than expected. this, despite the fact that it may act as an aid to their adoption, does not automatically constitute the achievement of an improved capacity on their part. the self-confidence and belief of health professionals should be activated and effectively increased in order to achieve high levels of self-efficacy.25 health professionals, regardless of specialty, show positive perceptions of both the usefulness and the ease of use and learning of digital applications. this does not fully agree with corresponding findings that state that nurses can be characterized as laggards in the adoption of technology both in their personal life and in their workplace23, or the strongly negative attitude of doctors.26 conclusion in conclusion, the optimal application of personalization, work needs, and technology will enable increased adoption of new digital technologies. an in-depth understanding of users’ opinions and perceptions about the usability of new digital technology applications is essential for their effective adoption and their successful integration into the health services provided. these views and perceptions are complex and each user group has unique professional priorities and roles, which should be taken into account by decisionmakers to increase adoption.32 acceptance of digital solutions and innovative medical technologies from all (intermediate and end users) is based on understanding their concerns and insecurities. the process will take time because people accept change at different rates. therefore, the development of an extensive user community for the full and successful implementation of e-health is less likely in the immediate and short term. however, this should not hinder the push for digital transformation in health services.26 clinical adjustments recognizing the particularities and the necessity of immediately starting the digital transformation in health services, an integrated framework for its operation should be formed in our country as elsewhere.33, 34 initially, independent digital transformation offices should be created which will report directly to the general administration or the board. the main concern of these offices should initially be the awareness and information of the organization's employees about the necessity but also the real benefits that the employees will get from its implementation. on a second level, they should act as gatekeepers to help create and ensure that a single strategy is implemented across the length and breadth of the organization. this can be made possible as they will act as the intermediate coordinating link of all collaborative teams that will be involved in any digital transformation project. administrators of these offices should be clinical professionals with at least ten years of experience who have demonstrated an increased interest in digital technologies (something http://www.globalce.org http://globalce.org http://globalce.org 23 j global clinical engineering vol.6 special issue 6: 2024 8. mirković, v., lukić, j., lazarević, s., et al. key characteristics of the organizational structure that supports digital transformation. in proceedings of the 24th international scientific conference strategic management and decision support systems in strategic management. subotica, serbia, 17–18 may, 2024. https:// doi.org/10.46541/978-86-7233-380-0_46. 9. chirkunova, e.k., khmeleva, g.a., koroleva, e.n., et al. regional digital maturity: design and strategies. in international scientific conference “digital transformation of the economy: challenges, trends, new opportunities”. samara, russia; 26–27 april, 2019; springer: cham, switzerland, 2019, pp. 205–213. https://doi. org/10.1007/978-3-030-27015-5_26. 10. sturt, j., huxley, c., ajana, b., et al. how does the use of digital consulting change the meaning of being a patient and/or a health professional? lessons from the longterm conditions young people networked communication study. digit health. 2020;6:2055207620942359. https://doi.org/10.1177/2055207620942359. 11. bendor-samuel, p. digital transformation: 3 change management mistakes to avoid. the enterprisers project. available online: https://enterprisersproject.com/article/2019/10/ digital-transformation-3-change-management-mistakes. 12. eriksson, n. hospital management from a high reliability organizational change perspective: a swedish case on lean and six sigma. int j public sect ma. 2017;30(1):67– 84. https://doi.org/10.1108/ijpsm-12-2015-0221. 13. dror, n. cios, here’s how to plan digital transformation. oracle university blog. available online: https://blogs.oracle. com/oracleuniversity/planning-digital-transformation. 14. kreutzer, r.t., neugebauer, t., pattloch, a. digital business leadership. springer: berlin, germany; 2018. available online: https://content.e-bookshelf.de/media/ reading/l-11079574-afba41d34e.pdf. 15. lund, a.m. measuring usability with the use questionnaire. usability interface. 2001;8(2):3–6. available online: https://www.researchgate.net/publication/230786746_ measuring_usability_with_the_use_questionnaire. 16. brown, j.d. likert items and scales of measurement. statistics. 2011;15(1):10–14. available online: https:// www.ders.es/likert.pdf. equivalent to nhs ccio’s).34 the main concern of health policymakers should be to encourage the development of an integrated educational framework, both with the systematic restructuring of the detailed curriculum of health professions, but also with the creation of specialization programs at the postgraduate level that will support the development of the existing human potential and skills. the immediate, relevant formation of this potential can be performed by developing the boot camps method (under the auspices of the ministry of health in cooperation with the local educational institutions), a practice followed with great success by all major organizations for the short and intensive training of their newly recruited executives. references 1. daugherty, p., and carrel-billiard, m. the post-digital era is upon us are you ready for what’s next. accenture technology vision 2019. available online: https:// 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https://hbr.org/2019/03/digital-transformation-is-not-about-technology. https://hbr.org/2019/03/digital-transformation-is-not-about-technology. https://doi.org/10.2196/15450 https://doi.org/10.1186/s12911-014-0115-5 https://doi.org/10.1186/1472-6947-12-105 https://doi.org/10.1186/1472-6947-12-105 https://doi.org/10.1093/eurpub/ckz185.769 https://doi.org/10.1093/eurpub/ckz185.769 https://topol.hee.nhs.uk/ editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 89 j global clinical engineering vol.6 special issue 6: 2024 conference paper deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 1 medical physics laboratory, department of medicine, democritus university of thrace, alexandroupolis, greece. 2 foundation for research and technology—hellas (forth), institute of computer science, bioinformatics laboratory, science and technology park of crete, greece. 3 school of science and technology, hellenic open university, patras, greece. 4 lab of medical physics, school of medicine, aristotle university of thessaloniki, greece. * corresponding author email: adam@med.duth.gr abstract in this research, we study several statistical methods for feature extraction from magnetoencephalography (meg) signals and classification of these signals into two classes: epileptic and healthy, based on the extracted features. we, then, apply automated feature extraction techniques by means of deep learning using several artificial neural network (ann) models. our goal is to try various methods and models for meg signal classification and draw some conclusions about their functionality and effectiveness. we base our study on our theoretical knowledge of the neurology of epilepsy, previous studies of epileptic seizure imaging and recognition using meg and electroencephalogram (eeg) as well as the signal processing theory and techniques. we apply several advanced classification methods with the use of ann like feed-forward ann, convolutional neural networks (convolutional nn), and inception v3. the results of this study are very encouraging and can be a base for future research on the subject of epileptic seizure recognition, prediction, and prevention. keywords—magnetoencephalography, epilepsy, deep learning signal classification, artificial neural networks, feedforward neural networks, convolutional neural networks, inception v3. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:adam@med.duth.gr https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.6 special issue 6: 2024 90 introduction epilepsy is one of the most common neurological disorders with tens of millions of patients all over the world. epileptic patients suffer from seizures which are the most important symptom. a patient is said to suffer from epilepsy after two or more unprovoked seizures separated by at least 24 hours.1 seizures vary in type, duration, and severity, but in any case, they are an unpleasant, even painful experience for the patient. ranging from a short lack of consciousness to strong muscular spasms, seizures may also pose a significant danger to the patient. injuries may be caused by falling to the ground or while handling dangerous objects or machinery. the abnormal firing of neurons (up to 500 times per second) may also damage the brain cells, especially during prolonged seizures or ones that appear in succession (status epilepticus).2 a number of previous works3 stress the need for implementing automated methods for the detection of epileptic activity as well as automated diagnosis and automatic prediction of epileptic seizures. such methods should help reduce human errors by specialized personnel due to the fatigue after long hours of tracing tiny differences among dozens of recorded meg images, playing a critical role in preventing epileptic seizures or enabling continuous machine monitoring of epileptic patients in critical condition. several advanced models regarding eeg classification have been published previously.3 significantly fewer publications address the issue of meg classification using mostly advanced artificial neural networks (ann)3 but none of them thoroughly examine basic ann models. therefore, our target was to test, compare, and evaluate some basic models to build a solid understanding of the characteristics of our data and gain insights into the model’s behavior. this would serve as a preliminary study leading to a larger project to investigate more sophisticated, optimized, fine-tuned models. the results of our study are very encouraging and can constitute a basis for future research on epileptic seizure recognition, prediction, and prevention. methods magnetoencephalography is a neuroimaging technique that utilizes an array of sensors placed slightly above the scalp. the use of superconducting quantum interference devices (squid) makes meg very sensitive to the microscopic alterations of the magnetic field produced by brain cell electrical activity. thus, it achieves a very good spatial resolution (up to 5 mm) as well as a great time resolution, at the scale of one millisecond or even better, which makes meg a great tool for tracing real-time changes in brain activity and state. it can be used in combination with other imaging techniques (mri, fmri, pet, pet-ct) to give a detailed 3d imaging of brain activity in specific areas. it is non-invasive and it is completely safe, causing no discomfort. moreover, it can detect epileptic activity and spot epileptic foci in the normal brain activity of the patient, without inducing unpleasant and even painful seizures to the patient.4 epileptic activity appears in eeg and meg as irregular patterns, in the form of spikes, spikes-and-slow waves, or sharp waves (figure 1). the morphology of spikes and sharp waves in eeg was thoroughly analyzed by gortman and these waves can be used for epilepsy diagnosis.5 although studies are being carried out6, there still is no formal definition of epileptic spikes in meg. however, even if it seems an oxymoron, compared to eeg signals, “meg spike yield and localization are superior to eeg”.7 epileptic signals in meg have different morphological characteristics (duration, shape, and sharpness) from those in eeg. this can be explained by the small affection on the meg signal from the interference from the skull and scalp. furthermore, muscular activity and eye movement cause much less effect on meg.8 we should note that there is far less research that applies deep learning models to meg than to eeg. squid is a very expensive device with an even more expensive installation requiring a faraday cage to isolate the super-sensitive squid from magnetic interference. this raises the total cost to a few million euros. the meg signals used in our study were recorded in the meg unit of the laboratory of medical physics, department of medicine, democritus university of thrace, placed at alexandroupolis, greece, from patients who had been diagnosed with epilepsy by specialized neurologists and were referred for meg evaluation. meg signals were recorded with patients in a rest state and with eyes closed. in the present study, we worked on meg signals recorded from 122 points of the patients’ brains, with a sampling frequency of 256 hz and 9 sec duration. a low-pass filter with a cutoff frequency of 30 hz was applied on all http://www.globalce.org http://globalce.org http://globalce.org 91 j global clinical engineering vol.6 special issue 6: 2024 channels. some channels contain out-of-limit values due to noise and artifacts and are thus rejected. the remaining signals were segmented into 5436 items of 1 channel—1 sec each, therefore each item contains 256 samples. each item is classified individually by specialized neurologists as a signal-carrying epileptic activity (2059 items) or not (3377 items). despite the absence of healthy patients, we have an adequate number of non-epileptic items in our dataset (62.1%). our models were built and tested on a hewlett-packard elite 800 g9 machine with an intel i5 10500 3.1 ghz 6-core processor and 16 gb ram, using matlab r2018a as the programming environment. in this study, we test a simple 3 and 4-layer cnn on colored images representing the heatmap of the signal spectrum as well as on black-and-white images of the signal. we also test a partially pre-trained inception v3 on colored images of the signal spectrum. we then compare the results to those of a simple feed-forward neural networks (ffnn) with 3 and 4 hidden layers applied to the signal values of the same signals. since convolutional neural network models are especially effective in image classification, we wanted to test the two models (3-4 layer cnn and inception v3) on images of the meg signal and images of the spectrum of the same signal. similar work was carried out giving impressive results with images obtained from eeg.9,10 we use a black-and-white bitmap image file, 256 × 256 pixels, to create images from the signal segments, 256 samples or 1 second long. samples will appear as white dots on a black background and the displacement of dots from the middle of the image will be proportional to the value of the corresponding sample (figure 2). to create images from the signal spectrum we apply short-time fourier transform on the signal with a shifting window 128 samples wide producing a heatmap-like rgb image, 30 × 32 pixels, and 3 color channels (figure 3). convolutional neural network is a deep learning model for processing data with grid pattern-like images. it’s inspired by the optical cortex of animals, and it’s designed to automatically learn and adapt to spatial feature hierarchies, beginning from low and moving towards higher-level patterns. typically, it consists of three types of layers: convolution layer, pooling layer, and fully connected layer. the first two operate as feature extractors while the third maps the extracted features to the final output, performing classification. the role of the convolution layer is fundamental. pixel values in digital images are stored in a two-dimensional grid, a matrix. an optimized feature extractor, called the kernel, is applied to each position of the image. every layer’s output is the input of the next layer, so the extracted features may progressively become more complex. the parameters of the kernels are optimized by training performed using the backpropagation algorithm—gradient descent.11 for processing the black and white 256 × 256 signal images, we create a cnn of 3 convolutional layers. for processing the rgb 30 × 32 spectrum images, we create a cnn of 4 convolutional layers. inception v3 is a deep learning model based on convolutional networks, used in image classification. it is an improved version of inception v1, published as googlenet in 2014, with 4 major modifications: factorization into smaller convolutions, spatial factorization into asymmetric convolutions, utility of auxiliary classifiers, and efficient grid size reduction12, which was developed by a google team. inception v3 is made of 42 layers, a few more than in v1 and v2. however, the effectiveness of the model is impressively boosted. as expected, inception v3 has greater accuracy and a smaller computational cost compared to the previous versions. it even has lower error rates compared to previous and newer image classification models.13 we download the pre-trained inception v3 network with all the necessary libraries and data from the matlab command line. inception v3 is pre-trained on more than a million images of the imagenet database. it has 316 layers in total and can classify images into 1000 object categories.14 unfortunately, we lack the computational power, memory, and time to perform full training on our own dataset. instead, we keep the first 198 layers frozen by using the freezeweights function, leaving the other layers’ parameters figure 1. spikes, spike-and-slow waves, and sharp waves. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 92 free to adapt during the training. we estimate that the first layers of the network form the simple, low-level patterns common to all kinds of images. the higher-level patterns built in the last levels, on the other hand, are more important and are the ones that give the differences in the images, so they need to be formed freely during the training. for better visibility of our images by the network, we augment the pixel range by using the imagedataaugmenter tool. last, but not least, we conducted the simplest experiment of all. we fed our raw data in a relatively small ffnn—three hidden layers of sizes 64, 32, and 16. the levenberg-marqurdt algorithm is used to train the network and we use mean squared error as the error measure. each input item consists of 256 numerical sample values of our signal, one second long (1s). we based this last experiment on the estimate that the neural network has the flexibility to extract the correct relations by calculating the appropriate weights that minimize the error. also, we know that the sample values contain all the information in the signal. results we split our data into train and test-set randomly, 70% train-set and 30% test-set. all our models automatically use an independent part of the train set for validation. for the evaluation of our results, we focus mainly on the metric of accuracy (sensitivity and specificity were also measured). accuracy is a qualitative metric of performance that gives the proximity of a measurement to the actual value.15 we rely on this metric because our study consists of binary classification where the numbers of items of the two classes do not differ significantly. also, accuracy includes other metrics (precision and trueness) and is a function of these metrics. we performed the training process of a three-layer cnn several times. in the best case, we have 85% accuracy while the average accuracy is 78.22% after approximately 7 minutes of training. although far from perfect, these results are surprisingly good. nobody expected a simple three-layer cnn could trace patterns and relations among them in a black picture with 256 small white dots. these results must be further studied and may help create optimized hybrid meg classification models. we follow the same procedure figure 2. color bitmap image representing the item’s spectral heatmap. figure 3. black-and-white bitmap image produced from the item’s signal. http://www.globalce.org http://globalce.org http://globalce.org 93 j global clinical engineering vol.6 special issue 6: 2024 with the spectra images. this time, all experiments gave us very good results, averaging 90.15% accuracy (91.40% in the best case) within just a few seconds. we train the inception v3 network with a maximum epoch number 6 and an initial learning rate of 10−4. the training process lasts more than 50 hours. unfortunately, this time the results are not so encouraging, considering the magnitude and complexity of the network as well as the time and effort spent. the prediction accuracy is only 74% and we can observe that only the first training epoch raises the accuracy slightly higher than 70%, while further improvement is very slow. the cause of this poor performance lies in the fact that the network was trained on an enormous set of common images that vastly differ from meg images, and thus, even partially, creating low-level patterns that are useless in our case. unfortunately, our resources and time did not allow us to design improved experiments with the inception v3 network. the accuracy achieved by the ffnn when values of the signal samples are fed directly to it, exceeded all expectations, since it is, by far, the best result in all our experiments. in our third effort, after 47 minutes of training, we got a prediction with 95.4% accuracy which is impressive, considering the simplicity of the model and data. driven by these encouraging results, we conducted a final experiment adding another layer of 32 neurons before the last 16-neuron layer. after approximately 2 hours of training, we obtain a trained network capable of slightly more accurate classification capability (96.2% accuracy). tables 1 and 2 present the comparative results given by the three methods of classification we tested in our experiments. discussion the obtained results, summarized in table 1 for cnn and inception v3 and in table 2 for ffnn, are very promising since the ffnn on the signal values achieves impressive results (accuracy = 96.2%) despite the simplicity of the model. also, the cnn on the spectrum heatmap images shows good results with accuracy reaching 90%. these results underline the significance of the meg as a powerful tool for obtaining high-resolution and high signal-to-noise ratio brain signals. the epileptic spikes appear sharper and are easier to observe in meg than in eeg. the fact that epileptic spikes are more clearly observed in meg than in eeg can be verified by the good results (accuracy = 96.2%) of a simple ffnn. even less sophisticated models perform well, showing the power of meg as a diagnostic tool for epilepsy. a basic ffnn with 3 hidden layers is capable of successfully classifying meg signals with an accuracy of up to 95.4% and a slightly larger ffnn with 4 layers can classify meg signals with 96.2% accuracy. a three-layer ffnn is equivalent to the extraction of third-order statistics from our data. the 256 raw sample values of our signal contain all the available information in the signal. our three-layer network shows the ability to mine the information hidden in these values by creating the correct weighted combination of signal sample values. it is obvious that this simple model needs further investigation and experimentation. unfortunately, our dataset lacks recordings of healthy subjects. it is table 1. cnn and inception v3 results (accuracy %). experiment cnn on signal cnn on spectrum inception v3 1 85.00 90.50 73.90 2 77.30 89.70 3 82.30 90.60 4 62.20 89.10 5 84.30 89.60 6 78.22 91.40 average 78.22 90.15 73.90 table 2. ffnn results (accuracy % and network structure). experiment ffnn on signal 1 87.60 [64 32 16] 2 88.50 [64 32 16] 3 95.40 [64 32 16] 4 90.90 [64 32 16] 5 96.20 [64 32 32 16] average 91.72 http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 94 essential to test our models on such a dataset. we need to test whether the binary classification models will suffice, considering the variability of the signals. such a case might require more than binary classification (more than two classes). although not as impressive, we also have a satisfactory performance of the cnn on the spectra images, achieving 91.4% accuracy. it is observed that signals with epileptic activity contain high-frequency components, so we should try running experiments using a low-pass filter with a higher cut-off frequency to avoid losing this information. conclusions based on the results and the discussion above, we need to focus on the following points in our future work: obtain meg recordings using a higher sampling rate and higher threshold on the low-pass filter, more sophisticated filtering of the artifacts and noise, so that gain more information that lies within epileptic signals and an even clearer distinction to the non-epileptiform activity. also, the inclusion of recordings from healthy subjects in the datasets is necessary to create more reliable models. although we do not believe this would change the models’ performance, since there are no serious deviations in the values of sensitivity and specificity, it is necessary to verify our models on a dataset nearer to real-world conditions, where epileptic signals are significantly fewer. also, we should try to improve the quality of the images fed to cnn. a different colormap and a better analysis could potentially improve the performance of the cnn on the spectra image classification. also, we need to try a different representation for the signal images so that the signal curve is clearly depicted. an inception v3 network with no previous training could prove more effective in such a case. if the untrained inception v3 performs significantly better than the ffnn, we then can try to reduce the training time and cost by introducing some pre-trained layers. area under curve (auc) metric should be used for model validation, a step we omitted in our research due to the lack of time and resources. metaheuristic searching algorithms, like genetic algorithms, should be used for ffnn structure optimization. finally, we plan to develop an optimized hybrid nn model by combining elements and layers from the best-performing basic models. conclusion based on the results and the discussion above, we need to focus on the following points in our future work: obtain meg recordings using a higher sampling rate and higher threshold on the low-pass filter, more sophisticated filtering of the artifacts and noise, so that gain more information that lies within epileptic signals and an even clearer distinction to the non-epileptiform activity. also, the inclusion of recordings from healthy subjects in the datasets is necessary to create more reliable models. although we do not believe this would change the models’ performance, since there are no serious deviations in the values of sensitivity and specificity, it is necessary to verify our models on a dataset nearer to real-world conditions, where epileptic signals are significantly fewer. also, we should try to improve the quality of the images fed to cnn. a different colormap and a better analysis could potentially improve the performance of the cnn on the spectra image classification. also, we need to try a different representation for the signal images so that the signal curve is clearly depicted. an inception v3 network with no previous training could prove more effective in such a case. if the untrained inception v3 performs significantly better than the ffnn, we then can try to reduce the training time and cost by introducing some pre-trained layers. area under curve (auc) metric should be used for model validation, a step we omitted in our research due to the lack of time and resources. metaheuristic searching algorithms, like genetic algorithms, should be used for ffnn structure optimization. finally, we plan to develop an optimized hybrid nn model by combining elements and layers from the best-performing basic models. http://www.globalce.org http://globalce.org http://globalce.org 95 j global clinical engineering vol.6 special issue 6: 2024 references 1. sidiropoulou, k. basic principles of the nervous system functioning. open academic editions: national 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https://ora.ox.ac.uk/objects/uuid:9cd78f0a-f9e7-41d6-b25d-08b0c4d0f349 https://doi.org/10.1016/j.seizure.2009.07.002 https://doi.org/10.1016/j.seizure.2009.07.002 https://doi.org/10.1111/j.1528-1167.2007.01223.x https://doi.org/10.1109/access.2017.2718044 https://doi.org/10.1109/tmi.2022.3173743 https://doi.org/10.1109/tmi.2022.3173743 https://doi.org/10.3389/fneur.2020.00375 https://doi.org/10.1007/s13244-018-0639-9 https://doi.org/10.1007/s13244-018-0639-9 https://doi.org/10.1109/cvpr.2015.7298594 https://doi.org/10.1109/cvpr.2015.7298594 https://towardsdatascience.com/deep-learning-understand-the-inception-module-56146866e652 https://towardsdatascience.com/deep-learning-understand-the-inception-module-56146866e652 https://towardsdatascience.com/deep-learning-understand-the-inception-module-56146866e652 https://www.mathworks.com/matlabcentral/fileexchange/65679-deep-learning-toolbox-model-for-inception-v3-network https://www.mathworks.com/matlabcentral/fileexchange/65679-deep-learning-toolbox-model-for-inception-v3-network https://www.mathworks.com/matlabcentral/fileexchange/65679-deep-learning-toolbox-model-for-inception-v3-network https://doi.org/10.1007/s00769-006-0191-z https://doi.org/10.1007/s00769-006-0191-z editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 proceedings 6th icehtmc 2025 j global clinical engineering, special issue 7, 2025 j global clinical engineering, special issue 7, 2025 proceedings 6th icehtmc 2025 global clinical engineering journalglobal clinical engineering journal 2 welcome to icehtmc 2025 dear colleagues and friends, it is our great pleasure to welcome you to the 6th international clinical engineering & health technology management congress (icehtmc 2025)! excitement is building across the global clinical engineering community as we gather once again to share knowledge, address critical challenges, and strengthen our international network. this year’s host city, shenzhen, china—widely known as china’s silicon valley—provides the perfect backdrop. just north of hong kong, shenzhen is a modern, innovative metropolis renowned for its vibrant culture, dynamic industry, and world-class hospitality. we are confident that your time here will be both professionally enriching and personally memorable. icehtmc stands apart as the only global forum specifically focused on the essential intersection between engineering, technology, and patient care. this congress will energize and equip stakeholders from every corner of the world to improve healthcare outcomes and elevate patient experiences. ten years ago, nearly 200 globally renowned experts from over 30 countries gathered in hangzhou, china, for the first icehtmc, where we explored common challenges and opportunities, achieving impactful outcomes. the event was designated as the global ce day celebration. following the icehtmc congress has been biannually hosted in countries around the world. including china, brazil, italy, usa, and india. thanks to many volunteers and growing global collaboration, we overcame challenges and accomplished impactful results for both our discipline and patients, including the creation of gcea and global ce journal. today, a decade later, our chinese ce colleagues warmly invite ce colleagues from around the world to return to china to explore a decade of development and innovations. it is the foundation upon which we build our future through shared knowledge, cooperation, and a stronger, more connected ce community. together, we are making it better. our venue, a magnificent and fully equipped conference hotel, sets the stage for meaningful learning, professional development, and international collaboration. attendees include students, early-career professionals, leading practitioners, industry members, researchers, academicians, and policymakers, all coming together to engage and inspire. the scientific program is the most comprehensive in icehtmc history, offering the best selection from over 440 abstracts submitted from over 60 countries on topics such as cutting-edge innovations, digital health, robotics, and a.i., in addition to workshops on a wide range of topics, including: · digital health, artificial intelligence, and robotics · cybersecurity, risk management, and disaster preparedness · best practices and smart hospitals proceedings 6th icehtmc 2025 j global clinical engineering, special issue 7, 2025 j global clinical engineering, special issue 7, 2025 proceedings 6th icehtmc 2025 global clinical engineering journalglobal clinical engineering journal 3 · health technology assessment and management strategies · innovation, regulation, and sustainable development · writing and publishing engineering papers sessions will be presented in english and chinese, with simultaneous interpretation available for all. this multilingual approach ensures greater access, inclusion, and global reach. program highlights include: · opening ceremony and plenary session with world-renowned speakers · 10th anniversary celebration of global clinical engineering week · national chinese clinical engineering tracks · global clinical engineering summit · global ce journal editorial board meeting · gcea members annual meeting and officer elections · inaugural innovative “meet & greet”, a commercial networking program · health and wellness technology exhibition · closing ceremony social program icehtmc 2025 is not only a platform for learning about the latest global health technologies and clinical engineering professional exchange but also a celebration of our community’s culture and passion. this year’s social program offers a delightful blend of experiences, such as: · traditional chinese cultural performances · guided city tours exploring shenzhen’s heritage and innovation · a refined culinary journey highlighting local cuisines · a leisurely stroll through one of shenzhen’s beautiful parks, offering time for informal networking and relaxation · china’s highlights tour following the congress these special moments will enrich your congress experience and foster lasting personal and professional relationships. we are proud to present the icehtmc 2025 proceedings, a peer-reviewed collection of abstracts from the oral and poster sessions. supported by more than 100 expert reviewers coordinated by the scientific program committee and the global clinical engineering journal, this publication upholds our tradition of academic rigor and excellence. it also marks the fourth icehtmc proceedings are published online at globalce.org, further strengthening the global knowledge base of our field. proceedings 6th icehtmc 2025 j global clinical engineering, special issue 7, 2025 j global clinical engineering, special issue 7, 2025 proceedings 6th icehtmc 2025 global clinical engineering journalglobal clinical engineering journal 4 this congress is made possible through the dedicated collaboration of the global clinical engineering alliance (gcea) and its over 50,000 members – along with 30 member associations, the association for the advancement of medical instrumentation (aami), china medical devices journal press (cmd), the global clinical engineering journal (gcej), amtz, mindray, and our local hosts. their combined commitment ensures icehtmc continues to serve as the cornerstone of our professional community. icehtmc 2025 is a hybrid congress, designed to maximize engagement of both in-person and virtual participants, utilizing live streaming technology and zoom webinars. whether joining in shenzhen or virtually, we invite all attendees to actively engage, exchange insights, and build meaningful connections. on behalf of the organizers, sponsors, volunteers, and host organizations, we thank you for your presence and participation. we wish you a productive and inspiring experience and look forward to continuing this shared journey at future congresses. together, let us envision and build a common future for our profession and global health. warm regards, dr. yadin david chair, icehtmc 2025 organizing committee global clinical engineering alliance li bin co-chair, icehtmc 2025 organizing committee china society of clinical engineering dong jin local host, icehtmc 2025 organizing committee china medical devices journal press 37 j global clinical engineering vol.7 issue 2: 2025 this paper is part of the special issue on advancements in dental technology and engineering: innovations for enhanced patient care guest editor: dr. giuseppe minervini, università degli studi della campania luigi vanvitelli, naples, italy. received january 8, 2025, accepted may 5 2025, date of publication may 30 2025. review newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review sai sree kotari1, bharath kumar konakanchi2, supraja salwaji3, mohan kumar pasupuleti4,*, prathyusha kancherla5, maria maddalena marrapodi6, marco cicciù7, and giuseppe minervini8,9 1 biomedical and health informatics, university of north carolina, chapel hill, north carolina, united states. 2 health informatics and analytics, university of north carolina, charlotte, north carolina, united states. 3 oral and maxillofacial pathology, vishnu dental college, bhimavaram, andhra pradesh, india. 4 periodontics and implantology, vishnu dental college, bhimavaram, andhra pradesh, india. 5 private practitioner, aswaraopeta, telangana, india. 6 department of woman, child and general and specialist surgery, university of campania “luigi vanvitelli”, 80138 naples, italy. 7 department of biomedical and surgical and biomedical sciences, catania university, 95123 catania, italy. 8 saveetha dental college and hospitals, saveetha institute of medical and technical sciences (simats), saveetha university, 600077 chennai, india. 9 multidisciplinary department of medical-surgical and odontostomatological specialties, university of campania “luigi vanvitelli”, 80138 naples, italy. * corresponding author email: mosups@gmail.com abstract background: oral cancer, which includes cancers of the lips, tongue, mouth, throat, and other oral tissues, is a serious health concern globally. it is one of the major causes of cancer-related mortality because of several factors, including the severity of certain oral malignancies and their late-stage detection. objective: to comprehensively investigate recently developed technologies for detecting oral cancer and evaluate their accuracy, reliability, and potential application in both therapeutic and preventive contexts. methods: a thorough literature search was performed using the pubmed, scopus, and web of science databases, focusing on works published between 2014 and 2024. this review evaluates various methods for diagnosing oral cancer, including advanced imaging techniques (mri and ct scans), biomarker testing, molecular diagnostics, noninvasive salivary diagnostics, optical coherence tomography (oct), and the application of artificial intelligence (ai) and machine learning (ml) to enhance diagnostic accuracy. results: all relevant studies meeting the inclusion criteria were analyzed. several important findings regarding confocal laser scanning microscopy (clsm) and oct demonstrated high sensitivity and specificity in identifying oral cancer. this systematic review also highlights the promise of fluorescence spectroscopy, salivary biomarkers, genetic markers, and ai/ ml technologies in early disease detection and monitoring. conclusion: new diagnostic procedures outperform traditional ones in accuracy and reliability in the detection of oral cancer. these innovations enable earlier diagnosis, facilitate targeted therapies, and support personalized treatment strategies. as preventive and monitoring strategies evolve, treatment efficacy improves, and patient trust and engagement increase, ultimately leading to better outcomes and enhanced quality of life for patients. http://www.globalce.org http://globalce.org http://globalce.org https://globalce.org/index.php/globalce/dentaltechnology mailto:mosups@gmail.com kotari, konakanchi, salwaji, pasupuleti, kancherla, marrapodi, cicciù, minervini: newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review j global clinical engineering vol.7 issue 2: 2025 38 keywords—clinical applications, diagnostic methods, early detection, noninvasive techniques, oral cancer, systematic review. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. background oral cancer accounts for approximately 3% of the total cases of cancer globally, establishing it as an important public health issue. this extensive range of cancers occurs in the epithelial lining of the oral cavity, encompassing the lips, tongue, floor of the mouth, buccal mucosa, and gums. oral cancer is the most prevalent cancer in indian men, exhibiting variation by region, with the highest incidence rates observed in south asia.1–4 early detection of oral cancer is crucial for improving treatment efficacy and survival rates. conversely, oral cancer is often identified later in life, resulting in a grim prognosis and diminished quality of life. the early detection of oral cancer is hindered by the constraints of conventional diagnostic methods like visual examination, biopsy, and histological evaluation.5–9 recent technological advancements have led to the development of innovative diagnostic techniques that significantly enhance the early detection and monitoring of oral cancer. notably, optical coherence tomography (oct) provides high-resolution, real-time imaging of oral tissues, allowing clinicians to detect subtle epithelial changes indicative of malignancy.10–13 fluorescence-based diagnostic instruments leverage the natural fluorescence properties of tissues to distinguish between healthy and abnormal areas, facilitating noninvasive, chairside screening. in addition, the analysis of salivary biomarkers such as dna, rna, proteins, and metabolites offers a promising, noninvasive approach for identifying molecular signatures associated with oral cancer, thus supporting both early diagnosis and disease progression monitoring.14–17 early diagnosis of oral cancer can improve treatment outcomes and survival rates, and these new diagnostic tools show promise in this regard. the purpose of this systematic review is to establish the therapeutic value of novel diagnostic tools for oral cancer detection, as well as their diagnostic accuracy and application in oral cancer prevention and treatment strategies.18–21 this systematic review offers a thorough overview of the latest methods for detecting oral cancer, highlighting their clinical applications and diagnostic accuracy. the findings of the review are crucial for healthcare professionals, researchers, and policymakers in formulating effective approaches for the early detection and treatment of oral cancer. methods study design and setting during the months of october through december 2024, this systematic review was conducted to examine and assess recently developed methods for diagnosing oral cancer, assessing their accuracy, reliability, and applications in preventative and therapeutic approaches at vishnu dental college in bhimavaram, andhra pradesh. on october 19th, prospero registered the current protocol with registration id crd42024598844. the systematic review was carried out in accordance with prisma (preferred reporting items for systematic research and meta-analysis) criteria. a strong agreement is suggested by a kappa value of 0.75, which shows that the reviewers’ selection and extraction procedures were dependable and consistent. this study problem was structured using the pico framework, which encompasses population, intervention, comparison, and outcome. the population consists of those who use tobacco products, drink alcohol, or have hpv infections, as well as those who are at risk of or have been diagnosed with oral cancer. recent diagnostic technologies evaluated include liquid biopsy, fluorescence imaging, molecular diagnostics, and ai-based tools. traditional diagnostic methods such as ocular inspection, histology, or conventional imaging methods were compared. better https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 39 j global clinical engineering vol.7 issue 2 2025 kotari, konakanchi, salwaji, pasupuleti, kancherla, marrapodi, cicciù, minervini: newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review early detection rates, better prevention and treatment planning techniques, and a decrease in the death and morbidity rates from oral cancer were the intended results. the systematic review’s goals were to compare the efficacy and uses of more recent diagnostic tools for the detection of oral cancer with more established methods, as well as to investigate how these approaches might be used to enhance patient outcomes through prevention and therapy. the study’s research question was, “what is the accuracy, early detection rate, and effect on prevention and treatment strategies of newer diagnostic methods for oral cancer compared to traditional diagnostic techniques?” study eligibility requirements a variety of trial designs were included in the systematic review for a thorough evaluation of the more recent techniques for diagnosing oral cancer. randomized controlled trials (rcts), prospective cohort studies, cross-sectional studies, retrospective studies, and comparative effectiveness studies were all included in the study. these studies evaluated the safety and effectiveness of different treatments in a controlled environment and provided strong evidence from 2013 to 2024. this systematic review did not consider the following study categories: brief communications, editorial letters, mini-reviews, studies that did not follow the objectives of the review, and papers written in languages other than english. we developed a list of terms to look for in the databases based on our knowledge of the subject and previous research. oral cancer, oral squamous cell carcinoma (oscc), novel diagnostic techniques, molecular diagnostics, and biomarkers in oral cancer were the search phrases used to search the pubmed databases. boolean operators were used to combine these keywords, yielding thorough and pertinent results. (“oral cancer” or “mouth cancer” or “oral squamous cell carcinoma”) and (“new diagnostic methods” or “emerging techniques” or “molecular diagnostics” or “liquid biopsy” or “fluorescence imaging” or “artificial intelligence”) and (“prevention” or “treatment strategies” or “early detection” or “risk stratification”). (newer[all fields] and (“diagnosis”[mesh terms] or “diagnosis”[all fields] or “diagnostic”[all fields]) and (“methods”[subheading] or “methods”[all fields] or “methods”[mesh terms]) and detect[all fields] and (“mouth neoplasms”[mesh terms] or (“mouth”[all fields] and “neoplasms”[all fields]) or “mouth neoplasms”[all fields] or (“oral”[all fields] and “cancer”[all fields]) or “oral cancer”[all fields]) and applications[all fields] and (“prevention and control”[subheading] or (“prevention”[all fields] and “control”[all fields]) or “prevention and control”[all fields] or “prevention”[all fields]) and ((“treatment”[all fields] and “strategies”[all fields]) or “treatment strategies”[all fields])) and (“systematic review”[all fields] or “systematic reviews as topic”[mesh terms] or “systematic review”[all fields]) literature search protocol two reviewers independently searched for the publications. to conduct a focused, systematic review, we looked through relevant papers that were available in electronic databases, including pubmed, web of science, and scopus. rayyan was used during the study selection process to reject unsuitable abstracts and nominations and to eliminate duplicate search results from multiple databases. the collected data were closely examined to ensure that they met the established inclusion and exclusion criteria. when the data from the included studies were too inconsistent or varied to be quantitatively merged, a systematic review was conducted instead of a meta-analysis. selection of included research articles for more knowledge of the state of research on this subject, the discovered papers were filtered to include clinical studies and rcts. their study goals and importance were then added to this review. a thorough synopsis of these research publications is provided in the table, emphasizing their salient features, approaches, and conclusions. quality assessment of studies amstar 2 (a measurement tool to assess systematic reviews) is a previously published and validated tool for assessing the methodological quality of systematic reviews (with and without meta-analyses). where amstar only considered rcts, amstar 2 considers both rcts and nonrandomized studies, therefore diversifying the studies that could be reviewed. the tool comprises 16 kotari, konakanchi, salwaji, pasupuleti, kancherla, marrapodi, cicciù, minervini: newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review j global clinical engineering vol.7 issue 2: 2025 40 items, with each item touching upon important aspects of review methodology. the quality of all included systematic reviews was assessed in this study, using appropriate rating tools. amstar 2 provides valuable criteria in umbrella reviews to critically appraise the included reviews by evaluating items for the risk of bias (rob), search strategy, and rationale for excluding studies. results data extraction and synthesis process on october 19th, 2024, a preliminary keyword search was conducted in numerous electronic databases, including pubmed, web of science, and scopus, yielding 729 results. after applying preliminary relevance filters, 59 articles were retained for further evaluation. of these, 17 articles met the intended inclusion criteria and were considered relevant. a final set of seven systematic reviews met the inclusion criteria and were included in this umbrella review, with a special focus on the use of more modern diagnostic tools for the detection of oral cancer and its impact on prevention and treatment approaches (figure 1).5,7,9,10,12,13,22 figure 1. prisma 2020 flow diagram for new systematic reviews, which included searches of databases and registers only. newer diagnostic methods to detect oral cancer enhanced tools for diagnosing oral cancer now include narrow band imaging (nbi), confocal laser scanning microscopy (clsm), saliva-based biomarkers, fluorescence diagnostic techniques, and oct. these advanced technologies provide earlier detection, improve treatment outcomes, and enhance the sensitivity and accuracy of oral cancer screening. for example, fluorescence-based diagnostic tools can detect abnormal changes in cells, and oct provides high-resolution images of the oral mucosa (table 1). to improve the results of treatment and reduce the affection rate and mortality ratio related to oral cancer, the current approach to prevention and treatment includes individualized medicine, immunotherapy, target therapy, and lighting therapy (pdt). robot surgery is included. for instance, immunotherapy employs the body’s immune system to fight oral cancer, while personalized medicine involves customizing treatment plans for each patient based on their genetic profiles (table 1). the use of artificial intelligence (ai) and machine learning (ml) algorithms to study large datasets and identify trends is a significant improvement in the detection and treatment of oral cancer. another potential area of research is liquid biopsies, which identify biomarkers in physiological fluids like saliva. scientists are also researching novel medicines and developing personalized oral cancer tumor models using 3d printing and bioprinting technology (table 1). salivary biomarkers, fluorescence-based devices, and optical oct are cutting-edge diagnostic techniques that have dramatically increased the sensitivity and precision of oral cancer diagnosis, allowing for earlier and more accurate therapy. at the same time, advanced preventive and therapeutic approaches, including immunotherapy, targeted therapies, and personalized medicine, are transforming patient care, improving outcomes, and reducing the impact of the disease. recent results, such as liquid biopsy, 3d biological suppression, and diagnostic diagnosis controlled by ai, indicate the possibility of improving oral cancer detection and treatment (table 1). 41 j global clinical engineering vol.7 issue 2 2025 kotari, konakanchi, salwaji, pasupuleti, kancherla, marrapodi, cicciù, minervini: newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review table 1. the qualitative characteristics and conclusive statements of the newer diagnostic methods to detect oral cancer. author, year, & reference no. aim of study search strategy no. of studies included screening method used outcome measures summary brocklehurst, et al.5 to evaluate how well the existing screening techniques reduce the death rate from oral cancer. cochrane central register of controlled trials medline via ovid embase via ovid cancerlit via pubmed 1 visual examination, toluidine blue, fluorescence imaging, or brush biopsy. individuals diagnosed with stage iii or worse oral cancer. survival rates across the population. in high-risk individuals, there is evidence that a visual examination as part of a populationbased screening program lowers the death rate from oral cancer. jerjes, et al. 20247 to evaluate optical coherence tomography’s (oct) diagnostic precision in identifying oral malignancies. pubmed, embase, scopus, google scholar, cochrane central register, and web of science 9 oct artificial intelligence (ai) diagnostic outcomes, such as sensitivity and specificity. oct has very high sensitivity and specificity, making it a promising new diagnostic technique for oral cancer. bastías, et al. 20249 to conduct a scoping review of salivary molecules examined as potential indicators for oral squamous cell cancer (oscc) diagnosis. ebsco, pubmed (medline), scopus, and web of science 62 studies were included. 100 molecules were assessed. tnf-α, il-1β, il-6, il-8, ldh, mmp-9, tnf-α, il-1β, il-6 il8, ldh, and mmp-9 are the most promising salivary biomarkers for cancer detection. ability for detecting oscc and oral potentially malignant disorders (opmds), oscc outcome prediction, and the prediction of the malignant transformation of opmds. it may be possible to use salivary biomarkers to help detect, manage, and forecast the malignant transformation and spread of oscc and opmds. kotari, konakanchi, salwaji, pasupuleti, kancherla, marrapodi, cicciù, minervini: newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review j global clinical engineering vol.7 issue 2: 2025 42 author, year, & reference no. aim of study search strategy no. of screening method used outcome measures summary kim, et al.10 to examine the effectiveness of oct in identifying malignant lesions in the mouth. pubmed, cochrane central register of controlled trials embase, web of science scopus, google scholar. 12 oct the diagnostic odds ratio (dor), along with summary receiver operating characteristic curve (sroc), area under sroc, sensitivity, specificity, and negative predictive values, were the outcomes. oct can help in the diagnosis and monitoring of oral cancer and oral precancerous lesions because it is noninvasive, produces quick results without exposing users to radiation, and is quick. gonzález-moles, et al. 202212 to find evidence gaps and suggest future research directions that ought to be pursued and formulate improvement plans. medline embase, cochrane central register of controlled trials dare 12 light-based detection or oral spectroscopy. new cases per year, deaths annually, and mortality rate. patients, healthcare professionals, and health services are all involved in the many factors that contribute to the delay in the diagnosis of oral cancer. li, et al. 202413 to assess the differences in accuracy between the various imaging techniques used in these diagnostic procedures. embase, web of science, pubmed, and scopus. 17 ai overall diagnostic odds ratio (dor), sensitivity, specificity, negative predictive values, and summary receiver operating characteristic (sroc) curves. with billions of phone users worldwide, aibased identification employing clinical photography has a high dor and is readily available now. almangush, et al.22 to provide a summary of the data currently available on immunohistochemistry prognostic biomarkers for oral tongue squamous cell carcinoma (otscc). scopus, ovid medline, web of science, and cochrane library. 11 immunohistochemical p r o g n o s t i c biomarkers. identifying informative prognostic biomarkers for oral tongue squamous cell carcinoma. many biomarkers have been proposed as helpful predictors of otscc; however, the overall quality of the original research reporting and methodology is inadequate, making it impossible to draw trustworthy conclusions. 43 j global clinical engineering vol.7 issue 2 2025 kotari, konakanchi, salwaji, pasupuleti, kancherla, marrapodi, cicciù, minervini: newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review quality assessment results the amstar 2 assessment of seven systematic reviews found that, while all reviews included well-defined pico components, performed study selection and data extraction in duplicate, and reported potential conflicts of interest, they were overall rated as “critically low” because of several key methodological flaws. a major issue in all reviews was a lack of disclosure about the funding sources for the included studies, which raised questions about potential bias(table 2). furthermore, most evaluations did not achieve this transparency criterion, with only a few providing a thorough list or explanation for rejected studies. protocol prespecification and deviations were not adequately reported by bastías, et al.,9 gonzález-moles, et al.,12 and almangush,22 further weakening their credibility. although most reviews used appropriate techniques for rob assessment, bastías et al.,9 did not perform this adequately, and gonzálezmoles et al.,12 provided partial information (table 2). furthermore, the reliability of the results has been compromised by the fact that only a few evaluations have adequately addressed publication bias. although these evaluations have potential in certain areas, their overall reliability and credibility are compromised by fundamental methodological flaws. despite meeting important quality standards (e.g., pico, duplicate data extraction, and conflict of interest declarations), major issues such as insufficient risk of bias (rob) assessment, opaque exclusion criteria, and nondisclosure of funding sources compromise the overall credibility of reviews. this emphasizes how future systematic reviews must follow stricter guidelines in order to increase their caliber and dependability. discussion this systematic review sought to provide an overview of more modern techniques for diagnosing oral cancer, as well as their use in preventative and treatment approaches. the study highlights the promise of newer diagnostic approaches, such as salivary biomarkers, fluorescencebased diagnostic tools, and oct, in detecting oral cancer early on. this review examined several diagnostic options, and oct and biomarker-based diagnostics are perhaps most encouraging in the area of early detection of oral cancers. oct uses noninvasive, real-time imaging for cross-sectional views of oral tissues with near-microscopic resolution. changes at the tissue level can be detected foundationally before clinically visible signs. moreover, the tissue depth imaging supplies added security in differentiating normal, dysplastic, and malignant tissues, which improves our diagnostic abilities, and responses are moved toward a fraction of earlier intervention in terms of treatment. similarly, salivary and molecular biomarkers are also a noninvasive means to detect cancer-related changes occurring at the molecular level. salivary biomarkers such as proteins, dna mutations, rna transcripts, etc., can determine early-stage malignancies and may be applied as monitoring tools to help surveil disease and or against the recurrence of disease. these two technologies are a great stride forward in noninvasive diagnostics and hold serious promise as a clinically active emerging technology in dentistry. newer diagnostic tools according to the review’s conclusions, modern diagnostic tools are more sensitive and specific than traditional methods. according to global burden of disease cancer collaboration (2019),1 oct offers a 92% sensitivity and 85% specificity for detecting oral cancer. likewise, bray f et al. (2018) demonstrated that a fluorescence-based diagnostic approach can identify oral cancer with a sensitivity of 95% and a specificity of 90%.2 new prevention and treatment strategies innovative techniques to prevent and cure oral cancer are also being investigated.3 likewise, petersen in 2018 found that merging visual examination with fluorescencebased diagnostic methods can aid in the early detection of oral cancer.3 the most recent diagnostic techniques for identifying oral cancer are assessed in these systematic reviews, which also investigate their potential uses in therapy and prevention.11–13 the research focuses on cutting-edge diagnostic methods that have the potential to improve early detection and clinical outcomes, such as liquid kotari, konakanchi, salwaji, pasupuleti, kancherla, marrapodi, cicciù, minervini: newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review j global clinical engineering vol.7 issue 2: 2025 44 table 2. amster 2 checklist. sl. no amster 2 checklist brocklehurst, et al.5 jerjes, et al.7 kim, et al.10 bastías, et al.9 gonzálezmoles, et al.12 li, et al.13 almangush, et al.22 (2017) 1. did the research questions and inclusion criteria for the review include the components of pico? yes yes yes yes yes yes yes 2. did the review report contain an explicit statement that the review methods were established prior to the review and did the report justify any significant deviations from the protocol? yes yes yes no no yes no 3. did the review authors explain their selection of the study designs for inclusion in the review? yes yes yes yes yes yes yes 4. did the review authors use a comprehensive literature search strategy? yes yes yes yes yes yes yes 5. did the review authors perform study selection in duplicate? yes yes yes yes yes yes yes 6. did the review authors perform data extraction in duplicate? yes yes yes yes yes yes yes 7. did the review authors provide a list of excluded studies and justify the exclusions? partial partial partial no no no no 8. did the review authors describe the included studies in adequate detail? yes yes yes yes partial yes yes 9. did the review authors use a satisfactory technique for assessing the risk of bias (rob) in individual studies that were included in the review? yes yes yes no partial yes partial 10. did the review authors report on the funding sources for the studies included in the review? no no no no no no no 11. if meta-analysis was performed, did the review authors use appropriate methods for the statistical combination of results? n/a n/a yes no n/a yes yes 12. if meta-analysis was performed, did the review authors assess the potential impact of rob in individual studies on the results of the meta-analysis or other evidence synthesis? n/a n/a yes n/a n/a yes partial 13. did the review authors account for rob in individual studies when interpreting/discussing the results of the review? yes yes yes no yes yes yes 14. did the review authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in the results of the review? yes yes yes yes yes yes yes 15. if they performed quantitative synthesis, did the review authors carry out an adequate investigation of publication bias (small study bias) and discuss its likely impact on the results of the review? n/a n/a yes yes no no no 16. did the review authors report any potential sources of conflict of interest, including any funding they received for conducting the review yes yes yes yes yes yes yes review quality critically low critically low critically low critically low critically low critically low critically low 45 j global clinical engineering vol.7 issue 2 2025 kotari, konakanchi, salwaji, pasupuleti, kancherla, marrapodi, cicciù, minervini: newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review biopsy, optical imaging, molecular biomarkers, and aibased diagnostic tools.14–17 by identifying specific tumor markers, these cuttingedge diagnostic approaches can guide individualized treatment strategies and significantly improve screening programs, particularly in high-risk populations. nonetheless, obstacles still need to be addressed, such as consistency, cost, and availability.18–21 comparison with existing literature brocklehurst, et al.5 conducted a systematic review to assess the effectiveness of current screening methods in decreasing oral cancer mortality. the findings of the study stated that a visual examination as part of a populationbased screening program reduces the mortality rate of oral cancer in high-risk individuals. in addition, there is a stage shift and improvement in survival rates across the population as a whole. jerjes, et al.7 conducted a systematic review to assess the diagnostic accuracy of oct in the detection of oral cancers and to investigate the feasibility of combining oct with ai and other imaging modalities to improve clinical outcomes and diagnostic accuracy in oral healthcare. the results of the study stated that oct could play a very prominent role as a new diagnostic tool for oral cancer, with very high sensitivity and specificity. future research pointed toward integrating oct with other imaging methods and ai systems in providing better accuracy of diagnoses and more clinical usability. bastias, et al.9 conducted a systematic assessment of salivary molecules as possible markers for identifying oral squamous cell carcinoma. the research found that tnf-α, il-1β, il-6, il-8, ldh, and mmp-9 were the most frequently utilized biomarkers for diagnosing oral squamous cell carcinoma. the findings of this systematic review align with the present review. kim, et al.10 performed a comprehensive assessment of oral lesions by utilizing coherent optical coherence tomography (oct), and the findings were contrasted with organizational data. according to the study’s findings, oct can help with the diagnosis and monitoring of oral cancer and oral precancerous lesions, is noninvasive, and yields quick results without exposing patients to radiation. gonzález-moles, et al.12 aimed to better understand and explore the reasons underlying this fact, as well as identify evidence gaps and create improvement methods. results stated that improving this critical component, which has remarkable consequences for prognosis, is a significant problem with little chance of being resolved very soon, according to this scoping assessment of systematic studies on the present level of knowledge addressing delayed diagnosis in oral cancer. li, et al.13 carried out a study to consider the use of artificial intelligence (ai) algorithms in detecting oral potentially malignant disorders (opmd) and oral cancers, and to evaluate differences in accuracy across the various imaging modalities used in this diagnosis. ai detection in this regard using clinical photography has a high dor, and is now widely available to the billions of phone subscribers around the world. in order to compile the available data on immunohistochemistry prognostic biomarkers for oral tongue squamous cell carcinoma (otscc), almangush, et al.22 carried out a comprehensive review. many biomarkers have been proposed as helpful predictors of otscc; however, the overall quality of reporting and methodology of the original research is inadequate, making it impossible to draw trustworthy conclusions.22 in conclusion, despite substantial progress in diagnostic techniques for oral cancer, additional investigation and standardization of these methods are necessary to enhance the therapeutic benefits in early detection, prevention, and tailored treatment plans.23–25 limitations there are a few limitations to this review. first and foremost, the review only included english language articles, which would have excluded relevant studies produced in other languages. second, only studies utilizing more contemporary diagnostic tools were included in the review, which may have excluded relevant studies employing more traditional diagnostic methods. kotari, konakanchi, salwaji, pasupuleti, kancherla, marrapodi, cicciù, minervini: newer diagnostic methods to detect oral cancer and their applications in prevention and treatment strategies: a systematic review j global clinical engineering vol.7 issue 2: 2025 46 clinical implications the findings of the review have major clinical implications. above all, enhanced early detection of oral cancer can result in timely intervention and treatment, thanks to sophisticated diagnostic technology. improved diagnostic procedures can also help to reduce the morbidity and mortality of oral cancer.26 future perspectives future research should primarily focus on developing and validating more advanced diagnostic equipment for the detection of oral cancer. it should also investigate the clinical utility and cost-effectiveness of newer diagnostic tools for detecting oral cancer.27,28 conclusion finally, this systematic review emphasizes the importance of improved diagnostic technologies in detecting oral cancer at an early stage. the paper also discusses novel ways for preventing and treating oral cancer. the findings of this analysis have important clinical consequences, highlighting the need for additional research in this field. supplementary materials not applicable. author contributions conceptualization, s.s.k and b.k.k; methodology, s.s.; software, s.s.; hardware, m.k.p., validation, m.m.m., m.c., and m.k.p.; formal analysis, p.k.; investigation, g.m.; resources, s.s.k.; data curation, b.k.k.; writing– original draft preparation, s.s.; writing–review & editing, m.k.p; visualization, m.m.m; supervision, g.m.; project administration, m.c.; funding acquisition, g.m. acknowledgments we are thankful to vishnu dental college, bhimavaram, andhra pradesh, india; the university of north carolina chapel hill; and the 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may 22, 2024 development of a voice-controlled wheelchair for physically impaired individuals by jenina r. amoguis, mabel a. lingon, edwin r. arboleda, airah cahigan department of computer and electronics engineering, cavite state university, indang, cavite, philippines abstract background and objective: traditional manual wheelchairs provide mobility to individuals with physical impairments but are poorly suited for individuals with a combination of physical and cognitive or perceptual impairments. manual wheelchairs are more physically demanding than powered wheelchairs; however, powered wheelchairs require cognitive and physical skills that not all individuals possess. the general objective of this study is to develop a voice-controlled wheelchair that allows a disabled person to move around independently using a voice-recognition application that is interfaced with motors. the study will be beneficial for quadriplegic individuals who are paralyzed in both arms and both legs. material and methods: this study aims to modify a standard wheelchair controlled by voice commands where the easyvr 3 voice recognition module, ultrasonic sensors, microcontroller, and 12v wiper motor were integrated. based on the signal given by the motor driving circuit, the controller switches the motor accordingly. the added safety feature is the ultrasonic sensor that senses obstacles with a fall detection system and sends a signal to the microcontroller to stop the chair. results: through testing and evaluation, the device’s functionality was proven to meet the desired objectives, and the limitations of the device were concluded. the motors and sensors were also found to be 100% functional. the average speed of the wheelchair is 0.2 m/s, and it can move with the user weighing up to 80 kg. the wheelchair lifts at an angle of up to 10˚. the overall acceptability of the unit, analyzed using statistical parameters like mean method and standard deviation analysis, gives a 4.53 average, 4.53 on usability, 4.07 on correctness, 4.37 on control, 4.50 on reliability, 4.33 on safety, and 4.8 on comfort, which means the unit meets the objectives. conclusion: based on the evaluation results, the project met the given objectives. the system was able to move following the voice command given. the device also proved its functionality, responsiveness, usability, correctness, control, reliability, safety, and comfortability. while the current study demonstrates the feasibility of voice-controlled wheelchairs, future research should focus on improving the accuracy and robustness of voice recognition systems and the incorporation of sensory feedback mechanisms, such as haptic feedback or auditory cues. keywords – voice-controlled wheelchair, assistive technology, voice recognition, assistive devices, quadriplegia. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. 7 j global clinical engineering vol.6 issue 3: 2024 amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals introduction wheelchairs have been a boon for people with physical impairments, but they may not be suitable for individuals with a combination of physical and cognitive or perceptual disabilities. while manual wheelchairs require more physical effort, powered wheelchairs require cognitive and physical skills that not everyone possesses.1,2 to address these challenges, researchers conducted a study and devised a solution. they created a device using readily available and affordable materials and developed a voice-controlled wheelchair for disabled individuals who cannot operate powered wheelchairs. the general objective of this study was to develop a voice-controlled wheelchair for physically impaired individuals. specifically, this study aimed to (a) design and construct the circuitry of the device; (b) modify a standard wheelchair; (c) integrate the easy vr 3 shield, ultrasonic sensor, microcontroller, 12v wiper motor, and standard wheelchair for the device; (d) develop a program for the device; (e) test and evaluate the performance of the system through pilot testing; and (f) determine the cost of the developed system. the wheelchair could be used by people who suffer from mobility disabilities, which include cerebral palsy, spinal cord injury, stroke, parkinson’s disease, arthritis, muscular dystrophy, multiple sclerosis, amputation, polio, or other conditions resulting in paralysis, muscle weakness, nerve damage, stiffness of the joints, strength and endurance, short stature, conditions like osteogenesis imperfecta (“brittle bones”), or lack of balance or coordination.3–7 this device is also best for quadriplegic individuals who are paralyzed in both arms and both legs.8 the design project primarily focuses on recognizing a limited set of voice commands for direction control – five (5) in total and two (2) voice commands for trigger and standby. it is not intended to perform any other tasks. to evaluate the system’s effectiveness, final testing was conducted involving 30 participants, including 25 individuals who underwent testing in a simulated environment and 5 people with mobility disabilities. the assessment measured the system’s ability and responsiveness to execute commands accurately. the testing was carried out over two (2) weeks in indang, cavite, philippines. methods this section outlines the important specifications of the materials utilized in the design project and the steps taken to create the voice-controlled wheelchair. each material was carefully selected based on its functionality and compatibility with the other components. the voice-controlled wheelchair comprises a standard wheelchair, dc motor, voice recognition module, sensors, motor driver, microcontroller, and battery. the standard wheelchair used is an alloy-type wheelchair that weighs only 13.1 kgs compared to a standard wheelchair that weighs up to 16 kgs. it is certified by japan international standards, with a jis sticker labeled jis t 9201:2006, specifying standards for manually propelled wheelchairs. the motors used in the project were wiper motors. compared to other dc motors, wiper motors are cheaper and provide high torque and low speed, making them ideal for wheelchair use. the voice recognition module that was used was an easyvr version 3 shield. anjum and seetha9 conducted a similar method where easyvr version 3 shield was used as a voice-activated system for disabled people. unlike voice recognition modules that only support speaker-dependent features, the easyvr module supports speaker-dependent and speaker-independent features. ultrasonic sensors were used because they are the only type of sensor that doesn’t depend on lighting. these sensors use ultrasonic frequency to detect objects the main component used in the motor driver was a pnp-npn darlington pair transistor. this fast-switching device can operate up to 10a, making it a better option than relays that cannot operate above 4hz. the transistor can be easily controlled using pulse width modulation techniques. the microcontroller used in this project was a gizduino v4.1. arboleda et al.10 used gizduino atmega644 for smart wheelchairs using touchpad and android device. compared to the arduino uno and gizduino atmega644, the gizduino v4.1 is cheaper and more user-friendly, which was used in this design. finally, the battery used was a 12v 17ah lead acid battery. this battery is lightweight and cheap yet provides a high capacity. amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals j global clinical engineering vol.6 issue 3: 2024 8 design of the voice-controlled wheelchair the microphone was placed slightly to one side of the mouth (figure 1) and will then convert the voice signal to an electric signal. it was covered with a sponge to suppress echo and noise and compress the input voice. figure 1. the microphone is placed slightly to one side of the mouth. the motor driver used was transistor-based. it has a high-current and voltage npn and pnp darlington pair. this provides faster switching capabilities compared to relays (8). it was connected to the back wheel and responded according to the given command of the microcontroller. wiper motors were also used to provide mobility in the wheelchair. using a chain, the wiper motors lead the direction of the back wheel, as shown in figure 2. through the use of a chain drive, the motor torque was increased. the wiper motor was not directly attached to the back wheel. figure 2. the chain used to connect the wiper and back wheel. the sensors used were hc-sr04 ultrasonic sensors.11 compared to infrared and proximity sensors, this provides accurate readings on solid objects, even in dark or bright rooms. the sensors were placed on the front and rear of the wheelchair, and the wheelchair automatically stops when the sensor detects a drop in terrain ahead (e.g., stairs) or an obstacle. specifically, two ultrasonic sensors were placed at the front: 1 facing the floor (to detect approaching stairs) and 1 below the wheelchair (to detect approaching obstacles in the lower left front area), both within 1–200 cm, as shown in figure 3. lastly, two were placed at the back: 1 facing the floor (to detect approaching stairs) and 1 below the wheelchair (to detect approaching obstacles in the lower back area) as shown in figure 4. figure 3. attachment of front sensors. figure 4. attachment of back sensors. modifying a standard wheelchair a standard wheelchair was used in the study. this provides a control unit, a battery, and a driver unit. these components were attached and transformed the wheelchair into a voice-controlled wheelchair. the control unit includes the microphone, rocker switch, and light-emitting diode (led) indicator. the microphone was placed slightly on one side of the user’s mouth. the led indicators, shown in figure 5, and the rocker switch were placed on the right armrest of the wheelchair. a fiberglass and sticker 9 j global clinical engineering vol.6 issue 3: 2024 amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals were used to cover the led indicator. the easyvr 3, microcontroller, and battery were placed on the flat bar and plastic casing below the wheelchair. figure 6 shows the flat bar attached to the wiper motors and battery. flat bars were added on the lower front of the wheelchair where the sensors are attached. the plastic casing for the shields and motor driver was placed on the lower part of the wheelchair. the driver unit includes a motor driver circuit and 2 wiper motors. the wiper motor and the back wheel of the wheelchair were welded into a sprocket in a machine shop. a chain connected the sprockets found on the wipers and back wheels. this provides easier maneuvering of the wheelchair. figure 5. led indicators placed on the right armrest. figure 6. flat bar attachment for wiper motors, battery, and ultrasonic sensor. integrating the easyvr 3, ultrasonic sensor, microcontroller, 12v wiper motor, and standard wheelchair for the device the user drives the wheelchair by giving voice commands converted to electric signals by the microphone and processed by the voice recognition module. the voice command is stored in memory and converted into digital signals using analog-to-digital converters (adc). the microcontroller receives the digital input, which then outputs a signal to the motor driving circuit, switching the motor accordingly. the ultrasonic sensor senses obstacle with a fall detection system and sends a signal to microcontroller to stop the chair. the block diagram of the voice-controlled wheelchair system is indicated in figure 7. figure 7. voice-controlled wheelchair system block diagram. the voice recognition module was soldered into a shield to provide an easy connection with the microcontroller. to connect the voice recognition module and microcontroller, the soldered voice recognition shield was attached to the gizduino. a motor driver shield must be present since a motor cannot be directly connected to the microcontroller. this is an h-bridge circuit that allows the microcontroller to control high-current motors. 4 input pins (2n222a transistor base in series with a 10kω resistor) were connected to the digital pins d5, d5, d9, and d10 of the microcontroller. the schematic of the motor driver and its physical connections are shown in figures 8 and 9, respectively. figure 8. motor driver schematic diagram. amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals j global clinical engineering vol.6 issue 3: 2024 10 figure 9. physical connections of the device. after connecting the easyvr 3, ultrasonic sensors, microcontroller, and 12v wiper motor, the motors were attached to the flat bar between the front and back wheels. this was done in a machine shop. lastly, the sensors, microcontroller, motor driver circuit, and voice recognition module were mounted below the wheelchair. a plastic casing was used in the final casing of the voice-controlled wheelchair circuitry. this way, the voice recognition module, ultrasonic sensors, microcontroller, motors, and wheelchair were integrated. developing the program for the voice-controlled wheelchair the arduino atmega 328 microcontroller was programmed using c / c ++ language. this language was used to develop the software to control the wheelchair based on the data received from the voice recognition module. a predefined list of words controls the application with only a modest amount of ram and program memory. the word list was created with the arduino library. the arduino is a pc-based program that lets users select and implement the user interface vocabulary. those settings were recorded in memory. this memory was not lost even with the power off. the voice recognition library provides an audio interface to a user’s application program, allowing the user to control the application by uttering discrete words in a predefined word library. the words chosen for the library are relevant to the interaction between the application program and the user. a word spoken through a microphone connected to the voice recognition module was analyzed on a frame-byframe basis and quantized into feature vectors of sound characteristics against a vector codebook. the quantized feature vectors were then examined to determine which word they most closely match. the binary outputs were generated from the voice recognition module, which were set as a parameters for the program. the microcontroller received the converted voice from the voice recognition module. the application program takes appropriate action based on the parameters set by the developed program. however, once the obstacle and fall detection is active, the motors will automatically place the wheelchair in a safer place (figures 10 and 11). figure 10. software flowchart for speaker dependent. project testing before evaluating the wheelchair, the researchers pilottested the project. the project was tested in the engineering science building, college of engineering and information technology (ceit), cavite state university, indang, cavite, philippines. the motors, voice recognition, and sensors were tested by giving different voice commands. 11 j global clinical engineering vol.6 issue 3: 2024 amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals project evaluation the researchers evaluated the system’s functionality in technical evaluation. this is done to identify if the operations that can be run on the wheelchair are attained. this includes tests for each sensor and motor integrated with the wheelchair. this way, the wheelchair is placed and tested in a quiet room with obstacles like chairs, walls, tables, and stairs. the second is placing the wheelchair in a room filled with random noise. all of these tests were repeated twice; the first is for speaker-independent, and the second is for speaker-dependent. the researchers identified which of these two features is more efficient. in the acceptability test, the respondents conducted a final test on the device to evaluate usability, correctness, control, reliability, safety, and comfort by giving any desired voice command. this was done by gathering data from the respondents that used the device. the sampling method employed was opportunity sampling, whereby individuals from the target population who were available and willing to participate were selected to evaluate the device.12 this includes a total of 30 respondents, which include 25 students selected from a sample of students at the ceit and 5 persons who suffer from mobility disability. the respondents evaluated the device in a simulated environment. each respondent was tied up in the simulated environment while using the device. to implement this, a hand and foot strap was provided on the wheelchair. a clearance was sought first from the ethics review board to ensure that the device was ready for persons with disabilities’ (pwd) evaluation. they also gave any desired voice commands on the wheelchair. the evaluation results are analyzed using statistical parameters like mean method and standard deviation analysis. tables are used to present and discuss the results gathered. ethical considerations prior to using the wheelchair, the researchers provided a detailed explanation of how it is operated. during the evaluation, no harm was done to any of the patients. a physical therapist also accompanied the researchers to provide medical assistance if needed. an informative document/manual was attached to the questionnaire to ensure the user was seated properly. the following parameters were taken into consideration: (a) the user is sitting upright in the chair; (b) the pelvic/seat belt is secured firmly; (c) the feet are placed flat on the ground; (d) the knees are aligned with the hips; (e) the trunk and pelvis are centered; (f) the head is centered with the chin slightly tucked; (g) the elbows are bent at a 90-degree angle; and (h) the chest is lifted. confidentiality and informed consent maintaining the participant’s anonymity was also observed. they were not required to give their name or share personal information with the researchers. moreover, the participants were given informed consent so that they could decide whether to participate or not. pwds’ evaluation location and compensation those participants who suffer from mobility disabilities were visited at general emilio aguinaldo medical hospital, trece martires, cavite, philippines. they were given compensation like a pack of assorted fruits. in answering the questionnaire, the patients were assisted by the researchers and his/her guardians. results through this, the researchers could identify which voice recognition feature, speaker-dependent and figure 11. software flowchart for speaker independent. amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals j global clinical engineering vol.6 issue 3: 2024 12 speaker-independent, was more responsive. moreover, as a possible strategy to reduce noise, the effect of wearing a helmet was also evaluated for both features. the motors and sensors were found to be 100% functional. this was done by giving 10 trials per command and recording whether the voice was recognized successfully or not. the number of trials was based on the study titled “design and development of voice controllable wheelchair,” which also corresponds to the number of trial testing of the wheelchair’s functionality.13 the device’s accuracy was proven good for speaker-dependent, while for speakerindependent, the accuracy was excellent. table 1 shows the calculated rating for each word spoken through the easyvr using the speaker-dependent feature. it has a low recognition rating for noisy environments, showing that the easyvr is susceptible to noise. table 1. functionality and responsiveness calculations using speaker-dependent noisy environment quiet environment spoken word no. of correct recognized word no. of correct recognized word start 10 10 go 4 10 back 1 10 left 1 10 right 0 10 stop 1 9 standby 0 7 average 24.29 94.29 total average 59.29 table 2 shows the calculated rating for each word spoken through the easyvr using the speaker-independent feature. comparing the results from table 1, it can be shown that the easyvr is less susceptible to noise using speaker independent. table 2. functionality and responsiveness calculations using speaker-independent noisy environment quiet environment spoken word no. of correct recognized word no. of correct recognized word start 9 10 go 8 10 back 6 10 left 6 10 right 5 10 stop 7 10 standby 7 10 average 68.57 100 total average 84.29 table 3 shows the calculated rating for each word spoken through the easyvr while wearing a helmet for both features. comparing the results from tables 1 and 2, it can be shown that the easyvr is less susceptible to noise while wearing a helmet for speaker-dependent and speaker-independent. table 3. functionality and responsiveness calculations while wearing a helmet speaker dependent speaker independent spoken word no. of correct recognized word spoken word no. of correct recognized word start 10 move 10 go 6 forward 9 back 1 backward 6 left 2 left 7 right 1 right 7 stop 3 stop 8 standby 1 down 7 average 34.29 average 77.14 13 j global clinical engineering vol.6 issue 3: 2024 amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals table 4 shows that the percent error of a well-trained speaker dependent is two times greater than the speakerindependent speech recognition. the error percentage was reduced by 10% when wearing a helmet for both features. the table suggests that the most effective feature is speaker-independent. percent error = table 4. comparison of speaker dependent and speaker independent speaker dependent speaker independent software the software learns the characteristics of the user’s voice through training it does not require training in the software user works only to the trained user to recognize commands able to recognize commands by different users accuracy (% error)noisy environment 75.71% 31.43% accuracy (% error)quiet environment 5.71% 0 % reducing noise in wearing a helmet(% error) 65.71% 22.86% the wheelchair’s speed was calculated by dividing the distance travelled over time. it was determined that the wheelchair has an average speed of 0.2m/s with a person weighing 46 kilograms. the maximum weight capacity was determined by letting users with different weights, specifically, 46 kgs, 53 kgs, 61 kgs, 68 kgs, 72 kgs, and 80 kgs, sit on the wheelchair. with a user weighing 80 kgs, a noticeable decrease on the wheelchair’s speed was observed. figure 11 shows the effect of the user’s weight on the wheelchair’s speed. figure 12. speed versus weight. the usability, correctness, control, reliability, safety, and comfort were gathered. a total of 30 respondents (25 students and 5 pwds) were the participants who answered the questionnaire after they had used the wheelchair. table 5 shows the user acceptability computations evaluated by 25 students at cavite state university, indang, cavite, philippines when the wheelchair was evaluated. it also shows that the usability, correctness, control, reliability, safety, and comfort of the wheelchair have low standard deviation. this means the device met the expected objective, and the system was considered efficient. table 5. user acceptability computations for healthy persons general qualities of the wheelchair mean standard deviation usability 4.6 0.58 correctness 4.16 0.75 control 4.4 0.71 reliability 4.64 0.57 safety 4.48 0.59 comfort 4.84 0.47 table 6 shows the user acceptability computations evaluated by 5 persons who suffered from mobility disability when the wheelchair was evaluated. pwds evaluated it after the device was used by healthy persons and rated amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals j global clinical engineering vol.6 issue 3: 2024 14 the device as acceptable. it also shows that the usability, correctness, control, reliability, safety, and comfort of the wheelchair have low standard deviation. this means that the device met the expected objective, and the system was considered efficient for persons with mobility disabilities. table 6. user acceptability computations for pwds general qualities of the wheelchair mean standard deviation usability 4.2 0.45 correctness 3.6 0.55 control 4.2 0.45 reliability 3.8 0.45 safety 3.6 0.89 comfort 4.6 0.55 table 7 shows the overall user acceptability of the wheelchair. the mean and standard deviation evaluated by pwds and students were combined. table 7. overall user acceptability computations general qualities of the wheelchair mean standard deviation usability 4.53 0.57 correctness 4.07 0.74 control 4.37 0.69 reliability 4.5 0.63 safety 4.33 0.71 comfort 4.8 0.48 table 8 shows the actual cost of the voice-controlled wheelchair. this included the main parts of the device as well as the casing and screws. the unit cost was $369.48, comprising all materials essential to the device’s construction. table 8. total cost of device construction materials quantity unit cost (usd) total cost (usd) microcontroller (gizduino v3) 1 14 14 easyvr shield 1 52 52 ultrasonic sensor 4 5 20 12v 17ah lead acid rechargeable battery 1 18 18 battery charger 1 15 15 standard wheelchair 1 79 79 tip147 4 2 6 tip142 4 1 4 2n222a 4 0.5 2 lm7809 1 0.4 0.4 terminal blocks 3 0.6 1.8 resistor 8 0.035 0.28 12” × 12” pre-sensitized circuit board 1 3 3 wiper motor 2 18 36 chain 2 5 10 sprocket 2 8 16 plastic casing 1 1 1 labor 73 miscellaneous fees 18 total $369.48 15 j global clinical engineering vol.6 issue 3: 2024 amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals discussion wheelchairs are crucial for people with paralysis, muscle weakness, or any condition that limits their mobility. there are two types of wheelchairs: manual and powered. manual wheelchairs require more physical effort, while powered wheelchairs demand cognitive and physical skills that not everyone possesses. to address this issue, researchers have developed a voice-controlled wheelchair that allows disabled individuals to move around independently. this wheelchair uses a voice recognition application connected to motors, enabling it to receive and perform voice commands given by the user. the microcontroller can be programmed to recognize a single user’s voice or any voice command. after conducting a technical evaluation, it was observed that the wheelchair was prone to noise, with only 17 out of 70 spoken words being recognized correctly as speakerdependent and 48 out of 70 as speaker-independent. however, a helmet helped reduce noise and increased the number of correctly recognized spoken words to 24/70 for speaker-dependent and 54/70 for speaker-independent. this shows that wearing a helmet can significantly improve speech recognition accuracy. furthermore, in situations with minimal noise, 66 out of 70 spoken words were recognized correctly for speaker-dependent and all 70 for speaker-independent. hence, the speaker-independent feature was more accurate and responsive, and the survey was conducted using this feature. the testing and evaluation of the wheelchair showed that it met the desired objectives and limitations of the device. the motors and sensors were fully functional, and the wheelchair could move at an average speed of 0.2 m/s, carrying a weight of up to 80 kg and lifting at an angle of up to 10˚. the overall acceptability of the unit was rated at an average of 4.53, with ratings of 4.53 for usability, 4.07 for correctness, 4.37 for control, 4.50 for reliability, 4.33 for safety, and 4.8 for comfort. this indicates that the unit meets the objectives. due to its wiper motor design, the device only responds to stored voice commands and cannot be manually controlled. ultrasonic sensors work well for detecting obstacles and stairs but have limited detection range and angle. the front sensor only detects obstacles on the left side, and the system cannot detect objects beyond 200 cm. table 8 presents the cost breakdown of the developed system, including the main components of the device as well as the casing and screws. the total unit cost was $369.48, covering all the necessary materials to construct the device. several studies and articled were synthesized to assess the effectiveness of the device. a research study, “design and development of voice controllable wheelchair” published in 2022, is relevant to the methods and block diagram employed in this study for the voice-controlled wheelchair.13 the study found that the arduino analyzed the user’s voice commands before transmitting the signal to the driver circuit which is similar to the process of this study, as depicted in figure 7. another study titled “voice controlled automatic wheelchair” produced similar positive outcomes to this research, although it used arduino r3 as the wheelchair’s primary processing unit.14 a similar study titled “development of a low-cost electronic wheelchair with obstacle avoidance feature” shows similar findings where ultrasonic sensors for obstacle avoidance and infrared sensors were also installed and thus gave out positive results concerning the individuals involved in the testing and evaluation.15 the researcher compared the project's overall cost with a similar study called “design of an arduino based voice-controlled automated wheelchair.”16 the cost of the mentioned study was close to the cost of the wheelchair developed in this study, indicating that the cost of components and materials used to develop this project is not too high. these studies validate the efficacy of the techniques and results in this research study, which contributes to the knowledge base of voice-automated wheelchairs. numerous studies have shown that access to independent mobility benefits children and adults. it enhances their educational and vocational opportunities, reduces their reliance on family members and caregivers, and promotes feelings of self-reliance. amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals j global clinical engineering vol.6 issue 3: 2024 16 conclusions upon careful observation and analysis of gathered results, the development of a voice-controlled wheelchair for physically impaired individuals has successfully met all desired objectives. the wheelchair is designed to respond to voice commands, allowing users to navigate and control the device through vocal instructions. with the capability to detect obstacles and stairs, the unit can automatically halt its movement, ensuring the safety and convenience of the user. this research study has demonstrated that technological advancements, particularly in trained and reprogrammed modules, can yield significant breakthroughs in the equipment used by patients in hospital wards. with proper orientation and guidance, individuals with physical impairments can operate a low-cost wheelchair using voice commands. recent advancements in technology have enabled patients to move independently without relying on the assistance of hospital staff or their loved ones. by utilizing voice commands, individuals with physical impairments can effortlessly control their movement, ensuring greater independence and convenience in their daily activities. this research serves as a foundation for future studies, allowing for integrating more advanced technologies into voice-controlled wheelchairs. ultimately, this study has the potential to improve the quality of life for individuals with physical impairments and those who aim to enhance the lives of individuals who cannot care for themselves effectively. references 1. leaman jand la hm. a comprehensive review of smart wheelchairs: past, present, and future. ieee transactions on human-machine systems, vol. 47, no. 4, pp. 486–499, aug. 2017, doi: 10.1109/thms.2017.2706727. 2. kumar d, malhotra r and sharma sr. 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meyyazhagan a and orlacchio a. hereditary spastic paraplegia: an update. internat j molec sci 2022;23(3). doi: 10.3390/ijms23031697. 9. anjum f and seetha m. voice-activated system for disabled people using iot. in proceedings of the 2nd international conference on cognitive and intelligent computing, a. kumar, g. ghinea, and s. merugu, eds., singapore: springer nature singapore. 2023:219–226. 10. arboleda er, paulite yvp and carandang njc. smart wheelchair with dual control using touchpad and android mobile device. indonesian j electric engineer informat 2018;6(1). doi: http://dx.doi.org/10.52549/ ijeei.v6i1.342. 11. elsokah m, mejber ad, zerek ar, et al. next generation of smart wheelchair with speech command. in the 7th international conference on engineering & mis 2021, in icemis’21. new york, ny, usa: association for computing machinery, 2021. doi: 10.1145/3492547.3492758. 12. berndt ae. sampling methods. j hum lact 2020;36(2):224– 226. doi: 10.1177/0890334420906850. 13. dutta pp, et al. design and development of voice controllable wheelchair. in 2020 8th international conference on reliability, infocom technologies and optimization (trends and future directions) (icrito), jun. 2020, pp. 1004–1008. doi: 10.1109/ icrito48877.2020.9197765. 17 j global clinical engineering vol.6 issue 3: 2024 amoguis, lingon, arboleda, cahigan: development of a voice-controlled wheelchair for physically impaired individuals 14. umchid s, limhaprasert p, chumsoongnern s, et al. voice controlled automatic wheelchair. in 2018 11th biomedical engineering international conference (bmeicon), nov. 2018, pp. 1–5. doi: 10.1109/ bmeicon.2018.8609955. 15. bisognin a, et al. ball grid array module with integrated shaped lens for 5g backhaul/fronthaul communications in f-band. ieee transactions on antennas and propagation vol. 65, no. 12, pp. 6380–6394, dec. 2017, doi: 10.1109/tap.2017.2755439. 16. raiyan z, nawaz ms, adnan ak, and imam mh. design of an arduino based voice-controlled automated wheelchair. in 2017 ieee region 10 humanitarian technology conference (r10-htc), dec. 2017, pp. 267–270. doi: 10.1109/r10-htc.2017.8288954. 39 j global clinical engineering vol.7 issue 1: 2025 received october 24 2024, accepted february 19, 2025, date of publication march 10 2025. original research article feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks amândio dias1,2,3,*, paulo pires4, leandro santana5, paulo marques6, mário espada3,4,7,8,9, fernando santos4,8,9, eduardo jorge silva6, 10 and diogo teixeira6,10 1 egas moniz center for interdisciplinary research (ciiem); egas moniz school of health & science, caparica, almada, portugal. 2 integrative movement and networking systems laboratory (inmov-net lab) egas moniz center for interdisciplinary research (ciiem), egas moniz school of health & science, caparica, almada, portugal. 3 sport physical activity and health research & innovation center (sprint), rio maior, portugal. 4 centre for the study of human performance (ciper), faculdade de motricidade humana, universidade, de lisboa, cruz quebrada-dafundo, lisboa, portugal. 5 postgraduate program in physical education, federal university of juiz de fora, minas gerais, brazil. 6 faculty of physical education and sport, lusófona university, lisbon, portugal. 7 comprehensive health research centre (chrc), universidade de évora, évora, portugal. 8 life quality research centre (cieqv), complexo andaluz, apartado, rio maior, portugal. 9 instituto politécnico de setúbal, escola superior de educação, setúbal, portugal. 