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 condi- tions. 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 recommen- dations 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 - Attribu- tion 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 trans- formation, “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 En- gineering worldwide that strongly harmonize with the recommendations contained in this article.12 WHY CLINICAL and BIOMEDICAL ENGINEERS? Traditionally, Clinical Engineers and Biomedical Engi- neers 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 in- creasing velocity and scope, these life-saving engineering professions are also evolving and expanding to incorpo- rate 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 gen- eration 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 de- signing or improving diagnostic devices,13 monitoring,17 or therapeutic devices that are technically complex,18 multifunctional, networked,16 and designed for “preci- sion 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 train- ing, 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 recommen- dations 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 manage- ment (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 neces- sary 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 profes- sional 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 pro- fessional 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 (EAM- BES),29 and the Global CE Journal30 are creating new, global frameworks for research,31 professional develop- ment, 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 de- ter 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 RE- SOURCES section at the end of this document, grouped by topic) 1. Understand your existing local, national, and inter- national 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 con- sortium, government agency, legislative and regu- latory 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, in- terdisciplinary 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 inter- dependencies and risk/failure points that other stakeholders might ignore. 3. Promote regional and national purchasing coop- eratives to maximize cost-savings over the lifecycle of devices and services, including specific disaster- related 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 next- generation device/system design, with all necessary safeguards for patient privacy and confidentiality). Formalize consulting relations between CEs and manufacturers to conduct regular design consulta- tions as part of the contractual relationship. b. Define, design, and enforce Universal Mini- mum 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 condi- tions, 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 de- vices 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 in- terfaces. 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 in- appropriate 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 iden- tify strategic pathways for medical technologies and services with a 5- to 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 technolo- gies 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 even- tually 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 medi- cal devices with computing capabilities so they have extensive, built-in capabilities for universal time synchronization, self-monitoring, self-reporting, self- updating, 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 prov- enance, 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, compli- ance, 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 im- portant 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 man- agement, 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 consum- ables 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 life- cycles, 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 di- saster conditions by guiding staff through auto- mated, 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 prepa- ration, requiring the setup of emergency hospital capa- bilities 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 decision- making 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, medi- cations, 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 loca- tions, facilities and profiles. Update annually. This will enable instantaneous activation of a regional incident tracking utility, enabling Emergency Op- erations 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 ac- cess, medical gasses, waste management, security, maintenance and repair parts, disinfection, IT coordination. g. Arrange to serve as a multifunctional Engineer- ing 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, Con- tainerized Clinics. i. Perform quarterly updates of ASOC status to identify any significant changes in readiness, re- sources, staffing, plans. j. Evaluate the role of portable Emergency Elec- tronic 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 iden- tify probable stress points, gaps, failures, and decision-making bottlenecks that may impede rapid ramping up of disaster response actions: vendor contracts, pre- orders, 3-D printing, open-source online design specifications, delivery, receiving, storage, distribution, security, configura- tion 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 re- sulting health threats (e.g., simultaneous pandemic and earthquake victims). m. Identify multiple constituencies/stakeholders who need to be involved in normal and ASOC ca- pability 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 transla- tors, 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 im- pact 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 civil- ian 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 compat- ibility between civilian and military services, and shall include a least-common-denominator of clini- cal 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, includ- ing multiple disaster situations (e.g., simultane- ous 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 net- work 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 informa- tion 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 self- administered 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 moni- tors, 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 technolo- gies 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 Communica- tions 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 ca- pabilities 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 infrastruc- ture 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 spe- cific 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 as- signments 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 cross- training 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 be- tween 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 medi- cal 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 condi- tions that may require rapid changes in disaster re- sponse – 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 inci- dents, 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, pharma- ceuticals, 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 engi- neering, best-practice identification, and dissemination. a. Form a dedicated DP/DM team to sustain multi- year 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 dis- seminate proceedings of events to media outlets, including social media. CONCLUSION Taken together, these aspirational recommendations offer a comprehensive, but not yet exhaustive set of ac- tions that can improve outcomes and alter the historical trajectory of the CE profession and DM capabilities world- wide. 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 Military Health System Unprepared. Project on Government Oversight. May 2020. Available at: https://www.pogo.org/analysis/2020/05/ignored- warnings-left-the-military-health-system-unprepared/ 3. Castle S and Landler M. 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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-risk- reduction-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 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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/3d- printing-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-granting- disaster-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%2FCapability- Frameworks-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 residen- tial 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 pro- cess 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 mod- ern healthcare systems worldwide. He lives in Cotacachi, Ecuador and is active in a variety of projects to strengthen indigenous Kichwa culture, improve local health ser- vices, 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.