The U.S. FDA has ruled that there is insufficient evidence to currently “justify imposing additional/different burdensome regulatory requirements” on third-party servicers of medical devices. The decision appeared in the agency’s report on the quality, safety, and effectiveness of medical device servicing—which was mandated as part of the FDA Reauthorization Act of 2017.
In the report, the FDA said the agency didn’t come to this decision lightly; it considered information presented at a public workshop, as well as responses to a request for comments, and evaluated evidence related to the quality, safety and effectiveness of medical device security.
After all, the FDA wrote: “Stakeholders have differing views about the quality, safety, and effectiveness of servicing performed by original equipment manufacturers (OEMs) and third-party entities, and the need for imposing additional regulation.”
Based on this information, the agency said that it has concluded:
- The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time.
- The objective evidence indicates that many OEMs and third-party entities provide high quality, safe, and effective servicing of medical devices.
- Most comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufacturing” and not “servicing”.
- The continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.
Still, despite the fact that the FDA does “not believe that additional, formal regulatory action is warranted,” the agency said that it will:
- Promote the adoption of quality management principles
- Clarify the difference between servicing and remanufacturing
- Strengthen cybersecurity practices associated with the servicing of medical
- Foster evidence development to assess the quality, safety and effectiveness of medical device servicing
Further, the FDA revealed that as part of its 2018-2020 strategic priorities, the agency’s Center for Devices and Radiological Health is seeking to establish so-called “Collaborative Communities.” “We believe there may be value in the creation of a public-private forum, such as a Collaborative Community, to address the challenges associated with delivering high-quality, safe, and effective servicing of medical devices,” the FDA wrote in the report. If stakeholder groups are willing to get behind this, the FDA said it will facilitate the creation of a Collaborative Community.
To AAMI President and CEO Robert Jensen, the FDA’s report is a step in the right direction. Although he says AAMI is still analyzing the full report, “the emphasis appears to be on using data to make informed decisions, and that’s an idea central to the very essence of safety in healthcare.”
“We encourage all stakeholders to read the FDA report in full and consider how they can contribute to the shared goal of safe and effective servicing of medical devices,” Jensen adds. To read the report in its entirety, click here.
![National [Electronics] Right-to-Repair Bill Filed in Congress](https://24x7mag.com/wp-content/uploads/2017/03/congress-440x264.jpg)
This report is well written, balanced and objective, despite the Rumfeld-esque “unknown unknown” disclaimer at the beginning (which was the position taken by the CDRH Director at the congressional hearing last year).
Although “third party” (including in-house) servicers may want to celebrate another hard won battle, the history included in this report suggests that this is a long war that is unlikely to cease anytime soon. I would like very much to see the FDA proposed Collaborative Community idea work but since money is the ultimate root cause, it is not going to be an easy task. Even if we were to lock up the leaders of all major stakeholders in Gitmo and only release them after signing an agreement, I am not sure they will follow through after release.
In addition to collaboration, I think we need to encourage all stakeholders to also act as public safety officers in reporting gross violations. This is akin to the “If you see something, say something” that you see posted in airports and other public spaces. We are all responsible as we all shall be patients sooner or later! (Hope this is not too depressing for the younger readers.)
It was good to see facts win out over sensationalism–at least up to this point. This has (temporarily?) saved us from a solution in search of a problem, and from undocumented “anecdotes” and the hypothetical being used to enhance the self-interest of some of the parties to this “debate” who would like to restrict service by other than the OEMs.
(However I am still confused by there being OEMs and “third parties”, but no “second” parties which I would think were the in-house people servicing the equipment that their institution owns. Binseng attempts to sweep them into “third” but I’m not convinced.)
Professor Hyman apparently forgot that the FDA is the one who decided to include in-house teams into the “third parties” when it stated in the 2016 RfC (FDA-2016-N-0436) “… activities that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments.” I admit I am a bit old but not absent-minded yet 🙂
I yield to the better memory.
Now the question is are we stuck with the FDA’s unhelpful terminology.
I am very pleased with the report. I was there and spoke on behalf of all of us who are out there doing the job, for our caregivers and their patients. I spoke on some of the panels and let the FDA know loud and clear that our nation’s Biomeds and CEs need service manuals service parts, passwords and software and our industry needs fair, affordable and open collaboration from the medical equipment manufacturers that supply equipment for America’s caregivers. I also made the point that America’s 3rd party parts service and equipment vendors and companies are essential partners to America’s BMETS and CEs. Please know, The Fight is far from over. Equipment manufacturers trade lobbyists will be trying to get federal legislation going that serves interests that are not in sync with what is best for (IMHO), America’s HTM profession and the caregivers and hospitals we serve. They are also quite active in state legislatures trying to exempt or nullify right to repair laws by ask lawmakers to excluded medical equipment from the bills. If you are a BMET in the states with right to repair legislation pending, please support it with letters, phone calls and attending hearings.
Take a moment to read thru the FDA report and gain some perspective and also review recent journal articles on the topic. I recommend becoming and informed and active and work to support our great profession.
after all, in HTM, “we are stronger in numbers”
wishing all a happy HTM CE Biomed week.
J Scot Mackeil CBET – 2018 AAMI BMET of the year
The term “third party” is a legal term with many definitions. My favorite, and the one I think really applies here, is “A generic legal term for any individual who does not have a direct connection with a legal transaction but who might be affected by it.” The first party would be the manufacturer/seller, the second party is the purchaser/hospital. That makes everyone else a “third party.”