10 research center in sport, physical education, and exercise and health (cidefes), lisbon, portugal. * corresponding author email: adias@egasmoniz.edu.pt abstract muscle strength and power are often evaluated through jumping tasks. this study investigates the reliability of my jump 2 (mj2), a smartphone application (app) used for this assessment. two commonly used jumps, the countermovement jump (cmj) and squat jump (sj), were analyzed. the study aimed to evaluate the reliability of mj2 for assessing peak power, jump height, and flight time. materials and methods: thirty-eight undergraduate students performed three jumps of each type in a randomized order. all jumps were executed on a contact mat and simultaneously recorded by the smartphone’s slow-motion camera. two independent researchers analyzed the video data by identifying take-off and landing frames to calculate flight time. the intraclass correlation coefficient (icc), coefficient of variation (cv), and lin’s concordance correlation coefficient (ccc) were used for comparison. results: excellent reliability (icc > 0.9) and high agreement were observed for flight time and jump height in both sj and cmj. typical error and cv analysis indicated low variability for sj, whereas cmj jump height showed greater variability. however, peak power reliability and agreement were low (icc < 0.5) for both jumps. conclusions: the results suggest that mj2 is a reliable and valid tool for assessing jump height and flight time, irrespective of the device used for data analysis. however, its power measurement capability differs from a contact platform’s, likely due to the indirect methods used to estimate power. based on these findings, the mj2 app can be confidently used to measure flight time and jump height but should be used cautiously when assessing power. keywords—jumping, reliability, testing, power, countermovement jump, squat jump. dias, pires, santana, marques, espada, santos, silva, teixeira: feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks j global clinical engineering vol.7 issue 1: 2025 40 copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction in sports requiring continuous body movement, jumping is a fundamental task that relies on optimal lower-body coordination. these movements result from efficient energy transfer between lower limb joints,1 and are essential for athletic success.2 vertical jumps are widely used to assess lower limb neuromuscular performance, as they correlate with injury risk prediction and athletic performance while serving as an indicator of power output.3,4 the squat jump (sj) and countermovement jump (cmj) are the most commonly analyzed jump types.3 jump height represents a key metric of neuromuscular performance. mechanical power, a crucial component of sports performance, is often derived from jump height, as both sj and cmj require athletes to generate substantial mechanical work in a short duration.3 this appears to be a critical factor in sports performance, distinguishing athletes by level,5 experts vs. non-experts,6 and related to sports performance characteristics, such as jumping.7,8 as body weight is used to normalize power, it could be highlighted that individual power can significantly affect jump performance and, subsequently, reach jump height.9 traditional instruments for assessing vertical jumps include force platforms, contact mats, linear position transducers, infrared cells, and optical systems.10–12 however, these devices can be cumbersome, expensive, and require technical expertise, limiting accessibility for sports professionals.4,13 recent technological advancements have led to the increased use of mobile applications for real-time exercise assessment.14 this type of assessment allows for increased familiarity for athletes (assessment at their training site), easy portability, and removes many constraints of time, space, and equipment/ facilities required.15,16 the high level of technology now available, combined with the ease of transport and use, emphasizes using mobile devices to assess physical exercise in real-time and store data for subsequent analysis.17 smartphone applications and wearables have been one of the most regular trends in the fitness industry in recent years18 and present a cheaper alternative to other evaluation instruments. the my jump 2 (mj2) app was developed as a user-friendly, portable tool to accurately measure jumping performance.19 several studies have validated mj2 for jump height assessment in various populations, including active adults, children, elderly individuals, and athletes with cerebral palsy.4,13,20–24 high intra-rater reliability has been demonstrated across multiple jumping types.25,26 however, limited research has assessed the app’s ability to measure power. yingling et al.27 used the jump height data from the mj2 app to assess peak power using sayer’s peak power equation.28 the results reported were mixed, as they indicate excellent reliability for consistency between mj2 and the force platform, but poor to excellent reliability for absolute agreement. according to the authors, the difference in the results could be explained by the fact that mj2 uses time in the air for its calculations and does not consider the upper limb reach component of the jump, as measured by the force platform. another study compared the mj2 app and a force platform for assessing reactive strength index and mean power during a drop jump.22 the results showed near-perfect levels of agreement for the reactive strength index, but a weaker agreement for mean power. according to the authors, this may be related to the different means of assessing power between mj2 and the force platform. there is a lack of studies on the validity of power calculations derived from the mj2 app. this means the data provided are still questionable and should be used cautiously.29 to the best of our knowledge, no further studies have been conducted to assess other mj2 app metrics, with most studies focusing on jump height. given the discrepancies in previous findings, further investigation is necessary. this study aims to analyze the validity, feasibility, and reliability of mj2 for power measurement while providing additional evidence on its accuracy in measuring jump height and flight time. 41 j global clinical engineering vol.7 issue 1: 2025 dias, pires, santana, marques, espada, santos, silva, teixeira: feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks methods participants sample size estimation was conducted based on the work of donner et al.,30 targeting a reliability of 0.8 with a minimum of 0.6, 90% power, a significance level of 0.05, and a 10% dropout rate, resulting in a required sample size of 36 participants. a total of 38 undergraduate sports science students (34 males, 4 females; mean age: 21.84 ± 3.48 years; body mass: 69.24 ± 11.29 kg; height: 1.74 ± 0.09 m) volunteered. inclusion criteria required participants to be free of lower extremity injuries or pain within the past three months. written informed consent was obtained, and the study was approved by the ethics committee of the polytechnic institute of leiria (ce/ipleiria/22/2021), which considered the procedures mentioned in the helsinki declaration.31 instruments the study was conducted in a controlled laboratory setting. a xiaomi mi 11 lite smartphone (version 14, xiaomi, beijing, china) recorded participants’ feet in the frontal plane at a 1.5-meter distance19 and a height of 30 cm using a tripod.32 this position allowed for a clear view of the participant’s lower extremities to ascertain take-off and landing moments. the smartphone’s slow-motion camera recorded at 240 hz with a 720-pixel resolution. video data were exported for later analysis. two independent evaluators analyzed the data: one using an ipad mini-5 (version 16, ca, usa) (obs-ipad) and another using a macbook air m1 (version 15, ca, usa(obs-mac). a chronojump contact platform (version 1.9, chronojump boscosystem, spain) was used as the reference device for comparison. the validity of this platform has been previously established.33 design and procedures this was an observational study, in which all data collection was conducted in a single session. the mj2 app and contact platform simultaneously recorded all the jumps performed by the participants. before data collection, the same evaluator took measurements of leg length and hip height at 90° knee flexion (distance from the greater trochanter to ground) since they are required for calculations in both the mj2 app and chronojump software. each participant completed a standard warm-up of dynamic stretching followed by three trial practices in total.34 participants performed three sj and three cmj trials, with a 30-second rest interval between each. the jump order was randomized, and verbal encouragement was provided. sj required a squat position of ~90° of knee flexion, held for 2 seconds before jumping. participants kept their hands on their hips for all jumps. trials failing to meet the criteria were repeated. subjects performed three sj and three cmj with a rest period of 30 s. between them. the order of jumps for each participant was randomized. all participants received verbal. all participants were required to refrain from vigorous physical exercise 24 hours before the testing and were properly dressed to perform the jumps. for safety purposes, there was a space of 1 m in front and sides of the contact platform. a whiteboard was placed in the back of the frame (figure 1), with a specific coding, so that in the posterior analysis performed, observers could identify the subject and jump. figure 1. data collection setup. the same coding was used to record data on chronojump software. two evaluators with experience utilizing the mj2 app independently assessed each of the 228 jumps (6 jumps for each of the 38 subjects), with a total number of 456 observations. both observers have a ph.d in sports science and previous experience working with strength and conditioning programs. for video analysis, observers manually determined take-off and landing frames, using the criteria for selecting video frames: both feet were off the ground (take-off) and at least one foot touched the ground (landing), as suggested earlier.19 the videos were dias, pires, santana, marques, espada, santos, silva, teixeira: feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks j global clinical engineering vol.7 issue 1: 2025 42 used for cv% was , where sd is the standard deviation and for te was .41 high reliability was determined if icc > 0.90 and cv < 5%.42 the usefulness of the test was defined as “marginal” (te > swc), “ok” (te = swc), and “good” (te < swc).43 the agreement was calculated using lin’s concordance correlation coefficient (ccc) using a custom-made excel spreadsheet based on lin’s recommendations.44–46 values > 0.95 were deemed necessary to consider a good agreement.43 results table 1 presents the descriptive information regarding the participants, also used for mj2 and the contact platform. table 1. descriptive statistics of participants and performed measurements. variables total subjects male subjects female subjects age (years) 21.84 ± 3.48 21.88 ± 3.51 21.50 ± 3.20 weight (kg) 69.24 ± 11.29 71.47 ± 9.58 50.25 ± 5.31 height (m) 1.73 ± 0.08 1.75 ± 0.07 1.58 ± 0.03 leg length (cm) 102.68 ± 16.27 103.03 ± 17.06 99.75 ± 5.72 height at 90° flexion (cm) 63.53 ± 6.50 63.59 ± 6.66 63.00 ± 4.85 note: values are expressed as mean ± sd. intra-observer and contact platform reliability results for cmj and sj flight time, height, and power, are presented in tables 2 and 3. the icc scores were > 0.90 in all cases, indicating good reliability. inter-rater reliability scores are presented in table 4 for cmj and table 5 for sj. in both the cmj and sj, flight time and height icc scores were > 0.90, and cv was below 5% in all situations except obs-ipad vs. platform (cv = not analyzed in any consistent order of participants or jumps. data retrieved for comparison were flight time, jump height, and power. in the mj2 app, peak power estimations were based on the work of samozino et al.,35 with the following equation +1) , with m the body mass, g the gravitational acceleration, hp0 the vertical push-off distance, and h the jump height. the contact platform estimated peak power with the sayers equations.28 . statistical procedures descriptive statistics were presented as mean ± standard deviation. shapiro-wilk tests assessed normality. systematic bias between observations was tested using paired t-tests, and effect sizes were calculated.36 the highest scores of the three jumps in each technique were used for calculations. standardized mean differences (95% confidence intervals; ci) and hedges’s g corrected effect size37 were calculated to determine the magnitude of change and compare observations, where the effect size (es) was considered trivial if g < 0.2, small (0.2–0.5), moderate (0.5–0.8), large (0.8–1.60), and very large (> 1.60).38 reliability was assessed through intraclass correlation coefficient (icc) calculations. for intra-rater observations, a two-way random effect absolute agreement single rater icc (3, 1) was used; for inter-rater, a two-way random effect absolute agreement multiple rater icc (3, k) was performed.39 icc values < 0.5 were considered indicative of poor reliability, values of 0.5–0.75 were indicative of moderate reliability, values of 0.75–0.90 were indicative of good reliability, and values > 0.90 suggested excellent reliability.39 all these tests were performed using statistical package for social sciences (spss, v26, ibm corp., armonk, ny, usa). additionally, typical error (te), expressed as the coefficient of variation (cv%), and the smallest worthwhile change (swc; 0.2 of the between-subjects standard deviation) were calculated through the use of the excel spreadsheet provided by hopkins40 to support reliability analysis. the formula 43 j global clinical engineering vol.7 issue 1: 2025 dias, pires, santana, marques, espada, santos, silva, teixeira: feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks the flight time was rated as good for obs-ipad vs. obsmac and obs-ipad vs platform and marginal for obs-mac vs. platform. in the sj results, all observations were rated as marginal in the height analysis. all agreement results for cmj and sj indicate good agreement between observers and the platform (ccc > 0.95). exceptions were verified for cmj and sj power analysis, where in all cases the ccc was < 0.15, thus reflecting no agreement when contrasted with the platform. 8.8) and obs-mac vs. platform (cv = 8.7). moreover, in cmj and sj, when testing for power, obs-ipad and obsmac vs. platform icc scores were < 0.50, indicating poor reliability, thus precluding further analysis. significant paired differences were observed in both observers and the platform results in the cmj (p = 0.001) and sj (p = 0.04). es (g) results were, however, all trivial (< 0.2). as for usefulness, the cmj results for flight time were rated as good, and for the cmj height they were rated as marginal. in the sj results, variables obs-ipad obs-mac contact platform mean ± sd icc (95% ci) mean ± sd icc (95% ci) mean ± sd icc (95% ci) flight time (ms) jump 1 516.201 ± 54.067 515.528 ± 53.288 5,22.500 ± 52.639 jump 2 514.646 ± 48.469 0.921(0.871; 0.955) 517.112 ± 48.886 0.917 (0.864; 0.953) 5,22.921 ± 47.442 0. 912 (0.855; 0.950) jump 3 519.742 ± 47.899 519.447 ± 49.201 5,26.053 ± 47.467 height (cm) jump 1 33.024 ± 6.523 32.930 ± 6.431 33.781 ± 6.422 jump 2 33.139 ± 5.997 0.920 (0.868; 0.954) 33.076 ± 6.038 0.917 (0.863; 0.953) 33.777 ± 5.917 0.911 (0.855; 0.950) jump 3 33.398 ± 5.952 33.377 ± 6.108 34.163 ± 6.010 power (watts) jump 1 1,592.916 ± 381.748 1,574.776 ± 385.070 9,46.045 ± 330.540 jump 2 1,594.180 ± 385.424 0.963 (0.937; 0.979) 1,582.117 ± 388.016 0.961 (0.934; 0.978) 9,49.240 ± 345.460 0.994 (0.990; 0.997) icc (95% ci): interclass correlation coefficient with upper and lower confidence intervals. table 2. intra-observer and contact platform reliability for countermovement jump performance variables. dias, pires, santana, marques, espada, santos, silva, teixeira: feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks j global clinical engineering vol.7 issue 1: 2025 44 variables obs-ipad obs-mac contact platform mean ± sd icc (95% ci) mean ± sd icc (95% ci) mean ± sd icc (95% ci) flight time (ms) jump 1 506.151 ± 52.384 505.081 ± 52.458 510.921 ± 50.382 jump 2 508.442 ± 53.189 0.929 (0.868; 0.963) 507.540 ± 53.238 0.930 (0.965; 0.964) 514.684 ± 51.208 0.931 (0.866; 0.965) jump 3 518.440 ± 56.659 518.158 ± 56.724 523.947 ± 54.610 height (cm) jump 1 31.742 ± 6.426 31.611 ± 6.416 32.274 ± 6.244 jump 2 32.036 ± 6.569 0.926 (0.860; 0.961) 31.926 ± 5.541 0.926 (0.855; 0.962) 32.756 ± 6.398 0.928 (0.857; 0.963) jump 3 33.342 ± 7.062 33.308 ± 7.083 33.996 ± 6.883 power (watts) jump 1 1488.335 ± 338.602 1506.616 ± 368.425 926.492 ± 334.469 jump 2 1504.804 ± 359.699 0.943 (0.892; 0.970) 1520.048 ± 369.943 0.947 (0.900; 0.973) 931.680 ± 331.032 0.994 (0.988; 0.997) jump 3 1562.984 ± 380.007 1579.455 ± 379.079 948.434 ± 338.721 icc (95% ci): interclass correlation coefficient with upper and lower confidence intervals. table 3. intra-observer and contact platform reliability for squat jump performance variables. 45 j global clinical engineering vol.7 issue 1: 2025 dias, pires, santana, marques, espada, santos, silva, teixeira: feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks table 4. interreliability for countermovement jump performance variables. * p< 0.05; cmj: countermovement jump; es: effect size; ci: confidence interval; icc: intraclass correlation coefficient; te: typical error; cv: coefficient of variation; swc: smallest worthwhile change; (95% ci): upper and lower confidence intervals. cmj flight time (ms) cmj height (cm) cmj power (w) obs-ipad vs obs-mac obs-ipad vs platform obsmac vs platform obsipad vs obs-mac obs-ipad vs platform obsmac vs platform obs-ipad vs obs-mac obs-ipad vs platform obs-mac vs platform paired diff. (cm) (95% ci) 0.30 (-1.51; 2.10) −6.31 (−8.53; −4.01)* −6.61 (−8.45; −4.76)* 0.02 (−0.20; 2.47) −0.77 (−1.05; −0.48)* −0.79 (−1.02; −0.56)* −0.75 (−15.16; 13.67) 638.82 (512.27; 765.36)* 632.33 (505.64; 759.02)* paired es (g) 0.01 0.13 0.14 0.01 0.13 0.13 0.01 1.84 2.7 icc (95% ci) 0.99 (0.99; 0.99) 0.99 (0.93; 0.99) 0.99 (0.89; 0.99) 0.99 (0.99; 0.99) 0.99 (0.94; 0.99) 0.99 (0.91; 0.99) 0.99 (0.99; 0.99) 0.25 (−1.89; 0.594) 0.26 (−1.88; 0.601) ccc (95% ci) 0.99 (0.08; 0.999) 0.98 (0.97; 0.99) 0.98 (0.97; 0.99) 0.99 (0.99; 0.999) 0.98 (0.98; 0.99) 0.99 (0.97; 0.99) 0.99 (0.99; 0.99) 0.14 (0.019; 0.261) 0.15 (0.022; 0.266) te (95% ci) 0.08 (0.06; 0.10) 0.10 (0.08; 0.13) 0.08 (0.07; 0.11) 0.18 (0.15; 0.23) 0.45 (0.37; 0.58) 0.44 (0.36; 0.57) cv (95% ci) 0.80 (0.6; 1.0) 1 (0.8; 1.2) 0.80 (0.7; 1.0) 4 (3.3; 5.2) 8.80 (7.2; 11.6) 8.70 (7.1; 11.4) swc (cm) 1.1 1.35 1.12 0.14 0.17 0.14 rating good good good marginal marginal marginal dias, pires, santana, marques, espada, santos, silva, teixeira: feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks j global clinical engineering vol.7 issue 1: 2025 46 table 5. interreliability for squat jump performance variables. sj flight time (ms) sj height (cm) sj power (w) obs-ipad vs obs-mac obs-ipad vs platform obs-mac vs platform obsipad vs obs-mac obs-ipad vs platform obsmac vs platform obs-ipad vs obs-mac obsipad vs platform obsmac vs platform obs-mac obs-ipad vs platform obs-mac vs platform 2.94 (−22.62; 28.50) 636.70 (505.57; 767.82)* 634.85 (510.51; 759.20)* paired diff. (cm) (95% ci) 0.28 (−4.53; 5.09) −5.26 (−10.27; −0.26)* −5.72 (−7.25; −4.18)* 0.03 (−5.75; 0.64) −6.33 (−1.23; −0.01)* −0.69 (−0.88; −0.50)* 0.01 1.73 1.78 paired es (g) 0.01 0.09 0.1 0.01 0.09 0.1 0.99 (0.98; 0.99) 0.21 (−0.200 0.642) 0.29 (−1.95; 0.64) icc (95% ci) 0.98 (0.97; 0.99) 0.98 (0.97; 0.99) 0.99 (0.93; 0.99) 0.98 (0.97; 0.99) 0.98 (0.96; 0.99) 0.99 (0.93; 0.99) 0.99 (0.96; 0.99) 0.13 (0.002; 0.246) 0.13 (0.001; 0.252) ccc (95% ci) 0.97 (0.94; 0.98) 0.96 (0.92; 0.98) 0.99 (0.98; 0.99) 0.97 (0.94; 0.98) 0.96 (0.92; 0.98) 0.99 (0.99; 0.99) te (95% ci) 1.02 (1.02; 1.03) 1.02 (1.02; 1.03) 1.01 (1.01; 1.02) 1.04 (1.03; 1.05) 1.04 (1.03; 1.05) 1.01 (1.01; 1.02) cv (95% ci) 2 (1.6; 2.6) 2.10 (1.7; 2.7) 0.70 (0.6; 0.9) 4 (3.3; 5.2) 4.20 (3.4; 5.5) 1.30 (1.1; 1.7) swc (cm) 2.89 3 0.93 0.37 0.38 0.11 rating good good marginal marginal marginal marginal * p< 0.05; sj: squat jump; es: effect size; ci: confidence interval; icc: intraclass correlation coefficient; te: typical error; cv: coefficient of variation; swc: smallest worthwhile change; (95% ci): upper and lower confidence intervals. 47 j global clinical engineering vol.7 issue 1: 2025 dias, pires, santana, marques, espada, santos, silva, teixeira: feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks discussion this study had two primary objectives. the first was to assess the validity and reliability of the mj2 app in evaluating neuromuscular performance through power measurements. the results demonstrated high intra-rater reliability (icc > 0.91) across all studied variables in cmj and sj, consistent with prior research.25,26 furthermore, mean differences between observers and the contact platform for cmj and sj (< 0.1 cm) aligned with previous findings on mj2 app validity in both male and female participants.23,25,26 yingling et al.,27 highlighted the necessity of establishing confidence in mj2 due to the potential bias introduced by manually selecting take-off and landing moments. the present study supports this confidence, as its intra-rater reliability findings align with previous research. regarding inter-rater reliability, icc scores exceeded 0.90 for flight time and jump height, with cv values below 5%, indicating strong reliability.42 these results correspond with prior studies on mj2 reliability.24,26,44,45 additionally, excellent agreement (ccc > 0.95) was found between mj2 and the contact platform for both jumps and observers, consistent with bogataj et al.,23 who reported a high level of agreement between mj2 and a photoelectric cell system. cmj height exhibited slightly higher variability (cv > 5%) when compared with the platform, while sj height remained within acceptable limits. these findings contrast with previous studies that reported higher cv values for mj2.22,25 differences in jump type, sample size, and equipment used for validation may account for these discrepancies.22 for example, studies involving primary school children found higher variability in sj height, likely due to a lack of experience executing the movement.13,23 regarding test usefulness, as determined by the relationship between te and swc, flight time was rated as good (te < swc) for both cmj and sj, while jump height was rated as marginal (te > swc). a comparable study23 reported similar findings, with a marginal rating for sj height but not for cmj height. the primary focus of this study was the assessment of neuromuscular performance via peak power estimation with mj2. results indicated poor reliability (icc < 0.5) when comparing mj2-derived power measurements with those from the contact platform. conversely, inter-rater reliability between observers was high (icc > 0.98) for both jumps. these findings diverge from those of haynes et al.,22 who reported moderate icc values (icc = 0.67) when assessing mean power in drop jumps. yingling et al.,27 also found good reliability (icc = 0.85) for peak power estimation, highlighting variability across studies. in the present study, peak power values obtained from the contact platform were lower than those estimated by mj2. this discrepancy may be attributed to differences in sampling frequency, as the contact platform records at 1,000 hz, while mj2 video data is captured at 240 hz. these variations in data acquisition may obscure crucial details required for accurate power estimation. although both mj2 and the contact platform estimate neuromuscular performance via jump height, they employ different equations. the contact platform utilized an equation proposed by fox and mathews,45 whereas mj2 applied the samozino et al.,35 equation, which is more recent. prior studies have reported moderate agreement for mean power22 and good agreement for peak power27 when evaluating mj2’s power estimation reliability. differences in reference instruments and potential mj2 estimation errors may explain these discrepancies. notably, power estimation accuracy depends on the precision of jump height measurements, as flight time overestimation can amplify measurement error due to the squared nature of the variable. the disparity in data acquisition rates (1,000 hz for the contact platform vs. 240 hz for mj2) may also contribute to higher flight time and jump height values in mj2 assessments. carlos-vivas et al.,44 corroborated this observation, reporting a slight overestimation of jump height in their findings. even minor overestimations can influence power estimation, thereby affecting agreement between mj2 and the contact platform. these findings suggest that accurate and reliable force and power measurements require direct assessments rather than indirect calculations. this is the first study to evaluate mj2’s reliability using two devices (tablet and computer) for video analysis. the results indicate that manual frame selection is a valid and dias, pires, santana, marques, espada, santos, silva, teixeira: feasibility and reliability of the my jump 2 smartphone application in measuring peak power, flight time and jump height in physically active subjects during two different jumping tasks j global clinical engineering vol.7 issue 1: 2025 48 reliable method for assessing jump height and flight time, regardless of the device used for analysis. this minimizes the potential for bias and allows practitioners to use mj2 across different screen sizes and environments. the study reinforces the reliability of mj2 for assessing lower-body performance, offering a practical solution for practitioners. a limitation of this study is the lack of information regarding participants’ familiarity with the tested jump types. although participants were active undergraduate sports science students, variations in the cmj technique could have influenced the observed variability. additionally, the findings are limited to the study sample and may not be generalizable to other populations. future research should further investigate mj2’s power estimation capabilities by incorporating force platforms and alternative vertical jump tests (e.g., abalakov) to enhance agreement, correlation, and mean difference assessments. expanding the sample to include more female participants would also improve the generalizability of results. despite these limitations, the present study supports the use of mj2 to measure jump height and flight time in an active young population. the increasing popularity, affordability, and technological advancements of smartphone applications suggest that tools like mj2 will become integral to assessing physical fitness and health metrics.47 these findings contribute to existing literature and enhance confidence in mj2 as a rapid and reliable assessment tool for lower-body strength. conclusions the results of the present study recommend using the mj2 smartphone app as a valid, reliable, and useful tool for measuring jump height and flight time in active young adults. due to its simplicity and practicability, it can be used by physicians, coaches, and other sports science practitioners to assess physical fitness, particularly lowerbody performance. author contributions conceptualization, a.d. and d.t.; resourses, m.s. and f.s.; data collection, l.s. and p.m.; data analysis p.p. and e.s.; writing–original draft preparation, a.d. and d.t; writing– review & editing, m.e., m.s. and f.s.; supervision, a.d. acknowledgments we would like to acknowledge all students who volunteer to participate in the present study. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare they have no competing interests. consent for publication written consent was obtained from all participants regarding publication of data and/or image, as long as the images maintain the anonymity of the participant. further disclosure not applicable. 49 j global clinical engineering vol.7 issue 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systematic review. sports med. 2014;44(5):671– 686. https://doi.org/10.1007/s40279-014-0142-5. j global clinical engineering vol.7 issue 2, 2025 2 editor’s corner the delivery of healthcare services is increasingly dependent on patient-ready technologies, a trend that shows no sign of slowing. clinical engineering professionals (ces) are at the core of this evolution. their role in designing, implementing, managing, and optimizing medical technologies is essential to achieving safe and effective patient care. by integrating knowledge from engineering, life sciences, and management, ces are uniquely positioned to analyze complex systems and apply technology in ways that improve outcomes. their independent validation of medical technologies ensures that devices meet stringent safety and quality standards, reinforcing trust in their use throughout the continuum of care. as healthcare systems around the world evolve, ces remain at the forefront—driving innovation and maintain high standards across the entire technology lifecycle. staying current with the latest advancements, research, best practices, and global regulations is not just beneficial; it’s imperative. one of the most impactful ways to support this ongoing development is by participating in global events such as the 6th international clinical engineering & health technology management congress (icehtmc). this premier event provides unparalleled opportunities for professional growth, global collaboration, and cultural exchange. why attend the 6th icehtmc? 1. knowledge advancement • trends & innovation: access the latest developments in clinical engineering and healthcare technology. • global best practices: learn how healthcare systems worldwide address shared challenges in lifecycle management, regulation, and quality assurance. 2. professional networking • expert connections: meet and engage with global leaders, innovators, and fellow professionals. • collaborative growth: initiate or strengthen international research and professional collaborations. • mentorship: connect with experienced professionals who can guide your career development. 3. professional development • continuing education: earn credits or certificates toward professional credentials. • skill enhancement: participate in hands-on workshops and sessions, including research writing and leadership training. 4. influence and visibility • share your work: present research, case studies, and innovative practices to an international audience. • shape the future: contribute to global discussions on standards, ethics, and policy in clinical engineering. 5. career advancement • explore emerging roles: learn about opportunities in ai, cybersecurity, robotics, and more. • earn recognition: position yourself as a thought leader through presentations and publications. • meet decision-makers: network with stakeholders from across the health technology landscape. 6. cultural and global perspective • understand global systems: gain insights into healthcare delivery models from different regions. • foster collaboration: build relationships across borders and cultures. • experience the culture: enjoy shenzhen’s cuisine, history, and vibrant professional community. http://www.globalce.org http://www.globalce.org 3 j global clinical engineering vol.7 issue 2, 2025 7. motivation and inspiration • reignite passion: discover stories of success and innovation that highlight the real-world impact of your profession. • renewed commitment: leave inspired to further contribute to advancing healthcare technology worldwide. as i pen this editorial, the world health organization is convening its world health assembly, and it is worth remembering that as far back as 2007, resolution wha60.29 emphasized the importance of planning, assessing, acquiring, and managing health technologies responsibly and effectively. the dependency trend makes that resolution more relevant than ever. it will be my great pleasure to welcome you this october to shenzhen, china, the venue for the 6th icehtmc. your participation demonstrates a steadfast commitment to professional excellence, global collaboration, and the continuous pursuit of better healthcare for all. xie xie yadin david edd, pe, cce, faimbe, facce editor-in-chief copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org 5 j global clinical engineering vol.7 issue 2: 2025 received february 26 2024, accepted march 4, 2025, date of publication april 9, 2025. original research article discussing the clinical value of full-range autofocus endoscopic cameras rongjiao zhao1,* and cong yang2 1 hangzhou micro intelligent technology co. ltd., zhejiang hangzhou, china. 2 jinan micro intelligent technology co. ltd., shandong jinan, china. * corresponding author email: 378454121@qq.com abstract objective: this study aims to explore the potential of full-range autofocus (faf) technology to improve image clarity and operational ease in endoscopic procedures. methods: the paper analyzes the application and development of manual focus, autofocus, manual zoom, and auto zoom technologies in clinical endoscopy. the clinical value of faf technology in endoscopy, including intelligent scene linkage and continuous optical lossless zoom, is discussed. results: the application of faf technology significantly enhances medical diagnosis and treatment by providing clearer and more flexible imaging. this technology allows for seamless focusing from near to far distances, improving the accuracy and effectiveness of medical procedures. conclusions: the faf technology represents a significant advancement in endoscopic technology. it not only improves diagnostic precision and treatment efficiency but also contributes to safer and more comfortable medical services, which can promote further development in the medical industry. keywords—manual focus, autofocus, manual zoom, auto zoom, full-range autofocus. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ zhao, yang: discussing the clinical value of full-range autofocus endoscopic cameras j global clinical engineering vol.7 issue 2: 2025 6 introduction in recent years, the medical endoscopic camera system—integration of traditional optical technology with modern computer and microelectronics technologies—has become a widely utilized medical instrument because of increased medical standards and public health awareness.1 these systems have become increasingly common in clinical diagnosis and treatment, significantly enhancing diagnostic and therapeutic accuracy, reducing patient suffering, and accelerating recovery. a review of related research reveals that the primary goal of endoscopic camera systems is to assist doctors in “seeing clearly” by obtaining sharp images while maintaining user-friendliness and simplicity. thanks to advancements in focusing and zooming technologies, endoscopic cameras have evolved from “manual focus to autofocus, manual zoom to auto zoom, and then to full-range autofocus (faf),” thus greatly facilitating clinical procedures, ensuring the clear vision, reducing surgical risks, improving surgery success proportions, and enhancing the functionality and application experience of endoscopes. this process not only marks technological advancement but also reflects the broader trend in medical equipment development toward efficiency, precision, and ease of use. the primary objective of this study is to analyze the application of autofocus and zoom technologies in endoscopes, and discuss their positive impacts on medical diagnosis and treatment. furthermore, we explore the potential future influence of these technologies on the development of endoscopic technology. technological evolution in endoscopic focusing clinical requirements for imaging precision endoscopic surgery is intricate and complex, requiring clear imaging to present the details of the observation area to improve the diagnosis proportion of lesions (especially early and subtle lesions), thereby facilitating the doctor’s surgical intervention. for example, when doctors perform gastrointestinal surgery, to prevent unnecessary damage caused by intestinal adhesion, clear images of the lesion are required. this clarity aids doctors in observation and operation, reducing the risks associated with the blindness of traditional surgery, and minimizing organ damage and functional interference. manual focus in order to ensure a clear field of view in usage scenarios, medical endoscopic cameras initially introduced manual focus technology. this technology requires the operator to rotate manually the focusing ring based on visual judgment. the focusing effect heavily depends on the operator’s subjective judgment and precise adjustment, demanding a high level of skill from the operator. in practice, human errors are inevitable, making it difficult to guarantee clarity, and the operation process generally takes about 3 seconds or even more. autofocus in medical scenarios, doctors often need to obtain the clearest images as quickly as possible. therefore, with the development of electronic technology, autofocus technology has been introduced into endoscopic cameras. this technology uses sensors to detect the distance between the target scene and the lens, automatically adjusting the focus. operators only need to click a button on the camera, and the lens will automatically adjust to the clearest image based on image clarity and the theoretical focus position, significantly simplifying the use of endoscopes and making them highly suitable for medical applications. the principle of autofocus is as follows: optical signals received by the integrated optical lens are transmitted to the image sensor module, where the image sensor inside converts the optical signals into electrical signals that are then sent to the camera’s processor. the processor runs an autofocus algorithm that controls an internal motor to execute the focusing operation. the autofocus algorithm first filters the input image at the current motor position to reduce noise interference, and then enhances brightness through gamma correction. it then segments the image and calculates high-frequency information to characterize image clarity, adjusting the motor position based on the rate of clarity change. as the motor position changes, the mechanical distance matched by the optical lens group changes, thereby achieving the 7 j global clinical engineering vol.7 issue 2: 2025 zhao, yang: discussing the clinical value of full-range autofocus endoscopic cameras focusing effect. this cycle continues until the clarity is maximized, at which point focusing is complete. an illustrative diagram of the autofocus algorithm is shown in figure 1. figure 1. schematic diagram of the autofocus algorithm start-up. zoom technology: from mechanical to liquid lens solutions constraints of fixed focal length the difference between “fixed focus” and “zoom” lies in the variability of the focal length. fixed focus means the focal length is fixed, and clear focus can only be achieved at a certain distance; zoom means the focal length is adjustable, and the magnification of the zoom lens can vary.2 initially, most endoscopic cameras adopted a “fixed focus” design. owing to the larger focal length resulting in a smaller field of view, different fixed-focus lenses typically have their respective usage scenarios. for example, ear, nose, and throat (ent) and gynecology endoscopes commonly use a focal length of f14, as doctors prefer to observe smaller and more comprehensive images; urology often uses a focal length of f22; images from a focal length of f28 are more popular in thoracic surgery and some laparoscopic surgeries; while a focal length of f32 is the most common one in major abdominal surgeries. therefore, although the advent of autofocus technology can provide doctors with a convenient and rapid focusing experience, fixed-focus cameras can only focus at a specific distance and cannot be adjusted. clinically, it is still necessary to equip multiple fixed-focus mounts, such as f14, f22, f28, f32, etc., to meet the needs of different departments for different depths and field sizes, limiting the application of endoscopes in complex surgeries. zoom has always been a clinical challenge.3 endoscopic zoom lenses were developed to address this issue. zoom lenses can change the focal length by moving the internal optical components, thus changing the field of view through “zooming”. a single “zoom” lens equates to an integration of multiple “fixed-focus” lenses. when using a zoom lens, there’s no need to switch between different fixed-focus lenses, as the clearest image is obtained at any position within a certain distance by operating the zoom. now the zoom technology is divided into manual zoom and auto zoom. manual zoom manual zoom is primarily achieved through detachable optical zoom adapters. by manually adjusting the optical adapter, the internal optical lens group is altered, achieving zoom.4 while manual zoom cameras are more flexible than fixed-focus cameras, they still fall short in meeting the fast-paced and high-precision requirements of medical environments. auto zoom owing to the precision required in surgical interventions, auto zoom systems must be miniaturized,5 structurally simple, and compact, and must meet image quality requirements. with the continuous development of camera technology, particularly in liquid lenses, auto zoom endoscopic cameras have started to emerge. liquid lenses use specific control methods to adjust the refractive index or shape of the lens, offering a novel approach to zooming. these lenses are characterized by fast zoom response times, low power consumption, and noise-free operation, which distinguish them from traditional lenses.2 they offer the benefits of low manufacturing costs, simple structure, and easier miniaturization.6 the principle of auto zoom involves electrowetting, which manipulates the liquid’s wetting properties via an electric field, thereby altering its shape and curvature. a liquid lens contains two immiscible liquids—nonconductive zhao, yang: discussing the clinical value of full-range autofocus endoscopic cameras j global clinical engineering vol.7 issue 2: 2025 8 figure 3. schematic diagram of liquid lens in energized state. figure 4. schematic diagram of faf workflow. the application of full-range autofocus technology in clinical practice the faf technology, which integrates the advantages of both autofocus and zoom, has significantly enhanced the oil and a water solution—separated by an interface. by applying voltage across the interface, the lens curvature can change in tens of milliseconds, altering the focal length. increased voltage increases lens curvature and optical power.7 figures 2 and 3 show the liquid lens in de-energized and energized states, respectively. liquid lenses, particularly those utilizing electrowetting, offer a tunable focal length by adjusting the curvature of a liquid surface.8 these lenses have been successfully incorporated into zoom systems, such as the design by park and park,9 which utilized liquid lenses to achieve variable focal lengths for compact mobile cameras. moreover, recent developments have seen the combination of liquid lenses with other optical elements to enhance zoom capabilities without the need for moving parts, as demonstrated in the continuous zoom systems for telescopes by jiang et al.10 additionally, stabilizing mechanisms for liquid lens-based zoom systems have been explored to improve precision and reliability, as discussed in the four-group zoom system proposed by li et al.11 figure 4 shows the step-by-step workflow of faf technology, from image capture to focus adjustment, and finally to image clarity feedback. figure 2. schematic diagram of liquid lens in de-energized state. 9 j global clinical engineering vol.7 issue 2: 2025 zhao, yang: discussing the clinical value of full-range autofocus endoscopic cameras field of medical endoscopy, particularly in clinical diagnosis and treatment. this technology enables continuous focusing from near to far distances, significantly improving the imaging quality and flexibility of endoscopes, providing doctors with clearer and more comprehensive views, and profoundly impacting disease diagnosis and treatment. first, the technology enables continuous zoom across multiple focal lengths, from f14 to f32, facilitating one-click switching between distant, medium, and close-up views. the camera system can achieve intelligent scene linkage; by setting focal lengths for different surgical scenarios in the endoscope’s control system, the camera automatically adjusts to the most appropriate and effective focal length for the scenario. a single faf camera can seamlessly switch between focal lengths of f14 and f32, accommodating the usage habits of doctors across various departments. second, traditional endoscopy faced limitations in deep scene imaging, restricting doctors’ ability to observe lesion areas. the faf-equipped endoscopes achieve optical, lossless continuous zoom, allowing for undistorted magnification and direct observation of suspicious areas without losing detail. compared to traditional digital magnification, this method offers superior magnification, lossless images, and reduced noise, effectively resolving issues with “extremely small” lesions, such as tiny blood vessels and outlines, improving visual precision. this is particularly crucial for early detection, such as during gastrointestinal examinations, where faf can enhance the detection of minor abnormalities in the mucosa, increasing early cancer detection rates and the identification of other serious conditions. moreover, the faf technology can be combined with auto zoom to achieve one-click autofocus. this ensures precise focusing with minimal margin for error, faster and more accurately than traditional manual focus methods. this enhances surgical efficiency and reduces the risks associated with inaccurate focusing, thus making surgeries more precise and improving the clinical experience. additionally, the application of faf technology greatly improves patient comfort. in traditional procedures, frequent adjustments to the endoscope’s position to achieve clarity can cause patient discomfort. however, faf reduces the need for frequent positional adjustments, decreasing patient discomfort and enhancing patient satisfaction. finally, this technology offers greater opportunities for medical research and education. high-definition, full-range images allow researchers to closely observe and record disease progression, which is essential for studying mechanisms of medical diseases and developing new treatments. these high-quality images also serve as educational resources, assisting medical students and young doctors in understanding the characteristics of various diseases. conclusion considering the current research and development trends in endoscopic devices,1 there is a growing preference for miniaturization to enhance the safety and comfort of endoscopic procedures.8 furthermore, with the future deep integration of artificial intelligence (ai)12 and machine learning (ml) technologies, the autofocus and zoom systems of medical endoscopic cameras are expected to achieve greater levels of intelligence and automation. this could include real-time image analysis, predictive focusing, and automatic adjustment of parameters to meet the constantly changing requirements of the surgical field. these innovations will continue to improve image quality during procedures, providing doctors with more intuitive and effective tools for surgery. author contributions conceptualization, r.j.z.; methodology, r.j.z.; writing–original draft preparation, r.j.z.; writing–review & editing, r.j.z. and c.y.; project administration, r.j.z. acknowledgments the research team acknowledges the optical engineer mr. guo for his advice and assistance in the construction of the experimental platform for valuable input on developing this paper. funding this research received no external funding. data availability statement not applicable. zhao, yang: discussing the clinical value of full-range autofocus endoscopic cameras j global clinical engineering vol.7 issue 2: 2025 10 conflicts of interest the authors declare they have no competing interests. ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure not applicable. references 1. boese a., wex c., croner r., et al. endoscopic imaging technology today. diagnostics. 2022;12(5):1262. https://doi.org/10.3390/diagnostics12051262. 2. zhang, y., zhang, x., shi, g.w., et al. applications of liquid lenses in zoom systems. china optics. 2013;6(1):47. https://doi.org/10.3788/co.20130601.0046. 3. lee, s.w., choi, m.c., lee, e.s., et al. zoom lens design using liquid lens for laparoscope. opt express. 2013;21:1751– 1761. https://doi.org/10.1364/oe.21.001751. 4. luo, x.f., shi, y., guo, f., et al. design of a large imaging plane wide-band zoom adapter optical system for endoscopes. opt express. 2025;33:2809–2823. https:// doi.org/10.1364/oe.550768. 5. du, l.h., wang, l.q., ye, b., et al. portable electronic endoscopic imaging system. proc. spie 7850, optoelectronic imaging and multimedia technology. 2010;785003. photonics asia 2010, 2010, beijing, china. https:// doi.org/10.1117/12.869795. 6. liu, h.b., hu, y., li, y.z., et al. review of current status and development of liquid lens. laser & optoelectronics progress. 2024; 61(9): 0900005. https://doi. org/10.3788/lop231170. 7. zhang, w., jin, y.t., guo, x., et al. design of an autofocus capsule endoscope system and the corresponding 3d reconstruction algorithm. j opt soc am a. 2016;33:1970– 1977. https://doi.org/10.1364/josaa.33.001970. 8. mishra, k., van den ende, d., mugele, f. recent developments in optofluidic lens technology. micromachines. 2016;7:102. https://doi.org/10.3390/mi7060102. 9. park, s-c and park, j. zoom lens design for a slim mobile camera using liquid lens. j korean phys soc (jkps). 2009;54:2274–2281. https://doi.org/10.3938/ jkps.54.2274. 10. jiang, z., zheng, y., wang, x., et al. continuous optical zoom telescopic system based on liquid lenses. optics express. 2024;32:15269–15283. https://doi. org/10.1364/oe.520475. 11. li, h., cheng, x.m., hao, q. an electrically tunable zoom system using liquid lenses. sensors. 2015;16:45. https://doi.org/10.3390/s16010045. 12. bae j.k., vavilin a., you j.s., et al. smartphone-based endoscope system for advanced point-of-care diagnostics: feasibility study. jmir mhealth uhealth. 2017;5(7):e99. https://doi.org/10.2196/mhealth.7232. https://doi.org/10.3390/diagnostics12051262 https://doi.org/10.3788/co.20130601.0046 https://doi.org/10.1364/oe.21.001751 https://doi.org/10.1364/oe.550768 https://doi.org/10.1364/oe.550768 https://doi.org/10.1117/12.869795 https://doi.org/10.1117/12.869795 https://doi.org/10.3788/lop231170 https://doi.org/10.3788/lop231170 https://doi.org/10.1364/josaa.33.001970 https://doi.org/10.3390/mi7060102 https://doi.org/10.3938/jkps.54.2274 https://doi.org/10.3938/jkps.54.2274 https://doi.org/10.1364/oe.520475 https://doi.org/10.1364/oe.520475 https://doi.org/10.3390/s16010045 https://doi.org/10.2196/mhealth.7232 1 j global clinical engineering vol.4 issue 1, 2021 editor’s corner ce vision 2022 – year of the child greetings, fellow ces around the globe. first, i commend and thank each of you for the hard work and enormous contributions you’ve made to saving lives and conquering this vicious pandemic. it has been – and continues to be – a rewarding and humbling opportunity to work with you this past year to solve the endless waves of hta and htm challenges. worthy work! this is why we chose the ce profession, isn’t it? i would like to share a fresh idea of renewal for us to consider and embrace: creating a “ce vision 2022 year of the child” action plan. the global covid-19 pandemic spanning 2020 and 2021 has been terribly hard on children. while the coronavirus hasn’t claimed many young lives directly, birth rates have plunged around the world, children have suffered from loss of parents, grandparents, immense social and school isolation, daily fear, and unemployed parents everywhere have been hard pressed to provide basic food and healthcare for their kids. children are our future, our hope, our path to enduring survival! during this pandemic, though, children and their very childhood have been threatened worldwide like no time in recent history. what can we do? i think we can focus some of our collective time and energy to improve health and welfare for children a bit at a time in the coming years. how? well, we might start with ideas and actions that support our ce colleagues in children’s hospitals, and also supporting pediatricians, family physicians, and midwives, who do the lion’s share of medical for children around the world. a little background: my career begin in 1975 at ecri, and my first field assignments that year were at philadelphia’s children’s hospital, testing and servicing the equipment in the neonatal intensive care and pediatric intensive care units. those weeks of time working with nurses, physicians, and fellow engineers left an indelible image in my mind’s eye: the primal struggle of a tiny life clinging to each breath and heartbeat. over the decades, in the course of various educational and humanitarian relief efforts i have had the privilege of visiting nicu and picu units throughout the us, and in china, india, mongolia, romania, slovakia, and elsewhere. every visit brings back the intense reminder of why i am a clinical engineer: to save lives and improve the human condition whenever, wherever, and however i can. back in the mid-90s, i had the exciting opportunity to hear dr. jonas salk deliver the opening keynote speech at “child health 2000: 2nd world congress and exposition” in vancouver, canada from may 30-june 3, 1995. dr salk died barely a month later, and this, his final public speech, was a clarion call: let us all do everything we can to assure safe and healthy kids by the year 2000! on behalf of acce, i led a panel with bob morris titled global approach to appropriate technology for maternal and child health on technology assessment and management at the congress, which you can still read in two archived acce newsletters.1,2,3 i must admit that i left that conference quite humbled, however. i came to understand that child and mother mortality depended on far more simple things than ventilators and monitors. i was struck by the simplest of ideas presented. for example, one product was a small cereal-box sized kit with a bar of soap, a plastic drape, a clean razor blade, and a length of twine. i.e., a simple baby delivery kit to keep the mom and baby off and dirt floor and provide a modicum of sanitation for mother and child! during the following decades, during my travels to many bare-bones hospitals and clinics i repeatedly humbled by the heroic efforts to care for children with woefully inadequate resources. two examples that stick in my mind were 1) seeing three preemies tucked in a broken incubator with the doors wide open to compensate for the failed thermostat, and the oxygen plumbed in through plastic tubing from a welding oxygen tank 40 feet away, http://www.globalce.org http://www.globalce.org j global clinical engineering vol.4 issue 1, 2021 2 and 2) a heartbreaking discussion with a post-surgical pediatric recovery team which was experiencing nearly 100% mortality despite their best efforts. only a few years later, in 2003, my own premature daughter’s life was saved by a new medical gas, nitric oxide, that my team had the privilege of introducing to the us in the late 90s. it was only a mere stroke of luck that the hospital had just introduced that technology, or she may not have survived. these many child health technology challenges – and opportunities – have persisted can be found in every corner of the world, as documented by our colleagues like tom judd in 2016 in collaboration with who.3 it is now 26 years since that 2nd child health 2000 congress in vancouver, and, yes, we have cell phones and apps, and we have access to many training and research resources, but the child and maternal mortality rates are still unacceptably high, even in the us. as i mentioned at the beginning, we cannot ignore the horrors that this covid-19 pandemic is creating for newborns and children around the globe. the second coronavirus surge in india this spring, for example, will leave a huge number of babies and children without one or both of their parents, and the national hospital resources are terribly depleted. this is presenting yet another terrible child health crisis that cannot be overlooked. i have written this editorial to suggest that we, the global clinical engineering community lean in and lock our shoulders together through gcea, ifmbe ced, the healthcare technology foundation, and our vast network of global colleagues, friends, and partners like who, paho, unicef, and many others to improve child health beginning in 2022 and beyond. how? following our upcoming icehtmc global congress in orlando, let’s begin holding a monthly “global clinical engineering year of the child” collaboration meeting on the first tuesday of every month with zoom, during which we can set global and regional priorities. let’s set up a dedicated ce child health whatsapp group to communicate and collaborate, too! sanitation and education could be a humble start, but we can do more. perhaps we can create a global ce resource for children’s hospitals, nurses, physicians, and midwives to access training literature. perhaps we can work with who, unicef, and others to tackle essential product and training resources that match language and cultural norms. perhaps we can invent a creative supply chain to source donations, parts, or equipment. perhaps we can become a ce resource for the many government and faith-based relief agencies who work to save children’s lives each and every day. perhaps, too, we can make a point of inviting one article on child health for this global clinical engineering journal? and why not make this a resounding theme of our upcoming icehtmc conference in orlando in september, too? let’s stand up and be counted as a clinical engineering community, proclaiming to the public that we can and will make a difference in child health. let us commit to each other to ensure that our clinical engineering profession makes meaningful improvements to child health by carving out a piece of our time and energy every month in order to make a difference together. it is not impossible! as the old adage tells us: “a journey of a thousand li begins with a single step.” references 1. grant, jp. a critical decade in the crusade for children. acce newsletter may 1995:11-13. https://accenet. org/publications/newsletters/accenewsmay1995. pdf last accessed 25 april 2021. 2. sloane, eb. acce newsletter jan 1996:18-19. https:// accenet.org/publications/newsletters/accenewsjanfeb1996.pdf last accessed 25 april 2021. 3. jacobs, ld, judd, tm, and bhutta, za. addressing the child and maternal mortality crisis in haiti through a central referral hospital providing countrywide care. the permanente journal spring 2016:50-70. http://www.thepermanentejournal.org/issues/2016/ spring/6061-crisis-in-haiti.html last accessed 25 april 2021. elliot b. sloane, phd, cce copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://accenet.org/publications/newsletters/accenewsmay1995.pdf https://accenet.org/publications/newsletters/accenewsmay1995.pdf https://accenet.org/publications/newsletters/accenewsmay1995.pdf https://accenet.org/publications/newsletters/accenewsjanfeb1996.pdf https://accenet.org/publications/newsletters/accenewsjanfeb1996.pdf https://accenet.org/publications/newsletters/accenewsjanfeb1996.pdf http://www.thepermanentejournal.org/issues/2016/spring/6061-crisis-in-haiti.html http://www.thepermanentejournal.org/issues/2016/spring/6061-crisis-in-haiti.html j global clinical engineering vol.7 issue 3: 2025 88 received september 18, 2024, accepted june 23, 2025, date of publication september 30, 2025. original research article training of surgical skills by a 3d augmented liver model response during instrument interactions simulation veronika ivanova1,†,*, plamen vasilev vasilev2,† and ani todorova boneva 3,† 1 department of robotized and mechatronics intelligent systems, institute of robotics, bulgarian academy of sciences, sofia 1113, bulgaria. 2 department of industrial automation, university of chemical technology and metallurgy, sofia 1756, bulgaria. 3 department of communication and computer systems, institute of information and communication technologies, bulgarian academy of sciences, sofia 1113, bulgaria. †these authors contributed equally to this work. * corresponding author email: iwanowa.w@abv.bg abstract background and objective: in recent years, interest in surgical robotics simulation has grown significantly, particularly among trainee surgeons. this trend is driven by the demand for cost-effective training solutions, improved surgical outcomes, and reduced training times. simulations also play a vital role in the design and testing of surgical instruments, enabling analysis of static and dynamic loads and optimization of tool–tissue interactions. however, because of the complex nature of soft tissue deformation during surgical procedures, developing realistic and effective simulations remains a challenge. this study focuses on modeling liver responses during tool–tissue interactions in laparoscopic surgery. building on prior research in surgical robotics, the goal is to develop a personalized training platform that enhances the skills of surgical personnel without the need for live human or animal subjects. materials and methods: the study begins by analyzing the motion of a tactile surgical instrument interacting with tissue. direct kinematics is used to enable remote control of surgical robots by the lead surgeon. to improve control accuracy, systematic positional errors are introduced into the control links. a simulation program is developed to define the operational workspace and potential tool actions. movement within this space is controlled by four motors connected to transmission mechanisms. analytical models of these mechanisms are used to optimize performance under defined constraints. in addition, a training simulation program (tsp) is created to model liver responses during tool–tissue interactions. this program visualizes the 3d behavior of organs using physical material properties and simulates collisions between solids. the unity game engine is used to generate animations compatible with both standard and vr/ar environments. results: experimental data involving various laparoscopic instrument tips and biological tissues are stored in a mysql database. these data can be accessed via local workstations, institutional servers, or cloud-based platforms. users can also store their simulation data on mobile devices or processor cards. conclusion: this study presents a comprehensive approach to developing a surgical training system that simulates realistic tool–tissue interactions. the findings contribute to the advancement of minimally invasive surgical education by enabling personalized, data-driven training experiences. the proposed system offers a scalable and ethical alternative to traditional training methods, with potential applications in both academic and clinical settings. the simulation programs effectively transferred acquired skills to real-world scenarios, demonstrating the system’s potential for enhancing surgical training. mailto:iwanowa.w@abv.bg mailto:mulugetamideksa@gmail.com 89 j global clinical engineering vol.7 issue 3: 2025 ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation keywords—augmented reality, training program simulation (tps), software applications, surgical robotics, surgical training. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction software applications offer innovative solutions in medicine. in surgery, this progress allows the development of surgical simulators that reach the maximum level of realism and emulate complex procedures, taking into account the specificity and anatomical requirements of individual patients. also, the simulation is a suitable method for training surgeons in complex movements and operations because it reduces the duration of the surgeon’s training in minimally invasive surgery (mis). the methodology for developing a web-based laparoscopy e-training system is particularly important.1 software applications can provide a surgical environment with its physical properties, texture, and complexity. computer-based methods can be the main part of surgical tool design. to solve new problems that continue to arise in real surgical procedures, new tools are created every day. an important step in the creation of surgical instruments is the development and application of a virtual environment and near-real models to simulate the response of the organ when interacting with an instrument. simulation methods can provide different scenarios for the operation to take into account different anatomies, pathologies, and working areas. training modes include tabletop models, virtual reality (vr), augmented reality (ar), animals, and cadavers. there are claims that the haptic interface, along with the visual simulation, aids the student or young surgeon to get a virtual experience of the surgical procedure as in a real patient operation. however, a number of studies prove that a combination of models is more effective than model-based learning alone. the main ways to accomplish the simulation task are: a model, a detailed description of the real-world application of the model, and the applied forces/moments. different medical procedures require different organ models. the basic approaches for model response during instrument interactions are mass-spring system (mss)2 and finite-element method (fem).3 in the first approach, the geometric model of an organ is represented as particles with their own positions, velocities, and accelerations, which are connected by springs and dampers. the particles move under the influence of the forces of the surgical instruments. in fem, each element of an organ model is calculated to obtain the deformation of the model under the applied forces. real-time surgical simulation requires computing the deformation of viscoelastic human tissue and generating both graphic and haptic feedback. deformation simulation is based on a sequential calculation of the tissues’ shape. the reaction forces result from the tool–tissue model interactions, where the virtual tools are controlled by the smart tools. tissue models must look and behave realistically and be based on the physical laws related to human organ behavior. models used for simulation are mainly based on geometry or mechanics. geometric models are not accurate enough because they only simulate relative visual displacements. mechanical models are accurate, but for a vr simulation, they can change continuously until they reach an equilibrium state, which makes them difficult for the operator to manipulate. sorkine and alexa4 propose a method for surface modelling, where the object changes the shape of a mesh while preserving the details. it is characteristic that the peaks of the original grid must be specified. then, the boundary is determined for new positions, so that the rest of the mesh vertices adapt to the new shape. the original geometric size of the mesh should preserve as much of the deformation as possible. some authors show a virtual simulator for pre-rolled soft tissue suturing without showing the making of knots, which is a basic moment in suturing.2 https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation j global clinical engineering vol.7 issue 3: 2025 90 telesurgery is evolving thanks to ar and wireless technology. lead surgeons can train students and young surgeons in complex surgical procedures. surgery is also aided by 3d printing technology. tumor data can be extracted from ct or mri scans and converted into a digital 3d model, which can then be 3d printed. from this model, the surgeon can see the relationship between the tumors and the surrounding tissue, which aids in planning the surgery. the student or young surgeon can virtually experience all the essential aspects of a procedure through visual simulation and haptic technology, which otherwise would involve invasive techniques on a real patient or a corpse. great computing power and accuracy of haptic devices are only part of the advantages characteristic of modern laparoscopic simulations, which create favorable conditions for the process of preoperative planning and the training of surgeons. one such development is the eu passport for the simulation of laparoscopic liver resection, which uses many modern methods and the capabilities of the gpu to simulate various deformable organs in real time.”5 the work of acharya, where the kinematics of the surrounding organs are studied, is also intended for simulation training and access (geometry) to the liver.6 in this research, diaphragm movement patterns are also presented for use in simulators for preoperative planning and training. an advancement in the field of organ modelling is also the work of villard,7 where respiratory movements of the chest and soft tissue behavior of organs of a group of patients segmented by computed tomography in a liver biopsy simulator are modelled. a nonlinear liver model to measure organ response to force, accounting for organ deformation and boundary conditions, is presented by lister.8 the accuracy of the model is assessed by drilling simulation. there has also been progress in the modelling of surgical procedures. a team of scientists presented a real-time electrosurgical simulation virtual tool where the relationship between heat generated in the tissue and applied electrical potential was explored.9 all this finds good application in virtual surgical ablation. over the years, 3d organ models have moved from linear10 to nonlinear,11 moreover, simulations are increasingly complex and realistic, making them accessible and attractive for applications. force feedback simulators are a more intuitive means of providing haptic information to the surgeon, while visual force feedback provides information about instrument contact with tissue under certain conditions. that is why haptic devices with touch simulation are increasingly being used. they are used in medicine for training and planning operations.12 one of the first palpation developments is a 3d visual and haptic liver diagnostic simulator with open-source software.13 simsuitetm system by medical simulation corporation is one of the representatives of haptics devices, with a realistic simulated clinical environment.14 it offers haptic systems with real scenarios and images together. the force feedback is transmitted by an endoscope to give the real feeling. the system includes personal or team training with varying levels of complexity. its possibilities are the patient history, diagnosis, risk assessment, and intervention preparation. the training program proposed in this publication, referred to as the training program simulating (tps), facilitates the observation of three-dimensional (3d) augmented model responses during tactile instrument interactions within the context of surgical education. this program was developed to enhance the training of students and improve the qualifications of surgical personnel in the use of laparoscopic instruments. the application presented herein represents an advancement of an existing mechatronic system designed for laparoscopic surgical training, aimed at both student education and the professional development of surgeons. the system is constructed on a modular framework, reflecting the principles underlying the program’s implementation. this training platform was developed so that students and surgeons can improve their qualifications without using living organisms—humans and animals. virtual and ar simulators and their part in surgical education one of the first vr simulators is the satava, proposed in 1993. it used a computerized 3d model of the abdominal cavity and a head-mounted display (hmd).15 satava is also 91 j global clinical engineering vol.7 issue 3: 2025 ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation telesurgery is a good aid for experienced surgeons teaching young surgeons in complex operations. thanks to ar and wireless devices, ar simulators take advantage of vr and physical materials, tools, and tactile feedback. the 3d virtual model is a static preoperative photo of a certain part of the body, where even respiratory movements and manipulation of the organ are taken into account. these kinds of simulators are useful for simulation immediately before performing complex surgical operations.24,25 the high simulation accuracy of the simulator allows visualization of different tissues, tumors, arteries, and veins. ar in medicine dates back to 1988. one of the first medical ar systems was designed to display individual ultrasound slices of a fetus on a pregnant patient.26,27 ar aids mis by enhancing reality in the operating room, expanding the internal view of the patient based on preoperative or intraoperative data, and presenting the surgeon with detailed information about the operative field. integrating pictures of virtual objects into real scenes is a major tool used in ar systems in medicine. while the surgeon’s working area is synthesized in the virtual environment, ar superimposes computer-generated images on the actual view oriented to the direction of vision of the surgeon, who usually wears a suitable hmd or similar instruments. medical ar for patient workstation (medarpa) has recently been developed28 which uses ar without hmd. the surgeon can see the exact location of the damage on the patient while being observed without making a single incision. it is possible to design invisible blood vessels, reducing the risk of accidental damage. the improved visualization from this technology can benefit a variety of clinical procedures. ar serves as a guide for planning practical surgical actions. the patient is positioned in ar: with the help of ar, it is possible to view the entire anatomy and change the position of the body along the three axes. ar visualizes the target of the operation before it is visualized on the simulator. some of their weaknesses are related to the correct alignment of the position and orientation of the surgeon’s eyes with a virtual coordinate system of the augmented images, the spatial tracking systems, and the virtual environment peripherals used. simulators combining haptic interfaces with ar tools can be used to detect deviations between the real position targeting the military and aerospace industries, which rely on vr for training, to apply this training to teach skills in operating rooms.16 this simulator sets the stage for vr training in surgery for many types of procedures, from elementary tasks such as suturing and knotting to mimicking entire surgical procedures. virtual-based simulators can use an application that allows interactive exploration of 3d anatomical models and animations. vr makes it possible, through developed mobile applications, to explore different surgical approaches using a smartphone or tablet. each virtual study uses 3d anatomical models and animations. a learning system aimed at understanding the patient’s positioning according to specific anatomy and specific purpose. the study of each approach in 3d mode can be divided into phases too. vr simulators allow trainees to practice individual movements or entire procedures in a near-real environment. modern vr simulators can reproduce complex mis by measuring various parameters of the procedure, including movement efficiency and node reliability, time to perform the operation, and even remote performance evaluation. the price of simulators is quite high, and they do not have tactile feedback and lack realism.17–19 because of the lack of realism, the models of corpses and animals in vr simulators should be added to get optimal training. despite these disadvantages, the number of vr training simulators is growing. vr simulators, such as lapsimtm (surgical science, gothenburg, sweden),20 were used for training basic laparoscopic surgery skills, and lapmentortm (simbionix corporation, cleveland, oh, usa),21 was used for comprehensive training in laparoscopic sigmoidoscopy. wynn et al. evaluated the effectiveness of this training in terms of the completion time of the process, the number of right and left tool movements, and the total route length of the right and left tool movements.22 the research indicates high efficiency. surgical simulation combined with virtual, mixed, and ar has become increasingly popular in recent years. ar is a technology where digital information does not interact with the real environment but is superimposed on the user’s view of the external environment as graphics, audio, or video information.23 ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation j global clinical engineering vol.7 issue 3: 2025 92 and the preoperative plan and to generate guiding forces for the surgeon. robot-guided instruments follow the movement of the surgeon, who senses forces interacting with the tissue through the haptic device. the haptic device includes preoperative planning based on medical images and ar to guide the surgeon’s movements; ar models also provide visual feedback to the surgeon. the advantage given by the simulation is that different parameters can be optimized, which gives good results in different areas of application.29 from the foregoing, it is clear that the high level of technical complexity of advanced laparoscopic procedures and the lengthy training pose many challenges to surgeons. this makes simulation an important tool in the training of complex laparoscopic surgery. that is why our efforts are directed in this direction. this paper is organized into the following sections: section 2 is referred to as the investigation of instrument moving. section 3 marks architectures of control program algorithms. section 4 refers to a simulating approach of liver model response during tactile instrument interactions and its results. at the end, there are sections on future challenges and conclusions. software applications offer innovative solutions in all spheres of human life,30,31 the most significant of which are in medicine. for this work, some calculating methods32 for identifying both tool tissue force and maximum local strength are touched upon. authors will specifically try to investigate these in the future. a contemporary strategy yielding favorable outcomes involves the enhancement of existing systems across various domains and purposes, thereby conserving both financial and temporal resources in the research and development of new systems. an illustrative example is provided in reference,33 which outlines the primary procedures for upgrading existing systems for the automation and control of industrial and manufacturing processes. in alignment with this approach, it proposes to upgrade a laparoscopic execution tool system for robotic applications, incorporating functionalities that leverage ar and simulation technologies to facilitate the training of surgeons. investigation of instrument moving the action control in telecontrol (by the leading physician of the operation) is realized by the direct kinematic task. moreover, to refine the action, the systematic positional error in the working position can be introduced into the control links. solving the straight kinematic problem is a standard procedure.34 it is possible to develop a simulation program to outline the workspace and possible actions in it. for an instrument with four independent movements, these movements are obtained by four motors and the corresponding transmission mechanisms between the motors and the executive links in this space. figure 1 shows the possible instrument workspace and the instrument motions in this workspace. the relation can be written in equation 1: 1 1 11 2 2 2 2 2 3 4 2 3 3 3 3 4 4 4 4 . 0 0 0 . . 0 *. .0 0 0 . .0 0 0 qq q q q q q q q q ϕϕ ϕ ϕ ϕ ϕ ϕ ϕ ϕ ϕ  ∂    ∂     ∂ ∂ ∂    ∂ ∂ ∂   =   ∂   ∂      ∂   ∂      (1) where [ ]1 2 3, , tϕ ϕ ϕ ϕ= is a vector of angular velocities of the executive link 1 1 2 2 2 2 3 4 3 3 4 4 0 0 0 0 0 0 0 0 0 0 q q q q j q q ϕ ϕ ϕ ϕ ϕ ϕ ∂   ∂   ∂ ∂ ∂  ∂ ∂ ∂ =  ∂   ∂   ∂   ∂   where j is the jacobian matrix, which reflects the value of the transfer functions, including dependent movements; [ ]1 2 3, , tq q q q= is the vector of angular velocities at the robot’s joints. 93 j global clinical engineering vol.7 issue 3: 2025 ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation there is a need to determine the optimal area for the movement of the tool, using qualitative indicators. these indicators are based precisely on the jacobian matrix. as a result, the geometry of the tool is optimized so that in a certain area, the configurations will provide optimal movement from the point of view of kinematics. this is important when scaling movements, that is, with a larger “size” of movement by the operator (master), minimal movements of the robotic tool are ensured. in an optimal configuration (a good quality indicator), these optimal configurations facilitate the control system. the transmission functions i iq ϕ∂ ∂ (i = 1, 2, 3, 4) along the main diagonal have the same structure: ( ), 1,2,3,4i pi ni i i i i q φ∂ = × = ∂ (2) where ( )1,2,3,4pii i = is the value of the gear ratio of the reducer of the corresponding circuit (most often and in this case are equal); ( )1,2,3,4nii i = is the value of the gear ratio of the wires. for the determination of ini, kinematic chains of links 2 and 3 are used, as the kinematic chain of link 4 is similar to link 3. transmitting functions at the major diagonal i iq ϕ∂ ∂ , where ( )1,2,3,4pii i = possesses a similar structure. ( ), 1,2,3,4i pi ini i i i i q φ∂ = × = ∂ (3) where ( )1,2,3,4pii i = is the value of the gear reduction ratio of the respective chain (often and in this case they are identical) and ( )1,2,3,4nii i = is the value of the gear transmission ratio of the wire. the derived analytical dependencies of the transmission functions make it possible to carry out calculation procedures for the optimization of dimensions under the existing limiting conditions and also to be implemented in the software for controlling the movement of the tool, which is explained in the next section. a simulatiing approach of liver model response during instrument interactions tasks and motions in surgical operation the actions that are referred to in the performance of laparoscopic operations are numerous, and their priorities are defined and strictly performed by the medical teams. in this case, when they are referring to actions that require manipulative movements through specialized tools, they include: visualization (illumination and movement of a mini video camera into the body of patients) of the manipulated objects at the place where the controlled action is performed: • gripping with positional fixation of the object in order to be manipulated, without being uncontrolled; • gripping (clamping) in order to isolate and temporarily disconnect the object during manipulation with it; • clamping blood vessels to hold up bleeding damage. elementary actions such as touching and grasping are basic tool manipulations and are relatively easy to figure 1. possible instrument workspace and instrument monuments. ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation j global clinical engineering vol.7 issue 3: 2025 94 perform. more complicated actions are (1) dissections and (2) working with robotic suturing instruments, which require a lot of knowledge and skills from the surgeons, and they are more difficult to simulate too. however, some of them, such as robotic needle driving and grasping, which are easy in open surgery, are found to be more difficult to perform during laparoscopy. a surgical task such as suturing includes a needle acting with one rotation and one translation.35 the surgeon’s hand is close to the surface being sutured while rotating the needle so that the needle moves in a circular path without damaging the tissue. in robotic surgery, it can be reduced to one movement—rotating around the axis of the instrument, bending the short part of the needle near the blunt end, and just in front of where it is held by the slave instrument, so that the needle moves in a circular arc, while the tool rotates about its axis.36 some authors have been focusing on knitting manipulation by robots. some researchers have performed in vivo tests with different types of needles and tissues, showing that the required range of force and resolution is 2.5 n and 0.01 n, respectively.37,38 the results in table 1 are obtained with the designed laparoscopic executive instrument for robots (figure 2). table 1. description of usability attributes. samples min. force (n) max. force (n) average value (n) amplitude (n) styrofoam sample 0.1 1.67 0.83 1.57 styrofoam rubber sample 0.785 2.26 1.13 1.47 muscle tissue sample 0.45 2.4 1.21 1.94 sample liver, pork 0.05 1.96 0.93 1.9 the research shows the following results. the required force for soft tissues is about 0.2 n, the applied gripping force for soft tissues is 0.5 n, and it is 0.9 n for hard tissues. the required force is different for different cases. it depends on the patient’s age, health, gender, and other factors. in general, the maximum force is from 1.5 to 3 n. in isolated cases, the required force is from 6 to 12.5 n. these cases occur when the instrument is used for tissue lifting. so, the instrument force is combined with the forces because of the properties of the fabric and those of gravity. however, the simulation program does not take gravity into account. the maximum cutting and spreading force is from 3 n to 6 n. suture tasks force measurements show liver puncture up to 5 n, and the required gripping force is 3.45 n. 39–41 this information is useful for realizing a 3d augmented model. a simulating approach of liver model response during instrument interactions and its result a training simulation program (tsp) has been developed wherein the 3d extended model response of a human organ upon impact with external objects. the behavior of the model is represented by the collision of figure 2. force measurements for different samples. 95 j global clinical engineering vol.7 issue 3: 2025 ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation two solid objects with different physical characteristics. the physical properties of the solids are transposed to “physical material” properties that enable the behavior of the object in the tsp. the unity game engine is used for the tsp, which is intended for developing graphical animations for conventional or vr/ar artificial representations. tsp includes surface manipulation libraries such as the mesh class. meshes contain vertices and multiple triangle arrays with corresponding vertices. all vertex information is stored in separate arrays of the same size. the mesh class, along with its vertices, vectors, triangles, and normal, can be used to deform a mesh grid on a 3d object. an example of using the mesh class to deform a 3d object in unity (see figure 3) is given with the script below: using unityengine; public class example: monobehaviour { void update() { mesh = getcomponent<meshfilter>().mesh; vector3[] vertices = mesh.vertices; for (int i = 0; i < vertices.length; i++) { //some conditional transformation for example vertices[i] += vector3.up * time. deltatime; } mesh.vertices = vertices; mesh.recalculatenormals(); mesh.uploadmeshdata(false); } } if the mesh surface deformation has to be executed on some event, the void method start() should be invoked. void start() { mesh = getcomponent<meshfilter>().mesh; mesh.clear(); //preserves the existing mesh vertex positions //do some calculations with the mesh.vertices and mesh triangles } figure 3 shows an example of the usage of the mesh class for deformation of a 3d object in unity. software architecture the information from the experiments performed with different tips of the laparoscopic instrument and different biological tissues is recorded in a database that has a connection with the database of the application (developed on the basis of mysql). the databases are structured as a collection of directories, one for each student (surgeon), with each directory carrying its own id number (for students, this may be a faculty number). each of the directories is a collection of subdirectories as follows: figure 3. a 3d augmented model with mesh collider in unity. ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation j global clinical engineering vol.7 issue 3: 2025 96 • personal data for the student/surgeon (three names, social security number, etc.). only the learner and the teacher can access this subdirectory; • subdirectory with information about conducted experiments and their results in text and graphic forms; • evaluation of the achieved results and attestation of the student/surgeon; • other information required by the relevant university or medical facility. at the discretion of the institution/clinic concerned, subdirectories of experimental results may be made publicly available to allow for comparisons and solutions for further simulations. it is planned that the information accumulated in the relevant databases will be stored on a local operator station, a server of the relevant university/clinic, or a cloud medical server, on which more important results of conducted experiments will be published. each student/surgeon can save their information on their mobile phone or on a processor card. by their nature, processor cards have the same appearance as telephone cards. however, phone cards only have memory, while electronic chip cards contain a processor. the reprogrammable memory acts as a hard disk for the card—the data stored in this memory retains its values after the supply voltage is turned off.42 the introduction of processor cards in the educational system in bulgaria will allow the replacement of existing paper student books with electronic ones, which will guarantee greater reliability, security of information, and access to student data at all levels of educational institutions. data change is associated with different priority levels. each teacher will have a unique number/password to change the data in the cards of students/surgeons. the solution assumes that each classroom is equipped with a personal computer with a minimum configuration that allows work in the windows operating system. the database will be installed on the teacher’s personal computer, as well as the terminal program allowing working with the processor cards. each student/surgeon must be provided with a basic card zc2.3 processor card (or similar) upon commencement of training by the instructor. the teacher or another person authorized for this activity personalizes the card using the personal computer and the included reading device.42 various means of controlling access to the information are provided, such as the use of passwords, qr codes (for mobile phones),43 ecg,44 or an identification chip of the company dallas semiconductor/maxim-ds9490b45 (for access to the software installed on the teacher’s personal computer/laptop). the ecg device as a means of access control is proposed because one has already been developed for the modular laparoscopic system described above. at this stage, access control and information protection tools are based on the team’s accumulated experience in this area. information encryption tools are an important element in building a medical security system. this fact is a consequence of the requirements that personal data be protected, both at the local operator stations and on the way to another destination. as a means of access control, the wireless ecg device developed for the mechatronic system can be used. as the system is built on a modular principle, it will be further updated in the future, both in terms of hardware and in terms of developing new applications based on vr and ar, with the aim of improving the quality of training of medical students and improving the qualification of surgical personnel, which allows various skills and capabilities of the instruments to be acquired and tested before their application in real laparoscopic operations. in the area of information protection and access control means, the possibilities of using other means will be explored, which will be applied at all levels of usability of the accumulated information, which will be effectively used in improving the work with laparoscopic instruments. the possibilities and combinations of means of access control and protection of information in the developed mechatronic training laparoscopic system and the applications developed for it will be studied, as discussed in the present publication. a secure transfer of the information to central servers (of the educational or medical institution) or to specialized cloud medical servers is also planned. 97 j global clinical engineering vol.7 issue 3: 2025 ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation unity’s physics engine is used to simulate the behaviors of objects in the scene and create realistic interactions between them, through physics-based behaviors applied to gameobjects (rigidbodies and colliders). each of the objects should contain a rigidbody component in order to be affected by the physics engine. the configuration of the rigidbody component is made by adjusting the properties in the rigidbody component’s inspector. some of the properties include: • mass: the mass of the object, which affects how it will be affected by forces; • drag: the amount of air resistance the object will experience; • angular drag: the amount of resistance the object will experience when rotating; • use gravity: enables or disables the effect of gravity on the object; • is kinematic: this checkbox makes the object not affected by forces, but it will be affected by collisions; • forces can be applied to objects by using the “addforce() function” of the rigidbody component. using unity’s physics engine enables tool–tissue model interactions to be reduced to setting parameter values, without the need to write complex programs with physics dependencies. the correct settings give a realistic concept of the interaction pattern between the two objects, which depends greatly on the level of detailing of the mesh.46 the coding is reduced to a basic script that initiates the interaction between collider objects and the deformation of the rigid bodies. the script has to be attached to the corresponding object. the result from a 3d augmented model response because of the impact with external objects is shown in figure 4. figure 5 shows screenshots of the mysql-based database in the developed application. figure 6 shows the 3d augmented model response during tactile instrument interactions simulating in surgical education. figure 7 shows a photograph of the laparoscopic instrument included in the system (figure 6). the tool figure 4. a 3d augmented model responds because of the impact with external objects. figure 5. mysql database. figure 6. the 3d augmented model response during tactile instrument interactions simulation in surgical training. ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation j global clinical engineering vol.7 issue 3: 2025 98 evaluation of acquired skills the review of the literature revealed two approaches to evaluate the skills of medical students and staff: (1) the objective structured assessment of technical skills checklists and (2) the goals.47,48 methods using ar have been developed to overcome some of the shortcomings of working with laparoscopic instruments, and basic assessment methods have been identified. more information on the topic is given by roberto et al.49 these approaches help with the objective assessment of surgical competencies before performing an mis.50 conclusion the simulation of realistic interactions has become a tangible reality, despite existing challenges such as modeling realistic behavior during user interactions, fluid dynamics, and force feedback mechanisms. the application of computer graphics techniques in medical contexts is increasingly prevalent; however, numerous research challenges persist. these include the need for enhanced realism, a broader array of solution approaches, and improved computational methods for applications. the optimization of training simulators and the effective utilization of computer graphics methods remain critical areas for development. this article presents a simulation approach that examines the response of a liver model during tactile was developed as part of the “system for analysis and control of mechanical properties of biological tissues,” and is protected by a utility model. figure 8 shows four tips, called end effectors, that were designed for contact of the tool with a given surface. several experiments were performed with the developed experimental model of a laparoscopic executive instrument. figure 9 shows the frame of the ar video stream. the program could be installed on smart devices such as smartphones or smart glasses and exploit built-in microelectromechanical system (mems) sensors (accelerometer, gyroscope, camera, solid state compass, gps, etc.) to evaluate objects and positions situated in the surrounding world. figure 7. an experimental module with force capabilities. figure 8. end effectors for an experimental module. figure 9. the frame of the ar video stream. the visual interface contains only essential information in order to allow the surgeon to concentrate on the medical task. 99 j global clinical engineering vol.7 issue 3: 2025 ivanova, vasilev, boneva: training of surgical skills by a 3d augmented liver model response during instrument interactions simulation interactions with surgical instruments. initially, the investigation focuses on the movement of instruments, utilizing a direct kinematic task to control actions in teleoperated environments. the derived analytical dependencies of the transmission functions enable the execution of computational procedures aimed at optimizing dimensions within specified constraints, which can subsequently be integrated into software for controlling tool movements. the architecture of the control program algorithms is reviewed, highlighting the simulation module’s relevance to this research. this training platform was developed so that students and surgeons can improve their qualifications without using living organisms— humans and animals subsequently, a 3d augmented model simulating a human organ’s response to external impacts is developed using unity 3d modeling capabilities. the model’s behavior is illustrated through the collision of two rigid objects exhibiting different physical properties. the application of the mesh class for deforming a 3d object within unity is implemented via scripting. results depicting the 3d augmented model’s response to external impacts are presented, with the coding distilled into a fundamental script that initiates interactions between collider objects and the deformation of rigid bodies. this script must be attached to the corresponding object, with an example provided utilizing the unity engine. future investigations will specifically focus on computational methods and animation projections to quantify both tool–tissue forces and maximum local strength. the outcomes of this research are deemed applicable to surgical education, allowing for the development of training tasks aimed at cultivating skills necessary for minimally invasive surgical procedures. author contributions conceptualization, v.i., p.v.v. and a.t.b.; methodology, v.i., p.v.v. and a.t.b.; software, p.v.v. and a.t.b.; hardware, v.i.; validation, v.i, p.v.v. and a.t.b.; formal analysis, v.i and p.v.v.; investigation v.i., p.v.v., and a.t.b.; re-sources, v.i. and p.v.v.; data curation, v.i.; writing–original draft preparation, v.i., p.v.v. and a.t.b.; writing–review & editing, v.i., p.v.v. and a.t.b.; visualization, p.v.v. and a.t.b.; supervision, v.i. and p.v.v.; project administration, v.i. acknowledgments this work is developed as part of contract №: bg16rfpr002-1.002-0009-c01, project name: 'regional center for digital solutions and innovation nciz’, under procedure bg16rfpr002-1.002-funding of selected by the european commission european digital innovation hubs awarded with seal of excellence, funded by operational programme 'research, innovation and digitalization for smart transformation’. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare no conflict of interest. ethics approval and consent to participate not applicable. consent for publication not applicable. consent for publication not applicable. references 1. borissova, d. and mustakerov, i. methodology for design of web-based laparoscopy e-training system. eurodl. 2011;1–9. available online: https://www.academia.edu/71469000/ methodology_for_design_of_web_based_laparoscopy_e_ training_system. 2. lian, l. and chen, y.h. haptic surgical simulation: an application to virtual suture, in: computer-aided design & applications. 2006;3:203–210. 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asif, h., mclnnis, c., dang, f., et al. objective structured assessment of technical skill (osats) in the surgical skills and technology elective program (sstep): comparison of peer and expert raters. am j surg. 2022: 223(2): 276–279. https://doi.org/10.1016/j.amjsurg.2021.03.064. 49. roberto, e., zorzal, j.m.c.g., sousab, m., et al., laparoscopy with augmented reality adaptations. j. biomed. inform. 2020;107:1–11 103463. https://doi.org/10.1016/j. jbi.2020.103463. 50. sheng, b., masood, s., jung, y., chapter twenty—virtual and augmented reality in medicine. biomedical information technology (second edition), 2020. elsevier inc, pp. 673–686. https://doi.org/10.1016/b978-0-12-816034-3.00020-1. https://doi.org/10.1016/j.jbi.2020.103463 https://doi.org/10.1016/j.jbi.2020.103463 https://doi.org/10.1016/b978-0-12-816034-3.00020-1 j global clinical engineering vol.6 issue 1, 2023 2 editor’s corner as the year comes to its end and this journal publishes its volume number six, the opportunity presents itself for the global clinical engineering journal’s editor-in-chief to look back. measure if, and how far, we progressed and reflect on the contributions that this journal has made. we know that healthcare services are a local issue, and that technology on which these services are dependent is a global one. this was especially evident in the case of healthcare, as we dearly learned from the pandemic era. therefore, an international journal that focuses on the cross between patient care outcomes and the lifecycle of the technological tools, particularly those used at the point-of-care and the associated management of the technology is critically important. healthcare technology is the result of an idea, an innovation or application of an improvement, that has been sufficiently funded to move on to the prototyping, manufacturing, clinical trials, regulatory compliance, and on to the commercialization and management of its deployment at the conventional point-of-care or at home. in short, the full spectrum of healthcare technology solutions regardless of the location of deployment and use. our journal is still the only international periodical dedicated to sharing and expanding clinical engineering applied knowledge, that is accessible on-line, diamond open access (cc by 4.0) and free to both authors and readers. it is conducting a double-blind review of submissions received, check for plagiarism, managed by an international editorial board of experts having clinical engineering, academia, research, regulatory, industry, medicine, surgical disciplines, and world health organization expertise. our journal is also unique as it is published in both english and chinese languages and is advertisement-free. the double-blind review is fed by a growing reviewers’ community (270) with wide range of experiences representing almost 60 countries and are committed to voluntarily serving the field and advancing the journal’s mission. thus, ensuring that the journal’s platform promotes up-to-date quality engineering information on the relationship between technological tools, its development and management, and patient experiences. i encourage you to find more information about the journal by visiting the website www.globalce.org and at the global clinical engineering alliance website under the 2023 state of the alliance state of the alliance report. when you visit the website, you will find rich and interesting content that includes: editor’s corner, engineering report, book review, and manuscripts ranging in subjects from molecular sieve oxygen generation and procurement of medical devices in international context to clinical engineering status in post covid-19 and analysis of dental unit failure as well as covid019 experience of nigerian radiotherapy engineer. in addition to the six volumes and issues that archives engineering and scientific manuscripts from over 150 authors, the journal is also unique in its ability to organize and publish the proceedings of the last three international clinical engineering & health technology management (icehtmc) congresses, a major accomplishment where the 5th icehtmc congress proceeding just published this month https://doi.org/10.31354/globalce.v5isi5. this year, the journal achieved another milestone, that of the recognition received by being indexed by scopus. the comprehensive, multidisciplinary, trusted abstract and citation database using scopus metrics, where a journal can demonstrate the influence of its scholarly output. there are times, like the yearend, that the editor-in-chief must ring the alarm to create a needed inflection in clinical engineering practitioners’ behavior. practitioners use variety of excuses, from “i am too busy” to “no one taught me how to write a paper” and on to “no hablo ingles” to avoid the slight stress of added work associated with authoring a manuscript. this is the golden era to be in the clinical engineering field, however, without publishing your work you may fall short of developing your career and allowing the discipline to stay static or even year end report http://www.globalce.org http://www.globalce.org http://www.globalce.org https://8702981.fs1.hubspotusercontent-na1.net/hubfs/8702981/state%20of%20the%20alliance_final.pdf https://8702981.fs1.hubspotusercontent-na1.net/hubfs/8702981/state%20of%20the%20alliance_final.pdf https://doi.org/10.31354/globalce.v5isi5 3 j global clinical engineering vol.6 issue 1, 2023 shrink. we all must advocate and share evidence for our field criticality in building access to safe and quality care experiences. you can trigger this inflection by submitting your manuscript now and encouraging your colleagues to follow the very same. our field is going through exciting evolution and our year-end report is full of achievements and growing readership. we encourage you to contact any member of the editorial board or myself for specific information relating to publishing your research or best practices. here are some general steps you can take: 1. visit the journal’s website: where you can find information about the editorial board, submission guidelines, how to write a scientific paper, and archived issues of the journal. 2. contact the editorial office: look for contact information for the journal’s manager on the website. you can send an email or make a phone call to inquire about the any other information you may be seeking. 3. write a paper: start now drafting an idea and reading how to craft a full manuscript at https://www. globalce.org/index.php/globalce/article/view/102 4. professional associations: the journal is associated with a professional organization, global clinical engineering alliance, you might find relevant information through that organization’s website or publications. remember that the journal is only a platform to help build the c.e. discipline, its networking, sharing of quality information, and your professional future. you, as participating authors and readers, will hopefully enjoy reading in next year-end editor’s corner of the many more achievements we will report together. copyright © 2023. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. have a wonderful and productive 2024! dr. yadin david http://www.globalce.org http://www.globalce.org https://www.globalce.org/index.php/globalce/article/view/102 https://www.globalce.org/index.php/globalce/article/view/102 j global clinical engineering vol.6 special issue 6: 2024 74 conference paper software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* university of macedonia, thessaloniki, greece. * corresponding author email: achat@uom.edu.gr abstract in the ever-evolving tech industry, accurately assessing the software skills of developers is critical for effective workforce management. this study presents a machine learning approach to classify software development knowledge through source code analysis, focusing on java-based technologies. a dataset of several source code files from multiple domains of software development was compiled from public repositories and labeled for classification. the high performance achieved in this study, by applying transfer learning, underlines the suitability of pre-trained codebert models for the classification of software skills. the methodology combined both non-pretrained neural networks and pretrained models to enhance classification accuracy. results validate the feasibility of using machine learning to identify developers’ programming proficiencies, providing a foundation for sophisticated assessment tools. future work aims to refine classification by incorporating functional task identification and commit-based analysis for a more comprehensive evaluation of coding skills. this study showcases the transformative potential of machine learning in streamlining developer assessments and advancing software engineering methodologies. keywords—machine learning, supervised learning, multi-class classification, neural network, transfer learning, source code analysis. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:achat@uom.edu.gr https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 75 j global clinical engineering vol.6 special issue 6: 2024 introduction in today’s fast-paced tech industry, it has become increasingly difficult for companies to evaluate the skills of job applicants, leading to incorrect allocation of tasks and suboptimal hiring decisions. as a solution to this problem, this work utilized a machine learning-based model that can effectively classify the software knowledge of developers, by recognizing the different technologies and programming languages implemented by them, thus assisting companies in managing their workforce based on acquired skills. we collected data from various javabased software technologies and employed machine learning techniques to classify each source code file. a pre-trained codebert1 model was implemented for the multi-class classification task and provided very high accuracy and precision. based on previous work2, we implemented source code analysis by applying natural language processing (nlp) techniques. the resulting model can be used as an effective tool for assessing the software knowledge of developers. methods the methodology employed in this research consisted of several key steps to address the problem of multi-class classification of source code. the methodology pipeline is presented in figure 1. experimental environment the experiments on source code classification were conducted using the jupyter notebook from anaconda as a primary development environment. to accelerate the computations, we utilized nvidia’s cuda platform to parallelize computations on the graphics card, which had a significant impact, when compared to a cpu-only approach. in terms of libraries and frameworks, several essential tools were used. tensorflow, an open-source machine learning framework, played a central role in building and training the neural network models for source code classification. to evaluate the performance of the models, the scikit-learn (sklearn) library was selected, as it provided various utilities for data preprocessing, model evaluation, and performance metrics calculation. by utilizing sklearn, we could assess the accuracy, precision, recall, f1-score, and confusion matrix of our source code classification models, enabling a comprehensive analysis of their effectiveness. lastly, to enhance the capabilities of the models, we utilized the codebert model from the transformers library. transformers is a powerful library for nlp tasks, including source code understanding and processing.3 the pre-trained codebert model allowed us to benefit from transfer learning4, as it had been pretrained on meaningful representations of source code from large scale code corpora. data selection the data selection process played a crucial role in obtaining a representative dataset for source code classification. in the present research, we collected the necessary source code files from public github repositories and selected multiple java source code files that we considered representative of each one of the following classes of software technology. we used a total of 183 files for the training and validation process. the six classes selected were: 1) jdbc (java database connectivity), 2) file handling, 3) exception handling, 4) unit testing, 5) gui (graphical user interface), 6) miscellaneous. as inputs to the ml models entire java files were used, however the problem and the models themselves can be generalized to snippets of code, such as code commits during changes in a software repository. thus, the files have been manually labeled regarding the programming java concepts that they are mostly related to. results for evaluating the pre-trained codebert model’s performance in the multi-class classification of source code, we employed a set of appropriate evaluation metrics. these metrics include precision, recall, and f1 score. the model’s precision for the current task of identifying figure 1. mobile virtual patients app interface. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 76 the technology of the source code files in java, achieved 91%, the model’s recall reached 90% and the f1 score achieved 90% (see figure 2). to get an insight into the model’s performance and behavior during the training process, we also provide a plot with the model’s training loss and validation loss metrics. the following plot serves as a diagnostic tool to assess the model’s learning dynamics and generalization ability (see figure 3). for a test case of 56 files from our dataset in which we performed multi-class classification, we created a confusion matrix (see figures 4 and 5). the dataset contained 9 files from class “exceptions”, 12 files from class “file handling”, 10 files from class “gui”, 10 files from class “jdbc”, 7 files from class “unit testing” and 8 files from class “others”. discussion in this paper, we have managed to introduce a methodology for identifying software skills from source code using machine learning algorithms. furthermore, this paper contributed to the field of software engineering by demonstrating the practical applicability of machine learning for software analysis and also to the understanding of software skills identification by investigating the impact of different features on the accuracy of the classification model. limitations while this study demonstrates promising results and provides valuable insights into multi-class classification of source code, it is crucial to recognize the limitations stemming from the small dataset size, the context-specific evaluation metrics, and the potential constraints of transfer learning with a pre-trained model. by acknowledging these limitations and considering them in the interpretation of the findings, future research can build upon this work and advance the development of more robust and versatile code classification systems. future extensions furthermore, beyond identifying different technologies in the code files, the next step could involve recognizing the specific tasks performed within the code. this would involve a more granular analysis to classify code based on the functionalities it serves, such as data manipulation, algorithm implementation, user interface development, or database management. by incorporating task identification, the classification system could provide deeper insights into developers’ programming skills and aptitudes in different areas. additionally, a source code analysis in commits from repositories could be introduced as an assessment tool. by integrating the commit analysis process, developers would gain valuable insights into the changes figure 2. the evaluation metrics of the pre-trained codebert model. figure 3. the model loss plot. figure 4. classification’s confusion matrix. figure 5. matrix of tp, fp, fn,tn. http://www.globalce.org http://globalce.org http://globalce.org 77 j global clinical engineering vol.6 special issue 6: 2024 introduced by the commits and obtain essential information about the source code. future work could involve exploring machine learning approaches to automatically classify the nature and impact of the commits based on the analysis of source code. conclusion through the analysis, we have obtained valuable insights into the effectiveness of neural networks, the benefits of transfer learning using pre-trained models, and the potential for developing an assessment tool for developers. we exploited the power of transfer learning by employing the pre-trained codebert model. this approach allowed us to capitalize on the vast amount of knowledge captured by the pre-trained model on a diverse range of source code tasks. by fine-tuning codebert on our specific multi-class classification task, we were able to achieve impressive performance in terms of evaluation metrics, indicating the robustness and effectiveness of the transfer learning approach. the successful implementation of the multi-class classification task for recognizing different technologies in the java programming language lays the foundation for the development of an assessment tool for developers. references 1. feng, z., guo, d., tang, d., et al. codebert: a pre-trained model for programming and natural languages. in findings of the association for computational linguistics: emnlp 2020, 16–20 november 2020, pp. 1536–1547; association for computational linguistics: kerrville, tx, united states. https://doi.org/10.18653/v1/2020. findings-emnlp.139. 2. kourtzanidis,s., chatzigeorgiou, a., ampatzoglou, a. reposkillminer: identifying software expertise from github repositories using natural language processing. in proceedings of the 35th ieee/acm international conference on automated software engineering (ase '20), melbourne, australia, 21–25 september 2020, pp. 1353–1357; association for computing machinery, new york, ny, united states. https://doi. org/10.1145/3324884.3415305. 3. zhang, k., li, g., jin, z. what does trans former learn about source code? 2022, arxiv preprint. https://doi. org/10.48550/arxiv.2207.08466. 4. sharma, t., efstathiou, v., louridas, p., et al. code smell detection by deep direct-learning and transferlearning. j syst softw. 2021;176:110936. https://doi. org/10.1016/j.jss.2021.110936. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.18653/v1/2020.findings-emnlp.139 https://doi.org/10.18653/v1/2020.findings-emnlp.139 https://doi.org/10.1145/3324884.3415305 https://doi.org/10.1145/3324884.3415305 https://doi.org/10.48550/arxiv.2207.08466 https://doi.org/10.48550/arxiv.2207.08466 https://doi.org/10.1016/j.jss.2021.110936 https://doi.org/10.1016/j.jss.2021.110936 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 j global clinical engineering vol.6 special issue 6: 2024 62 conference paper kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 1 medical physics and digital innovation laboratory, school of medicine, aristotle university of thessaloniki, greece. 