By Patrick Lynch, CBET, CCE, CHTM, CPHIMS, FACCE
2016, for the most part, was spent waiting to see whether the U.S. FDA would increase regulations for medical equipment servicers. After all, since March 2015, the FDA has been collecting information and receiving factual and anecdotal comments concerning whether there is a public health and safety issue that warrants increased regulation and oversight of medical device companies and individuals.
This issue culminated in October’s two-day workshop of presentations to the FDA .
Attendees of the workshop could be classified into several groups—manufacturers, government, independent service organizations (ISOs)/independent servicers, standards organizations, hospitals and end users, and trade associations.Administrators accounted for the majority of attendees, with their job titles spanning from president, vice president, general counsel, general manager to director. (This speaks to the perceived importance of the issues at hand.)
Manufacturers making formal presentations were Bayer, GE Healthcare, Hitachi America, Johnson & Johnson, the Medical Device Manufacturers Association (MDMA), Medtronic, Pentax America, Philips Healthcare, Siemens, and Varian Medical Systems.
The only government agency that presented formally was the U.S. Federal Trade Commission (FTC). During the FTC’s presentation, officials admonished the FDA and referred to President Obama’s April 2016 Executive Order, in which he urged all federal agencies to make no decisions that would harm competition without clear data to support the need for such rulings.
The ISOs and independent servicers that presented formally were the Afya Foundation, Alpha Source, First Source, Integrated Medical Systems, Mobile Instrument Service and Repair, Oxford Instruments, Paragon Services, Tri-Imaging, and TriMedX, while AAMI and Cambridge Polymer Group accounted for the standards organizations making such presentations.
Further, the hospitals and end users making formal presentations were the American College of Clinical Engineers, the U.S. Department of Veterans Affairs (VA), ECRI Institute, Healthcare Technology Consulting, ISS Solutions, the James J. Peters VA Medical Center, Massachusetts General Hospital, TriMedX, the Clement J. Zablocki VA Medical Center, and the VA National Center for Patient Safety.
Advamed, the International Association of Medical Equipment Remarketers and Servicers, MDMA, and the Medical Imaging & Technology Alliance (MITA) accounted for the trade associations that formally presented.
During the workshop, representatives from several of the groups presented their respective positions via four formal panels. (Such presentations are available on the FDA’s website). Opportunities for audience comments then followed.
The conference was about not only servicers, but also concerned the five “Rs”: refurbishers, reconditioners, rebuilders, remarketers, and remanufacturers. Curiously, the discussion and presentations were all about the service side of the house while the five “Rs” were largely ignored.
With little exception, each major group represented had a consistent set of beliefs and reasons that the FDA should act in a certain way. Even so, all manufacturers who were also ISOs only took the manufacturers’ stance and ignored that of the dedicated ISOs.
Furthermore, the end users, hospitals, ECRI Institute, the VA, and the ISOs/independent servicers all made the case that there is no record of any pattern of, or statistically significant numbers of adverse events or patient injuries associated with the repair of medical equipment, either by the manufacturer or by anyone else.
In fact, ECRI’s analysis of the FDA’s own patient injuries database revealed that maintenance-related injuries occurred in only 0.005% of reported patient injuries. Each person and company that testified to the FDA reported that these percentages were consistent with their own experiences.
Even so, the manufacturers—and the associations that represented them—believed that there are many more patient injuries than the data shows. They urged the FDA to ignore the data of 3.5 million reported events and, instead, use their reported evidence. And the manufacturers were all very careful to preface their comments by saying that they were only concerned with safety issues and had no financial interest in increased regulation.
What’s the Problem?
Here is my problem with the evidence presented by the manufacturers’ lobbyists: The MDMA showed only four (not 4,000, not 400—not even 40; just four!) alleged improper servicing events, complete with photographs and labels to point out the problem areas. None of these problems cited actually resulted in any patient injury or error, although they “could have”.
Let me note that there is no chain of evidence; they can’t say who made these alleged service errors. All we know is what they allege in their photographed labels and statements. Could their own people have made the mistakes? Could the equipment have been doctored to impress the FDA? I just know that these photographs would not have been accepted in a court of law without some sort of proof about where they came from and who did the work.
So there we have it. The facts presented demonstrated that nobody has been harmed. One group—which serves to gain financially—urged us to ignore the facts and believe their miniscule amount of self-discovered problems. And the FDA is being asked to impose a myriad of regulation and oversight to cure a problem that does not exist.
Who will bear the burden of the cost of the increased time, trouble, reporting, and inspection? We all know that the companies and healthcare institutions themselves will absorb much of it—but eventually, it will only increase the cost of an already out-of-control healthcare system, while providing no benefit for anyone.
What harm will it do? Well, it will certainly put some low-cost medical equipment service providers out of business, thus decreasing access to quality, affordable service in some of the neediest and remotest areas of the country. And decreasing competition will allow some of the remaining players (and some manufacturers) to increase their rates, costs, and take even more advantage of their place in the food chain since fewer businesses will provide the services.
Here’s an idea that I heard toward the end of the conference that caused the manufacturers to pause and think. (And it’s one I support). If ECRI-provided statistics show that service doesn’t cause injuries to patients, why not remove FDA oversight and reporting from all servicers—manufacturers and all?
But until we hear something else from those in charge, we will just have to wait. After all, there’s really no telling what the FDA will do. Will they follow the facts and regulate based on evidence? Or will lobbyists and capital-heavy manufacturers inordinately influence them? Again, we will just have to wait and see.
For more information about this subject, download my PowerPoint presentation from the December Florida Biomedical Society symposium at www.htma-sc.org. It’s free to join as a member.
Patrick Lynch, CBET, CCE, CHTM, CPHIMS, FACCE, is a biomedical manager with 40 years’ experience.