PART 2: Third Party Repairs of Medical Devices – Why All the Fuss?
G. Wayne Moore
April 12, 2016
Listening in to a webinar focused on the FDA docket concerning service and repair of medical devices by 3rd Party entities was indeed an educational session. It would have been useful though to have someone on the Panel who has been and is actually currently engaged with the FDA on this issue rather than relying on questions like; “what do you think the FDA is trying to do?”, “do you think the OEMs are driving this issue?”, or “what do you think about the concerns of bad service or bad parts, are they real or just an excuse?” In my experience, and all too often, the lack of actual subject-matter information and/or data in webinar forums like these leads to non-value added dialogue that is colored by the prism through which the audience views any given subject. When someone says to me that all OEMs are “evil, greedy, and just want to stick it to hospitals” it tells me more about the person saying it than it does about the OEMs. The French author La Rochefoucauld observed that; “We like to judge others, but we do not like to be judged ourselves.”
Impugning the motives of OEM concerns with product repair safety as a ruse to cover their greed demonstrates cynicism at its worst. Believe it or not the OEMs have legitimate concerns with patient safety as it relates to the repair and servicing of the medical devices they design and manufacturer. Additionally, in many areas of medical device service OEMs are also acting as 3rd Parties, specifically as it relates to multi-vendor service; so they are not simply targeting non-OEM service providers. In my view as a non-OEM of medical devices the question is one of quality and accountability, both by OEMs and 3rd Parties, and should be framed accordingly. I heard on the webinar, for example, the claim that “…there are no examples of safety related problems with 3rd Party repairs or the parts used.” This is the type of unsupported broad-brush claim that weakens rather than strengthens any argument in favor of non-FDA oversight of the 3rd Party repair industry. The FDA knows that examples do exist, they have been provided with them already. The challenge for the FDA is gaining an idea of how broad this problem is; not whether or not it exists at all. This is where accountability comes in to play. For example, traceability. If a 3rd Party repairs a finished medical device what type of labeling, if any, do they put on the device indicating it was repaired by so-and-so, on Feb 2016? If there is no change to the OEM labeling how is one to know if a patient or end-user safety issue was potentially related to the repair and the repair entity? Without this information if there is a patient event and an MDR (medical device report) is issued the product description would only list the OEM and the model of the device. In this case the old maxim “the absence of evidence is not evidence of its absence” applies. If device problems are not being correctly attributed to the Party responsible for them then of course there will be a sparsity of evidence pointing to non-OEM repair and parts entities.
On the webinar call the Panel suggested more than once that 3rd Party repairs account for more repairs than OEMs. They also stated that “3rd Parties are as good as OEMs in repairing systems”. If that is true then a good first order approximation of how many faulty repairs are performed by 3rd Parties would be roughly the same number as those performed by OEMs. Lastly, if what the Panel said about the number of 3rd Party repairs is true then it makes it even more reasonable to conclude that such a volume of unaccountable repairs be brought under the watchful eye of the FDA.
I know I might not make a lot of new friends with this article, but I would ask and advise all my HTM and 3rd Party friends to think about both sides of the argument prior to sending comments to the FDA. If your comments come across as too self-serving, hyperbolic, or non-data driven hand-waving, then I believe your comments may be significantly discounted.
About the Author, G. Wayne Moore:
A 30-year veteran of the diagnostic ultrasound market Wayne has held senior level positions with several major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. Wayne has been directly involved in the development and commercialization of more than 15 technologically intensive ultrasound systems. He is widely published in diagnostic ultrasound literature, a sought after speaker at medical imaging conferences, has served as an expert witness in multiple ultrasound litigations, and holds more than 16 United States ultrasound related patents. Wayne obtained his MBA from the University of Denver – Daniels College of Business.