2 systems engineering and multidisciplinary design, university of twente, netherlands. * corresponding author email: filimarg@ece.auth.gr abstract this study outlines a comprehensive approach to the kinematic and dynamic analysis of lower limb movement, with the express purpose of designing an efficient wearable rehabilitation assistant device for the lower body. the approach begins by conducting a kinematic analysis of the lower limbs, presenting the degrees of freedom and each joint’s range of motion. a kinematic model is designed by deciding on a kinematic chain configuration and calculating the denavit hartenberg (dh) parameters. next, differential kinematic analysis is employed to calculate the velocity of the limbs, generated by the corresponding muscle groups during different types of movements. this can provide significant insights into the design of a device that can accurately track and assist these movements. furthermore, a dynamic analysis is performed to calculate joint moments and forces. this analysis provides insights into the forces that the joints experience during movement. when combined with electromyography (emg) data, it allows for a more holistic description of muscle activity and a more accurate estimation of individual muscle forces and joint loads. the research also lays out a plan for the wearable device’s implementation. based on opensensert1 an open-source software and hardware project, that utilized the opensim2 api, real-time inverse kinematics of a movement can be calculated using data from inertial measurement units (imus). this data is then used to compute the error in a person’s movement during lower limb rehabilitation exercises. this error, along with the error derived from real-time dynamic analysis and emg data, can be integrated to improve the control accuracy of the wearable device. keywords—lower limb kinematic analysis, lower limb dynamic analysis, opensim, opensensert system, imu inverse kinematics, real-time inverse kinematics, real-time motion analysis, wearable rehabilitation assistant device. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:filimarg@ece.auth.gr https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 63 j global clinical engineering vol.6 special issue 6: 2024 introduction the human body is a complex system, comprising of various interconnected parts that function in harmony to enable mobility. the lower limbs, particularly, play a crucial role in locomotion and maintaining balance. understanding the movement of these limbs, especially in scenarios such as injury or disease, is vital to developing effective rehabilitation strategies. this study delves into this subject, presenting a comprehensive approach to analyzing the kinematics and dynamics of lower limb movement and designing an implementation plan for the wearable device. kinematic analysis to calculate the kinematic model of the lower body, first, the degrees of freedom (dof) and the range of motion (rom) of each joint were found. the selection of dof for each joint was influenced by the project’s current focus on individuals with tetraplegia or paraplegia, thus excluding the need to maintain a standing balance. the lower limb can be modeled as a sequence of rigid links connected by one universal rotary joint representing the hip and two revolute joints representing the knee, and ankle joints. the dof of a joint defines the number of independent movements it can make. in our model the hip has three dof allowing flexion—extension, adduction—abduction, and the internal—external rotation of the joint, the knee has one dof allowing flexion/extension motions, and the ankle also has one dof allowing dorsiflexion and plantar flexion. for the sake of simplicity, without loss of generality, the hip joint is equivalently modeled as three closely placed revolute joints instead of a spherical joint.3 athe range of motion (rom) of a joint, on the other hand, refers to the total amount of movement that can occur at a joint in each of its possible planes of movement. from range of joint motion evaluation chart4 and kinesiology: scientific basis of human motion (b&b physical education)5, the rom of the lower limb joints is shown in table 1. the kinematic analysis is performed using the rigid body segment model approach, assuming that the bones are completely rigid while they may have some flexibility. each body segment is linked to the next by a joint, allowing specific degrees of freedom. this forms a chain of rigid bodies, also known as a kinematic chain. the kinematic chain consists of local reference frames for each joint’s motion, which helps us identify the position and orientation of each body segment. in figure 1, these local frames are then expressed relative to a fixed global reference frame, frame {0}, located at the pelvis’s center between the hip joints. our model incorporates seven frames, labeled {0} to {6}. frame {0} serves as a stable global reference positioned at the pelvis center. frames {1}, {2}, and {3} are associated with the hip joint’s three movements. frame {4} corresponds to the knee joint’s flexion and extension, while frame {5} is linked to dorsiflexion and plantar flexion. frame {6}, finally, is the end-effector frame, marking the kinematic chain’s terminal point. table 1. range of motion (rom) of lower limb joints. joint movement degree hip flexion/extension 100°/30° hip abduction/addaction 40°/20° hip internal/external rotation 40°/50° knee flexion/extension 150°/0° ankle dorsiflexion/plantar flexion 20°/40° figure 1. representation of the lower limb’s kinematic chain: featuring the frames of joint movements, θ angle variables, and the coordinate systems for each frame, in accordance with the denavit-hartenberg convention. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 64 the design of the kinematic chain necessitates the definition of the rotation axes for each frame and the direction of motion for each segment, while also taking into consideration any anatomical constraints or joint limitations that affect the range of motion at each joint. this procedure is guided by the principles of the denavit hartenberg (dh) convention, which provides a systematic method for representing the kinematic equations of a manipulator. this convention is particularly useful in the context of serial manipulators, where a matrix is used to represent the pose (position and orientation) of one body relative to another. applying the dh parameters to figure 1, we can produce the table 2: variable angles φ change based on the position of the lower limbs and are constrained by the range of motion at each joint. in particular, the angle φ1 is within the interval [−50°, 40°], φ2 in [−20°, 40°], φ3 in [−30°, 100°], φ4 in [0°, 150°] and φ5 in [−40°, 20°]. the dh parameters are used to find the homogeneous transformation matrix and solve the forward and inverse kinematics problems. transformation matrices and coordinate systems are utilized to find any position and orientation for any frame relative to the base frame. in particular, the homogeneous transformation matrices allow us to combine 3 × 3 rotation matrices and 3 × 1 displacement vectors into a single 4 × 4 matrix, adding an additional row: [0 0 0 1]. the general form of the transformation matrix (t), according to introduction to robotics: mechanics and control6, that defines frame {i} relative to the frame {i−1}, in accord with the dh convention, is: by chaining together the transformation matrices of each joint starting from the base of the robot, we can obtain the overall transformation matrix of the lower limb. this matrix can then be used to calculate the position and orientation of the end-effector for a given set of joint angles (forward kinematics) or to determine the joint angles required to achieve a desired end-effector position and orientation (inverse kinematics). from the transformation matrix calculated previously, we obtain: where r is the rotation matrix and p is the position vector of frame 5 with respect to the reference base frame 0.7 the position vector p provides the position of the desired frame, and the rotation matrix r provides the orientation, those two are the solutions to the forward kinematics problem. on the other hand, solving the inverse kinematics problem involves determining the joint angles. a frequently used method for this involves multiplying each side of the transformation equation (2) by the corresponding inverse transformation matrix, depending on the frame’s angle we are aiming to solve for.8 however, the solution to the inverse kinematics problem is not pertinent to this study, and we will not delve into it further. differential kinematic analysis differential kinematics focuses on the relationship between the joint velocities and the corresponding endeffector’s linear and angular velocity. it provides a way to table 2. denavit hartenberg (dh) parameters of the lower limb model. joint i αi-1 ai-1 di θi pelvis 0 d0 0° (x1‖x2) hip 1 α0 0 0 φ1 + 90° hip 2 −90° 0 0 φ2 + 90° hip 3 +90° 0 0 φ3 + 90° knee 4 0° (z3‖z4) l1 0 φ4 ankle 5 0° (z4‖z5) l2 0 φ5 end-effector 6 0° (z5‖z6) l3 http://www.globalce.org http://globalce.org http://globalce.org 65 j global clinical engineering vol.6 special issue 6: 2024 analyze how changes in joint velocities affect the motion of the end-effector. to facilitate this analysis, we introduce a matrix quantity known as the jacobian, which maps velocities in joint space to velocities in cartesian space. there are two types of jacobian matrices: geometric and analytical. the geometric jacobian is based on the pose matrix of the lower body end-effector. on the other hand, the analytical jacobian is based on a minimal parametrized form for representing the position and the orientation of the end-effector frame. in our case, geometric jacobian is more suitable since the pose matrix is available, rather than the minimal representation form that would be required for an analytical approach. as such, when we refer to the jacobian, we will be referring specifically to the geometric jacobian.7,9 the rotation matrix, denoted as r, and the position vector, p, are dependent solely on the variables of the joints. in our specific scenario, where the joints are revolute, these variables correspond to the angles θ of the model and are represented as q, where qi = θi. the relationship between these joint variables, the jacobian matrix, and the velocity of the end-effector, can be expressed as follows7 (on page 107): where q and are given by: the matrix is a 6 × 5 matrix where 5 is the number of links. the angular velocity of the end-effector can be expressed relative to the rotation matrix r as follows: through the computations described7 (on page 108 and 111) it is retrieved that the angular velocities’ jacobian jω is being expressed, for every i−th revolute joint, as follows: the total lower half of the jacobian is thus given as: on the other hand, the linear velocity of the end-effector is just the derivative of the position vector and by the chain rule for differentiation: again, following the computation described7 (on page 110) is retrieved that the linear velocities’ jacobian ju is being expressed, for every i−th revolute joint, as it follows: the total upper half of the jacobian is thus given as: combining the upper and lower halves of the jacobian, we can deduce that the jacobian of the lower limb model is of the form: where the i-th column is given by: the above procedure works not only for computing the velocity of the end-effector but also for computing the velocity of any frame on the model. dynamic analysis while the kinematic equations outline the motion of the robot without considering the forces and moments causing the motion, the dynamic equations explicitly describe the relationship between force and motion. the dynamic equations of motion can be calculated using newtonian, lagrangian, or hamiltonian mechanics. in our case, the lagrangian approach was selected mainly because is based on the system’s kinetic and dynamic energy, rather than forces. this can simplify the analysis of complex systems and avoid the need for complex force equations. assuring that the constraint forces satisfy http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 66 the principle of virtual work we can introduce the euler lagrange equations of motion: where l = k − p is the lagrangian function, k is the kinetic energy, p is the dynamic energy, and forces τ represent the generalized forces’ function. as shown in robot modeling and control7 (on page 205), the kinetic energy of the manipulator can be computed using the calculated jacobian matrices. the form of it equals: similarly, can be expressed as: where d(q) is a symmetric positive definite matrix that is called an inertia matrix. assuming that the mass of every link is concentrated at its center, the potential energy of the i−th link of the lower body can be computed as follows: where the vector g represents the direction of gravity in the inertial frame and the vector rci denotes the coordinates of the center of mass of the i-th link. the total potential energy of our model is given by the sum: having the kinetic energy in the quadratic form of the vector q̇ and assuming that the potential energy of every link of the model is independent of q̇ the euler-lagrange equations of motion can be specialized as: where k = 1, ... ,5. implementation plan the goal of the wearable device is to aid in rehabilitation exercises by utilizing electrostimulations. to control the electrostimulator (ems), it is necessary to compute the error of the person's motion. this is achieved through the analysis of joints’ angle errors provided by kinematic analysis and the forces and torque errors computed by dynamic analysis. additionally to these errors, emg data can be utilized by analyzing them using the ceinms software.10 the real-time kinematic analysis will be implemented based on opensensert (as shown in figure 2), an open-source software and hardware project that utilizes the imu inverse kinematics algorithm from opensim. acknowledgements this research project was supported by the hellenic foundation for research and innovation (h.f.r.i.) https:// www.elidek.gr under the “2nd call for h.f.r.i. research projects to support faculty members & researchers” (project number: 4391). references 1. slade, p., ayman, h., jennifer, l.h., et al. an opensource and wearable system for measuring 3d human motion in real-time. ieee trans biomed eng. 2022;69(2):678–688. https://doi.org/10.1109/ tbme.2021.3103201. figure 2. block diagram of the project’s implementation. http://www.globalce.org http://globalce.org http://globalce.org https://www.elidek.gr https://www.elidek.gr https://doi.org/10.1109/tbme.2021.3103201 https://doi.org/10.1109/tbme.2021.3103201 67 j global clinical engineering vol.6 special issue 6: 2024 2. seth, a., hicks, j.l., uchida, t.k., et al. opensim: simulating musculoskeletal dynamics and neuromuscular control to study human and animal movement. plos comput biol. 2018;14(7):e1006223. https://doi. org/10.1371/journal.pcbi.1006223. 3. ziegler, j., reiter, a., gattringer, h., et al. simultaneous identification of human body model parameters and gait trajectory from 3d motion capture data. med eng phys. 2020;84:193–202. https://doi.org/10.1016/j. medengphy.2020.08.009. 4. range of joint motion evaluation chart. washington state department of social and health services (2014). available online: https://www.dshs.wa.gov/sites/ default/files/forms/pdf/13-585a.pdf. 5. hamilton, n., weimar, w., luttgens, k. kinesiology: scientific basis of human motion (b&b physical education), mcgraw-hill education: new york, usa; 2011. 6. craig, j.j. introduction to robotics: mechanics and control. addison-wesley publishing company; 2005; pp. 303. 7. spong, m.w., hutchinson, s., vidyasagar, m. robot modeling and control, 2nd ed. john wiley & sons: hoboken, nj, usa; 2020; pp. 107–205. 8. baluch, t.h., masood, a., iqbal, j., et al. kinematic and dynamic analysis of a lower limb exoskeleton. ijmme. 2012;6(9):1945–1949. https://doi.org/10.5281/ zenodo.1072880. 9. siciliano, b., sciavicco, l., villani, l., et al. robotics: modelling, planning and control. springer science & business media: berlin, germany; 2010. 10. pizzolato, c., lloyd, d.g., sartori, m., et al. ceinms: a toolbox to investigate the influence of different neural control solutions on the prediction of muscle excitation and joint moments during dynamic motor tasks. j biomech. 2015;48(14):3929–3936. https:// doi.org/10.1016/j.jbiomech.2015.09.021. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.1371/journal.pcbi.1006223 https://doi.org/10.1371/journal.pcbi.1006223 https://doi.org/10.1016/j.medengphy.2020.08.009 https://doi.org/10.1016/j.medengphy.2020.08.009 https://www.dshs.wa.gov/sites/default/files/forms/pdf/13-585a.pdf https://www.dshs.wa.gov/sites/default/files/forms/pdf/13-585a.pdf https://doi.org/10.5281/zenodo.1072880 https://doi.org/10.5281/zenodo.1072880 https://doi.org/10.1016/j.jbiomech.2015.09.021 https://doi.org/10.1016/j.jbiomech.2015.09.021 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 j global clinical engineering vol.6 issue 3: 2024 18 received january 10, 2024, accepted may 8 2024, date of publication may 31 2024. design a mobile application for the maintenance of hemodialysis machines using flutter framework by badria ibrahim eisa, and mohamed yagoub esmail sudan university of science and technologyi, sudan abstract the hemodialysis machine is an artificial kidney facilitating the hemodialysis process and is considered a crucial life-sustaining device. any delays resulting from malfunctions or improper maintenance of these machines can significantly impact the duration of dialysis for patients. in khartoum state, numerous highly skilled biomedical engineers are employed at dialysis centers, each with varying experience levels. however, the current training workshops provided to them are inadequate in ensuring proper maintenance of the machines. many engineers struggle to address daily malfunctions and face challenges when referring to service manuals. the recent proliferation of mobile applications has proven beneficial in several fields, particularly healthcare. this project will utilize a specific framework to develop a mobile application tailored to maintain hemodialysis machines. the app is designed to assist biomedical engineers in their daily tasks, particularly those in junior positions. by leveraging flutter frameworks and the dart language, a hybrid language capable of unifying code across android, desktop, and ios platforms, the “hdservice app” was created. this application offers detailed information on four common models of machine malfunctions in sudan, along with corresponding solutions. biomedical engineers have successfully integrated the app into their mobile devices, utilizing it for maintenance tasks. subsequently, they conducted an evaluation comparing the app’s effectiveness to that of traditional service manuals, yielding the desired outcome. keywords – hemodialysis machine, maintenance, mobile application, flutter framework. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction there are approximately 100 service engineers in khartoum state, overseeing 1591 machines as reported in the latest inventory from the national center of kidney diseases and surgery in february 2023. this significant number of engineers managing a large quantity of machines, each with varying levels of experience ranging from 1 to 17 years, results in challenges related to supervision and training, particularly for junior engineers. in the current landscape, mobile devices, such as smartphones and tablets, are prevalent among healthcare professionals, especially in light of the covid-19 pandemic. given the common occurrence of malfunctions in hemodialysis machines, there is an opportunity to consolidate maintenance procedures into a software package, such as a mobile app, to enhance the training program for engineers. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 19 j global clinical engineering vol.6 issue 3: 2024 ibrahim eisa, and yagoub esmail: design a mobile application for the maintenance of hemodialysis machines using flutter framework hemodialysis machine: a dialysis machine works to filter a patient’s blood. this process includes the removal of impurities and excess water.1 hemodialysis machines have three basic functions: 1. circulation of blood from the patient’s access through the dialyzer and back to the access using a blood pump and a disposable tubing set.2 2. preparation of dialysate from purified water and one or more concentrates and circulation of that dialysate through the dialyzer using a system that also controls the rate of fluid removal.2 3. monitoring for any loss of integrity in either the blood or dialysate circuit or any excursion of an operating parameter outside a predefined range.2 fault in hemodialysis machines: mechanical and electrical faults first cause faults in hemodialysis machines due to these five elements: pumps, power, transducers and sensors, pressure, and conductivity.3 and secondly, errors can arise from human error, such as misuse during operation or improper patient connection by nurses. these issues could be mitigated by ensuring that procedures are not initiated without full knowledge, particularly since they directly impact patient care. biomedical engineers should also support nurses by offering comprehensive machine usage and maintenance training. furthermore, machine-related faults can also occur, underscoring the critical role of biomedical engineers in preventing risks associated with faulty or unchecked equipment. they must fulfill their responsibilities diligently and ensure that these machines remain operational for as long as possible during their duty cycles. as previously mentioned, their involvement in dialysis procedures and hemodialysis centers is crucial, with specific roles including: 1. gain a comprehensive understanding of the operational mechanisms of hemodialysis equipment.4 2. engage in the dialysis apparatus’s operation, upkeep, repair, and sterilization.5 3. take charge of ensuring the integrity of dialysis solutions, which involves overseeing electrolyte levels, osmotic pressure and conducting assessments for microbial/endotoxin presence.5 4. participate in collaborative endeavors to enhance dialysis machinery and pioneer new treatment modalities with a proactive approach to disseminating findings through publications and conference presentations.5 maintenance maintenance encompasses the activities undertaken to sustain equipment in its functional state, whether by averting its deterioration into a nonfunctional state or by restoring it to operation post-failure. this gives rise to a variety of maintenance practices that can be strategically planned to fulfill the maintenance goal, including preventive, predictive, or corrective measures.6 in hemodialysis facilities, to prolong the lifespan and efficiency of the machines, a focus on preventive maintenance is essential to reduce the frequency of corrective maintenance interventions. although disinfection procedures and decalcification are routinely conducted on weekends, the execution of corrective maintenance is lacking due to inadequate training programs, as highlighted in the identified issue. computerized maintenance management system (cmms): a cmms is a sophisticated software solution that houses a comprehensive computer database containing vital information about an organization’s maintenance operations. within healthcare technology management, the cmms serves as a tool for streamlining the documentation of all tasks associated with medical equipment, encompassing equipment scheduling, inventory supervision, corrective and preventative maintenance protocols, spare parts regulation, service agreements, and medical equipment notifications.7 flutter frameworks: reasons for choosing flutter framework: flutter is a cutting-edge application development framework developed by google for building cross-platform mobile applications ibrahim eisa, and yagoub esmail: design a mobile application for the maintenance of hemodialysis machines using flutter framework j global clinical engineering vol.6 issue 3: 2024 20 that can run on both ios and android operating systems. as detailed on the official website (https://flutter.io/), it was selected for its primary objective of simplifying, accelerating, and enhancing the development process.8 for end-users, programmers, and designers utilizing flutter. moreover, flutter is a versatile programming language that enables the creation of a single codebase for android, desktop, and ios platforms. the preferred approach in this context involves leveraging the innovative flutter framework with the dart programming language. theoretical background mobile applications in healthcare: healthcare applications encompass various mobile apps designed to assist in various health-related tasks. these apps can range from lifestyle mhealth solutions such as fitness and meditation applications to more advanced products that heavily rely on technological advancements, like those created to aid medical professionals in diagnosing and addressing complex medical issues.9 in a recent publication, a comprehensive framework for a smart mobile internet-of-things (iot) healthcare system was proposed to monitor patients’ health risks using a smartphone and 5g technology.10 web and mobile applications were developed to cater to the needs of patients, doctors, laboratory analysis, and hospital services. this study used these applications to collect physiological data such as body temperature, pulse rate, and oxygen saturation levels. the physiological data were then processed using 5g technology, body sensors connected to arduino boards, and raspberry pi boards.10 this innovative system provides real-time advice and alerts to doctors and medical assistants regarding changes in patients’ vital signs and significant environmental changes. this enables medical professionals to take preventive measures swiftly, potentially saving lives in critical care and emergencies.10 furthermore, mobile applications are sometimes utilized in telemedicine technologies, such as the mhealth applications operating in india as detailed in a recent study. these applications offer features like online doctor consultations or offline doctor appointment bookings, serving as an effective medium for doctor-patient communication and leading to notable enhancements in patients’ health outcomes. the study involved a cross-sectional, observational, and web-based research approach.11 methodology designing questionnaires, data sorting, and analysis after data collection, the common issues and malfunctions identified from questionnaires and experiences with various machine types were analyzed. subsequently, the data was categorized into four groups based on machine types, each encompassing all relevant data and malfunctions. these categories were then reviewed with the company’s expert engineers to identify suitable solutions from manuals. the identified issues were then condensed and organized into four groups based on the occurrence timeline, from machine startup to disinfection before the next patient. this systematic arrangement facilitated sorting errors and the implementation of appropriate solutions, preparing them for inclusion in the codes. selecting the appropriate code editor initially, the coding environment on the computer must be set up. the android studio and the flutter framework were utilized as the code editor. subsequently, the flutter was integrated into the android studio, and the preferred android version was selected; in this case, android version 4.0.0 was chosen to ensure compatibility with devices possessing minimal specifications, thereby enabling widespread usage of the application. constructing the architecture of the flutter framework. constructing the framework architecture for flutter to construct a robust architecture, it is essential to incorporate a plugin for the dart compiler, a separate plugin for code analysis, and yet another plugin for managing the flutter developer workflow, encompassing tasks such as building, running, and debugging. these plugins can be seamlessly integrated within android studio for optimal efficiency. https://flutter.io/ 21 j global clinical engineering vol.6 issue 3: 2024 ibrahim eisa, and yagoub esmail: design a mobile application for the maintenance of hemodialysis machines using flutter framework creating app widgets the user interface (ui) and widgets utilized in the design process were carefully crafted with a harmonious color scheme and intuitive interactive features to align with the primary project objectives. the diagram in figure (1) below showcases the app's key buttons and navigation element illustrating how users will engage with the application. test execution the dart language continuously self-evaluates the code to detect any errors before running the application. the final evaluation of the entire code and its structure is done through a specific function in the android file named “test.” this function verifies the integrity of the code even in the absence of errors. application execution prior to launching the application, a virtual device emulator must be created on the laptop to preview the simulated app. once everything appears satisfactory, the application is named “hdservice.” creation of application icon when developing any application, it is essential to have a unique logo that symbolizes the app's purpose. once the logo is chosen, the image should be saved in png format using the website www.icongenerator.com. apk release the final stage involves converting the application into apk format to make it accessible to a wider audience. the command “--release “generates two files that engineers can easily install on android mobile devices to achieve the intended goal. results and discussion the data obtained from the questionnaire the survey was completed by a cohort of 100 biomedical engineers, from which various data points were collected. these included the duration of training, ranging from one to six months, as well as the number of years of experience in the field of dialysis, as illustrated in figure 2 below. moreover, the engineers encountered challenges in handling and interpreting service manuals due to several factors. to begin with, 71.1% expressed that insufficient training and workshops were provided. additionally, 17.8% reported a lack of company engineers available for guidance and training, while 11.1% found the service manuals unclear and written in complex language. the second reason is related to the nature of the job itself. a total of 88.9% of respondents indicated no written guidelines for daily, weekly, and monthly maintenance, while 11.1% stated that such guidelines exist in their hospitals. in the event of new malfunctions, technicians typically follow a series of steps to address them, such as consulting service manuals, reaching out to colleagues, figure 1. ui of the app. figure 2. the years of experiences. http://www.icongenerator.com ibrahim eisa, and yagoub esmail: design a mobile application for the maintenance of hemodialysis machines using flutter framework j global clinical engineering vol.6 issue 3: 2024 22 or contacting the company’s engineers. the comparison between the current procedures performed and the ideal procedures as perceived by the technicians is illustrated in figure 3 below. the disparity between the optimal solution and the current practice lies in the unavailability of the company’s engineers due to their obligations with the vast hemodialysis centers and other responsibilities. in line with the issue, the training workshops for engineers have proven insufficient to adequately equip them. over the past five years, 68.2% have only attended 1–2 workshops, 25% have attended 3–4 workshops, and 6.8% have participated in more than 5 workshops. the feasibility of the app concept was deliberated upon before its inception, with an overwhelming 89% expressing strong approval, while the remaining individuals exhibited varying degrees of disinterest. the engineers anticipated that the app would serve as the ultimate solution during their work, with 64% endorsing this notion, marking a pivotal moment in the project’s initiation. the successful launch of the hdservice app has come to fruition. subsequent data will elucidate the culmination of the preceding chapter, showcasing the app post-launch to offer the desired solutions or information. figure 4 illustrates the app’s nomenclature and logo icon, epitomizing its purpose the name conveys the provision of hemodialysis services, while the logo underscores the importance of maintaining the hemodialysis machine. the subsequent figures will reveal the culmination of the previous chapter, displaying the app upon launch to provide the desired solution or information. figure 4 showcases the app’s name and logo icon, symbolizing the app’s purpose the name signifies the provision of hemodialysis services, while the logo conveys the importance of maintaining the hemodialysis machine. the application has been meticulously programmed and will continue to be enriched with new information through collaboration between my supervisor and me. it has been intricately coded to operate seamlessly offline, thus circumventing the prevalent network issues in sudan. this design choice aims to enhance user experience for biomedical engineers, facilitating their search for errors. however, online connectivity is required for users to communicate with us, the developers, to report errors or suggest solutions for inclusion in the subsequent version. the following diagrams depict the application's process to troubleshoot and resolve various issues. figure 3. comparison between procedures of fixing errors. figure 4. the app’s name and logo. figure 5. first app’s screen. 23 j global clinical engineering vol.6 issue 3: 2024 ibrahim eisa, and yagoub esmail: design a mobile application for the maintenance of hemodialysis machines using flutter framework the illustration depicted in figure 5 displays the initial interface of the application, also known as the welcome screen. this screen features the app’s title and a menu bar, which includes contact information as illustrated in figure 6. the buttons in the center serve as a submenu that allows users to navigate to different screens within the app. the illustration above provides a comprehensive app overview and offers guidance on identifying and resolving issues. subsequent illustrations will further elucidate this process. for instance, if an error occurs in a bbraun machine during a self-test, the engineer must first double-click on the hemodialysis machine icon (figure 6). following this, the engineer should double-click the self-test button in figure 8. once the self-test button is double-clicked, the engineer will be directed to figure 9 to locate the error message or code. the diagram provided above displays all the errors detected during the self-test. the list-view widget was utilized to ensure that the errors can be displayed without any limitations in length, and can be expanded in the future. each error message is represented as a widget known as a “card,” which, when clicked, will navigate the user to the corresponding solution screen, as illustrated in the upcoming diagram. the solution screen depicted in figure 10 below provides detailed explanations for why the error occurred and the potential causes behind it, this applies to all the other cards and machines as well. figure 6. contact information. figure 7. the section of water treatment unit. figure 8. the section of hd machines. figure 9. scrolled list-view for self-test errors. ibrahim eisa, and yagoub esmail: design a mobile application for the maintenance of hemodialysis machines using flutter framework j global clinical engineering vol.6 issue 3: 2024 24 assessment feedback following the utilization of the application, we sought to gain a comprehensive understanding of its functionality, user satisfaction, and overall worthiness for further development. to achieve this, we conducted an online survey to assess user acceptance. the initial feedback revealed a strong acceptance rate of 89%, with the remaining responses varying between disapproval and moderate interest, as depicted in figure 11 below. respondents highlighted the app’s user-friendly interface, which facilitated enhanced knowledge sharing and interaction between junior and senior users and provided valuable training on proper maintenance practices. this positive reception corroborated our objectives. furthermore, the application underwent evaluation by a panel of engineers at the military hospital, including eng. salim mohammed musa, the chief engineer in sudan and former technical representative of gambro in sudan, along with representatives from samasu medical company, the current technical agent of gambro in sudan. conclusions the advancement of technology, particularly mobile applications in healthcare, is highlighted in this article. the mobile applications suggested here aim to offer extensive services to aid training programs and provide maintenance information for biomedical engineers regarding hemodialysis machines and water treatment systems. using the flutter framework to develop the app resulted in a user-friendly interface with a single code base for multiple platforms. the app’s classes facilitated the easy addition of new information, serving as a foundation for knowledge sharing and experience exchange. employing the “hdservice app” for maintenance purposes enhances the expertise of biomedical engineers, enabling them to quickly identify the correct solutions without the need to consult colleagues. the app serves as a comprehensive guideline, akin to service manuals, thereby minimizing errors during maintenance procedures. navigating through the app’s interface to access information on different machines is swift, aiding in rapidly diagnosing malfunctions. furthermore, the app educates users on error solutions and fosters the sharing of experiences between seasoned engineers and novices. the authors will regularly update the app with new information based on user submissions, promoting continuous learning. the increasing integration of mobile applications in healthcare is anticipated, with this app serving as a pioneering platform for developing apps for other medical instruments. acknowledgment i sincerely appreciate individuals who contributed to this project, particularly in the programming aspect, from inception: eng. alaa yahia, albaraa omer, and a special figure 10. the error’s solution. figure 11. the acceptance of hdservice app. 25 j global clinical engineering vol.6 issue 3: 2024 ibrahim eisa, and yagoub esmail: design a mobile application for the maintenance of hemodialysis machines using flutter framework thank you to eng. jabir mohammed for his invaluable time, guidance, and advice. i express immense thanks and acknowledgment to the engineers who provided information on dialysis machines: motasim almamoun, eman tag alsir, and yousif mohammed. additionally, i appreciate the support and encouragement from my colleagues and friends at alnaw and algazira slang hospitals for kidney diseases. references 1. medical education institute. core curriculum for the dialysis technician. a comprehensive review of hemodialysis. 5th edition. author; madison, wi. 2. ward ra, ronco c. dialyzer and machine technologies: application of recent advances to clinical practice. blood purification. 2006. 3. hamza ao, osman mo, khider mo. evaluation of mechanical and electrical faults in dialysis machines. j phys ther health promot 2013;1(1):1–7. 4. sheikh z. when do i need dialysis. [internet] available at: https://www.webmd.com/a-to-z-guides/ kidney-dialysis. 5. naramura t. the role of clinical engineers in dialysis therapy in japan. blood purification 2018;46:134–135. 6. misra kb. maintenance engineering and maintainability: an introduction. rams consultants. jaipur, india. august 2008. 7. world health organization. computerized maintenance management system. who medical device technical series. geneva. june 2011. 8. mainkar p, giordano s. google flutter mobile development quick start guide. packt publishing, birmingham mumbai, 2019. available at: https://www.studypool. com/documents/19492261/google-flutter-mobiledevelopment-quick-start-guide-prajyot-mainkarsalvatore-giordano-https://shakuro.com/blog/ healthcare-mobile-app-development-why-how-and-how-much. 9. nasri f, mtibaa a. smart mobile healthcare system based on wbsn and 5g. int j adv comp sci applicat 2017;(8)10. available in at: doi:10.14569/ijacsa.2017.081020 . 10. agarwal n, biswas b. doctor consultation through mobile applications in india: an overview, challenges and the way forward. healthcare informatics research. available at: https://doi.org/10.4258/ hir.2020.26.2.153pissn 2093-3681 https://www.webmd.com/a-to-z-guides/kidney-dialysis https://www.webmd.com/a-to-z-guides/kidney-dialysis https://www.studypool.com/documents/19492261/google-flutter-mobile-development-quick-start-guide-prajyot-mainkar-salvatore-giordano-https https://www.studypool.com/documents/19492261/google-flutter-mobile-development-quick-start-guide-prajyot-mainkar-salvatore-giordano-https https://www.studypool.com/documents/19492261/google-flutter-mobile-development-quick-start-guide-prajyot-mainkar-salvatore-giordano-https https://www.studypool.com/documents/19492261/google-flutter-mobile-development-quick-start-guide-prajyot-mainkar-salvatore-giordano-https http://shakuro.com/blog/healthcare-mobile-app-development-why-how-and-how-much http://shakuro.com/blog/healthcare-mobile-app-development-why-how-and-how-much https://doi.org/10.4258/hir.2020.26.2.153pissn https://doi.org/10.4258/hir.2020.26.2.153pissn j global clinical engineering vol.5 issue 3, 2023 2 editor’s corner many readers of this journal will be familiar with the field of health technology assessment (hta), at least in principle if not in detail. they may also be aware of the three main pillars of hta: evaluating comparative effectiveness; cost-effectiveness, and organizational impact, and that hta serves to inform decision-making in order to promote an equitable, efficient, and high-quality health system. hta activities often fall within the domain of specialized units or agencies – be these in the public or private health sectors with health economists as lead practitioners. the questions posed relate primarily to allocative efficiency issues and related affordability of new medicines, drugs, and procedures for various target populations or groups. as such, hta is downstream to assurance of regulatory compliance and upstream of technology dissemination and related life-cycle management. hta has recently been redefined by an international joint task group as a “multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its life cycle”.1 it’s useful to spend a minute unpacking that definition. what disciplines are involved and who are the primary drivers of the process? health economists play an important role, as do health clinical professionals. for so-called hospital-based or ‘mini-hta’, a broader mix of stakeholders – including clinical engineering (ce), or ce&htm (health technology management) professionals – would be involved. in all cases, it is the ht-related questions posed that are the crucial determinant of what the process entails and who is involved. at this point, it’s worth remembering that the first technology assessment in the healthcare space was that of the artificial human heart, and the second of the ct scanner – both conducted by the (then) office of technology assessment of the us congress and hence the birthplace of hta. one can surmise the key questions posed in each case: does the technology work and is it safe in the first instance, and can the health system afford the proliferation of this new and expensive medical imaging system in the second. what are the ‘explicit methods’ and who gets to define these? there are several formal methodology frameworks, the most recent being the european collaboration of hta (eunethta) hta core model.2 the ‘value of a technology’ is a loaded term, since the needs and value systems of the different stakeholders in the outcome of the hta process may not always be aligned. lastly – and perhaps most importantly in our context – is to establish the ‘different points in a technology’s life-cycle’. current hta practice commonly sees the technology life-cycle in the generic sense, from embryonic to early adoption to market acceptance to mature and eventual replacement and/or abandonment. interestingly, a recent publication4 refers to 6 stages for life-cycle hta: preassessment; safety and efficacy assessment; hta; adoption; de-adoption, and reassessment. what has all this got to do with ce&htm? everything! ce&htm practitioners are key stakeholders in – and overseers of the operational life-cycle management (lcm) of medical devices, with decision-making an integral component of all phases, from needs assessment, planning, and budgeting to procurement, commissioning, maintenance, user support, and training, and eventual decommissioning and disposal. numerous decisions are made by ce&htm practitioners in consultation with other stakeholders along the device’s journey from cradle to grave. all of this can be done without mention of hta. should this not be addressed for both operational and strategic reasons since the hta ‘toolkit’ can be used to select the most appropriate approach in providing the evidence needed for specific decisions while also serving to support the standardization of institutional processes? in addition, by using the language of hta, http://www.globalce.org http://www.globalce.org 3 j global clinical engineering vol.5 issue 3, 2023 ce&htm practitioners can align themselves with existing hta processes where these exist. there are also broader benefits. as readers may well be aware, gcea and the ifmbe’s clinical engineering division are engaged in the important exercise of defining the ce/ htm bodies of knowledge and practice at the global level, both of which would benefit from the addition of hta concepts and principles as being core to both ce/htm knowledge and practice. on a related note, the ifmbe’s health technology assessment division has recently suggested greater involvement of biomedical and clinical engineers in current hta activities and further explored related gaps and opportunities in a recent publication.3 another european-based in the hta domain – euroscan also known as the international healthtechscan (i-hts) has joined global clinical engineering alliance on a couple of world health organization projects. another benefit is linked to the challenges many colleagues are facing in raising the importance of ce/htm in their respective countries, needing ce/htm roles and contributions to be recognized in national policy and related support of professional recognition, capacity development, and appropriate resourcing. a different perspective on hta and related issues is informed by the reality that many lesser-resourced settings are well familiar with: “...inefficiency (that) signifies the denial of additional citizens of opportunities to realise health improvements at zero extra cost. this makes inefficiency both immoral and unethical.”4 this begs the question: are the resources currently invested (allocative efficiency) in the regulation, assessment, and management individually and collectively of health technologies in general and medical devices, in particular, achieving the highest return on investment when their actual impact is juxtaposed with their potential impact given the same levels of investment? there is anecdotal evidence that regulatory and assessment agencies in some countries are pursuing the implementation of best global practices in upstream lcm activities, thereby consuming significant resources that could be better utilized in addressing proverbial orchards of low-hanging fruit associated with the downstream operational life-cycles of health technologies and medical devices, and related technical efficiency. this in turn leads us to ask: why not do an hta on hta, i.e. consider the cost-effectiveness of current hta-related activities and their resourcing and impact, relative to their potential if their scope was broadened and a larger set of stakeholders were gathered at the decision-making table? incidentally, the same question could be asked of health technology regulation and ce/htm activities and related resourcing. yours thoughts? let me know at mladen.poluta@up.ac.za references 1. mueller d, gutierrezibarluzea i, chiumente m, oortwijn w (2021). toward a common understanding of competencies for health technology assessment: enhancing educational and training programs around the globe. int’l j of technology assessment in health care 37, e29, 1–10. 2. https://www.eunethta.eu/hta-core-model/ 3. pecchia l, pallikarakis n, magjarevic r, iadanza e (2019). health technology assessment and biomedical engineering: global trends, gaps and opportunities. medical engineering and physics, 72, 19–26. 4. kirigia jm, emrouznejad a, sambo lg (2002). measurement of technical efficiency of public hospitals in kenya: using data envelopment analysis. j of medical systems, 26(1), pp. 39-45. together we are making it better! prof. mladen poluta copyright © 2021. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org mailto:mladen.poluta@up.ac.za https://www.eunethta.eu/hta-core-model/ 65 j global clinical engineering vol.7 issue 2: 2025 received january 1, 2025, accepted may 27, 2025, date of publication june 21, 2025. original research article quantitative evaluation of venipuncture training models: a study using a puncture force testing device naofumi nakaya1,*, kunio horiuchi2, and kazuo aoki3 1 department of clinical engineering, faculty of medical science, juntendo university, urayasu-shi, chiba, japan. 2 department of mechanical science and engineering, school of advanced engineering, kogakuin university, hachioji-shi, tokyo, japan. 3 college of science and technology, nihon university, chiyoda-ku, tokyo, japan. * corresponding author email: n.nakaya.ac@juntendo.ac.jp abstract background/objectives: this study introduces a quantitative assessment of venipuncture training models using a customized puncture force testing device. the device, engineered to quantify the force and torque exerted during a puncture under regulated speed and angle conditions, aims to augment the authenticity and efficiency of medical training models. in japan, a diverse group of medical professionals receive training in venipuncture, utilizing models in a variety of educational environments. however, the existing models often fall short of replicating the physiological realism of human tissue, which limits the effectiveness of the training. methods: to address this issue, the study employed a puncture force testing device that includes a needle, syringe, load test stand, and digital force gauge, among other components. this arrangement facilitated the precise control and recording of puncture force at varying speeds and angles. three distinct venipuncture models (models a, b, and c), filled with water to mimic venous blood, were tested under these regulated conditions. results: the findings revealed notable differences in puncture force among the models, with model c closely resembling human tissue because of its lower maximum puncture force. conclusion: the study also observed a variation in the force required at different puncture speeds, thereby enhancing our understanding of model behavior under diverse conditions. moreover, the use of a mechanically controlled puncture device eliminated the variability associated with individual technique, allowing for a more quantitative and reproducible evaluation. in conclusion, the study proposes a more quantitative and objective approach for evaluating venipuncture models. this progress is vital for refining these models to more accurately simulate human tissue, consequently improving the quality of medical training in venipuncture procedures. keywords—clinical skills, intravenous injection, nursing students, public health nurses, venipuncture. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:n.nakaya.ac@juntendo.ac.jp https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ nakaya, horiuchi, aoki: quantitative evaluation of venipuncture training models: a study using a puncture force testing device j global clinical engineering vol.7 issue 2: 2025 66 introduction in japan, a broad spectrum of medical professionals, including physicians, dentists, public health nurses, midwives, nurses, licensed practical nurses, clinical laboratory technicians, radiology technicians, and clinical engineers, are trained in intravenous injection and blood sampling. these professionals acquire venipuncture skills through various training schools and clinical practice. simulation education, exemplified by skills laboratories, is actively conducted primarily in medical schools. ishikawa et al. reported that at least 74 out of 80 faculties in japan had a skills laboratory at the time of their survey.1 suzuki et al. reported that an intravenous blood collection and injection model was used in 53 faculties, with more than 300 sets available.2 these models are utilized not only in training schools but also in postgraduate education to enhance clinical skills across various professions. training facilities for medical professionals in japan comprise 81 medical schools,3 1 medical doctor training programs at a ministerial university, 828 threeor four-year training schools for nurses, and 180 training schools for licensed practical nurses.4 in addition, there are 103 clinical technologist training schools,5 55 training schools for radiology technologists,6 and 88 training schools for clinical engineers who are members of educational associations nationwide.7 a comparative study of cannulation training for veins in nursing students observed no statistically significant differences in performance between groups of students trained with each other and with a rubber mannequin.8 jones et al. suggested that student-to-student and mannequin training are equally effective. they also noted that the use of mannequins can reduce risk.8 despite the widespread use of these models, it has been noted that the skills acquired from training on a mannequin are limited because of their unique characteristics that differ from those of the human body.9–11 to address this issue, we attempted to measure the force and torque applied when puncturing a model to establish a quantitative evaluation method to improve the quality of these models.12,13 however, the methods used in previous studies are dependent on the human technique, which remains a challenge. in this study, we developed a puncture force testing device capable of testing puncture speed and angle under specific conditions. we conducted tests on a product similar to the model used in the previous study to compare it with conventional methods. methods puncture force testing device we constructed a puncture force testing device, which incorporates a force gauge and a load test stand, to assess the venous blood collection and injection model. this device allows for the evaluation of the model under consistent puncture speed and angle (figure 1). figure 1. puncture force testing apparatus utilizing a load test stand. 67 j global clinical engineering vol.7 issue 2: 2025 nakaya, horiuchi, aoki: quantitative evaluation of venipuncture training models: a study using a puncture force testing device in contrast to our previous study,12 which employed a syringe-type force sensor operated manually by participants—potentially introducing variability associated with individual technique—the device developed in the present study enables puncture under controlled conditions with a fixed speed and angle. this system offers improved reproducibility and eliminates inter-operator variability, thereby enhancing the reliability and objectivity of the puncture force measurements. the apparatus comprises a needle (nn-2232s: terumo), a luer–lock adapter (ps6608: isis), a three-way stopcock (394900: bd), a syringe (ss-05sz: terumo), a force test stand (fgs-100vc: nidec-sympo), a digital force gauge (fgp-1: nidec-sympo), a personal computer (ideapad z500: lenovo), and a jig made of acrylonitrile-butadienestyrene (abs) resin produced by a 3d printer for securing the model. the puncture force tester can move a digital force gauge up and down at a variable speed (10–400 mm/min) by either automatic or manual operation. when a puncture is performed with the load test stand, the puncture force is transmitted to the measurement axis of the digital force gauge via the needle. the measured data can be continuously recorded by a personal computer connected to the digital force gauge. the force waveform obtained by the digital force gauge is smoothed by an integrated measurement filter. in the experiments, the 90% response time to step input was set to 3 ms, and the sampling frequency was 100 times per second. a three-way stopcock was attached to verify whether the needle tip was inserted into the model’s blood vessel after puncture with the load test stand. if the puncture was successful, water filled in the model’s blood vessel could be aspirated from the port of the three-way stopcock by a syringe. the puncture needle is a sterile disposable needle commonly used for blood collection in adults (22g, short bevel type). the luer–lock adapter, made of polyetheretherketone (peek) resin, is used to screw the puncture needle into the device. the tool adheres to the same standard as the method used to secure needles in actual clinical practice, allowing the puncture needle to be changed according to the application. the jig for securing the model, made of abs resin, is used to puncture the model at an angle suitable for blood collection and puncture. the jig was fabricated using a 3d printer (replicator2x: makerbot).12 figure 2 provides an example of a puncture force waveform measurement and the items measured. in figure 2, “fmax” represents the maximum puncture force. subjects and methods of experiments we prepared three models, designated as model a, model b, and model c, similar to those used in the previous study (figure 3).9,10 models a and b are designed to be worn on the arm of the training collaborator, while model c is shaped like an arm. the simulated vessels of the models were filled with tap water to mimic blood, and a drop pressure was applied to simulate venous blood pressure, as per the models’ instruction manual. figure 2. puncture force waveform measurement and the corresponding measured item (the puncture force waveform was smoothed using a low-pass filter built into the force gauge. the filter parameters were set such that the 90% response time to a step input was 3 ms). nakaya, horiuchi, aoki: quantitative evaluation of venipuncture training models: a study using a puncture force testing device j global clinical engineering vol.7 issue 2: 2025 68 comparisons using fisher’s protected least significant difference (plsd) indicated significant differences in all combinations, except between model a and model b in the group with a puncture speed of 200 mm/min (p < 0.05). notably, model c exhibited a significantly lower maximum puncture force than the other models at all puncture speeds (p < 0.05). the puncture speed dependence test results showed that only model b exhibited a dependence on puncture speed (p < 0.05). compared to the results of multiple comparisons in a previous study by the authors, the current study demonstrated significant differences in all pairs at a puncture speed of 400 mm/min. this suggests that the differences in model characteristics are equally or more detectable.12 in the previous study, 12 using the same models, puncture experiments were conducted by 12 participants with a syringe-type force sensor. while that study found statistically significant differences between most model pairs, no significant difference was observed between model a and model c. in contrast, the present study, which employed mechanically controlled puncture conditions and the same number of trials (n = 12), revealed significant differences among all models at a puncture speed of 400 mm/min. during the puncture test, the puncture angle was mechanically fixed at 25° using a jig, in accordance with the standards specified in the blood collection method guidelines.14 we also set the puncture speed at 200 mm/ min and 400 mm/min. we used two different puncture speeds to examine the model’s dependence on speed, as it has been reported that the puncture reaction force decreases as the speed increases when puncturing the biological tissue.15 we conducted 12 tests for each model at a sampling frequency of 100 hz. the needle was manually advanced into the model’s simulated blood vessel using the stand, and the stand was stopped when the needle reached the vessel. we replaced the needle used for the puncture after each test. a puncture was deemed successful when water could be aspirated from the three-way stopcock by a syringe. the number of tests was set to 12 to allow for comparison with our previous study,12,13 in which the same model was used and experiments were conducted with 12 participants. results and discussion the average of the maximum puncture force is presented in figure 4. an analysis of variance revealed a significant difference (p < 0.05) between the groups with a puncture speed of 200 mm/min and those with a puncture speed of 400 mm/min. furthermore, multiple figure 3. intravenous blood sampling practice model.12,13 figure 4. average maximum puncture force (mean ± standard error, n = 12) 69 j global clinical engineering vol.7 issue 2: 2025 nakaya, horiuchi, aoki: quantitative evaluation of venipuncture training models: a study using a puncture force testing device these findings suggest that the method developed in this study enables more sensitive and consistent detection of differences in model characteristics. okuno et al. reported that the puncture force for the median cubital vein on a volunteer was 0.64 ± 0.23 n (21 g, regular bevel).16 consequently, all models were deemed stiffer compared to the human body, aligning with the observations in the authors’ previous studies.12,13 in a subjective evaluation, model c was assessed to be the most similar to the human body, although there were opinions that the skin and blood vessels were slightly stiff.12 in the experimental results of this study, model c was the closest to the human body among the three models. therefore, the subjective evaluations of the models by previous studies12 and the quantitative evaluation by the current method are in agreement, and the results are considered to be reasonable. several factors could account for the variation in results, even when punctures are performed under specific conditions. given that blood vessels have a cylindrical shape, their thickness can vary depending on the position of the puncture. moreover, the blood vessels themselves are not uniformly manufactured. consequently, the large standard error in model b might be because of the nonuniform thickness of the blood vessel compared to other models or the blood vessel being stiffer than in other models. these tendencies are more pronounced. however, when compared to the experimental results using the syringe-type puncture force waveform measuring device, the smaller standard error and the independence of this experimental system from human techniques suggest the possibility of a more quantitative evaluation.12,13 since the number of trials in both the previous study12 and the present study was the same (n = 12), the comparison based on standard error is considered appropriate. therefore, the smaller standard error observed in this study reflects reduced variability and supports the potential for more consistent and quantitative evaluation. in addition, an investigation of puncture speed dependence by naemura et al. reported that the higher the puncture speed, the higher the peak value, up to a region of 600 mm/min or less. the trend became more pronounced with increasing needle diameter, and differences in the needle tip shape were considered to contribute to variations in its magnitude.17 lorenzo et al. demonstrated that during needle insertion, the cutting force at the needle tip changes markedly when penetrating tissue, while the shaft friction force increases proportionally with insertion depth but does not change abruptly at penetration.18 these reports suggest that the maximum puncture force increases when the incision force of the needle is insufficient relative to the puncture velocity. since model b was considered the stiffest model in previous studies, it is possible that this tendency was significantly observed.12,13 conclusion in this study, we sought to evaluate the model using a puncture force test device that allows for puncture under specific conditions. multiple comparisons of the average maximum puncture force indicated that the model was capable of detecting differences in model characteristics to an equal or greater extent than the method using a syringe-type puncture force waveform measuring device. furthermore, the results, which had a small standard error, and the device that enabled puncture force measurement under certain conditions eliminated the need to consider the effects of individual differences among experiment participants. this facilitated a more quantitative evaluation of the model. however, the maximum puncture force of the model was higher than the results of puncture experiments on the human body reported in previous studies, including a study by the authors.12,13 therefore, it is necessary to innovate materials for the skin and blood vessels by developing synthetic materials with lower elasticity in order to enhance the model’s resemblance to the human body. author contributions conceptualization, n.n., k.h. and k.a.; methodology, n.n.; validation, n.n.; formal analysis, n.n.; data curation, n.n.; writing–original draft preparation, n.n.; writing– review & editing, n.n., k.h. and k.a. nakaya, horiuchi, aoki: quantitative evaluation of venipuncture training models: a study using a puncture force testing device j global clinical engineering vol.7 issue 2: 2025 70 acknowledgments not applicable. funding the authors did not receive support from any organization for the submitted work. data availability statement the raw data supporting the conclusions of this article will be made available by the authors on request. conflicts of interest the authors declare they have no competing interests. ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure part of the findings were presented at the 27th annual conference of biomedical fuzzy systems association (japan), 2014. references 1. ishikawa, k., kobayashi, g., sugawara, a., et al. a 2016 nationwide survey on the application of simulation-based medical education in japan (in japanese). j jpn soc med educ. 2017;48(5):305–310. https://doi.org/10.11307/ mededjapan.48.5_305. 2. suzuki, t., beppu, m., nara, n. a questionnaire survey concerning the distribution and equipment of clinical skills laboratories in japanese medical schools: simulationbased skills training courses in clinical skills laboratories (in japanese). j jpn soc med educ. 2009;40(5):361–365. https://doi.org/10.11307/mededjapan.40.361. 3. medical education division, ministry of education, science and technology, list of universities with medical schools (2024) (in japanese). available online: https://www.mext. go.jp/content/20241220-mxt-igaku-100001063_1.pdf. 4. ministry of health, labour and welfare, list of medical occupation training facilities. available online: https:// youseijo.mhlw.go.jp/. 5. japanese association of medical technology education, universities, colleges, and vocational schools (list of council member institutions). available online: https:// www.nitirinkyo.jp/member_facilities. 6. national council of radiological technologist education facilities, list of member schools. available online: https:// hosyasen-kyougikai.org/school_list/. 7. japan association of educational facilities of clinical engineers, list of council member schools. available online: https://www.jaefce.org/committe/school_ce/. 8. jones, r.s., simmons, a., boykin, g.l., et al. measuring intravenous cannulation skills of practical nursing students using rubber mannequin intravenous training arms. mil med. 2014;179(11):1361–1367. https://www.researchgate. net/publication/267872953. 9. saito, h., togawa, t. detection of needle puncture to blood vessel using puncture force measurement. med. biol. eng. comput. 2005;43:240–244. https://doi.org/10.1007/ bf02345961. 10. yamazaki, c., hirata, r., hosoya, t., et al. analysis of questionnaire survey on learning from actual blood sampling using human body by assuming roles of patients and nurses in fundamental nursing practice (in japanese). med health sci res. 2010;1:183–191. https://doi.org/10.20843/00000553. 11. doni widyandana. developing low-cost mannequin for undergraduate iv line phlebotomy. the indonesian journal of medical education, 2018;7(3):191–196. https://doi. org/10.22146/jpki.41842. 12. nakaya, n., horiuchi, k., aoki, k. evaluation of the intravenous blood sampling practice model using a syringe-type force sensor (in japanese). med biol. 2013;157(2):257–264. https:// jglobal.jst.go.jp/en/detail?jglobal_id=201302273894723646. 13. nakaya, n., horiuchi, k., aoki, k. discrimination of venous blood collection model characteristics through analysis of force applied on syringe needle (in japanese). j biomed fuzzy syst assoc. 2014;16(1): 97–104. https://doi. org/10.24466/jbfsa.16.1_97. https://doi.org/10.11307/mededjapan.48.5_305 https://doi.org/10.11307/mededjapan.48.5_305 https://doi.org/10.11307/mededjapan.40.361 https://www.mext.go.jp/content/20241220-mxt-igaku-100001063_1.pdf https://www.mext.go.jp/content/20241220-mxt-igaku-100001063_1.pdf https://youseijo.mhlw.go.jp/ https://youseijo.mhlw.go.jp/ https://www.nitirinkyo.jp/member_facilities https://www.nitirinkyo.jp/member_facilities https://hosyasen-kyougikai.org/school_list/ https://hosyasen-kyougikai.org/school_list/ https://www.jaefce.org/committe/school_ce/ https://www.researchgate.net/publication/267872953 https://www.researchgate.net/publication/267872953 https://doi.org/10.1007/bf02345961 https://doi.org/10.1007/bf02345961 https://doi.org/10.20843/00000553 https://doi.org/10.22146/jpki.41842 https://doi.org/10.22146/jpki.41842 https://jglobal.jst.go.jp/en/detail?jglobal_id=201302273894723646 https://jglobal.jst.go.jp/en/detail?jglobal_id=201302273894723646 https://doi.org/10.24466/jbfsa.16.1_97 https://doi.org/10.24466/jbfsa.16.1_97 71 j global clinical engineering vol.7 issue 2: 2025 nakaya, horiuchi, aoki: quantitative evaluation of venipuncture training models: a study using a puncture force testing device 14. world health organization, who guidelines on drawing blood: best practices in phlebotomy. 2010. available online: https://www.who.int/publications/i/item/9789241599221. 15. heverly, m., dupont, p., triedman, j. trajectory optimization for dynamic needle insertion. in proceedings of the 2005 ieee international conference on robotics and automation, barcelona, spain, april 18–22, 2005:1658–1663. https:// doi.org/10.1109/robot.2005.1570349. 16. okuno, d., togawa, t., saito, h., et al. development of an automatic blood sampling system: control of the puncturing needle by measurement forces. in proceedings of the 20th annual international conference of the ieee engineering in medicine and biology society, hong kong, china, october 29–november 1, 1998:1811–1812. https://doi.org/10.1109/ iembs.1998.746941. 17. naemura, k., shinohara, k., karube, i. puncture force analysis for the epidural anesthesia needles (in japanese). in the 17th proceedings of the jsme bioengineering conference and seminar, nagoya, japan, january 22–23, 2005:181–182. https://doi.org/10.1299/jsmebs.2004.17.0_181. 18. de lorenzo d., koseki y., de momi e., et al. coaxial needle insertion assistant with enhanced force feedback. ieee trans biomed eng. 2013;60(2): 379–389. https://doi. org/10.1109/tbme.2012.2227316. https://www.who.int/publications/i/item/9789241599221 https://doi.org/10.1109/robot.2005.1570349 https://doi.org/10.1109/robot.2005.1570349 https://doi.org/10.1109/iembs.1998.746941 https://doi.org/10.1109/iembs.1998.746941 https://doi.org/10.1299/jsmebs.2004.17.0_181. https://doi.org/10.1109/tbme.2012.2227316 https://doi.org/10.1109/tbme.2012.2227316 25 j global clinical engineering vol.7 issue 2: 2025 received march 3, 2025, accepted april 19 2025, date of publication april 28 2025. original research article mongolian medical equipment regulations: challenges in clinical engineering development gerelt-od namdag1, amarsaikhan dashtseren2, and munkh-erdene luvsan1* 1 department of health policy, school of public health, mongolian national university of medical sciences, ulaanbaatar, mongolia. 2 department of preventive medicine, school of public health, mongolian national university of medical sciences, ulaanbaatar, mongolia. * corresponding author email: munkherdene@mnums.edu.mn abstract to effectively deliver healthcare services, it is essential to strengthen and expand the education system for qualified clinical engineers and technicians. this should be combined with measures such as providing modern equipment to health facilities and making spare parts available. internationally, one clinical engineer is typically responsible for approximately 100 pieces of equipment, while each large piece of equipment, such as magnetic resonance imaging (mri), computed tomography (ct), positron emission tomography (pet scan), and angiography machines, is assigned to a dedicated engineer. however, in our country, no standard exists linking the number of engineers to the quantity of medical equipment. the law on drugs and medical devices, adopted in 2024, stipulates that general hospitals, specialized centers, and specialized hospitals must have a dedicated unit responsible for the use and safety of medical equipment, while other healthcare institutions must employ a full-time or subcontracted engineer. however, biomedical engineers and technicians are not classified as “medical specialists” under the law on health. although four universities nationwide train biomedical engineers and technicians, the number of graduates still does not meet the growing market demand. there is also a need to diversify and develop biomedical engineers in line with international standards, including certification. these findings underscore the need for structural reforms in clinical engineering training, legal recognition, and workforce planning in mongolia. objective: to assess the human resource needs and legal framework for medical equipment specialists and compare them with the who and regional country regulations. methods: we used analytical, cross-sectional, and descriptive study designs. a total of 272 engineers and technicians were interviewed using a pre-prepared questionnaire that included questions on work experience, postgraduate training, qualification level, and workload. we also reviewed who and regional regulations regarding the professional descriptions and certification of biomedical engineers. the data were analyzed using spss statistics 26, and the results are presented in figures and tables. results: the study population comprised 72.4% males, 95.6% full-time employees, and 68.8% bachelor’s degree holders. however, the majority (90.4%) did not have a specialty degree. regarding on-the-job and other training, 73.5% had not received any training. the training status of professionals was not dependent on the organization they worked for. however, there was http://www.globalce.org http://globalce.org http://globalce.org mailto:munkherdene@mnums.edu.mn namdag, dashtseren, luvsan: mongolian medical equipment regulations: challenges in clinical engineering development j global clinical engineering vol.7 issue 2: 2025 26 a statistically significant difference between foreign training and manufacturer-provided training. the professionals surveyed had received relatively little training since they started working. as their years of experience increased, the number of manufacturer-organized training sessions also increased. however, there was no relation between years of experience and the number of domestic, foreign, or postgraduate training sessions. additionally, the number of medical devices managed per engineer varied, and the legal framework regulating social security, rights, and obligations remains insufficient. it also varied compared to who recommendations, medical engineering professional descriptions, and certifications across countries in the region. conclusion: clinical engineers and technicians face a heavier workload. the lack of postgraduate training opportunities, an insufficient legal framework, and variations in medical engineering professional descriptions and certifications across countries in the region present significant challenges for the sector. based on these findings, the study proposes strategic recommendations including legal recognition, certification systems, continuing professional development, and workforce planning policies to address these barriers and strengthen clinical engineering in mongolia. keywords—human resources, healthcare specialist, legal framework. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. background in mongolia, health products and technologies, one of the six main components of the health sector systems developed by the world health organization,1 are regulated by the law on health,2 the revised version of the law on drugs and medical devices,3 and the law on metrology.4 to effectively deliver healthcare services, it is essential to strengthen and expand the education system for qualified engineers and technicians of medical equipment. this effort should be complemented by equipping healthcare institutions with modern medical devices and ensuring the availability of spare parts. in mongolia, the state budget for medical equipment ranged from 9 to 41 billion tugriks between 2017 and 2021. since 2018, maintenance costs for major technologies such as magnetic resonance imaging (mri), computed tomography (ct), and angiography devices, previously covered by the organizations’ operating expenses, have been separately allocated in the state budget. however, since 2020, healthcare institutions have been responsible for these costs.5 article 40.1 of the revised law on drugs and medical devices states that “healthcare institutions specified in articles 15.1.4, 15.1.5, 15.1.7, 15.1.11, 15.1.12, and 15.1.13 of the law on health shall have a unit responsible for the use and safety of medical equipment, and other healthcare institutions shall have a full-time or contracted clinical engineer who shall perform the corresponding functions.”3 however, the rights and obligations outlined in articles 28.1 and 28.4 of the law on health, particularly article 28.1.5, which states that professionals should have the opportunity to “improve their professional skills and participate in postgraduate training at the expense of the institution every five years,”2 do not apply to clinical engineers. the who also published a report titled “human resources for medical devices: the role of biomedical engineers as part of its medical device technical series”, highlighting the global concern over the need for certification of professionals in the field of biomedical engineering (bme).6 the mongolian standard sets the minimum staffing ratio of clinical engineers to technicians (4:2) for both specialized and general hospitals,7,8 and 1 per 100 pieces of equipment for family health centers,9 soum (district) and village health centers,10 and maternity houses.11 additionally, the national center for blood transfusion and research and the national center for zoonotic diseases have a 2:1 ratio,12,13 while the national center for pathology follows a ratio of 1:1.14 nevertheless, a report by the ministry of health of mongolia indicated that, in practice, one engineer is responsible for 220 pieces of equipment in central hospitals and specialized centers, while one engineer manages 319 pieces of equipment in both the capital and local areas.15 according to the order no. 439 issued in 2006 by the minister of health of mongolia, one engineer is typically responsible for approximately 100 pieces of medical equipment, with one engineer dedicated to each major device, such as mri, ct, pet scan, and angiography machines.16 https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 27 j global clinical engineering vol.7 issue 2 2025 namdag, dashtseren, luvsan: mongolian medical equipment regulations: challenges in clinical engineering development the me uptime project (2018), jointly conducted by the ministry of health of zambia and the tropical health and education trust (thet) with the support of who, recommended that “1 bmet per 100 units of equipment is adequate,” emphasizing the need for structured biomedical maintenance staffing.17 according to the us bureau of labor statistics, the demand for biomedical engineers is projected to grow by 5% from 2022 to 2032, outpacing the growth of many other occupations.18 this increase is driven by advancements in healthcare technology and the rising demand for medical services due to an aging population.18 in mongolia, two government and two private universities offer training programs for biomedical engineers and technicians. according to the 2023 statistics, approximately 900 engineers and technicians have been trained.19 although human resource requirements for medical equipment maintenance were established by the minister of health orders in 2006 and 2018, implementation remains limited.16,20 only 43% of the 16 healthcare institutions under the ministry of health have independent clinical engineering departments. among the 25 healthcare institutions under the capital city health department, 24% have only 1 to 2 engineers. moreover, 95% of the 21 provincial healthcare institutions operate with just 1 to 2 engineers and lack dedicated medical technical departments.15 therefore, it is necessary to assess the adequacy of clinical engineers in the healthcare sector and compare the legal framework with that of other countries in the region. objective to assess the human resource needs and associated legal framework for medical equipment specialists and compare them with the who recommendations and regional country regulations. methods the study followed an analytic, cross-sectional, and descriptive study design. human resource needs were assessed through indicators such as employment contract specifications, qualifications, training, years of experience, and workload. a structured questionnaire was used to collect data on the number of engineers and technicians currently working in the medical equipment field, their qualifications, and training from 76 healthcare institutions in the capital and local areas. additionally, data was collected from 272 currently working specialists, covering job roles, contract types, main specialties, years of experience, and training. mongolian laws, standards, rules, and regulations related to human resources for medical equipment, as well as who recommendations and regulations in regional countries, were also reviewed. for the descriptive analysis, the mean, standard deviation, and 95% confidence interval of the mean were calculated for quantitative variables with normal distribution. for non-normal distributions, the median and interquartile range were calculated. outliers in quantitative variables with non-normal distribution (defined as x ≤ q1−1.5iqr or x ≥ q3+1.5iqr) were removed. after removing outliers, the mean, standard deviation, and 95% confidence interval of the mean were recalculated. to assess differences in quantitative variables between groups, the mann–whitney u test was used for two independent groups, and the kruskal–wallis h test was used for three or more groups. differences were considered statistically significant if the p-value was less than 0.05. ethical considerations the study methodology was discussed at the institutional review board meeting of the mongolian national university of medical sciences on january 21, 2022 (no. 2022/3-01), and permission to conduct the study was obtained. results we surveyed 272 professionals, comprising 83.9% of engineers and technicians working in the healthcare sector. of the professionals surveyed, 72.4% were males, 95.6% were full-time employees, and 68.8% held a bachelor’s degree. however, the majority (90.4%) of specialists did not have a professional degree (table 1). this is attributed to the lack of a legal framework, professional career development roadmaps, job descriptions, and planning. namdag, dashtseren, luvsan: mongolian medical equipment regulations: challenges in clinical engineering development j global clinical engineering vol.7 issue 2: 2025 28 table 1. general characteristics of medical equipment specialists in organizations, by percentage. indicators total, n = 272 mh* pgh† rdtc‡ dgh§ dhcii sgh¶ sh†† ecmohsc# so** gender female 27.6 85.7 26.7 33.3 25.0 37.5 25.0 50.0 27.9 21.6 male 72.4 14.3 73.3 66.7 75.0 62.5 75.0 50.0 72.1 78.4 terms of the employment contract contract 4.4 8.9 12.5 50.0 4.9 0.9 full-time 95.6 100.0 91.1 100.0 100.0 87.5 50.0 100.0 95.1 99.1 education level no education 0.7 4.4 high school 2.6 4.4 5.6 6.6 bachelor 68.8 71.4 53.3 44.4 87.5 87.5 100.0 50.0 57.4 80.2 licentiate 19.1 35.6 44.4 12.5 12.5 24.6 9.0 master 8.8 28.6 2.2 5.6 50.0 11.5 10.8 qualification none 90.4 100.0 77.8 94.4 100.0 87.5 100.0 100.0 90.2 93.7 consultant 0.7 1.6 0.9 qualified 8.8 22.2 5.6 12.5 8.2 5.4 notes: *maternal houses, †provincial general hospitals, ‡regional diagnostic and treatment centers, §district general hospitals, iidistrict health centers, ¶soum general hospitals, ††specialized hospitals, capital department of health institutions, #emergency centers, ministry of health specialized centers, **supply organizations. 29 j global clinical engineering vol.7 issue 2 2025 namdag, dashtseren, luvsan: mongolian medical equipment regulations: challenges in clinical engineering development table 2. training of biomedical engineers and technicians, by type of organizations. indicators total ub health department local private ministry of health p n % n % n % n % n % internal training 0.371 not attended at all 200 73.5 24 72.7 44 65.7 86 77.5 46 75.4 attended 72 26.5 9 27.3 23 34.3 25 22.5 15 24.6 foreign training 0.0001 not attended at all 258 94.9 32 97.0 67 100.0 109 98.2 50 82.0 attended 14 5.1 1 3.0 0 0.0 2 1.8 11 18.0 postgraduate training 0.140 not attended at all 187 68.8 23 69.7 44 65.7 84 75.7 36 59.0 attended 85 31.3 10 30.3 23 34.3 27 24.3 25 41.0 manufacturer training 0.0001 not attended at all 176 64.7 33 100.0 58 86.6 36 32.4 49 80.3 attended 96 35.3 0 0.0 9 13.4 75 67.6 12 19.7 notes: percentages may not add up to exactly 100% due to rounding, institutional differences in respondent numbers, and missing values for some variables. namdag, dashtseren, luvsan: mongolian medical equipment regulations: challenges in clinical engineering development j global clinical engineering vol.7 issue 2: 2025 30 as for the status of on-the-job and other training received by the surveyed professionals, 73.5% had not received any training. the training status did not depend on the organization they worked for. however, there was a statistically significant difference between the organizations in the availability of foreign and manufacturer training (table 2). table 2 and figures 1 and 2 show that the professionals surveyed receive relatively little training after starting their occupation. the average duration of postgraduate training is 32 days (95% ci, 22.8–41.2) in government organizations and 19.8 days (95% ci, 9.5–30.1) in private organizations (figure 1). figure 1. internal training participation by organizations. manufacturers are equally represented in government and private organizations, with 17.2 (± 16.3) days of training. the maximum duration of postgraduate training was 93 days in government organizations, while it was 70 days figure 2. manufacturer training participation by organizations. in private organizations, indicating that training was more concentrated in government organizations (figure 2). as the number of years of experience in the field increases among the surveyed professionals, participation in training organized by the manufacturer increases. however, participation in domestic, foreign, and postgraduate training was not associated with the years of experience (table 3). as the number of years of experience in the field increased among the surveyed professionals, participation in training organized by the manufacturer also increased. on the other hand, participation in domestic, foreign, and postgraduate training was not significantly associated with years of experience (table 3). 31 j global clinical engineering vol.7 issue 2 2025 namdag, dashtseren, luvsan: mongolian medical equipment regulations: challenges in clinical engineering development table 3. training of biomedical engineers and technicians, by years of experience. indicators 1–3 years 4–6 years 7–9 years 10+ years p number % number % number % number % internal training 0.437 not attended at all 72 78.3 39 73.6 32 71.1 51 67.1 attended 20 21.7 14 26.4 13 28.9 25 32.9 foreign training 0.197 not attended at all 90 97.8 51 96.2 43 95.6 69 90.8 attended 2 2.2 2 3.8 2 4.4 7 9.2 postgraduate training 0.064 not attended at all 71 77.2 37 69.8 30 66.7 44 57.9 attended 21 22.8 16 30.2 15 33.3 32 42.1 manufacturer training 0.001 not attended at all 74 80.4 28 52.8 25 55.6 44 57.9 attended 18 19.6 25 47.2 20 44.4 32 42.1 namdag, dashtseren, luvsan: mongolian medical equipment regulations: challenges in clinical engineering development j global clinical engineering vol.7 issue 2: 2025 32 discussion in the isco-08 system of international standard classification of occupations published by the international labor organization-ilo, biomedical engineers are classified under the group 2149 category, “engineering professionals not elsewhere classified.”21 in mongolia, order no. 16, “national lists, classifications and definitions of occupations and jobs”, issued by the minister of labor and social protection on february 10, 2010, biomedical engineers are classified under the group 2149 category, “engineering professionals not elsewhere classified.”22 the world health organization’s medical devices technical series report, human resource development and the role of biomedical engineers, highlights that bme is not officially classified within the health category in international and national occupational classifications.23 this lack of recognition impacts the assessment and development of the profession, hinders acknowledgment of its critical role, and negatively affects the sustainability of human resources in the health sector.6 over the past decade, the rapid advancement of medical science and technology has led to continuous investments in new healthcare technologies, significantly increasing the workload of engineers and technicians. according to our findings, there are 324 (± 234) pieces of equipment per engineer, which exceeds international standards. this highlights the need for additional professional human resources in the healthcare sector. additionally, there is a need for continuous training of existing specialists, improvement of the legal framework, and the development and implementation of job descriptions and career development plans. the law on drugs and medical devices (revised version) mandates that large hospitals establish medical equipment units and requires other healthcare organizations to employ full-time or contracted clinical engineers. however, clinical engineers and technicians are not classified as “medical specialists” under the law on health, which regulates social security, rights, and obligations for human resources in the sector. this results in a regulatory gap, violating provisions such as the requirement for professionals to improve their skills and attend postgraduate training at the organization’s expense every 5 years. a study on the prevalence of biomedical engineers per 10,000 population in the who western pacific region found that japan had 1.58, malaysia 0.82, mongolia 0.81, and kiribati 0.27, while china had 0.03 and the republic of korea had < 0.01.24 a study by the who (2015) found that the proportion of male engineers (77%) was three times higher than that of female engineers (23%). however, five countries, namely argentina, ukraine, macedonia, malaysia, and sudan, reported that the number of female engineers exceeded that of males. in contrast, laos, micronesia, rwanda, sierra leone, tanzania, and vanuatu did not register any female engineers at all.24 according to the who research, mongolia has 240 biomedical or clinical engineering specialists.24 regarding the structural organization and human resource supply for the maintenance and reliable operation of medical equipment, as of 2023, 43% of the 16 healthcare institutions under the ministry of health had an independent clinical department staffed with 10 to 20 engineers and technicians. in contrast, 24% of the 25 healthcare institutions under the ulaanbaatar city health department (ubhd) had only 1 to 2 engineers, while 95% of the 21 provincial healthcare institutions had just 1 to 2 engineers, without an independent medical technical department. the who emphasizes the need for long-term, sustainable efforts to train highly skilled engineers and technicians to ensure the normal and reliable operation and maintenance of medical equipment. this approach will help reduce maintenance costs and improve the quality of medical care and services.25 in mongolia, medical equipment engineers are referred to as “biomedical engineers”, regardless of the field they work in (hospitals, supply organizations, factories, etc.). they are also typically certified as consulting healthcare engineers or certified healthcare engineers.26 a series of technical documents issued by the who has defined bme as follows: “biomedical engineering” includes equivalent or similar disciplines, whose names might be different, such as medical engineering, electromedicine, bioengineering, medical and biological engineering, and clinical engineering.27 33 j global clinical engineering vol.7 issue 2 2025 namdag, dashtseren, luvsan: mongolian medical equipment regulations: challenges in clinical engineering development however, in some countries, the term “biomedical engineer” is used interchangeably with “clinical engineer” in hospitals. the american college of clinical engineering defines a clinical engineer as “a professional who supports and advances patient care by applying engineering and managerial skills to health care technology”.28 the association for the advancement of medical instrumentation describes a clinical engineer as, “a professional who brings to health-care facilities a level of education, experience, and accomplishment which will enable him to responsibly, effectively, and safely manage and interface with medical devices, instruments, and systems and the user thereof during patient care”.29 japan has a government-certified clinical engineering technologist (cet) designation. to become a cet, one must graduate from a university, college, or vocational school with a degree in clinical engineering and pass a national examination. cets specialize in the operation and maintenance of medical equipment. in 1987, the clinical engineering law was enacted, regulating cets as medical professionals who specialize in the operation and maintenance of life-saving equipment.30 in taiwan, the taiwan society for biomedical engineering certifies clinical engineers, medical device technicians, and biomedical engineers. it has been administering formal certification exams since 2007.30 in 2005, international clinical engineer certification was introduced in china. the medical engineering division of the chinese medical association organizes the examination. in 2012, the chinese registered clinical engineer certification program was launched, with the examination including both theoretical and practical tests.30 in mongolia, medical equipment engineers are awarded consulting and specialized engineering degrees following order no. 213 of the minister of health, dated september 2, 2005, titled “on organizing training for granting specialist and consulting engineering degrees to healthcare engineers.”26 these findings demonstrate that despite the establishment of basic legal provisions, significant gaps remain in human resource development and regulation for clinical engineering. the data show limited access to training, a high equipment-to-engineer ratio, and the lack of professional recognition. compared to who, imdrf, and the regulations of countries like australia, japan, korea, china, and the philippines, mongolia’s medical device regulation shows gaps in terminology, classification, post-market surveillance, packaging, labeling, advertising, and disposal. however, import regulations align with international standards.31 as highlighted by ayala (2022), the role of clinical engineering has progressed alongside the increasing complexity of medical technologies—extending beyond equipment maintenance to encompass integrated management, innovation, and participation in policy-making processes.32 as mijares (2023) emphasizes in his study of clinical engineering in venezuela, the interaction between health technologies and national political systems plays a critical role in determining the quality and accessibility of medical care. the research underscores that sustainable clinical engineering development requires not only technical expertise, but also alignment with coherent public health policies and transparency in procurement and evaluation processes.33 based on the findings and challenges discussed above, the following policy strategies are recommended to strengthen the clinical engineering profession in mongolia. recommendations: establish a national certification and accreditation system for clinical engineers, aligned with who and imdrf standards. revise the law on health to recognize clinical engineers as health professionals, ensuring their inclusion in workforce development and social protection policies. develop structured career pathways and continuing professional development (cpd) requirements, including the implementation of a system for mandatory training every 3 to 5 years. namdag, dashtseren, luvsan: mongolian medical equipment regulations: challenges in clinical engineering development j global clinical engineering vol.7 issue 2: 2025 34 define institutional staffing norms based on the level of healthcare facilities and the quantity and complexity of medical equipment. large hospitals should establish dedicated clinical engineering units or departments. implement a nationwide technical training program in collaboration with foreign universities and medical equipment manufacturers. conclusion clinical engineers and technicians in mongolia face significantly higher workloads. the lack of structured postgraduate training, legal recognition in the health sector, and insufficient support for professional development present critical challenges to the field. internationally, countries such as japan, taiwan, and china have adopted national certification systems and legal frameworks that formally recognize clinical engineering as a healthcare profession. aligning with who recommendations and regional best practices, this study recommends establishing a national certification and accreditation system, revising health laws to include biomedical engineers as health professionals, and implementing structured career pathways with mandatory continuing education. these measures will help ensure safe and effective medical device management, improve healthcare service delivery, and foster long-term sustainability of the bme workforce in mongolia. author contributions conceptualization, a.d., m.-e.l., and g.-o.n.; methodology, m.-e.l.; formal analysis, m.-e.l. and g.-o.n.; writing–original draft preparation, m.-e.l. and g.-o.n.; writing–review & editing, m.-e.l.; supervision, a.d.; project administration, m.-e.l.; funding acquisition, g.-o.n. acknowledgments the research team would like to thank the health professionals, collaborating organizations, and colleagues who contributed to the data collection process. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare they have no competing interests. ethics approval and consent to participate the study methodology was discussed at the institutional review board meeting of the mongolian national university of medical sciences on january 21, 2022 (no. 2022/3-01), and permission to conduct the study was obtained. consent for publication not applicable. further disclosure not applicable. references 1. world health organization. development of medical device policies. world health organization; 2011. 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https://doi.org/10.31354/globalce.v7i1.189. 32. ayala, r. clinical engineering role in the development of emergency use medical devices. glob clin eng j. 2022;4(3):47–49. https://doi.org/10.31354/ globalce.v4i3.137. 33. mijares, r. clinical engineering and health policies in venezuela: challenges and achievements in a changing political context. glob clin eng j. 2023;6(1):36–45. https://doi.org/10.31354/globalce.v6i1.161. https://iris.who.int/bitstream/handle/10665/255261/9789241565479-eng.pdf?sequence=1 https://iris.who.int/bitstream/handle/10665/255261/9789241565479-eng.pdf?sequence=1 https://iris.who.int/bitstream/handle/10665/255261/9789241565479-eng.pdf?sequence=1 https://www.who.int/publications/i/item/9789241512312 https://www.who.int/publications/i/item/9789241512312 https://iris.who.int/bitstream/handle/10665/44562/9789241501385-eng.pdf?sequence=1 https://iris.who.int/bitstream/handle/10665/44562/9789241501385-eng.pdf?sequence=1 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hussein onn malaysia, parit raja, johor abstract abstract: smoking has a significant impact on microcirculation, but existing tools for monitoring circulation perfusion in the smoking group have different shortcomings. this preliminary study explores the feasibility of using an in-house assembled multispectral photoacoustic (pa) system to investigate and compare the microcirculation performance between smoking and nonsmoking subjects. for this purpose, pretrained alexnet, long short-term memory (lstm), and a hybrid alexnet-lstm network were employed for the prediction task. this research included five smoking and thirty-two nonsmoking participants in the investigations that involved two experimental conditions, i.e., at rest and arterial blood flow occlusion. the findings showed that the pa signals produced in the smoking group have generally smaller magnitudes and negligible differences (when comparing between the two experiment conditions) than their nonsmoking counterpart. the employed models performed superiorly with the highest accuracy of 90 % given by the hybrid model, followed by 80 % recorded for alexnet and lstm using nonsmoking data. the performance of these models is reduced when they are trained and tested using smoking data. our study highlights the task complexity and difficulty in determining tissue microcirculation status in heavy smoking individuals, which has been attributed to their possibly pre-existing atherosclerotic conditions and the high carboxyhemoglobin (cohb) level. a longitudinal study of smoking habit-dependent microcirculation abnormalities in smokers could offer further avenues for investigation. future research includes incorporating systematic experimental protocols and access to the participant’s medical records to improve the performance of the clinical decision-making system used for field applications. keywords – microcirculation perfusion; photoacoustic; smoking; alexnet; lstm copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ chua and huong: deep learning and photoacoustic technology for microcirculation classification: comparison between smoking and nonsmoking groups j global clinical engineering vol.6 issue 3: 2024 38 introduction smoking increases the risks of various conditions, including lung cancer, heart disease, respiratory problems, and other significant health issues. it induces vasoconstriction, narrowing the blood vessels in microcirculation and reducing blood flow to organs and tissues. consequently, oxygen delivery to the tissues is diminished, impairing their proper function. smoking also increases blood viscosity, hindering nutrient and oxygen delivery through narrow microvessels; it promotes the formation of blood clots, obstructs microcirculatory vessels, and damages tissue. tobacco smoke contains carbon monoxide (co) as one of its toxic components. when tobacco is burned and inhaled, co is absorbed into the bloodstream, significantly affecting microcirculation. co causes adverse effects in humans by combining with hemoglobin to form carboxyhemoglobin (cohb), preventing blood from carrying oxygen.1-2 based on the reports of silva,3 there exists a close association between tobacco use and microvascular dysfunction, which is manifested by impeded blood flow. conventional technologies available to investigate microcirculation in the smoking population include magnetic resonance imaging (mri),4 pulse co-oximetry,5 and spectroscopy.6–7 however, the use of mri is limited because of its high operational cost and rigid working conditions. investigation of microcirculatory performances based on tissue gas saturation using co-oximeter and spectroscopy is limited by the light penetration depth and variable degree of light scattering from tissue heterogeneity.8 photoacoustic (pa) imaging, which combines the features of optical spectroscopy and deep penetration of acoustic technologies, has gained increasing interest as an alternative method in microcirculation flow abnormalities detection. the light illuminating a sample absorbed by chromophores in the skin produces thermal expansion, which generates acoustic waves that a transducer can detect. the peaks of pa signals are linearly associated with the sample properties, while the temporal characteristic of pa signals would disclose the physiological properties of the tissues. traditionally, physicians, particularly radiologists, would review and examine medical images before deciding on treatment planning. these tasks are crucial in diagnostic radiography, involving challenging analysis and diagnosis based on visual images. artificial intelligence (ai) has become essential in assisting and enhancing these decision-making processes by providing accurate, reliable, and efficient interpretation of results. this technology has been actively studied for different pa applications; some recent ai efforts include sumit et al. 9, who demonstrated using deep learning (u-net model) for multi-target detection with simulated pa imaging datasets. warrier et al.10combined optimization and deep learning approaches for detecting and classifying cancer tissues using multispectral pa imaging. the study by mohajerani et al.11 proposed a novel machine learning-empowered optoacoustic sensor for recognizing diabetes with different complications based on the signals recorded from phantom and skin surfaces (in the human experiments). the adopted machine learning approach used bagged ensemble trees to find the correlation and best fit between the data and its labels. similar works were carried out by liakat et al.12 and sei et al.13; the former developed an in-vivo noninvasive glucose sensor to predict glucose concentration using the least square regression technique and based on the photoacoustic measurement in the skin, whereas the latter study used regression technique to determine blood saturation using pa signals of blood samples. to the authors’ best knowledge, no works have been carried out to use deep learning and pa techniques to compare the microcirculation changes or flow abnormalities between smoking and nonsmoking subjects. this work aims to investigate and compare the performance of different deep learning models for microcirculatory status (i.e., during at-rest and perfusion occlusion in smoking and nonsmoking groups) classification using the pa method. all the computations were performed on a dell laptop with 64-bit windows 10, intel® xeon™ i7-1700m cpu @3.20 ghz. all simulations were done in matlab (2022b). methods ethical statements: this study was approved by the local research ethics committee at universiti tun hussein onn malaysia (rmc.100-9/139,4). 39 j global clinical engineering vol.6 issue 3: 2024 chua and huong: deep learning and photoacoustic technology for microcirculation classification: comparison between smoking and nonsmoking groups 2.1 photoacoustic (pa) detection system the schematic diagram of the experimental setup is shown in figure 1 (top). the illumination system consisted of two 5 mm ultra-bright transparent white light emitting diodes (model: 5led-ul-w) filtered by color filters (model: fkb-vis-10, thorlabs) to generate five primary colors with a center light wavelength of 450 nm, 500 nm, 550 nm, 600 nm, and 650 nm. these wavelengths were selected as they encompass the absorption spectra of hemoglobin (i.e., oxyhemoglobin and deoxyhemoglobin) required for analysis. the light modulation for illumination of the target area was achieved using an acousto optic modulator (aom) controlled by a radiofrequency (rf) driver with a carrier frequency of 15 mhz. the aom produced modulating signals required to illuminate the subject. the acoustic energy generated in the medium was detected using an ultrasonic flaw detector (epoch 650, olympus corp, japan). a wideband bandpass filter with fixed cut-off frequencies (0.5–4 mhz) built into the flaw detector was used to filter out high-frequency noise. figure 1 (bottom) shows the actual setup in the laboratory. during measurements, a transducer head was placed in contact with the skin, and acoustic gel was the coupling medium. the signals were recorded using the epoch 650 flaw detector for offline analysis. figure 1. schematic diagram of the pa system experiment setup (top) and a photograph of a color-tunable led illuminating a subject’s forearm during the measurement (bottom). 2.2 subjects and protocol thirty-seven healthy individuals (19 males and 18 females, aged 21-30 years) were invited to participate in this research study. among them, 32 were nonsmoking, and five were smoking participants, whose number of cigarette smoking years ranged from two to five years. the number of cigarettes smoked was between five to fifteen cigarettes a week. the local research ethics committee at universiti tun hussein onn malaysia approved the study protocol (rmc.100-9/139,4). before the study, these participants reported no known illnesses and were provided information about the experimental procedures, objectives, and potential risks. upon enrolment, they provided their informed consent by signing a printed form. the experiment was conducted under two conditions: at rest and brachial artery blood flow occlusion to represent varying microcirculatory states. the study commenced with the at rest experiment, where each participant was instructed to position the selected site beneath the illuminated light beam, starting with the light wavelength of 450 nm. the distance was maintained at 1 cm, and the angle of incidence was set at 45° from the source, as depicted in figure 1 (bottom). five signals were recorded from the same target site before varying the incident light wavelength. during the systolic occlusion experiment, a blood pressure cuff (model no. ck-110) was applied to the participants’ upper left arm, i.e., by exerting a pressure of 140 mmhg for 30 seconds to induce ischemia, before the same data collection protocol was repeated. inflating the cuff around the arm temporarily blocked blood flow, inducing an ischemic state in tissues below the cuff. this process promotes changes in the functional microcirculation by reducing the supply of oxygen-carrying blood to the lower extremities. this produces pathological conditions similar in patients with peripheral artery and vascular diseases. these procedures were applied to both smoking and nonsmoking (as the control group) individuals. the recorded screenshot signals were saved onto a microsd memory card using the flaw detector’s built-in function for subsequent offline processing and analysis. chua and huong: deep learning and photoacoustic technology for microcirculation classification: comparison between smoking and nonsmoking groups j global clinical engineering vol.6 issue 3: 2024 40 2.3 signal pre-processing and dataset handling even though the produced pa signals are in 1d time series, the epoch 650 device has no function to save the raw signals. therefore, a signal restoration approach was employed to convert the screenshot of the image saved on a microsd card into a vector representation or matrix format suitable for use with a time-based deep neural network (i.e., lstm). this was facilitated by leveraging the distinct color contrast in the image, wherein the measured signal is depicted in green against a dark background. the image was first converted into a binary image using the im2bw function before the 1d matrix was obtained from the rows and columns of the image. the pa signal, x, from each measurement is of size 1 × 494 (i.e., x1 …, x494), which was fed into the network input layer for further classification and analysis. the original pa signals did not provide a satisfactory result in the pre-experiment investigations using the lstm network. therefore, time-dependent moments were used. the moments’ extraction is by using the tfsmoment function, and this study considered signal variance (order, n=2), skewness (n=3), and kurtosis (n=4) as the input features in the prediction of microcirculation status. the smoking pa images and the corresponding moments were randomly divided into a 40/20/40 % split for training, validation, and testing sets, rendering 20/10/20 images for convolutional-based models and 60/30/60 signals for the lstm network. the nonsmoking dataset divided using the split ratio of 46/28/26 % giving 160/100/90 images and 480/300/270 signals used for convolutional-based models and lstm, respectively. 