From the May 2018 issue of HealthCare Business News magazine
It’s not just independent servicers who are experiencing challenges in obtaining this information. The HTM community is reportedly experiencing this problem. A few years ago, I was contacted at the request of a manufacturer who was apparently frustrated that another manufacturer had reportedly declined to provide information. I forwarded the letters IAMERS had received from the FDA which helped to clarify regulatory responsibilities to turnover information for radiation-emitting devices.
For smaller companies, there is a fear that complaining to manufacturers about uncooperative practices could lead to further problems. They could find themselves in a pattern of having their requests ignored or perhaps other services affected.
Additional regulations are not the solution
It seems clear from the FOIA responses to IAMERS requests to the FDA, the FDA docket response, and statements at the October 2016 FDA workshop, that a manufacturer’s trade association was urging the FDA to further regulate independent servicers of diagnostic imaging equipment. Thereafter, legislation was filed. From financial disclosure statements filed with the Congress it also seems that significant resources have been spent advocating on Capitol Hill for greater regulation of servicers.
In my view, encouraging independent service companies is in the best interest of the already overburdened U.S. healthcare system. Voluntary adoption of quality management systems should continue. In this regard, IAMERS Best Practices Committee has prepared for its members some robust QMS templates and guidelines for its members.
Training should be available for both the HTM and independent servicer community. Indeed, some IAMERS members currently both support and train manufacturers engaged in multi-vendor servicing. Future opportunities for collaboration should be explored, as many independent servicers are intimately familiar with the equipment and some older modalities are no longer fully supported by their manufacturers.
Collaboration may occur on many levels. For example, a manufacturer’s representative contributed effectively to an IAMERS committee on the UDI regulation and assisted IAMERS in responding cooperatively to the FDA’s request for feedback.
Sometimes with a new game plan 1+1 = 3. Can’t we take to heart Friedman’s challenges and try to reimagine? Or is it time to take a closer look at whether some of these practices are impermissible restraints of trade? Did I mention I want to remain an optimist?
About the author: Robert J. Kerwin has served as general counsel to the International Association of Medical Equipment Remarketers and Servicers Inc. for over twenty years.
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