









































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. 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