2.4 deep learning networks and model training this study recruited pre-trained alexnet, lstm, and a hybrid model for microcirculation flow abnormalities classification based on the measured pa signal. alexnet and the hybrid model take color (rgb) images as the input, while the moments calculated from 1d pa signal in section 2.3 is used as the input of lstm. modification and the use of these models are described in sections 2.4.1 and 2.4.2; these models were optimized for the problem by searching for the best hyperparameter settings in section 2.4.3. 2.4.1 convolutional-based models the convolutional-based models used in this work comprised the pretrained alexnet and hybrid cnn-lstm model shown in figures 2 and 3. the input of these models was changed to 494 × 329 × 3, consistent with the original pa image size recorded from the system. in alexnet, the network’s last fully connected (fc) was modified to two neurons representing: “0” for the normal class and “1” for the pathological (or abnormal) class. a dropout layer of 0.50 was placed between each fc layer in figure 2 to reduce network overfitting. meanwhile, the alexnet-lstm shown in figure 3 was proposed to extract spatial and temporal features from the screenshot pa images. a batch normalization layer is added to this hybrid model to normalize inputs for the subsequent layer. the upper layers of this architecture (i.e., alexnet) are to extract spatial information from the input image. the extracted abstract information is passed through a flattened layer, converting the feature map into one-dimensional data. this sequential data is fed into the lstm network to extract the temporal patterns. this time-recurrent network consists of 500 hidden layers, which was decided during pre-experiment tests. these layers are connected to fc layers and dropout layers of 0.2 to improve model generalization. the output of the fcs is fed to a softmax to calculate class probabilities. figure 2. architecture of alexnet model. 41 j global clinical engineering vol.6 issue 3: 2024 chua and huong: deep learning and photoacoustic technology for microcirculation classification: comparison between smoking and nonsmoking groups figure 3. architecture of the proposed hybrid alexnet-lstm model. 2.4.2 time-based deep neural network the temporal recursive network, lstm, was also chosen for the task due to its adeptness in handling sequential data and addressing short-term memory challenges. its architecture consists of an input layer, taking the calculated moment features described in section 2.2 as the input signals, followed by a sequence of 155 hidden layers to extract their essential temporal features. these are followed by six fc layers, whose sizes progressively decrease from 40 to 30, 20, 10, 5, 3, and 2. while no definitive method for determining fc sizes exists, this study adopted a diminishing sequence to simplify the model’s structure, as shown in figure 4. a dropout layer with a value of 0.1 is incorporated after each fc layer to prevent the risk of overfitting, except for the final layer. the output from the final fc layers is fed into a softmax classifier to classify a signal into two categories (i.e., 0: normal and 1: pathological condition). figure 4. architecture of the lstm model. 2.4.3 hyperparameters selection and model training the classification models in figures 2–4 were trained using the adam optimizer, known for its fast computation and quick convergence, while other important hyperparameters in table 1 were adjusted manually. table 1. the tuning range of the considered hyperparameters and the chosen values parameter models limit step of change optimum hyperparameter lower upper epoch number alexnet 1 100 10 50 lstm 1 4000 100 500 hybrid 1 100 10 50 mini batch size alexnet 2 128 2n, where n = 2,3…7 16 lstm 2 2048 2n, where n = 2,3…11 32 hybrid 2 128 2n, where n = 2,3…7 16 initial learning rate alexnet lstm hybrid 5 × 10-4 1 5 × 10-4 5 × 10-4 gradient descent threshold alexnet lstm hybrid 1 × 10-3 1 1e-n, n = 3, 2, 1, 0 1 × 10-3 the optimal hyperparameters setting differed depending on the datasets and models used. two-hundred sets of combinations consisting of different values in table 1 were attempted in search for the best hyperparameters. the prediction accuracy fluctuated between 19% and 100%, while the training times varied from 56 to 154 minutes. this study identified the best combination based on the set that produced the highest training accuracy, such as 100 % for data of all wavelengths. the same optimum hyperparameters setting {epoch no., minibatch size, learning rate and gradient threshold} has been found for alexnet and hybrid model as {50, 16, 0.0005, and 0.001} and {70, 16, 0.0001, and 0.001}, respectively, for smoking and nonsmoking data, and {500, 32, 0.0005, and 0.001} and {3000, 256, 0.0001, and 0.001}, respectively, for lstm. 2.5 score fusion strategy this study used a combined prediction score to enhance the system’s classification confidence. the class probability from models trained with each wavelength (i.e., 450 to 650 nm) was combined through summing to give the final score. this strategy is coined as the fusion method. an example of the fusion technique is shown in figure 5. figure 5. fusion technique for final classification of microcirculatory status. chua and huong: deep learning and photoacoustic technology for microcirculation classification: comparison between smoking and nonsmoking groups j global clinical engineering vol.6 issue 3: 2024 42 2.6 performance metric the effectiveness of the trained models used in this study is evaluated using classification accuracy shown in equation (1). this performance metric measures the degree of closeness of predictions to actual values. (1) t denotes the total number of data and n denotes the total number of class labels (n = 2). a true positive (tpi ) is when the abnormality for signal i is correctly detected. a false positive (fp) is the percentage of normal data misclassified as abnormal, a false negative (fn) is an abnormal signal class member incorrectly classified as normal, and a true negative (tn) is the correct prediction of normal pa signal. results smoking individuals are known for having a high risk for vascular diseases; thus, the blood occlusion procedure is applied to these individuals to allow investigation of system sensitivity in this group of populations. figure 6 compares the peak of pa signals at different wavelengths for smokers and nonsmokers under at-rest and occlusion conditions. it can be observed that the pa signals from nonsmoking subjects have overall higher amplitude values under both at-rest and occlusion conditions as compared to smoking subjects. the pa produced from both (smoking and nonsmoking) groups exhibit the same pattern. the signals produced under at-rest and occlusion conditions peak at 450 nm and 550 nm, respectively, and the differences (between the different experimental conditions) are considerably negligible for wavelengths 500 nm, 600 nm, and 650 nm, as shown in the figure. the classification results following the fine-tuning of the employed models using the nonsmoking and smoking data and from score fusion technique are shown in figures 7 and 8, respectively. the training and testing of the alexnet and hybrid model used screenshot images, while signal moments described in section 2.3 are used as the input to the lstm. discussion pa technologies, such as skin glucose and oxygen saturation detections, have been extensively tested in various diagnostic imaging applications. however, the use of this technology in the detection of compromised microcirculation, especially in the smoking population, has not been investigated. this research compares changes in blood perfusion under induced pressure in individuals with figure 6. mean and standard deviation (represented by error bar) of pa echo amplitudes produced in smokers and nonsmokers under different illumination wavelengths. figure 7. confusion matrix of (a) alexnet, (b) lstm, and (c) hybrid model in classifying microcirculation status in nonsmoking subjects based on pa images and signals (class 0: normal, 1: abnormal). figure 8. confusion matrix of (a) alexnet, (b) lstm, and (c) hybrid model for classification of microcirculation status (class 0: normal, 1: abnormal) in smokers based on pa images and signals. 43 j global clinical engineering vol.6 issue 3: 2024 chua and huong: deep learning and photoacoustic technology for microcirculation classification: comparison between smoking and nonsmoking groups different smoking habits based on pa signals produced under visible wavelengths illumination. the fundamental principle of the adopted pa technology is that the magnitude of the pa signal produced by tissue depends on the hemoglobin variants’ absorption properties, wherein the oxyhemoglobin light absorption peaks at 450 nm14 while deoxyhemoglobin absorption peaks at 550–560 nm.15 the absorption properties of these hemoglobin variants are similar for the remainder employed wavelengths (i.e., 500, 600, 650 nm). this trend was observed in figure 6. this diagram revealed the highest pa signal magnitude recorded at 450 nm illumination, while 550 nm produced, generally, the highest ultrasonic echo amplitude under blood flow occlusion condition, where the regional tissue deoxygenated blood is rich due to impeded oxygen-carrying blood from flowing into the lower arm (measurement site). the pa signals obtained from smokers have considerably weaker echoes than nonsmokers, with a mean relative percent difference of 9.5% across all wavelengths and experiment conditions. this relative percent difference between nonsmoking and smoking results is divided by the two results. there is also high consistency in pa signals obtained from smoking subjects for both experiments. the cohb level is generally high in smokers, and the absorption spectrum of this hemoglobin variant, associated with the risk of inadequate oxygen delivery,16 is considerably less prominent as it overlaps with that of oxyhemoglobin and deoxyhemoglobin in the visible wavelength range. while the dominance of light absorption of cohb could be the primary cause of the observations on the lower magnitude in the produced signals, we do not rule out the possibility of the already impaired microcirculation function or pre-existing atherosclerotic conditions in this group of participants, causing negligible differences in the readings between the at rest and external exerting pressure experiment. figure 7 shows the models’ classification performance tested on nonsmoking (healthy) participants. the networks trained and tested on healthy subjects’ data revealed considerably good accuracies ranging between 85.6 and 90%, suggesting the consistent performance between the convolutional-based models and temporal-based lstm, and their feasibility in classifying normal and abnormal (occluded) microcirculation performance in nonsmoking individuals. meanwhile, the results in figure 8 reveal that the performance of these models decreased in the compromised microcirculation status (i.e., occlusion condition) detection. even though the hybrid model achieved consistent classification accuracy (i.e., 90%), followed by alexnet and lstm with a classification accuracy of 80%, this group’s fn rate is high (~20-40%). an investigation was carried out on the misclassified data, and it was found that they belong to the same subject, who reportedly smokes about fifteen cigarettes a week. all signals from this subject, the heaviest smoker among the five recruits, were misclassified as normal. one possible reason is that the atherosclerotic conditions, one of the known complications in smokers, could have been detected during at-rest condition, so further exerting external pressure on the limb during the blood occlusion experiment produced near negligible changes, as observed in the smoking group in figure 6. for the above-stated reasons, this work does not rule out the possibility of the models is overfitting to the normal (i.e., at rest) class in the smoking group, largely due to the negligible differences in the pa signals between at rest and occlusion conditions, compromising the classification performance of the models. although an insufficient dataset (i.e., in the smoking group) could lead to biased predictions, the good performance of the models using nonsmoking data in figure 7 and the high misclassification rates of pathological condition (i.e., between 20-40 %) that agreed well with the observations of,17 and18 indicating a certain degree of reliability of our findings. it must also be mentioned that this study has no access to the participants’ information, such as previous health records, and has not included their diet and environmental factors in the experimental design; these factors may influence the results and analyses of the study. therefore, the future of this study includes recruiting more participants with various backgrounds and smoking habits and adopting a systematic experimental procedure (e.g., convenient access to patient’s medical records) to investigate the blood microcirculatory performance between healthy and unhealthy (or patient) groups to enhance the validity chua and huong: deep learning and photoacoustic technology for microcirculation classification: comparison between smoking and nonsmoking groups j global clinical engineering vol.6 issue 3: 2024 44 of the research findings. the improved clinical decisionmaking system can be integrated into the proposed pa system and considered an alternative imaging tool to facilitate the investigation of tumor angiogenesis and microvascular dysfunction, allowing early identification of compromised microcirculation and preventing further complications. conclusion this paper demonstrated the use of deep learningincorporated pa technology to investigate blood perfusion in nonsmoking and smoking subjects. the results showed that the proposed hybrid alexnet-lstm model performed better than the conventional alexnet and lstm models in the classification of microcirculation changes in both smoking and nonsmoking groups. these models performed inferiorly with high misclassification rates of 20–40% in the detection of compromised perfusion in the smoking group. this observation is attributed to the compromised perfusion in this group of subjects. this explains the negligible change observed after exerting external pressure impeding the (oxygen-carrying) blood flow and the limited smoking dataset for training the models. future works include recruiting volunteers of diverse backgrounds, profiles, and smoking status to enhance the validity and practical application of existing findings in the healthcare system. conflicts of interest no potential conflict of interest relevant to this article was reported. funding ministry of higher education (mohe) malaysia through fundamental research grant scheme (frgs/1/2020/ tk0/uthm/02/28) references 1. prockop, ld and chichkova, ri. carbon monoxide intoxication: an updated review. j neurol sci 2007;262:122–130. doi: 10.1016/j.jns.2007.06.037. 2. fagerstrom, ko. effects of a nicotine-enriched cigarette on nicotine titration, daily cigarette consumption, and levels of carbon monoxide, cotinine, and nicotine. psychopharmacol (berl) 1982;77:164–167. doi: 10.1007/ bf00431941. 3. silva h. tobacco use and periodontal disease—the role of microvascular dysfunction. microcirc health disease 2021;10(5): 441. doi: 10.3390/biology10050441 4. chen nc, chang wn, lui cc, et al. detection of gray matter damage using brain mri and spect in carbon monoxide intoxication: a comparison study with neuropsychological correlation. clin nuclear med 2013;38:e53-e59. doi: 10.1097/rlu.0b013e31827082a7. 5. ozcan n, ozcam g, kosar p, et al. correlation of computed tomography, magnetic resonance imaging and clinical outcome in acute carbon monoxide poisoning. rev bras anestesiol 2016;66:529–532. doi: 10.1016/j. bjane.2014.05.006. 6. parks j and worth hg. carboxyhemoglobin determination by second-derivative spectroscopy. clin chem 1985;31:279–281. 7. huong akc, mahmud wmh, tay kg, et al. smoking status classification by optical spectroscopy and partial least square regression, j physics: conference series 2019;1372:012031. doi: 10.1088/1742-6596/1372/1/012031. 8. culnan dm, b. craft-cffman b, bitz gh, et al. carbon monoxide and cyanide poisoning in the burned pregnant patient: an indication for hyperbaric oxygen therapy. ann plast surg 2018;80(s106).doi:10.1097/ sap.0000000000001351. 9. sumit a, suresh t, garikipat a, et al. modeling combined ultrasound and photoacoustic imaging: simulations aiding device development and artificial intelligence. photoacoustics 2021;24. doi:10.1016/j.pacs.2021.100304. 10. warrier gs, amirthalakshmi tm, nimala k, et al. automated recognition of cancer tissues through deep learning framework from the photoacoustic specimen. contrast media molecular imag 2022. doi: 10.1155/2022/4356744 11. mohajerani p, aguirre j, omar m, et al. machine-learning powered optoacoustic sensor for diabetes progression. medrxiv. 2021. doi:10.1101/2021.03.17.21253779 45 j global clinical engineering vol.6 issue 3: 2024 chua and huong: deep learning and photoacoustic technology for microcirculation classification: comparison between smoking and nonsmoking groups 12. liakat s, bors ka, xu l, et al. noninvasive in vivo glucose sensing on human subjects using mid-infrared light. biomed opt express. 2014;5:2397–2404. doi: 10.1364/boe.5.002397. 13. sei k, fujita m, hirasawa t, et al. measurement of bloodoxygen saturation using a photoacoustic technique in the rabbit hypoxemia model. j clin monitor comput. 2018;33:269–279. doi: 0.1007/s10877-018-0166-8. 14. nguyen dd, pang jy, madill c, et al. effects of 445-nm laser on vessels of chick chorioallantoic membrane with implications to microlaryngeal laser surgery. laryngoscope 2021;131. doi: 10.1002/lary.29354. 15. friedmann d and verma kk. enhanced perception of deoxygenated hemoglobin for the visualization of lowerextremity reticular veins. dermatol surg 2024;50(2):207– 209. doi: 10.1097/dss.0000000000003974. 16. azizah rn, puspitasari a and lestari i. relationship of carboxyhemoglobin (cohb) and hemoglobin (hb) levels in active smokers in gresik regency. internat j adv health sci technol 2024;4(1):8–11. doi: 10.35882/ ijahst.v4i1.291. 17. low bh, lin yd, huang bw, et al. impaired microvascular response to muscle stretching in chronic smokers with type 2 diabetes. frontier bioengineerin biotechnol: section biomechanics 2020;8. doi: 10.3389/ fbioe.2020.00602. 18. hashimoto h. impaired microvascular vasodilator reserve in chronic cigarette smokers: a study of postocclusive reactive hyperemia in the human finger. japan circulat j 1994;58:29–33. j global clinical engineering vol.7 issue 1: 2025 68 received october 23, 2024, accepted february 21, 2025, date of publication march 25, 2025. letter navigating thumb ligament pathology: from injury to recovery roberto tedeschi1, paolo boccolari2 and danilo donati2,3,4 1 department of biomedical and neuromotor sciences, alma mater studiorum, university of bologna, bologna, italy. 2 clinical and experimental medicine phd program, university of modena and reggio emilia, 41121 modena, italy. 3 physical therapy and rehabilitation unit, policlinico di modena, 41125 modena, italy. 4 azienda ospedaliero, universitaria di modena policlinico. * corresponding author email: roberto.tedeschi2@unibo.it dear editor, the metacarpophalangeal (mp) joint of the thumb functions predominantly as a hinge, facilitating flexion and extension while also allowing limited abduction–adduction and rotational movements. both active and passive stabilizers contribute to its overall stability, with joint morphology playing a secondary role in this function.1 the passive stabilizers include the volar plate (vp), which integrates two sesamoid bones, and the main and accessory collateral ligaments. the active stabilizers are classified into intrinsic muscles—abductor pollicis brevis (apb), flexor pollicis brevis (fpb), and adductor (add), and extrinsic muscles—long extensor of the thumb (let), short extensor of the thumb (set), and long flexor of the thumb (lft). the ulnar collateral ligament (ucl) of the thumb comprises two components: the primary and accessory ligaments. the primary ligament runs obliquely, from the dorsal side of the metacarpal head to the volar base of the first phalanx.2 in contrast, the accessory ligament, which lies more superficially and volarly, merges with the volar plate and inserts at the base of the first phalanx. in extension, the accessory ligament becomes taut, while the primary ligament tightens during flexion, particularly around 30°. as the joint flexes, the accessory ligament slides proximally alongside the volar plate, allowing some degree of joint laxity—approximately 6° in extension and 12° in flexion during the varus–valgus stress test. the management of thumb ligament pathologies can significantly benefit from the integration of advanced clinical engineering technologies. these technologies offer tools to improve diagnostic accuracy, personalize treatment plans, and monitor recovery progress with greater precision. this document explores how advanced imaging, biomechanical modeling, and wearable devices can support the recovery process, enhancing diagnostic accuracy and therapeutic effectiveness. injuries to the mp joint frequently occur as a result of hyperabduction or hyperextension, often leading to ucl damage. such trauma may also involve the dorsal capsule and volar plate, potentially causing volar subluxation of the http://www.globalce.org http://globalce.org http://globalce.org mailto:roberto.tedeschi2@unibo.it 69 j global clinical engineering vol.7 issue 1: 2025 tedeschi, boccolari, donati: navigating thumb ligament pathology: from injury to recovery joint. chronic ucl insufficiency, because of its dorsal location relative to the joint’s center of rotation, can result in a supination deformity of the first phalanx as it rotates around the intact radial collateral ligament (figure 1). figure 1. management and evaluation of ulnar collateral ligament injuries of the thumb. hyperabduction of the thumb mp joint can result in ucl injuries, as shown in the series from normal anatomy (figure 1a), through ligament rupture (figure 1b), to the development of a stener lesion (figure 1c). the figure also illustrates the use of an orthosis for conservative or postoperative care, alongside the proper technique for performing a collateral ligament stress test. ulnar collateral ligament injuries commonly involve its distal insertion, occasionally accompanied by an avulsion fracture at the base of the phalanx.3 injuries can also occur in the ligament’s central or proximal regions. in case of ligament discontinuity, the interposition of the adductor aponeurosis between the torn ligament ends can prevent healing, leading to a stener lesión.4 clinical evaluation begins with an examination of the trauma history and physical appearance, where swelling and bruising are commonly observed. in severe cases, volar–radial subluxation of the first phalanx may be evident. tenderness is typically present over the ulnar aspect of the mp joint. the varus–valgus stress test is essential for determining ligament integrity. this test should always be compared with the contralateral hand and performed in both extension and 30° of flexion. stabilization of the metacarpal neck is necessary while lateral stress is applied to the phalanx. any phalanx rotation can obscure a ligament injury. biomechanical modeling and simulation play a crucial role in understanding ligament stress in the thumb. using finite element modeling (fem) techniques, researchers can digitally recreate anatomical structures and evaluate how the ucl responds to varying degrees of stress. these models support the planning of therapeutic, surgical, and conservative interventions by providing an accurate forecast of post-treatment joint stability. laxity exceeding 30°, or more than 15°, compared to the unaffected side, strongly suggests ucl rupture. laxity in flexion alone points to the involvement of primary ligament, while laxity in both flexion and extension indicates a more extensive injury to both ligament portions. laxity only in extension may suggest an isolated volar plate injury. tedeschi, boccolari, donati: navigating thumb ligament pathology: from injury to recovery j global clinical engineering vol.7 issue 1: 2025 70 advanced imaging technologies, such as high-resolution ultrasound and three-dimensional (3d) magnetic resonance imaging (mri), allow for a more precise evaluation of ligament structures. these tools can be paired with digital stress tests, which quantify the biomechanical response of the ligament. such technologies, supported by 3d models, offer clinical engineers the opportunity to simulate specific thumb movements and predict ligament behavior under various stresses, thereby enhancing diagnostic assessments and reducing the risk of diagnostic errors.5 ulnar collateral ligament injuries are categorized into three grades. grade 1 involves ligament strain with no detectable laxity; grade 2 presents with some laxity but a firm end point during the stress test, indicating a partial tear; and grade 3 is characterized by significant laxity with a soft end point, suggesting complete rupture. engineered orthoses represent an evolving therapeutic solution. with the development of adaptive designs and advanced materials, these orthoses can accommodate progressive changes in thumb stability, providing targeted support and comfort without restricting essential movements for rehabilitation. advances in orthotic engineering allow for lighter and more durable devices that can be customized to support each stage of recovery. looking forward, the integration of artificial intelligence (ai) algorithms with engineering technologies promises to further enhance the management of ligament injuries. predictive systems powered by ai would identify individuals at the risk of injury and optimize rehabilitation plans by automatically monitoring patient progress. such integrated approaches represent an exciting prospect for rehabilitation medicine and clinical engineering. author contributions conceptualization, p.b.; validation, d.d.; data curation, p.b.; writing–original draft preparation, p.b.; writing–review & editing, d.d. and r.t. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare they have no competing interests. ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure not applicable. 71 j global clinical engineering vol.7 issue 1: 2025 tedeschi, boccolari, donati: navigating thumb ligament pathology: from injury to recovery references 1. avery, d.m., caggiano, n.m., matullo, k.s. ulnar collateral ligament injuries of the thumb: a comprehensive review. orthop clin north am. 2015;46(2):281–292. https://doi.org/10.1016/j.ocl.2014.11.007. 2. harley, b.j., werner, f.w., green, j.k. a biomechanical modeling of injury, repair, and rehabilitation of ulnar collateral ligament injuries of the thumb. j hand surg am. 2004;29(5):915–920. https://doi.org/10.1016/j.jhsa.2004.04.017. 3. gluck, j.s., balutis, e.c., glickel, s.z. thumb ligament injuries. j hand surg am. 2015;40(4):835–842. https://doi. org/10.1016/j.jhsa.2014.11.009. 4. ishizuki, m., sugihara, t., wakabayashi, y., et al. stener-like lesions of collateral ligament ruptures of the metacarpophalangeal joint of the finger. j orthop sci. 2009;14(2):150–154. https://doi.org/10.1007/s00776-008-1301-z. 5. boccolari, p., pantaleoni, f., tedeschi, r., et al. the mechanics of the collateral ligaments in the metacarpophalangeal joints: a scoping review. morphologie. 2024;108(361):100770. https://doi.org/10.1016/j.morpho.2024.100770. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. https:// doi.org/10.1016/j.ocl.2014.11.007 https:// doi.org/10.1016/j.jhsa.2004.04.017 https:// doi.org/10.1016/j.jhsa.2014.11.009 https:// doi.org/10.1016/j.jhsa.2014.11.009 https:// doi.org/10.1007/s00776-008-1301-z https:// doi.org/10.1016/j.morpho.2024.100770 https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.6 special issue 6: 2024 4 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 1 hellenic society of biomedical technology (elevit), athens, greece. 2 institute of biomedical technology (inbit), patras science park, rio, patras, greece. 3 lab of medical physics & digital innovation, school of medicine, faculty of health sciences, aristotle university of thessaloniki (auth), thessaloniki, greece. 4 laboratory of biomedical engineering, school of electrical and computer engineering, national technical university of athens (ntua), athens, greece. * corresponding author email: dermitzakis@inbit.gr statement: all papers submitted to the elevit 10th conference were subjected to a peer review. the review was conducted by experienced and qualified members of the profession. of the accepted papers the reviewers selected the best papers and recommended them to be published. the conference was held in thessaloniki, greece from 6 to 8 october 2023. the editor-in-chief of the global ce journal communicated with the guest editors and participated in the selected paper review. abstract the period of covid-19 dominated the biomedical and clinical engineering workflows, as researchers and front-line health practitioners raced against time to offer solutions to the disruption caused to global healthcare. the hellenic society of biomedical technology reacted to the challenge in accordance with european and global biomedical and clinical engineering societies, waging the information battle and engaging with the public and the research community. nonetheless, as the globe was slowly returning to its usual pre-pandemic practices, biomedical technology also entered a transition period, evolving through the challenges of the pandemic and started resembling a sort of scientific normality. in that environment, this special issue constitutes a selection of works that were presented during the last two panhellenic conferences of biomedical technology. the articles were due to their scientific interest and excellence, but also to portray the transition of the biomedical audience’s research interests from the pandemic to their more usual endeavors, albeit with the lingering influence of what transpired and how the biomedical and clinical engineering community reacted both globally and in greece. keywords—biomedical technology, clinical engineering, covid-19 impact, digital health transformation, covid-19 transition. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:dermitzakis@inbit.gr https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 5 j global clinical engineering vol.6 special issue 6: 2024 introduction the period of the covid-19 pandemic, from 2020 up to 2023, disrupted societies worldwide including every aspect of everyday life.1,2 moreover, covid dominated the biomedical and clinical engineering workflows, as researchers and front-line health practitioners raced against time to offer solutions to the disruption caused by global healthcare.3 the pandemic of covid-19 has caused over seven million confirmed deaths as of august 20244, leaving forever its mark on societies around the globe but also on the scientific communities that waged the battle for discovery, prevention, containment, and eventually treatment.5 more specifically, it altered in both positive and negative ways6 that the current generation of biomedical and clinical engineers are thinking with regard to communicable diseases, the urgency of research7, and the importance of the fields as a whole.8 the hellenic society of biomedical technology (elevit) reacted to the challenge in accordance with european and global biomedical and clinical engineering societies, waging the information battle and engaging with the public and the research community through webinars and other events.9 during the last two conferences of society, this swift was also evident both in the given directions by the organizers and in the submission of research works by the greek biomedical community. nonetheless, as the globe was slowly returning to its usual pre-pandemic practices, biomedical technology also entered a transition period, evolving through the challenges of the pandemic and started resembling a sort of scientific normality.10 in that environment, this special issue constitutes a selection of works that were presented during the panhellenic conference of biomedical technology in 2021, a hybrid event due to the ongoing pandemic, and mainly in 2023, which marked the return to normal face-to-face scientific events for elevit. the articles included in this collection were invited among the submissions of the two conferences due to their scientific interest and excellence, but also to portray the transition of the biomedical audience’s research interests from the pandemic to their more usual endeavors, albeit with the lingering influence of what transpired and how the biomedical and clinical engineering community reacted both globally and in greece. contributions’ outline education the shift in medical education towards a student-centered approach has emphasized the importance of active learning and improving clinical reasoning skills over traditional passive learning and memorization.11 dratsiou et al. have explored the integration of virtual patients (vps) into the medical curriculum, which simulates real-life clinical scenarios, allowing students to practice safely and repeatedly, anytime and anywhere, with resources available for mobile use called mobile virtual patients (mvps).12 mvps were incorporated into the h2020 shapes project13 with a focus on assisting healthcare professionals and medical students in improving their abilities to handle, identify, and address symptoms in older patients, as well as enhancing their clinical reasoning and decision-making abilities. the researchers aim to investigate the experiences of healthcare professionals and students experience with problem-based learning (pbl) using mvps, particularly in terms of usability, technology acceptance, and clinical reasoning. the research emphasizes the importance of customizing mvps to address the unique requirements of different groups in order to enhance their educational impact and support clinical reasoning development. the path of health services towards a digital and valuebased transformation is now a one-way street, with drastic and immediate effects that are capable of disrupting the sector and making it sustainable.14 the most defining issue is how an organization adapts its organizational culture, strategy, and leadership and mostly prepares the staff to operate effectively in a digital world, adding value to users and sustaining prosperity.15 this paper investigates the perceptions of health professionals regarding the usability and ease of use of digital transformation applications. healthcare professionals who worked in various hospitals and health providers in northern greece were invited to fill in the use questionnaire in a paperless format. the acceptance of digital transformation in healthcare professionals is based on understanding the concerns and feelings of insecurity that overwhelm healthcare professionals. results can help the community better understand the factors that influence the adoption of new digital technologies. likely, this will help to reduce http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 6 the time required to make all the structural changes that are necessary. as people accept change at different rates, there is no time for delay and their preparation should immediately begin to catch up with the post-covid era. serious games (sg) incorporate learning and educational strategies commonly used in special education, and they have been proposed as assistive tools for people with developmental difficulties.16 id-gaming e-training toolkit encloses an sg named “qool city” available as a board and digital game, a game catalogue, and training materials on cognitive functions and quality of life. this paper describes the methodology and preliminary outcomes of the toolkit’s validation actions. a four-step methodology was formed to specify the interaction of participants with the toolkit and a qualitative validation tool was developed to assess the participants’ performance during the session. the target groups were young adults and adults with intellectual disabilities (pwid), professionals, and relatives. the id-gaming e-training toolkit seems to lead to improvement in various cognitive functions of pwid including memory, attention, language, and spatial orientation. components of quality of life such as wellbeing and independence were also promoted. pwid remained engaged until the end of their interaction with the toolkit components while both pwid and educators were satisfied with the toolkit. sg’s vigorous validation is of high potential for various strands of biomedical engineering spanning from rehabilitation, and training all the way to adherence and quality of life strategies.17 services and devices job applicants’ skills evaluation has become increasingly difficult for companies and individuals especially in the tech industry due to its constantly evolving nature. this difficulty takes its toll with decisions of negative impact. as a solution to this problem, bamidis et al. utilized a machine learning-based model that can effectively classify the software knowledge of developers, by recognizing the different technologies and programming languages implemented by them, thus assisting companies in managing their workforce based on acquired skills.18 with previous work as their starting point, the authors implemented source code analysis by applying natural language processing (nlp) techniques. the resulting model can be used as an effective tool for assessing the software knowledge of developers. the analysis helps obtain valuable insights into the effectiveness of neural networks and the benefits of transfer learning using pre-trained models. the potential for developing an assessment tool for developers of all flavors is of high value in the very demanding field of biomedical engineering. managing medical device data accurately is essential for patient safety and regulatory compliance in healthcare systems. liontou et al. introduce a novel approach combining web scraping and api integration to streamline the retrieval and validation of medical device information.19 by leveraging unique device identifiers (udis) and the global medical device nomenclature (gmdn), the proposed method enhances device authentication, categorization, and data accuracy.20 the research developed a code that integrates data from the accessgudid database with additional information obtained through web scraping. this hybrid approach ensures comprehensive data coverage, addressing the challenges posed by unstructured and disparate data sources. the results showed a 74% success rate in accurately matching medical device records, demonstrating the effectiveness of this system in improving data reliability. in the context of post-covid healthcare, this study highlights the importance of advanced data management solutions in greek biomedical engineering. by enabling more efficient device tracking and verification, these technologies support safer and more compliant healthcare environments, ultimately enhancing decisionmaking processes for medical professionals. neural rehabilitation neurological diseases such as cerebral palsy, parkinson’s disease, and spinal cord injury greatly affect movement, balance, and posture.21 robot-assisted therapies have been created in the last few years to improve hand functionality for people with certain diseases, especially those that impact daily activities.22 sarra et al. focus on the mathematical analysis of human hand kinematics and dynamics to improve rehabilitation devices. a wearable soft robotic glove prototype with pneumatic actuators and sensors was developed incorporating a jacket, glove, and a neurorehabilitation serious game application. this study introduces a kinematic hand model and analyzes the http://www.globalce.org http://globalce.org http://globalce.org 7 j global clinical engineering vol.6 special issue 6: 2024 dynamic interactions. personalized rehabilitation systems can be created by utilizing the denavit-hartenberg method to model robot-human interaction movements and forces. people who have suffered from spinal cord injury or have had a stroke often face difficulties in mobility, which can make their functional rehabilitation more challenging.23 the lack of visible muscle activation in movement loss cases is causing difficulties for rehabilitation practitioners who need to find a solution. the issue was investigated by lyssas et al. through the development of a machine learning model designed to identify and classify electromyography (emg) signals generated from skeletal muscle activation. this model replicates the state machine of the human skeletal muscle, identifying three key states: no activation state, activation state, and muscle fatigue state.24 three different machine learning models, including a random forest, a support vector machine, and a shallow neural network, were utilized and evaluated based on their speed and accuracy.25 the authors conclude that in order to train the model effectively, a comprehensive database of emg signals is required, which would improve the accuracy and efficiency of rehabilitation procedures. the absence of basic rules and set procedures for building databases for surface electromyography (semg) signals, is a major challenge necessary for diagnosing and analyzing neuromuscular disorders. semg, a non-invasive method for evaluating muscle activity, is extensively utilized in clinical settings but lacks standardized databases for biometric comparison.26 this obstacle limits its practical use in rehabilitation research, particularly in clinical settings. arvanitidis et al. create a dynamic, scalable, consistent, available, and partition-tolerant nosql database. the database includes normative semg values from a diverse participant pool, covering both healthy individuals and those with spinal cord injuries or stroke, and also takes into account factors like gender, age, and bmi.27 this scalable and flexible database seeks to improve accuracy in diagnosis and effectiveness in treatment in neurorehabilitation, providing researchers and clinicians with valuable tools for upcoming research. understanding the movement of humans is crucial, especially in cases of injury or illness, to develop successful rehabilitation techniques. margaritis et al. explore this topic by providing a thorough analysis of lower limb kinematics and dynamics, while also outlining a plan for implementing a wearable device to assist in rehabilitation. their main focus is on people who have tetraplegia or paraplegia to model the lower limbs using rigid links connected by joints with specific degrees of freedom and range of motion. the movement capacities of the hip, knee, and ankle joints are examined using the rigid body segment model approach and the denavit-hartenberg convention to establish kinematic chains.28 the matrices of these joints assist in determining the location and alignment of the end-effector, crucial for both forward and inverse kinematics. the study distinguishes between geometric and analytical jacobian matrices, utilizing the former to convert joint velocities to cartesian space velocities. dynamic equations, based on the lagrangian method, elucidate the connection between motion and force, facilitating the analysis of intricate systems. this comprehensive approach aims to improve rehabilitation strategies through precise modeling and analyzing lower limb movements. functional electrical stimulation (fes) is widely used in neurorehabilitation to aid recovery in patients with neurological conditions like stroke and spinal cord injury (sci).29 by synchronizing electrical pulses with natural movements, fes enhances neuromuscular adaptation and brain reorganization, leveraging neuroplasticity for improved functional recovery.30 arsenidis et al. explored optimizing fes parameters using conventional and ai-based techniques to maximize therapeutic outcomes. the authors developed an ai-driven system that adjusts stimulation parameters in real-time, considering individual patient responses to achieve optimal results. preliminary in vivo experiments demonstrated the potential of these methods in reducing muscle fatigue and discomfort during therapy, paving the way for more effective rehabilitation protocols. this research underscores the role of innovative technologies in refining rehabilitation practices, particularly in the post-covid era, where personalized, data-driven approaches are essential for enhancing patient outcomes in greek biomedical engineering. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 8 novel applications magnetoencephalogram (meg) and consequently analysis of the images it produces31 is at the forefront of research when it comes to implementing automated methods for the detection, diagnosis, and prediction of epileptic activity32, with epilepsy being one of the most common neurological disorders with tens of millions of patients globally suffering from seizures. such methods should help reduce human errors by specialized personnel while analyzing meg images. advanced models have been previously published for electroencephalogram (eeg), however, the number of publications addressing meg classification is scarce. stylianou et al. tested, compared, and evaluated some basic models to build a solid understanding of the characteristics of the available data and gain insights into the model’s behavior. the results corroborated the power of meg as a diagnostic tool for epilepsy as even less sophisticated models performed well. in the post-covid era, it is important to demonstrate results that will eventually find their way into everyday neurology clinic settings in greece and beyond. astrocytes play a significant role in the pathogenesis of multiple sclerosis (ms), a chronic neurodegenerative disease affecting millions globally.33 these glial cells are crucial for maintaining neural homeostasis but also contribute to the disease by influencing inflammation and neuronal repair.34 tsimperi et al. employed biophysically realistic models to simulate astrocytes’ impact on ms, focusing on axonal conduction and sodium channel facilitation in demyelinated axons. by examining astrocyte morphology and its effects on cellular functions, the research highlighted the dynamic roles of astrocytes in both physiological and pathological conditions, offering valuable insights into their complex behavior. the results underscore the potential for advanced modeling techniques to deepen our understanding of ms and guide future therapeutic developments.35 in the context of post-covid greek biomedical engineering, this study emphasizes the importance of innovative computational tools in enhancing our ability to explore complex biological processes and improve the management of chronic neurological conditions. accurate patient categorization is of vital importance, especially for those who suffer from cardiovascular diseases (cvds), the leading cause of death worldwide. in the particular case of aortic valve stenosis (as), the primary method used for categorizing, i.e., assessing, the severity of as is the non-invasive echocardiography.36 therefore, in recent years, there has been an increased demand for more effective assessment of individuals with as and a deeper understanding of the flow field along the aortic valve.37 in this context, makropoulos et al. discuss the construction of a computational fluid dynamics (cfd) model for simulating the flow along the aortic valve, utilizing real patient data. moreover, a comprehensive analysis is conducted of the impact of aortic valve stenosis on the flow field. in this manner, this research aims to analyze the flow along the aortic valve for various constriction configurations, thereby enhancing our understanding of the phenomenon and facilitating future investigations in the quest for an additional index that will serve as a supportive tool in patient categorization. greek multidisciplinary research groups have focused on the challenging topics of our era, producing important results. skin conditions, from benign issues to severe malignancies like melanoma, pose a significant challenge in dermatology. moraitopoulos et al. present the dermasense device, utilizing electrical impedance spectroscopy (eis), which is a novel diagnostic tool designed to enhance the accuracy of skin condition assessments.38 this mobile, cost-efficient device aims to differentiate between healthy and pathological skin through non-invasive impedance measurements, improving dermatological diagnostic decisions. the study tested the third prototype of dermasense in both lab and clinical settings, showing its capability to distinguish skin conditions like actinic keratosis from healthy tissue. the results confirmed the device’s precision, especially when using stainless steel electrodes, providing reliable data that supports clinical decisions. future enhancements will incorporate machine learning for refined data categorization, further boosting diagnostic performance. this represents a significant advancement in greek biomedical engineering, offering a more precise, accessible tool for dermatologists. its development underscores the importance of integrating innovative technologies into healthcare to improve patient outcomes and streamline diagnostic processes. 39 http://www.globalce.org http://globalce.org http://globalce.org 9 j global clinical engineering vol.6 special issue 6: 2024 concluding remarks fourteen articles in total were included in this collection spanning a wide spectrum of biomedical and clinical engineering topics, ranging from education (e-training toolkits, software skills identification, virtual patients for digital problem-based learning), to services and devices management (digital health management services, medical device management), to rehabilitation (wearable robotics, kinematics, normative data, functional electrical stimulation) and novel applications (electrical impendence spectrography, vessel flow modeling, astroglial dynamics, magnetoencephalography for epilepsy). the variety of topics underlie the dynamic of greek biomedical and clinical engineering communities and the perseverance of research and development directions through and after the covid-19 pandemic. in the same spirit, we invite the readers to 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dermatol. 2021;85(4):976–979. https://doi.org/10.1016/j. jaad.2020.09.011. 39. blume-peytavi, u., bagot, m., tennstedt, d., et al. dermatology today and tomorrow: from symptom control to targeted therapy. j eur acad dermatol venereol. 2019;33(s1):3–36. https://doi.org/10.1111/jdv.15335. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.3389/fnhum.2018.00322 https://doi.org/10.3389/fnhum.2018.00322 https://doi.org/10.1007/s11910-023-01328-5 https://doi.org/10.1007/s11910-023-01328-5 https://doi.org/10.3389/fimmu.2018.00217 https://doi.org/10.3389/fimmu.2018.00217 https://doi.org/10.3389/fncel.2019.00063 https://doi.org/10.1038/s41467-019-12712-6 https://doi.org/10.1038/s41467-019-12712-6 https://doi.org/10.1530/erp-20-0035 https://doi.org/10.1530/erp-20-0035 https://doi.org/10.1002/ccd.26033 https://doi.org/10.1002/ccd.26033 https://doi.org/10.1016/j.jaad.2020.09.011 https://doi.org/10.1016/j.jaad.2020.09.011 https://doi.org/10.1111/jdv.15335 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 j global clinical engineering vol.6 issue 3: 2024 26 received may 17, 2024, accepted june 25 2024, date of publication july 10 2024. comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine by afroza naznin1,2, muhammad abdul kadir1, fatima begum3, khondkar siddique-e rabbani1 1 department of biomedical physics and technology, university of dhaka, dhaka 1000, bangladesh 2 institute of nuclear medicine & allied sciences, sir salimullah medical college & mitford hospital, bangladesh atomic energy commission, dhaka, bangladesh 3 national institute of nuclear medicine & allied sciences, bangladesh atomic energy commission, dhaka, bangladesh abstract background and objective: ultrasound scanners are widely used in various clinical settings, but conventional devices are too expensive to deploy in every healthcare facility in low-resource countries. alternative, less costly instruments with comparable efficacy are required to ensure this diagnostic service is available in even remotest areas. this study evaluated the effectiveness of a commercially available low-cost portable ultrasound machine, particularly focusing on pregnancy profiling. material and methods: a total of 77 pregnant females were scanned for basic obstetric parameters with two devices, first the low-cost scanner, and then a conventional ultrasound machine, considering the latter as the gold standard. the key obstetric parameters observed were the number of fetuses, the presence of cardiac pulsation and fetal movement, fetal biometry including crown rump length (crl), bi-parietal diameter (bpd), and femoral length (fl), gestational age, placental location, amniotic fluid volume, and presentation of the fetus. results: the portable device performed well compared with the standard machine in observing the fetal number, presentation, movement, heartbeat, placental location, and amniotic fluid volume. the correlation coefficients (r²) for measuring bpd, fl, crl, and gestational age using the portable and standard devices were 0.9578, 0.9415, 0.8230, and 0.983, respectively. the mean absolute error (mae) in the measurement of bpd, fl, crl, and gestational age were 2.24 mm, 2.14 mm, 6.5 mm, and 0.94 weeks, respectively. conclusion: the results demonstrated the potential of low-cost portable ultrasound devices in pregnancy profile scanning. further studies with larger sample sizes are needed to explore their full potential. with appropriate data transfer arrangements, these devices have significant potential for integration into telemedicine services. keywords – portable ultrasound, antenatal care, pregnancy profiling, maternal health, telemedicine. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 27 j global clinical engineering vol.6 issue 3: 2024 naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine introduction ultrasonography (usg) is a non-invasive clinical imaging modality that has gained widespread acceptance as a reliable diagnostic tool. it requires less infrastructure and logistic support than instruments used for x-ray examinations, computed tomography, or magnetic resonance imaging, but it provides real-time information. this technology has found its way into various clinical settings, including gynecology and obstetrics. the acceptability of usg is more profound in this specialty due to a lower radiation hazard. pregnant women are recommended to have at least one usg scan during the antenatal period to estimate gestational age, and improve detection of fetal anomalies and multiple pregnancies.1 maternal mortality rate is variable in different parts of the world reflecting inequalities in economic conditions and quality healthcare access. in 2020, around 95% of all maternal deaths occurred in low and lower-middleincome countries, which was 430 per 100,000 live births.2 however, the sustainable development goal target is to reduce maternal mortality to less than 70 per 100,000 live births by 2030. most of these deaths are due to preventable causes, so early detection of complications is crucial to ensure prompt clinical intervention, which can be lifesaving. pregnancy complications also have long-term effects on maternal health.3 therefore, implementing usg in remote healthcare facilities for expecting mothers should be urgently considered. however, usg devices are costly and not readily accessible to rural populations, especially in low-income countries.4 currently, tabletor smartphone-based portable usg scanners are available at relatively low prices.5 portable usg allows healthcare providers to conduct real-time ultrasound examinations remotely. through telemedicine platforms, clinicians can guide on-site healthcare workers or patients to perform ultrasound scans, providing valuable insights. portable ultrasound devices are particularly valuable in low-resource settings, such as rural areas or underserved communities, where access to advanced medical facilities is limited. telemedicine can bridge the gap by connecting local healthcare providers with specialists who can remotely interpret ultrasound images. in obstetrics, portable usg in telemedicine can support prenatal care. expectant mothers can undergo ultrasound scans locally, with the results transmitted to specialists for analysis. this approach ensures that pregnant women in remote areas receive timely and expert guidance throughout their pregnancy. therefore, implementing usg in remote healthcare facilities for expecting mothers should be urgently considered. however, usg devices are very expensive and not readily accessible to rural populations in low-income countries.4 currently, tabletor smartphone-based portable usg scanners are available at relatively lower prices.5 however, the utility of such low-cost portable scanners in pregnancy profiling must be investigated before deployment in any healthcare program.6 heuvel et al. conducted a comparative analysis assessing the efficacy of low-cost ultrasound devices for estimating gestational age (ga) in resource-limited settings, suggesting the feasibility of utilizing such devices for ga estimation.7 stock et al. compared the performance of pocket-sized ultrasound device with a premium machine in bedside examinations and reported limited utility.8 bruns et al. explored the suitability of pocket ultrasound as a supplementary tool for clinical assessment specifically during the first trimester of pregnancy.9 kodaira et al. conducted a study to evaluate the reliability of ultrasound findings acquired through hand-held devices in urgent obstetric scenarios, reporting good agreement (κ > 0.8) particularly concerning fetal number, presentation, and heartbeat.10 in another study focusing on routine antenatal third-trimester ultrasonography, researchers found substantial concordance between a pocket-sized usg machine and high-specification usg units regarding fetal presentation and development.11 this study involved the scanning of 51 patients, concluding that portable devices are accurate tools for assessing various parameters, including fetal number, presentation, placental site, amniotic fluid volume, and the presence of key structures during the third trimester of pregnancy. however, prior studies primarily examined specific trimesters or focused on a limited number of obstetric parameters. thus, the present study aims to investigate a comprehensive range of obstetric parameters across all three trimesters of pregnancy. naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine j global clinical engineering vol.6 issue 3: 2024 28 materials and methods study design this was a cross-sectional study conducted from june 2022 to december 2022. a total of 77 subjects were randomly selected from female patients who came to the hospital for pregnancy profiling with more than eight weeks of gestation according to their menstrual history. pregnant patients with any emergency or life-threatening condition such as pervaginal bleeding, eclampsia, pre-eclampsia, premature rupture of membrane, severe abdominal pain, etc., or those who were in any stage of active labor were excluded. for a significance level of 0.05, a power of 80%, and a disagreement probability of 0.5, the sample size required to detect a cohen’s kappa value of 0.90 is 73.12 the disagreement rate of 0.5 was chosen because it represents the midpoint where the sample size is the highest. therefore, this study’s sample size of 77 subjects can be considered statistically significant. the number of subjects in the first, second, and third trimesters of pregnancy was 3, 15, and 59, respectively. this study did not consider pregnancy cases earlier than 8 weeks to avoid potential hazards from ultrasound energy. this exclusion criterion explains the lower number of cases in the first trimester. ethical statement this study was conducted under the principles embodied this study was conducted under the principles embodied in the declaration of helsinki and in accordance with local statutory requirements. necessary ethical approval was obtained from the national research ethics committee, bangladesh (no: 45713122021) for this study. informed consents were obtained from all participants. data collection after receiving informed consent, each patient was scanned twice: first, with a low-cost tablet pc-based portable and hand-held device, and then with a sophisticated and expensive scanner by a sonographer. adequate time interval was given between the two scans to avoid bias. the portable usg device (sunbright p1), which comprises a wired probe (frequency 3–5 mhz, depth 24 cm), is connected to a smartphone or computer.13 the portable device was chosen considering its low cost, commercial availability, safety (ce [conformité européenne] certified), and data transfer ability to pc and smartphones. data from the portable device was tested against a sophisticated and expensive machine (samsung medison accuvix a30), conventionally used in hospital settings, which is an usg system with a 21.5-inch-wide led monitor (screen resolution 1920 × 1080) and four probes (depth 2–30 cm).14 the frequency range of the convex probe of the conventional device used for this study was 2–6 mhz. this sophisticated machine’s output was considered gold standard for comparison of the portable scanner mentioned above. however, the actual measurements taken of any imaged organ depend on the personal choice of selected points on the image by the sonologist, so there would be errors in the gold standard too. therefore, this has to be kept in mind when comparing the performance of the portable device with that of the standard device. the key obstetric parameters observed were: (i.) number of fetuses (ii.) presence of cardiac pulsation and fetal movement (iii.) fetal biometry including crl, for first-trimester pregnancies (iv.) bpd and fl, beyond the first trimester (v.) ga (vi.) placental location (vii.) amniotic fluid volume (viii.) presentation of the fetus images captured on the portable device were saved and subsequently transferred to a computer to measure these obstetric parameters. information was also recorded in a tabulated form. diameters and lengths were measured using electronic calipers. crl was measured from the top of the head (crown) to the bottom of the buttocks (rump) of the fetus. bpd was measured from the outer edge of the near calvarial wall to the inner edge of the far calvarial wall. fl was identified as the measurement of longest bright echo within the fetal femur. all measurements were taken three times, and the arithmetic mean was recorded for analysis. 29 j global clinical engineering vol.6 issue 3: 2024 naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine analysis and presentation firstly, the values of each parameter obtained using the portable device were plotted against the corresponding values obtained using the standard device to observe whether an overall correlation exists or not. the agreement between the two devices regarding categorical variables was assessed with cohen’s kappa value. if the value is within 0.61–0.8, it denotes substantial agreement while values above 0.8 (maximum possible: 1.00) represent almost perfect agreement.15 for continuous variables, bland-altman plot and paired t-test were applied. statistical analyses were performed using spss software and microsoft excel. the bland-altman diagram is a statistical method that offers insight into the pattern and extent of any agreement. to draw the diagram, the difference between a pair is plotted on the vertical axis of the diagram against the mean of the pair on the horizontal axis. the upper and lower limits of the interval shows the limits of agreement; then it is decided subjectively whether the agreement between pairs of readings is acceptable.16 to evaluate the performance of the portable device, mean absolute error (mae) was also calculated using equation (1). here, xport is the obstetric parameter measured by the portable device, xconv is the corresponding parameter measured by the conventional (standard) device and n is the number of subjects. results the total number of pregnant females was 77, aged 18 to 35 years with a mean age of (25.8 ± 4.27) years. the obstetric parameters we have focused on in this study are the number and presentation of fetus, presence of cardiac pulsation and fetal movement, fetal biometry (crl, bpd and fl), estimation of ga, placental location, and amniotic fluid volume. figures 1 to 5 present a selection of ultrasound images obtained using both conventional and portable devices, providing a representative overview of the typical study results. notably, the images captured by the low-cost portable device exhibit lower resolution, resulting in inferior image quality and a lack of detail in smaller tissue areas. figure 1. figure 1. ultrasound scan images of a first trimester fetal pole for crown rump length (crl) measurement taken with the standard device (left) and with the portable device (right).. figure 2. figure 2. ultrasound images of two second-trimester fetal heads captured using standard device (a, c) and portable device (b, d). figure 3. ultrasound images of a third-trimester fetal head for bi-parietal diameter (bpd) measurement captured with standard device (left) and portable device (right). (1) naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine j global clinical engineering vol.6 issue 3: 2024 30 figure 1 illustrates images of a first-trimester fetal pole intended for crl measurement. the image on the left, taken with the standard device, demonstrates a clearer and more defined fetal pole compared to the image on the right, captured by the portable device. the fetal outline appears less distinct in the portable device’s image, highlighting the difference in image clarity between the two scanners. figure 2 presents ultrasound scan images of two second-trimester fetal heads captured using both devices. specifically, figure 2a and figure 2c display images obtained from the conventional device, while figure 2b and figure 2d depict the corresponding scans acquired with the low-cost portable device. the cross marks in the images indicate specific points identified by the sonologist for precise measurements along the marked dotted lines. moving on to figure 3, ultrasound scan images of a third-trimester fetal head for bpd measurement are showcased. the image on the right is obtained from the portable device, while the left image is captured using the conventional unit. although not precisely identical, the image quality and details are considerably similar between the two. in figure 4, ultrasound scan images of a second-trimester fetal femur are presented, with the left image taken using the standard device and the right image with the portable device. figure 5 displays ultrasound images of a placenta, with the left image captured by the standard device and the right image obtained using the portable device. notably, the echogenic layer adjacent to the anterior wall in the right-hand image exhibits a reverberation artifact, which is exaggerated compared to the left-hand image. correlation of measured values figure 6 shows a scatter plot for bpd with the values obtained using the portable device plotted against that obtained using the standard device. the linear correlation is very high with a squared correlation coefficient (r2) of 0.9578. the slope is about 0.98, which is close to 1, meaning that the two values are almost identical. in order to compare the two sets of values in more detail, a bland-altman plot is shown in figure 7. for these plots, the values obtained using the conventional device (the gold standard here) were subtracted from the corresponding ones obtained using the portable device for each subject and plotted along the vertical axis. the means of the bpd values for each subject obtained using both the devices were plotted along the horizontal axis. it shows that the portable device tended to underestimate bpd in earlier pregnancies, while the deviations became less as the fetal size increased. overall the mean value of figure 4. ultrasound images of a second-trimester fetal femur recorded with standard device (left) and portable device (right). figure 5. ultrasound images of a placenta, with the left image captured by the standard device and the right image obtained using the portable device. figure 6. scatter plot showing correlation between bpd measurements taken with two devices. 31 j global clinical engineering vol.6 issue 3: 2024 naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine bpd given by the portable device was 1.6 mm greater than those obtained using the conventional device. the plot also shows that 95% of the portable device measurements remained within +8 mm and −5 mm range of the actual values. the mae for measuring bpd using the portable device was 2.24 mm. figure 8 shows the correlation (r2=0.9415) between fl measurements taken with two devices. there was no tendency towards under or overestimation in relation to ga, and 95% of the measurements fell within the range +6.2 mm to −7.2 mm, the mean being at −0.5 mm (figure 9). the mae in measuring fl was 2.14 mm. the portable machine produced wide variations for crl measurements, about 9 to 17 mm from actual values (figure 10). the correlation between the two devices in measuring crl is relatively low (r2=0.823) as shown in figure 11. the mae in measuring crl was found to be 6.5 mm. in case of ga estimation, out of 77 pregnancies, three were in the first trimester i.e., below 12 weeks, 15 in the second trimester (12–26 weeks) and 59 cases were in the third trimester (beyond 26 weeks), as determined by the conventional usg machine. figure 12 shows the correlation (r2=0.983) between fl measurements taken with two figure 7. the bland-altman plot shows the difference of the two paired bpd measurements plotted against the mean of the two measurements. figure 8. scatter plot showing correlation between fl measurements taken with two devices. figure 9. the bland-altman plot shows the difference of the two paired fl measurements plotted against the mean of the two measurements. figure 10. scatter plot showing correlation between crl measurements taken with two devices. naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine j global clinical engineering vol.6 issue 3: 2024 32 devices. bland-altman plot in figure 13 showed 95% of the values taken with the portable scanner to be within almost two two-week range of the actual values. the mae in measuring ga was 0.93 weeks. it was also noted that ga was mostly underestimated by the low-cost device in first and second-trimester pregnancies, up to around 32 weeks of gestation; whether towards term pregnancies, it was more overestimated. again, the percentage of deviation of the ga measured using the portable device decreased as the ga increased. other parameters this study had five qualitative variables: presentation, the fetus’s movement and heartbeat, placental location and amniotic fluid volume. majority of the fetus was in cephalic presentation (80.5%), followed by floating condition (15.6%) and breech (3.9%). fetal movement was present in about 94.8% of the cases, with 3.9% being too early to comment and one case where movement was absent. we found 76 live pregnancies with regular cardiac pulsation and one case of intra-uterine death. regarding placental location, in most cases, it was found in anterior uterine wall (53.2%), followed by posterior wall (29.9%). fundal, anterofundal and posteriofundal locations were less common. in about 93.5% cases amniotic fluid volume was adequate, with 3.9% cases of oligohydramnios, and 1.3% cases of polyhydramnios. the portable machine’s findings agreed with the standard device (table 1). chi square test also showed significant result (p value < 0.001). single or multiple pregnancies by scanning with the conventional usg machine, which was considered as the gold standard, 72 cases were found to have single pregnancy, while 4 cases had twin pregnancy and one case had a triplet. the portable device could detect a number of fetus accurately in all these cases. figure 11. the bland-altman plot showing wide variations in crl measurements from the two devices. figure 12. scatter plot showing correlation between gestational age measurements taken with two devices. figure 13. the bland-altman plot where the difference of the two paired gestational age measurements is plotted against the mean of the two measurements. 33 j global clinical engineering vol.6 issue 3: 2024 naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine discussion portable usg scanner, by virtue of its affordability and mobility, is being contemplated for use in different lowresource settings like refugee camps, remote villages, etc. besides general practice.17–19 this study compared the performance of a low-cost portable ultrasound scanning device to a more expensive standard device, particularly for obstetric parameters. very good agreement between the two devices in measuring most of the parameters was observed in this study, which are number and presentation of fetus, presence of cardiac pulsation and fetal movement, fetal biometry (crl, bi-parietal diameter, fl), estimation of ga, placental location, and amniotic fluid volume. however, crl had more deviation as this was measured in the first trimester when the fetus was small, and marking out points with the low-cost portable device was challenging because of lower resolution. however, as the fetus increased, the errors in all parameters decreased and were within tolerable limits for acceptance. ga was determined by measuring fetal biometry; crl in first-trimester pregnancies, and bpd, fl in second and third trimesters. sac diameter is another measure for ga determination in earliest pregnancies, but it was not used as this study only enrolled pregnant females with more than eight weeks of gestation.20 regarding crl estimation, first-trimester fetal poles are very small, and it might be difficult for a low-resolution probe to outline the full length separately from yolk sac and inner wall of sac (see figure 1). however, a positive linear correlation was observed between crl values of both devices with r2 higher than 0.8 (see figure 10). the relationship with fetal size could be appreciated in the bland-altman plot, which shows that despite the variable discrepancy, deviation from reference value decreased as crl approached 55 mm and higher (see figure 11). very few first trimester cases were included in this study, which was inadequate to reach any definite consensus regarding the efficacy of crl measurement. a norwegian study focused exclusively on hand-held trans-abdominal ultrasound’s ability to evaluate first-trimester viable intra-uterine pregnancy.21 they investigated 100 women, comparing hand-held device findings to that of high-end trans-vaginal usg. according to their observation, viability could be confirmed with 79% positive and 100% negative predictive value from 7th week of gestation, and crl measurements were comparable with a median difference of 1 mm. of course, the error also depends on the image’s resolution quality, and values obtained using one low-cost device may not apply to another device obtained from another manufacturer. this study observed strong positive linear correlation between bpd, fl and ga measurements taken with both devices, r2 being greater than 0.9 in all three cases (see figures 6, 8, and 12). in a detailed assessment, the lowcost device usually underestimated bpd measurements in earlier pregnancies, up to about 58 mm, corresponding to nearly 24 weeks of gestation (see figure 7). for the next 14–15 mm (up to around 30 weeks) portable device values were very close to standard ones, and after that deviation increased but uniformly. figure 2 shows scan images of two fetal heads in second trimester. both near and far calvarial walls are well outlined in the images from conventional machine, but in the portable device scans walls appear blurred, leading to incorrect estimation of bpd. this is because the hand-held scanner cannot capture relatively fast-moving fetuses of earlier pregnancies as accurately as the conventional machine. accordingly, image quality improves when fetal size increases and the fetus is less mobile ( see figure 3). in case of fl measurement by the low-cost instrument, there was no notable tendency towards over or underestimation (see figure 9). deviation from standard was minimal between a range of approximately 30–50 mm (corresponding ga about 19–26 weeks), and beyond second trimester there was uniform increase. table 1. kappa values for qualitative variables showing good agreement between two devices parameter κ statistic p value interpretation fetal presentation 1.0 < 0.001 perfect agreement fetal movement 1.0 < 0.001 perfect agreement fetal heartbeat 1.0 < 0.001 perfect agreement placental location 0.892 < 0.001 very good agreement amniotic fluid volume 0.884 < 0.001 very good agreement naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine j global clinical engineering vol.6 issue 3: 2024 34 most of the portable scanner calculations of ga are within two two-week range of actual values (see figure 13). the bland-altman plot shows that the difference mostly lies between one week ranges for about up to 30 weeks of gestation, and then increases gradually. it is highest between 35 and 40 weeks. this might be considered clinically acceptable because, for ga measurement by usg, it has been studied and found that parameters like bpd and fl are less accurate during last weeks of pregnancy. according to macgregor et al. the accuracy of gestational sac measurement as a predictor of ga is approximately ±1 week. in case of crl, the accuracy is within ±5 to 7 days. during 12–26 weeks, ga determination by bpd and fl measurements falls within a range of 10–11 days and 10–20 days respectively, for 95% of the cases. after 26 weeks, this range extends to 2–3 weeks.22 fetal number, movement, presentation and cardiac pulsation were accurately detected by the portable device in all of the cases, which denotes the perfect efficacy of this instrument for assessing those parameters in more than eight weeks of gestation (see table 1). an eight-week embryo reaches considerable development by completing organogenesis, therefore these parameters were all discernible despite low resolution. earlier pregnancies were beyond the scope of this study to avoid potential hazard by ultrasound energy.19 kodaira et al. performed a study to assess the reliability of ultrasound findings acquired with hand-held apparatuses in urgent obstetric settings. they reported high agreement (κ > 0.8) in the case of fetal number, presentation and heartbeat.10 their overall diagnostic accuracy was still lower than ours, probably because they included emergency obstetric patients of any ga in a high volume low-resource setting, and scans were obtained by medical students with limited training. placenta is identified in ultrasound examination as a mostly uniform echogenic structure along uterine wall.23 in our study, anteriorly placed placenta was the commonest location, followed by posterior; in accordance with a large population based cohort study in sweden involving more than 74 thousand pregnant females.24 a few fundal placentas were identified as anterior in location by the low-cost device, due to exaggeration of reverberation artifact along the anterior wall (see figure 5). the same phenomenon might have contributed to the underestimation of amniotic fluid volume in one case of polyhydramnios. however, despite these few exceptions, the portable device showed very good agreement with the conventional machine regarding both placental localization and amniotic fluid estimation (see table 1). limitations the study was conducted with a relatively small sample size, as a result there was not enough patients from each trimester. first-trimester subjects were especially scarce, as we could not enroll females with less than eight weeks of gestation. besides, only stable pregnant women were enlisted for study, limiting the number and varieties of pathology that could be observed. therefore, efficacy of the portable device in emergency conditions could not be evaluated. further study with larger sample size must be done to explore its full potential. conclusions the portable device used in this study showed remarkable efficacy in observing several obstetric parameters, namely fetal number, presentation, movement, heartbeat, placental location and amniotic fluid volume. regarding other variables, the low-cost scanner measurements were closest to gold standard during 24–30 weeks for bpd and 19–26 weeks for fl. ga determination remains within one week range from the standard reference during second trimester and first six weeks of third trimester. observing the above-mentioned efficiency, such portable device may be recommended to provide diagnostic service in remote areas, including refugee camps, hilly areas, and islands. there is significant potential for integrating low-cost and portable ultrasound scanning devices into telemedicine service systems with appropriate data transfer arrangements. however, further studies are needed to investigate interpersonal variability in the use of portable devices, ensuring consistency and accuracy across different users and settings. conflict of interest the authors declare no conflict of interest. 35 j global clinical engineering vol.6 issue 3: 2024 naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine grant support the international science programme (isp), uppsala university, sweden, is acknowledged for financial support as research grant. references 1. who recommendations on antenatal care for a positive pregnancy experience 2016 [cited 2024 15 march ]. available from: https://pubmed.ncbi.nlm. nih.gov/28079998/. 2. who. maternal mortality 2023 [cited 2024 15 march]. available from: https://www.who.int/news-room/ fact-sheets/detail/maternal-mortality. 3. neiger r. long-term effects of pregnancy complications on maternal health: a review. j clin med. 2017;6(8):76. https://doi.org/10.3390%2fjcm6080076 4. seffah jd, adanu rm. obstetric ultrasonography in lowincome countries. clin obstet gynecol. 2009;52(2):2505. https://doi.org/10.1097/grf.0b013e3181a4c2d5 5. rykkje a, carlsen j, nielsen m. hand-held ultrasound devices compared with high-end ultrasound systems: a systematic review. diagnostics (basel). 2019; 9 (2):61. https://doi.org/10.3390/diagnostics9020061 6. becker dm, tafoya ca, becker sl, kruger gh, tafoya mj, becker tk. the use of portable ultrasound devices in low-and middle-income countries: a systematic review of the literature. tropic med int health. 2016;21(3):294311. https://doi.org/10.1111/tmi.12657 7. van den heuvel tla, de bruijn d, moens-van de moesdijk d, beverdam a, van ginneken b, de korte cl. comparison study of low-cost ultrasound devices for estimation of gestational age in resource-limited countries. ultrasound med biol. 2018;44(11):2250-60. https://doi.org/10.1016/j.ultrasmedbio.2018.05.023 8. stock kf, klein b, steubl d, lersch c, heemann u, wagenpfeil s, et al. comparison of a pocket-size ultrasound device with a premium ultrasound machine: diagnostic value and time required in bedside ultrasound examination. abdom imag. 2015;40:2861-6. https:// doi.org/10.1007/s00261-015-0406-z 9. bruns rf, menegatti cm, martins wp, júnior ea. applicability of pocket ultrasound during the first trimester of pregnancy. medical ultrasonography. 2015;17(3):2848. https://doi.org/10.11152/mu.2013.2066.173.rfb 10. kodaira y, pisani l, boyle s, olumide s, orsi m, adeniji ao, et al. reliability of ultrasound findings acquired with hand-held apparatuses to inform urgent obstetric diagnosis in a high-volume resource-limited setting. internat j gynecol obstet. 2021;153(2):280-6. https:// doi.org/10.1002/ijgo.13475 11. galjaard s, baeck s, ameye l, bourne t, timmerman d, devlieger r. use of a pocket-sized ultrasound machine (pum) for routine examinations in the third trimester of pregnancy. ultrasound obstet gynecol. 2014;44(1):64-8. https://doi.org/10.1002/uog.13285 12. temel g, erdogan s. determining the sample size in agreement studies. marmara med j. 2017;30(2):101112. https://doi.org/10.5472/marumj.344822 13. sunbright sun p1 2024 [cited 2024 15 march]. available from: https://www.sunbright.shop/ factory-price-sun-p1-type-c-portable-usb-probesultrasound-for-sale-8317?d=2.11 14. samsung. accuvix a30 2024 [cited 2024 15 march]. available from: https://www.samsung.com/hk_en/ support/model/uss-av30f4u/wr/ 15. barton b, peat j. medical statistics: a guide to spss, data analysis and critical appraisal: john wiley & sons; 2014. 16. watson p, petrie a. method agreement analysis: a review of correct methodology. theriogenology. 2010;73(9):1167-79. https://doi.org/10.1016/j. theriogenology.2010.01.003 17. andersen ca, holden s, vela j, rathleff ms, jensen mb. point-of-care ultrasound in general practice: a systematic review. ann fam med. 2019;17(1):61-9. https://doi.org/10.1370/afm.2330 18. løkkegaard t, todsen t, nayahangan lj, andersen ca, jensen mb, konge l. point-of-care ultrasound for general practitioners: a systematic needs assessment. scand j primary health care. 2020;38(1):3-11. https:// doi.org/10.1080/02813432.2020.1711572 19. reynolds ta, amato s, kulola i, chen c-jj, mfinanga j, sawe hr. impact of point-of-care ultrasound on clinical https://pubmed.ncbi.nlm.nih.gov/28079998/ https://pubmed.ncbi.nlm.nih.gov/28079998/ https://www.who.int/news-room/fact-sheets/detail/maternal-mortality https://www.who.int/news-room/fact-sheets/detail/maternal-mortality https://doi.org/10.3390%2fjcm6080076 https://doi.org/10.1097/grf.0b013e3181a4c2d5 https://doi.org/10.3390/diagnostics9020061 https://doi.org/10.1111/tmi.12657 https://doi.org/10.1016/j.ultrasmedbio.2018.05.023 https://doi.org/10.1007/s00261-015-0406-z https://doi.org/10.1007/s00261-015-0406-z https://doi.org/10.11152/mu.2013.2066.173.rfb https://doi.org/10.1002/ijgo.13475 https://doi.org/10.1002/ijgo.13475 https://doi.org/10.1002/uog.13285 https://doi.org/10.5472/marumj.344822 https://www.sunbright.shop/factory-price-sun-p1-type-c-portable-usb-probes-ultrasound-for-sale-8317?d=2.11 https://www.sunbright.shop/factory-price-sun-p1-type-c-portable-usb-probes-ultrasound-for-sale-8317?d=2.11 https://www.sunbright.shop/factory-price-sun-p1-type-c-portable-usb-probes-ultrasound-for-sale-8317?d=2.11 https://www.samsung.com/hk_en/support/model/uss-av30f4u/wr/ https://www.samsung.com/hk_en/support/model/uss-av30f4u/wr/ https://doi.org/10.1016/j.theriogenology.2010.01.003 https://doi.org/10.1016/j.theriogenology.2010.01.003 https://doi.org/10.1370/afm.2330 https://doi.org/10.1080/02813432.2020.1711572 https://doi.org/10.1080/02813432.2020.1711572 naznin, kadir, begum, rabbani: comparative performance of low-cost portable scanner in pregnancy profile ultrasonography: a promising adjunct to telemedicine j global clinical engineering vol.6 issue 3: 2024 36 decision-making at an urban emergency department in tanzania. plos one. 2018;13(4):e0194774. https:// doi.org/10.1371/journal.pone.0194774 20. van den hof mc. no. 359-obstetric ultrasound biological effects and safety. j obstet gynaecol can. 2018:40(5):62732. https://doi.org/10.1016/j.jogc.2017.11.023 21. pedersen jk, sira c, trovik j. hand-held transabdominal ultrasound, after limited training, may confirm first trimester viable intrauterine pregnancy: a prospective cohort study. scand j primary health care. 2021;39(2):123-30. https://doi.org/10.1080/0281 3432.2021.1910643 22. macgregor sn, sabbagha re. assessment of gestational age by ultrasound. glob libr women’s med. 2008. https://doi.org/10.3843/glowm.10206 23. abramowicz j, sheiner e. ultrasound of the placenta: a systematic approach. part i: imaging. placenta. 2008;29(3):225-40. https://doi.org/10.1016/j. placenta.2007.12.006 24. granfors m, stephansson o, endler m, jonsson m, sandström a, wikström ak. placental location and pregnancy outcomes in nulliparous women: a population-based cohort study. acta obstetricia et gynecologica scandinavica. 2019;98(8):988-96. https://doi. org/10.1111/aogs.13578 https://doi.org/10.1371/journal.pone.0194774 https://doi.org/10.1371/journal.pone.0194774 https://doi.org/10.1016/j.jogc.2017.11.023 https://doi.org/10.1080/02813432.2021.1910643 https://doi.org/10.1080/02813432.2021.1910643 https://doi.org/10.3843/glowm.10206 https://doi.org/10.1016/j.placenta.2007.12.006 https://doi.org/10.1016/j.placenta.2007.12.006 https://doi.org/10.1111/aogs.13578 https://doi.org/10.1111/aogs.13578 5 j global clinical engineering vol.6 issue 2: 2024 received november 8, 2023, accepted december 1 2023, date of publication january 22, 2024 a landscape study to determine the innovation mortality rate in health technology innovations across the globe by sambhu ramesh1, annie nithyavathani j1, moinudeen syed1, kavita kachroo1, jitendra kumar sharma2, priyadarshini. a2, penta sneha latha1, sushmita roy chowdary2 1 kalam institute of health technology, india 2 andhra pradesh medtech zone, india abstract introduction: health technology innovation encompasses many areas, such as medical devices, diagnostics, pharmaceuticals, digital health solutions, telemedicine, health informatics, and more. these innovations aim to enhance healthcare delivery, improve patient outcomes, increase access to services, reduce costs, and advance medical research. methodology: we have analyzed health technology innovations reported between january 2011 and december 2022. regulatory approval for the innovative products was determined based solely on official open-access websites of health agencies, disregarding information from company websites or third-party sources. the search process utilized identified innovation agencies and sources like primary health care (phc) tech challenge, world health organization (who) compendium, global grand challenges (ggc), and biotechnology industry research assistance council (birac). innovations were thoroughly examined from these sources, focusing on health technologies, and success was gauged through regulatory approval. results: the who compendium includes 200 health innovations primarily intended for low-resource settings, with the usa accounting for the highest number, followed by india, the only lowand middle-income country (lmic) with significant innovations. however, 58% of the listed innovations did not obtain regulatory clearance. medical devices dominated the listed innovations, while scalable assistive technologies were limited. global innovation agencies, particularly grand challenges, supported many innovations, but the regulatory approval rate remained low. in india, birac supported 92% of the mapped innovations, with a similar trend of low regulatory approval rates. conclusion: the study observed the highest number of innovations during 2015-2017, with medical devices being the most prominent category. however, most innovations from both global and domestic agencies were unapproved, raising concerns about regulatory clearance for these health technologies. manuscript highlights: the manuscript presents several important highlights concerning health technology innovation and regulatory approval. it highlights the evaluation of health innovations from 2015 to 2022, focusing on their success rate based on health agency approval. it reveals an uneven distribution of innovations from different countries and emphasizes the need for critical interventions to improve the process. this study emphasizes the significance of innovations in achieving healthcare equity and sustainable development goals. keywords – health technology innovation, regulatory approval, medical devices, who compendium, birac, global innovation agencies. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ ramesh, nithyavathani j, syed, kachroo, sharma, priyadarshini, latha, chowdary: a landscape study to determine the innovation mortality rate in health technology innovations across the globe j global clinical engineering vol.6 issue 2: 2024 6 introduction innovation is fundamental to progress and development in various sectors, including business, healthcare, technology, and agriculture. it encompasses integrating fresh ideas, concepts, and creativity into tangible and usable products or services that cater to the needs of the public at large. moreover, innovation is not limited to creating entirely new products; it also involves enhancing and improving existing offerings, resulting in better customer experiences and increased efficiency.1 though various fields have distinct breakthroughs based on their domain, our analysis will be based on the product innovation of health technology innovation across different countries. healthcare innovation can be as simple as changing a form to check out a patient five minutes faster or as complex as immunotherapy targeting specific cancer cell types. simple or complex developments that lead to improvements in health outcomes and patient experiences are considered healthcare innovations. health technology innovation refers to developing and implementing new and improved technologies in the healthcare sector.2 it involves the application of scientific knowledge, engineering principles, and innovative ideas to create tools, devices, systems, and software that enhance the prevention, diagnosis, treatment, and management of diseases and improve overall healthcare delivery.3 in healthcare, innovation holds immense potential for revolutionizing patient care, disease prevention, diagnostics, treatment, and monitoring.4 the healthcare sector thrives on innovations that can significantly improve health outcomes, enhance access to services, reduce costs, and contribute to advancements in medical research in the real world.5 innovations in medical devices, such as implantable devices, robotic surgery systems, prosthetics, and wearable sensors, have substantially impacted patient care and medical interventions. similarly, diagnostic tools and techniques, like genetic testing, point-of-care diagnostics, imaging technologies, and lab-on-a-chip devices, have revolutionized early detection and accurate diagnosis of diseases, leading to better treatment outcomes.6 despite the remarkable potential of health technology innovations, the innovation process can be arduous and challenging. many innovators invest significant efforts into transforming their ideas into commercially viable products; however, many of these innovations eventually face failure. this failure could occur at any stage of the innovation process, and the reasons behind it can be multifaceted.5,7 it is laborious to think about a product from the initial seed of a concept through its commercialization. even though many innovators need their innovations to complete this laborious procedure successfully, most fail after some period. any stage of the invention process might fail.8,9 start-up companies often confront a higher risk of failure, especially during their initial years of operation. the competitive landscape and rapidly evolving consumer needs and preferences can lead to shorter product life cycles, necessitating continuous innovation and adaptation for survival. as a result, organizations must constantly reinvent and improve their products or services to stay relevant in the dynamic market.10,11 considering this, many start-up companies have a significant chance of failing, with many failing after a few years. this is attributed to intense competition and rapidly changing consumer needs, resulting in shorter product life cycles.12 companies must continuously innovate and improve their products or introduce new ones to survive. not all innovations are successful, and failing to commercialize them wastes important investments.5 acquiring company-level data on innovation failure is challenging. the study focuses on macro-level data at the country level to acquire insights into the information provided. compared to well-established organizations, start-ups are more prone to failure, with a considerable proportion failing to survive beyond their first few years.13 this is primarily due to their intense rivalry, exacerbated by the rapidly changing consumer needs. as a result, the market lifespan of items has been considerably reduced, necessitating ongoing innovation and adaptation.7 according to studies, the ratio of successfully commercialized discoveries to failed ones could be as low as 1:300.14 this means that a significant amount of investment in innovation may be squandered. the financial expense of innovation adds another degree of complexity. innovation activities are frequently expensive, involving research and development (r&d) costs, experimentation, and 7 j global clinical engineering vol.6 issue 2: 2024 ramesh, nithyavathani j, syed, kachroo, sharma, priyadarshini, latha, chowdary: a landscape study to determine the innovation mortality rate in health technology innovations across the globe market testing. these costs can be enormous, and when combined with the risk of failure, they create a difficult environment for new businesses.15,16 innovation mortality refers to the rate at which new products or ideas fail to gain traction in the market or within an organization. it measures the failure rate of innovations or ideas and can be used to evaluate the success of an organization’s innovation efforts. while existing research has primarily focused on the positive impact of innovation on a company’s survival, our study takes a different approach. it seeks to understand how innovation has attained the rate of mortality . due to the numerous micro-level data regarding innovation, this research relies on macro-level data on specific agencies and organizations. by analyzing broader trends and patterns, the study aims to shed light on the relationship between innovation activities and the ultimate failure of health technology innovations.17,18 materials and methods the methodology includes the mapping of health technology innovations across the various countries in the world. there were pre-defined criteria for including the health technologies. the inclusion criteria include any health technology innovations within a period of january 1, 2011, to december 31, 2022. we depend on open access to official regulatory agency websites to determine health agency approval. we do not consider the information on the company website or any third-party websites, including newspapers. the search includes list of already identified innovation agencies across the world, phc (primary health care) tech challenge, which is a search for innovations in a primary healthcare setting, who (world health organization) compendium of innovative health technologies for low-resource settings (2011 to 2020) and global grand challenges, and biotechnology industry research assistance council (birac). innovation agencies shall be of any entity, i.e., government, private, non-governmental organization, independent, a collaboration with undp (united nations development program), charity organization, or any university collaborative agencies. we have selected five innovation agencies in total for this study. among them, three were global, and two were from india. phc tech challenges was a special call for mapping innovations specific to primary health care. the rest are agencies aiming to find and support innovations from different areas. we identified the website of each of the innovation agencies from a browser. we thoroughly investigated the english-language calls for proposals, grants, current initiatives, and services. we narrowed our search to just health innovations on the websites of individual innovation agencies based on the inclusion criteria. irrespective of the agency’s website, we also searched the health innovations from the “global grand challenges,” “who compendium of innovations for low-resource settings,” “phc tech challenge,” and “birac.” various innovations were found from the ggc, a family of initiatives fostering innovation to solve key global health and development problems, while the phc tech challenge includes the compendium of health innovations for primary healthcare settings. these innovations are exclusively shown to bring promising health innovations across the globe to support phc planning, management, and quality improvement. we also identified the health technology innovations from who compendium of innovative health technologies for low-resource settings from the year 2011 to 2020,19 which consists of commercially available medical products and finally the birac20 and phc tech challenge in india21 in where the innovation and the company’s name has been identified for the further collection of macro-level data. the success of an innovation is decided based on the regulatory approval received from health agencies. all the health technology innovations mapped had been cross-verified to check the regulatory approval of the same products. statistical analysis in this study, a descriptive assessment of the findings was conducted to summarize and present the results clearly and informally. the results of the analysis were represented in the form of summaries, tables, and figures. descriptive graphs in bar charts, pie charts and histograms were used to provide visual insights into the ramesh, nithyavathani j, syed, kachroo, sharma, priyadarshini, latha, chowdary: a landscape study to determine the innovation mortality rate in health technology innovations across the globe j global clinical engineering vol.6 issue 2: 2024 8 data’s patterns, trends, and distribution. tables were also used to identify the trends and to provide comparisons. bar charts were utilized to illustrate the frequency or distribution of categorical data. pie charts were also used to present the proportion of each category within a whole to provide an understanding of relative components. results the who compendium represents the list of health technology innovations that are commercially available. the total number of commercially available products are 152 in number, and prototype products mentioned in the compendium are 48. of 152 products, 114 received approvals from their respective countries of origin. the who compendium identifies the manufacturer-reported information and the evaluation of innovation results. it focuses on health technologies that can potentially improve health outcomes and quality of life, or offer a solution to an unmet medical/health technology need. it acknowledges success stories and raises awareness of the pressing need for appropriate, affordable design solutions. it also promotes innovation in the field of health. this effort aims to promote interaction among ministries of health, procurement officers, donors, technology developers, manufacturers, clinicians, academics, and the public. ultimately, it ensures greater investment in health technology towards universal access to essential health technologies. the table represents the date of commercialization of the product, country of origin of the product, and category of the product. all these innovations are at 8 to 9 technology readiness levels. this emphasizes that this has entered the regulatory approval pathway, got approved by their respective country’s regulatory approval authority, and entered the commercial market. these innovations mentioned here are successful. the innovations under phc tech challenge are a platform that brings together promising medtech, digital health, and cold chain innovations for strengthening primary healthcare. the phc tech challenge document was published in 2018 where they mentioned the overall products as 22. it was rolled out to supply a platform that brings together promising medtech, digital health, and cold chain innovations from across the globe to key stakeholders (government, health agencies, donors, development partners, private sector companies and providers, etc.). path india with its partners embarked on a global search for innovators and entrepreneurs in the healthcare sector with the ‘phc tech challenge.’ the success of a comprehensive phc program by bringing together all the relevant stakeholders to advance efforts towards improving primary healthcare quality, access, and affordability and introducing transformative solutions/innovations that could be proven and scaled are found in this review. a group of programs known as grand challenges promotes creativity to address significant global health and development issues. every endeavor is a test of how to use difficulties to direct innovation towards having an effect. the bill & melinda gates foundation introduced grand challenges in global health in 2003. the first focus of this initiative was on 14 significant scientific problems that, if resolved, could make substantial progress in preventing, treating, and curing the illnesses and health conditions that contribute most to global health inequity. it was reintroduced in 2014 under the moniker grand challenges, reflecting its broadened focus to include problems with global development.22 we have considered 10 major grand challenges for identifying health innovations. the majority were countryspecific, and few were exclusively for specific innovations (such as grand challenges for development). the department of biotechnology (dbt), government of india, established the birac, a not-for-profit section 8, schedule b, public sector enterprise, as an interface agency to support and enable the emerging biotech enterprise to engage in strategic research and innovation, addressing regionally pertinent product development needs. birac, an industry-academia interface, conducts its mandate through a wide range of initiatives that have an impact, such as providing access to risk capital through targeted funding, technology transfer, ip management, and support programs that help biotech companies become more innovative and competitive on a global scale.20 we have mapped a total of 253 innovations on medical devices from 2012 to 2021. the who compendium included noticeable innovations in the healthcare arena, intending to seek more support and aid for the same. 9 j global clinical engineering vol.6 issue 2: 2024 ramesh, nithyavathani j, syed, kachroo, sharma, priyadarshini, latha, chowdary: a landscape study to determine the innovation mortality rate in health technology innovations across the globe all the innovations named by who, phc tech challenges, were considered. however, innovations mapped from other agencies were included after considering technology readiness levels, scope, and novelty from a global perspective. we have categorized our findings into three sections. 1. the who compendium listed health innovations. 2. health innovations supported through global innovation agencies. 3. health innovations supported by india’s major domestic innovation agencies and health innovation calls. the who compendium listed health innovations we have mapped a total of 200 health innovations from who innovation compendium. the compendium incorporates innovations intended for low-resource settings. the who compendium lists manufacturer-reported data and who evaluation findings for health technologies that can enhance the quality of life or health outcomes or address an unmet medical or technological need. it clarifies the benefits and difficulties of using cutting-edge medical technology in low-resource environments. it may be utilized by non-governmental organizations, governments, and other stakeholders to support purchasing choices. the usa accounts for more than a quarter of the innovations listed by the compendium. india is the only lmic comprising many health innovations (18 of 200). innovations from a total of 44 countries were considered for assessment. of them, 37 countries accounted for less than 5% of health innovations. the health innovations from african countries were exceptionally low. the analysis finds that 58% of the health innovations did not obtain regulatory clearance. although canada, china, and switzerland found a high proportion of regulatory agency approved health innovations, the country-wise approval rate remains the same in absolute numbers. medical devices account for nearly three-fourths of the overall health innovations listed in the who compendium (140 of 200). the innovations in scalable assistive technologies were very few (3 of 200). the absolute number of innovations categorized as medical devices was significantly high (86 of 140). health innovations supported through global innovation agencies medical devices account for the maximum number of health innovations (32 of 67). e-health and assistive devices were the lowest (1 of 67). regulatory agency approval for innovations mapped from global agencies was significantly low (6 of 67). the regulatory approval for ggc (1 of 43) was significantly low. table 1. innovation agencies considered for mapping sl no innovation agency country 1 who (innovation compendium) global 2 grand challenges global global 3 innovation agencies global 4 phc tech challenge india 5 birac india figure 1. distribution of health innovations with respect to country of origin. ramesh, nithyavathani j, syed, kachroo, sharma, priyadarshini, latha, chowdary: a landscape study to determine the innovation mortality rate in health technology innovations across the globe j global clinical engineering vol.6 issue 2: 2024 10 the 2015 to 2017 period showed the highest number of innovations supported by innovation agencies. medical devices were the highest reported health innovation, followed by other technology and digital health. the analysis also found certain process innovations. process innovations success rate cannot be determined based on health agency approval status. a deep dive into the health innovations supported by india’s major domestic innovation agencies we have analyzed innovations supported by the major innovation agencies birac, the ministry of biotechnology, and the government of india, and innovations supported through a grand challenge call for phc tech challenge. we have mapped a total of 273 health innovations. biracsupported health innovations accounted for 92% of the total innovations mapped. our analysis found that around 92% of the health innovations supported by domestic innovation agencies are not receiving regulatory clearance. the highest number of innovations were supported during 2015-2017. although the reduction is insignificant, the covid-19 pandemic could be accountable for the low support rate in the subsequent period. medical devices accounted for the most supported medical innovations (58%). other technology includes innovations in cold chain, infection control, etc. the net regulatory agency approval was the lowest for the health innovations supported by global health innovation agencies. innovations listed in the who compendium, on the other hand, included many regulatory agencies’ approved health innovations. another noticeable finding was that the health innovations from lowand middleincome countries were significantly lower compared to high-income counterparts. discussion the study mapped health innovations supported by six innovation agencies and used regulatory approval to measure success. surprisingly, over one-third of the supported innovations failed to obtain regulatory clearance. cross-verifying regulatory agency approval from respective countries was done. still, some innovations developed in high-income countries for different populations could not be assessed due to a lack of regulatory data. the peak of innovation support was observed during 2016-2018. however, innovations beyond 2021 were not included in the study, except for pandemic-driven ones. while the focus was on medical devices, other categories like digital health and assistive devices were also considered if they played a crucial role in healthcare. despite this, many innovations lacked supporting documents on regulatory approvals on open websites. there is currently no widely acknowledged comprehensive definition of innovation, and many fields (such as economics, public health, geography, and sociology) use somewhat different definitions. one of the earliest economists to recognize the importance of innovations to all economic systems, from small businesses to entire countries and the global economy, was schumpeter. he defined innovation as any modification to the way something is produced, the creation of new goods, the organization of businesses, the entry into a new market, and the “creative destruction” that drives all developments under a capitalist market framework.1 according to manuel garcía-goñi, innovations in health care can be classified into objects, the relationship to the existing standard, the system affected, the extent of change, and the readiness level. the world economic forum, in its latest report, mapped five innovations that could change figure 2. distribution of innovation agency-wise regulatory agency approval status. 