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 in- dustries 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 infor- mation 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 medi- cal 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 en- tities 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? Hope- fully, 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 oc- cupation 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 ethi- cal 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 Pan- demic | 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-an- engineer-or-do-you-have-to-be-born-into-it-with- natural-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_En- gineering_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 - Attribu- tion 4.0 International - CC BY 4.0. 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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