The recent FDA press release of March 4 titled, “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments,” is important for TechNation readers.
It now brings the alternative equipment service provider and in-house HTM groups to what could be the final decision and action point as to how they will continue to exist in the U.S. health care industry.
This FDA message should not be a surprise for those who have been in tune with the affects from the Affordable Care Act (ACA) nor the positioning statement released in the “December Letter of 2013” by the Centers of Medicare and Medicaid Services (CMS). The directional lean of the FDA is for all providers of medical equipment service to comply fully with the original equipment manufacturers’ (OEM) specifications and regulated practices. It sounds pretty simple. But wait, it may not be viewed in the same context by all.
A long-standing area of industry contention has focused on the question: Why are OEMs required to be regulated and held to the highest standards by the FDA and other governmental agencies as to the products they manufacture and support, while others entities such as the alternative medical equipment service provider sector and in-house HTM departments are not held to those same stringent rules? It is a valid question and makes a strong point – wouldn’t you agree?
So, where is this latest FDA movement going and how will the HTM service community react? The social media outlets are “buzzing” and several articles in industry publications have already been circulating. In my opinion, the stage is being set for an FDA regulatory platform that will now impact alternative medical equipment support providers – both third-party service providers and in-house HTM departments. Could it be that an ISO 9001 certification could become a requirement for an alternative medical equipment support provider to operate in this space? Perhaps even a newly created “FDA 510K” type of accreditation process will be created for alternative medical equipment support providers. One thing is certain – this latest FDA movement will not fade away as it did in the late 1990s. It has resurfaced during what is the greatest time of historic change the health care community has ever seen. The providers who are smart enough to realize it will need to overcome this challenge or become extinct!
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