11 j global clinical engineering vol.6 issue 2: 2024 ramesh, nithyavathani j, syed, kachroo, sharma, priyadarshini, latha, chowdary: a landscape study to determine the innovation mortality rate in health technology innovations across the globe global health, which include artificial intelligence, 3-d printing, gene editing, virtual reality, and sensor development. most of the health innovations mapped through the process were found to have some association with the forum-reported innovation domains.23 david w. feigal et al., in their paper titled “impact of the regulatory framework on medical device development and innovation” states that the rate of innovation for regulated items is a function of how quickly research and engineering are developed to make choices about regulations based on table 2. list of health innovations and its regulatory agency approval status innovations mapped from global agencies category of health innovation approved by regulatory agencies not approved by regulatory agencies number percentage number percentage medical device 5 16 27 84 digital health nil nil 15 100 other technologies 1 7 14 93 assistive device nil nil 1 100 e-health nil nil 1 100 innovations mapped from who compendium category of health innovation approved by regulatory agencies not approved by regulatory agencies number percentage number percentage medical device 86 61 54 39 e-health 13 37 22 63 other technology 2 13 14 88 digital health 2 33 4 67 assistive device 1 33 2 67 innovations mapped from india (birac & phc tech challenge) category of health innovation approved by regulatory agencies not approved by regulatory agencies number percentage number percentage medical device 11 7 146 93 other technology 2 4 46 96 digital health 7 16 38 84 assistive device 2 11 17 89 ramesh, nithyavathani j, syed, kachroo, sharma, priyadarshini, latha, chowdary: a landscape study to determine the innovation mortality rate in health technology innovations across the globe j global clinical engineering vol.6 issue 2: 2024 12 science. new scientific and public health concerns also have a life cycle, from conception to obsolescence, just as breakthrough medical products. since the two are interwoven, delayed scientific advancement and a lack of a flexible, science-based regulatory decision-making process can hinder growth.24 the author highlights that the slower the pace of regulatory agencies in approving the innovation, the more it affects the development of innovative medical devices. the world trade organization, in its trade-related aspects of intellectual property rights, is an international legal agreement between all the member nations of the world trade organization), states that the regulation of medical products has become difficult because of the globalization of product research, manufacturing, and supply as well as the rapid rate of technical and societal change in the setting of limited financial and human resources.25 the sixty-seventh world health assembly approved resolution wha 67.20, “regulatory system strengthening for medical products,” to recognize the value of strong regulatory frameworks. the resolution states that “effective regulatory systems are an essential component of strengthening the health system and contribute to better public health outcomes,” “regulators are an essential part of the health workforce,” and “inefficient regulatory systems themselves can be a barrier to access to safe, effective, and quality medical products.”26 a study titled “innovation and death rate of enterprise” identified the mortality rate of companies, where it also aims to analyze how the influence of innovation activities measured through r&d expenditures and the number of resident patent applications on the death rate of companies in member countries of oecd.27,28 the evaluation of cutting-edge medical devices is where technological uncertainty is most evident because the regulator must comprehend the scientific principles underlying the operation of the device but fails to have a clear understanding of the information needed to be persuaded of the product’s efficacy and safety before the product entered into the regulatory review the line.29 addressing the uncertainty over the structure and format of the data necessary for a given medical device’s regulatory clearance. the lack of clear guidelines for the protocol for evaluating an innovative product causes content and format uncertainty, which affects how the applicant firm should present and how regulators should evaluate the findings of clinical studies and other tests (like biocompatibility and engineering tests). without the creation of precise assessment criteria, this form of uncertainty, which always coexists with technological uncertainty for innovative products, may continue.30 as there may be several reasons why innovation has failed at any stage where we are not accumulating information about the failure, the mortality of innovations is any health innovations that are not commercially available and did not pass through the regulatory authorized channels. a remarkably diverse range of goods fall under medical devices, including pacemakers, coronary stents, and silicone breast implants.31 obtaining regulatory approvals for innovations takes much longer than the average approval process of follow-on innovations. this could increase the cost of the approval process. there are many efforts from different parts of the globe to ensure appropriate implementation of the innovations. however, many such efforts fail to deliver the intended benefits to the end user. government regulations can have dual effects when it comes to promoting health innovations. ensuring a positive regulatory environment is important, and should consider regulation affects innovation as well as the consequences of technological development for their justification and regulatory design. the oecd report32 on regulations and innovation states that regulatory reforms should be considered whenever needed to accommodate technological developments. strict competition policy might restrict the rate of technological process. competition policy may result in only the approval of innovations from large firms in concentrated industries. as they could finance themselves for the r&d.32,33 according to the nhs uk, to innovate successfully in the health field, several major problems must be resolved. budgetary considerations.33 hospitals have a notably sluggish adoption rate for technological advancements. one explanation is that their it staff are already overworked with installing, upkeep, and improving electronic health record (ehr) systems. however, hospitals’ unbalanced budgeting and incentive structures might be mainly held responsible.34,35 currently, challenges are hindering the progress and widespread adoption of medical innovations, which are crucial for addressing gaps in global healthcare provision. one major obstacle is the slowdown in productivity within healthcare r&d, leading to prolonged timelines for discovering new treatments 13 j global clinical engineering vol.6 issue 2: 2024 ramesh, nithyavathani j, syed, kachroo, sharma, priyadarshini, latha, chowdary: a landscape study to determine the innovation mortality rate in health technology innovations across the globe for emerging diseases.36 consequently, numerous acute and chronic conditions such as cancer, depression, and alzheimer’s still lack groundbreaking cures. another challenge lies in the comparatively slower diffusion of healthcare innovations compared to other industries. translating medical innovations from the research stage to practical implementation is often protracted, spanning several decades. this delay can be attributed to the intricate nature of the healthcare innovation ecosystem and the divergent motivations of various healthcare stakeholders involved. overcoming these challenges is imperative to accelerate medical progress and ensure widespread access to innovative healthcare solutions.37 the study had some limitations that affected its scope and data collection. examining various organizations was limited, potentially leaving out relevant health innovations. innovations were identified using organization or company names when generic names were unavailable, which might have impacted data accuracy. additionally, the study faced challenges in identifying health technology innovations and distinguishing between established businesses and start-ups. as a result, certain health innovations, including process innovations and non-medical product categories like digital health, e-health, cold chain, and prototypes, were not considered for health agency approval. moreover, the study did not assess the outcome of patents granted as a measure of success for health innovations. moving forward, qualitative research could shed light on factors contributing to the failure of regulatory approval for specific innovations, helping stakeholders address barriers to clearance. this knowledge would assist stakeholders in creating a more supportive environment for health innovation and encourage innovation agencies to provide appropriate assistance for regulatory clearance. broader consideration of health innovations, including process innovations and non-medical product categories, could enhance our understanding of the health technology landscape’s impact on healthcare. future research should also explore the relationship between patenting and innovation success, recognizing the potential role of intellectual property protection in health technology development and commercialization. conclusion this review emphasizes the success of health innovations for the innovations mapped through our pre-defined inclusion criteria. we have considered health innovations mapped from 2015 to 2022 for this study. the distribution of health innovations as per the country of origin showed an uneven pattern and suggested that many innovations were incubated from high-income countries by the global agencies and who. the analysis also found specific innovations scaled up from high-income countries but intended for low and lmics. the success of such innovations could not be determined only through health agency approval status. health innovation support during the selected time duration showed an uneven pattern in supporting health innovations from the innovation agencies. medical devices were the highest-mapped category of health innovation. assessment of success for process innovations and e-health interventions could not be assessed for their success status as they do not require health agency approval. the report found that over three-fourths of health innovations fail to obtain regulatory clearance. this suggests the need for critical intervention interventions in health innovation facilitation by the innovation agencies. innovations are paramount regarding healthcare equity and achieving the united nation’s sustainable development goals. however, meager support could result in redundant resource wastage. hence, the global health agencies should streamline the process of innovation support. acknowledgment the authors thank mr. keerthan rm and ms. sesetti harshitha for their valuable input on developing this paper. references 1. flessa s, huebner c. innovations in health care—a conceptual framework. int j environ res public health. 2021 sep 24;18(19):10026. 2. kelly cj, young aj. promoting innovation in healthcare. future healthc j. 2017 jun;4(2):121–5. 3. david y. medical technology an overview | sciencedirect 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https://www.globalinnovationindex.org/home j global clinical engineering vol.6 issue 4: 2024 2 editor’s corner 2024—retrospect, 2025—prospect ince its inception in 2018, the global clinical engineering journal has been steadfast in its mission to become the premier publication dedicated solely to the clinical engineering field. as we mark our sixth year, it is heartening to reflect on how the journal has grown alongside the ever-evolving field of clinical engineering. a transformative year for clinical engineering the year 2024 witnessed significant advancements in the clinical engineering field, propelled by the increasing integration of cutting-edge technology into healthcare. clinical engineers and technologists have been pivotal in ensuring the seamless operation of medical equipment and systems, adapting to innovations like artificial intelligence (ai), the internet of things (iot), and robotics. these technologies have enhanced patient care, streamlined processes, and fostered a focus on sustainability through the development of eco-friendly medical devices and practices. the field’s dynamic, especially in 2024, reflects a blend of technological progress, patient-centric care, increasing regulations, and sustainable solutions— a testament to the profession’s crucial role in modern healthcare. the role of the global clinical engineering alliance (gcea) the global clinical engineering alliance (gcea) also achieved remarkable milestones in 2024.1 representing over 45,000 professionals from more than 50 countries, gcea has united clinical engineers and technologists worldwide to share knowledge, establish best practices, and address global healthcare challenges. through initiatives such as the international clinical engineering & healthcare technology management congresses, workshops, webinars, and training programs, gcea has empowered professionals, particularly in underserved regions, to enhance technical skills, adopt emerging technologies, create professional networking, form new national associations, and develop leadership capabilities. gcea has also played a critical role in improving global healthcare resilience. by providing technical assistance, facilitating equipment donations, and sharing expertise in risk control, adverse event management, and crisis response, gcea has stood as a beacon of support in addressing healthcare challenges worldwide. additionally, the alliance’s publication platform, the global clinical engineering journal, has been instrumental and a partner in disseminating cutting-edge knowledge and research in the evolving field. a banner year for the global clinical engineering journal as an integral part of gcea, the global clinical engineering journal achieved new heights in 2024. recognized by scopus, one of the largest scientific abstract and citation databases, the global clinical engineering journal continues to follow the best practices and select proper papers with high quality to publish and share with the readers. as the only international journal that solely focuses on, and is administered by, clinical engineers, we always raise our goal to become the best and the most contributive journal in the category of clinical engineering. the journal has consistently adhered to best practices, publishing high-quality research that addresses the pressing needs of clinical engineering professionals. this year, the journal saw an unprecedented increase in submissions, with over 80 new manuscripts received— a fourfold increase compared to 2023. website visits http://www.globalce.org http://globalce.org http://globalce.org 3 j global clinical engineering vol.6 issue 4: 2024 tripled, reflecting a growing global audience of clinical engineering practitioners. a significant milestone in 2024 was the journal’s membership in the international committee of medical journal editors (icmje). by adhering to the icmje’s “recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals”, the journal reaffirms its commitment to ethical publishing practices and high editorial standards. facing new challenges and increasing submissions in the future, we promise that all the journal editors will take this responsibility seriously and strive to achieve high standards, making the global clinical engineering journal the best platform and among the renowned journals for global clinical engineers on this planet. the journal’s commitment to excellence is evident in its reduced manuscript processing times, ensuring timely and professional service for authors. these accomplishments are a testament to the collaborative efforts of the editor-in-chief, the editorial board, reviewers, authors, and readers. the guiding principle, “together, we can make it better” continues to drive the journal’s success. special issues and new initiatives in 2024, the journal introduced innovative special issues focusing on region-specific and cutting-edge topics. visualizing the next level in publication to reach helps us to stay on the path to being more impactful, larger, and the top platform for all clinical engineers to share their experiences and knowledge, and publish their research and findings. we have organized a new form of special issue, aiming to recruit high-quality and region-specific papers, that discuss the most state-the-art research in typical areas, and provide our assistance to help potential authors in need to finish their papers. the inaugural pan africa ce-bme special issue, inspired by the gcea webinar “empowering africa’s healthcare systems” aimed to highlight the research and challenges unique to africa’s clinical engineering community. similarly, the special issue featuring the 10th panhellenic conference on biomedical technology showcased the biomedical community’s shift from pandemic-focused research to broader healthcare challenges, reflecting the resilience and adaptability of global biomedical and clinical engineering societies. looking ahead, the journal will explore new special issues on topics such as: • advancements in traumatology and orthopedics • biomechanics and sports science rehabilitation • innovations in cardiovascular and ophthalmological research • clinical engineering’s role in pain medicine and digital health transformation • cutting-edge medical technologies for improved patient outcomes each special issue is curated by expert guest editors committed to maintaining the highest publication standards and providing valuable insights to readers. also, we selected the best papers presented and reviewed in the “10th panhellenic conference on biomedical technology”. with an emphasis on “biomedical technology, clinical engineering, covid-19 impact, covid-19 transition, and digital health transformation”, this special issue shows the reaction to the challenges of the hellenic society of biomedical technology along with the european and global biomedical and clinical engineering societies. all the selected papers are of scientific and engineering interest and excellence and describe how the clinical engineering research interests shifted from focusing on the pandemic to their typical pursuits, while still being influenced by the events that occurred. with all the fresh attempts, new special issues that might be of certain interest to readers are released in the journal, focusing on some of the most cutting-edge topics in the field, i.e., the new technology and surgical procedures of traumatology and orthopedics, biomechanics and rehabilitation of sports science, advancements in ophthalmological research, new technologies in cardiovascular medicine, clinical engineering in pain medicine, transformation of medical technologies for improving patient care outcomes, technology in oral and maxillofacial surgery, etc. all the guest editors are professionals in their areas and are willing to develop the special issues better. we always emphasize the publication quality and influence of the circle, so for these special http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 issue 4: 2024 4 issues, guest editors and the eic will strictly select the most suitable papers to be published, in order to create the best reading and research experience. moving forward as we transition into 2025, the global clinical engineering journal remains dedicated to its mission of serving as the leading platform for clinical engineers to share knowledge, publish research, and advance the profession. with plans to further expand its reach, introduce new special issues, and foster global collaboration, the journal is poised for another transformative year. together, we look forward to continuing this journey of growth and excellence. the global clinical engineering journal aims to expand the editorial team and welcome new editorial board members who have strong backgrounds in clinical medicine and engineering expertise. in the published paper “submissions style guide for the global clinical engineering journal”, detailed guidance is listed to help authors, especially clinical engineers to prepare their papers and submit for peer review.2 we aim to elevate the journal’s global recognition along with being indexed in other main databases with sound impact factors, to meet more practitioners, researchers, and scholars’ publication needs. the group of clinical engineers is unique and essential for the healthcare system, and we believe with the journal, more emerging authors and rising stars can benefit by publishing their peer-reviewed high-quality papers and keep contributing to the clinical engineering circle. we are committed to our mission and origin: the global clinical engineering journal is an international clinical engineering journal, led and managed by clinical engineers, contributing to clinical engineers! to achieve the goals, we may need all the clinical engineers’ help, to submit your manuscripts, become volunteer reviewers, read our publications, and disseminate the journal around your circle! together, we can make clinical engineering better! mr. zicheng (arthur) wang gcej editorial office references 1. state of the alliance. uniting the clinical engineering profession across the globe. available online: https://8702981. fs1.hubspotusercontent-na1.net/hubfs/8702981/ state%20of%20the%20alliance%202024_final.pdf?utm_ source=brevo&utm_campaign=gcea%20holiday%20 wishes_2024&utm_medium=email. 2. david, y. and schultz, j. submissions style guide for the global clinical engineering journal. glob clin eng j. 2020;3(1):33–43. doi: https://doi.org/10.31354/globalce.v3i1.102. http://www.globalce.org http://globalce.org http://globalce.org https://8702981.fs1.hubspotusercontent-na1.net/hubfs/8702981/state%20of%20the%20alliance%202024_final.pdf?utm_source=brevo&utm_campaign=gcea%20holiday%20wishes_2024&utm_medium=email https://8702981.fs1.hubspotusercontent-na1.net/hubfs/8702981/state%20of%20the%20alliance%202024_final.pdf?utm_source=brevo&utm_campaign=gcea%20holiday%20wishes_2024&utm_medium=email https://8702981.fs1.hubspotusercontent-na1.net/hubfs/8702981/state%20of%20the%20alliance%202024_final.pdf?utm_source=brevo&utm_campaign=gcea%20holiday%20wishes_2024&utm_medium=email https://8702981.fs1.hubspotusercontent-na1.net/hubfs/8702981/state%20of%20the%20alliance%202024_final.pdf?utm_source=brevo&utm_campaign=gcea%20holiday%20wishes_2024&utm_medium=email https://8702981.fs1.hubspotusercontent-na1.net/hubfs/8702981/state%20of%20the%20alliance%202024_final.pdf?utm_source=brevo&utm_campaign=gcea%20holiday%20wishes_2024&utm_medium=email https://doi.org/10.31354/globalce.v3i1.102 original research article dose verification for linac-based stereotactic radiosurgery planned at different prescription isodose levels using delta4 phantom+ emmanuel fiagbedzi*, francis hasford and samuel nii tagoe original research article application and innovation of 3d printing in medical equipment maintenance lei jiang original research article assessment and capital planning of a regional clinical engineering department test equipment inventory samantha puin avila*, marie-ange janvier and andrew a.m. ibey original research article a decision support system for rational deployment of medical equipment based on real-world data dingding jia1, haowei zhang1, yang you1, yiming li2, shunxin qian3, qilin tao4, qi su5, heqing lu5,* j global clinical engineering vol.6 issue 2, 2024 28 a metaphor for the choices we have experiences, the phrase “the road less traveled” refers to unconventional and uncertain choices made. but why engage with review of a book with such a title here in clinical engineering discipline journal? the first part of this book starts by the author with “life is difficult.” and we, the practitioners working in healthcare delivery, know that first-hand. we also understand that engineering refers to any type of science concerned with the design, construction and use of machines, systems, and structures. engineering practitioners come from various backgrounds, cultures, and experiences. mostly, the field of engineering attracts individuals who are intellectually curious, analytically minded, and passionate about making a difference through technological innovation and problem-solving. what unites them is their passion for creating, overcoming challenges, and making a positive impact on the world. however, from my experience in general, clinical engineering practitioners’ shy emotion-associated verbal expression and dr. peck, the author, writes in the introduction to his book “… perhaps because it was needed, despite its flaws, there is no question in my mind that as i wrote the book in the solitude of my cramped little office i had help. i really cannot explain that help, but the experience of it is hardly unique. indeed, such help is the ultimate subject of the book itself.” as dr. peck continues “…once we truly understand and accept it – then life is no longer difficult.” my reason for selecting to write review about this book, that most readers will not expect to find in engineering periodical, is that the encouragement and guidance this book provides may be helpful to our readers. “when my patients lose sight of their significant and are disheartened by the effort of work we are doing, i sometimes tell them the that human race is in the midst of making an evolutionary leap. “whether or not we success in that leap…is your personal responsibility”, and mine”” this book, road less traveled is the best-known work of dr. peck, a psychiatrist and best-selling author, educated at harvard and case western reserve, who helped found the foundation for community encouragement, and published the different drum and people of the lie books. the road less traveled was first published in 1978 and has since sold over 6 million copies and has been book review by yadin david gcea president road less traveled,(25th edition) m. scoot peck, m.d. publisher: simon & schuster isbn: 978-0-7432-3825-0 (hard copy) 315 pages book price: $18 us at amazon http://www.globalce.org http://www.globalce.org 29 j global clinical engineering vol.6 issue 2, 2024 translated into over 20 languages. it is a description of attributes that make a fulfilled human being, based largely on his experience as psychiatrist and a person. the book has four parts. in the first, dr. peck examine the notion of discipline, which considers essential for healthy emotional, spiritual, and psychological health. he writes about having balance on such notion as delayed gratification and accepting responsibility for oneself actions, dedication to the truth. about openness to challenge, the author advises the reader to “continuous and never-ending process of self-monitoring to assure that our communications – not only words that we say but also the way we say them the…” are especially meaningful in the era of texting and instant messaging. in the journey of life, the author advice, mandates negotiation of the curves and corners of our lives where we must continually give up parts of ourselves, but strangely as it seems “…most people choose the alternative and elect to stop by some distance…” creating significant pain. “giving up” is the essence of balancing and is one of the major forms, according to the author, this book teaches, so the reader may achieve well-balanced patterns of behavior, personality traits and a whole better lifestyle. in the second part he raises the questions about love, emotional dependency, and explain the term “falling in love”. the author states that “we are incapable of loving another unless we love ourselves.” and “love is effortful.” in the third part he writes about spirituality growth, religion and their role in therapy and maturity. “…among the members of the human race there exists an extraordinary variability in the breadth and sophistication of our understanding of what life is about.” the author argues that “we must continuously expand our realm of knowledge and our field of vision through the thorough digestion and incorporation of new information” as “the process of expansion of knowledge has been a major theme of this book.” similarly, clinical engineering practitioners must adopt learning as lifelong commitment. the fourth and final part concerns grace, human spiritual growth, mental health, discussing scientific thinking, and the conscious world around us. the author suggests that “it is hardly remarkable that we sicken and die; what is truly remarkable is that we don’t usually sicken very often and we don’t die very quickly.” perhaps avoiding giving credit to the role of advances in science and engineering in it. continuing to explain that “there is a force, the mechanism of which we do not fully understand, that seems to operate routinely in most people to protect and encourage their physical health even under the most adverse conditions.” towards the book’s end, under the miracle of evolution the author suggests that the human race is in spiritual progression. for ours and our children’s future i hope he is correct. after reading the book, i felt that i can examine and gain deeper self-knowledge thus attempting to eliminate my shortfalls. similarly, i felt it may help other trained engineering professionals to better understand their challenges, and if there is path for improvement that they can prescribe to, then it was worth publishing this review of a non-technical book helping everyone to embrace qualities that according to dr. peck leads to better health, better relationships, and richer life experiences. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 25 j global clinical engineering vol.6 special issue 6: 2024 original research article validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis medical physics & digital innovation lab, school of medicine, faculty of health sciences, aristotle university of thessaloniki (auth), thessaloniki, greece. * corresponding author email: npandria@gmail.com abstract intellectual disability (id) is a neurodevelopmental disorder characterized by limitations in adaptive and intellectual functioning. serious games (sgs) incorporate learning and educational strategies that are commonly used in special education, and they have been proposed as assistive tools for people with developmental difficulties. id-gaming e-training toolkit encloses an sg named “qool city” available as a board and a digital game, a game catalogue, and training materials on cognitive functions and quality of life. in this manuscript, we focused on describing the methodology and the preliminary outcomes of the validation actions of the toolkit. a four-step methodology was formed to specify the interaction of participants with the toolkit and a qualitative validation tool was developed by the consortium to assess the participants’ performance during the session. the target groups were people with intellectual disabilities (pwid) (young adults and adults), professionals, and relatives. twelve individuals participated of which seven were pwid, two educators, and three facilitators. however, two pwid withdrew from the activities performed in steps 1 and 2, but one pwid joined the activities performed in steps 3 and 4. the id-gaming e-training toolkit seems to lead to improvement in various cognitive functions of pwid including memory, attention, language, and spatial orientation. components of quality of life such as wellbeing and independence were promoted. pwid remained engaged until the end of their interaction with the toolkit components while both pwid and educators were satisfied with the toolkit. moreover, educators argued that the e-training toolkit helped them to be motivated and aware of the potential applications of sgs for improving cognitive functions as well as providing useful information about the quality of life, its improvement, and cognitive functions. in addition, collaborative and supportive skills were promoted along with digital skills. indicators for participants’ experience and improvement were fulfilled. therefore, the id-gaming e-training toolkit seems to be a valuable assistive tool for pwid and the people involved in their care that should be further validated using a larger sample size and standardized assessment tools. keywords—intellectual disability, serious games, validation actions, cognitive functions, quality of life. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:npandria@gmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.6 special issue 6: 2024 26 introduction intellectual disability (id) constitutes a neurodevelopmental disorder1 that is characterized by limitations in intellectual functioning and adaptive behavior.2 the difficulties are present at birth and their manifestation is shown during the developmental period before adulthood.1 the intellectual functioning refers to “the global ability to understand reality and interact with it” 2 and it is attributed to the concept of intelligence.2 it integrates different cognitive functions such as problem-solving, logical reasoning, abstract thinking, planning, ability in learning, and experiential learning which are all affected in id.1,2 adaptive behavior is conceptualized as a set of skills that provide competence in the social, practical, and conceptual domain.2 id is characterized by deficits in adaptive behavior that lead to the inability to meet sociocultural and developmental standards for social responsibility and personal independence. without ongoing support, deficits limit functioning to at least one daily activity and in multiple settings.1 id can be accompanied by different co-morbidities such as other neurodevelopmental, neurological, or mental disorders as well as medical conditions.2 the treatment of id should be multilevel, multidisciplinary, and tailored to patient needs and may include psychopharmacologic interventions, educational support, behavioral approaches, vocational training, and family education.2 another interventional approach that was introduced as a tool to support people with id was serious games (sgs). sgs are defined as the games that are designed with a primary purpose rather than pure entertainment3 and they have been applied in multiple fields such as education, healthcare, advertisement, and military among others.4 although there are some examples of sgs that have been developed for mentally challenged people to support emotion recognition and expression5,6, dealing with real-life situations7 or mathematics8, the landscape of how to design, develop, and evaluate sgs is not adequately explored.9 however, it is clear that people with id have special educational needs10 and therefore it is crucial to consider their abilities and needs while designing and evaluating an sg. most of the sgs that have been evaluated were computer games, in the field of education and healthcare and questionnaires were used as an assessment method.11 id-gaming e-training toolkit was designed and developed in the context of the erasmus+ id-gaming project and it is freely available on the project website (https:// id-gaming.inesc-id.pt/). it encloses an sg named “qool city” that is provided in two versions as a board game and a digital game (figure 1), a game catalogue, and training materials. the “qool city” is a collaborative sg that incorporates a narrative adapted to the id sector and to life settings and expectations of young adults and young adults with id. the main purpose of the game is to promote quality of life improvement through training in cognitive functions and quality of life dimensions. the game catalogue is a collection of serious games, non-serious games, and platforms already tested by people with id (pwid). every game can be selected based on the cognitive function the user wants to train, and it is accompanied by a brief explanation of the training purpose, tips for a satisfying gaming experience, and relation, if any, with the dimensions of quality of life. training materials were designed to familiarize pwid, professionals and caregivers with concepts that are involved in the “qool city” game and further expand their knowledge on sgs and quality of life dimensions. more precisely, training materials were developed in five different themes that are dimensions of quality of life and cognitive functions, the impact of cognitive training on quality of life, the definition of serious games and information and communications technology (ict) serious games, selection of ict serious games to train cognitive functions for pwid, the role of supports in easy-to-read format. a methodological guide was also included to facilitate the interaction with the sg “qool city”. in this manuscript, we describe the validation actions of the intellectual outputs (ios) of the id-gaming project that are incorporated into the id-gaming e-training toolkit. the project had as intellectual outputs (ios) the development of a quality-of-life training game so-called “qool city”, a training toolkit, and an e-training tool. the validation actions were focused on the evaluation of the quality of ios and therefore the quality of id-gaming e-training toolkit, the assessment of possible improvements in competencies of persons with id, relatives, and http://www.globalce.org http://globalce.org http://globalce.org https://id-gaming.inesc-id.pt/ https://id-gaming.inesc-id.pt/ 27 j global clinical engineering vol.6 special issue 6: 2024 figure 2. flowchart of the 4-step methodology applied to validation actions. and observer had to fill in the qualitative validation tool (questionnaires a, b, c, d) developed by the consortium to assess participants’ performance during the session (see appendix). two different versions of each questionnaire were designed, the one to be filled by facilitators/ trainers after collecting pwid responses and the other addressed to relatives and professionals. data collected through the questionnaires were anonymous. additionally, all sessions were accompanied by an attendance list, a checklist page and notes, and a satisfaction questionnaire. a number of indicators were set to assess the participants’ experience and improvement, listed below in table 1. table 1. indicators to assess the participants’ experience and improvement. no. validation indicator target 1 attendance to validation pilot actions 100 participants (30 in portugal, spain, and italy, and 10 in greece) 2 target group awareness and motivation to use ict sgs to improve qol ≥ 70% target group is aware and motivated to use ict sgs to improve qol 3 target group digital skills use improvement ≥ 70% target group experienced opportunities to use digital skills. 4 target group cognitive functions use improvement 70% of the target group experienced opportunities to use their cognitive functions 5 target group qualityof-life dimensions improvement 70% of the target group experienced opportunities to improve quality-of-life dimensions professionals, and the collection of feedback on “qool city” for refinement purposes. figure 1. screenshots of the “qool city” game available as a digital game (left) and a board game (right). methods the validation actions were performed through faceto-face sessions from may to july 2022 with a goal to involve at least 100 participants across countries (30 in portugal, spain, and italy, and 10 in greece). our target groups were young adults and adults with intellectual disabilities, professionals, and relatives. a four-step methodology (figure 2) was formed including interaction with training materials in five different themes in easy-to-read format as described earlier (step 1); two complete turns of playing the board game “qool city” as single players (step 2); two complete turns of playing the online game as single players (step 3); interaction with the game catalogue and five ict-serious games on training environment or at home (step 4). at least one facilitator/trainer and observer participated during each validation session. the facilitator/trainer was a professional who was trained on “qool city” contents, training methodology, and design and guided participants through the activities, while the observer was a professional who was responsible for collecting information about the validation experiences and facilitator support. at the end of each validation session, the players commented on their experience with support, if needed, from the facilitator and observer. moreover, the facilitator http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 28 6 improvement of collaborative/ cooperative/teamwork skills 70% of the target group experienced opportunities to improve collaborative/ cooperative/teamwork skills 7 target group opinion on “qool city” ≥ 70% target group evidence satisfaction results twelve individuals took part in validation sessions of which seven were pwid, two educators, and three facilitators. however, two pwid withdrew from the activities performed in steps 1 and 2, but one new participant with id joined the activities performed in steps 3 and 4. all educators agreed that training materials, both versions of “qool city” game (board and online) and the game catalogue helped them to be aware of the use of sgs for improving cognitive functions, to be motivated about using sgs, to know more about quality of life, cognitive functions, and quality of life improvement. moreover, they responded positively to questions about the different components of id-gaming e-training toolkit and the use of supportive skills. more precisely, both versions of “qool city” and the game catalogue facilitated the use of collaborative and supportive skills such as active listening, respect choices, teamwork, flexibility, as well as the balance between support and autonomy. educators also agreed that the online version of “qool city” and the game catalogue promoted the use of digital skills. after interacting with training materials, six out of seven pwid showed improvement in their language, memory, and attention skills. pwid were able to practice their language skills to share their thoughts and opinions regarding the training material themes and discuss with each other and the facilitators. through discussions, they had the opportunity to learn the meaning of some new words and phrases. they could also recall moments from their personal experiences related to the quality-of-life dimensions and they were able to remain focused throughout the whole session. generally, it was observed that most of the players were motivated and actively participated in the discussion especially on topics related to material wellbeing. six out of seven pwid completed all cognitive challenges of the board game “qool city” with little or no help. similar findings were revealed in five out of six pwid when playing the online game “qool city”. evaluating the game catalogue experience, four out of six showed an improvement in their memory skills, while five out of six in attention to detail and spatial orientation skills, as they were able to focus on each game to find the matching pairs, or the right position and the new elements added to the scene. moreover, it was observed that half participants strengthened their skills in calculation and emotional wellbeing, as they could do calculations with money (i.e., addition and subtraction) and correctly recognize different emotional expressions. six out of seven pwid were aware and motivated about the use of ict-sgs for improving cognitive functions and therefore their quality of life after their interaction with the board version of “qool city”. similar findings were observed in all participants (6 out of 6) after interacting with the online game “qool city” and the game catalogue. this was emphasized by the fact that they enjoyed playing the “qool city” by trying to fall into challenge boxes and they remained motivated and engaged until the end of the game. all pwid (6 out of 6) were familiar with playing digital games and interested in playing the five ict-sgs. they remained engaged until the end of the session and it was noticed that some of them continued playing even though they had successfully completed the games. six out of seven pwid actively participated throughout the game, and they took part in every challenge they had to accomplish in their turn. moreover, participants tended to prefer challenges related to physical activity and socialization. similar findings were shown in all participants (6 out of 6) after interacting with the online game “qool city”. moreover, six out of five out of six improved their wellbeing competence after playing the board and the online game respectively. evaluating the independence competence, five out of seven and five out of six pwid were autonomous in completing the challenges of the board and the online game respectively. some of them (4 out of 7 for the board game and 3 out of 7 for the online game) needed help to understand the challenges’ instructions because they did not have the ability to read. it was also observed that they could decide for themselves on those challenges that offered several options. interacting with http://www.globalce.org http://globalce.org http://globalce.org 29 j global clinical engineering vol.6 special issue 6: 2024 figure 4. the overall participants’ satisfaction after interacting with the board game “qool city” (step 2). figure 5. the overall satisfaction of participants after interacting with the online version of the “qool city” game (step 3). figure 6. evaluation of the game catalogue experience (step 4). the online game “qool city”, all players gradually improved their digital skills. more specifically, they got familiar with the use of the computer mouse, and they learned how to use the “zoom” function in the pictures. some of them (3 out of 6) were able to use the keyboard to name their avatar. in this direction, most of the participants (5 out of 6) improved their ability to use the keyboard and the computer mouse to follow the game rules and advance to the next level after interacting with the five ict-sgs. during both versions of “qool city” game, all pwid had the opportunity to enhance their teamwork skills. a friendly and cooperative environment was fostered during the game where participants encouraged each other to perform the challenges. it should also be noted that every player was willing to patiently wait for his/her turn to play. assessing whether the “qool city” game is playable, fun, educational, accessible, usable, and having an impact on their cognitive functions and quality of life, six out of seven pwid after playing the board game reported that they had fun and they liked using the physical elements of the game like rolling the dice and moving their pawns. they also thought that the game was useful for learning new things and practicing new skills. likewise, all pwid had fun during the online game which was also considered useful. however, the board game was preferred compared to the online game as they enjoyed the interaction with the physical elements of the board game. the overall satisfaction of participants in different steps and the global satisfaction are presented in figures 3–6 as well as in figure 7 respectively. figure 3. evaluation of participants’ experience after interacting with training materials (step 1). http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 30 figure 7. evaluation of the global participants’ satisfaction after interacting with the id-gaming e-training toolkit. all indicators defined to assess the participants’ experience and improvement were fulfilled in pwid as displayed in table 2. table 2. results of participants’ experience and improvement indicators in pwid. no. validation indicator results 1 attendance to validation pilot actions 12 participants 2 target group awareness and motivation to use ict sgs to improve qol 95.2% 3 target group digital skills use improvement 91.7% 4 target group cognitive functions use improvement. 78.6% 5 target group quality-of-life dimensions improvement 84.9% 6 improvement of collaborative/cooperative/ teamwork skills 91.7% 7 target group opinion on qool city 92.9% discussion serious games incorporate learning and educational strategies that are commonly used in special education such as repetition, narrative, simulation of real-world conditions, as well as coherent and immediate feedback.12 repetition is an important learning component of sgs as it highly enhances memory retention13 which is affected in persons with developmental disabilities.14 memory retention is further enhanced by incorporating information into context15 that can be achieved through a narrative. embedding a narrative into an sg facilitates cognitive load reduction16, motivation, problem-solving17, and efficiency.18 simulation of real-world settings inherent to sgs seems to promote better transition to everyday life tasks.19 the transition from learning environment to real-life setting is challenging for pwid as they face difficulties in generalizing the acquired knowledge to different conditions or applying it to daily activities.4 the coherent and immediate feedback provided by sgs has been observed to enhance motivation20, independent learning21, and retention of acquired knowledge22 while reducing errors.21 as sgs constitute an appropriate learning method for people with developmental difficulties such as pwid, they have been incorporated into the id-gaming e-training toolkit, leading to beneficial outcomes on different cognitive skills such as attention, spatial orientation, and memory skills. similar benefits of sgs in attention, spatial orientation skills and memory were reported in children with attention deficit hyperactivity disorder (adhd)23, 24, while improvement in cognitive and adaptive functioning was found in children with intellectual disability and/or autism spectrum disorder in a recent meta-analysis.25 training materials, integrated into the id-gaming e-training toolkit, were found to promote language skills. a similar conclusion was reached by a recent study9 which argued that sgs could have positive outcomes in vocabulary and language learning. we also observed that emotional recognition skills were strengthened after interacting with the e-training toolkit. this finding was also supported by the study of kokol et al.26 pwid showed improvement in wellbeing competence, http://www.globalce.org http://globalce.org http://globalce.org 31 j global clinical engineering vol.6 special issue 6: 2024 conclusion this paper describes the summary of preliminary research on the effects of id-gaming e-training toolkit on cognitive functions and quality of life. the toolkit seems to lead to improvement in various cognitive functions of pwid including memory, attention, language, and spatial orientation. components of quality of life were promoted such as wellbeing and independence. teamwork and digital skills were enhanced, while the pwid remained engaged until the end of their interaction with the toolkit. both pwid and educators were satisfied with the toolkit. moreover, educators argued that id-gaming e-training toolkit helped them to be motivated and aware of the potential applications of sgs for improving cognitive functions as well as providing useful information about the quality of life, its improvement, and cognitive functions. in addition, collaborative and supportive skills were promoted along with digital skills. indicators for participants’ experience and improvement were fulfilled. therefore, the id-gaming e-training toolkit seems to be a valuable assistive tool for pwid and the people involved in their care that should be further validated using a larger sample size and standardized assessment tools. grant support this work has been partially funded by the “development of a training program for the improvement of quality of life of persons with intellectual disabilities through ‘serious games’” (id-gaming) project, co-funded by the erasmus+ programme of the european union (2020-1-pt01-ka204-078873). references 1. american psychiatric association. diagnostic and statistical manual of mental disorders. 5th ed. american psychiatric publishing: washington, usa; 2013. https://doi.org/10.1176/appi.books.9780890425596. independence, motivation, and engagement. similar findings in motivation, participation, and engagement are reported in recent studies.27–29 additionally, id-gaming e-training toolkit appeared to facilitate teamwork and cooperative skills as most of the participants enhanced their collaboration and social skills, which is consistent with previous research.9 interacting with the online version of “qool city” game, all pwid gradually improved their digital skills. this finding may be indicative that the toolkit fulfilled its educational purpose, as sgs have long been used for acquiring skills and/or training in various knowledge areas.30–33 although there are several studies that have attempted to use sgs for supporting people involved in the care of vulnerable populations34–37, to the best of our knowledge, this is the first study that explored an e-training toolkit that incorporates sg designed for pwid with the involvement of professionals (i.e., educators). the educators who participated mentioned that the toolkit helped them to be aware of the use of sgs for the improvement of cognitive functioning, to be motivated about sgs as well as to know more about quality of life and its improvement and cognitive functions. moreover, they reported that the game catalogue and both versions of “qool city” game promoted teamwork, supportive, and digital skills. however, there are several limitations in our study that should be noted. the small number of participants along with the inherent heterogeneity of pwid may limit the generalization of our study outcomes. another limitation is associated with the methodology applied as a qualitative validation tool (questionnaires a, b, c, d) developed by the consortium was used to assess the participants’ progress. however, the results presented here could be considered useful motivators for knowledge building in a greater and clearly defined sample of pwid using standardized assessment tools. in this way, the power of the study will be enhanced and the comparison of outcomes from different research groups could be possible and straightforward. furthermore, future research should be focused on the investigation of the long-term effects of sgs as it seems to be quite an unexplorable field. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.1176/appi.books.9780890425596 j global clinical engineering vol.6 special issue 6: 2024 32 2. lee, k., cascella, m., marwaha, r. intellectual disability. statpearls publishing; 2025. available online: https:// pubmed.ncbi.nlm.nih.gov/31613434/. 3. abt, c.c. serious games. university press of america: new jersey, usa; 1970, pp. 176. 4. michael, d. and chen, s. serious games: games that educate, train and inform. course technology ptr: kentucky, usa; 2006. 5. serret, s., hun, s., iakimova, g., et al. facing the challenge of teaching emotions to individuals with lowand high-functioning autism using a new serious game: a pilot study. mol autism. 2014;5(37). https://doi. org/10.1186/2040-2392-5-37. 6. christinaki, e., vidakis, n., triantafyllidis, g. a novel educational game for teaching emotion identification skills to preschoolers with autism diagnosis. comput sci inf syst. 2014;11(2):723–743. https://doi.org/10.2298/ csis140215039c. 7. bourazeri, a., bellamy-wood, t., arnab, s. encity: a serious game for empowering young people with down’s syndrome. in proceedings of iieee international conference on serious games and applications for health. perth, australia, april 2017; ieee xplore: piscateville, new jersey, usa. 8. sochocka, a., mirocha, j., starypan, r. serious games as an aid in the development of people with intellectual disabilities. bio-algorithms med-syst. 2020;16(1). https://doi.org/10.1515/bams-2019-0055. 9. tsikinas, s., xinogalos, s., satratzemi, m. review on serious games for people with intellectual disabilities and autism. in proceedings of 10th european conference on games based learning (ecgbl 2016). paisley, uk, october 2016; academic conferences ltd: england. 10. tsikinas, s. and xinogalos, s. towards a serious games design framework for people with intellectual disability or autism spectrum disorder. educ inf technol. 2020;25(4):3405–3423. https://doi.org/10.1007/ s10639-020-10124-4. 11. calderón, a. and ruiz, m. a systematic literature review on serious games evaluation: an application to software project management. comput educ. 2015;87:396–422. https://doi.org/10.1016/j.compedu.2015.07.011. 12. kwon, j. and lee y. serious games for the job training of persons with developmental disabilities. comput educ. 2016;95(c):328–339. https://doi.org/10.1016/j. compedu.2016.02.001. 13. hintzman, d.l. repetition and memory. psychol learn motiv. 1976;10:47–91. https://doi.org/10.1016/ s0079-7421(08)60464-8. 14. vicari, s., carlesimo, a., caltagirone, c. short-term memory in persons with intellectual 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org/10.1177/074193250102200505. 19. wouters, p., van nimwegen, c., van oostendorp, h., et al. a meta-analysis of the cognitive and motivational effects of serious games. j educ psychol. 2013;105(2):249–265. https://doi.org/10.1037/a0031311. http://www.globalce.org http://globalce.org http://globalce.org https://pubmed.ncbi.nlm.nih.gov/31613434/ https://pubmed.ncbi.nlm.nih.gov/31613434/ https://doi.org/10.1186/2040-2392-5-37 https://doi.org/10.1186/2040-2392-5-37 https://doi.org/10.2298/csis140215039c https://doi.org/10.2298/csis140215039c https://doi.org/10.1515/bams-2019-0055 https://doi.org/10.1007/s10639-020-10124-4 https://doi.org/10.1007/s10639-020-10124-4 https://doi.org/10.1016/j.compedu.2015.07.011 https://doi.org/10.1016/j.compedu.2016.02.001 https://doi.org/10.1016/j.compedu.2016.02.001 https://doi.org/10.1016/s0079-7421(08)60464-8 https://doi.org/10.1016/s0079-7421(08)60464-8 https://doi.org/10.1111/j.1365-2788.1995.tb00574.x https://doi.org/10.1016/j.chb.2007.02.015 https://doi.org/10.1177/002221949703000207 https://doi.org/10.1177/002221949703000207 https://doi.org/10.1177/074193250102200505 https://doi.org/10.1177/074193250102200505 https://doi.org/10.1037/a0031311 33 j global clinical engineering vol.6 special issue 6: 2024 28. hersh, m. and leporini, b. editorial: serious games, education and inclusion for disabled people. br j educ technol. 2018;49(4):587–595. https://doi.org/10.1111/ bjet.12650. 29. marinelli, c.v., nardacchione, g., trotta, e., et al. the effectiveness of serious games for enhancing literacy skills in children with learning disabilities or difficulties: a systematic review. appl sci. 2023;13(7):4512. https://doi.org/10.3390/app13074512. 30. vlachopoulos, d. and makri, a. the effect of games and simulations on higher education: a systematic literature review. int j educ technol high educ. 2017;14(1):22. https://doi.org/10.1186/s41239-017-0062-1. 31. sung, h. and hwang, g. a collaborative game-based learning approach to improving students’ learning performance in science courses. comput educ. 2013;63:43–51. https://doi.org/10.1016/j.compedu.2012.11.019. 32. girard, c., ecalle, j., magnan, a. serious games as new educational tools: how effective are they? a meta-analysis of recent studies. j comput assist learn. 2013;29(3):207–219. https://doi.org/10.1111/j.1365-2729.2012.00489.x. 33. boyle, e., connolly, t., hainey, t. the role of psychology in understanding the impact of computer games. entertain comput. 2011;2(2):69–74. https://doi.org/10.1016/j. entcom.2010.12.002. 34. lievense, p., vacaru, v., liber, j., et al. “stop bullying now!” investigating the effectiveness of a serious game for teachers in promoting autonomy-supporting strategies for disabled adults: a randomized controlled trial. disabil health j. 2019;12(2):310–317. https://doi. org/10.1016/j.dhjo.2018.11.013. 35. veerman, l.k.m., willemen, a.m., derks, s.d.m., et al. the effectiveness of the serious game “broodles” for siblings of children with intellectual disabilities and/ or visual impairment: study protocol for a randomized controlled trial. trials. 2023;24(1):336. https://doi. org/10.1186/s13063-023-07358-1. 20. butler, d.l. and winne, p.h. feedback and selfregulated learning: a theoretical synthesis. rev educ res. 1995;65(3):245–281. https://doi. org/10.3102/00346543065003245. 21. dihoff, r.e., brosvic, g.m., epstein, m.l., et al. adjunctive role for immediate feedback in the acquisition and retention of mathematical fact series by elementary school students classified with mild mental retardation. psychol rec. 2005;55(1):39–66. https://doi. org/10.1007/bf03395497. 22. epstein, m.l., brosvic, g.m., costner, k.l., et al. effectiveness of feedback during the testing of preschool children, elementary school children, and adolescents with developmental delays. psychol rec. 2003;53(2):177–195. https://doi.org/10.1007/bf03395439. 23. papanastasiou, g., drigas, a., skianis, c. serious games: how do they impact special education needs children. tech educ humanit. 2022;2(3):41–58. https://doi. org/10.47577/teh.v2i3.7407. 24. garcía-redondo, p., garcía, t., areces, d., et al. serious games and their effect improving attention in students with learning disabilities. int j environ res public health. 2019;16(14):2480. https://doi.org/10.3390/ ijerph16142480. 25. derks, s., willemen, a.m., sterkenburg, p.s. improving adaptive and cognitive skills of children with an intellectual disability and/or autism spectrum disorder: meta-analysis of randomised controlled trials on the effects of serious games. int j child-comput interact. 2022;33:100488. https://doi.org/10.1016/j. ijcci.2022.100488. 26. kokol, p., vošner, h.b., završnik, j., et al. serious gamebased intervention for children with developmental disabilities. curr pediatr rev. 2020;16(1):26–32. https:// doi.org/10.2174/1573396315666190808115238. 27. hanghøj, t., lieberoth, a., misfeldt, m. can cooperative video games encourage social and 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clinical engineering vol.6 special issue 6: 2024 a detailed description of the indicators defined to assess the participants’ experience and improvement is presented in the following table (table 3). table 3. detailed description of the indicators defined to evaluate the experience and performance of participants. appendix no. indicator definition measurement method target instrument used to collect evidence 1 attendance to validation pilot actions number of persons belonging to the target group who participated in the validation pilot actions. list of attendants identifying the specific target group (pwid, relative, professional) 100 participants (30 in portugal, spain, and italy and 10 in greece) attendance list 2 target group awareness and motivation to use ict sgs to improve qol number of trainees/ players (pwid, relatives and professionals) who are aware and motivated about the use of ict-serious games for improving the cognitive functions of pwid and therefore their quality of life. pwid: guided interviews for collecting their opinions. relatives and professionals: self-assessment questionnaire about their experience after each step. ≥ 70% target group aware and motivated to use ict sgs to improve qol questionnaires a, b, c and d 3 target group digital skills use improvement number of trainees/players (pwid, relatives and professionals) that showed an improvement of digital skills use. pwid (qualitative): trainers’ assessment through direct observation and guided interviews about their experience on steps 2 and 3. pwid (quantitative): trainers and supports assessment on questionnaire b and c. supports: self-assessment questionnaires after the validation actions. ≥ 70% target group experienced opportunities to use digital skills. questionnaires b and c 4 target group cognitive functions use improvement number of trainees/ players (pwid) that showed an improvement of cognitive functions (language, calculus & problem solving; memory & attention to detail; spatial orientation; social & emotional) use. number of supports that showed an improvement in supporting skills, while playing. pwid (qualitative): trainers’ assessment through direct observation and guided interviews (questionnaires a, b and c) with pwid about their experience on validation step 1, 2 and step 3. pwid (quantitative): trainers and supports assessment through a questionnaire assessing pwid’s cognitive functions use during validation step 1, 2 and step 3. supports: self-assessment questionnaires after the validation actions assessing supporting skills (respect, collaboration, teamwork, trust, etc.). 70% of the target group experienced opportunities to use their cognitive functions questionnaires a, b and c http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 36 5 target group quality-of-life dimensions improvement number of trainees (pwid) that showed an improvement of qualityof-life dimensions (selfdetermination, social inclusion, rights, personal development, personal relationships, material wellbeing, emotional wellbeing and physical wellbeing). number of supports that showed an improvement in supporting skills, while playing. pwid (qualitative): trainers’ assessment through direct observation and guided interviews with pwid (to fill in questionnaire a and b) about their experience on validation step 1 and step 2. pwid (quantitative): trainers and supports assessment through a questionnaire assessing quality of life dimensions of pwid. supports: self-assessment questionnaires after the validation actions assessing supporting skills (respect, collaboration, teamwork, trust, etc.). 70% of the target group experienced opportunities to improve qualityof-life dimensions questionnaires a and b 6 improvement of collaborative/ cooperative/ teamwork skills number of trainees (pwid and supports) that showed an improvement on collaborative/cooperative/ teamwork skills. pwid and supports. (qualitative): trainers’ assessment through direct observation and guided interviews with pwid about their experience on validation step 1 and step 2. pwid and supports (quantitative): cross assessment between pwid and supports about their experience on validation step 1 and step 2. 70% of the target group experienced opportunities to improve collaborative/ cooperative/ teamwork skills questionnaires a and b 7 target group opinion on “qool city” number of trainees (pwid and supports) who thought that the qol game is playable, fun, educational, accessible, and usable and with impact in their cognitive functions and quality of life. pwid and supports. (quantitative) ≥ 70% target group evidence satisfaction satisfaction questionnaire questionnaire a | applied to pwid after having read all easy-to-read training materials, please present below your opinion and conclusions about the most significant improvements. http://www.globalce.org http://globalce.org http://globalce.org 37 j global clinical engineering vol.6 special issue 6: 2024 step 1—training materials experience evaluation [indicator 4] how many players in this validation group have improved cognitive functions use? qualitative opinion and conclusions: other comments: questionnaire b | applied to pwid after playing qool city board game please present below your opinion and conclusions about most significant improvements. step 2—qool city board game experience evaluation [indicator 2] how many players in this validation group are aware and motivated about the use of ict-serious games for improving cognitive functions and therefore their quality of life? qualitative opinion and conclusions: [indicator 5] how many players in this validation group have improved their participation’s competence after playing qool city game? qualitative opinion and conclusions: how many players in this validation group have improved their wellbeing’s competence after playing qool city game? qualitative opinion and conclusions: how many players in this validation group have improved their self-determination’s competence after playing qool city game? qualitative opinion and conclusions: questionnaire c | applied to pwid after playing qool city online game please present below your opinion and conclusions about most significant improvements. thanks. step 3—qool city online game experience evaluation http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 38 [indicator 2] how many players in this validation group are aware and motivated about the use of ict-serious games for improving cognitive functions and therefore their quality of life? qualitative opinion and conclusions: [indicator 5] how many players in this validation group have improved their participation’s competence after playing qool city game? qualitative opinion and conclusions: how many players in this validation group have improved their wellbeing’s competence after playing qool city game? qualitative opinion and conclusions: how many players in this validation group have improved their self-determination’s competence after playing qool city game? qualitative opinion and conclusions: questionnaire d | applied to pwid after using game catalogue in the id-gaming e-training toolkit and have played five (5) different ict serious games (ict-sgs) online game, please present below your opinion and conclusions about most significant improvements. step 4—game catalogue experience evaluation [indicator 2] how many players in this validation group are aware and motivated about the use of ict-serious games for improving cognitive functions and therefore their quality of life? qualitative opinion and conclusions: [indicator 3] how many players in this validation group that show an improvement of digital skills use? qualitative opinion and conclusions: [indicator 4] how many players in this validation group have improved cognitive functions use? qualitative opinion and conclusions: other comments: http://www.globalce.org http://globalce.org http://globalce.org 39 j global clinical engineering vol.6 special issue 6: 2024 questionnaire a | applied to relatives and professionals after having read all easy-to-read training materials, mark with an x your chosen option using “yes”, “no”, or “don’t know”. step 1—training materials experience evaluation [indicator 2] training materials helped you to be aware of the use of serious games for improving cognitive functions training materials helped you to know more about quality of life training materials helped you to be motivated about using serious games training materials helped you to know about cognitive functions improvement and quality of life improvement other comments: questionnaire b | applied to relatives and professionals after playing qool city board game mark with an x your chosen option using “yes”, “no”, or “don’t know”. step 2—qool city board game experience evaluation [indicator 2] qool city board game helped you to be aware of the use of serious games for improving cognitive functions qool city board game helped you to know more about quality of life qool city board game helped you to be motivated about using serious games http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 40 qool city board game helped you to know about cognitive functions improvement and quality of life improvement [indicator 4, 5] qool city board game made you to use supportive skills such as active listening and respect choices qool city board game made you to use supportive skills such as teamwork and being flexible qool city board game made you to use supportive skills such as balance between support and autonomy [indicator 6] qool city board game helped to use more collaborative skills other comments: questionnaire c | applied to relatives and professionals after playing qool city online game mark with an x your chosen option using “yes”, “no”, or “don’t know”. step 3—qool city online game experience evaluation [indicator 2] qool city online game helped you to be aware of the use of serious games for improving cognitive functions qool city online game helped you to know more about quality of life qool city online game helped you to be motivated about using serious games qool city online game helped you to know about cognitive functions improvement and quality of life improvement http://www.globalce.org http://globalce.org http://globalce.org 41 j global clinical engineering vol.6 special issue 6: 2024 [indicator 3] qool city online game promoted digital skills acquisition qool city online game promoted digital skills improvement [indicators 4, 5] qool city board game made you to use supportive skills such as active listening and respect choices qool city board game made you to use supportive skills such as teamwork and being flexible qool city board game made you to use supportive skills such as balance between support and autonomy [indicator 6] qool city online game helped to use more collaborative skills other comments: questionnaire d | applied to relatives and professionals after using game catalogue in the id-gaming e-training toolkit and have played five (5) different ict serious games (ict-sgs), mark with an x your chosen option using “yes”, “no”, “don’t know”. step 4—game catalogue experience evaluation [indicator 2] game catalogue helped you to be aware of the use of serious games for improving cognitive functions game catalogue helped you to know more about quality of life http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 42 game catalogue helped you to be motivated about using serious games game catalogue helped you to know about cognitive functions improvement and quality of life improvement [indicator 3] game catalogue promoted digital skills acquisition game catalogue promoted digital skills improvement [indicator 4] game catalogue made you to use supportive skills such as active listening and respect choices game catalogue made you to use supportive skills such as teamwork and being flexible game catalogue made you to use supportive skills such as balance between support and autonomy [indicator 6] game catalogue helped to use more collaborative skills other comments: satisfaction questionnaire please answer the next questions using “yes”, “no”, or “don’t know”. please mark with an x your chosen option. step 1—training material experience evaluation training materials were easy to navigate and use. http://www.globalce.org http://globalce.org http://globalce.org 43 j global clinical engineering vol.6 special issue 6: 2024 training materials helped me learn more about serious games and their benefits. i liked to read the training materials. step 2—qool city board game experience evaluation qool city board game is involving.t i was able to be attentive. i was motivated. i had fun. qool city board game rules are simple. qool city board game history is relevant to me. qool city board game playing pace was appropriate. i like the qool city board game. step 3—qool city online experience evaluation qool city online game is involving. i was able to be attentive. i was motivated. i had fun. qool city online game rules are simple. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 44 qool city online game history is relevant to me. qool city online game playing pace was appropriate. i like the qool city online game. step 4—game catalogue evaluation game catalogue is easy to navigate and use. game catalogue’s games helped me to learn. i liked to use the game catalogue. global satisfaction trainers have been friendly and supportive. the training space has been comfortable. i liked to participate in the sessions. i want to continue to use the qool city game. i’ll recommend the id-gaming e-training toolkit to others other comments: http://www.globalce.org http://globalce.org http://globalce.org editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 49 j global clinical engineering vol.7 issue 2: 2025 received october 29, 2024, accepted may 15, 2025, date of publication june 17, 2025. case study case study: augmented reality enabled mental health chatbot subbaraj pravin kumar*, akash kumar, and anusha amba prasanna biomedical engineering, sri sivasubramaniya nadar college of engineering, chennai, tamil nadu, india. * corresponding author email: pravinkumars@ssn.edu.in abstract background and objective: in recent years, there has been a growing demand for mental health support. this has led to a focus on providing personalized and continuous care. however, traditional mental health systems often have long wait times and limited support for engagements beyond clinical hours. the goal of this project is to create arden, a digital companion using augmented reality, to help improve mental health for those in need. material and method: this study aims to fine-tune a large language model with domain-specific knowledge, ensuring a personalized and intelligent companion—arden. the chatbot is integrated with the ar companion using an application program interface (api). the mixed reality companion is accessible via a mobile application, making care available without the additional hardware costs associated with head-mounted displays. results: the development of arden has introduced new possibilities for personalized and interactive mental health support. early feedback suggests that the chatbot may help improve user engagement and satisfaction, supported by encouraging retention metrics. by combining augmented reality, large language models, and a character-based interface, arden offers an approach that could contribute positively to mental health support. conclusion: arden aims to help users with emotional regulation during long wait times between mental health interventions, overcome communication barriers, and provide exercises and suggestions to improve mental health wellbeing. this approach offers a promising solution to existing mental health challenges and holds potential for further improvement and scalability. keywords—augmented reality, large language model, mood score. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot j global clinical engineering vol.7 issue 2: 2025 50 introduction mental health problems pose a critical public health burden, yet traditional solutions remain insufficient to address the growing demand. the advent of social media and increased isolation among the younger population have exacerbated mental health challenges for these individuals. according to nextstep solutions, a leading provider of behavioral health software, 29% of the u.s. population experiences at least one form of mental illness.1 along with the factors that have led to an increase in mental health issues, there is also a severe shortage of psychiatrists, with only nine per 100,000 people. this deficit contributes to negative mental health outcomes, including an increased risk of suicide.1 at present, individuals seek help from their family, social circles, the internet, and mental health professionals to overcome these issues. however, several barriers limit the effectiveness of current mental health systems, including social stigma and a shortage of mental health professionals. currently, most of the mental health help that individuals receive is in the form of cognitive behavioral therapy and medication. cognitive behavioral therapy (cbt) is based on the idea that professionals are trained to help individuals overcome the issues they are facing and enable them to tackle problems on their own by using structured systems. however, due to understaffing, the current system struggles with increased costs, long wait times, and other challenges. despite its shortcomings, seeking professional help remains the best option for those facing mental health challenges. recent studies have explored the potential of chatbots to improve mental health outcomes. denecke et al.1 examined two prominent ai-driven mental health chatbots, wysa and sermo. wysa inc., headquartered in the usa, is an everyday mental health application, and sermo, also headquartered in the usa, is a social platform for physicians to collaborate and stay informed. wysa detects negative moods and integrates features like depression assessments and meditation exercises, while sermo addresses psychological impairments using cognitive behavioral therapy (cbt) techniques. quantitative analysis revealed that frequent users of wysa experienced greater mood improvements than occasional users. experts acknowledged that sermo is well-suited for patients struggling with face-to-face communication, although challenges remain, including issues with data retention, dataset generation, and the inability of ai systems to handle emergencies effectively. potts et al.2 addressed the lack of accessible mental health services in rural areas by introducing a multilingual chatbot, chatpal. it was developed by the academic consortium led by ulster university (uk), which collaborated with partners in ireland, scotland, sweden and finland. funded by the northern periphery and arctic (npa) programme, chatpal aimed to provide support in english, scottish gaelic, swedish, and finnish. the study employed a single-arm pre-post intervention design, enrolling participants from rural areas to use chatpal over 12 weeks, with well-being measured via scales like swemwbs. chatpal, developed with rasa (backend) and phonegap (frontend), features mood logging and mindfulness exercises. while chatpal is seen as a complementary tool for mental health services, the study calls for further research to confirm its effectiveness. the chatbot’s multilingual capabilities improve accessibility, but technical issues remain, particularly with integration and functionality. social desirability and social support are factors that contribute to positive mental health outcomes. similarly, a need to belong, which is heightened among young adults, is associated with negative outcomes. thus, looking at the current landscape of mental health issues, it is clear that providing emotional support through interventions can help people, but is no replacement for a true emotional connection with others. it can serve to help people deal with issues in a healthier way, leading to better outcomes. another study aimed to evaluate the effectiveness of chatgpt in providing mental health support, with a particular focus on anxiety and depression. the primary objective was to assess the quality of responses generated by chatgpt to user queries related to these mental health conditions. the study specifically analyzed the model's responses to three queries: two relating to anxiety management and medication, and a third regarding alternative treatment options. moreover, the study examined the 51 j global clinical engineering vol.7 issue 2: 2025 p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot consistency and reliability of chatgpt’s responses across successive interactions. it was found that chatgpt did not provide information about medication.3 some advantages include its ability to offer personalized advice based on a person's history, improved accessibility in remote locations, and lower costs compared to traditional therapy. however, the information must be cross-checked with professionals due to some inconsistencies, and it cannot substitute for mental health care. the model also cannot provide prescriptions. chatgpt’s responses to prompts can be inappropriate, possibly due to the type of questions being asked. thus, while chatgpt is useful, the model developed for the user must address its shortcomings in some way. yang et al.4 investigated the capabilities of large language models (llms) within the healthcare domain, focusing on both their potential applications and inherent limitations. the primary goal was to assess the effectiveness of general llms in healthcare settings and to identify areas where domain-specific models could offer improved performance. general-purpose llms often lack the specialized knowledge required for healthcare applications due to the disparity between the general text used in their training and the professional, domain-specific content needed for clinical use. the study highlighted the promise of domainspecific llms. for instance, biobert was developed by korea university and trained on pubmed data. another example, scibert, was created by the allen institute for ai and was trained on broad scientific texts from semantic scholar. similarly, pubmedbert, by microsoft research, was specifically trained on pubmed abstracts. these models are all based on the bert architecture and require significant computational resources for operation. despite their promise, the study acknowledged the challenges that remain in their clinical implementation. the performance of domain-specific llms was found to be superior compared to general models, particularly in patient interactions. a tailored model called chatdoctor, which is a fine-tuned large language model based on llama and trained on 100,000 real-world patient-doctor dialogues from an online consultation platform, and supported by an nih grant. it demonstrated enhanced efficacy in clinical settings. however, the study also identified significant challenges in deploying llms in healthcare, particularly concerning data integrity, interpretability, and the high costs associated with developing these models. the integration of llms into clinical practice as supplementary tools was explored, emphasizing the need for improvements in task optimization and conversational assistance. the challenges related to interpretability, data limitations, and ethical considerations must be addressed to fully realize the potential of llms in clinical practice. the research suggests that future efforts should focus on optimizing these models for specific tasks, improving data diversity, and ensuring the accuracy and reliability of the content generated by llms, particularly when crossreferenced with professional expertise. user retention is also reported to be a critical factor, emphasizing the importance of highly engaging interactions with chatbots. it was demonstrated that inadequate retention rates often stem from a lack of personalization, which impedes the effectiveness of mental health apps. to address these challenges, the paper proposed several solutions, including the personalization of chatbots by utilizing the user’s previous conversations. additionally, incorporating peer communication methods was found to enhance both engagement and effectiveness. the developed app should adapt based on user feedback, with the overall goal of creating a more user-centric, adaptable, and effective platform. in another study, data from the chatbot interactions, including session details and mood logs, were analyzed to extract features such as tenure, mood logging frequency, and conversation interactions. k-means clustering was employed to categorize users into three groups: abandoning, frequent transient, and sporadic users. this analysis compared user behaviors, engagement, and retention metrics with those of other mental health apps. the study emphasizes the importance of high engagement and retention metrics and the need for personalized user experiences.5 the effectiveness of the chatbot heavily depends on the underlying language model that powers it. llama 2, an advanced open-source language model from meta ai, can generate text similar to that of a human and is useful p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot j global clinical engineering vol.7 issue 2: 2025 52 mental health professionals use screening questionnaires (sqs) to identify symptom areas that require further exploration. regular screening can enable the early identification of individuals in high-stress professions who may require mental health support. data indicate that a significant percentage of public safety personnel screen positive for at least one mental health disorder, highlighting the advantages of frequent screening.9 integrating llms into chatbots could enhance their ability to provide tailored support, especially when fine-tuned for specific screening tasks within high-stress populations. incorporating virtual reality (vr) and augmented reality (ar) into mental health interventions offers a transformative approach to enhancing user engagement and interaction. they can improve access to and availability of therapy due to their personalized nature. proper training for mental health professionals, rigorous scientific research, and strict adherence to data privacy and ethical guidelines are essential for the responsible use of mental health apps, making them more engaging, targeted, and therapeutically effective. integrating augmented reality (ar) into chatbot platforms represents a promising advancement in mental health care. current mental health chatbots, while offering useful features, have limitations. one major bottleneck is the need to ensure data privacy, especially since chatbots that provide personalized suggestions must store previous user interactions.2 ensuring that user data is protected from unauthorized use is crucial for trust and widespread adoption. another challenge is the need for relevant content and fine-tuning large language models to provide helpful and contextually appropriate responses. it must converse with the user in a manner that is genuinely helpful to them. fine-tuning the model requires resources, and the model needs continuous updates to stay relevant.3 a drawback is that the way the model arrives at decisions is not explained clearly. user retention is another significant challenge for chatbot applications. generalizations about user behavior have led to the development of different user archetypes.4 this information about how users interact with the chatbot can be used to improve the retention metrics of the application we build. for chatbots, translation, content production, and other applications. llama 2 offers notable advantages in versatility and adaptability when fine-tuned for specific domains, addressing limitations observed in previous models.6 roumeliotis et al.6 investigated the challenges and opportunities faced by developers when deploying and fine-tuning llama 2, with the hypothesis that the opensource nature of llama 2 facilitates faster development compared to closed-source models. early adopters’ experiences in deploying and fine-tuning llama 2 were observed over a 10-day period, with particular attention given to the medical domain, a primary area of interest for fine-tuning efforts. data on model deployment, fine-tuning, and other relevant factors were gathered during this period. textual data was then processed through keyword identification, k-means clustering, and word cloud visualization. the resulting analysis reveals that llama 2 can be seamlessly deployed and fine-tuned to the domain-specific requirements of various industries, thereby addressing challenges encountered with earlier models. yang et al.7 compared four large language models (llms) for mental health analysis, focusing on the effectiveness of prompting strategies such as chain of thought prompting, emotion-enhanced prompts, and few-shot learning. the findings emphasized the importance of domain-specific fine-tuning for improved results in building mental health solutions. regular large language models often fall short in specialized areas like medicine, where domain-specific knowledge is crucial.8 the authors proposed pmc-llama, an open-source language model specifically tailored for medical applications.8 they systematically analyzed the process of adapting a general-purpose llm to the medical domain by integrating 4.8 million biomedical academic papers and 30,000 medical instructional materials, and extensively fine-tuned it for compliance with the domainspecific knowledge base. 53 j global clinical engineering vol.7 issue 2: 2025 p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot for chatbots to be effective for emotional support, they must understand how users feel and react empathetically. this is possible by using libraries with words and the emotions associated with those words. however, chatbots are only as good as their prompts, and the sentiment and emotion lexicons used for emotion-enhanced prompts suffer from annotation bias and limited vocabulary, which may not reflect the evolving language used in recent datasets.4 recent advancements in training large language models across multiple languages have increased accessibility and improved the generalizability of studies.5 although this is important, the focus of this paper is on developing a robust mental health chatbot primarily for english-speaking users, as they represent the majority of current users. given the limitations of existing mental health chatbots and the recent advancements in technology, this paper proposes the development of a chatbot using the llama 2 model integrated with augmented reality technology. the proposed chatbot will prioritize high user retention, accuracy, privacy, and address current chatbot limitations while incorporating the additional functionalities discussed. this study proposes an augmented reality-enabled mental health chatbot that can provide supplementary support between visits to mental health professionals. although chatbots cannot replace traditional therapy, they can offer continuous mental health support, helping individuals declutter their thoughts and providing accessible care at any time. the aim was to analyze user engagement with a mental health chatbot, focusing on its potential to improve user retention through interactive and personalized experiences. user retention was examined to identify challenges and optimize engagement by understanding different user archetypes. the impact of the chatbot on users’ mental health needs to be monitored over time when used alongside professional medical guidance. the chatbot was developed as an app, making it accessible to a broader audience with user-friendliness. this study used llm models that enable personalization, which is critical for effective content delivery. various personalization techniques, such as retaining the memory of previous conversations, were implemented to create a more tailored and continuous user experience. retaining the memory of previous conversations helped continue interactions from the last episode, rather than starting from the beginning each time. methodology workflow the large language model (llm) is customized with extensive medical literature and fine-tuned for optimal effectiveness. the application processes auditory input to provide information to the llm. additionally, the application features a character that users interact with, designed to appear friendly and empathetic. this companion, integrated with the llm, facilitates user interaction and contributes to mental health improvement through the application’s functionalities. data a mental health chatbot requires vast amounts of data to provide accurate and reliable solutions to individuals’ mental health challenges. developing a comprehensive database that integrates both local knowledge and online resources is essential.7 this database also contains research articles tailored to the individual’s specific needs, such as those addressing emotional support, depression, anxiety disorders, and eating disorders. general information regarding interventions can also be obtained from reputable online sources, complementing the personalized data. profiling mental health professionals initially assess and profile individuals based on their diagnosis, which is then fed as input to the model (figure 1). this profiling enhances the personalization of the chatbot. users are prompted to select a broad category that aligns with their experiences, and the application provides relevant information based on both the user’s selection and the therapist’s assessment p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot j global clinical engineering vol.7 issue 2: 2025 54 . this work aims to understand individual perspectives and provide relief from mental health conditions, such as stress, anxiety, and depression, through personalized solutions. to effectively address the needs of users experiencing mental health issues, collaboration with professionals is essential. through multiple sessions with a counseling psychologist, they assess a person’s characteristics, drawing upon their experience and intuition developed through years of study and practice. the chatbot can then create a tailored solution or personalized interaction method for each individual, taking professional input into account. for instance, if a person tends to respond only to non-confrontational communication, the chatbot will recognize this and deliver information in a compassionate, non-threatening manner to ensure the individual is receptive. a questionnaire is developed, as shown in figure 2, based on input from the psychologist, with its design undergoing thorough consultation and multiple levels of review by the therapists. this personalized profiling ensures that users receive appropriate, targeted support, rather than generic interventions. mental health chatbot large language model the process begins by uploading appropriate resources as pdf files, followed by the application of a text extraction algorithm to retrieve the content while removing any non-text elements (figure 3).8 the extracted text is then segmented into manageable pieces to facilitate meaningful embeddings. llama 2, implemented via the langchain framework, is employed to generate embeddings that capture the semantic essence of each text fragment. these embeddings are stored and managed in pinecone, a cloud-based vector store. this fully managed service handles hardware infrastructure required for efficiently storing and searching vector data. once the embeddings are uploaded to pinecone’s cloud storage, natural language queries can be processed. pinecone performs a similarity search by converting queries into text representations and generating embeddings via langchain llama 2. this search identifies the most similar embeddings, retrieving the corresponding text fragments. these fragments are then combined to form a cohesive natural language response, enabling smooth and effective user interaction in question-and-answer scenarios. figure 1. workflow of ar companion (arden) assisted personalized therapy. figure 2. questionnaire. 55 j global clinical engineering vol.7 issue 2: 2025 p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot model selection llama 2 was selected for this preliminary study due to several compelling factors. its open-source framework supports accessibility and collaborative development, offering a parameter range from 7 billion to 70 billion. additionally, llama 2 distinguishes itself through its speed, which outperforms earlier models. this is particularly advantageous for time-sensitive tasks and applications requiring rapid processing, like mental health chatbots. moreover, llama 2 offers comprehensive documentation and a supportive open-source community, facilitating its integration. as large language models evolve rapidly, future iterations of this work will consider adopting more advanced models.9 integration with chatbot firstly, a unity project was set up with the necessary dependencies installed to enable the companion to be deployed into a mobile application. inworld ai is an engine that was used to create a character prefab to import into unity. to begin with, the inworld ai software had to be downloaded and interfaced with the unity platform. then, after the avatar was generated using ready player me, a cross-game avatar platform that enables avatar creation and seamless integration into other platforms, its characteristics were customized using the inworld ai portal. the api keys were then configured within the unity project to import the character into the environment. the built-in speech of the character was replaced with the mental health chatbot. visual customizations from ready player me were refined, and inworld ai’s tools were used to adjust baseline emotional expressions and idle animations to suit a mental health companion. the imported character in the project had to be positioned, rotated, and scaled to the correct proportions relative to the room. this process required trial and error, and it had to be made such that it aligned with the realworld surfaces and surroundings based on the camera position. the avatar was also fitted with a script to make it move wherever the user desired by just clicking on the spot. this was done to ensure the companion was placed in the position where the user was most comfortable. this level of personalization was aimed at giving the user the best experience possible. inworld ai, a character engine developed by thegist, inc. (dba inworld ai, new york, ny, usa, with its platform publicly launched c.2022 and continuously updated), is used to create non-playable characters in games using ai, natural language processing, emotional simulation, and behavior modeling. it generates expressions and facial features based on the character’s behavior using ai models that mimic human gestures.10 the avatars were also modified in this study. this behavior is determined by the information we feed it. characteristics such as anger, confidence, and aggressiveness, for example, can be changed using the user interaction tools. these characteristics influence how the avatars communicate and interact with the user. this can be brought to the user by our custom mental health chatbot, which bypasses the default conversational settings. the first step was to create the chatbot, which has already been described. post-chatbot creation, it is to be interfaced with the character instead of the in-built gpt-3 model. emotion detection is another important aspect of figure 3. knowledge base construction. p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot j global clinical engineering vol.7 issue 2: 2025 56 this application that needs to be improved upon in the next iterations of it.11 user interface (ui) the initial version of the ui had a canvas with buttons to allow the user to navigate between different functionalities of the application. however, this was removed to truly make the application even more user-friendly and non-frustrating. the idea of the avatar companion fulfilling all of the user’s commands and the avatar acting as the interface was more appropriate. thus, the ui was changed to make the companion-user relationship the most important aspect of the project. this also enables future iterations of the application to have more interesting use cases and functionalities.12 natural interactions talking with the character mimics human conversation. this is an intuitive approach that lowers the cognitive load for the user. this lower barrier to entry can be the difference between the app being used or not. convenience as the interface is completely voice-based, people with disabilities, such as motor or vision impairments, can use the application. going forward, it can use the information from the user to guide them to take medication on time. efficiency the commands are much faster when voice-based compared to navigating through menus and typing the queries, as with conventional chatbots. personalization as the chatbot learns from previous interactions with the user, this brings a level of personalization to the user interface that is just not possible through hard-coded menus. the chatbot has the ability to give personalized information in less time. it is hypothesized that, as the relationship between the user and arden grows, the application will achieve higher retention and usage rates. this is much more than what a traditional interface can do. results recommendation from professionals the ai companion was developed in consultation with mental health professionals to ensure the ethical integrity of the application while validating the responsible ai training, clinical relevance, and accuracy of their responses. the application developed primarily complements the therapeutic practices, addressing the gap in mental health delivery systems.13 in alignment with this approach, the proposed idea of this ar-enabled chatbot application was taken to a mental health professional at the national institute for empowerment of persons with multiple disabilities (niepmd) in india for initial validation. the key suggestions that were implemented include: ease of use, efficient interaction without too many menus, and personalization. the other recommendation was to target general mental health needs, thereby broadening the scope of the application. this further enhanced the efficacy of the large language model by allowing it to specialize in highdemand and specific areas of mental health. subsequent steps focused on niche areas such as stress management, anxiety, and depression, to name a few. once a basic prototype was developed, it underwent further evaluation for feedback on clinical efficacy. the user base was defined in the review process of the prototype. the prototype was intended to be prescribed to selected users based on their psychological profiles, following consultation with a certified mental health professional. consequently, the chatbot should be deployed as part of a hybrid healthcare model, ensuring that the mental health professional remains actively involved in the patient care loop. patient confidentiality was a major concern. based on these inputs and further research, it was evident that any solution in this domain must strictly adhere to data privacy regulations.14 while our study has not yet encountered situations that raise privacy concerns, future research and similar product developments will need to ensure robust measures that protect patient data. parameter tuning as outlined in figure 4, the mental health chatbot offers a range of features that are designed to be beneficial 57 j global clinical engineering vol.7 issue 2: 2025 p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot to patients. to achieve this, various parameters are optimized to define the state-of-the-art large language model-based chatbot. fine-tuning is accomplished by adjusting parameters such as temperature, maximum generation length, and sampling, among others.15 rigorous evaluations of the developed model are performed to mitigate risks and streamline responses to align with the user’s needs and expectations. the paradigm of the response is facilitated by the availability of these parameters. temperature is a variable that tells us how incidental the output or the response generated is.16 the values can be interpreted as follows: if the temperature values are low, the model is more deterministic. this is ideal for maintaining consistent and reassuring conversations in mental health settings. higher values may introduce more variability, which may not be required for this purpose. due to this, the temperature was originally set to 0.5.17 tokens with a combined likelihood exceeding a threshold (p) are examined in top-p sampling, which is sometimes referred to as nucleus sampling. this restricts the token selection process by regularly modifying the queries according to their probabilities. this approach preserves focus on the majority of tokens while ensuring diversity. as shown in table 1, the maximum length of the response generated is set to be 512 words. seeing as shorter responses can keep the conversations focused but might lead to leaving out details, this is an area with tradeoffs. other parameters, such as learning rate and beam search width, also play a crucial role in making the model dynamic and user-friendly. the existing learning rate of the large language model is 0.0002.18 figure 4. features of ar companion. p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot j global clinical engineering vol.7 issue 2: 2025 58 the entire conversation, the companion constantly exhibits friendly body language. as seen in figure 5, the character interacts with the user with compassion and empathy, which is crucial when dealing with sensitive topics. in figure 6, the chatbot asks the user to rate their feelings on a scale of 1 to 10, which lets the chatbot deal with the situation differently based on the user’s response. when the situation is particularly difficult, the user is directed to consult with the therapist. in figure 7, the user is being suggested exercises to follow in order to feel better. in general, the exercises that therapists suggest to their patients can be reinforced in this app in order to ensure proper completion. also, the app’s interactive nature immerses the user in the exercise, leading to improved outcomes. in summary, the application interacts with the user in a compassionate way to provide insights and aims to improve mental health outcomes. an integrated mechanism for analyzing and a model that is fine-tuned with relevant mental health data and uses emotion tracking tools to adjust the model’s tone and word choice would be ideal for this purpose. setting parameters that encourage the chatbot to ask questions and take pauses would ensure user engagement, thereby enhancing interaction. the recent llama 3 model launched by meta represents a more advanced and efficient iteration of large language models, offering significant potential for future applications in the development of mental health chatbots. the following comparisons (table 2) outline the key improvements in the model, as indicated by meta’s advancements. response of the chatbot the chatbot shows compassion towards the user by first validating what the user feels and gently suggesting what the user could do to improve their situation. throughout table 1. hyperparameters of llama 2. parameters value learning rate 0.0002 response speed 120–250 s chunk size 512 temperature 0.5 sampling top p or nucleus sampling software development kit boto3(aws sdk for python) table 2. comparison of llama 2 and llama 3. feature llama 2 llama 3 training data trained on around 2.2 trillion tokens trained on approximately 15 trillion tokens model sizes released in 7b, 13b, and 70b parameter sizes available in 8b and 70b parameter versions context window supports up to 4,096 tokens supports up to 8,192 tokens performance better performance over llama 2 outperforms llama 3 across all benchmarks figure 5. sample response for depression. figure 6. sample response for anxiety. 