What is H.R.2118? It is the Medical Device Servicing Safety and Accountability Act. What is the purpose? It is a bill introduced to the House of Representatives to “amend the Federal Food, Drug, and Cosmetic Act to require the registration of establishments that service devices, and for other purposes”
This bill requiring “any person who owns or operates any establishment in any State engaged in the servicing of a device or devices, or is otherwise engaged in the servicing of a device or devices, to register with the Secretary.
It also requires that such a person establish a complaint handling system equivalent to a system meeting the requirements of section 820.198 of title 21, Code of Federal Regulations (or successor regulations).”
“The term ‘servicing’ includes, with respect to a device, refurbishing, reconditioning, rebuilding, remarketing, repairing, or other servicing of the device by a person other than the manufacturer of the device.”
I’ve read quotes on AAMI’s website from others in the industry saying: “You’ve got OEMs hiding behind the word ‘safety.’ In the eyes of OEMs, in-house BMETs are not ‘trained professionals’ who can work on these devices.” The debate over who can – and should – repair medical devices has been roiling the industry for years. On one side, OEMs say that third-party servicers, such as independent service organizations, need greater federal oversight to ensure patient safety. They contend that some third parties have, at times, used unqualified personnel to service devices, and inadequately documented their work. On the other, HTM professionals cite statistics showing there is no evidence of a patient safety issue.”
What does all this mean? The way I look at is is that if this bill passes, service companies may have to register with the Secretary. I’m not sure who the Secretary is? I’m guessing it would be at the state level? It could be overseen by the FDA. For years we have been talking about this. I think I have been asked in the past what I thought of registration. I still think the same – I know other people outside the health care profession who are required to register with the state and provide a minimum level of training/education and also a minimum level of continuing education to keep their registration and they have to display their registration at their workplace. Professions such as beautician, massage therapist, etc. They can also undergo unannounced inspections from the state.
Why don’t we have anything like that in our profession? You can currently go to a one-day training session and call yourself a BMET. Or, you can graduate with a four-year degree and also call yourself a BMET! There has to be something in the middle that would be a minimum requirement? Currently, there is not. Anyone can call themselves a BMET. And to me, that does not hold a lot of weight because it doesn’t show that you have any met any minimum requirements.
A former co-worker of mine was once an automotive mechanic. He was a mechanic for several years. They are now called automotive technicians and are no longer referred to as “mechanics.” Over the years automobiles evolved to where they are today. I have heard that today’s auto has more computing power than was used in the Apollo mission to the moon! Talking with him about the history of the automotive mechanic/technician I learned about ASE Certification. You see it posted on the front door or window of almost all independent garages. It was not the standard previously in this profession, but it is today. In the auto mechanic industry, this is considered the standard and there are different certifications available for different assemblies of the automotive.
You see ASE at dealership garages too. Dealerships also send their mechanics to service schools that are specific to that make and model of auto. Could the HTM profession ever go in this direction? Maybe there is an opportunity? ASE is a general certification regarding the way a particular system works then the dealership schooling would be the equivalent or similar in our profession to a manufacturer school that is model specific.
What makes someone a “trained professional?” I think that just like the other professions I mentioned, the HTM profession should have to meet some requirements. Such as some kind of college or technical school education or experience, then certification of some sort. We have a certification system now. Is it good enough or does it need improvement? Will it go the same way as ASE certification? Or, will it be something entirely different?
Our profession is evolving just like other professions have evolved. I think a step in the right direction is to at least get your CBET certification as that does hold some weight and demonstrates a certain knowledge level. I’m not sure what manufacturers are going to do or why their service professionals are “more qualified” or why “trained professionals” are more so than someone who has met minimum requirements needed to take the CBET exam and who has proven a knowledge level high enough to pass the exam. Maybe manufacturer service personnel will have to also meet a certification requirement or register? What are they currently doing that is so different than the rest of us to make them any more qualified to repair medical equipment? Or, at least that’s their argument behind this bill.
For now, we will have to wait and see where H.R.2118 ends up or what version, if any, gets passed into law. This could have a big impact on all of our futures. Get ready!
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