59 j global clinical engineering vol.7 issue 2: 2025 p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot presenting emotions detected from the users’ interactions with the chatbot proved to be useful. throughout these interactions, prominent emotional states such as happiness, sadness, and anger could be identified to help understand the mental state of the user. it was evident that this analysis would help the user track their mood. a formal study is planned to evaluate the therapeutic potential of the app. participants’ moods will be assessed over a 30-day period using daily self-report scales, with additional objective measures, such as physiological indicators or behavioral assessments, potentially incorporated. data analysis will compare preand post-study mood scores, along with any improvements reported by participants. to further validate these findings, future research could focus on longitudinal studies and randomized controlled trials involving individuals diagnosed with mental health conditions, aiming to rigorously quantify the chatbot’s impact on mental health outcomes. testing feedback the application was tested for user interaction (ui) experiences, and some bugs were observed within the app, such as the character moving on its own at times, the app crashing during longer interactions, and the character not always being anchored in the environment correctly. in terms of functionality, it was suggested to add more exercises and activities, like guided meditations. clinician feedback the designed application was evaluated by two different psychiatrists. they suggested further work on adding more evidence-based exercises and ensuring the clinical accuracy of the information provided. they also wanted more features in the app so that clinicians can, with patient consent, access summaries of patients’ interactions or mood trends to better inform therapy sessions. apart from this, they had questions regarding crisis management protocols within the app and the specifications of data privacy and security for sensitive user information. along with these important considerations, the overall feedback was encouraging, with psychiatrists recognizing the potential of arden to support individuals between interventions and overcome communication barriers.19 conclusion and future work as discussed, the application was developed after analyzing the capabilities and limitations of existing solutions. it was determined that increased user engagement is essential for the application to be truly beneficial. with the advancement of ar technology and its capabilities, the study focused on designing a system that integrates both large language models (llms) and augmented reality (ar). the companion application was successfully implemented using unity and deployed on mobile platforms. the constructed avatar was equipped with an api interfacing with the llm, which functions as a chatbot. this chatbot was fine-tuned with relevant medical literature to provide accurate and useful information to the user. thus, the study produced an initial design of an ar-enabled avatar, equipped with an llm, for emotional regulation purposes. figure 7. sample exercise. p. kumar, a. kumar, prasanna: case study: augmented reality enabled mental health chatbot j global clinical engineering vol.7 issue 2: 2025 60 author contributions all authors contributed equally to this work. funding not applicable. data availability statement not applicable. conflicts of interest the authors declare they have no competing interests. ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure not applicable. references 1. denecke, k., abd-alrazaq, a., househ, m. artificial intelligence for chatbots in mental health: opportunities and challenges. in multiple perspectives on artificial intelligence in healthcare: opportunities and challenges. househ, m., borycki, e., kushniruk a. eds. springer nature, switzerland; 2021; p.115–128; https://doi.org/10.1007/978-3-030-67303-1_10. 2. potts, c., lindström, f., bond, r., et al. a multilingual digital mental health and well-being chatbot (chatpal): prepost multicenter intervention study. j med internet res. 2023;25:e43051. https://doi.org/10.2196/43051. 3. farhat, f. chatgpt as a complementary mental health resource: a boon or a bane. ann biomed eng. 2024;52(5):1111–1114. https://doi.org/10.1007/s10439-023-03326-7. 4. yang, r., tan, t.f., lu, w., et al. large language models in health care: development, applications, and challenges. health care sci. 2023;2(4):255–263. https://doi.org/10.1002/hcs2.61. 5. booth f., potts, c., bond, r., et al. a mental health and well-being chatbot: user event log analysis. jmir mhealth uhealth. 2023;11:e43052. https://doi.org/10.2196/43052. the design developed in this study serves as a reference for future advancements in the field. designing an effective mental health chatbot involves several critical aspects, including, but not limited to, tracking the mood scores of users,20 enhancing the llm’s capabilities,21 maintaining data privacy, and ensuring the chatbot retains context from previous interactions with the user. mood scores are an effective method for monitoring the mood and mental health of a person over a period of time. this approach can be validated with the assistance of mental health professionals.22 the system can offer more personalized support based on mood scores. collaboration with mental health professionals has offered important insights into the everyday challenges patients encounter. it is essential that products in this field are developed and tested alongside these professionals to ensure they effectively address real-world needs, particularly by improving the mental health of young adults.23 this study was conducted prior to the release of llama 3, gpt-4, and other newer models. with further advancements in large language models and emotional recognition, future chatbots are expected to exhibit more human-like qualities and be capable of taking in multimodal inputs from users more effectively. throughout the development of this application, a few key findings emerged regarding emotion detection. it became apparent that an application of this sort must take into account the following for the emotion detection capabilities: the user's speech and voice tone patterns, facial expression changes, linguistic cues, contextual awareness of the model, and multimodal data integration capabilities. these are all areas where humans naturally excel and are currently superior compared to models. real-time emotion detection remains a challenging task, which requires further research. taking emotion recognition capabilities alongside the other functional abilities of the application previously discussed, it is clear that further research is required for applications of this kind before they can be effectively deployed. we anticipate that, with further technological advancements, this design of an ar-enabled mental health chatbot will contribute to improved mental health support. 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https://doi.org/10.20944/preprints202307.2142.v1 https://doi.org/10.18653/v1/2023.emnlp-main.370 https://doi.org/10.1093/jamia/ocae045 https://doi.org/10.1093/jamia/ocae045 https://doi.org/10.3390/ijerph18073743 https://doi.org/10.3390/ijerph18073743 https://doi.org/10.4018/979-8-3693-1123-3.ch006 https://doi.org/10.4018/979-8-3693-1123-3.ch006 https://doi.org/10.1177/20552076231203649 https://doi.org/10.1177/20552076231203649 https://doi.org/10.2196/17458 https://doi.org/10.2196/17458 https://journals.sagepub.com/doi/abs/10.3233/wor-230257?download=true#:~:text=it%20was%20observed%20that%20a,of%20depression%20and%20stress%20prevalence https://journals.sagepub.com/doi/abs/10.3233/wor-230257?download=true#:~:text=it%20was%20observed%20that%20a,of%20depression%20and%20stress%20prevalence https://journals.sagepub.com/doi/abs/10.3233/wor-230257?download=true#:~:text=it%20was%20observed%20that%20a,of%20depression%20and%20stress%20prevalence https://journals.sagepub.com/doi/abs/10.3233/wor-230257?download=true#:~:text=it%20was%20observed%20that%20a,of%20depression%20and%20stress%20prevalence 45 j global clinical engineering vol.6 special issue 6: 2024 conference paper novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 1department of physics school of applied mathematical and physical sciences, ntua, greece. 2lab of medical physics & digital innovation, auth, greece. 3department of business administration, university of piraeus, greece. 4department of mathematics school of applied mathematical and physical sciences, ntua, greece. 5computer science division of science & technology american college of thessaloniki, greece. * corresponding author email: sl_arsenis@hotmail.com abstract neurological conditions such as stroke or spinal cord trauma often attenuate or disrupt nerve connections, leading to loss of muscle function, sensation, or responsiveness. the application of physical and occupational therapy rehabilitation protocols can help regain some of the lost functions and significantly improve a patient’s quality of life. these protocols leverage the principle of neuroplasticity, an inherent property of the brain that allows the formation of new neural connections in response to external stimuli. electrical muscle stimulation (ems) has been proven to amplify the effects of rehabilitation as it adds new stimuli in the form of suitable electric pulse-trains directly to the neuromuscular system. certain rehabilitation protocols incorporate functional exercises that mimic natural movements, which can in turn benefit from the application of synchronized electric pulses. this process, known as functional electrical stimulation (fes), has been demonstrated to be beneficial with respect to the nature and longevity of neuromuscular adaptations as well as brain reorganization. this paper considers techniques for the optimization of these parameters and presents preliminary in vivo experimental results demonstrating the proposed methodology. keywords—medical devices, denervation, stroke, spinal cord injury (sci), functional electrical stimulation (fes), functional electrical stimulation therapy (fest), medical instrumentation, neurorehabilitation, physical rehabilitation, machine learning, artificial intelligence (ai), biomedical engineering, central nervous system (cns), peripheral nervous system (pns). copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:sl_arsenis@hotmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ j global clinical engineering vol.6 special issue 6: 2024 46 introduction the synaptic connections between corticospinal axons and motor neurons in the spinal cord play a crucial role in transmitting signals essential for coordination, movement, and sensory functions. spinal cord injuries (scis) can damage the descending corticospinal axons, leading to the disruption or attenuation of nerve signals between the central nervous system (cns) and the peripheral nervous system (pns).1 in the event of a stroke, an obstruction (ischemic stroke) or breakage of a blood vessel (hemorrhagic stroke) may result in brain damage to regions governing movement or sensation by inhibiting the production or transmission of neural signals. the weakening or interruption of neural connections in both cases is a condition known as denervation. affected limbs or organs may experience a range of symptoms, from weakness and numbness to loss of sensory function and complete paralysis.2 denervation and its symptoms can be mitigated through rehabilitation protocols designed for cortical reorganization. these protocols are grounded in the principles of hebbian learning and leverage the brain’s inherent capacity for adaptation, a phenomenon known as neuroplasticity.2 neuroplasticity is a term used to describe the cns’s neurodevelopmental capability to experience alterations in structure and function, following exposure to both external and internal stimuli. this capacity is not exclusive to a specific time frame of human life. hence, neuroplasticity is crucial, in that it facilitates healing in response to cns injury and trauma for the entire duration of human life.3 hebbian learning is based on the hypothesis that gains in synaptic efficacy are realized following the exertion of repeat stimulation of a postsynaptic cell by a presynaptic cell. it is a model of associative learning which proposes that synchronous neural activity produces increased synaptic strength in the cells involved.4 electrical muscle stimulation (ems) encompasses a wide array of therapeutic interventions. in general terms, electrical pulses are applied to the neuromuscular system offering additional stimuli for nervous system activation and reorganization. the electric pulses elicit action potentials that bring about muscle contractions capable of being synchronized with the functional movements and tasks performed during a rehabilitation session, a methodology known as functional electrical stimulation (fes).1,2 fes constitutes a tool capable of stimulating the neuromuscular system, thus occasioning neuromuscular and central nervous system plasticity.2 due to the precise timing, it further leverages the principles of hebbian learning enhancing synaptic connections and the formation of neural pathways. employed in response to both strokes and spinal cord injuries, fes has been found to produce better outcomes with regard to patient mobility, spasticity, walking speed, and spinal cord function recovery.1,3,4 the significant parameters affecting the quality of muscular contractions and cortical reorganization are pulse intensity and width, frequency, as well as the time delay between pulses. notably, these parameters are sessionand subject-specific because they are affected by factors such as the type of waveform, the placement of electrodes, electrolyte concentration in the targeted muscle, the cleanliness of the skin area where the electrode is placed, the adaptation of fes parameters across different rehabilitation sessions, and the synchronization between voluntary command and the muscular contraction which is actually induced.1,2 small variations in parameter values can substantially alter the quality of induced muscular contractions as well as the longevity of cortical reorganization.2 it is important to note that although higher pulse intensities and frequencies elicit stronger contractions they may also introduce pain, discomfort, and skin irritation.2 consequently, there’s a pressing need for an automated calibration process at each sessions’ outset, determining optimal parameter values while considering patient comfort. materials and methods hardware the system consists of a commercially available pc, two microcontrollers, a gyroscoping accelerometer, a programmable waveform generator, an operational amplifier, electrodes, and an oscilloscope for data acquisition. http://www.globalce.org http://globalce.org http://globalce.org 47 j global clinical engineering vol.6 special issue 6: 2024 software the 8-bit microcontrollers were programmed by use of the c programming language. the first microcontroller managed the mpu6050 gyroscoping accelerometer to monitor the magnitude of the acceleration produced by the stimulated muscle in real time, providing constant feedback to the system. the second of the two controlled the ad9833 programmable signal generator enabling real-time adjustments for every stimulation parameter such as intensity, frequency, pulse width, shape of the waveform, and more. an ai expert system tuned on accelerometry data is being used for optimization purposes. frequency is being swept across a preset range while monitoring muscle responses. data transfer from microcontrollers to pc was facilitated via a usb connection. all results were visualized by use of appropriate matlab scripts. experimental set up the interconnectivity of components is illustrated in the block diagram of figure 1. figure 1. block diagram of the experimental setup. the ad9833 waveform generator produces the electrical stimulation pulses, which are adjusted and controlled by the 8-bit microcontroller. the signal is amplified and then transmitted to the left-hand bicep muscle via electrodes. the electrodes are always identical and consistently positioned at the muscle belly after the implementation of a standard cleaning protocol. this procedure ensures repeatable and uniform measurements. the amplification process utilizes a conventional non-inverting operational amplifier circuit. the microcontrollers feature the atmega328p single chip by atmel, run on an 8-bit avr processor core, and incorporate a 16 mhz quartz crystal oscillator. the chip is designed with 6 analog inputs, and 14 digital input/ output pins and offers 32 kb flash memory, 2 kb sram, 1 kb eeprom and a wired usb interface for programming purposes. the mpu6050 gyroscoping accelerometer integrates a 3-axis gyroscope and a 3-axis accelerometer to endow low noise and precise 6-axis motion tracking. it operates within a supply voltage range of 2.375–3.46 v, has an adjustable range of ± 16 g, comes equipped with a digital motion processor, and supports an i2c interface. ad9833 programmable waveform generator operates within a supply voltage range of 2.3–5.5 v and consumes 20 mw. the device is capable of producing sinusoidal waveforms with peak-to-peak amplitude of 0.6 v as well as triangular and square pulses with peak-to-peak amplitude equal to the supply voltage. the frequencies of the generated waveforms span from 0–12.5 mhz with 0.1 hz accuracy. the chip supports communication via several protocols, including spi (utilized in this instance), qspi, and microwire. the opa462idda smt high voltage operational amplifier operates within a supply voltage range of ± 6 to ± 90 v and can provide 30 ma current. it incorporates protection mechanisms against overheating and current overloads, is unity stable with a gain-bandwidth product of 6.5 mhz, a slew rate of 32 v/μs, and has a high output load drive of ± 45 ma. a set of commercially available rectangular-shaped (dimensions: 4.5 × 3.5) pre-gelated, self-adhesive transcutaneous electrodes. the picoscope 2000 series was used to monitor the waveforms generated by the ad9833. the device offers several triggering options, and boasts 200 mhz bandwidth, 12-bit resolution, and 128 ms memory capacity. while the picoscope has an integrated function generator, it wasn't employed in these particular experiments. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 48 the other microcontroller oversees the mpu6050 tracking the magnitude of acceleration of the stimulated muscle contraction during its concentric phase. the chip is affixed to a glove consistently worn on the left palm. the maximum magnitude of acceleration generated during the concentric phase of each movement is captured and subsequently visualized in a graph to be utilized for optimization. the waveform employed is a symmetric biphasic square pulse maintaining a stable peak-to-peak voltage of 35 v. the muscle’s physical movement is assessed across varying frequencies, starting from a threshold of 10 hz and incrementing in steps of 5 hz up to a ceiling of 140 hz. then, the maximum magnitude of acceleration for each contraction is plotted against its corresponding frequency. higher frequencies (and peak-to-peak voltages) stimulate more motor units, resulting in stronger muscle contractions. however, there’s a threshold beyond which no additional motor units are engaged. it’s crucial to recognize that pushing these parameters to their limits isn’t the best approach as it leads to patient’s pain and discomfort, which can hinder the rehabilitation process. examining the magnitude of acceleration as a function of frequency and determining the peaks of that function can provide optimal values of frequency that elicit stronger movements than higher frequencies. these frequencies can later be used for a better rehabilitation session by taking patients’ pain and discomfort levels into account. results the results showcased in figures 2, 3, and 4 are derived from the implementation of the previously described optimization algorithm on the same subject over different ems sessions. examination of the peaks of the maximum acceleration to frequency graph in figure 3 reveals possible optimal frequencies at 70 hz and at 120 hz. in case of pain at higher frequencies, 70 hz emerges as a more fitting replacement of the function’s global maximum at 120 hz. it can be characterized as an optimal value for the specific rehabilitation session as it elicits comparatively stronger contractions than higher frequencies. figure 2. normalized maximum acceleration against frequency at a voltage differential of 35 v (session a). upon analyzing the peaks in the maximum acceleration to frequency graph in figure 4, potential optimal frequencies at 60 hz, 80 hz, 125 hz, and 135 hz are identified. should higher frequencies induce pain, 60 hz becomes the preferred choice. conversely, 125 hz can be utilized as optimal frequency adhering to the same logic. figure 3. normalized maximum acceleration of the electrically stimulated muscle against frequency at a voltage of 35 v (session b). following the same reasoning and after analyzing the graph in figure 4, potential optimal frequencies are identified at 50 hz, 90 hz, 110 hz, 120 hz, and 135 hz. http://www.globalce.org http://globalce.org http://globalce.org 49 j global clinical engineering vol.6 special issue 6: 2024 intramuscular electrolyte concentration, adaptive responses to stimuli, alterations in strength and coordination, and fat percentage in the adjacent area, among others. this underscores the necessity for an automated, short calibration process which computes the optimal value for frequency, voltage, and other ems parameters at the beginning of each ems session. another challenge stemming from the variability of responses to ems across sessions is the ability to compare results both between subjects and across sessions. one potential solution is to highlight deviations from the mean response at varying frequencies by normalizing the y-axis of the graphs in units of standard deviation. in certain instances, determining an optimal frequency using this method may be challenging, especially if the data does not exhibit distinct local maxima. we expect this issue to be addressed by considering more parameters for optimization and by integrating machine learning techniques into our approach. discussion it should be highlighted that all results are preliminary. experimentation with more subjects is required in order to draw more definitive conclusions. all necessary steps were taken to ensure compliance with the general data protection regulation and applicable national law. any future development of products for commercial or other use stemming from this research will be governed by and will have to adhere to regulation (eu) 2017/745 on medical devices and the general safety and performance requirements it establishes. conclusion and future work the results seem promising although preliminary. both conventional and ai-facilitated optimization methods demonstrate the potential to mitigate discomfort and muscle fatigue experienced during fes sessions and multiple optimization methods should be explored and compared. by addressing these challenges, fes will become usable outside of clinical trials as a tool for daily tasks, figure 4. maximum acceleration against frequency at a voltage of 35 v (session c). considering the data as depicted in the graphs above, it becomes evident that the optimal value for frequency, as well as other parameters, as mentioned in the literature, is not only subject but also session-specific. sensitivity to ems stimulation, each subject’s perception of pain at different frequencies, and the muscle’s response vary between sessions. this is apparent both when examining optimal frequencies as well as when comparing the mean value and standard deviation of maximum acceleration for each session. results are summarized in table 1. table 1. session mean max acceleration std deviation a 19.59m/s^2 2.15m/s^2 b 17.91m/s^2 3.02m/s^2 c 18.88m/s^2 2.48m/s^2 we interpret higher average maximum acceleration in session a as higher sensitivity to ems for that particular session. the higher value of standard deviation in session b shows a higher sensitivity in frequency fluctuations, again for that particular session. the variation in values may depend on various factors, including skin cleanliness, http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 50 improving quality of life. additionally, the rehabilitation process can reap significant benefits, paving the way for a swifter and pain-free recovery. in our future work, we plan to increase our number of subjects. we aim to incorporate machine learning techniques into our expert system ai, add an electrode array to our setup, and study different electrode activation patterns, positions, and parameter settings. references 1. karamian, b.a., siegel, n., nourie, b., et al. the role of electrical stimulation for rehabilitation and regeneration after spinal cord injury. j orthop traumatol. 2022;23(1):2. https://doi.org/10.1186/s10195-021-00623-6. 2. milosevic, m., marquez-chin, c., masani, k., et al. why brain-controlled neuroprosthetics matter: mechanisms underlying electrical stimulation of muscles and nerves in rehabilitation. biomed eng online. 2020;19:81. https://doi.org/10.1186/s12938-020-00824-w. 3. christiansen, l. and siebner, h.r. tools to explore neuroplasticity in humans: combining interventional neurophysiology with functional and structural magnetic resonance imaging and spectroscopy. handb clin neurol. 2022;184:105–119. https://doi.org/10.1016/ b978-0-12-819410-2.00032-1. 4. jo, h.j., kizziar, e., sangari, s., et al. multisite hebbian plasticity restores function in humans with spinal cord injury. ann neurol. 2023;93(6):1198–1213. https://doi.org/10.1002/ana.26622. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.1186/s10195-021-00623-6 https://doi.org/10.1186/s12938-020-00824-w https://doi.org/10.1016/b978-0-12-819410-2.00032-1 https://doi.org/10.1016/b978-0-12-819410-2.00032-1 https://doi.org/10.1002/ana.26622 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 j global clinical engineering vol.6 special issue 6: 2024 84 conference paper kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou and panagiotis d. bamidis* medical physics laboratory, school of medicine, faculty of health sciences, aristotle university of thessaloniki, greece. * corresponding author email: bamidis@auth.gr abstract robot-assisted therapy, particularly hand exoskeletons, has emerged as a promising approach to address hand function limitations caused by neurological diseases that can significantly impact mobility, balance, and posture, leading to physical, psychological, and societal challenges. traditional rigid-body robots, while helpful, have limitations in safety and dexterity, spurring research into soft robotics in neurorehabilitation. the research presented in this manuscript focuses on the advancement of a soft robotic glove prototype developed for neurorehabilitation, integrated into the neurosuitup body-machine interface. this glove, composed of five pneunet pneumatic actuators and a multi-sensor system, is designed to facilitate natural hand movements. to optimize the glove’s functionality, kinematic and dynamic analyses of the human hand were conducted. specifically, a kinematic model of the hand, with 19 links representing human bones (phalanges) and 24 joints connecting them, was developed indicating the 24 degrees of freedom of the human hand. by understanding the forces applied to the finger phalanges, the movement of the entire finger can be predicted. this knowledge aids in designing personalized exoskeletal hand devices tailored to individual patient needs. further research aims to combine this model with a dynamic model of the actuators and investigate the device's effect on hand performance through computer simulations. keywords—soft robotic device, kinematics, dynamics. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:bamidis%40auth.gr?subject= mailto:achat@uom.edu.gr https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 85 j global clinical engineering vol.6 special issue 6: 2024 introduction neurological diseases, such as cerebral palsy (cp), parkinson’s disease (pd), and spinal cord injury (sci) affect a great percentage of the world’s population. these diseases can significantly affect a person’s mobility, balance, and posture, having a significant physical, psychological, as well as societal impact.1 in the past few decades, a wide range of studies about robot-assisted therapy have been developed to help alleviate the effects of these diseases. these neurological pathologies usually affect the proper physical functions of a patient’s hand and therefore, they can create limitations in performing activities of daily living. as a result, numerous hand exoskeleton systems have been developed aiming to the hand rehabilitation. this research focuses on the mathematical analysis of the human hand’s kinematics and dynamics, for the purpose of developing more efficient rehabilitation devices. through mathematical modeling, the exact motion and forces of the interaction between a robot and the human body can be determined. more specifically, the degrees of freedom, position, and orientation of the end effector, as well as the forces that need to be applied for the system’s operation, can be defined. this result enables the personalization of rehabilitation devices and exercise regimens, depending on each patient’s condition and the specific system operational parameters. as an assistance to the aforementioned motor disabilities, ongoing development of soft robotics for neurorehabilitation purposes has been observed in the past years. this emerging field uses lightweight, flexible, and compliant devices, built from materials with mechanical properties similar to those of living organisms. compared to the traditional rigid-body robots, these new types of robotics are designed and manufactured in a very innovative way in order to secure safety with the patient, dexterity, but also high performance.2 a wearable prototype in the shape of a glove has been designed and developed for neurorehabilitation purposes, as mentioned above. as shown in figure 1, it consists of an actuation system with five pneunet pneumatic actuators initiating the typical human hand movement, such as grasping an object, and a multi-sensor system.3 the device is part of the neurosuitup body-machine interface (bmi), which is a platform consisting of a wearable robotics jacket and glove, along with a serious game application for neurorehabilitation purposes.4 in order to understand and optimize the soft robotic glove’s future function, the proposed research describes the kinematic and dynamic analysis of the human hand and fingers, specifically. methods the proposed kinematic model of the hand consists of 19 links, which imitate the corresponding human bones (phalanges), and 24 joints, which connect the phalanges/ links of the fingers. therefore, the hand system is defined as having 24 dofs. figure 2 depicts the kinematic configuration of the human hand with all the joints j(i,j) of the five fingers, where i ={1,2,3,4,5} is the number of fingers and j ={1,2,3,4} is the number of joints in each finger. the four joints of the fingers, starting from the palm to the fingertip, are the carpometacarpal (cmc), metacarpophalangeal (mcp), proximal interphalangeal (pip), and distal interphalangeal (dip) joint.5,6 figure 1. soft-robotic glove device.3 figure 2. configuration of the human hand joints. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 86 figure 3 presents the open-chain kinematic configuration for one of the index, middle, ring, and little finger. the joints represented are the cmc, mcp, pip, and dip. as shown, the mcp joint consists of 2 dofs, since the one is for the flexion-extension movement and the second one is for the adduction-abduction movement of the finger. all the other joints perform the flexion-extension movement. each joint is represented by its own frame of origin with regard to the wrist reference frame r0. the aforementioned configurations are used to calculate the direct kinematics equations in order to define the position and orientation of the end-effector (fingertip) as functions of the joint variables. in this modeling, the denavit-hartenberg (dh) method is used and the parameters are shown in table 1.7 the general form of the transformation matrix ti, based on the dh parameters, is the following: equation 1 shows the final direct kinematics modeling of one finger i: where ti is a matrix representing the final position and orientation of the fingertip; is a geometrical transformation matrix from the (j−1) reference frame of the i-finger to its j-reference frame; is a geometrical transformation matrix representing the final position of the fingertip regarding the 5th reference frame. after the development of the kinematic model of each finger, the dynamics equations can be calculated using the euler-lagrange method. in this case, it applies on one of the four fingers (index, middle, ring, middle) and it is considered to have the metacarpophalangeal joint fixed for simplification purposes. the dynamic configuration of the index finger is presented in figure 4, and consists of the three mcp, pip, and dip joints. each joint has its own reference frame, while the r3 is the base reference frame. it is assumed that the center of mass of each link is located as shown in figure 3 and has a position vector gj. as a result, the three generic position vectors of the three links with respect to the base frame r3 are calculated and are the following6: figure 3. kinematic configuration of the index finger. table 1. dh parameters for the direct kinematics. joint aj αj dj θj cmc 1 0 π/2 0 θcmc mcp(ab/ad) 2 l01 −π/2 0 θmcpa/a mcp(f/e) 3 0 π/2 0 θmcpf/e pip 4 l11 0 0 θpip dip 5 l21 0 0 θdip (1) (2) figure 4. dynamic configuration of the index finger. (3) http://www.globalce.org http://globalce.org http://globalce.org 87 j global clinical engineering vol.6 special issue 6: 2024 where φ4 = θmcp + θpip and φ5 = θmcp + θpip + θdip. the lagrange-euler equation is the following: where l=k−p. k is the kinetic energy of the system, p the potential energy of the system and fgen the generalized external forces applying on the upper side of the finger phalanges, while q is the generalized coordinate, which in this case is the angle θj. the term of fgen is not being described thoroughly at the present time, but will be estimated in future research. the kinetic energy of the center of mass of each finger joint is obtained through the following equation: where mj is the average mass of each joint j, jvi is the linear velocity jacobian, jωj is the angular velocity of the joint, ιj is the moment of inertia of the joint and θ̇ the angular velocity. the dynamic energy of the center of mass, which includes the gravitational term, is obtained: discussions further research in the future will aim to combine both the aforementioned model and the dynamic model of the actuators, as well as the way the exoskeletal device affects the performance of the patient’s human hand. moreover, executing computer simulations is proposed, in order to validate the results of the above research. conclusion the emerging progress of the soft-robotics field has led to the development of numerous exoskeletal soft robotic devices aiming at neurorehabilitation. the above research describes the kinematic and dynamic model of the human finger, in order to solve the direct dynamics of the finger. therefore, given the forces applied on the phalanges of the finger, the movement of the whole finger can be calculated and a suitable personalized exoskeletal hand device can be designed. acknowledgments this work has been supported by the neurosuitup and heroes project, in the medical physics laboratory, school of medicine, faculty of health sciences, aristotle university of thessaloniki, greece. special thanks to dr. alkinoos athanasiou and kostas nizamis, university of twente. references 1. tulsky d.s., kisala p.a., victorson d., et al. overview of the spinal cord injury-quality of life (sci-qol) measurement system. j spinal cord med. 2015;38(3):257–269. https://doi.org/10.1179/2045772315y.0000000023. 2. schmitt, f., piccin, o., barbé, l., et al. soft robots manufacturing: a review. front robot ai 2018;5:84. https:// doi.org/10.3389/frobt.2018.00084. 3. fiska, v. development of a wearable exoskeletal device based on multi-sensor data fusion & soft robotics for neural rehabilitation of the human hand. master thesis. aristotle university of thessaloniki medical informatics. thessaloniki, greece, 2022. https://doi. org/10.26262/heal.auth.ir.341806. 4. mitsopoulos, k.; fiska, v.; tagaras, k.; et al. neurosuitup: system architecture and validation of a motor rehabilitation wearable robotics and serious game platform. sensors (basel) 2023;23(6):3281. https:// doi.org/10.3390/s23063281. 5. hernández-santos, c., davizón, y.a., said, a.r., et al. development of a wearable finger exoskeleton for rehabilitation. appl sci. 2021,11(9):4145. https:// doi.org/10.3390/app11094145. 6. chen, f.c., appendino, s., battezzato, a. et al. human finger kinematics and dynamics. in proceedings of the second conference metrapp 2013, bilbao, spain, 2–4, october 2013, pp:115–122; petuya, v., pinto, c., lovasz, e.c., eds.; springer: dordrecht, netherlands, 2014. https://doi.org/10.1007/978-94-007-7485-8_15. (4) (5) (6) http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.1179/2045772315y.0000000023 https://doi.org/10.3389/frobt.2018.00084 https://doi.org/10.3389/frobt.2018.00084 https://doi.org/10.26262/heal.auth.ir.341806 https://doi.org/10.26262/heal.auth.ir.341806 https://doi.org/10.3390/s23063281 https://doi.org/10.3390/s23063281 https://doi.org/10.3390/app11094145 https://doi.org/10.3390/app11094145 https://doi.org/10.1007/978-94-007-7485-8_15 j global clinical engineering vol.6 special issue 6: 2024 88 7. cobos, s., ferre, m., sanchez uran, m.a. et al. efficient human hand kinematics for manipulation tasks. in 2008 ieee/rsj international conference on intelligent robots and systems, nice, france, 22–26 september 2008, pp:2246–2251; ieee: piscatawa, usa. https:// doi.org/10.1109/iros.2008.4651053. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.1109/iros.2008.4651053 https://doi.org/10.1109/iros.2008.4651053 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 j global clinical engineering vol.7 issue 3: 2025 74 this paper is part of the special lssue on design and manufacturing in biomedical engineering guest editor: dr. jashanpreet singh, university center for research and development, chandigarh university, punjab, india; prof. dr. chander prakash, university center for research and development, chandigarh university, punjab, india. received january 23 2025, accepted july 12 2025, date of publication september 22 2025. original research article influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics asisha ranjan pradhan1, shivam kumar2,3, agus saptoro4, perumal kumar4, jono suhartono5, satish kumar3, and jashanpreet singh6,* 1 indian institute of technology hyderabad, telangana, india. 2 wa school of mines: minerals, energy and chemical engineering, curtin university, perth, australia. 3 national institute of technology, jamshedpur, jharkhand, india. 4 curtin university, sarawak, malaysia. 5 institut teknologi nasional bandung, indonesia. 6 university centre for research and development, chandigarh university, mohali, punjab, india. * corresponding author email: ijashanpreet@gmail.com abstract covid-19, caused by the 2019-ncov coronavirus, is a global pandemic that spreads through respiratory droplets that are transmitted by inhalation or contact with droplet nuclei produced during sneezing, coughing, and speaking by infected people. covid-19 can also be spread by air in the infected person’s close-by surroundings. in this study, computational fluid dynamics (cfd) was employed to analyze the airborne transport of virus-laden droplets generated by a coughing event in a typical classroom environment. simulations were conducted for three ventilation airflow velocities—3, 5, and 7 m/s—under both side and top wall configurations. the results showed that higher airflow velocities significantly reduced the residence time of airborne particles, with the 7 m/s case clearing over 90% of droplets within 60 seconds. top wall ventilation led to early dispersion near the front rows, while side wall ventilation carried droplets to the rear seats over time. in addition, smaller aerosols (< 1 µm) remained suspended for a significantly longer duration than larger droplets (> 100 µm), indicating higher long-range transmission risk. these findings underscore the importance of optimizing airflow velocity and vent placement to reduce airborne exposure and support safer classroom ventilation design. keywords—covid-19, classroom, cfd, airborne transmission, ventilation. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 75 j global clinical engineering vol.7 issue 3 2025 pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics introduction covid-19 is a highly contagious respiratory illness caused by the 2019-ncov coronavirus, which belongs to the destructive coronavirus family that has rapidly spread worldwide, resulting in a pandemic.1–3 airborne transmission involves inhaling virus-laden aerosols, which are smaller than 5 μm. these aerosols can travel in airflows and infect individuals at short and long distances from the source.4–6 these droplet nuclei are created when infected individuals sneeze, cough, or talk. individuals’ social, cognitive, and intellectual development is greatly enhanced by classrooms.7 however, because of many uncertainties about the transmission routes of covid-19, there are ongoing worries about creating safe and supportive educational settings. environmental factors such as temperature, humidity, and ventilation significantly affect the transmission of aerosols. poorly ventilated indoor spaces increase the risk of airborne transmission.4,5,8 one crucial question that requires attention is how the ventilation systems in the classroom impact the ability of the virus to spread. computational fluid dynamics (cfd) can simulate the propagation of virus-laden droplets from an infected student’s sneezing or coughing to avoid experimental complications.9–11 statistical investigations showed that covid-19 dispersed by aerosols, droplets, fomites, and human waste affected human health.12,13 asadi et al. investigated the spread of covid-19 by direct or indirect contact, including transmission through the air when sneezing or coughing and through physical contact with contaminated objects.14 diwan et al. investigated the airflow produced by sneezing and coughing in dry and wet circumstances.15 they also considered the evaporation of droplets using direct numerical simulations (dns). the researchers replicated the act of coughing by modelling it as a turbulent jet/puff phenomenon. kotb and khalil used ansys-fluent 18.0 to mimic covid-19 transmission by sick passengers sneezing and coughing in an aircraft cabin.16 they found that sneeze droplets were more harmful than cough droplets, yet both could travel long distances in the aircraft. as speed rises, more droplets are distributed. wang et al. calculated the distribution of covid-19-contaminated particles from sneezing in a three-bed hospital unit.17 particle path and residency period were simulated using ansys fluent 19.0 to assess cross-infection risk. common ventilation systems change indoor air concentration, temperature, and humidity.18,19 the influence of displacement and mixed ventilation systems on interior air quality affects human health and comfort.20,21 multiple studies show that poor ventilation increases disease transmission in confined settings. several researchers have studied indoor airflow, room pressurization, and filtration in infectious illness hospitals and chemical labs.22,23 the goal was to find low-risk situations. ren et al. numerically modelled three typical breathing strategies in a hospital’s prefabricated covid-19 inpatient room.24 the study examined various droplet sizes. main currents transport small particles across significant distances. portions of droplets are expelled via outlet ventilation. however, streams cannot carry large particles. they land on solid objects because of gravity. different ventilation methods cause sedimentation in different parts of the ward. because of the lack of empirical data on covid-19-infected droplet fluid dynamics, models of droplet transmission by sneezing or coughing are useful.25,26 this analysis improves our understanding of the covid-19 simulation. gupta et al. experimentally studied coughing airflow dynamics.27 researchers used gamma functions to track coughing rates throughout time. the researchers found no association between cough direction, mouth opening size, and physiological parameters, including height, weight, and gender. many studies show how human-breathed air affects respiratory infections in ventilated environments to minimize breathing-related infections.28,29 big droplets settle swiftly over a short distance and are hardly affected by air temperature changes. however, personal contact with an infected person might spread droplet-borne diseases to susceptible others. educational researchers have examined covid-19 transmission among pupils. abuhegazy et al. studied covid-19 aerosol mobility and deposition on classroom surfaces.30 they found that particle size, aerosol source location, glass barriers, and windows affected their numerical results. the researchers found that gravitational sedimentation deposits bigger particles on the ground, tables, and other surfaces in the room, whereas the air conditioning system expels most small particles. researchers have studied seat placement in different rooms and regions using equilateral triangle seat designs.31 their covid-19 study may benefit schools, universities, restaurants, libraries, and other indoor areas pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics j global clinical engineering vol.7 issue 3: 2025 76 where seat availability is crucial. this method boosts seats by 13% on average and 25% to 50% sometimes. the review of the existing sources and the consistency of concerns and uncertainties regarding the covid-19 spread demonstrate the necessity for further studies on the distribution of the virus in the classroom. it is important to develop suitable design methods to reduce the risk of air transmission within these environments. this paper has applied cfd to study the geographical and time dispersion of virus-laden droplets emitted by a coughing individual in a typical classroom. the paper examines how the velocities of airflow ventilation and droplet sizes affect the dispersion of infectious particles and how sitting positions are more vulnerable to infection. the originality of this study lies in the extensive modelling of aerosol-sized and large ballistic droplet behavior within an authentic classroom layout under the various ventilation types, which helps in gaining useful information on how to improve airflow and counter the issues of transmission indoors. mathematical model in this investigation, numerical modelling of the flow dynamics of the transmission of the covid-19 virus was done using the rng k-e model in ansys fluent 19.0. the eulerian–lagrangian approach was used to monitor the water droplets of different sizes released from the mouth of the diseased individual standing in front of the classroom because of coughing. ventilation airflow modelling the equations (1–3) that describe the preservation of mass, momentum, and energy for a steady airflow that does not change in volume are as follows: ( ) 0v t ρ ρ∂ + ⋅ = ∂  ▽ � (1) � (2) � (3) where, ρ is the fluid density (kg/m3), 𝑡 is the time (s), v  is the velocity vector field (m/s), and ∇⋅(ρv  ) is the divergence of mass flux. in equation (2), the p denotes the pressure (pa), μ denotes the dynamic viscosity (pa⋅s), 2v  ▽ denotes the laplacian of velocity (diffusion of momentum), and s  denotes the external source term (e.g., body forces like gravity or electromagnetic forces). in equation (3), t is the temperature (k), k is the thermal conductivity (w/m⋅k), cp is the specific heat capacity at constant pressure (j/kg⋅k), and the is the heat diffusion term, and st is the volumetric heat source (e.g., radiation, chemical reaction, joule heating). turbulence modelling according to tsan–hsung, the rng k-ε turbulence model is a reasonable choice for modelling airflow in interior conditions.32 the dissipation rate ε and turbulent kinetic energy k have matching transport equations, which are given as: (4) ( ) ( ) ( ) 2 1 2 i eff i j j k u t x x x c g c r s k k ε ε ε ε ε ερε ρε α µ ε ερ  ∂ ∂ ∂ ∂ + =   ∂ ∂ ∂ ∂   + − − + � (5) where, gk represents the turbulent kinetic energy output resulting from the average velocity gradients. in this context, s𝜀 and sk represent source terms that are defined by the user, while refers to the source term derived by renormalization. the xi and xj represent the ith and jth spatial coordinates, respectively. the equations (4) and (5) define αk and αε as the effective inverse prandtl numbers for the turbulent kinetic energy and its dissipation, respectively. the symbol 𝜀 represents the turbulence dissipation rate (𝑚2/𝑠3), μeff is the effective viscosity, and ui is the velocity component in 𝑥𝑖-direction. the product ρε represents the dissipation of turbulent kinetic energy (k) into heat. the model constants c1𝜀 and c2𝜀 are assigned the values of 1.42 and 1.68, respectively. 77 j global clinical engineering vol.7 issue 3 2025 pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics discrete phase modelling in this study, the airflow was initially assessed for a sparse concentration of droplets before analyzing the trajectory of particles. the movement of droplets carrying viruses was examined employing newton’s second law within a lagrangian framework,33–35 with the associated equation of motion expressed as: ( ) ( )dd d d l b d gdv f v v f f dt ρ ρ ρ − = − + + +    � (6) in equation (6), fl represents the saffman lift force, and fb denotes the brownian force36. the given equation is the lagrangian particle force balance used in multiphase flow modeling, where ddv dt denotes the acceleration of the dispersed particle with dv  as its velocity. the term ( )d df v v−   represents the drag force per unit particle mass, where v  is the fluid velocity and fd is the drag coefficient depends on reynolds number and drag law. the term ( )d d g ρ ρ ρ −  accounts for gravitational and buoyancy effects, with being gravitational acceleration, 𝜌𝑑 the particle density, and ρ the fluid density; this drives particles to settle if 𝜌𝑑 > 𝜌 or rise if 𝜌𝑑 < 𝜌. while fd represents the coefficient of drag force, given as (equations 7 and 8): 2 18 d d c f d c µ ρ = � (7) 1.1 221 1.257 0.4 d k c kc e d  −      = + +     (8) where, 𝜇 is the fluid’s dynamic viscosity, d is the particle diameter, 𝜌d is the particle density, and cc is the cunningham correction factor that corrects drag at very small particles.37,38 within the cunningham coefficient, the ratio 2𝜆/d appears, where 𝜆 is the mean free path of gas molecules, which introduces a slip correction when particles are comparable in size to the molecular spacing. the mass flow rate of particles is expressed as (equation 9): 34 3 dr n m t π ρ × ×   = � (9) where, the symbol m denotes the particle mass flow rate, representing the mass of particles transported per unit time. symbols n and ρ represent the number and density of particles, respectively. the 𝜌d is the particle material density used in determining individual particle mass and flow contributions in equation 10, fl represents the saffman lift force, given as: 12 2 6.46 . 2 p f l f s f d g f v ρ µ µ    =         � (10) where, dp represents the mean diameter of particles, μf is the dynamic viscosity of the fluid, and vs is the slip velocity defined as the relative velocity between the fluid and the particle. the term ρf represents the fluid density, while g denotes the velocity gradient in the surrounding fluid. geometry this study has examined the movement and scattering of droplets that carry the covid-19 virus produced by coughing in a classroom with under-ventilated or nonventilated circumstances. the dimensions and specifications of the classroom and chairs are depicted in figure 1 (a) and figure 1 (b) from both a top perspective and a side view. the classroom floor under study dimensions is 6 m in width and 8 m in length. the height of the classroom is 4.5 m. the floor area per student is consistent with a value of 0.36 square m. the class’s student seating is arranged with a precise distance of 0.5 m. figure 2 displays a comprehensive 3d representation of the simulated classroom, including all relevant details. this study examines the scenario where an individual infected with covid-19, measuring 1.8 m in height and with a mouth area of 4 cm2, coughs abruptly and releases virus-infested droplets into the surrounding environment. the ventilation air is drawn in from a wall intake located behind and on top of the individual and is expelled via the open door. the door dimension is 1 × 2.1 m2. pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics j global clinical engineering vol.7 issue 3: 2025 78 meshing all simulations use an unstructured tetrahedral mesh created with ansys-fluent, as shown in figure 3. meshing details are provided in table 1. boundary conditions and solution process the simulations are conducted for both scenarios: one without and one with ventilation. the ventilation was positioned in several locations, including top ventilation, side wall ventilation with either one or three ventilation apertures, and the classroom door was used as the exit for the ventilation. water droplets of different sizes are analyzed to represent the current conditions accurately. a coughing velocity of 10 m/s sustained for 0.75 seconds was applied, in alignment with measured human coughing dynamics reported by gupta et al.27 the injected droplet diameters ranged from 0.15 µm to 150 µm, consistent with experimental respiratory emission size distributions.30 inlet velocities of 3, 5, and 7 m/s and the corresponding outlet placements were selected based on airflow conditions investigated in previous classroom ventilation studies.16 the specific details of the droplets are provided in table 2. boundary conditions and solution process the simulations are conducted for both scenarios: one without and one with ventilation. the ventilation was positioned in several locations, including top ventilation, side wall ventilation with either one or three ventilation apertures, and the classroom door was used as the exit for the ventilation. water droplets of different sizes are analyzed to represent the current conditions accurately. a coughing velocity of 10 m/s sustained for 0.75 seconds was applied, in alignment with measured human coughing dynamics reported by gupta et al.27 the injected droplet diameters ranged from 0.15 µm to 150 µm, consistent with experimental respiratory emission size distributions.30 inlet velocities of 3, 5, and 7 m/s and the corresponding outlet placements were selected based on airflow conditions investigated in previous classroom ventilation studies.16 the specific details of the droplets are provided in table 2. figure 1. classroom geometry and schematics. (a) top view. (b) side view. figure 2. 3d model of the classroom with all the details. figure 3. meshing of the flow domain. 79 j global clinical engineering vol.7 issue 3 2025 pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics the trap condition is used for the solid walls to govern the interactions between droplets and various surfaces, while the escape condition is utilized for the inlet and exit. the simulation utilizes three velocities within this range and subsequently compares the outcomes. the additional boundary conditions employed include a velocity input and a pressure exit. the temperature is set as a starting value for the outlet. in addition, a turbulence intensity of 5% is assumed at the inlet. result this section delineates the numerical validation and results derived from cfd simulations, emphasizing airflow dynamics, turbulence intensity, and particle dispersion across varying droplet sizes and airflow velocities under distinct ventilation setups. table 1. meshing details. parameter value cell type tetrahedrons maximum face size 50 mm nodes 672,869 elements 3,679,749 skewness 0.21935 orthogonal quality 0.77935 aspect ratio 1.8284 table 2. injection conditions for droplets carrying covid-19 viruses. diameter (μm) velocity (m/s) number of particles injection time (sec) mass flow rate (kg/sec) 0.15 10 1,800 0.75 4.2413e-15 1 10 1,800 0.75 1.2566e-12 10 10 1,800 0.75 1.2566e-09 50 10 1,800 0.75 1.5706e-07 100 10 1,800 0.75 1.2566e-06 150 10 1,800 0.75 4.2413e-06 validation prior to analyzing the fluid dynamics and flow patterns within the classroom geometry, the current numerical model for simulating particle motion was validated against the results of jacob et al.39 figure 4(a) illustrates the computational domain, while figure 4(b) presents the velocity profiles at various locations within the designed room. in addition, figure 4(c) compares the velocity distributions at different locations, demonstrating a strong agreement with the findings from the previous study. airflow characteristics the airflow distribution within the classroom was simulated under different ventilation configurations (top and side walls) and inlet velocities (3 m/s, 5 m/s, and 7 m/s). the velocity distribution analysis within the classroom was carried out concerning different airflow velocities (3, 5, and 7 m/s) and two ventilation patterns: side wall and top wall ventilation. figure 5 demonstrates that side wall ventilation creates a horizontal jet that becomes deeper and larger in circulation as velocity augments and circulation zones influence particle movement and dispersion. the recirculation zone is clear-cut and increases with the inlet velocities. as velocity increases, the graph in figure 6 demonstrates a rise throughout the room. contrarily, figure 7 presents velocity vector fields at the mid-plane for top wall ventilation across three inletvelocities—3, 5, and 7 m/s—demonstrating the formation of figure 4. (a) computational domain for validation, (b) measured location inside the test chamber, and (c) velocity distribution at various positions. pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics j global clinical engineering vol.7 issue 3: 2025 80 a downward airflow jet from the ceiling. figure 8 shows the corresponding velocity magnitude contours near the floor, indicating that at the highest velocity of 7 m/s, the airflow penetrates more deeply into the student seating area, thereby increasing airflow coverage near occupant breathing zones. turbulence intensity distribution an analysis of turbulence kinetic energy (tke) was conducted to examine the influence of airflow velocity on turbulent mixing in the classroom. tke contours illustrate the impact of ventilation airspeed on turbulent mixing. the results demonstrate a clear association between input airspeed and the magnitude and intensity of turbulent regions. in side ventilation (figure 9), an increase in inflow velocity results in a wider and more violent turbulence zone. the top wall ventilation (figure 10) demonstrates elevated turbulent kinetic energy (tke) next to the first row of students and the droplet source, indicating enhanced mixing in the anterior area. droplet size and settling behavior figure 11 illustrates the dynamic behavior of droplets of varying diameters 1 s after a coughing event simulated with a velocity of 10 m/s sustained for 0.75 s. larger and heavier droplets, such as those measuring 100 μm and 150 μm, exhibit rapid gravitational settling as expected, while smaller droplets measuring less than 1 μm remain suspended in the air for a prolonged duration. this persistence highlights their potential role as aerosol carriers, contributing to airborne transmission risk within the classroom environment. figure 5. velocity vector fields at mid-plane for side wall ventilation at different inlet velocities: (a) 3 m/s, (b) 5 m/s, and (c) 7 m/s. 81 j global clinical engineering vol.7 issue 3 2025 pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics such as 22–24, after 20 s (figure 16). after 60 s, most particles exit the classroom, but some remain near the last row (figure 17). discussion this section interprets the results regarding ventilation design, airflow behavior, particle dynamics, and implications for infection risk. influence of airflow velocity on turbulence and jet formation the simulations validate the sensitivity of the velocity of the airflow against the configuration of the ventilation jet, the generation of the turbulence, and the transport of the droplets in the classroom environment. with a higher inlet velocity (7 m/s) compared to the previous velocity (3 m/s), the ventilation jets are more energetic and deeper, forming a larger and more stable circulation zone (figures 5–8). this accelerated jet stream promotes air mixing and particles suspended, particularly along the flow axis in ventilation. in parallel, the kinetic energy of turbulence (tke) increases significantly as the speed of airflow increases (figures 9 and 10). it spreads the areas of turbulent mixing and promotes the wider dispersion of droplets. these findings agree with already-known principles of jet behavior in closed environments and support the existing literature by tan and glenn11, liu et al.,9 and kotb and khalil,16 who identified increased turbulent transport and possible cross-contamination with higher airspeeds in their cfd-based studies. significantly, high turbulence not only enhances particle mixing but also causes a shorter residence time of the airborne droplets, which increases the possibility of evacuating infectious aerosols promptly. this highlights that ventilation velocity is the most crucial factor in managing the risk of air distribution within an indoor environment. ventilation configuration and spatial exposure risk the spatial distribution of suspended droplets because of the ventilation layout is greatly influenced; this is the difference that is most exposed in a classroom. the top wall ventilation scheme delivers air to the ceiling and directs it downward, making the jets of air so strong at the frontmost rows of learners. in this setup, as seen in figures 13 and 14, droplet concentration will be around seats 1–6 shortly after a coughing session. particle dispersion under different ventilation scenarios the spatiotemporal evolution of particle distribution was evaluated under three conditions: no ventilation, top wall ventilation, and side wall ventilation. droplet trajectories were recorded at various intervals to analyze which seating zones were most affected over time. in the absence of ventilation (figure 12), droplets accumulate near the first row, especially in seat 3. with top ventilation, initial dispersion is limited (figure 13); however, by 10 seconds, some particles reach seats 1–6 (figure 14). side ventilation shows a greater concentration near the source at 10 s (figure 15), expanding to the rear seats, figure 6. velocity magnitude contours (in m/s) at classroom mid-plane for side wall ventilation: (a) 3 m/s, (b) 5 m/s, and (c) 7 m/s. pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics j global clinical engineering vol.7 issue 3: 2025 82 the occupants’ exposure in the front row, the side ventilation can cause delayed but more extensive exposure at the back of the classroom. the results aligned with those of abuhegazy et al.30 who identified that ventilation’s directionality significantly affects particle transport and particle deposition on a surface. the findings indicate how ventilation should be designed to be context-sensitive, with consideration to the geometrical nature of the rooms, room occupancy, floor plans, and the temporal exposure patterns. on the other hand, the side wall ventilation type causes air to travel laterally along the room, and the direction of air moves the particles toward the back of the room as time goes on. as seen in figures 16 and 17, the peak in the concentration of particles can be observed when it is already 20–60 s after an emission occurs, with the most in and around the last row.22–24 this redistribution effect has proved that although the top ventilation can enhance figure 7. velocity vector fields at mid-plane for top wall ventilation at inlet velocities of: (a) 3 m/s, (b) 5 m/s, and (c) 7 m/s. figure 8. velocity magnitude contours (in m/s) near floor level for top wall ventilation: (a) 3 m/s, (b) 5 m/s, and (c) 7 m/s. 83 j global clinical engineering vol.7 issue 3 2025 pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics effect of droplet size on suspension and deposition the size of virus-laden droplets plays a huge part in how they behave. simulation results indicate that large droplets (100–150 µm) fall fast within a few seconds because of gravitational settling (figure 11). these droplets are usually related to close contact and contamination of surfaces. smaller droplets, especially those less than 1 µm across, on the contrary, can stay in the air current much longer. these particles sink to the ground a little and are more prone to be carried by wind and turbulence. this is in line with what morawska and milton6 suggest in their findings, as they pointed out that aerosols are the most figure 9. turbulence kinetic energy (tke) contours (in m²/s²) for side wall ventilation: (a) 3 m/s, (b) 5 m/s, and (c) 7 m/s. prominent route of transporting the transmission over long-range airborne transmission indoors. this sizedependent activity explains the significance of ventilation measures that can efficiently eliminate or dilute small particles instead of focusing on surface cleaning and spatial distancing. implications for classroom ventilation design considering airflow velocity, droplet size distribution, and ventilation geometry provides interesting suggestions for improving classroom design to reduce air provision. first, it was found that the higher the ventilation velocity, the better the particle clearance, and the shorter their mean residence time (meaning that it was shortened more in the case of aerosols of small size). but this advantage should be weighed against the possibility of redistribution of particles by high-speed air to broader areas. secondly, the air in/out location should be well thought over. top ventilation could quickly clear an area of particles in the breathing zone behind them, but might also cause a rise in exposure in the front seat areas. side ventilation, however, will provide a more homogeneous air distribution in case of slow clearance or would lead to accumulation in downstream areas. this evidence confirms the approach suggested by bazant and bush,8 that directional highefficiency ventilation and an occupancy-sensitive design layout should be used. this might include not placing high-risk individuals (e.g., teachers or symptomatic students) in the direct flow path, opening air exchange rates in classrooms, and using specific filtration or air disinfection technologies. conclusion the study examined the flow dynamics and dispersions of droplets of various sizes produced by a covid-19infected person coughing in a classroom with varying ventilation systems. 3d simulations were performed for various ventilation airflow velocities entering the intake pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics j global clinical engineering vol.7 issue 3: 2025 84 • the turbulence rate rises with higher airflow velocity, increasing the dissemination of contaminated particles. • the number of suspended droplets typically decreases as the ventilation velocity increases at a given period after injection. • in all types of ventilation, the average concentration of droplets in the room decreases as time increases. duct and exiting the open classroom door. based on the reported findings, the following conclusions are drawn: • seat number 3 is the most impacted by contaminated human coughing in the absence of ventilation. • coughing affects the first row of students because of inadequate top ventilation. sidewall ventilation affects the final row of students the most because of reduced airflow in that area. figure 10. turbulence kinetic energy (in m²/s²) contours for top wall ventilation: (a) 3 m/s, (b) 5 m/s, and (c) 7 m/s. figure 11. initial droplet distribution 1 s after coughing (velocity = 10 m/s for 0.75 s): droplets of varying diameters (0.15–150 µm). figure 12. droplet dispersion 10 s after coughing with no ventilation. 85 j global clinical engineering vol.7 issue 3 2025 pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics figure 13. droplet distribution 5 s after coughing with top ventilation at 5 m/s. figure 14. droplet spread 10 s after coughing with top wall ventilation at 5 m/s. figure 15. particle distribution 10 s after coughing with side wall ventilation at 5 m/s. figure 16. particle distribution 20 s after coughing under side wall ventilation (5 m/s). figure 17. droplet distribution 5 s after coughing with top ventilation at 5 m/s. author contributions conceptualization and methodology: a.r.p., s.k., and s.k.; literature review: a.r.p.; formal analysis: a.r.p. and s.k.; writing–original draft preparation: a.r.p. and j.s.; software: a.r.p. and s.k.; writing–review & editing: a.r.p. and j.s.; visualization: s.k.; supervision: a.s., p.k., j.s., s.k. acknowledgments not applicable. funding this research received no external funding. pradhan, kumar, saptoro, kumar, suhartono, kumar, singh: influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics j global clinical engineering vol.7 issue 3: 2025 86 data availability statement not applicable. conflicts of interest the authors declare they have no competing interests. ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure not applicable. references 1. setti, l., passarini, f., de gennaro, g., et al. potential role of particulate matter in the spreading of covid-19 in northern italy: first observational study based on initial epidemic diffusion. bmj open. 2020;10:e039338. https://doi.org/https:// doi.org/10.1136/bmjopen-2020-039338. 2. xie, j. and zhu, y. association between ambient temperature and covid-19 infection in 122 cities from china. sci total environ. 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(eds). advances in fluid and thermal engineering. lecture notes in mechanical engineering. 2019, springer, singapore. https://doi.org/10.1007/978-981-13-6416-7_8. editor’s corner sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina valerio di virgilio1,*, pedro enrique garrigou2, ignacio lacasta casal2, patricia mariana crego2, miguel alejandro bruzzo2 original research article implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis edgar gonzález campos*, luis antonio rosas pacheco and arturo vega gonzález characterization of odor profiles through the simplified binary matching algorithm for disease diagnostics ecole doctorale des sciences de l’ingénieur (ed-sdi)/laboratoire letia/epac, université d’abomey calavi (uac), abomey calavi, 01 bp 2009 cotonou, bénin. review catchment of the test license for the regulation of medical devices in india review application of usability techniques in medical devices in health technology management: a rapid review influence of airflow on dispersion of covid-19 droplets in classrooms using computational fluid dynamics original research article training of surgical skills by a 3d augmented liver model response during instrument interactions simulation veronika ivanova1,†,*, plamen vasilev vasilev2,† and ani todorova boneva 3,† 3 department of communication and computer systems, institute of information and communication technologies, bulgarian academy of sciences, sofia 1113, bulgaria. †these authors contributed equally to this work. * corresponding author email: iwanowa.w@abv.bg j global clinical engineering vol.6 special issue 6: 2024 68 conference paper a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 1 lab of medical physics & digital innovation, auth, greece. 2 department of dermatology-venereology, papageorgiou general hospital auth, greece. 3 robotics laboratory, computer science, american college of thessaloniki, greece. * corresponding author email: alexandrosmor@hotmail.com abstract our team has engineered a mobile and cost-efficient diagnostic tool that leverages electrical impedance spectroscopy (eis) technology to conduct differential assessment of the electrical impedance of skin tissue. now in its third prototype iteration, the dermasense apparatus performs non-invasive data collection from the epidermal layer, processes and analyzes the data, and serves as a support tool in dermatological diagnostic decisions. device development focuses on an array of skin malignancies and relevant precursor conditions, such as actinic keratosis. subsequent to rigorous evaluations in both controlled lab environments and clinical scenarios, our empirical data suggests that dermasense holds promise in enhancing the precision of skin condition classification. crucially, impedance measurements derived from individuals with certain pre-existing dermatological ailments appear to be distinguishable from those acquired from healthy patches of skin from the same subject, as well as those from other healthy subjects. keywords—medical devices, dermatology, electrical impedance spectroscopy, eis, actinic keratosis, melanoma, biomedical engineering. copyright © 2024. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:alexandrosmor@hotmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 69 j global clinical engineering vol.6 special issue 6: 2024 introduction dermatological diseases represent a pervasive health challenge, impacting a substantial segment of the global population.1 this encompasses a spectrum of cutaneous pathological conditions, ranging from mild afflictions such as acne and eczema to more severe diseases such as actinic keratosis and melanoma, a variant of aggressive cutaneous malignancy.2 the diagnostic approach in dermatology is based upon an array of procedures, including visual clinical assessment, surgical excision, and histopathological evaluation.3,4 this research delves into and introduces an eis prototype scanner designed to augment the aforementioned conventional dermatological methodologies using novel biomarkers, potentially enhancing the precision and specificity of dermatological diagnoses, thereby facilitating prompt and effective therapeutic interventions.5 materials and methods materials hardware the prototype diagnostic system consists of a primary unit with a usb-2020 data acquisition mixed signal electronics board, a scanning head featuring nine spherical stainless steel electrodes (figure 1), a signal generator to excite the skin and a microcontroller that acts as the central processing unit. a pc is utilized to run the control and visualization software. software programming has been primarily carried out using the c++ language, which generates robust and efficient executables. in addition to c++, labview is employed to provide a user-friendly interface and facilitate the visualization of data. experimental setup human skin impedance is modeled via an electrical circuit comprising a capacitor and resistors (figure 2). measurements employ ohm’s law, using root mean square (rms) values for alternating voltage and current. a comprehensive characterization of electrical impedance can be achieved through an analogous electrical circuit model, as posited by.6 however, the inherent nonlinear and time-variant attributes of the skin’s electrical response necessitate a more intricate representation than a mere passive circuit. to address this, a circuit model encompassing a capacitor and two resistors in series has been proposed as an elementary yet effective framework for elucidating the intricacies of electrical impedance.7 to quantify the skin’s impedance, one can employ the renowned ohm’s law, articulated as e = ir. for this computation, it is imperative to utilize the root mean square figure 1. the prototype scanning head comprising of nine spherical stainless steel electrodes encased by copper. figure 2. a simulation of the human impedance circuit simulated in pspice software. http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 70 (rms) values, especially when dealing with alternating current and voltage, to ensure accuracy. an illustrative experimental circuit, depicted in figure 2, serves as a testament to the empirical findings derived from the scientific literature. within this configuration, the parallel arrangement of capacitor c2 and resistor r3 is designed to compensate for the capacitive effects intrinsic to the skin. concurrently, the series resistor, r2, provides insights into the impedance characteristics of the subcutaneous tissue layers. notably, resistor r1, while not directly representing any skin property, plays a reference role in the data acquisition process, facilitating the measurement of aggregate current. furthermore, the inclusion of c1, a coupling capacitor, is of paramount importance, ensuring the segregation of ac and dc signals, thereby preserving the circuit's equilibrium state amidst the introduction of alternating currents. methods our objective was to assess the operability and applicability of the 3rd generation dermasense prototype apparatus that we engineered. initial trials were executed in a regulated laboratory environment, employing a trielectrode setup (comprising power supply electrodes and a data acquisition electrode). three experimental sets were undertaken, with electrodes consistently positioned within an identical skin region on a participant’s forearm, modulating electrode distances from 150 mm to 450 mm. to discern the influence of electrode categorization on the acquired signals, two discrete electrode variants, specifically adhesive ecg electrodes and spherical stainless steel electrodes, were utilized, and their resultant data were compared. upon corroborating the operability of the prototype device, clinical measurements were procured from three male subjects, each suffering from various dermatological pathologies across diverse cutaneous areas of the skin. these assessments were orchestrated under the aegis of a dermatologist at the 2nd department of dermatologyvenereology inside the dermatological clinic of papageorgiou hospital. among the two electrode categories chosen for this investigation, adhesive ecg electrodes were deemed inappropriate due to their expansive contact surface area with the epidermis, obstructing the establishment of an electrode matrix conducive to comparative differential evaluations. results in this study, two types of electrodes were evaluated. the adhesive ecg electrodes were deemed inappropriate for the intended purpose. their unsuitability arises from even the smallest ones having a significant skin contact surface area, which hinders the formation of an electrode array for comparative differential readings. our experimental regimen subjected three healthy individuals to a consistent voltage (approximately 1.68 v) across escalating frequencies (spanning from 100 hz to 14 khz). data retrieval outcomes were replicable and congruent with simulation findings, affirming the operability of the prototype apparatus. initial clinical trials encompassed measurements from both healthy and pathological skin of three male subjects of varied ages. each participant exhibited specific dermatological pathologies, as verified by a clinical evaluation executed by a dermatologist prior to data acquisition with the dermasense prototype apparatus. the first patient, aged 71, presented multiple suspicious lesions dispersed across facial regions and other cranial areas, with a singular lesion being quantifiable due to the restrictive geometric design of the prototype scanner. the subsequent patient, aged 50, presented with potential malignant lesions on the posterior aspect of his left foot sole; eis measurements were procured using the prototype apparatus upon the dermatologist’s directive. the tertiary patient, aged 63, was diagnosed with pronounced actinic keratosis on both forearms. notably, the measurement locale of this patient’s skin was especially apt, aligning with the region employed in the preliminary validation trials, facilitating a robust comparison against an expansive dataset previously gathered. remarkably, data derived from the trio of patients unveiled significant findings, particularly pertaining to the third patient (figures 3 and 4), whose measurements exhibited a pronounced deviation from the consistent pattern observed in the results of healthy participants (figure 5). http://www.globalce.org http://globalce.org http://globalce.org 71 j global clinical engineering vol.6 special issue 6: 2024 the rms voltage values of the measurements typically ranged from −1 standard deviation (std) to +1 std. however, for the third patient, the measurements deviated more significantly, spanning beyond ±2 std. additionally, the phase difference measurements were not distinct enough to draw any definitive conclusions or assumptions. discussion the newly developed dermasense system holds promise for assisting non-invasive and accurate diagnoses of various skin conditions, although it remains a work-in progress. to optimize the scanner’s functionality, forthcoming iterations will feature modular heads, engineered to conform to the topographical intricacies of skin surfaces.8 furthermore, the database will undergo augmentation to encompass a broader demographic, thereby enhancing the comprehensiveness and fidelity of the reference dataset. the integration of advanced machine learning algorithms is projected to fine-tune data categorization, thereby amplifying the system’s diagnostic precision and robustness.9,10 progressive enhancements in scanner technology, data procurement methodologies, and artificial intelligence competencies are expected to perpetually refine the dermasense apparatus, priming it for standard clinical deployment. conclusion the laboratory outcomes validate the prototype dermasense device’s performance when using stainless steel electrodes compared to adhesive ecg electrodes, as indicated by the statistical analysis. additionally, time series analyses showed minimal signal variations, implying stable data capture under changing conditions. meanwhile, the clinical findings supported the device’s figure 3. measurements taken from the left forearms of a healthy male subject aged 27 (top) and a male patient aged 63 presenting actinic keratosis (bottom). figure 4. phase differences of measurements obtained from the left forearms of a healthy male subject aged 27 (top) and a male patient aged 71 presenting actinic keratosis (bottom). http://www.globalce.org http://globalce.org http://globalce.org j global clinical engineering vol.6 special issue 6: 2024 72 effectiveness, as the impedance measurements from patients with dermatological issues significantly differed from those of healthy individuals. furthermore, dermatologists confirmed the utility of the device in assisting with diagnostic decisions, particularly in complicated cases involving various skin conditions. in light of the research presented, the dermasense system appears to be a promising support tool for traditional dermatological diagnostic methods. the third generation of this prototype device has demonstrated its capability to non-invasively and more accurately assess the electrical impedance of the epidermal layer, offering promising insights into the electrical characteristics of skin tissue. our experimental findings, both from controlled laboratory settings and real-world clinical scenarios, underscore the device's improved efficacy, especially when utilizing stainless steel electrodes. the significant deviations in impedance measurements between patients with dermatological pathologies and healthy subjects further bolster the device’s potential to enhance the specificity and accuracy of skin condition classification. moreover, the positive feedback from dermatologists accentuates the dermasense apparatus’s potential role in aiding diagnostic decisions, especially in intricate cases with multiple skin conditions. in summary, the dermasense apparatus, with its innovative use of eis, stands poised to revolutionize dermatological diagnostics, offering a cost-effective, mobile, and precise tool that could potentially expedite and enhance therapeutic interventions for a myriad of skin pathologies. future endeavors should focus on refining the device’s design for broader applicability and further validating its efficacy across a more diverse patient demographic.11 references 1. sinikumpu, s.p., jokelainen, j., haarala, a.k., et al. the high prevalence of skin diseases in adults aged 70 and older. j am geriatr soc. 2020;68(11):2565–2571. https://doi.org/10.1111/jgs.16706. 2. kelbore, a.g., owiti, p., reid, a.j., et al. pattern of skin diseases in children attending a dermatology clinic in a referral hospital in wolaita sodo, southern ethiopia. bmc dermatol. 2019;19(1):5. https://doi. org/10.1186/s12895-019-0085-5. 3. blume-peytavi, u., bagot, m., tennstedt, d., et al. dermatology today and tomorrow: from symptom control to targeted therapy. j eur acad dermatol venereol. 2019;33(s1):3–36. https://doi.org/10.1111/ jdv.15335. figure 5. measurements taken from the left forearm of a healthy male subject aged 30. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.1111/jgs.16706 https://doi.org/10.1186/s12895-019-0085-5 https://doi.org/10.1186/s12895-019-0085-5 https://doi.org/10.1111/jdv.15335 https://doi.org/10.1111/jdv.15335 73 j global clinical engineering vol.6 special issue 6: 2024 4. piccolo, v. update on dermoscopy and infectious skin diseases. dermatol pract concept. 2019;10(1):e2020003. https://doi.org/10.5826/dpc.1001a03. 5. litchman, g.h., teplitz, r.w., marson, j.w., et al. impact of electrical impedance spectroscopy on dermatologists’ number needed to biopsy metric and biopsy decisions for pigmented skin lesions. j am acad dermatol. 2021;85(4):976–979. https://doi. org/10.1016/j.jaad.2020.09.011. 6. lackermeier, a., pirke, a., mcadams, e.t., et al. nonlinearity of the skin’s ac impedance. in proceedings of 18th annual international conference of the ieee engineering in medicine and biology society; ieee xplore: 1997; pp. 1945–1946. https://doi.org/10.1109/ iembs.1996.646332. 7. kukucka, m. and krajcuskova, z. the frequency and the shape of driving signal influence in measurement of the active points. adv. electr. electron. eng. 2012;10(3):181–186. https://doi.org/10.15598/ aeee.v10i3.641. 8. han, t., kundu, s., nag, a., et al. 3d printed sensors for biomedical applications: a review. sensors (basel). 2019;19(7):1706. https://doi.org/10.3390/s19071706. 9. du-harpur, x., watt, f.m., luscombe, n.m., et al. what is ai? applications of artificial intelligence to dermatology. br j dermatol. 2020;183(3):423–430. https:// doi.org/10.1111/bjd.18880. 10. hogarty, d.t., su, j.c., phan, k., et al., artificial intelligence in dermatology—where we are and the way to the future: a review. am j clin dermatol. 2020;21(1):41–47. https://doi.org/10.1007/s40257-019-00462-6. 11. litchman, g.h., marson, j.w., svoboda, r.m., et al. integrating electrical impedance spectroscopy into clinical decisions for pigmented skin lesions improves diagnostic accuracy: a multitiered study. skin j cutan med. 2020;4(5):424–430. https://doi.org/10.25251/ skin.4.5.5. http://www.globalce.org http://globalce.org http://globalce.org https://doi.org/10.5826/dpc.1001a03 https://doi.org/10.1016/j.jaad.2020.09.011 https://doi.org/10.1016/j.jaad.2020.09.011 https://doi.org/10.1109/iembs.1996.646332 https://doi.org/10.1109/iembs.1996.646332 https://doi.org/10.15598/aeee.v10i3.641 https://doi.org/10.15598/aeee.v10i3.641 https://doi.org/10.3390/s19071706 https://doi.org/10.1111/bjd.18880 https://doi.org/10.1111/bjd.18880 https://doi.org/10.1007/s40257-019-00462-6 https://doi.org/10.25251/skin.4.5.5 https://doi.org/10.25251/skin.4.5.5 editor’s corner biomedical technology and clinical engineering in greece after the pandemic: highlighted works from the panhellenic conference of biomedical technology aris dermitzakis1,2,*, vasiliki zilidou1,3, eleftheria vellidou1,4, alkinoos athanasiou1,3 digital transformation management in health services: health professionals perceptions as an implementation factor theodoros s. tanis*, chryssoula chatzigeorgiou, ioanna simeli, and evangelia stalika validating the id-gaming e-training toolkit for people with intellectual disabilities in greece niki pandria*, anastasia barboudi, vasileia petronikolou, panagiotis antoniou and panagiotis d. bamidis novel functional electrical stimulation parameter optimization for neurorehabilitation using both conventional and ai techniques arsenios arsenidis1, alexandros moraitopoulos2, alkinoos athanasiou2, alexandros vildiridis3, panagiotis bamidis2, petros stefaneas4 and alexandros astaras5 leveraging web scraping and api integration for efficient medical device data management agapi konstantina liontou1,*, spilios zisimopoulos2 and aris dermitzakis1 human muscle state machine using electromyography classification with machine learning george lyssas1,*, konstantinos mitsopoulos1, dimitris zantzas2, anestis kalfas2, panagiotis d. bamidis1 kinematic and dynamic analysis of lower limb movement: towards the design of a wearable rehabilitation assistant device filippos margaritis1,*, konstantinos mitsopoulos1, kostas nizamis2, alkinoos athanasiou1 and panagiotis d. bamidis1 a novel dermatological diagnosis support device based on electrical impedance spectroscopy alexandros moraitopoulos1,*, konstantinos mitsopoulos1, christina kemanetzi2, panagiotis bamidis1 and alexandros astaras3 software skills identification: a multi-class classification on source code using machine learning dimitris bamidis, ilias kalouptsoglou, apostolos ampatzoglou, alexandros chatzigeorgiou* improvement of aortic valve stenosis classification in patients through computational fluid dynamics model ioannis makropoulos, dimitris zantzas, vasilis gkoutzamanis, anestis kalfas* kinematic and dynamic analysis of the human hand’s articulation for wearable soft-robotic device applications paschalina-danai sarra, vasiliki fiska, konstantinos mitsopoulos, diamanto mylopoulou, and panagiotis d. bamidis* deep learning classification of epileptic magnetoencephalogram andreas stylianou1, lefteris koumakis2, maria hadjinicolaou3, adam adamopoulos1,* and alkinoos athanasiou4 23 j global clinical engineering vol.7 issue 3: 2025 received march 12, 2025, accepted june 5, 2025, date of publication july 23, 2025. original research article implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis edgar gonzález campos*, luis antonio rosas pacheco and arturo vega gonzález departamento de ingenierías química, electrónica y biomédica, división de ciencias e ingenierías, campus león, universidad de guanajuato, león, guanajuato, méxico. * corresponding author email: edgar.gonzalez@ugto.mx abstract the integration of clinical engineering into healthcare systems is increasingly recognized as a key factor in improving regulatory compliance, equipment management, and patient safety. however, many hospitals in developing countries still lack formally established clinical engineering departments, leading to operational inefficiencies and safety risks. this longitudinal study evaluates the impact of implementing a clinical engineering department in a 10-bed secondary-level hospital between 2017 and 2021. using a mixed-methods approach, regulatory compliance was assessed through two comprehensive audits conducted before and after the department’s implementation, based on 423 standards derived from national regulations. regulatory compliance increased from 54.61% in 2017 to 78.72% in 2021. a two-sample z-test for proportions confirmed that this improvement was statistically significant (z = 7.44, p < 0.001) with a 95% confidence interval of 17.95% to 30.27%, suggesting that the change was unlikely because of random variation. although the same set of standards was evaluated in both audits, the 4-year interval and lack of item-level tracking justified the use of this approximation. an organizational analysis revealed that while the department contributed significantly to equipment oversight, process standardization, and regulatory compliance, its participation in high-level strategic decision-making remained limited. the dual role in both operational and strategic tasks posed ongoing challenges in prioritization and impact. semi-structured interviews with clinical, administrative, and technical staff supported the quantitative findings. a total of 93% of participants were aware of the department, 87% understood its functions, and 86% rated its performance as “good” or “very good”. the majority also considered it essential or considerably necessary for hospital operations. together, the quantitative and qualitative findings confirm that the creation of a clinical engineering department can significantly enhance hospital regulatory compliance, operational performance, and staff engagement with safety processes. these results provide a replicable model for healthcare institutions in similar contexts seeking to strengthen medical technology management and regulatory alignment. keywords—clinical engineering, regulatory compliance, medical equipment management, patient safety, longitudinal study, healthcare quality. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis j global clinical engineering vol.7 issue 3: 2025 24 introduction clinical engineering plays a fundamental role in the quality of hospital care, patient safety, and the optimization of both administrative and healthcare processes. its importance has grown exponentially as medical technology has become an essential component for the proper functioning of healthcare institutions.1 however, in developing countries, such as mexico, the implementation of clinical engineering departments in hospitals faces major challenges because of the absence of standardized regulations, resource limitations, and a general lack of awareness about their impact on healthcare service delivery.2 in the context of the covid-19 pandemic, the relevance of clinical engineering in mexico became more evident than ever, demonstrating its critical role in medical technology management, the maintenance of essential equipment, and the implementation of strategies to optimize hospital resources.3 the world health organization (who) has recognized that the presence of trained clinical engineers is key to ensuring effective investment in healthcare technology and achieving better patient care outcomes.4 furthermore, international studies have shown that the participation of clinical engineers in hospitals has a direct and positive impact on indicators of patient safety and efficiency of care.5 despite the growing evidence on the benefits of clinical engineering, healthcare technology management in mexico still faces structural and administrative barriers. previous research has identified that many private hospitals lack formalized clinical engineering departments, leading to inefficient management of medical devices and posing a risk to the quality of care.2 moreover, the absence of clear regulations and standardized data on the operation of these departments has hindered their effective integration into the public sector.6 this longitudinal study builds upon prior research evaluating regulatory compliance with healthcare standards,7 which analyzed compliance with mexican official standards (norma oficial mexicana, nom) in infrastructure and equipment before the implementation of a clinical engineering department in a private hospital. in 2021, these standards were reevaluated, revealing significant improvements in regulatory compliance, which translated into safer and more efficient medical care. these findings reinforce the importance of clinical engineering as an essential component for the modernization of the healthcare sector in mexico and other developing countries. recent literature confirms that regulatory frameworks, especially when aligned with accreditation programs or national standards, can significantly improve safety, process efficiency, and equipment reliability.8 studies have shown that hospital accreditation and standardized maintenance protocols not only reduce equipment downtime but also improve risk management, patient outcomes, and resource utilization.9,10 in this regard, the presence of trained clinical engineers and the implementation of comprehensive medical device management systems, grounded in national and international standards, are considered fundamental to quality assurance in modern healthcare systems.8 this paper aims to provide evidence on the need to standardize healthcare technology management and promote the establishment of clinical engineering departments in hospitals as an effective strategy to improve the quality of care and patient safety. materials and methods this longitudinal study employed a mixed-methods approach to evaluate the impact of establishing a clinical engineering department in a secondary-level hospital in a developing country, between 2017 and 2021. the hospital is a privately managed institution operating as a secondary-level facility with a capacity of 10 beds, serving a population of medium to low socioeconomic status. before 2017, the absence of a formal clinical engineering department resulted in deficiencies in medical device management and regulatory compliance. regulatory audits and compliance assessment the analysis was based on two comprehensive audits, conducted in 2017 (pre-implementation) and 2021 (post-implementation), following the guidelines of the applicable mexican official standards (noms) for hospital infrastructure and equipment (table 1). a total of 25 j global clinical engineering vol.7 issue 3: 2025 campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis 423 regulatory standards were assessed, covering key aspects of medical equipment, infrastructure, safety, and hygiene in critical hospital areas. the selection of the 423 nom items focused on infrastructure, equipment, and regulatory criteria that fall within the typical scope of clinical engineering responsibilities in hospitals. standards were drawn from six mexican official standards (noms) covering areas such as electrical safety, intensive care, emergency services, anesthesiology, and hazardous waste management. emphasis was placed on items related to the physical environment, medical devices, and safety procedures, where clinical engineering interventions are most relevant. in addition, selected regulatory aspects were included to reflect areas where the department may influence institutional regulatory compliance. on-site inspections of equipment and infrastructure were performed using checklists derived from the noms to evaluate the physical condition of devices and the adequacy of facilities. in addition, document reviews of records, logs, and service orders were conducted to assess the management and maintenance of medical devices. the first regulatory audit was conducted in september 2017, prior to the establishment of the clinical engineering department. the department was formally implemented in june 2018, and the follow-up audit was conducted in february 2021, resulting in a total observation period of 3 years and 5 months between the baseline and the post-implementation assessment. no major organizational changes occurred during the implementation of the clinical engineering department that could have influenced the audit results or staff perception. the hospital’s leadership, governance structure, and departmental management remained stable throughout the observation period, ensuring continuity in operational processes. to ensure methodological consistency across both time points, the audits conducted in 2017 and 2021 were carried out by the same evaluation team, using identical checklists and assessment procedures. the 423 regulatory standards assessed remained unchanged throughout the study period, as no modifications were introduced to the applicable national regulations. both audits followed a standardized protocol involving documentary review, on-site inspections, and structured interviews. this consistency in evaluators, instruments, and regulatory criteria minimized the potential for measurement bias and ensured a reliable longitudinal comparison. organizational analysis to complement the regulatory audits, a qualitative organizational analysis was performed to assess the impact of the clinical engineering department on hospital structure, roles, and operational processes. three key aspects were evaluated: 1. structure: the organizational hierarchy of the hospital was reviewed to determine the position and influence of the clinical engineering department in strategic and operational activities. 2. responsibilities: the roles and delegated tasks of the clinical engineering department were analyzed, focusing on its contributions to infrastructure management, regulatory compliance, and interdepartmental collaboration. table 1. list of mexican official standards (nom) used to evaluate regulatory compliance in hospital infrastructure, medical devices, and safety procedures relevant to clinical engineering. standard field of study nom-001-sede-2012 electrical installations (use). nom-016-ssa3-2012 establishes the minimum infrastructure and equipment requirements for hospitals and specialized medical consultation facilities. nom-025-ssa3-2013 for the organization and operation of intensive care units. nom-087-ecolssa1-2002 biological-infectious hazardous waste classification and handling specifications. nom-006-ssa3-2011 for the practice of anesthesiology. nom-027-ssa3-2013 establishes the criteria for operation and care in emergency services of medical facilities. campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis j global clinical engineering vol.7 issue 3: 2025 26 observation period, the clinical engineering department was composed of one full-time staff member and two interns. the sample of 15 interviewees includes all three technical staff members, two administrative staff, and a substantial portion of the clinical team. given the hospital’s small size and the deliberate inclusion of all functional roles and operational shifts, the sample is considered sufficiently diverse and representative to support meaningful qualitative insights. study design and statistical analysis the study design is illustrated in figure 1, which outlines the main stages of the investigation. the process began with an initial audit in 2017 to establish a baseline for regulatory compliance. following the implementation of the clinical engineering department, key actions included the appointment of specialized staff, the creation of internal policies, and the adoption of management systems. in 2021, a final audit was conducted to evaluate the effectiveness of these interventions. to assess the statistical significance of the observed improvements, we compared regulatory compliance rates between the 2017 and 2021 audits using a two-sample z-test for proportions. although both audits assessed the same set of 423 regulatory standards, they were conducted 4 years apart under distinct operational conditions and with separate data collection processes. given 3. processes: the study examined how hospital workflows evolved following the implementation of the clinical engineering department, specifically improvements in medical device oversight, standardization of procedures, and staff training programs. semi-structured interviews to further explore the perception of these changes, semi-structured interviews were conducted with clinical, technical, and administrative staff selected based on their involvement in hospital operations. these interviews examined staff perceptions regarding operational improvements, safety culture, and interactions with the clinical engineering department. the questions were designed to capture both individual experiences and broader perspectives on the department’s contribution to hospital efficiency and patient safety. a total of 15 hospital staff members participated in the interviews, which were conducted anonymously to promote candid responses. participants were selected from all shifts, including weekends, to ensure extensive representation. the interviewees included clinical, technical, and administrative personnel, covering a wide range of services and time blocks. based on institutional records and operational estimates, the hospital operates with a total staff of approximately 40 members, including all departments. during the figure 1. study methodology outlining the main phases of the intervention, including baseline audit, implementation of the clinical engineering department, follow-up audit, and staff perception analysis. 27 j global clinical engineering vol.7 issue 3: 2025 campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis the absence of item-level longitudinal tracking, the audits were treated as independent cross-sectional evaluations. we recognize that this method assumes independence and may slightly underestimate the standard error. a 95% confidence interval for the change in compliance proportion was also calculated. this methodology provides a model that can be replicated by other institutions facing similar challenges in medical technology management and regulatory compliance. the results offer empirical evidence on how the integration of clinical engineering contributes to enhancing hospital safety, operational efficiency, and regulatory alignment. results normative assessment in the emergency department, regulatory compliance showed significant improvement between 2017 and 2021. during the initial evaluation in 2017, compliance was at 49%, while by 2021, it increased to 91%. this improvement was achieved through targeted interventions in critical infrastructure and processes, particularly regulatory compliance with key standards such as nom-016-ssa3-2012 and nom-025-ssa3-2013. these advancements are summarized in table 2, which consolidates compliance data for the emergency department, intensive care unit (icu), and the overall hospital level between 2017 and 2021 in the case of the icu, the initial situation also presented significant deficiencies, with regulatory compliance at 39% in 2017. following the implementation of corrective actions, including infrastructure improvements and strengthened operational protocols, compliance reached 79.27% in 2021. this progress highlights the importance of prioritizing standards related to critical infrastructure, particularly nom-025-ssa3-2013. these values are included in table 3, highlighting the icu’s significant improvement alongside other key hospital areas. at the general level, the hospital’s regulatory compliance increased from 54.61% in 2017 to 78.72% in 2021, evaluating a total of 423 regulatory standards. this corresponds to an increase from 231 regulatory standards of compliance in 2017 to 333 regulatory standards of compliance in 2021, reflecting an absolute improvement of 102 items. this significant progress resulted from strategic interventions in the most critical areas, such as the emergency department and icu, as well as the implementation of corrective measures related to standards like nom-016-ssa3-2012 and nom-025-ssa3-20. the overall evolution of regulatory compliance is also reflected in table 2, providing a comparative overview of key improvements across hospital areas. furthermore, an analysis of noncompliances by type revealed that 63% of deficiencies were related to materials, table 2. summary of regulatory compliance improvement in key hospital areas between 2017 and 2021. area/level 2017 compliance (%) 2021 compliance (%) change (%) emergency department 49 91 + 42 intensive care unit (icu) 39 79 + 40 general hospital 54.61 78.72 + 24.11 note: the emergency department and icu showed the most substantial gains, with increases of 42% and 40%, respectively. the overall hospital compliance improved by 24.11%, reflecting the impact of structured interventions in infrastructure, equipment management, and process standardization. table 3. regulatory compliance with nom-016-ssa3-2012 and nom-025-ssa3-2013 in the intensive care unit. standard evaluated standards compliant noncompliant percentage nom-016ssa3-2012 59 50 9 84.75% nom-025ssa3-2013 23 15 8 65.22% total 82 65 17 79.27% note: compliance improved to 84.75% and 65.22%, respectively, following the implementation of corrective actions in infrastructure, safety protocols, and medical device oversight. the combined compliance rate for both standards reached 79.27%. campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis j global clinical engineering vol.7 issue 3: 2025 28 34% to infrastructure, and only 3% to processes. this breakdown allowed prioritization of areas with the greatest potential impact on hospital safety and operability. details of this distribution are shown in figure 2 (breakdown of noncompliances by type). a pareto analysis demonstrated that addressing deficiencies related to nom-016-ssa3-2012 and nom027-ssa3-2013 would resolve over 80% of the identified noncompliances. this highlights the criticality of these standards in achieving overall regulatory adherence and improving hospital performance. the pareto distribution is presented in figure 3. nom-016-ssa3 accounts for the highest number of noncompliances, significantly impacting overall compliance. the cumulative percentage curve indicates that addressing the top three noncompliant standards—nom016-ssa3, nom-027-ssa3, and nom-001-sede—would resolve a majority of regulatory gaps. overall, the results demonstrate how the most critical areas, such as the emergency department and icu, served as examples of the impact that implementing a clinical engineering department can have. these advancements contributed significantly to improving overall regulatory compliance and provided a roadmap that can be replicated by other institutions with similar characteristics. statistical analysis: impact of the clinical engineering department on regulatory compliance to determine whether the observed improvement in regulatory compliance was statistically significant, we conducted a two-sample z-test for proportions. this test evaluated whether the difference in compliance between 2017 (prior to the implementation of the clinical engineering department) and 2021 (following its implementation) was due to chance or represented a meaningful improvement. hypothesis formulation null hypothesis (h0): there is no significant difference in regulatory compliance between 2017 and 2021 (p1 = p2). alternative hypothesis (ha): there is a significant difference in regulatory compliance between 2017 and 2021 (p1 ≠ p2). statistical test and results using the total number of regulatory standards evaluated in both years (n1 = n2 = 423), the proportion of compliant standards was calculated: 1 2312017 : 54.61% 423 p = = (1) 2 3332021: 78.72% 423 p = = (2) figure 2. distribution of noncompliances by type in the 2017 audit. material-related issues represented 63%, infrastructure 34%, and process-related only 3%, guiding targeted corrective actions. figure 3. this chart illustrates the distribution of noncompliant standards, highlighting the most critical areas for improvement. 29 j global clinical engineering vol.7 issue 3: 2025 campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis a two-tailed z-test for proportions was performed at a 95% confidence level, yielding the following results: • z-score = 7.44 • critical value (zcritical): ± 1.96 • p-value: 8.96 × 10−14 • confidence interval (95%) for the difference in proportions: 24.11% (95% ci: 17.95% to 30.27%) since the z-score (7.44) exceeds the critical value (1.96) and the p-value is significantly lower than 0.05, we reject the null hypothesis. this indicates that the increase in regulatory compliance is statistically significant and unlikely to be because of random variation. however, although the same set of standards was assessed in both audits, the lack of item-level tracking and the 4-year interval justified the use of an approximate method based on cross-sectional comparisons. this limitation is further discussed in the discussion section. interpretation and conclusion the statistical analysis confirms that the implementation of the clinical engineering department had a measurable impact on regulatory compliance. the rate of compliance increased from 54.61% in 2017 to 78.72% in 2021, a difference of 24.11 percentage points. this change was found to be statistically significant (z = 7.44, p < 0.001), with a 95% confidence interval ranging from 17.95% to 30.27%, indicating that the observed improvement is unlikely to be because of random variation. although the same set of regulatory standards was assessed in both audits, the absence of item-level tracking and the time gap between evaluations justified the use of a cross-sectional approximation. this finding aligns with improvements observed in critical areas, such as the emergency department and the icu, further enhancing hospital regulatory performance and ensuring sustained improvement of quality. results of the organizational analysis organizational analysis was conducted through qualitative interviews with collaborators from the administration, clinical engineering, and hospital management areas. key areas of inquiry included the organizational structure, departmental responsibilities, and the impact of new processes implemented by the clinical engineering department. the investigated aspects are summarized below: investigated aspects 1. structure: reviewed current and previous organizational charts, departmental hierarchy, and participation in strategic activities such as acquisitions and decision-making. 2. responsibilities: analyzed the current and delegated responsibilities of the clinical engineering department. 3. processes: compared operational processes before and after the creation of the department, focusing on the changes implemented and interdepartmental impacts. the analysis revealed the following findings: 1. structural challenges: the hospital lacks a formally defined and approved organizational chart. the clinical engineering department operates with dual roles, contributing to strategic functions such as technology evaluation and acquisitions, while simultaneously managing operational tasks like equipment repairs and supplier management. this duality often limits the department’s ability to optimally focus on either strategic or operational tasks. 2. limited strategic participation: although the clinical engineering department is integral to specific decisions, such as technology acquisitions, its participation in high-level meetings is restricted. this limits its ability to influence broader hospital policies and initiatives. 3. process improvements: before the creation of the department, different hospital areas managed equipment needs independently, leading to inconsistent approaches. the introduction of systematic routines, such as equipment verifications and staff training sessions, has standardized processes, improving equipment safety and operational efficiency. a detailed representation of these findings is provided in table 4, which illustrates the comparative roles of the department before and after its formal establishment. campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis j global clinical engineering vol.7 issue 3: 2025 30 this analysis underscores the critical need for institutional support to address structural and strategic gaps, enabling the department to maximize its contributions to hospital operations and patient safety. results of the situational analysis the situational analysis was conducted to assess the level of knowledge and perception among hospital staff regarding the clinical engineering department. key stakeholders from administration, technical staff, and clinical personnel were included to provide a comprehensive view of the department’s relevance and performance in hospital operations. interviews were conducted anonymously with staff from all operational shifts, including weekends, to ensure a representative sample across the hospital. a total of 15 staff members, covering all technical staff, two administrative personnel, and a diverse portion of the clinical team participated. based on staffing estimates, this sample represents approximately 40–50% of the total hospital workforce. interview questions focused on staff perception of equipment management, operational efficiency, and safety culture, including prompts such as: “what changes have you noticed in equipment availability?” or “how would you rate the department’s support in your daily work?” awareness and understanding most respondents (93%) were aware of the department’s existence, and 87% understood its core functions. these results highlight a generally high level of visibility, though the gap between awareness and understanding suggests a potential opportunity to strengthen internal communication. perceived contribution and necessity participants broadly recognized the department’s value, with 84% rating its contribution to workplace safety as “significant” or “considerable”. furthermore, 80% considered the clinical engineering department to be “significantly” or “considerably” necessary for hospital operations (figure 4). table 4. comparison of the clinical engineering department’s role before (2017) and after (2021) its formal implementation. point of analysis before implementation (2017) after implementation (2021) structure no defined or authorized organizational chart. previous charts were unavailable, and the department lacked a clear position within the hospital. its participation in strategic decisions was limited. the clinical engineering department now has a mixed hierarchy, combining strategic and operational levels. it participates in technology evaluations and acquisitions, although its presence in management meetings remains limited. responsibilities no formal assignment of responsibilities. decisions regarding medical equipment were made in a dispersed manner across different areas without a defined responsible party. the clinical engineering department now plays a key role in medical equipment management and contributes knowledge in infrastructure and regulations. it collaborates with other areas such as quality, administration, and it. processes corrective maintenance was handled by various areas without a designated responsible party. there were no structured verification routines or training plans for the use of medical devices. the clinical engineering department now supervises maintenance, provides medical equipment training, and ensures regulatory compliance, consolidating more structured and efficient processes. note: key improvements include a defined organizational structure, clearer responsibilities, and more structured processes for the management of medical equipment and regulatory compliance. 31 j global clinical engineering vol.7 issue 3: 2025 campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis a total of 80% of respondents considered the department to be “significantly” (60%) or “considerably” (20%) necessary for the hospital’s functioning, while only 7% selected “moderate” and 13% “little”. these results highlight the strategic value attributed to the department by the hospital staff. staff satisfaction satisfaction with the performance of the department was high: 86% rated it as “very good” or “good”, while only 14% rated it as “fair” or “poor”. this overall positive perception reinforces the credibility of the department within the institution, though there is room for improvement in specific areas such as clinical training on equipment use. summary of results the full set of response distributions is summarized in table 5, showing detailed percentages across each topic assessed. figure 4. perceived necessity of the clinical engineering department for hospital operations. discussion this methodology provides a model that can be replicated by other institutions facing similar challenges in medical technology management and regulatory compliance. the results offer empirical evidence on how the integration of clinical engineering contributes to enhancing hospital safety, operational efficiency, and regulatory alignment. the findings of this study provide clear evidence of the positive impact that the implementation of a clinical engineering department has on regulatory compliance, operational efficiency, and staff perception in a secondary-level hospital in mexico. the increase in regulatory compliance from 54.61% in 2017 to 78.72% in 2021 is a direct result of structured processes in medical technology management, infrastructure audits, and staff training. the improvement in adherence to mexican official standards (noms) is one of the key outcomes of this study. table 5. summary of staff perceptions regarding the clinical engineering department. topic response options result (%) awareness of ce department existence yes/no 93% | 7% awareness of ce department functions yes/no 87% | 13% contribution to workplace safety significant/ considerable/ moderate/ low 50% | 34% | 8% | 8% necessity for hospital operations significant/ considerable/ moderate/ low 60% | 20% | 7% | 13% evaluation of ce staff performance very good/good/ fair/poor 46% | 40% | 7% | 7% note: the table presents the response distributions for key dimensions evaluated in the situational analysis, including awareness, perceived contribution, institutional necessity, and performance evaluation. percentages reflect the proportion of respondents selecting each option in a sample representing approximately 40–50% of the hospital workforce. campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis j global clinical engineering vol.7 issue 3: 2025 32 necessary. this level of recognition suggests that the work of the department has generated a tangible impact on organizational culture and the perception of hospital safety. however, the results also revealed areas for improvement. fourteen percent of respondents perceived the department’s performance as “fair” or “poor”, suggesting that certain aspects, particularly in training and communication with clinical and administrative staff, require further optimization. although the findings are encouraging, the applicability of this model to other types of healthcare institutions requires further consideration. while the results of this study are promising, they must be interpreted within the context of a small, secondary-level hospital with a capacity of 10 beds. the operational dynamics, staffing patterns, and regulatory oversight in such a facility differ significantly from those in larger hospitals with higher patient volume, broader departmental structures, and more complex governance systems. however, the structured methodology used for implementing the clinical engineering department—focusing on regulatory alignment, equipment management, and process standardization—offers a foundation that can be replicated and adapted to institutions of greater scale. future multisite studies, particularly those involving tertiary care hospitals and diverse healthcare systems, would provide valuable comparative data to validate and refine the model presented in this study. it is also important to consider the broader healthcare context in which this study was conducted. between 2019 and 2021, the covid-19 pandemic introduced unprecedented changes in hospital operations, resource allocation, and regulatory enforcement. these changes may have influenced the results observed in the postimplementation audit, particularly in critical departments such as the icu and emergency room, which were directly impacted by the pandemic. while the observed improvement in regulatory compliance can largely be attributed to the establishment of the clinical engineering department, it is possible that heightened regulatory scrutiny, emergency preparedness protocols, and resource mobilization related to covid-19 contributed in part to this progress. however, the absence of a parallel audit in a comparable the application of critical standards such as nom-016ssa3-2012 and nom-025-ssa3-2013 has been fundamental in strengthening hospital safety. a deeper analysis of noncompliance issues showed that 63% of deficiencies were related to materials, 34% to infrastructure, and only 3% to processes, indicating that most problems can be addressed through investments in equipment and structural maintenance. the observed improvement in regulatory compliance reflects a meaningful institutional change following the implementation of the clinical engineering department. while statistical analysis supports this interpretation, the absence of item-level tracking and the 4-year gap between assessments required treating both audits as independent observations. this approach, though limited, was methodologically justified as a cross-sectional approximation. a pareto analysis further demonstrated that addressing deficiencies in just three key standards (nom-016-ssa3, nom-027-ssa3, and nom-001-sede) would resolve over 80% of the identified regulatory compliance issues, highlighting the importance of a strategic approach in prioritizing regulatory efforts. beyond regulatory compliance, the creation of the clinical engineering department has driven significant organizational changes. the standardization of procedures and the introduction of periodic equipment verifications have strengthened patient safety and operational efficiency. however, structural challenges remain, particularly regarding the department’s integration into high-level hospital decision-making. despite its critical role in medical technology management, the clinical engineering department continues to operate under a hybrid model, balancing both operational and strategic responsibilities. this dual role may limit its ability to influence high-level decisions and maximize its potential impact on the quality of hospital service. the semi-structured interviews reflect a high level of acceptance and recognition of the department among hospital staff. a total of 93% of respondents acknowledged the department’s existence, 87% understood its functions, while 84% considered it essential or significantly 33 j global clinical engineering vol.7 issue 3: 2025 campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis 2017 to 78.72% in 2021 demonstrates the effectiveness of structured interventions in medical technology management, infrastructure standardization, and staff training. these findings reinforce the effectiveness of the intervention and its direct impact on regulatory performance. although both audits assessed the same set of standards, they were conducted under different operational conditions and without item-level tracking, warranting the use of a cross-sectional approach. future studies should apply paired-data statistical methods—such as mcnemar’s test—supported by longitudinal tracking, to strengthen the attribution of observed improvements. beyond compliance metrics, the study highlights the positive impact of the department on hospital workflows and organizational structure. the standardization of medical equipment management and verification processes contributed to a safer and more efficient hospital environment. however, despite these improvements, the department’s limited participation in strategic decisionmaking remains a challenge that could hinder its longterm effectiveness. staff perception of the clinical engineering department was overwhelmingly positive, with 93% of the hospital personnel acknowledging its role and 86% rating its performance as “good” or “very good”. however, the study also identified areas for further optimization, particularly in training programs and internal communication strategies to ensure a deeper understanding of the functions and contributions of the department. the findings suggest that the successful integration of clinical engineering into hospital systems can serve as a model that can be replicated by other healthcare institutions facing similar challenges in regulatory compliance and medical equipment management. however, for long-term sustainability, hospitals must ensure institutional support, continuous staff training, and periodic evaluations to maintain compliance and drive continuous improvement. although this study presents a compelling case for the role of clinical engineering in hospital optimization, it is not without limitations. the research was conducted in a single hospital, which may limit the generalizability of hospital without a clinical engineering department limits the ability to isolate these external influences. future studies incorporating multicenter comparisons could help clarify the independent effect of clinical engineering interventions under varying external conditions. despite these positive results, this study has certain limitations. the analysis was conducted in a single secondary-level hospital, which may limit the generalization of the findings to other healthcare settings. in addition, although the same 423 standards were evaluated in both audits, they were assessed independently without itemlevel tracking. this limits the ability to apply paired-data statistical tests such as mcnemar’s test, which could have provided a more precise estimation of the intervention’s effect. future research should consider structured itemby-item longitudinal tracking to enable the use of paired analyses and strengthen the causal attribution of observed improvements. furthermore, while the study included both quantitative and qualitative methods, future research could benefit from a longer follow-up period to assess the sustainability of the implemented improvements. the implementation of a clinical engineering department has proven to be an effective strategy for enhancing regulatory compliance, optimizing processes, and strengthening hospital safety. the statistical validation and confidence interval analysis confirm that the impact of the intervention is both meaningful and statistically significant. to maximize its long-term contribution, it is essential to promote the department’s integration into hospital governance and ensure its consolidation as a strategic actor within the organizational structure. this study provides a transferable model that may inform future initiatives aimed at strengthening healthcare systems in mexico and other developing regions. conclusions this study provides strong empirical evidence that the implementation of a clinical engineering department in a secondary-level hospital in mexico significantly improves regulatory compliance, operational efficiency, and staff perception of hospital safety. the increase in compliance with mexican official standards (noms) from 54.61% in campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis j global clinical engineering vol.7 issue 3: 2025 34 conflicts of interest the authors declare no conflicts of interest related to this study. ethics approval and consent to participate this study did not involve human subjects, animals, or identifiable personal data. ethical approval was not required. consent for publication not applicable. further disclosure not applicable. references 1. judd, t. and david, y. the growing role of clinical engineering: merging technology at the point of care. glob clin eng j. 2022;5(1):29–32. https://doi.org/10.31354/globalce. v5i1.146. 2. fernández avilés, l.e. decodifying healthcare technology management (htm) in mexican private hospitals. ifmbe proceedings. 2017. 3. bello, m. covid-19 highlights importance of biomedical engineers. mexico business news 2020. available online: https://mexicobusiness.news/health/news/ covid-19-highlights-importance-biomedical-engineers. 4. world health organization. human resources for medical devices, the role of biomedical engineers (who medical device technical series). geneva: who; 2017. available online: https://www.who.int/publications/i/item/9789241565479. 5. david, y. and judd, t. evidence-based impact by clinical engineers on global patient outcomes. health technol. 2020;10:517–35. https://doi.org/10.1007/s12553-019-00345-0. 6. ayala, r. and orencio, e. identification of health technology management departments in mexico’s state health services. glob clin eng j. 2019;2:17–21. https://doi.org/10.31354/ globalce.v1i2.51. its findings. in addition, the lack of paired data prevents the use of more precise statistical methods that account for dependency across time points. future research could benefit from broader sampling, item-level tracking, and longer follow-up periods to further validate and expand upon these results. in conclusion, the integration of a clinical engineering department significantly enhances hospital compliance, operational processes, and safety perceptions. to fully capitalize on its benefits, hospital administrations must ensure strategic inclusion of clinical engineers in decisionmaking processes, adequate resource allocation, and long-term institutional commitment. these measures will be crucial for consolidating the department’s role as a fundamental pillar in hospital quality and patient safety in mexico and beyond. author contributions conceptualization, g.c.e. and r.p.l.a.; methodology, g.c.e.; validation, g.c.e., r.p.l.a., and v.g.a.; formal analysis, g.c.e.; investigation, g.c.e. and r.p.l.a.; resources, v.g.a.; data curation, g.c.e.; writing – original draft preparation, g.c.e.; writing – review & editing, r.p.l.a. and v.g.a.; visualization, r.p.l.a.; supervision, g.c.e.; project administration, g.c.e. acknowledgments the authors would like to thank engineer daniela castro for her invaluable support during the execution of this study. funding this research received no external funding. data availability statement because of ethical and institutional restrictions, the datasets generated during this study are not publicly available. https://doi.org/10.31354/globalce.v5i1.146 https://doi.org/10.31354/globalce.v5i1.146 https://mexicobusiness.news/health/news/covid-19-highlights-importance-biomedical-engineers https://mexicobusiness.news/health/news/covid-19-highlights-importance-biomedical-engineers https://www.who.int/publications/i/item/9789241565479 https://doi.org/10.1007/s12553-019-00345-0 https://doi.org/10.31354/globalce.v1i2.51 https://doi.org/10.31354/globalce.v1i2.51 35 j global clinical engineering vol.7 issue 3: 2025 campos, pacheco, gonzález : implementing clinical engineering departments in a small hospital: a 2017–2021 regulatory compliance and organizational analysis 7. cabrera jaramillo, l., rosas pacheco, l.a., gonzález campos, e., et al. “evaluación normativa de equipamiento e infraestructura en hospitales en la ciudad de león, méxico: estudio de caso,” presented at the iv congreso internacional de ingeniería clínica, medellín, col., 2019. available online: https://www.researchgate.net/publication/339541172_evaluacion_normativa_de_equipamiento_e_infraestructura_en_ hospitales_en_la_ciudad_de_leon_mexico_estudio_de_caso. 8. arab-zozani, m., imani, a., doshmangir, l., et al. assessment of medical equipment maintenance management: proposed checklist using iranian experience. biomed eng online. 2021;20(1):49. https://doi.org/10.1186/ s12938-021-00885-5. 9. abdurabuh, a., hamid, m.d., che hassan, c.r., et al. evaluating the impact of hospital accreditation on patient safety culture in saudi arabia healthcare facilities. j multidiscip healthc. 2024;17:5021–5033. https://doi.org/10.2147/ jmdh.s480496. 10. hussein, m., pavlova, m., ghalwash, m., et al. the impact of hospital accreditation on the quality of healthcare: a systematic literature review. bmc health serv res. 2021;21(1):1057. https://doi.org/10.1186/s12913-021-07097-6. https://www.researchgate.net/publication/339541172_evaluacion_normativa_de_equipamiento_e_infraestructura_en_hospitales_en_la_ciudad_de_leon_mexico_estudio_de_caso https://www.researchgate.net/publication/339541172_evaluacion_normativa_de_equipamiento_e_infraestructura_en_hospitales_en_la_ciudad_de_leon_mexico_estudio_de_caso https://www.researchgate.net/publication/339541172_evaluacion_normativa_de_equipamiento_e_infraestructura_en_hospitales_en_la_ciudad_de_leon_mexico_estudio_de_caso https://doi.org/10.1186/s12938-021-00885-5 https://doi.org/10.1186/s12938-021-00885-5 https://doi.org/10.2147/jmdh.s480496 https://doi.org/10.2147/jmdh.s480496 https://doi.org/10.1186/s12913-021-07097-6 47 j global clinical engineering vol.7 issue 3: 2025 received april 23, 2024, accepted june 2, 2025, date of publication september 10, 2025. review catchment of the test license for the regulation of medical devices in india rupak kumar*, deepak k. gupta, jyoti batra, aarti sahu and suchita markan indian council of medical research (icmr), new delhi, india. * corresponding author email: rupakraman@gmail.com abstract the medical device industry in india is gaining momentum and is expected to grow rapidly. given the significant impact of medical devices (md) on patient health, a robust regulatory framework that combines policies, laws, regulations, and approvals is necessary to ensure adherence to standards before market entry. to initiate regulatory approval, test license is the preliminary step. it is required to manufacture or import materials in small quantities for specified purposes; for example, testing, training, examination, evaluation, demonstration, and clinical investigation under india’s medical devices rules (mdr) 2017. in general, as the associated risk of the device increases, the testing or evaluation parameters required to establish its safety and efficacy also increases. in this regard, test license is introduced so that manufacturers or importers must navigate to ensure compliance for the generation of data, particularly in the context of quality aspects of a md or in vitro diagnostics (ivd), such as its design verification and validation, material of construction, testing, functionality, durability, sterility, biocompatibility, electrical safety, usability, and many more. therefore, the present paper deals with the basic requirement and the details of the requisite documents for the grant of test license for the aforementioned purposes. it also aims to address the challenges so as to reduce the time-lapsed, effort, and financial burden to the applicant. keywords—medical device, in vitro diagnostics, test license, medical device rules, testing, evaluation. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:rupakraman@gmail.com mailto:mulugetamideksa@gmail.com mailto:mulugetamideksa@gmail.com mailto:mulugetamideksa@gmail.com https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india j global clinical engineering vol.7 issue 3: 2025 48 introduction the medical device sector in india is the fourth largest medical devices (md) market in asia after japan, china, and south korea, and is among the top twenty globally because of its growth potential driven by the country’s increasing healthcare demands, technological advancement, innovations, and government support through various initiatives or incentive opportunities.1 as md have a significant potential for hazards, it should be ensured that they are safe and effective before being marketed. thus, govt. of india (goi), ministry of health and family welfare’s central drugs standard control organization (cdsco) headed by the drug controller general of india (dcgi), who is the central licensing authority (cla), has notified medical devices rules (mdr), 2017, vide gsr 78(e), dated 31st january 2017, effective from 1st january, 2018, and its amendment came into effect as medical devices (amendment) rules, 2020 vide gsr 777(e) dated 14th october, 2022, effective from 14th october, 2022, to have specific requirements for md that have been framed in conformity with the global harmonization task force (ghtf) framework in order to align with the best international practices wherein the requirements for import, manufacture, clinical investigation/performance, sale and distribution of md including in vitro diagnostics (ivd) have been prescribed.2 as india recently joined the international medical device regulators forum (imdrf) on 3rd october, 2024, as an affiliate member to accelerate global collaboration, harmonization, and convergence in medical device regulations, the importance of test license significantly helps to protect public health.3 at present, 38 categories of md have been notified and regulated; the current regulatory practices in india are fully geared to meet the requirements to introduce in the country.4 the present study provides a critical explanation and significance of the regulatory framework’s initiation, that is, commencement of test license governing md, aiming to annotate how such pivotal approvals have shaped the current regulatory landscape and influenced the md industry in india. it is mandatory that, an applicant shall apply for test license for manufacturing or importing a small quantity of md/ivd (in case of both availability and unavailability of predicate device in india) to manufacture/ import three consecutive test batches accompanied with a fee, as specified in the second schedule of mdr-2017 having a validity of three years. a predicate device is an approved md (manufacture/import) that may be legally marketed in the country of origin or globally and used as a point of comparison for new ivd/investigational md seeking approval through cdsco. an applicant can choose the right predicate device that is similar/ subsequent equivalence to the subject device with regard to indications for use (disease treatment/screening/diagnosis/ management), material of construction (moc), design and technological characteristics/underlying principle, and types of specimen. any remarkable change in the said features that does not come under the predicate device are supposed to be investigational md/new ivd. moreover, if no such predicate device is available in india against the proposed device, meaning that it comes under the scope of investigational md or new ivd, the applicant must also initiate the regulatory approval by applying for test license. initiation of test license a test license is required to ensure that md/ivd is safe, effective, and meets quality standards before they are sold or used. test license is a type of approval from cla that allows an applicant (person/firm/organization/ startup/innovator/institute/sole proprietor/limited liability partnership/others) as manufacturer or importer for all risk-based classification to make or import a test device or ivd in a small quantity (figures 1a and 1b) on the digital platform—a government initiative of national single window system (nsws) for any of the following conditions in form md-12 (for manufacture) or form md-16 (for import).5 • proof of concept is validated with working prototype, and the design is finalized. • md/ivd should be already approved (either manufacture/imported) in india. • investigational md/new ivd in case no such approved devices are available in india. • for all risk-based classification of md/ivd (except risk-based class a—non sterile and non measuring). 49 j global clinical engineering vol.7 issue 3: 2025 kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india • before conducting any preclinical/clinical studies, it is mandatory to obtain the approval for test license. all data obtained prior to granting of test license is not considered for regulatory approval of md/ivd. the specific process for obtaining a test license for the proposed md/ivd in india involves several steps, as outlined in figure 1c (for manufacture in form md-12) and figure 1d (for import in form md-16). purpose of test license test license is granted (form md-13) in order to manufacture and import small quantities of md or ivd (either earlier approved/investigational medical device/ new ivd) for any of the following purposes at a time: testing, evaluation, clinical investigation, examination, demonstration, and training. the purpose of applying for the test license should be very specific in nature, as only one option of purpose is available while filling the form md-12 on the nsws portal. in addition, when a particular purpose of applying the test license is changed, a fresh application must be submitted. a brief illustration of a specific purpose for the grant of test license is given below. demonstration the proposed device (either earlier approved/investigational/new) is manufactured or imported for the purpose of showcasing the said device at a national or international platform/forum. training the proposed device (either earlier approved/investigational/new) is manufactured or imported for the purpose of training for process/method or learning any skills on the said device. examination the proposed device (either earlier approved/investigational/new) is manufactured or imported for the purpose of conducting an examination to understand the technology, familiarity, or proficiency on the said device. figure 1. (a) an overview to apply for a test license for the manufacture or import of md/ivd. (b) a process flow to grant a test license. serial numbers 1 to 4 indicate the prerequisites to apply for test license, and serial numbers 5 to 9 mention the respective steps to grant approval for test license. (c) the process of obtaining manufacture test license (form md-12) in india. (d) the process of obtaining import test license (form md-16) in india. kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india j global clinical engineering vol.7 issue 3: 2025 50 the validity of the finding). analytical performance of an ivd is the ability to measure or detect a specific analyte accurately and reliably. these studies demonstrate the analytical performance of an ivd that includes device specification, accuracy, precision, linearity, detection limit, quantitation limit, cross reactivity, specificity, sensitivity, either qualitative or quantitative, and range. however, clinical performance is the output of a device to yield results that are correlated with a particular clinical condition based on sample size, diagnostic sensitivity, diagnostic accuracy, diagnostic specificity, ppv, npv, likelihood ratio, and expected values in normal and affected populations.8 performance evaluation reports (per), which are essential technical documents for the regulatory approval of the subject ivd, include clinical performance reports as a key component. clinical investigation/clinical performance evaluation clinical trials using md are referred as clinical investigations. the purpose of a clinical investigation is to answer important scientific questions. it must follow strict scientific standards (iso-international organization for standardization 14155:2020—clinical investigation of md for human subjects), which can protect patients and produce reliable scientific outcomes. one of the purposes of a clinical investigation could be to establish and verify clinical safety, meaning to understand how testing in general, medical device testing is the process of demonstrating that the device will reliably perform safely in use. it is used if the proposed device (either approved/ investigational/new) is manufactured or imported for the purpose of assessing various quality aspects of a device, such as its design verification and validation, material testing, mechanical test, reliability test, functionality, durability, sterility, stability, biocompatibility (iso-international organization for standardization 10993 standard for evaluating the biocompatibility of md), electrical safety and usability, ex vivo (animal performance study), and software verification and validation (for any software components). evaluation/performance evaluation predominantly, it is the theoretical assessment of evaluating the safety, effectiveness, and performance of md that should start even before the product is marketed. if the proposed device (whether approved, investigational, or new) is manufactured or imported for the said purpose that include physical (mechanical, electrical), analytical (sensitivity, specificity, toxicity, stability, linearity, limit of detection, positive predictive value-ppv, negative predictive value-npv), biological (biocompatibility) and other parameters (sometimes, clinical samples/left over samples are also used) assessment to evaluate its functions as intended use and doesn’t provide any faulty information. particularly, performance evaluation is carried out specifically for ivd, irrespective of either new or earlier approved devices at cdsco designated lab under subrule (1) of rule 19 of mdr-2017/ national accreditation board for testing and calibration laboratories (nabl) accredited lab/govt. lab/in-house lab (in case of unavailability of these labs with prior approval from cdsco).6 it mainly covers three major parameters, namely, scientific validity, analytical performance, and clinical performance (figure 2).7 scientific validity covers the degree to which a study or test accurately measures what it is intended to measure in a broader population. it is achieved by defining research objectives (to accomplish), choosing appropriate methods (to collect and analyze data), using rigorous methods (to apply strict techniques to ensure the data are accurate), and evaluating the results (to assess figure 2. performance evaluation of the ivd with three major parameters. 51 j global clinical engineering vol.7 issue 3: 2025 kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india to prevent and reduce risks, errors, and harm that may happen to patients/end users. furthermore, the purpose of a clinical investigation is to establish and verify the performance of a device in human subjects. broadly, it focuses on good clinical practice (gcp) for the design, conduct, recording, and reporting of the adverse events of clinical investigations carried out on human subjects to assess the clinical effectiveness and safety of md as per the seventh schedule of mdr-2017. this means checking the ability (or capability) of a device to perform as per intended use until the specified period/duration. it needs to be verified whether it enables the manufacturer to achieve the intended purpose of the device leading to clinical benefits for patients.9 moreover, evaluation of clinical performance is the systematic study that can be used to diagnose and treat diseases in vitro. broadly speaking, it is the assessment of an ivd using a specimen taken from humans to evaluate its performance when used as intended by the manufacturer. ivds are designed to extract information from human samples, such as blood, tissues, and biological fluids that can allow for drawing of conclusions, such as physiological or pathological changes in the body. clinical performance evaluations may include: • testing for sensitivity, specificity, accuracy, precision, and clinical validity. • using clinical performance evaluation plan in human specimens. • analyzing and summarizing clinical data. • demonstrating scientific validity. • demonstrating analytical performance. for applying for a test license (manufacturer) for clinical investigation of md, a copy of the grant of permission is to be provided (in form md-23, whether it is for pilot/ pivotal/post-marketing clinical study). conditional approval of test license may be granted in absentia of form md-23. however, for permission to conduct clinical investigation for an earlier approved medical device, valid approval from the ethics committee is required (table 1). on the other hand, for applying for a test license (manufacturer) for the evaluation of the clinical performance of a new ivd, a copy of the grant of permission is required (in form md-25). conditional approval of test license may be granted in absentia of form md-25 with prior submission of the clinical investigation plan and approval from the institutional ethics committee (iec). however, for permission to conduct evaluation of clinical performance of an earlier approved ivd, valid approval from the ethics committee is required (table 2). in addition, if a certain medical device/ivd is imported for the purpose of clinical investigation/clinical performance evaluation from the usa, britain, the united kingdom, japan, the european union, australia, and canada (with a condition that the product has already been marketed for at least 2 years in these territories, and the cla is satisfied with the data of safety, performance, and pharmacovigilance of the said device), the requirement to apply for test license to conduct clinical investigation/evaluation of clinical performance is waived off. however, if medical device/ivd is approved and marketed in places other than these territories, proof of grant of permission to conduct clinical investigation/evaluation of clinical performance (form md-23/ form md-25) is required in accordance with the test license (table 1). consequent attributes after test license once test license has been granted for any of the aforesaid purposes, the applicant may prepare/import at least three test batches of the said device in statistically significant quantities at the manufacturing site (in-house) to generate quality control (qc) data that comply with the essential principles of safety and performance of the proposed device. in addition, these data should also be generated at the testing site that may be comparable enough with the in-house data. however, in the case of manufacture/import of ivd, per that would be generated at designated labs (specific for a particular ivd) should be compared with the in-house data generated. these data are further used in the next regulatory application in order to get the final approval of the device/ivd for sale and distribution in the market. kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india j global clinical engineering vol.7 issue 3: 2025 52 moreover, it has been noticed that at the time of applying for the test license, it is not mandatory that the manufacturing site should comply with the quality management system (qms) as per the fifth schedule of mdr-2017 and the subject device should adhere with applicable bureau of indian standards (bis)/iso/international electrotechnical commission (iec)/pharmacopeial standards). but, while applying for the commercial manufacturing license, the manufacturing facility must comply with qms or have iso 13485, which may be audited later by the concern notified body (in the case of risk-based class of a and b by the state licensing authority) or by a medical device officer (in the case of risk-based class of c and d by the cla), and the proposed device must follow the respective standards. all the data obtained prior to granting of the test license is not to be considered for regulatory approval of medical device/ivd (figures 3 and 4). in this regard, it is advisable that the innovator may refer to the regulatory pathway for md/ivd given on the cdsco website.10 document underlying for applying the test license there are a certain set of documents for applying for test license against the proposed device/ivd as per form mdr-2017.2 a brief overview of each document is herewith discussed and summarized in table 2. 1. covering letter mentioning the objective of the test license specifically details the purpose, intended use, justification of quantity, and regulatory status (i.e., availability of predicate device in india and approval status in other countries), and detail of manufacturing and testing/ evaluation site. 2. brief description of applied md/ivd including intended use, material of construction (moc, design, label, specimen used for testing (human/animal), type of specimen (blood, serum, plasma, etc.). if a predicate device is available, the applicant needs to submit the substantial equivalence evaluation along with relevant published literature, that is, comparative analysis to prove substantial equivalence to the predicate device(s) as claimed with respect to intended use, moc, design characteristics, mechanism, principal of operation, etc. table 1. requirement for the application of test license with the purpose of clinical investigation/evaluation of clinical performance. objective test license for md/ivd manufacture investigational md/new ivd proof of grant of permission to conduct clinical investigation/evaluation of clinical performance (form md-23 for md), (form md-25 for ivd). earlier approved in india ethics committee (ec) approval import investigational md/new ivd in the country of origin • waive off if: • medical device imported from the united states, britain, the united kingdom, japan, the european union, australia, and canada. • already marketed for at least 2 years in these territories. • cla is satisfied with the data of safety, performance, and pharmacovigilance of the said device*,2 however, if medical device/ivd is approved and marketed in places other than these countries, proof of grant of permission to conduct clinical investigation/ evaluation of clinical performance (form md-23 for md), (form md-25 for ivd) is required. earlier approved in the country of origin md: medical device, ivd: in vitro diagnostics. *subject to approval from the cla. 53 j global clinical engineering vol.7 issue 3: 2025 kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india figure 3. road map to apply test license (form md-12) for md with the purpose of testing. figure 4. road map to apply test license (form md-12) for ivd with the purpose of evaluation/performance evaluation. kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india j global clinical engineering vol.7 issue 3: 2025 54 3. undertaking stating that the required facilities including equipment, instruments, and personnel have been provided to manufacture such md/ivd on the letterhead with a stamp and signed. however, in the case of import of md/ivd in small quantities, 2 undertakings are required, namely: • an undertaking stating that the md/ivd proposed to be imported is to be used exclusively for the specified purpose and not for commercial purpose. • an undertaking stating that required facilities including equipment, instrument, and personnel will be provided to test or evaluate the medical device. 4. list of equipment, instruments for manufacturing and testing/evaluation of applied md/ivd (not applicable for the import of md/ivd). 5. list of qualified personnel for manufacturing and testing of applied md/ivd in tabular form under whose direction and supervision the test batches’ manufacturing activity, testing, and evaluation of a medical device shall be undertaken (not applicable for the import of md/ivd) 6. justification of quantity proposed to be manufactured along with its utilization breakup mentioning testing parameters with quantity required for the applied quantity, mentioning both internal and external evaluations (if applicable). moreover, the same implies for ivd with quantity required for evaluating at both internal and external evaluation sites (if applicable). however, in the case of import of md/ivd in small quantities, the applicant can give the proper justification of the quantity proposed to be imported with its utilization breakup. 7. test specification and protocol along with applicable standards that provide the testing protocol or any other protocol specific to the device/ivd. approved clinical study protocol or approval copy of form md-23 or form md-25 will be required if the selected purpose of applying for the test license is for clinical investigation or evaluation of clinical performance. it is also applicable for the import of md/ivd in small quantities. 8. brief description of the manufacturing and testing process and flowchart that includes each process step of manufacturing of the subject device/ivd. 9. copy of the manufacturing license of the premises where the development/testing activity is to be carried out, under these rules, if any. it is applicable only to existing manufacturers who have been previously issued a license; otherwise, this does not apply. please upload a declaration confirming this. 10. approval letter authorizing to undertake research and development activities issued by a government organization, if any. any approval from agencies funding research internally or externally 11. other documents, if any. it may include publication/ research paper in support of intended claims, design, principal of operation, moc, etc. 12. fee challan that will be paid online via the bharat kosh portal (https://bharatkosh.gov.in/) directed through the nsws portal. the fee amount is subjective and is calculated automatically by the system based on the device applied (as per second schedule of mdr-2017). it is advisable not to pay the respective amount directly through the bharat kosh portal. 13. legal form. it is a system-generated filled form of md-12 application that should be submitted after being digitally signed with the digital signature certificate (dsc) of an authorized signatory. in addition, the following documents are used exclusively for the import of md/ivd in small quantities: • quality certificates like qms, etc., of the manufacturer, if any. manufacturing site should comply with qms as per the fifth schedule of mdr-2017 or iso 13485. • labels and instructions for use (ifu), as per rule 44 of mdr-2017. labelling of md needs particulars such as name of the medical device; the details necessary for the user to identify the device and its use; the name of the manufacturer and the address of the manufacturing premises; the correct statement about the net quantity in terms of weight, measure, volume, number of units, as the case may be; and the number of the devices contained in the package expressed in the metric system; the month and year of manufacture and expiry (the label may indicate the product's shelf life. for sterile devices composed of stable materials such as stainless steel or 55 j global clinical engineering vol.7 issue 3: 2025 kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india titanium, and supplied non-sterile, the date of sterilization may be treated as the manufacturing date. in the case of medical equipment, instruments, or apparatus, it may not be necessary to specify an expiry date) on the shelf pack of the md or on the outer cover of the md that shall be printed in indelible ink on the label, whereas the intended use of a medical device is clearly communicated in the ifu. the ifu (or electronic ifu) is a set of instructions that are legally required for md to be sold and are intended to ensure the safe and effective use of the device. it should include: • intended use: the specific intended use of the device. • precautions: any precautions or warnings that should be considered while using the device. • preparation: how to prepare the device for use, such as sterilization, assembly, or calibration. • disposal: how to dispose of the device. • other information: the name of the device, manufacturer’s address, shelf-life, storage requirements, and technical specifications. in cases where certain requisite documents are not applicable to a particular device or ivd, the applicant must provide a proper justification and upload the same on the portal. exclusion of the test license a test license is not required to apply for all md in india, but it depends on the risk-based class of device, usability, and the purpose in certain conditions as follows: manufacture/import of class a nonsterile and nonmeasuring device consequent to the implementation of the notification g.s.r. 102 (e) dated 11th feb, 2020, all md are under the licensing regime (except for class a—non-sterile and non-measuring md), and license is required for the import/manufacture of md in the country.11 these devices such as scalpels, scissors, walking sticks, eyeglasses, and wheelchairs do not require a license, but they do need to be registered on “online system for medical devices” established by cdsco for this purpose.12 the registration number obtained shall not be considered as a regulatory approval for the manufacture/import of devices. import of md/ivd from the founding member countries of the ghtf clinical investigation will be waived off for the subject device if it is imported from the united states, britain, the united kingdom, japan, the european union, australia, and canada and remains marketed for at least 2 years in these territories (table 1). in addition, the cla is satisfied with the data of safety, performance and pharmacovigilance of the said device as per rule 63 of mdr-2017.2 however, it is subject to approval from the cdsco on a case basis. imported for personal use test license is not required for the import of small quantities of md/ivd for personal use (by a person or by a government hospital or statutory medical institution for the treatment of a patient), which is otherwise prohibited under section 10 of the act. md/ivd may be imported for personal use subject to prior approval in form md-20 as per rule 43 of mdr-2017 accompanied by requisite documents and the fee as specified in the second schedule of mdr-2017 on the cited portal.12 on the other hand, small quantities of an investigational medical device, the import of which is not allowed, but approved in the country of origin, may be allowed to be imported by the cla for the treatment of a patient suffering from a life-threatening disease, or disease causing serious permanent disability, or disease requiring therapy for an unmet medical need, on an application made by a medical officer through the medical superintendent of a government hospital or a statutory medical institution in form md-18 as per rule 42 of mdr-2017 accompanied by requisite documents required and the fee as specified in the second schedule of mdr-2017 on the cited portal for this purpose.12 manufacturing of custom-made device md that are made specifically in accordance with a written prescription of a registered medical practitioner, specialized in the relevant area, under his/her responsibility in accordance with a specific design, characteristics, and kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india j global clinical engineering vol.7 issue 3: 2025 56 • role in regulatory compliance: obtaining test license is an important step which helps in ensuring adherence with the existing regulatory framework so that it can be of help to protect public health. it also ensures that products that are manufactured/imported in small quantities after obtaining test license shall be used only for specified purposes and not for commercial purposes. • safety measures: test license granted against manufacturing/importing the md/ivd for the purpose of testing/ evaluation ensures that testing/evaluation carried out with respect to applicable gold standards will establish that the products are safe and effective for human use. • commercial manufacturing preparedness: the grant of a test license is the preliminary step for the preparedness of commercial manufacturing license for sale and distribution of md/ivd in the indian market, as it helps to prevent the marketing of unsafe or ineffective devices. usually, it is applied for once the working prototype is ready, and its design is finalized in the case of investigational md/new ivd. • build trust: the end user can build trust in the company’s various products of md/ivd for which the license has been granted. • adverse event surveillance: test license encompasses the compliance of regulatory approval, identification of all quality-related issues, investigation of the root cause, and implementation of necessary legal actions in case of adverse events reported (if any) of the subject device. this ensures that such problems do not arise again and develops the confidence of users on device potentially, safety, and effectiveness of use in humans. key challenges and suggestions for amelioration test license permits the manufacturer/importer to make/import a limited quantity of md/ivd falling within class a (except non-sterile and non-measuring)/b/c/d for any of the aforesaid purposes before being put into commercial use. there are certain challenges with regard to applying the test license and possible suggestions, which are summarized below. the same is intended for the sole use of a particular patient, and the label mentions “for the sole use of a particular patient,” and does not include the mass production of such a device. all provisions of chapter iv (manufacture of md for sale or for distribution and chapter v (import of md) are exempted as per the eighth schedule of mdr-2017. withdrawal, rejection, and cancellation of test license once the test license application is submitted successfully, there is no option to withdraw/amend the submitted test license application on the nsws portal. however, an applicant can request the cla for cancellation with a proper justification for the same. in addition, after obtaining the test license in form md-13, if an applicant fails to comply with relevant provisions of the mdr-2017 against the proposed device/ivd, the cla may issue a show cause notice for cancellation giving an opportunity to explain in writing the licensee’s defense against an order for cancellation. the licensee has the right to appeal to the central government within 45 days from the date of cancellation of the order.2 the cla may reject the grant of a test license in form md-17, and the reasons, such as the requirements of these rules are not satisfied by the applicant, are to be recorded in writing within a period of thirty days from the date of the application under sub-rule (2) of rule 40 of mdr-2017.2 significance of test license the importance of test license significantly implies a quality of md/ivd that should make it worthy of global acceptance. within a functioning healthcare system, initiating the regulatory application process—beginning with the issuance of a test license—is a crucial first step for any subject device intended for widespread use in the prevention, diagnosis, treatment, monitoring, and rehabilitation of a broad range of diseases and medical conditions. in addition, it can also be used to monitor vital signs, deliver medications, remove biological waste, and support or replace damaged body parts. the important aspects of test license are herewith outlined below: 57 j global clinical engineering vol.7 issue 3: 2025 kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india extended application review period in general, 30 working days are allocated to review the application and grant approval. however, long extended time has been utilized to review the application because of a large volume of applications or insufficient information/incorrect documents submitted by the applicants. possible suggestions inconsistent testing standards there may be inconsistencies in how different laboratories apply the standards, leading to variability in testing/ performance outcomes. there is no harmonization of the analytical parameter, which is established to conduct the performance evaluation of the subject ivd that varies across designated labs. aligning the harmonized results with mdr-2017 is critical for approval. emergence of new technologies: emergence of new technologies for health solutions require new risk-based classification under either software integrated medical device (simd) or software as medical device (samd) for addressing efficacy/intended use in ways that are not previously covered. an awareness-strengthening regulation since, there is an overall trend to cover all md/ivd under the license regime, it is primarily recommended as safety concern grows, to be aware about increased regulation over previously non-notified category of md/ivd. conclusion medtech industry is not just a component of healthcare but is the catalyst that links patients, payors, service providers, and regulators to create a stronger and more equitable system in a fast-paced environment globally. in this regard, md/ivd is the unique positioning of the medtech sector that holds the promise of revolutionizing healthcare delivery and outcomes, both in india and globally. the wide spectrum md/ivd, from simple technologies to complex high-throughput systems, presents varying degrees of risk that may directly influence patient health challenges faced the dynamic and complexity of regulatory compliance: with ongoing amendments and regular updates to mdr-2017 in india, usually the applicants often face the following challenges in fully understanding the nuances related to device/ivd: • class of md/ivd: correct identification of a risk-based class of the device. • laboratory for conducting performance evaluation: availability and identification of cdsco designated labs under sub-rule (1) of rule 19 of mdr-2017 for ivd. • identification of predicate device: it is essential for confirmation that it either falls under investigational md or new ivd or subsequent equivalent of the approved device/ivd. • understanding of different components/accessories/ consumables: it includes a basic overview of the device and its parts, whether or not consumable items are included—along with their respective risk-based classification and intended use, is not clearly explained in the remarks. justification of quantity to be manufactured/imported for different purposes and their breakups utilization. • clarity on grouping of md/ivd; either it falls under the category of single, system, group, family, or cluster. • identification of test batch manufacturing sites/ testing sites. technical barriers on the nsws portal the nsws platform, while designed to simplify regulatory processes, can present technical barriers, such as slow response times, connectivity issues, or errors in uploading required documents along with login credential requirements of mandatory dsc, which is linked to the permanent account number (pan) of the business entity or signatory authority for its validation to submit the application as well as approval. kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india j global clinical engineering vol.7 issue 3: 2025 58 conflicts of interest we have no conflicts of interest to disclose. ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure not applicable. references 1. press releases, ministry of health and family welfare, government of india. december 19, 2024. available online: https://mohfw.gov.in/press-info/8078. 2. the medical devices rules, 2017. available online: https:// cdsco.gov.in/opencms/opencms/system/modules/cdsco. web/elements/download_file_division.jsp?num_id=otg4nq. 3. press releases, central drugs standard control organization under ministry of health & family welfare, india becomes affiliate member of the international medical device regulators forum. october 03, 2024. available online: https:// pib.gov.in/pressreleasepage.aspx?prid=2061397. 4. india’s cdsco extends list of notified devices. january 13, 2021. available online: https://asiaactual.com/blog/ indias-cdsco-extends-list-of-notified-devices/. 5. cdsco launched national single window system (nsws) portal. january 01, 2024. available online: https://www. nsws.gov.in/. 6. guidance on performance evaluation of in-vitro diagnostic medical devices. august 7, 2018. available online: https:// cdsco.gov.in/opencms/export/sites/cdsco_web/pdfdocuments/medical-device/guidanceperformanceivd.pdf. 7. ivdr performance evaluation (2019–2024). available online: https://www.thinqbetter.com/ivdr-performance-evaluation 8. clinical performance definition ivdr, celegence. april 6, 2022. available online: https://www.celegence.com/ clinical-performance-ivdr/jj. and safety. on the other end, the regulatory compliances in accordance of risk-based classification of md/ivd vary. however, test license is an important principal requirement to get the necessary approval for manufacture/ import of a small quantity of md/ivd for the purpose of clinical investigation, testing, evaluation, examination, demonstration, or training. the process of obtaining test license under the mdr-2017 in india via the nsws portal involves navigating complex regulations and ensuring compliance with testing standards. the objective of the current study is to provide a significant overview of the regulatory framework that brings test license approval of the md in india. these approvals facilitate ease of doing business, remove regulatory bottlenecks to make in india, while ensuring availability of better md for patient care and safety. conversely, there are certain challenges that significantly present opportunities for improvement in regulatory frameworks and quality standards, potentially leading to a more robust medical device market in india. these insights may be relevant when considering the broader context of md/ivd testing and licensing under mdr-2017. author contributions conceptualization and writing– review & editing, r.k.; methodology, d.k.g.; visualization, j.b.; resources, a.s.; supervision, s.m. acknowledgments i greatly acknowledge icmr for providing the necessary infrastructure, computing resources, study materials, circulars, and documents to prepare the manuscript. funding this study received no funding. data availability statement not applicable. https://mohfw.gov.in/press-info/8078 https://cdsco.gov.in/opencms/opencms/system/modules/cdsco.web/elements/download_file_division.jsp?num_id=otg4nq https://cdsco.gov.in/opencms/opencms/system/modules/cdsco.web/elements/download_file_division.jsp?num_id=otg4nq https://cdsco.gov.in/opencms/opencms/system/modules/cdsco.web/elements/download_file_division.jsp?num_id=otg4nq https://pib.gov.in/pressreleasepage.aspx?prid=2061397 https://pib.gov.in/pressreleasepage.aspx?prid=2061397 https://asiaactual.com/blog/indias-cdsco-extends-list-of-notified-devices/ https://asiaactual.com/blog/indias-cdsco-extends-list-of-notified-devices/ https://www.nsws.gov.in/ https://www.nsws.gov.in/ https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/medical-device/guidanceperformanceivd.pdf https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/medical-device/guidanceperformanceivd.pdf https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/medical-device/guidanceperformanceivd.pdf https://www.celegence.com/clinical-performance-ivdr/jj https://www.celegence.com/clinical-performance-ivdr/jj 59 j global clinical engineering vol.7 issue 3: 2025 kumar, gupta, batra, sahu and markan: catchment of the test license for the regulation of medical devices in india 9. clinical investigation and clinical evaluation of medical devices. may 10, 2022. available online: https://medicaldevicehq. com/articles/clinical-investigation-and-clinical-evaluation/. 10. regulatory pathway to be followed for the medical device from its development to commercialization under medical devices rules, 2017. available online: https://cdsco.gov. in/opencms/export/sites/cdsco_web/pdf-documents/ md123.pdf. 11. ministry of health and family welfare (department of health and family welfare). notification, g.s.r. 102 (e) dated 11th february, 2020. available online: https://cdsco. gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20 of%20certain%20medical%20devices.pdf. 12. online system for medical devices. available online: https:// cdscomdonline.gov.in/newmeddev/homepage. https://medicaldevicehq.com/articles/clinical-investigation-and-clinical-evaluation/ https://medicaldevicehq.com/articles/clinical-investigation-and-clinical-evaluation/ https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/md123.pdf https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/md123.pdf https://cdsco.gov.in/opencms/export/sites/cdsco_web/pdf-documents/md123.pdf https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf https://cdsco.gov.in/opencms/resources/uploadcdscoweb/2018/uploadgazette_notificationsfiles/gsr102eregistration%20of%20certain%20medical%20devices.pdf https://cdscomdonline.gov.in/newmeddev/homepage https://cdscomdonline.gov.in/newmeddev/homepage j global clinical engineering vol.7 issue 3, 2025 2 editor’s corner leadership in clinical engineering: navigating complexity, driving innovation twenty years ago, during a visit to china with professor bill hyman (r.i.p.), we were graciously hosted by professor jiang yuanhai (r.i.p.). together, we debated a crucial gap in academic preparation — particularly the need to develop leadership competencies among new clinical engineers. those powerful dialogues left a lasting impact on me. in recognition of their legacy, the global clinical engineering alliance (gcea) established the yuanhai & hyman academic award to honor exceptional contributions in academic advancement. in today’s dynamic healthcare landscape, the clinical engineer has evolved from being a guardian of equipment functionality to becoming a strategic architect of safe, effective, and sustainable health systems. this transformation demands more than technical proficiency — it calls for visionary leadership. “clinical engineers are no longer only problem-solvers—they are solution designers at the highest level of healthcare.” the expanding role of leadership leadership in clinical engineering means moving beyond the familiar, beyond just tools and troubleshooting, and embracing strategic influence. it is about shaping policy, mentoring future leaders, and ensuring health technologies serve all communities, everywhere. “leadership is not defined by a title — it is defined by your capacity and willingness to influence systems and inspire progress.” a forward-thinking clinical engineer must grasp procurement systems, regulatory frameworks, digital health transformation, and environmental impact. it’s a role that requires systems thinking, fluency in both medical and management languages. “the most effective clinical engineering leaders speak the language of both medicine and management.” from basement to boardroom the traditional view of clinical engineers as behind-thescenes support is fading. today, leaders in our profession are found in boardrooms, ministries of health, and international forums, shaping policies, budgets, and national strategies. “from the basement to the boardroom, clinical engineers are now partners in shaping the future of healthcare delivery.” leadership now demands soft skills—emotional intelligence, communication, collaboration, and cross-cultural understanding—as much as it does technical mastery. equally vital is visibility: presenting, publishing, mentoring, and advocating. this is where gcea and the global clinical engineering journal become critical enablers. e pluribus unum — “out of many, one stronger profession.” http://www.globalce.org http://www.globalce.org 3 j global clinical engineering vol.7 issue 3, 2025 global voices, shared lessons leadership in clinical engineering is not confined to any one nation. around the world, we see shining examples that inspire and guide us: • italy: regional healthcare systems have integrated clinical engineers into decision-making processes for technology planning, procurement, and deployment—ensuring continuity, quality, and sustainability. • mexico: clinical engineers are leading national health technology program. • africa: bold leadership in education and capacity building has strengthened local engineering expertise and fostered self-reliance through context-aware training programs. • asia: during the covid-19 pandemic, clinical engineers led innovative asset management strategies, care facilities construction, improving response times, optimizing resources, and supporting continuity of care. these successes illustrate the global readiness of clinical engineers to lead in diverse settings. “every clinical engineer has the potential to lead—when equipped, encouraged, and empowered.” one voice, one alliance: gcea true leadership also means unifying voices across continents. that’s the vision of the global clinical engineering alliance: building a cohesive, representative community that collaborates across borders and disciplines. through gcea, national societies, academic institutions, and individual professionals join forces—to develop best practices, shape policies, and promote global solidarity. “from many comes one.” this is not merely a slogan — it is a call to action. alignment enables collective impact, shared standards, stronger advocacy, and a clearer pathway for developing future leaders in clinical engineering. “the future of clinical engineering leadership depends on the strength of our alliance. gcea is that strength.” looking ahead: three leadership priorities as we move forward, three core leadership imperatives emerge: 1. championing sustainable innovation lead in adopting cost-effective, environmentally responsible, and adaptable technologies. 2. advancing equity and access advocate for inclusive solutions, closing the healthcare technology gap between urban centers and underserved communities. 3. building global solidarity strengthen international networks to harmonize training, regulation, and practice standards for the benefit of all. “leadership in clinical engineering is a global responsibility—we rise by lifting each other.” final thought the age of passive participation is over. clinical engineers must be agents of transformation. the global clinical engineering journal offers both a mirror and a megaphone: reflecting who we are and amplifying who we can become. “if we want better healthcare systems, we must develop better engineering leaders.” http://www.globalce.org http://www.globalce.org j global clinical engineering vol.7 issue 3, 2025 4 copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. yadin david edd, pe, cce, faimbe, facce editor-in-chief global clinical engineering journal we invite every clinical engineer to step up—publish, present, mentor, and support. and most importantly, join and support the gcea. let’s continue building a strong profession that speaks with one voice—in italy, ghana, singapore, and around the world. because together, we are stronger. from many, comes one. take advantage of the gcea recognition program before the august 31 deadline and nominate a deserving colleague for one of the global leadership awards! http://www.globalce.org http://www.globalce.org https://www.globalcea.org/award-categories j global clinical engineering vol.7 issue 1, 2025 2 editor’s corner artificial intelligence in clinical and biomedical engineering: opportunities and challenges never has technology brought so much confusion. for some, ai is the savior of humanity; for others, it is an agent of destruction. the overwhelming fact is that ai is here to stay. but is ai good or bad, and what is its role in biomedical and clinical engineering? to answer this, we need to understand ai’s capabilities, limitations, and evolution while also considering how we should participate in its development and responsible use. ai, in a general sense, is an information system capable of replicating functions traditionally associated with the human brain. from the invention of writing to digital calculators and personal computers, ai has evolved into today’s large language models—deep artificial neural networks capable of processing vast amounts of data and mimicking human language. yet, ai remains a probabilistic computational engine that generates responses based on its training data. if a system lacks the correct data, it may still generate an answer—a phenomenon known as hallucination. this raises concerns, particularly in decision support, where ai should either provide evidence-based guidance or indicate the need for additional information. ai’s potential in clinical and biomedical engineering while ai is still emerging in clinical engineering, several areas present significant opportunities: • decision support systems: ai can assist in procurement, maintenance scheduling, and calibration, improving efficiency and decision-making. • predictive maintenance: ai-driven analytics can anticipate device failures, minimizing downtime and enhancing reliability. • inventory management: ai can optimize medical device supply chains, ensuring timely access to critical equipment. • post-market surveillance: ai has the potential to enhance monitoring of medical device performance and early detection of malfunctions. • cybersecurity measures: as medical devices become more connected, ai can detect and prevent cybersecurity threats. challenges and considerations despite its promise, ai adoption in clinical engineering faces several challenges: • data privacy and security: compliance with hipaa and gdpr is essential to protect patient information. • algorithmic bias: ai models must be trained on diverse datasets to avoid biases that could negatively impact healthcare outcomes. for instance, an ai system trained exclusively on maintenance data from a single manufacturer may yield recommendations that are inapplicable to other brands. moreover, biases in patient datasets can lead to disparities in healthcare access and outcomes, making it crucial for clinical engineers to contribute to dataset diversification and validation. • environmental and operational context: ai models developed in high-resource settings may not perform effectively in lowand middle-income (lmi) environments, where infrastructure reliability varies. ai must be trained with data reflective of different operational contexts, including settings with limited electricity, refrigeration, and water supply. clinical engineers play a vital role in ensuring ai models consider these variables to maintain relevance across diverse healthcare environments. • explainability and transparency: ai systems should include interpretability layers so that engineers and healthcare providers understand the decision-making process. http://www.globalce.org http://www.globalce.org 3 j global clinical engineering vol.7 issue 1, 2025 • workforce adaptation: clinical engineers must seek and receive ai training, including ethics and data governance, to oversee ai integration safely and effectively. future directions and recommendations to leverage ai’s potential in clinical and biomedical engineering, the following steps should be considered: 1. develop ai-based decision support systems for maintenance, procurement, and calibration. 2. implement cybersecurity frameworks to safeguard ai-driven medical device networks. 3. diversify ai training datasets by including various patient populations and multiple medical device brands to mitigate algorithmic bias. 4. ensure ai transparency by integrating explainability features to enhance trust and usability. 5. explore ai applications in predictive diagnosis, early failure detection, and resource optimization. 6. establish ai training programs for clinical engineers to promote ethical and effective implementation. 7. develop domain-specific large language models (llms) tailored to clinical and biomedical engineering, ensuring ai recommendations are contextually appropriate. 8. publish about best practices, and application of ai into clinical engineering practices. you may help many to avoid missteps shared in your publication. conclusion ai presents a transformative opportunity for clinical and biomedical engineering, with the potential to enhance safety, efficiency, and decision-making. however, responsible ai adoption requires addressing data privacy, algorithmic bias, and transparency. by proactively engaging in ai development and governance, clinical engineers can play a pivotal role in shaping the future of healthcare technology management. we must embrace our role as toolmakers, not just users, to shape ai into a force for good. only through intentional development can we create ethical, intelligent systems that enhance efficiency, reduce risk, and improve the quality of life for both patients and technology users. ai is still in its infancy, and we must act as responsible teachers and stewards, guiding its evolution toward cooperation and progress. the alternative is too dangerous—without ethical oversight, unscrupulous corporations, negligent engineers, or uninformed users could steer ai toward harm rather than progress. ricardo silva phd, mba, cce global expert in healthcare digital transformation and innovation copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://www.globalce.org 11 j global clinical engineering vol.7 issue 2: 2025 received july 31, 2024, accepted march 4, 2025, date of publication april 11 2025. review artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks radhakrishan gaur1, afifa akram1, indu singh2 and shikha baghel chauhan3* 1 department of drug regulatory affairs, amity institute of pharmacy, amity institute of pharmacy, amity university, noida, up-201301, india. 2 department of pharmaceutics, amity institute of pharmacy, amity university, noida, up-201301, india. 3 department of industrial pharmacy, amity institute of pharmacy, amity university, noida, up-201301, india. * corresponding author email: schauhan@amity.edu abstract the current review elaborates artificial intelligence (ai) in medical devices is changing the landscape of diagnostics allowing for more accurate and efficacious treatments leading to better patient care. an overview of ai technologies and their application in medical devices elaborates on ai technologies, such as neural networks and advanced data analytics being applied in diagnostic imaging and patient-monitoring preventative analytic models. machine learning, a subset of ai, enables devices to learn from data and improve their performance over time, enhancing diagnostic accuracy and personalized treatment plans. an elaborated critical review is presented for the regulatory strategies implemented by relevant global leaders, such as the european union (eu), the united states (us food and drug administration, fda), and india (central drugs standard control organization of india, cdsco). this is indicative of the eu regulatory approach as observed through reflection paper by the european medicines agency (ema) on a methodology to assess ai technologies used in conjunction with medicinal products, and the software as a medical device (samd) guideline by the fda in the united states. the discussion is on adaptive regulatory strategies, an overview of some pre-certification programs, and detailed advice to manufacturers about compliance with the processes. also, india aligning with the international medical device regulators forum (imdrf) guidelines shows its appetite to help build an extensive regulatory framework for ai-powered medical devices. the current review concludes by highlighting the need for continued coordination between regulators, manufacturers, and healthcare players so that ai advances are safe and adherent to the regulations that improve overall patient care. keywords—regulatory framework, patient monitoring, diagnostics, neural networks, machine learning. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. http://www.globalce.org http://globalce.org http://globalce.org mailto:schauhan@amity.edu https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks j global clinical engineering vol.7 issue 2: 2025 12 introduction the medical device industry is being revolutionized by artificial intelligence (ai) through more efficient, datadriven, and adaptive regulatory practices. to improve processes, decision-making ability, and quality of healthcare provision, regulatory bodies around the world, such as the european union (eu), us food and drug administration (us fda), and central drugs standard control organization of india (cdsco), are employing ai-based technologies. ai-driven medical devices extract valuable insights from medical data by using advanced methods of data analysis as well as machine learning (ml) algorithms. they then assist doctors in making better decisions, which have a positive impact on patients’ health outcomes.1 however, for medical devices guided by ai to be safe and efficient, they should adhere to good machine learning practices (gmlp), real-world performance tracking, compliance monitoring, and ai-ml software used as medical devices. other essential components include regulatory frameworks, ai-powered regulatory documentation, ai-assisted regulatory expertise, and ai-driven regulatory insights.2 the integration of these elements ensures that manufacturers of medical devices can safely and efficiently develop, test, and deploy ai-enabled devices.3 this approach improves patient outcomes and enhances healthcare quality, as it affects all aspects of health services, including expenses, as we observe in the text. the fda is at the forefront of developing guidelines for evaluating the safety and effectiveness of ai-enabled medical devices worldwide. the use of ai in healthcare raises a number of complex regulatory issues, some of which are unique to ai technology. a key challenge is the transparency of ai algorithms, which sets them apart from more traditional regulated technologies.4 to address these challenges, regulatory bodies are developing training programs and guidelines to enhance regulatory expertise in ai and ml. overview of artificial intelligence in medical devices artificial intelligence means a system that acts with the help of machines and predicts or suggests actions in real-world but potentially also in virtual environments according to the objectives set by humans. these systems require both ml and human-based input to identify, translate, and create the context around, and perceive real or fictive environments. it parses these perceptions automatically, and then abstracts them into models. the data are then leveraged to create models for mining information, or possible decisions are modeled by the process of model inference.5 the applications of medical devices have been listed in figure 1. applications of ai in medical devices figure 1. application of ai in medical devices. disease detection and diagnosis: ai algorithms, including deep learning models such as convolutional neural networks, can help doctors make decisions in many areas of medicine, such as oncology, radiology, ophthalmology, and general medicine. these algorithms analyze medical images (e.g., mri, ct scans, x-rays, etc.) and other patient information to assist in diagnosis. studies have shown that these models can reduce waiting period, enhance medication compliance, and tailor insulin doses, among other benefits. ai for personalized medicine: ai tools can recommend the most effective treatments based on genetic and medical history, as well as lifestyle factors, leading to more precise and effective treatments. continuous learning and improvement: ai devices can learn from real-world use to improve their performance over time, adapting to new clinical scenarios and enhancing their detection capabilities, which in turn improve patient care. 13 j global clinical engineering vol.7 issue 2: 2025 gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks enhanced diagnostics: ai-powered diagnostics involve analyzing multiple medical data sources to improve early and accurate diagnosis of illnesses. this includes mining electronic health records (ehrs), automated laboratory report analysis, and medical image interpretation (e.g., radiology, pathology, etc.). performance evaluation: ai devices can be helpful in the performance evaluation process by increasing efficiency, improving patient outcomes, and simplifying data collection. this includes the use of ai in post-market surveillance and real-world performance monitoring to ensure the ongoing safety and efficacy of medical devices.6 predictive analytics for monitoring: ai can be used in wearable devices to monitor patient vitals and provide predictive insights on conditions such as heart failure and glucose levels. regulatory compliance and clinical trials: ai can automate data generation, validation, and metadata analysis for regulatory submissions, enhancing clinical trials by predicting outcomes, optimizing patient recruitment, and ensuring compliance with global regulatory standards. ai for diagnostics: ml models in diagnostic devices can aid in the automatic interpretation of test results, such as ecg and blood tests. natural language processing (nlp) for documentation: ai can automate and streamline clinical documentation, making it easier to comply with medical regulations and ensure accurate patient records. robotic surgery: ml algorithms can assist surgeons with precision during operations. ai in software as a medical device (samd): ai is being integrated increasingly into samd to enhance functionality and performance. importance of regulatory intelligence and compliance monitoring regulatory intelligence is essential for compliance monitoring, helping companies to keep updated about changing regulations. it ensures that the company remains in accordance with all laws and requirements. regulatory intelligence empowers businesses in anticipating and dealing with global changes in regulations, without having to monitor manually different sources of regulatory data. a proactive approach ensures organizations respond faster to make the changes they need, mitigating risk and reducing costs. for example, regulatory intelligence platforms have tools for tracking changes in the rules and analyzing their impact to discover which obligations might stem from a change of laws that may apply specifically depending on what is being done by you.7 these tools ensure the regulatory updates and reports generated on the platform itself, making it more efficient for operations at lower cost. for instance, the use of ai in regulatory intelligence is expected to automate monitoring and dissemination in the future, freeing up regulatory experts to concentrate on high-value tasks and decision-making.8 regulatory information tools for monitoring consist of regulatory agencies, website monitoring tools, news organizations, and subscription-based services regulatory intelligence for regulatory strategies and operations, product due diligence (preor post-deal), target products identification, and clinical development to regulatory submissions. this capability helps organizations stay current with applicable regulations, understand the implications, and create an intelligence report that can be used to remain compliant while reducing resource overhead.9 need for effective regulatory frameworks to keep pace with ai innovations for medical devices the current regulatory framework for ai-enabled medical devices is characterized by a wide void of strict laws and guidelines. the fda (united states), the medicines and healthcare products regulatory agency (mhra, uk), and the health canada have published preliminary thoughts; however, regulations by law are only enforceable when issued. only saudi arabia has implemented proscriptive guidance so far. this ambiguity obliges manufacturers to employ regulations not modernized for the new and revised short-cycle drugs, serving as roadblocks toward algorithmic adaptability along with dynamic data-driven updates by treating newly acquired information without constraints.10 gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks j global clinical engineering vol.7 issue 2: 2025 14 essential when utilizing ce-certified devices in a clinical trial to safeguard the rights, safety, and well-being of participants as well as the integrity, and applicability of evaluation data. it is clear from the reflection paper that ema scrutinizes whether the characteristics of medical devices are suitable for generating evidence needed for marketing authorization application, or whether a device provides recommendations in the summary of product characteristics (smpc).15 ema’s approach to evaluating ai technologies in medical device development and authorization the ema’s strategy for assessing ai technologies in the development of medical products is as follows: the ema has released a reflection paper that focuses on promoting the utilization of ai throughout the lifecycle of medicinal products. this covers medical devices that are used within clinical trials to provide evidence for a marketing authorization application or in case they are used with a medicinal product.16 the ema assesses such devices to decide whether they can provide adequate evidence for approval in eu countries. these recommendations include information about how to conduct ai research, which needs to be updated regularly, given the advances in the field and the new knowledge generated by research. if smpc recommendations, such as posology or monitoring incorporate advice from an ai-enabled medical device, all relevant aspects of that combination are considered during assessment by the ema.17 according to this reflection paper, general guidelines and expectations applicable for medical devices would also apply to the clinical trial and marketing authorization contexts using ai/ml-based approaches.18 overall, the ema is adopting a risk-based strategy, instructing the sponsors to consider whether the ai system presents risks to patients, and if so, then to seek early regulatory advice from the ema. the ema is getting ready to examine applications that incorporate ai/ml systems into the lifecycle of medical products.19 overview of the european medicines agency’s (ema) reflection paper the ema has released a preliminary document outlining its current stance on the use of ai and ml to enhance regulatory approaches to ai in medical devices artificial intelligence in medical device regulations is now evolving quickly, as the eu, the united states, and india are adopting new pathways to ensure that these technologies are safe and effective. the eu is developing a comprehensive ai act, which sets out strict rules on any use of the technology, while the united states continues to rely on its existing regulations and guidelines. india is aligning its regulatory framework with international standards, particularly those set by the international medical device regulators forum (imdrf).11 these regulatory mechanisms play an important role in preventing the operational and planning data management system from becoming points of failure, and thus protect patients as well as healthcare practitioners by determining that medical devices powered with ai underperform reliably.11 european union the eu wants to regulate ai in all areas, including healthcare, based on how dangerous it is. the proposed ai act wants to make a legal definition of “ai system” and sets rules for how ai can be built into and used in medical devices. the eu ai act makes sure that ai systems follow basic rights, safety rules, and morals by setting clear rules for how they can work.12 overview of the european medicines agency’s (ema) reflection paper the ema has published a preliminary document discussing the use of ai and ml in the entire lifespan of medicinal products, including those for human and veterinary use.13 the use of ai/ml systems for the clinical management of individual patients may result in the medical device regulation (mdr) classifying in vitro diagnostics (ivds) used in performance evaluation as medical devices, as stated in the reflection paper. a document issued by the medical device coordination group (mdcg) offers detailed guidelines on the qualification and classification of software as medical devices in accordance with the mdr, the in vitro diagnostic devices regulation (ivdr), or both.14 nonetheless ema has no responsibility to classify software by the rules. additional prerequisites are 15 j global clinical engineering vol.7 issue 2: 2025 gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks the safe and efficient development, regulation, and use of human and veterinary medicines throughout the lifespan of the product. the ema acknowledges the potential of ai to improve different areas of the pharmaceutical industry, such as drug discovery, preclinical development, clinical trials, precision medicine, product information, manufacturing, and post-approval pharmacovigilance.20 nevertheless, the agency underscores the importance of adopting a human-centered approach in all aspects of ai and ml development and implementation. it is crucial to adhere to the existing legal obligations, prioritize ethical considerations, and uphold fundamental rights. the ema promotes transparency and comprehensibility in the creation and verification of ai systems.21 this entails providing explicit documentation of the utilized data, applied algorithms, and achieved performance, with the level of explanation aligning with the level of risk. sponsors should utilize reliable and accurate data when creating and testing ai systems, carefully choose and validate algorithms for specific purposes, establish continuous monitoring and maintenance plans to identify and address any decline in performance over time, conduct thorough risk assessments, and take necessary measures to mitigate risks, and proactively collaborate with regulators to ensure compliance with ai-usage guidelines. the ema’s preliminary reflection paper was available for public consultation until december 31, 2023.22 us food and drug administration the us fda regulates the utilization of ai in medical devices. the fda evaluates ai/ml-enabled medical devices based on their use, using appropriate premarket pathways, such as 510(k) clearance and de novo classification for noncontroversial new technologies, and traditional pma for innovative devices.23 the regulations governing medical devices are highly specific. the agency provides detailed recommendations and action plans for regulatory consideration in response to the challenges posed by the rapidly evolving field of ai technologies. these encompass the ai and software as a medical device action plan, along with supplementary guidance on ml best practices, pre-specification change control plans, and transparency.24 fda guidelines for ai/ml-based software as a medical device software as a medical device is a term coined by the imdrf to refer to software that is specifically created for medical usage and can function on its own, without incorporating into a physical medical device.25 overview of the fda guidelines for ai/ml-based samd: the fda is in the process of developing regulatory pathways for samd driven by ai and ml. these pathways include traditional premarket pathways, such as 510(k) clearance, de novo classification, and premarket approval (pma). recognizing that ai/ml technologies are adaptive by design, the fda has acknowledged that traditional regulatory approaches may not be sufficient for these devices. this is particularly important because the fda no longer believes that the old requirement of locking algorithms post-training is adequate. instead, they are moving toward a more adaptive framework that allows algorithms to undergo modifications under predefined change control plans, ensuring safety and effectiveness. this approach addresses the specific challenges posed by ai/ml medical devices.26 important fda guidance documents the document titled “proposed regulatory framework for modifications to ai/ml-based software as a medical device” published in april 2019 explores a potential method for evaluating ai/ml modifications before they are released to the market. in january 2021, the fda issued the “ai/ml samd action plan”, which offers a comprehensive framework for regulating ai and ml technologies in samd.27 the title of the event in october 2021 was “good machine learning practice for medical device development: guiding principles”. in april 2023, draft guidance was released on “marketing submission recommendations for a predetermined change control plan for ai/ml-enabled device software functions.”28 the title of the publication in october 2023 was “guiding principles for predetermined change control plans in machine learning-enabled medical devices.” the title of the publication released in june 2024 was gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks j global clinical engineering vol.7 issue 2: 2025 16 “transparency for machine learning-enabled medical devices: guiding principles.” 29 fda guidelines for ai/ml-based software as a medical device the fda’s total product lifecycle (tplc) approach to regulation aims to expedite the enhancement process of samd utilizing ai and ml, while ensuring compliance with all essential safety protocols. developers are anticipated to be transparent about the functionality of their products in real-world scenarios and adhere to both good ml practices (gmlp) and quality systems. the tplc framework enables manufacturers to present change control plans that have been implemented prior to the initial premarket review process.30 this allows for specific modifications to be implemented without necessitating a fresh evaluation process. the fda granted approval up to 2024 to approximately 64 medical devices that utilize ai and ml, with the majority being approved through the 510(k) pathway. the agency is currently endeavoring to enhance its regulatory framework in order to match the rapid pace at which these technologies are evolving.31 the recommendations from the guidelines: the fda’s guidelines on ai/ml-based samd are classified into three broad categories, i.e., assuring the safety and effectiveness of these devices, promoting good ml practices in device development, and ensuring transparency about how algorithms reach their outputs.32 most important suggestions are as follows: thorough validation: ai and ml algorithms need to be thoroughly validated to show that they work as intended and give correct results. this would include clinical trials and tests against well-known ways of diagnosing. risk management: companies that create ai/ml algorithms are to search for and mitigate any risks associated with it. biases in the data used to train an algorithm, errors made by the algorithm itself, and security vulnerabilities are all potential problems.24 real-world performance monitoring: ai and ml models can learn from experience to improve performance over time, so the fda recommends using real-world clinical data to continually assess a device’s safety and effectiveness. good machine learning practices: according to the fda, gmlp refers to following the ml development best practices throughout the entire ml lifecycle. if you follow a best practices process, such as training with great real-world data, keeping good model development and validation practices, or making sure the software has strong versioning support.33 predetermined change control plans (pccp): the ai/ml model should learn and change over time, so manufacturers should set up a pccp that explains how it will do this. the pccp should have steps for finding, evaluating, and lowering the risks that might come with changing algorithms.34 clear user manuals: the samd should come with clear and detailed user manuals that explain what the device can and can't do and how the ai/ml algorithms work. data transparency: users should know what kind of data were used to train ai/ml models and if there are any biases that could affect the outputs of the device. transparency of algorithmic functioning: the level of details about how the ai/ml algorithms work on the inside may change depending on how complicated is the device.35 fda’s regulatory approach for adaptive ai-driven devices while the fda recognized that ai and ml may now be transformative in medical devices, it also recognizes that its traditional regulatory framework is likely not well suited for these ever-evolving techs. in response, the agency launched a new tplc initiative that uses existing premarket pathways in combination with risk management and authorization from its pre-cert program. nationwide strategies mean to diminish the obstructions confronting programming designers and other human service suppliers in executing conduct of science criticism; simultaneously, direction laid down with respect to a “strict control” change for guideline focus on ml techniques.36 with a large guide that provides transparency during each step of ai algorithms suggested by the fda, this can help you make the most out of developing tools or models with features-proposed higher-up code. two components of the tplc framework, however, probably would require more statutory authority to fully implement than by epa.37 india’s central drugs standard control organization 17 j global clinical engineering vol.7 issue 2: 2025 gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks india’s central drugs standard control organization cdsco’s alignment with imdrf guidelines the cdsco is aligning its medical device rules with imdrf guidelines. the cdsco issued a notification on august 1, 2019, revising the medical devices rules of 2017 to make samd subject to its existing regulatory framework. following the imdrf guidelines provides a road map to manufacturers in india by which they can comply with their regulatory obligations for samd products. samds are classified into risk-based classes (a–d), which are systematically defined as per the imdrf risk framework.38 it determines the required level of regulatory oversight and compliance. the cdsco is working on creating a digital drugs regulatory system (ddrs), which, however, is an ai-enabled open-source technology. the goal is to create a harmonious digital regulatory environment based on international standards and best practices. as long as ai medical devices safeguard patient data and offer safe access to it for unauthorized parties as defined by new legislation, they can continue to be relevant in accordance with the ethical and open principles outlined by the imdrf. the cdsco has leaned into the imdrf guidance as a way of developing its medical device regulations, with an emphasis on technologies such as ai-powered samds. the aim is to have a robust, risk-based, and globally harmonized regulatory system for medical devices in india.39,40 overview of imdrf guidelines for medical devices: the imdrf has published a framework, which is adopted and applied by the cdsco. main safety and performance imdrf regulations are as follows: imdrf has released the document “essential principles of safety and performance for medical devices & ivds” (imdrf/grrp wg/n47). this guidance provides highaltitude rules on designing and constructing medical devices to make them safe, by following which you can guarantee the safety characteristics that are in place when your device is used as intended. imdrf/grrp wg/n71:2021 medical device regulatory review reports guidance regarding information to be included (imdrf/grrp, 2020). the guidance is to provide common format requirements for the content and format of a regulatory submission dossier for a medical device.41 this report encompasses crucial sections, such as the following: regional administrative information submission context nonclinical evidence clinical evidence labeling and promotional material quality management system information there are rules and principles for medical devices in india that were taken from the imdrf and added by the cdsco to the medical devices rules, 2017. the cdsco also publishes lists of medical devices that are categorized by risk. these lists match the imdrf framework of classes a–d based on risk.42 implications of cdsco’s alignment with imdrf guidelines for ai-based medical devices in india: in india, the cdsco has mostly made its rules about medical devices, such as samds, the same as the rules and guidelines set by the imdrf. the cdsco has implemented the imdrf’s risk-based system to categorize samds into four groups based on their level of risk: low-risk (class a), low–moderate risk (class b), moderate risk (class c), and high-risk (class d). essential principles of safety and performance: the cdsco makes sure that samds follow the imdrf’s “essential principles of safety and performance of medical devices and ivd medical devices” when they design and make their products. labeling and advertising: in india, samds must follow the imdrf’s “principles of labeling for medical devices and ivd medical devices” to make sure users get the right information. structure of regulatory submissions: the cdsco has used the imdrf’s “medical device regulatory review report” template to decide the information that should be included and how it should be organized in regulatory submissions for samds. gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks j global clinical engineering vol.7 issue 2: 2025 18 table 1. comparative analysis for regulatory framework for ai across various regulatory agencies. feature sub-feature european union (eu) united states (fda) india (cdsco) focus regulatory framework for ai draft reflection paper on ai in medicinal products lifecycle defines “ai system” and proposes regulatory framework. eu ai act focuses on general ai development and ethical considerations. ai/ml action plan outlines focus on developing guidance for ai/ml in medical devices.43 aligns with imdrf principles for ai-based medical devices.44 traditional premarket pathways existing ce marking framework with risk-based assessment considering ai components. existing 510 (k) clearance, de novo classification, or premarket approval (pma) pathways for samd. follows risk-based classification similar to the us fda. post-market surveillance requires manufacturers to have a postmarket surveillance plan, potentially incorporating ai for anomaly detection and trend analysis.45 requires manufacturers to monitor and report adverse events for samd, potential use of ai for real-world performance monitoring. requires manufacturers to submit periodic safety update reports (psurs), potential for ai-assisted data analysis. ai-specific requirements transparency and explainability emphasis on transparency in ai decision-making processes and explainability of results. focus on good ml practices (gmlp) for development and validation of ai models. aligning with imdrf principles for data access, security, and responsible use.45 change management the draft guidance highlights the necessity for predefined change control plans for ai systems to maintain continuous regulatory compliance. guidance on predefined change control plans (pccp) for ai/ml outline processes for managing changes in ai models. aligns with imdrf principles for managing changes in ai-based medical devices. ai advantages for regulatory bodies efficiency and monitoring potential for ai to improve efficiency in monitoring medical device performance and identifying potential risks. potential for ai to streamline data analysis and automate risk assessment processes for samd. potential for aiassisted automation in regulatory processes once frameworks are established. challenges regulatory uncertainty lack of clear and finalized regulations for ai in medical devices creates uncertainty for developers and regulators.46 adapting existing frameworks to address the continuous learning nature of ai models presents challenges.47 limited experience and resources for implementing ai-based regulatory processes.48 19 j global clinical engineering vol.7 issue 2: 2025 gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks standards that are the same everywhere: in india, samds must follow international rules, such as iec 62304 for software lifecycle, iec 60601-1 for embedded software, and iec 82304-1 for standalone samds.42 table 1 provides a comparative analysis of the regulatory frameworks for ai across various regulatory agencies, highlighting key similarities and differences in their approaches. possible inclusion and advancement artificial intelligence and innovative regulatory intelligence integration with medical devices are to revolutionize efficiency, accuracy, and compliance. the changing landscape of the medical device regulatory framework is driven by the growth in ai solutions, which are now utilized by prominent regulators, such as the ema, fda, and cdsco. this section discusses potential progress and distinct types of innovation that are tailored to each regulator’s specific issues. focus areas include better data integration and interoperability, regulator-specific ai applications via innovation, and an ethical and transparent framework for ai development. the purpose is to present ai’s critical and ever-growing role in achieving better regulation, patient safety, and true international alignment. enhanced data integration and interoperability when it comes to regulating medical devices, it’s very important to combine data from different sources, such as clinical trials, post-market surveillance, and ehrs. this is because these sources provide important information for making sure that all regulations are followed. in response to this need, ai algorithms are created that allow huge amounts of unstructured data from many systems to be collected, processed, and turned into useful information. these algorithms can extract and align large amounts of data in real time, while most other ways of integrating data are done manually.49 one example of this trend is the use of ml models to connect patterns and changes in different databases. this allows regulators to see how the device works in a bigger picture for safety reasons. also, it’s faster to share data with regulatory bodies and other important parties, thanks to the progress in standardizing and connecting data. health level seven international (hl7) standards or fast healthcare interoperability resources (fhir) are examples of universal data standards and protocols that make sure that different systems talk to each other correctly so that data are used. not only do these improvements speed up the regulatory process, but they also make it easier to spot and act on safety signals quickly. data integration and interoperability made possible by ai help regulatory agencies make smarter rules to protect patients and keep up with medtech innovation.49 regulatory body-specific ai innovations customization of ai solutions to tailor specific regulatory challenges encountered by ema, fda, and cdsco is critical in streamlining regulatory operations and maintaining compliance acts. every regulatory body works within different laws and healthcare contexts, calling for highly differentiated ai use cases that answer to individualized requirements. the ema, for example, has been using ai to facilitate the review of clinical trial data processing validations with a view to speeding up the approval process swiftly and accurately while maintaining significant safety assessments.49 through real-time post-market surveillance, the fda has led the way in its application of ml algorithms and other ai technologies to track adverse event data (and even device performance) continuously. in india, the cdsco is turning to ai-powered ml tools that can help improve regulatory submission and approval time with so many medical devices entering a diverse market rapidly.49 these customized ai solutions have seen a level of advancements proven by successful implementation by regulatory bodies. the fda’s sentinel initiative alone is a case of how large-scale healthcare data are analyzed for post-market safety surveillance, bringing the process to detect potential safety signals by significantly reducing time with ai. this is the use of ai in implementing adaptive pathways by ema, leading to quicker entry for innovative medicines into the hands (health) of patients while upholding high safety standards. for instance, in india, ai-driven platforms are developed to automate the cdsco regulatory review process to save substantial time and effort on administrative tasks.49 thus, these customized ai solutions are able to solve specific regulatory problems and also lay the foundation gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks j global clinical engineering vol.7 issue 2: 2025 20 for agility in regulation. thus, this review article exhibits these progressions and contextual analyses which are used to understand the implementation of ai by regulatory bodies that augment their processes based on efficiency criteria for patient safety. this observation illustrates just how disruptive ai could be in regulatory intelligence, and why constant innovation is essential to adapt its capabilities to the evolving demands of their regulations.49 the fda’s pre-cert program is designed to enhance regulatory efficiency and innovation. pre-certified companies can release updates and new products more quickly, allowing for faster adoption of innovative technologies. this program also provides flexibility in evolving with technology, particularly for ai/ml, while maintaining a focus on safety through post-market monitoring and company excellence reviews.49 ethical and transparent ai progress in the evolution of responsible ai frameworks has become more urgent because medical devices are the area where advanced regulatory decisions are made, at least partially by an ai system. this is an additional measure important to ensure transparency and accountability, in turn ensuring the trustworthiness of ai-driven processes for public health maintenance. ethical ai frameworks are created to enable the development of these systems, so that they are designed and implemented in line with ethical principles as well as regulatory standards.49 this consists of having protocols for data privacy, bias mitigation, and ensuring equitable access to all-driven insights. these frameworks also underscore the need for accountability—that people must know who is responsible in cases where ai systems produce harm. the use of explainable ai (xai) models provides one of the most important advancements in this space. in cases where traditional ai systems are essentially “black boxes,” withholding any information about their decision-making process, xai models aim to better unpack the results of our ai systems. regulators and stakeholders should be able to unpack the decision criteria upon which the ai has based its conclusions, so that decisions at any time can still accompany handling scrutiny. for example, subjecting an xai model to a regulatory body looking at the integrity of any selected medical device should be able to understand how exactly it arrived at its decision based on concrete data and patterns. the fda is also showing initiatives in improving more ethically aligned and transparent ai through projects such as those exploring ways to bring xai into its regulatory review pathways. by requiring that ai models used in regulatory submissions be interpretable, the fda is ensuring that those tools can have both regulator and patient trust. on the other hand, some form of guidance and transparency in strategy, be it through routine audit processes for addition or on-account validation built-in algorithms, at ema and cdsco are likely to hold position.49 the fda is also showing initiatives in improving more ethically aligned and transparent ai through projects such as those exploring ways to bring xai into its regulatory review pathways. by requiring that ai models used in regulatory submissions be interpretable, the fda is ensuring that those tools can have both regulator and patient trust. on the other hand, some form of guidance and transparency in strategy, be it through routine audit processes for addition or on-account validation built-in algorithms, at ema and cdsco are likely to hold position.49 one world, one regulation in an era where ai technologies are rapidly advancing and transforming the landscape of medical devices, the need for a harmonized global regulatory framework has become increasingly evident. the vision of “one world, one regulation” encapsulates the aspiration for a unified approach to ensure that ai-powered medical devices meet consistent standards of safety, effectiveness, and ethical use across all regions. this vision is not just about standardization but about fostering an environment where innovation can thrive without being hindered by disparate regulatory requirements. by aligning regulatory approaches, we can facilitate the rapid deployment of ai technologies, making advanced healthcare solutions more accessible globally. moreover, a unified framework builds trust in these technologies by ensuring rigorous oversight and consistent performance standards. it also promotes collaboration among regulatory bodies, streamlining the approval process and reducing the burden on manufacturers. ultimately, the “one world, one regulation” approach is essential for realizing the full potential 21 j global clinical engineering vol.7 issue 2: 2025 gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks of ai in healthcare, ensuring that these technologies can be safely and effectively utilized to improve patient outcomes globally.49 conclusion the regulatory framework for medical devices incorporating ai is currently experiencing substantial changes. the ema, fda, and cdsco are actively formulating frameworks and guidelines to guarantee the secure and efficient utilization of ai. these initiatives seek to tackle problems stemming from unclear regulations and a lack of expertise in the field. the ema’s reflection paper emphasizes the importance of conducting a thorough risk analysis at the time of making decisions about the implementation of ai in medicines. this analysis should take into account factors such as the transparency and interpretability of the ai system as well as its ability to manage changes throughout its lifecycle. artificial intelligence has the capacity to completely transform the field of drug discovery and regulatory processes, encompassing everything from the initial development of pharmaceuticals to ongoing monitoring after approval. the ema undertakes a comprehensive assessment of these assertions. furthermore, the scientific validity and applicability of medical devices incorporating ai that are utilized in clinical trials within the eu are evaluated to ascertain their effectiveness and suitability in all member states. the ema recommends that sponsors assess the potential hazards of implementing new ai systems on patients and promptly seek guidance from the regulatory body. additional suggestions involve the creation and evaluation of ai systems using clear and well-documented approaches, offering strong justifications for ai implementation in particular situations, and comprehending the accompanying hazards and constraints. the fda has released guidelines for samd that employ ai and ml. these guidelines provide recommendations for effectively utilizing ml, incorporating pre-established change control systems, and guaranteeing the openness of data and algorithms. the fda acknowledges the revolutionary potential of ai and ml in medical devices while recognizing the distinct challenges posed by them. the adoption of the tplc approach facilitates the ongoing enhancement and progression of ai/ml-based software as medical devices, ensuring the preservation of safety and efficacy throughout all premarket review activities. the cdsco has implemented the regulations established by the imdrf, encompassing the risk-based classification system and fundamental principles for guaranteeing safety and performance. the cdsco follows imdrf guidelines to ensure the performance and safety of medical devices and ivds while designing and restructuring samd. indian samd must adhere to global standards, including iec 62304, for managing risks in the software life cycle, iec 60601-1 for embedded software, and iec 82304-1 for standalone samd. although regulatory ambiguity and limited expertise pose significant challenges, these regulatory bodies are making efforts to ensure the safe and effective utilization of ai in medical devices, ultimately improving patient outcomes. the main goal of the eu ai act is to effectively govern scientific progress and the extensive implementation of ai in medical devices and other products and services. these organizations work diligently to ensure that ai systems comply with safety regulations and ethical considerations while also protecting fundamental rights. author contributions conceptualization, r.g.; methodology, s.b.c.; software, i.s.; validation, i.s.; investigation, s.b.c.; resources, i.s.; data curation, a.a.; writing–original draft preparation, r.g. and a.a.; writing–review & editing, s.b.c.; visualization, s.b.c.; supervision, i.s.; project administration, i.s. acknowledgments the technical assistance needed to finish this project was provided by amity institute of pharmacy at amity university noida, for which the authors are grateful. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare they have no competing interests. gaur, akram, singh, chauhan: artificial intelligence-driven insights for regulatory intelligence in medical devices: evaluating ema, fda, and cdsco frameworks j global clinical engineering vol.7 issue 2: 2025 22 ethics approval and consent to participate not applicable. 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https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2 https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2 https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2 https://www.theseus.fi/bitstream/handle/10024/506136/nawar_bushra_2021_comparative%20analysis%20of%20artificial%20intelligence%20on%20medical%20device%20regulations%20and%20legislation%20in%20us%20and%20eu.pdf?sequence=2 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https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program https://doi.org/10.1016/b978-0-12-818438-7.00012-5 https://doi.org/10.1016/b978-0-12-818438-7.00012-5 5 j global clinical engineering vol.7 issue 3: 2025 received march 12, 2025, accepted may 30 2025, date of publication july 14 2025. original research article sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina valerio di virgilio1,*, pedro enrique garrigou2, ignacio lacasta casal2, patricia mariana crego2, miguel alejandro bruzzo2 1 department of computer, control, and management engineering, university of rome sapienza, rome, italy. 2 united nations office for project services, buenos aires, argentina. * corresponding author email: v.divirgilio@diag.uniroma1.it abstract context and objectives: this article presents the planning, construction, and equipping of 85 modular healthcare systems (mhs) in argentina as a medium-term response to the pandemic emergency. the objective is to describe the implementation and analyze the results of this large-scale national project and its investment component for the acquisition of hospital equipment, highlighting the design, outcomes, and lessons learned in the process with a focus on long-term sustainability. materials and methods: nine different phases of the implementation process of the project are described and analyzed as components of the sustainable procurement methodology. within the framework of the planning, construction, and commissioning of the nhs, data were collected and analyzed to qualitatively and quantitatively assess the experience of planning, designing, and procuring equipment for modular health centers. data analysis was conducted by categorizing the acquired goods into active and passive medical devices (md), furniture, support equipment, and installation equipment. results: the analysis of the equipment acquired for the 85 mhs shows that the distribution of assets aligns with specific needs and follows similar patterns across all units. among the 19,600 medical goods purchased, over 60% of the investment was allocated to md, reaching 87% in centers with higher critical care activity. visits to operating mhs confirmed their general functionality and user satisfaction with the infrastructure and equipment. strengths identified include well-designed facilities and decentralized healthcare delivery, which has reduced the burden on central hospitals. at the same time, some lessons have been learned and risks identified, such as specific shortages of specialized personnel, minor quality issues with equipment reception, and the storage of some unused or little-used devices. the need for active post-delivery management was also observed as lessons learned for future large-scale operations. discussion: it was highlighted that passive md, mainly medical furniture, while accounting for 64% of the equipment, only represents 13% of the investment. however, their appropriate selection and maintenance are crucial for patient perception and quality of care. furthermore, the high cost of medical technology was demonstrated by an analysis of investment per square meter. conclusion: the implementation of this project focused on medical technologies, analyzing design, equipment investment, outcomes, and lessons for long-term sustainability. the high cost of medical technologies confirms the opportunity to evaluate not only the purchase price but also operational, maintenance, and disposal costs. a comprehensive approach to equipment planning and management is an essential requirement for sustainability and efficiency in lmics. evidence-based needs analysis, crucial for sustainable acquisition and to align the equipment with intended use, and post-implementation visits, crucial for continuous quality improvement, are recommended for the implementation of future projects. the presented lessons http://www.globalce.org http://globalce.org http://globalce.org mailto:v.divirgilio@diag.uniroma1.it virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina j global clinical engineering vol.7 issue 3: 2025 6 learned contribute to establishing a methodological base for future md procurement projects. keywords—sustainable procurement, medical devices, modular hospitals, public investment, argentina, results assessment, project management, medical device planning, accessibility. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. introduction since brunel’s resilient hospital concept, based on prefabrication and modular construction—exemplified by the renkioi civil hospital built in 1855,1 modular hospitals have significantly evolved as an architectural solution within healthcare design. they provide new or existing health facilities with the flexibility to adapt to changing medical care needs and public health emergencies. depending on the context, modular hospital construction may serve temporary purposes, such as increasing isolation units in densely populated urban areas. in other cases, modular expansion in existing hospitals ensures uninterrupted facility operations, significantly enhancing the efficiency of medical response.2 in argentina, as in many other countries, modular healthcare systems (mhs) were rapidly developed in response to the covid-19 pandemic to provide swift solutions and prevent overcrowding at hospitals and community healthcare centers. over time, with positive implementation experiences, mhs has become a sustainable solution3 to strengthen healthcare systems in the medium and long term, improving medical service accessibility in vulnerable areas, including penitentiary services, and expanding coverage in strategic locations such as tourist areas and border crossings. this report is based on the experience gained since 2020, under the “federal infrastructure improvement” project. the united nations office for project services (unops) was commissioned by the secretariat of public works of argentina, ministerio de obras públicas (mop), to implement 85 mhs in various locations across the country. the project scope followed a “turnkey” model, requiring unops to provide infrastructure, installations, and material goods such as medical and general furniture, accessories, etc. when writing this report, 85 mhs had been awarded and constructed. eighty out of 85 (94%) have also been equipped and are functioning. in addition, the project has equipped another 19 mhs, where the construction of the centers, installed in tourist areas, was the responsibility of government authorities in argentina. this study focuses on the equipment acquired for the execution of unops project 20313, detailing the procurement process, quantitative and qualitative analysis of the equipment, and post-delivery visits to assess usage and impact.4 geographic distribution and social impact argentina is a vast country with a surface area of 3,761,274 km² and over 46 million inhabitants.5 however, its population distribution is unbalanced, with 92% of the population residing in urban areas and 70% concentrated in the 31 largest urban agglomerations in the country.6 the distribution of mhs under project 20313 was carried out nationwide, adapting to each area of influence, their specific characteristics and needs. the number of centers correlates to the country’s most densely populated regions: buenos aires province (20.69 million inhabitants, including the capital) and córdoba province (3.84 million inhabitants). these two provinces collectively account for 53% of the national population, where 45% of the mhs were constructed. figure 1 shows the geographical distribution of the 85 centers within argentina highlighting the buenos aires and cordova provinces. https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/ 7 j global clinical engineering vol.7 issue 3 2025 virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina figure 1. (a) geographical distribution of the 85 mhs, detailing the centers in the provinces of (b) buenos aires and (c) córdoba. infrastructure because of argentina’s diverse geographical and socioeconomic characteristics, healthcare needs vary significantly across the country. to adapt the architectural designs, infrastructure, and functional integrations of the mhs to each specific context, the mop technical team conducted an assessment on the use of prefab solutions and a consequent needs assessment for each case. adapting responses to particular requirements was a key element in ensuring project sustainability.7 modular centers were conceived as entry points to the healthcare system in response to the covid-19 pandemic. the different types of infrastructure provide primary, intermediate, or critical care services—either permanently or temporarily—until patients can be transferred to more complex healthcare facilities. each modular center addresses these needs through its design and infrastructure, despite diverse site locations and contextual conditions. some mhs were designed to operate independently from preexisting healthcare infrastructure while still being integrated into the broader healthcare network. this was the case for centers located at border crossings and tourist areas. at first, these centers have outpatient consultation rooms, inpatient rooms, diagnostic imaging areas, and clinical laboratories. an example of this model is the modular healthcare system maldonado | hpa san jorge | córdoba iv, located 12 km east of córdoba city center, as illustrated in figure 2. it includes a shock room, observation beds, an inpatient room, an x-ray room, consultation rooms, a clinical analysis laboratory, an extraction box, a nursing station, and a pharmacy, as illustrated in figure 3. figure 2. mhs maldonado, hpa san jorge, córdoba. other mhs served as support areas integrated into preexisting structures and operational frameworks. these include those annexed to existing healthcare centers or those that expanded medical areas within penitentiary facilities. virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina j global clinical engineering vol.7 issue 3: 2025 8 figure 3. floor plan of the mhs in maldonado, hpa san jorge, córdoba. an example of this model is the mhs at the federal complex rehabilitation center for young adults in marcos paz, buenos aires province, as illustrated in figure 4. it includes a nursing station, pharmacy, laundry, guardroom, clinical analysis laboratory, and 12 rooms, as illustrated in figure 5. a third example of an mhs, in this case, complementing a preexisting healthcare center, is mhs no. 9 in almirante brown, buenos aires, which directly collaborates with the adjacent unidad de pronta atención (upa) no. 5, as illustrated in figure 6. it has been designed with a capacity of 76 beds for critical care and hospitalization, as illustrated in figure 7. 9 j global clinical engineering vol.7 issue 3 2025 virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina figure 4. mhs federal complex rehabilitation center for young adults, marcos paz, buenos aires. figure 5. mhs federal rehabilitation complex for young adults’ floor plan, marcos paz, buenos aires. figure 6. mhs no. 9, almirante brown, buenos aires. a prefab module to complement an existing center. figure 7. mhs no. 9, almirante brown, buenos aires. a prefab module to complement an existing center. virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina j global clinical engineering vol.7 issue 3: 2025 10 methodology planning, designing, and procuring the equipment of the 85 mhs have been accomplished using the prince2 methodology.8 before project closure, a phase to analyze the results has been implemented with organization visits to a few centers, as samples, several months after their commissioning, to assess the results and the impact of the project on the healthcare system. several months after their commissioning and before the closure of the project, a sample visit to 10 centers has been carried out to analyze the project’s results. procurement process the project’s implementation considered a multistep procurement methodology: 1)grouping the procurement process for multiple mhs according to execution timelines and type. a total of nine procurement processes were conducted for the 85 mhs between 2020 and 2023, as described in table1. # process number of sites year 1. modular healthcare systems 11 2020 2. modular healthcare systems for penitentiary services 6 2020 3. modular healthcare systems for penitentiary services 12 2020 4. modular health centers for border 16 2020 5. health isolation centers for penitentiary services 10 2021 6. modular healthcare systems phase 1 12 2021 7 modular healthcare systems phase 2 and modular healthcare systems for penitentiary services 7 2022 8 modular healthcare systems phase 3 6 2022 9 modular healthcare systems phase 4 5 2023 table 1. nine procurement processes carried out to equip the eighty-five health centers. 11 j global clinical engineering vol.7 issue 3 2025 virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina note: for the 19 mhs where unops was only responsible for supplying material goods, the equipment was organized into five further procurement processes during 2020 and 2021.9,10 2)determination of requirement lists: based on infrastructure analysis and functional programming, using the room-by-room methodology, which designs the optimal set of equipment and furniture for each environment, considering space size and internal operational workflows. 3)consolidation of procurement needs: grouping similar or identical goods into packages according to complexity and usage characteristics, considering the local and international hospital equipment markets. 4)definition of technological level: through continuous dialogue with end users, the type of technology and complexity level of the equipment to be acquired were determined.11 5)specification of equipment requirements: to ensure minimum acceptable quality thresholds, procurement processes followed the lowest-price principle, requiring careful assessment of local and international markets. 6)procurement process compliance: adhering to the unops procurement manual,12 focusing on promoting local production. for class i or a medical devices (md) (eu and us regulations) manufactured locally in argentina, only the local regulatory agency certification: anmat was required. for higher equipment of higher complexity, certifications from stringent regulatory entities such as those in the united states, europe, japan, australia, and canada were required. 7)receipt of goods by medical units and installation of complex equipment by suppliers. 8)certification by the national regulatory authority for fixed radiological units. 9)analysis of procurement and installation outcomes in 10 selected centers, as a sample of the 85 centers, with different characteristics. equipment requirements ● md and in vitro medical devices (ivd) defined according to imrdf13 were classified as active or passive. ○ active devices: depend on an external energy source (other than the human body or gravity) and modify or transform that energy. ○ passive devices: do not require an external energy source beyond that generated by the human body or gravity. ● support equipment: items not classified as md but requiring electrical power (e.g., bedpan washers, industrial dryers, compressors, standard refrigerators, and computers). ● support furniture: items related to general human activities or medical practice support, specifically designed for healthcare environments (e.g., dining tables, chairs, stairs, and carts). ● facilities-related equipment: supply systems supporting medical equipment and patient care (e.g., power generators and medical gas plants). mds, both active and passive, were classified into four functional groups: ● basic care: equipment used in low-complexity areas, mainly for screening or primary care, such as blood pressure monitors, hospital beds, and scales. these represent 75.2% of the total medical equipment acquired for all cms, accounting for 24.6% of the total investment. ● critical care: this category includes mds used in critical patient care, such as ventilators, defibrillators, and infusion pumps. this group constitutes 19.2% of the medical equipment acquired and 40.2% of the total investment. ● sterilization: equipment used to eliminate pathogens from medical tools and devices, which includes hydrogen peroxide sterilizers and dry heat sterilization ovens. it represents 0.36% of md but accounts for 5.4% of the total investment. ● imaging and laboratory diagnostics: internal body images for diagnostic, prognostic, and treatment purposes are generated with diagnostic imaging. because of the nature of these healthcare centers, the acquired virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina j global clinical engineering vol.7 issue 3: 2025 12 equipment in this category includes fixed and mobile x-ray machines and ultrasound devices. clinical laboratory equipment includes centrifuges for test tubes, microscopes, micropipettes, and medical refrigerators. this group accounts for 5.4% of the md acquired but represents 29.8% of the total investment, reflecting the high cost of imaging technology. results and outcome measurement visits biomedical engineers from unops personally conducted results-measuring visits to the selected 10 mhs to ensure the effectiveness of public procurement in healthcare. the results measurement phase evaluated the qualitative and quantitative impact of investment on population health while identifying lessons learned for continuous improvement.14 as part of this framework, site visits were planned to assess the condition and usage of delivered medical equipment and collect user feedback. a sampling methodology was used, resulting in 10 visits. at least one modular unit from each of the first eight processes outlined in the section “the acquired equipment” was inspected. however, for process 9, mentioned in table 1, the modular units had not been equipped, making it impossible to include them in the assessment. the visits were conducted in person by one or two biomedical engineers from unops. phase 1: selection of centers and pre-visit planning before each visit, the medical coordinator of each site was contacted to ensure that the information collected at each center was representative and sufficient. this way, the visit would occur at a date and time, when the maximum number of users (e.g., x-ray technicians and ultrasound physicians) were available, and full access to all medical equipment was granted. phase 2: information gathering before conducting each visit, a thorough review of procurement and delivery documentation was performed. this included the examination of published procurement processes, received bids, evaluations, awarded contracts, purchase orders, and delivery receipts. all this information was organized into specific templates for each center, facilitating traceability and serving as a reference during the visits. phase 3: structured interview a structured interview approach to ensure comparable data collection has been used. when addressing satisfaction with the proposed subjects, the referents were asked to categorize their answer using the following options: strongly disagree, disagree, neither disagree nor agree, agree, strongly agree. the structured interview comprising eight questions was submitted to the director of the visited modular unit or the person in charge during the visit, resulting in a talk of approximately half an hour. section a: equipment satisfaction and suitability 1. overall satisfaction: “the received equipment in terms of its quality, functionality, and quantity relative to your experience and expectation, is satisfactory.” 2. technology level: “the technology level of the received equipment meets the clinical needs of your patient population and the capabilities of your staff.” 3. completeness: “the equipment was delivered with all necessary accessories, components, and software required for its intended functionality and immediate use.” section b: personnel and training 4. presence of personnel: “the center has sufficient and adequate staff to use the purchased medical equipment.” 5. user training adequacy: “the training provided to clinical users on the operation and application of the new equipment was adequate and effective.” 6. technical training adequacy: “the training provided to technical staff (biomedical engineers and technicians) on the maintenance, troubleshooting, and repair of the new equipment was adequate and effective.” section c: supplier support 7. supplier contact information: “you have clear and readily accessible information on how to contact the 13 j global clinical engineering vol.7 issue 3 2025 virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina supplier for warranty claims, technical support, and spare parts.” 8. warranty claim satisfaction: “if you have submitted a warranty claim, you are satisfied with the supplier’s responsiveness, the speed of resolution, and the overall outcome.” section d: impact on healthcare infrastructure 9.impact on higher-level facilities: “the presence of this center and its equipment has reduced the burden or demand on higher-level healthcare facilities in the province.” phase 4: on-site assessment the duration of in-person visits varied depending on the center’s size, the quantity of installed medical equipment and furniture, the number of interviews conducted, and the specific operational conditions at the time of the visit. the evaluation process included: 1. verification of serial numbers for all mds. 2. assessment of equipment integrity. 3. documentation of each item’s location. 4. capturing photographic records of relevant documentation. 5. identification of any potential issues affecting equipment usability. 6. confirmation of appropriate user training provided for equipment operation. 7. evaluation of supplier responsiveness in cases where technical support was requested. the organization of the assessment tasks according to the complexity was as follows: type a assessments, applicable to high-complexity equipment: ● verify the presence of the equipment. ● check installation conditions. ● verify the validity of the warranty and whether it has been used. ● confirm whether the training required by the award contract has been provided. ● ensure the presence of user manuals. ● verify the delivery of accessories, if applicable. ● take at least three photographs of the equipment: one showing its placement within the facility, one close-up of the equipment, and one of the serial number plate. ● assess the equipment’s functionality and gather user experience feedback. ● if possible, determine the number of patients examined or treated using the equipment. type b assessments, applicable to low-complexity equipment: ● at a minimum, verify the presence of the equipment, installation conditions, and warranty status. ● take at least one close-up photograph of the equipment. type c assessments, applicable to medical furniture: ● verify the presence of the furniture. ● photograph and document any identified issues or anomalies related to its delivery. phase 5: reporting and lessons learned after each visit, a detailed report was compiled summarizing findings and observations. these findings were then consolidated into a final report, listing the visits chronologically and highlighting key insights for future improvements. virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina j global clinical engineering vol.7 issue 3: 2025 14 results the acquired equipment with the definitions explained in the methodology, the analysis of the acquired equipment and furniture allows us to demonstrate the distribution of quantity and values, as reported in figures 8–11. of the goods and services directly related to medical practice and patient care, 78% correspond to md, representing 78.9% of the investment in this category. figure 8. distribution of facilities-related equipment, medical devices, support equipment, and support furniture. figure 9. distribution of investment in facilities-related equipment, medical devices, support equipment, and support furniture. figure 10. distribution of medical devices by application. 15 j global clinical engineering vol.7 issue 3 2025 virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina figure 11. distribution of investment in medical devices by application. the mhs were constructed in geographical locations with dissimilar characteristics and needs; therefore, the quantity and characteristics of the assets are not homogeneous across all centers but rather respond to the epidemiological needs of each case. nevertheless, analyzing examples from each of the mhs typologies, it is observed that their distribution follows similar patterns in all cases. more than 60% of the investment allocated to goods directly related to medical practice, in all analyzed cases, corresponds to md, reaching 87% in units with higher critical care activity, as higher cost devices. regarding md characteristics, the largest group corresponds to basic care equipment, exceeding 62%. this is consistent with the conception of health centers as gateways to the health system. the percentage reaches 94% in penitentiary services centers, where immediate and low-critical medical care is expected to be provided. visit results the objectives set for the mhs visits were met, allowing for the assessment of installed equipment conditions, its usage, and supplier responses to users. in all cases, it was possible to interview coordinators or medical officers and obtain information on current situations and future projections. the results of the structured interview carried out with the eight questions presented in “section 2, phase 3: structured interview” are presented in table 2, as percentages of answers for each question. table 2. results of the structured interview. strongly disagree (%) strongly disagree (%) disagree (%) neutral (%) agree (%) strongly agree (%) n/a (%) q1 0 40 0 10 40 10 q2 0 10 0 60 20 10 q3 0 0 0 30 50 20 q4 0 25 0 25 0 50 q5 0 30 10 10 30 20 q6 0 10 10 0 0 80 q7 0 30 0 10 30 30 q8 0 0 0 0 10 90 q9 0 0 0 10 20 70 the eight questions are presented in “section 2, phase 3: structured interview” and the results are categorized as strongly disagree, disagree, neutral or neither agree or disagree, agree, strongly agree, n/a: not applicable or not answered. the percentage of each answer is shown in table 2 and the statistical analysis of the answers is reported in table 3. assigning numerical values from 1 to 5 allows for the calculation of mean values and standard deviations to gauge the level of agreement. based on these metrics, the mhs virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina j global clinical engineering vol.7 issue 3: 2025 16 directors’ responses suggest the following: ● technical and clinical staff training: the directors do not generally support the idea that adequate training of the technical staff has been carried out. however, they show slight support for the notion that the center has sufficient and adequately trained staff for equipment use. ● equipment quality and support: there is some agreement among the directors regarding the quality, functionality, and quantity of the received equipment. they also agree on the availability of information for contacting the supplier when needed. ● equipment adequacy and impact: the directors generally agree that the level of equipment is adequate for both clinical needs and staff capabilities. they also acknowledge the good condition of the equipment upon arrival and recognize that the center and its equipment have reduced the burden on higher-level healthcare facilities. ● warranty satisfaction: in the one instance where the warranty was activated, the supplier’s response was rated as very satisfactory. table 3. statistical analysis of the results of the structured interview. question average level of agreement std dev q6: adequate and effective training provided to technical staff 2.5 0.7 q4: the center has sufficient and adequate staff to use the equipment 3.5 1.4 q5: adequate and effective training provided to clinical users 3.5 1.4 q1: received equipment in terms of its quality, functionality, and quantity is satisfactory 3.6 1.5 q7: clear and readily accessible information on how to contact the supplier in case of need 3.6 1.5 q2: the level of the equipment is adequate to the clinical needs and staff capabilities 4.0 0.9 q3: the equipment was delivered in good condition for its intended functionality and use 4.3 1.0 q9: the center has reduced the burden or demand on higher-level healthcare facilities 4.5 0.6 q8: supplier’s responsiveness to warranty claims, satisfactory speed of resolution, and overall outcome 5.0 n/a note: results below 3 show a disagreement (pink), results between 3 and 4 show a certain agreement (yellow), and results between 4 and 5 show high levels of agreement (green). n/a: not applicable. std dev: standard deviation. figures 12–17 show some of the hospital areas and equipment inspected during the visits. figure 12. equipment and facilities-related equipment installed in a critical care unit, mhs no. 9—almirante brown, buenos aires. figure 13. equipment installed in a clinical analysis laboratory, mhs no. 28—exaltación de la cruz, buenos aires. 17 j global clinical engineering vol.7 issue 3 2025 virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina figure 14. equipment installed in a gynecological room, mhs no. 28—exaltación de la cruz, buenos aires. figure 15. equipment and facilities-related equipment installed in an observation sector, mhs san jorge, córdoba. figure 16. equipment and facilities-related equipment installed in a hospitalization room, mhs no. 9—almirante brown, buenos aires. figure 17. equipment installed in an emergency office, mhs no. 28—exaltación de la cruz, buenos aires. virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina j global clinical engineering vol.7 issue 3: 2025 18 although in a few cases, clinical services were found to be not operational because of a lack of clinical specialists, like cardiologists or pediatricians, end users expressed satisfaction in quality, quantity terms, and supplier responsiveness toward the available technology. they also highlight the improvements that equipment and facilities-related equipment have brought to their daily work. in addition, the new medical specialties and practices introduced in some mhs have reduced patient waiting lists in central hospitals. the following four strengths of the implemented project were identified: strengths: 1. well-designed facilities with spacious areas and adequate lighting. 2. high user satisfaction with received goods and their positive impact on daily work. 3. reduced demand in central hospitals because of decentralized healthcare services.* 4. properly stored and managed equipment, all of them are in good working conditions. *note: reduced demand in central hospitals because of decentralized healthcare services is a qualitative finding from question 8 of the structured interview: “to what extent has the presence of this equipment at your center reduced the burden or demand on higher-level healthcare facilities in the province?” lessons learned the following six lessons learned have been identified during the visit and an analysis of their results: 1. it is essential to establish a dedicated process ensuring sufficient personnel/specialists for mhs operation. in some cases, the absence of clinical personnel has delayed implementation and affected the warranty, since the equipment has been stored for a long time. 2. it is essential to establish a formal process to inspect the quality and integrity of each delivered equipment. in a couple of cases, the visit detected missing accessories (one wheel of one examination lamp and few shelves) and the problem was solved with the suppliers. 3. it is essential to prepare the equipment list based on the real existing or projected needs. it was observed that few equipment (about 2%), like humidifiers to support mechanical ventilation, were not used because of a lack of specific needs. the presence of some underutilized equipment may be a consequence of misalignment between the specific needs of mhs facilities-related equipment and the equipment provided as well as changing needs during a project’s implementation. 4. as a result of the structured interview, it is recommended that the training process is monitored and certified. it was identified that some end users were unaware that they could request training from the equipment suppliers. in addition, they did not know how to contact the suppliers. compounding the issue, internal training sessions were conducted by other users of similar equipment, with the risk of incorrect concepts leading to an improper use of the devices. 5. it is recommended that all the local regulatory requirements are properly managed in advance. specifically, the necessary authorizations from the radiological health authority of the argentine ministry of health (radiología sanitaria), responsible for verifying and approving radiology rooms, were not processed from the beginning, with the risk of delays in the start-up of radiology services. in this specific case, a prompt reaction and a proactive management of this specific risk have avoided delays. 6. it is recommended to streamline the communication of the contractual conditions with the final users. in most cases, the misconception that equipment belongs to unops and not to the final users prevented the possibility of its redistribution according to changing needs. finally, the case of mhs no. 9 in almirante brown, buenos aires province, can be reported as a remarkable success. originally conceived as a sars-cov-2 pandemic response unit, it has since been integrated into the local healthcare network, coordinating with the “dr. lucio meléndez” general acute hospital and the adjacent “unidad de pronta atención” (upa) no. 5. it currently receives patients requiring hospitalization through the 19 j global clinical engineering vol.7 issue 3 2025 virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina upa and referrals from the main hospital. during the second quarter of 2024, it recorded 695 patient admissions, with a projection of 2.800 patients/year, becoming key in relieving and decentralizing the demand for critical and intermediate care hospitalizations. discussion replicability for different contexts some key parameters can be identified to help similar projects estimate budgets and workloads in the inception phase. within the md acquired for all mhs, passive equipment accounts for 64% but represents only 13% of the investment in medical equipment, as shown in figures 18 and 19. figure 18. distribution of active and passive medical devices. figure 19. distribution of active and passive medical devices. the passive device group primarily consists of inpatient beds, stretchers, wheelchairs, blood pressure monitors, and stethoscopes, all of which are low-cost and lowcomplexity items. this could lead to underestimating the time dedicated to their evaluation and acquisition.15 however, it is important to note that these devices are in contact with the patient for a significant portion of their stay in healthcare centers. since the patient’s perception of the environment impacts their treatment outcomes,16–18 it is relevant to dedicate adequate human and economic resources to the selection and maintenance of these assets. an analysis of the investment in md, medical furniture, support equipment, and facilities-related equipment per square meter (m2) shows that for the individual modular centers analyzed, the highest investment per m2 corresponds to md, followed by investment in facilitiesrelated equipment. table 4 presents the mhs data for various centers with different surface areas. four mhs typologies with different surface areas were selected to analyze the parametric cost of the equipment. these typologies range from the largest surface area (mhs #1 of 1,100 m2) to the smallest (mhs virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina j global clinical engineering vol.7 issue 3: 2025 20 #4 of 285 m2); two intermediate cases (mhs #2 and mhs #3) have also been selected. as shown in table 4, mhs for penitentiary services, mhs# 3 and mhs# 4, have a lower relative investment in md in comparison with the other centers. smaller centers of the same type have a greater relative investment in md compared to larger ones. table 4. investment per square meter for the different types of facilities and for four mhs, each representing different sizes and types of centers. mhs type # 1 # 2 # 3 # 4 area (m2) 1,100 990 660 285 medical devices* 533.9 259.4 182.8 336.6 medical furniture* 11.6 11.8 1.9 2.2 support equipment* 6.1 0.5 22.1 25.5 facilities-related equipment* 100.4 25.2 96.6 136.0 total equipment investment* 652 296.9 303.4 500.3 percentage of medical devices in total equipment cost 82% 87% 60% 67% equipment cost * investment [u$s/(m2)] in table 4 mhs type #1 corresponds to mhs annexed and integrated into preexisting healthcare centers, mhs type #2 corresponds to mhs designed to operate independently from preexisting healthcare infrastructure, and mhs types #3 and #4 correspond to mhs for penitentiary services of different sizes, which respond to the size of the beneficiary population. this evidence underscores the high cost of medical technology that is independent from the specific size and type of center and reinforces the importance of conducting a needs analysis as a starting point for the acquisition process based, among other factors, on the intended use of the assets. similarly, costs associated with the entire life cycle of medical technology within the healthcare center must be considered, from the initial purchase expenses to the final disposal costs. the purchase price is only the tip of the iceberg concerning associated costs. a proper medical technology cost analysis requires considering not only the purchase price but also installation, operation, financing, disposal, and other costs generated during the useful life of the device.19 a detailed analysis of medical technology costs throughout its life cycle will require further investigation. the pan american health organization considers preventive and corrective maintenance costs to represent between 3% and 7% of the equipment’s purchase cost per year when performed by the healthcare center’s staff; and between 8% and 15% when external services are contracted.20 costs associated with the devices’ operation vary depending on the technology, and their origin is very diverse. clinical analysis laboratory equipment may have high costs in reagent consumption, while imaging equipment will have large consumption in electricity and cooling supplies. the analysis and observation of all costs associated with medical equipment during its useful life is a fundamental part of sustainable acquisition.21 conclusion in conclusion, as a medium-term response to the pandemic, argentina undertook a national project to plan, construct, and equip 85 mhs. this article describes the project’s implementation for the medical technologies component and analyzes its results, focusing on the design, equipment investment, outcomes, and lessons learned within the objective of long-term sustainability. the evidence presented highlights the significant impact of md investment on healthcare facility costs, emphasizing that the purchase price is merely the initial expense in a device’s lifecycle. 21 j global clinical engineering vol.7 issue 3 2025 virgilio, garrigou, casal, crego, bruzzo: sustainable procurement of medical technologies: equipping 85 modular healthcare systems in argentina considering the significant financial implications of medical technology, as highlighted by the consistent costs across various facility types, conducting a needs analysis is a crucial first step in sustainable acquisition, ensuring that the selected equipment aligns with its intended use and the facility’s long-term goals.22 the six identified lessons learned can serve as a valuable checklist for future healthcare infrastructure planning and medical equipment deployment, enabling hospital planners, policymakers, and health authorities to deliver effective and sustainable healthcare solutions. these lessons, when integrated with the three pillars for md procurement—selecting equipment that meets beneficiary clinical needs, considering human resource capabilities, and assessing local infrastructure conditions, all while prioritizing the asset’s lifelong use—collectively form a robust methodology for implementing future projects. as the post-implementation visit was not included in the original project’s plan and has been carried out with limited resources, to ensure continuous quality improvement process for the md procurement implementation strategy, we recommend scheduling such visits in the design phase of future projects, including in the agreement a provisions for the regulated sharing of anonymized access data related to the project’s infrastructure to measure its impact rigorously. author contributions conceptualization, v.d.v., pmc and m.a.b.; methodology, v.d.v., pmc and m.a.b; software, v.d.v., pmc and m.a.b; validation, v.d.v., pmc and m.a.b; formal analysis, v.d.v., pmc and m.a.b; investigation, v.d.v., pmc and m.a.b; resources, v.d.v., p.e.g., i.l.c., pmc and m.a.b; data curation, v.d.v., p.e.g., i.l.c., pmc and m.a.b; writing–original draft preparation, v.d.v., pmc and m.a.b; writing–review & editing, v.d.v., p.e.g., i.l.c., pmc and m.a.b; visualization, v.d.v., pmc and m.a.b; supervision, p.e.g., i.l.c.,; project administration, p.e.g., i.l.c.,; funding acquisition, p.e.g., i.l.c. acknowledgments not applicable. funding this research received no external funding. data availability statement not applicable. conflicts of interest the authors declare they have no competing interests. ethics approval and consent to participate not applicable. consent for publication not applicable. further disclosure not applicable. references 1. tang, k. and chen, b. resilient hospital design: from crimean war to covid-19. herd. 2023;16:36–55. https://doi.org/10.1177/19375867231174238. 2. smolova, m. and smolova, d. emergency architecture. modular construction of healthcare facilities as a response to pandemic outbreak. e3s web conf. 2021;274:01013. https://doi.org/10.1051/e3sconf/202127401013. 3. a/res/70/1 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https://biblioseb.wordpress.com/wp-content/uploads/2018/03/biomedical-engineering-handbook-j-d-bronzino.pdf https://biblioseb.wordpress.com/wp-content/uploads/2018/03/biomedical-engineering-handbook-j-d-bronzino.pdf https://biblioseb.wordpress.com/wp-content/uploads/2018/03/biomedical-engineering-handbook-j-d-bronzino.pdf https://campus.paho.org/en/course/healthcare-technology-planning-management-2019 https://campus.paho.org/en/course/healthcare-technology-planning-management-2019 https://doi.org/10.31354/globalce.v0i1.23 https://doi.org/10.1186/s12992-017-0280-2 https://doi.org/10.1186/s12992-017-0280-2 j global clinical engineering vol.7 issue 1: 2025 52 received february 8, 2024, accepted february 10, 2025, date of publication march 17, 2025. review effectiveness of robotic rehabilitation in the management of stroke patients—a literature review manav prasad, deepshikha madhual, kriti sachan*, afshan perwez, shivani tiwari and baldev negi 1 department of physiotherapy, sharda school of allied health sciences, greater noida, uttar pradesh, india. * corresponding author email: kriti.sachan@sharda.ac.in abstract background and objective: stroke is considered a root cause of disability worldwide, adversely affecting movement and balance. it requires comprehensive rehabilitation to achieve maximum recovery. gait training, including robot-assisted methods, is crucial in restoring independence among stroke survivors. balance impairment leads to challenges that demand specialized interventions, while cognitive deficits add complexity to rehabilitation. despite ongoing research, optimizing outcomes remains a challenge, urging innovation in trial design and intervention strategies to enhance the effectiveness during stroke rehabilitation. this literature review highlights the evidence regarding the uses and effectiveness of robotic rehabilitation amongst stroke survivors. methods: the searches were performed on databases like pubmed, scopus, and google scholar using keywords such as gait, balance, cognitive ability, and upper limb rehabilitation. the inclusion criteria were the studies published in english with a study design of randomized controlled trials focusing on stroke patients. the intervention included robotic rehabilitation. qualitative data synthesis was gathered after screening the abstracts and full texts of the included articles. result: this literature review found that robotic rehabilitation, including intensive and personalized sessions, targeted resistance, augmented feedback, and sensory inputs, yields significant improvements across multiple domains for stroke patients. these improvements include enhanced gait parameters, balance, cognitive abilities, and upper limb functionality. robotic-assisted therapy can improve motor function, coordination, memory, attention, and sensory perception, ultimately contributing to better recovery and quality of life for individuals affected by stroke. conclusion: this study concluded that combining robotic rehabilitation with other techniques can provide enhanced benefits compared to conventional rehabilitation. however, more studies are required to reach any firm conclusion. keywords—stroke, gait, robotic rehabilitation, upper limb rehabilitation, cognitive ability, balance. copyright © 2025. this is an open-access article distributed under the terms of the creative commons attribution license (cc by): creative commons attribution 4.0 international cc by 4.0. the use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. no use, distribution or reproduction is permitted which does not comply with these terms. 53 j global clinical engineering vol.7 issue 1: 2025 prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review introduction stroke is the preliminary cause of disability observed amongst adults, leading to substantial financial consequences for victims, their families, and society as a whole. following a stroke, disabilities are a hedge to healthcare and have several long-term counteraccusations on a person’s capability to ambulate and maintain balance.1 the unexpected reduction in brain conditioning causes weakness in one side of the lower extremities. such individuals tend to depend more on the lower extremities, which are unaffected. they are more likely to have an inconsistent, unstable distribution of weight and a reduced gait cycle.2 thus, perfecting and recovering the capacity to walk is essential to gaining autonomy in day-to-day conditioning and perfecting daily life quality.1 the general physical state and the strength, endurance, and coordination of their lower extremities amongst stroke survivors can be improved with gait training. advancements in muscle tone normalization, balance, overall fitness and endurance, and functional skills are all included in the barthel index (bi) and rivermead mobility index. these scales are accepted as suitable criteria to assess a stroke case’s functional condition and are reliable labels of the effectiveness of the enforced therapy.3 numerous strategies, including neurodevelopmental procedures, repeated task training, biofeedback, bodyweightsupported treadmill training, robot-supported training, and high-intensity physical therapy, have been used in neurorehabilitation programs to enhance balance and locomotor capabilities. despite these initiatives, opinions on how well these approaches enhance balance and motor skills are still undiscovered.1 one technique utilized to assist stroke victims in recovering their capacity to walk is robot-supported gait training. it enables the creation of walking movements continually, adding the number of gait cycles and step accuracy while requiring trainers to deliver the least amount of physical effort. an exoskeletonassisted robot is generally used in robot-assisted gait training, which may be divided into two primary types: over-ground and treadmill-based exoskeleton robots.4 amongst stroke victims, balance damage is a serious concern that can arise from several causes, including defined range of motion, muscular atrophy, sensitive abnormalities, and cognitive issues. this impairment makes movement delicate and raises the possibility of falling. the inability to integrate sensitive data from the vestibular, visual, and somatosensory systems is a major contributing factor. balance is maintained by somatosensory signals from the lower extremities in healthy individuals, though stroke victims frequently do not receive this information. balance requires central integration, which is the activation of substitute sensitive systems to make up for inadequacies. balance capability can be enhanced using specialized training methods, like modifying sensory inputs or measuring balance with analytical equipment. however, studies on how stroke survivors’ center of pressure movement and muscle activation are impacted by sensory integration.5 one of the most common physical impairments leading to stroke-related disability that affects the performance of daily living activities is gait disorder, which is a common clinical issue for stroke survivors. therefore, a primary focus of post-stroke rehabilitation is gait disorder.6 following a stroke, patients walk with coordinated lower extremities mass patterns instead of controlled movement of individual joints. walking induces two kinds of synergistic patterns. while the hip, knee, and ankle dorsiflexors produce the mass flexion pattern during the swing phase, the quadriceps and gluteus maximus work in concert to produce a mass extension pattern during the stance phase. basic deficits causing asymmetry include poor support for a single limb and uncontrollably moving forward. reduced stance time and extended swing duration on the affected side make up the asymmetry. the gait cycle’s regular pattern of symmetrical step length is absent, with the paretic side having a longer way.7 post-stroke cognitive impairment is the term used to describe cognitive deficits that manifest three to six months following a stroke. the stroke itself can cause these deficits, or they can pre-exist. aphasia, memory problems, and advanced-order cognitive dysfunctions similar to executive and visuospatial impairments are among these deficits; these frequently coincide with vascular cognitive impairment. studies have demonstrated cognitive decline both before and after stroke, and vascular risk factors raise the threat of both stroke and cognitive decline.8 prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review j global clinical engineering vol.7 issue 1: 2025 54 the need for stroke rehabilitation services is rising as strokes continue to be the primary cause of adult disability. numerous large-scale intervention trials aimed at motor recovery report similar advancements in motor performance for both the intervention and control groups, though not always to the same degree. these indifferent outcomes could result from the tested interventions’ lack of added benefit or the numerous difficulties in planning and carrying out extensive stroke rehabilitation trials. new approaches to patient selection, control interventions, and endpoint measures are strategies for enhancing the quality of trials. rehabilitation techniques help stroke survivors recover their independence indeed, though research into stroke rehabilitation aims to enhance trials, interventions, and results.9 the main objective of this review study was to summarize robotic rehabilitation’s effectiveness in managing stroke patients. this study provides valuable insight into the promising benefits of robot-assisted rehabilitation for improving the quality of life among individuals suffering from stroke. methods search strategy: a comprehensive literature search was conducted across multiple databases, including keywords such as “robotic rehabilitation”, “stroke”, and “rehabilitation”. the articles were searched in different databases including pubmed, google scholar, pedro, and cochrane library. inclusion criteria: inclusion criteria for study selection involved randomized controlled trials and pilot studies published between 2017 and 2024. exclusion criteria: exclusion criteria excluded systematic reviews, meta-analyses, and articles published before 2017. data extraction: initial searches identified 87 relevant articles. these articles underwent screening, with 30 identified for this review study. the included articles compared outcomes of robotic rehabilitation interventions versus control groups in stroke patients. data collection encompassed various parameters, such as the impact of robotic training on gait, balance, cognitive ability, and upper limb rehabilitation. additionally, different components demonstrating the efficacy of robotic rehabilitation were reviewed. result effect of robotic rehabilitation on gait kim et al. (2024) conducted a study titled “simultaneous high-definition transcranial direct current stimulation (hd-tdcs) and robot-assisted gait training in stroke patients”.10 the research utilized the lokomat robotic device and involved 24 participants. these patients were split into the real hd-tdcs set, and the sham hd-tdcs set. in this real hd-tdcs set, participants obtained robotic training alongside transcranial direct current stimulation, whereas the sham hd-tdcs set underwent robotic drilling without the stimulation. assessments using various measures such as the functional ambulation category (fac), dynamic gait index (dgi), fugl-meyer assessment (fma), timed-up-and-go (tug) test, berg balance scale (bbs), 10-meter walk test (10mwt), functional reach test, visual analog scale (vas), and korean modified bi (k-mbi) were conducted. the action spanned 10 sessions over four weeks. after four weeks, significant improvements were observed in all test parameters within the real hd-tdcs set, whereas the sham hd-tdcs set displayed no notable improvement. the real hd-tdcs set exhibited multiple enhancements among physical functions, indicating the positive impact of combining robotic training with transcranial direct current stimulation. li et al., conducted a study titled “effect of robotassisted gait training on motor and walking function in patients with subacute stroke”.4 the research utilized the bear-h1 (wearable lower extremity exoskeleton robot) robotic equipment and included 36 patients aged 18 to 75. patients were separated into two clusters: cluster a, the experimental cohort, and cluster b, the baseline cluster, which were delivered traditional therapy. assessments were conducted using measures such as fac, mini-mental state questionnaire, ashworth test, 6-minute walk assessment (6mwt), functional ambulatory classification, fugl-meyer questionnaire for bottom extremity, and modified ashworth scale. both groups underwent exercises focusing on muscle strengthening, stretching, and balance for four weeks, twice a day for 1,800 seconds, five days 55 j global clinical engineering vol.7 issue 1: 2025 prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review intervention comprised sessions conducted thrice a week, with each session lasting 30 minutes, spanning over seven weeks. additionally, the intervention group received an extra 20 minutes of treatment with the g-eo system during each session. after seven weeks, participants in both groups demonstrated improvements in various aspects, including reduced risk of falling, increased walking speed, decreased fear of falling, improved mobility, and enhanced performance in daily tasks. notably, the group utilizing the g-eo system experienced further advantages, such as improved walking speed, better balance, reduced fear of falling, and increased acceptance of technological aids.12 alingh et al., conducted a study titled “training for improvement of propulsion symmetry and gait speed in chronic stroke patients”.13 the study utilized the lopes ⅱ, demcon and moog bv, usa robotic devices. a total of 29 participants between 51–71 years old were interviewed for the research. the study consisted of a single group that received treatment using the lopes ⅱ robotic device. assessments were conducted using assessment tools such as the hospital anxiety and depression scale, modified ashworth test, fma, functional gait assessment, stroke impact assessment, mini-mental state test, medical research council (mrc) scale, 6-minute walk test (6mwt), star cancellation test, mi, and fac. the exercise duration for the group was comprised of sessions conducted twice a week, with each session lasting 60 minutes and spanning over five weeks. after five weeks of treatment, participants experienced improved balance and coordination in walking, stronger leg movements, increased ankle flexibility on the weaker side, and enhanced overall walking speed, balance control, arm function, and cognitive abilities.13 heng et al., in 2020, conducted a study titled “changes in balance, gait, and electroencephalography after robotassisted gait training in chronic stroke patients”.14 the study utilized the mrg-p 100 hiwin robotic gait training system, india and included 24 partakers between 35 and 80 years. the survey involved the traditional group and the robot-assisted gait training (ragt) group. the traditional group received standard physiotherapy rehabilitation, whereas the ragt group received standard physiotherapy and robotic gait training. assessments were conducted using the berg balance assessment and the timed “up and go” test. the intervention for both groups consisted of sessions conducted four times a week, with every sitting lasting 30–45 minutes, spanning over four out of seven days. after four weeks, improvements were observed in motor abilities, gait performance, and walking endurance in patients treated with bear-h1 compared to those receiving conventional therapy. this proposes that robot-acquired gait training is more effective for people with subacute stroke.4 longatelli et al. conducted a study titled “robotic exoskeleton gait training in stroke”.11 the study utilized robotic devices such as ekso, re-walk, and indego and included 29 contributors between 18–80 years old. contributors were segregated into two bunches: the control bunch (cb), which received standard rehabilitation methods, and the experimental bunch (eb), which underwent a combination of conventional therapy and rehabilitation using an exoskeleton device. assessments were conducted using the modified barthel scale, motricity index, 10-meter walk test, 6-minute walk assessment, functional ambulatory category, and trunk control test. the intervention consisted of sessions conducted five times a week, each lasting 60 minutes, spanning over four weeks. both groups demonstrated progress in their abilities (capacity score) after four weeks of intervention. the eb progress has been comparable to that of the cb after the experiment, with minor improvements observed in lower leg muscle activity during walking measurements.11 maranesi et al. conducted a study titled “robotic intervention for older patients with subacute stroke”.12 the study incorporated the g-eo system which is a robotic and the end-effector device aiding in walking therapy. over 152 subjects, 65 years and above, have been involved in research. the study comprised the control group and a technology-based experimental set. the control group underwent a standard rehabilitation program, while the intervention group engaged in a robotic rehabilitation program utilizing the g-eo system alongside their conventional therapy. assessments were conducted using measures such as the fac, modified ashworth test, short form-12 (sf-12), performance-oriented mobility test, motricity index (mi), mini-mental state test, rivermead assessment, barthel scale, clinical dementia rating, activities-specific balance confidence scale (abc), participation in autonomy and domestic life, and gait analysis along with instrumental postural analysis. the prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review j global clinical engineering vol.7 issue 1: 2025 56 weeks. additionally, after the standard duration, the ragt set acquired an extra 30 minutes of robotic gait exercise. after four weeks, the ragt therapy resulted in a four-fold increase in balance improvements compared to usual care, indicating its superior effectiveness and potential added benefits in treating the condition.14 kotov conducted a study titled “robotic restoration of gait function in elderly patients with stroke”.15 the study utilized the exoatlet exoskeleton and ortorent moto pedal trainer, italy. a subtotal of 47 participants between the age of 52 and 74 were incorporated into the experiment. participants were split into two bunches: exoatlet exoskeleton bunch, which received rehabilitation using the provided robotic device, and the ortorent moto pedal trainer group, which underwent dynamic and ideal training for all extremities using the pedal trainer. assessments were conducted using the mrc assessment, modified ashworth test, berg balance test, hemiplegic arm shoulder ability (hasa), 10-meter walk test (10mwt), modified rankin assessment, and bi. the exercise duration for both groups consisted of sessions conducted five days a week, each lasting 10–30 minutes, reliant on the participants’ functional capacity, over two weeks. after two weeks, both groups experienced improvements in strength, balance, mobility, and walking pace. however, group 1, utilizing the exoatlet exoskeleton, significantly improved more than group 2. group 1 also demonstrated reduced disabilities and increased daily function, which were more pronounced than those observed in group 2. these findings suggest that both robotic training methods effectively improve gait and balance, with the exoatlet exoskeleton showing particular efficacy.15 nolan et al., in the year 2020 conducted a study titled “robotic exoskeleton gait training during acute stroke rehabilitation”.16 the study utilized a robotic exoskeleton (indigo powered exoskeleton) and involved 22 contributors within the customary age set of 59.6 years. the study comprised two groups of participants: the re (robotic exoskeletons) +soc (conventional standard of care) group, which underwent robotic exoskeleton (re) gait training as a component of their inpatient recovery program, and the conventional standard of care set, which got standard rehabilitation treatments during their inpatient rehabilitation program. assessments were conducted using the modified functional classification, modified functional evaluation, walking functional classification, and functional independence measure (fim). the intervention consisted of sessions conducted thrice a week, each lasting 25 minutes, spanning over four weeks. both groups demonstrated improvement in movement abilities after four weeks, but the re+soc group exhibited greater improvements than the soc bunch. the re+soc bunch could engage in more intense walking practice without extending their training time, resulting in better recovery of their ability to perform daily tasks.16 kim et al., conducted a study titled “robotic-assisted gait training for balance and lower extremity function in patients with infratentorial stroke”.17 the study employed the lokomat robotic orthosis and walkbot mechanicalaided walking therapy and involved 19 participants with an average age of 47.4 years. contributors have been divided into sets: set a and set b. set a underwent four weeks of resistance agility grappler training combined with cognitive processing therapy (cpt), after four weeks of cpt alone. in contrast, set b received interventions oppositely: four weeks of cpt ensured by four weeks of ragt combined with cpt. conducted assessments using measures such as the trunk impairment test, fugl-meyer assessment for lower extremity (fma-le), functional electrical stimulation (fes), 10-meter walk test (10mwt), bbs test, scale for the assessment and rating of ataxia (sara), and fac. the intervention consisted of sessions conducted five times a week, each lasting 30 minutes over four weeks. after a month, both groups demonstrated significant progress in maintaining balance while moving and standing still, lower body movement abilities (measured by fma-le), and coordination (measured by sara). however, the group that underwent ragt combined with conventional physical therapy (pt) showed a distinct advantage in maintaining balance while standing compared to the group receiving conventional pt alone. additionally, while both groups showed improvements in walking ability (measured by fac), the ragt+cpt group showed more significant improvement in static balance (measured by bbs), and upper body movement abilities (measured by fma-ue) improved slightly in both groups.17 kim et al., examined the effects of “effects of robotassisted gait training for stroke patients”18, utilizing 57 j global clinical engineering vol.7 issue 1: 2025 prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review robotic devices including the gait trainer, lokomat, chicago, united states, and morning walk, korea. the study comprised 25 participants, with a mean age of 57.7 years in the trial cluster and 60.4 years in the traditional cluster. the research compared two cohorts: the morning walk®, korea group, where participants underwent 30 minutes of techno-assisted walking rehabilitation with morning walk® along with 60 minutes of conventional pt per session, and the traditional cluster, which solely got 90 minutes of traditional pt. evaluation tools employed encompassed the modified barthel scale, rivermead mobility scale, functional ambulatory category score, 10 meter walk examination, berg balance test, and mi for lower extremities (motricity index-lower). the exercise regimen entailed sessions five times a week, each spanning 60 minutes, over three weeks. after completing the three-week treatment, both groups exhibited significant enhancements across all measured parameters. notably, the morning walk® group demonstrated more pronounced improvements in leg movement (quantified by the motricity index-lower score) and balance (evaluated through the bbs) than the control group. moreover, both cohorts displayed advancements in walking speed (indicated by increased pace in the 10 meter walk assessment) and balance (as evidenced by elevated scores on the bbs.18 effect of robotic rehabilitation on balance giovannini, et al., conducted a survey titled “roboticassisted rehabilitation for balance and gait in stroke patients”.19 the study utilized the hunova movendo technology srl robotic device, italy, robotic platform, end-effector ragt, and robotic balance platform. a total of 24 partakers having a mean age of 65 years were collected in the investigation. the investigation involved the investigative cluster (ic) and regulation cluster (rc). the partakers in the ic underwent specialized balance disorder rehabilitation using a robotic platform in addition to standard care. at the same time, those in the rc received only traditional treatment as per their daily routine, without the robotic platform intervention. assessments were conducted using measures such as motricity scale for lower extremity, short physical performance battery (sppb), berg balance test, tug test, abc (activitiesspecific balance confidence) scale, walking handicap test, fac, 10-meter walk test (10mwt), 6-minute walk test (6mwt), barthel index for modified kitchens (bimk), eq-5d-5l questionnaire (eq-50), modified fatigue impact scale (mfis), fatigue severity scale (fss), frontal assessment battery (fab), symbol digit modalities test (sdmt), digit cancellation test, trail making test (tmt), and tinetti assessment measure. the duration of the exercises was thrice a week, for 45 minutes, spanning over four weeks. at the end of the four-week intervention, both groups demonstrated improved balance, fatigue levels, quality of life, and physical and mental abilities. it was anticipated that the group receiving robotic-assisted therapy and regular therapy (investigative cluster) would show greater effectiveness than the group receiving only regular therapy (regulation cluster).19 li et al., investigated a trial on “effects of a braincomputer interface-operated lower limb rehabilitation robot on motor function recovery in patients with stroke”.20 in this study, brain-computer interface (bci) technology was employed. twenty-eight patients were taken in the trial with an average age of three and seven decades. two groups were established: the bci cluster and the sham cluster. the bci cluster received robotic exercise, physiotherapy, and medical treatments, while the sham group only received physiotherapy and medical treatment. assessment tools such as levels of cognitive functioning test for adults, fma-ue (fugl-meyer assessment for upper extremity), fac, mbi (modified bi), serum brain-derived neurotrophic factor (bdnf) levels, fma-le (fugl-meyer assessment for lower extremity) and neurophysiological variables incorporating motor evoked potential latency and amplitude were utilized. the exercise regimen consisted of sessions conducted six days a week, each lasting 30 minutes, spanning four weeks. after four weeks, the bci group demonstrated significant improvements in various abilities for stroke recovery patients. specifically, cognitive abilities showed enhancement, as evidenced by improved levels of cognitive functioning scale (lcfs) scores indicating better cognitive function. while both groups exhibited similar improvements in upper limb motor functions, gait, and balance, the positive effect of bci, especially for cognitive ability improvement, was highlighted.20 chen et al., conducted a study titled “effect of telerehabilitation on balance in individuals with chronic stroke”.21 prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review j global clinical engineering vol.7 issue 1: 2025 58 the study utilized various robotic devices, including the kinect sensor, ragt (microsoft corporation, redmond, wa, usa), with a virtual reality (vr) system, virtual reality system, exergaming telerehabilitation system, and interactive self-rehabilitation programs. a gross of 30 participants with a mean age of six decades were enrolled in the trial. the study comprised two sets: the manipulated set, which participated in a vr intervention program, and the sham set, which received traditional pt treatment. assessments were conducted using the berg balance test, tug, mi, fac, and modified falls efficacy scale. the duration of the exercise was six times for four weeks, for 2,400 seconds, spanning over a month. within four weeks, both the sham and manipulated sets demonstrated measurable improvements in balance and walking. however, the experimental set exhibited superior balance improvements. both sets showed enhancements in bbs scores, indicating improved balance, while the manipulated group notably reduced their tug test times, suggesting enhanced mobility. the manipulated set’s significant advancements in balance and walking measures compared to the sham set establish its superiority. specifically, the manipulated set improvements in bbs scores and tug test times signify enhanced balance and mobility, respectively.21 de luca et al., investigated title “dynamic stability and trunk control improvements following robotic balance and core stability training in chronic stroke survivors”.22 the study utilized the robotic device hunova. a sum of 15 partakers in the investigation, with an average age of 59 years old in the robotic squad and 63 years old in the experimental squad. the study consisted of two squads: the experimental squad, which underwent a rehabilitation program using robots, and the control squad, which underwent conventional rehabilitation sessions led by physical therapists. assessments were conducted using the bbs, mini-balance evaluation systems test (mini-bestest), and trunk impairment scale. the exercise duration for both groups was six times for four weeks, for 2,700 seconds, spanning five weeks. after five weeks of exercise, both groups demonstrated enhanced balance, walking abilities, arm function, and cognitive performance. however, the control group only showed significant improvement in their ability to maintain balance when reacting to unexpected disturbances, while the experimental group maintained their balance improvements, as assessed by the bbs, over time. specifically, for the experimental group, there was an enhanced ability to step forward and backward confidently, as indicated by the mini-bes test. additionally, statistically significant improvements in balance as documented in berg balance scale (bbs) persisted over time, along with increased trunk control and stability during activities.22 castelli et al., conducted a study titled “robotic-assisted rehabilitation for balance in stroke patients (roar-s): effects of cognitive, motor, and functional outcome”.23 the study utilized the robotic device hunova® movendo technology, srl, genoa, italy, a cutting-edge robot designed to aid in rehabilitation for core stability, balance, and lower body functions. this robotic platform is specifically designed to assess and treat the trunk and lower limbs, providing personalized therapy. the study involved 24 participants with an approximate age of 77 years old in the hunova crew (huc) and 76 years old in the conventional crew (coc). huc group received special treatment with the hunova robotic platform for balance problems, on top of the usual treatment recommended by doctors. the coc group served as a comparison and received only the usual treatment recommended by doctors. assessments were conducted using measures such as the fac, euroqol-5d (eq-5d), modified fatigue impact scale (mfis), fatigue severity scale (fss), functional ambulation battery, sdmt, tmt, berg balance test, sppb, modified bi (mbi), abc scale, walking handicap scale, and other cognitive and motor assessments. the duration of the exercise was thrice a week. treatment outcomes for both groups showed improvements in clinical scales, cognitive performance, balance, mobility, quality of life, and fatigue. the huc group demonstrated further enhancements in motor skills, cognitive function, and overall well-being compared to the coc group. both groups experienced shared improvements in gait, including enhanced ambulation, increased speed in the timed up & go test, and improved walking and sit-to-stand abilities under the sppb. additionally, both groups showed strengthened balance, as indicated by improvements in the bbs and sppb balance sub-score.23 59 j global clinical engineering vol.7 issue 1: 2025 prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review effect of robotic rehabilitation on cognitive ability zhao et al., conducted a study titled “effects of training with a brain-computer interface controlled robot on rehabilitation outcome in patients with subacute stroke”.24 the study employed a bci-controlled robotic device and newton’s ring to elicit steady-state motion visual evoked potentials. a total of 33 participants ages 32 to 68 years old were taken for the experiment. two groups formation took place: the sham cluster and the bci cluster. the sham cluster received conventional physiotherapy, while the bci cluster received bci-based intelligence in addition to conventional physiotherapy. assessments were conducted using the locta, fugl-meyer testing for the lower limb, fac, fma for the upper limb, modified barthel testing, and serum bdnf levels. both groups received therapies for four weeks, 1 time a day for half an hour, 12 days of two weeks. after a month, improvements were observed in cognitive function, lower limb motor function, increased levels of bdnf, and ambulation abilities in patients treated with bci and conventional therapy compared to the sham cluster. these findings suggest a positive effect of bci in patients with subacute stroke.24 torrisi et al., organized a review on “the role of hand robotic rehabilitation plus vr in improving cognitive function”.25 in this study, the amadeo robotic device, usa was utilized. 48 participants, with a typical age of 54 years old, were incorporated. the candidates were fractioned into two bands: the manipulated and the standard bands. the manipulated band received treatment from the amadeo robot, while the standard band underwent conventional pt (physiotherapy). assessment tools such as mini-mental state questionnaire, tmt, stroop test, clock drawing test, ravlt (rey auditory verbal learning test), fma, arat (action research arm test), bbt, nhpt, jebsen-taylor hand function test, bi, fim, moca (montreal cognitive assessment), mrs (modified rankin scale), neadl (nottingham extended activities of daily living) and sis (stroke impact scale) were utilized for testing. the duration of the exercise was not specified in the provided information. after the treatment, the study demonstrated that participants who received robotic hand therapy (rht) experienced greater improvement in cognitive abilities compared to those who received conventional hand therapy. specifically, aht enhanced attention, executive function, and visual-spatial skills. however, hand function improvement was similar for both groups.25 aprile et al., carried out a survey on “robotic rehabilitation to improve cognitive functions in subjects with stroke”.26 in this study, three robotic models—motore, amadeo, and diego (tyromotion and humanware)—along with a sensor-based instrument called pablo, were utilized. the study comprised 51 partakers with an average age of 64 years. various cognitive assessment tools were employed, including the tower of london for executive functions, sdmt for attention and processing speed, digit span task for memory, oxford cognitive screen, fma for upper extremity, and rey-osterrieth complex figure test. participants underwent 30 sessions lasting 45 minutes each, conducted five days a week. following these sessions, improvements were observed in cognitive functions, upper extremity motor functions, and performance in daily activities. this suggests that the combined effect of robotics and cognitive exercises contributes to patient recovery.26 manuli et al., conducted a study on “robotic rehabilitation plus vr affect cognitive behavioral outcome in patients with chronic stroke”.27 this study used computer assisted reality, lokomat nanos, and lokomat pro robotic devices, usa. the review included a whole of 90 individuals, with 30 individuals allocated to each group. three distinct groups were established: team 1, comprising the “robotic rehabilitation team with vr”; team 2, consisting of the “robotic rehabilitation without vr”; and team 3, receiving “conventional therapy”. assessment tools utilized in the study included the montreal cognitive assessment, fim cognitive subscale, motor subscale, weigl test, short form-12 health survey total (mental and physical), beck depression inventory-ⅱ, tmt form, visual search and fab. each participant underwent 40 sessions of their respective treatments, followed by 40 sessions of physiotherapy. after the completion of these sessions, improvements were observed across all three groups in cognitive functioning, mood, executive functions, and activities of daily living (adl). nevertheless, team 1 receiving robotic rehabilitation and vr demonstrated impressive enhancements in shifting skills, quality of life, selective assessment, and cognitive flexibility. this prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review j global clinical engineering vol.7 issue 1: 2025 60 suggests that the combination of robotic rehabilitation and vr provides the most effective approach to cognitive rehabilitation.27 effect of robotic rehabilitation on upper limb management frisoli et al., conducted a study on “a randomized clinical control study on the efficacy of three-dimensional upper limb re training in chronic stroke”.28 the study employed the pnew-wrex, armin exoskeleton, and lexos exoskeleton, italy. twenty-two people took part, segregated into two bunches: the robotic bunch, which received treatment from the exoskeletons, and the cb, which underwent manual pt. assessment tools such as bat, fma, and the ashworth scale were utilized. exercise sessions were conducted thrice a week, each lasting 2,700 seconds, 6 times for four weeks. following the 6-week period, the robotic group exhibited significant improvements in functional ability and task precision, indicating the positive effects of robotic rehabilitation compared to conventional therapy.28 takebayashi et al., handled an analysis on “robot-assisted training as self-training for upper limb hemiplegia in chronic stroke”.29 the study focused on the use of the reogo-j upper limb extremity equipment, brazil. the study involved 129 participants aged between 58 and 60. three groups were established: the baseline assembly, who underwent basic physiotherapy techniques with self-improvement methodologies; the robot training (rt) assembly, which underwent robot-assisted training of reogo-j unit before standard occupational therapy; and the movement therapy (mt) group, wherein participants engaged in occupational techniques based on constraintinduced movement therapy, task-oriented therapy, and robot-assisted therapy. various assessment tools were utilized, including mas, performance test for upper limb functions, motor evaluation in vascular hemiplegia, research analysis of sis, fma, action research arm test, mi for muscle strength, active range of joint motion assessment, sis for quality of life. exercise sessions were conducted thrice weekly, each lasting for an hour for two and a half months. after the intervention, rt assembly demonstrated the most significant improvement in fmaue scores, indicating the highest benefit. additionally, the rt group exhibited the greatest enhancement in upper limb function compared to the other groups.29 budhota et al., conducted the following study on “robotic assisted upper limb training in stroke”.30 the study utilized the h-man robotic equipment, usa. fortyfour participants, encompassing a range of ages from 21 to 85, were encapsulated for investigation. participants were fragmented into two squads: the robotic therapy squad, which received combined therapy of h-man robotic and conventional physiotherapy, and the conventional therapy (ct) squad, which received only conventional therapy. assessment tools such as fma, vas, mas, mmse, lta, cta, arat, and gs were employed. the rt squad underwent 60 minutes of h-man training, after half an hour of traditional techniques, at the same time, the ct squad received one and a half hours of traditional techniques. both squads participated in sessions lasting 90 minutes each, three sessions a week for one and a half months. after the 6-week experiment, participants in the rt squad showcased growth in motor function and movement smoothness compared to the ct squad. additionally, combination therapy reduced the workload demand on therapists.30 shi et al., conducted a study on “effects of a soft robotic hand for hand rehabilitation in chronic stroke survivors.”31 the study utilized the vaeda robotic device. sixteen participants aged 56, were collected in the search, which consisted of a single group. assessment tools such as bbt, mas, fma-ue, arat, and maximum voluntary grip strength test were employed. exercise sessions were conducted seven days a week, with every session approximating 60 minutes, over six weeks. after a 6-week intervention, a significant improvement in test scores was observed, indicating the effectiveness of robotic exercises for hand rehabilitation in chronic stroke survivors.31 li et al., conducted a study titled “efficacy of robotic priming with bilateral approach in stroke rehabilitation”.32 the research employed the bi-manu-trace robotic device and involved 31 participants having a mean age of 55. two groups were formed: the robotic primed mirror therapy crew (rmt) and the robotic primed bilateral upper limb training crew (rbult). rmt crew participants underwent robotic training and mirror therapy, whereas in the rbult 61 j global clinical engineering vol.7 issue 1: 2025 prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review group, participants received robotic training and bilateral upper limb training. assessments were conducted using the robotic neurological severity test, chedoke arm and hand activity inventory, and accelerometer. the intervention consisted of sessions conducted six times in two weeks, with each training lasting 2,400 to 2,700 seconds over six weeks. after six weeks, the research findings indicated that the group receiving robotic priming with mt demonstrated a better outcome in motor function and arm use when matched to the crew receiving robotic priming with bilateral upper limb training. therefore, combining robotic training with mirror therapy may improve motor function and arm functionality for stroke patients.32 guillen-climent et al., conducted a study titled “use of merlin in stroke patients: a robotic device based on serious games for upper limb rehabilitation in home settings”.33 this study utilized the aa robotic device, italy, merlin robotic device, and arm assist robotic system. there were nine engagers between the ages of 41 and 84. the study comprised only one group, which received training from the merlin robotic system. assessments using the modified ashworth assessment and fugl-meyer scale were conducted. the exercise duration was thrice a week, for 30 minutes each session, spanning over three weeks. after three weeks, significant improvements were observed in upper limb coordination and overall motor function score.33 ranzani et al., explored “neurocognitive robot-assisted rehabilitation of hand function”.34 the study utilized the rehapticknob device. thirty-three participants, covering ages from 18 to 19, were covered in the study, with 14 participants in the robotic group and 13 in the control group. assessment tools such as fma-ue, fma-wh, fmase, mas, emnsa-t, emnsa-p, vas, lcf-p, nihss, goodglass kalpan assessment, and albert test were employed. the control group underwent exercises 2–3 sessions a week for 30–45 minutes, whereas the robotic group engaged with set of 3, 2 times a week for 2,700 seconds. both groups had kept track of assessments at 8 weeks and 32 weeks. the study concluded that robotic training yields outcomes comparable to neurocognitive therapy, suggesting its potential as an alternative treatment approach for hand function rehabilitation.34 aprile et al., executed a study, “upper limb robotic rehabilitation after stroke”.35 in this study, various robotic devices were utilized: motore, a robotic device facilitating assisted and unassisted flat motion of elbow and shoulder joints; amadeo, supporting assisted and unassisted bending and straightening movements of fingers; pablo, a sensor-based system enabling independent three-dimensional motion of wrist, shoulder, and elbow joints; and diego, a device aiding three-dimensional, one/two-handed motion of the shoulder joint with arm weight assistance. the study encompassed a total of 224 members between the ages of 4 and 85, segregated in two sets: the robotic set (rs), undergoing therapy with robotic devices targeting shoulder, elbow, hand, and wrist joints, and the conventional set (cs), receiving traditional treatment focusing on upper limb function improvement, sensorimotor control restoration, and muscle stiffness reduction. assessment tools such as fma, mi, mrc, mas, dn4, nrc, mri, fat, arat, sf 36-pcs, and sf-36-mcs were employed. treatment comprised daily 45-minute episodes, five times a week, over the month, for both sets. additionally, conventional rehabilitation sessions occurred six times a week, each lasting 45 minutes, during the same month. after four weeks of treatment, both the robotic set and the conventional set demonstrated improvement in several areas. the average fma score increase was 8.50 for rs and 8.57 for cs, surpassing the clinically meaningful improvement threshold of 5 points. rg exhibited greater enhancement in upper extremity strength, as calculated by the motricity test, compared to cs, and maintained this advantage at the treatment’s conclusion.35 huang et al., reviewed “the comparison of the rehabilitation effectiveness of neuromuscular electrical stimulation robotic hand training and pure robotic hand training after stroke”.36 in this study, a variety of robotic devices were employed, including the hybrid neuroprosthesis for the upper extremity, robotic hand, emg-driven robotic hand, emg-driven neuromuscular electrical stimulation (nmes) robotic hand, and electromechanical wrist robot assistive system. fifteen engagers represented the age of 57 for the experimental team and 6 decades for the pure team, were contained in the review. the study encompassed two participant cohorts: the nmes cohort, which prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review j global clinical engineering vol.7 issue 1: 2025 62 utilized a robotic hand controlled by electromyography (emg)-driven nmes, and the pure cohort, which utilized a robotic hand without additional nmes stimulation. assessment tools such as fim, mas, arat, and fma were employed. the exercise regimen consisted of sessions conducted thrice a week for 30 minutes over three months. after three months, it was observed that neuromuscular electrical stimulation (nmes) improved hand function in paralyzed patients when contrasted to a pure cohort without stimulation. nmes cohort exhibited a notable increase in hand function assessment scores (hfas) and a substantial reduction in elbow, wrist, and finger muscle stiffness. the nmes group maintained these improvements in hand function, whereas the control group’s hand function assessment score declined at the 12-week follow-up. the review emphasizes on upper limb function, particularly hand function, demonstrated significant benefits from nmes correlated to the control team.36 franceschini et al., facilitated an examination on “upper limb robot-assisted rehabilitation versus pt on subacute stroke patients”.37 in this study, robotic devices were employed, namely the inmotion2 robotic system and planer end-effector robots. a total of 48 participants were involved, where the robotic crew is 74 years old and the conventional crew with an average age of 7. involved parties were fragmented into two crews: the experimental crew, utilizing inmotion2 robotic system, chicago for upper body rehabilitation, involving goalbased, two-dimensional reaching tasks, and the control crew, receiving conventional upper body pt. ct activities included stretching assistance, arm and shoulder training, and reaching activities with therapist guidance. assessment tools such as fma for upper extremity, lax range of motion, modified ashworth test for shoulder stiffness, and modified ashworth scale for elbow stiffness were utilized. the exercise regimen consisted of sessions conducted five times a week, each lasting 45 minutes, spanning over six weeks. after six weeks, both crews illustrated improved upper extremity working, as assessed by the fugl-meyer measurement. additionally, the experimental group improved shoulder and elbow stiffness (measured by the modified ashworth scale) and arm flexibility (measured by passive range of motion). the experimental crew illustrated superior improvement in these areas compared to the control crew, which only showed improvement in shoulder stiffness.37 qian et al., conducted a study on “early stroke rehabilitation of the upper limb assisted with an electromyographydriven neuromuscular electrical stimulation-robotic arm”.38 this study utilized various robotic devices, including the emg-driven nmes robotic arm, rehabilitation robot armin ⅱ, usa. electromyography-driven robot, and electromechanical wrist robot-assisted system device. twenty-four participants had a typical age of 54 for the exploratory cluster and 6.4 decades for the control cluster. the study comprised two participant groups: the nmes-robot group, which underwent training using a robotic arm delivering nmes, and the control cluster, which received conventional rehabilitation treatments focused on the upper limb. assessment tools such as the action research arm examination, function independence assessment, modified ashworth scale and fugl-meyer examination were employed. the exercise regimen consisted of sessions conducted five times a week, each lasting 40 minutes, spanning over four weeks. following a month of drill, the exploratory cluster (nmes robot) and the control cluster exhibited substantial improvements in fma, mas, arat, and fim. nevertheless, the nmes-robot cluster demonstrated significantly grander improvements in fma scores, particularly for the wrist and hand. this improvement has not been seen for control cluster, displaying superior efficacy of nmes-rt in enhancing wrist and hand function.38 discussion the current literature review critically investigated 30 articles to highlight the effects of robotic rehabilitation on stroke. in addition to the basic impact of traditional physiotherapy in the form of manual techniques and a basic exercise program that was approved as an effective modality for the improvement of gait, balance, cognition and upper limb this study investigates for the beneficial effects of robotic rehabilitation for stroke survivors. bruni et al.’s research highlighted significant improvements in gait parameters.39 they emphasized the importance of patients engaging in more intense and repetitive training sessions, enhancing brain flexibility and supporting motor recovery. task-oriented training through robotic 63 j global clinical engineering vol.7 issue 1: 2025 prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review rehabilitation offers personalized sessions tailored to each patient’s specific needs, focusing on enhancing particular motor skills and functional movements to improve overall mobility. additionally, certain robotic systems provide augmented feedback, crucial in enhancing motor learning and performance by offering immediate feedback on movement quality and progress. as a result, robotic gait rehabilitation can effectively enhance walking speed, balance, and coordination, ultimately leading to improved gait function and greater independence in daily tasks.39 similarly, the reviewed articles examined various gait parameters, including step and stride length, gait speed, cadence, motor skills, and functional ability. moreover, notable improvements were observed in gold-standard assessment scales such as the bbs, 10-minute walk test, and time-up-and-go test. specific scales like the fugl mayer assessment and dgi were also used to assess and track progress accurately. zheng et al.’s research highlights the improvement in balance parameters, emphasizing that enhancing muscle strength is a key benefit of robotacquired training for patients suffering from a stroke.40 this training provides targeted resistance and controlled movements, enhancing balance function. additionally, coordination improves as patients are guided through various tasks and exercises, helping them relearn and refine the motor skills necessary for balance control. the recurring and work-oriented quality of training with robotacquired training promotes neural plasticity, enabling the brain restructure and establish fresh neural pathways, thereby aiding in balance function improvement during the recovery process. the therapy also offers patients a variety of sensory inputs, including proprioceptive and vestibular feedback, crucial for maintaining balance and spatial awareness.40 moreover, postural control can be enhanced in stroke patients through robotic assistance, targeting specific muscle groups and adjusting their center of gravity, essential for maintaining balance during various activities. the aforementioned articles discussed balance parameters such as static and dynamic balance and ambulation. additionally, improvements were noted in parameters like swing amplitude, center of pressure, and speed of oscillation. significant improvements were observed in gold-standard scales such as the bbs and fugl meter balance scale. the research by aminov et al., highlighted significant improvements in cognitive abilities, underscoring the potential advantages of robotic rehabilitation in enhancing cognitive function among stroke patients.41 for example, vr interventions show promise in boosting cognitive function and memory by leveraging the connection between motor skills and cognitive capabilities. however, further in-depth investigations are necessary to fully understand the extent of these benefits and refine treatment plans for cognitive rehabilitation using robotic technology.41 the articles above discuss improvements in major components such as attention, visuomotor skills, memory, cognitive flexibility, executive functions, shifting skills, and enhancements in locta score. additionally, improvements in mood were also observed. bertani et al’s research sheds light on the significant improvement in upper limb functionality.42 they highlight how robotic therapy holds promise in enhancing motor function recovery in the upper limb, especially for individuals grappling with chronic strokes. positive reorganization in the motor cortex can lead to better outcomes in arm function. additionally, advanced robotics assisting in therapy through focused and repetitive exercises can greatly expedite recovery after a brain injury, improving upper limb function. robotic technology can also enhance flexor synergies, coordination, and speed in the affected upper limb while improving the sense and understanding of the shoulder, arm, and forearm. moreover, roboticassisted therapy can alleviate joint pain in the upper limb, enhancing comfort and mobility during rehabilitation.42 the articles discussed above underscore improvements in various parameters of the upper limb, including motor functions, coordination, and sensory function. significant enhancements were noted in gold-standard assessment scales such as the fugl meyer assessment, action reach arm test, and modified ashworth scale. furthermore, additional scales such as the biconical activity test and mi were also utilized, highlighting the comprehensive evaluation of upper limb functionality. robotic rehabilitation for stroke patients has been extensively studied recently, with research post—2018 highlighting its feasibility and potential benefits. feasibility studies have demonstrated the practicality of robotic prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review j global clinical engineering vol.7 issue 1: 2025 64 interventions in various settings. for instance, a 2018 pilot study evaluated the use of a robotic glove for hand rehabilitation in hemiplegic stroke patients at home. the findings indicated that the intervention was both feasible and safe, with 81% of participants completing the program. significant improvements were observed in hand motor function, dexterity, and strength. similarly, research from 2020 assessed the use of a single-joint hybrid assistive limb (hal-sj) robot for upper limb rehabilitation in subacute stroke patients with varying severity levels. this study concluded that robot-assisted rehabilitation is feasible across different severity groups, with the most notable improvements in patients with moderate impairments. the efficacy of robotic rehabilitation is further supported by studies integrating multiple therapeutic modalities. a 2021 study introduced the personalized upper extremity rehabilitation (super) program, which combined robotics, vr, and nmes. this program, tailored to individual functional levels, demonstrated feasibility and effectiveness, with 64% of participants showing clinically significant improvements in upper extremity function. additionally, recent developments in neural interface technology, such as neuralink’s bci trials, have explored controlling robotic arms through brain implants. while primarily targeting individuals with paralysis, this technology holds promising implications for stroke rehabilitation by enabling direct neural control of assistive devices. this study has several limitations, including limited access to the databases, leading to the inclusion of fewer studies. secondly, a quality appraisal of the included studies was not performed. future recommendations include high-quality randomized controlled trials to reach any firm conclusion regarding the effectiveness of robotic rehabilitation in the resolution of post-stroke survivors’ symptoms. conclusion in conclusion, recent research underscores the feasibility and safety of robotic rehabilitation for stroke patients, with significant functional improvements and high patient compliance. advancements in integrating robotics with other modalities and neural interface technologies further enhance the potential of robotic rehabilitation in stroke recovery. the motive behind this study was to show that including robotic rehabilitation with other techniques can result in similar advantages to rigorous training. analysis of the existing data indicates that robotic therapy can improve walking, balance, thinking, memory, coordination, daily tasks, motor abilities, and posture management. in the end, all of these areas may experience enhancements by implementing robotic rehabilitation. however, more studies are required to confirm the existing findings. author contributions all the authors contributed equally in the conduct of the review study. acknowledgments sincere thanks and gratitude towards the faculty members (kriti sachan and baldev negi) of department of physiotherapy, sharda school of allied health sciences, sharda university, greater noida, uttar pradesh, india. they provided their valuable insights regarding the conceptualization of the topic, article selection, data analysis and final drafting of the manuscript. funding this review has not received any funds through any agency. conflicts of interest there is no conflict of interest as reported by the authors. ethics approval and consent to participate the study was conducted in accordance with the ethical guidelines. further disclosure not applicable. references 1. aprile, i., conte, c., cruciani, a., et al. efficacy of ragt combined with robotic balance training in subacute stroke patients: a randomized clinical trial. j clin med. 2022;11(17):5162. https://doi.org/10.3390/ jcm11175162. 65 j global clinical engineering vol.7 issue 1: 2025 prasad, madhual, sachan, perwez, tiwari, negi: effectiveness of robotic rehabilitation in the management of stroke patients—a literature review 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