by
Gus Iversen, Editor in Chief | May 20, 2020
FDA headquarters in Silver Spring, MD
In a setback for improved cooperation between different medical equipment service stakeholders, two of the leading manufacturer trade groups, the Medical Imaging & Technology Alliance (MITA) and AdvaMed, have announced they will no longer be participating with in-house and independent service organizations in FDA-recommended Medical Device Servicing Collaborative Communities (MDSCC).
The collaborative community was called for in a
highly anticipated 2018 FDA report, which capped off a two-year investigation finding evidence "not sufficient" to warrant increased regulation of non-OEM medical equipment service organizations. The communities were intended as an opportunity for different groups to forge ahead addressing the unique challenges they face, working together to resolve them.
"While we appreciated and supported FDA's aim of bringing together third-party servicers and manufacturers to address issues surrounding the safety of third-party servicing of medical devices, ultimately we did not feel the group made sufficient progress in basic organizational or other areas to justify AdvaMed's continued participation," an AdvaMed spokesperson told HCB News.
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In response to that statement, David Francoeur, senior vice president of marketing and sales at Tech Knowledge Associates, and a member of the MDSCC representing the non-OEM service viewpoint, said AdvaMed's reason for leaving mischaracterizes the FDA's aim in forming the collaboration to begin with, noting that the FDA was addressing quality and safety related to maintaining medical equipment as a whole — not third-party specifically.
In its own statement, MITA also commended the FDA's efforts, but added that "despite over a year of regular meetings and numerous attempts to find consensus, It has become clear that progress is unlikely any time soon, given the divergence of opinions held by participants, as well as the time constraints imposed on industry by the COVID-19 pandemic."
The divergence of opinion referenced by MITA has been well documented since 2016, when the FDA
first launched its investigation.
By and large, OEMs have taken the position that non-OEM service lacks oversight and represents a safety hazard. In a
2018 opinion piece for HCB News, Patrick Hope, the executive director of MITA, wrote, "While we agree with many FDA findings, we reach a far different conclusion on this one," and called for ending the "regulatory void" by passing legislation in Congress that would increase third-party oversight.
(1)
Wayne Webster
It's my way or the highway
May 22, 2020 10:55
AdvaMed and MITA representing their masters, the OEM's, had one goal from the start and that was to remove third parties service organizations from the market mix leaving the OEM's with a monopoly. With this monopoly in place the OEM's knew they could control pricing and the life-time of equipment. With the independents serving the market the OEM's knew they would have complete freedom to raise prices and declare end of life forcing replacement equipment purchases. The Federal Trade Commission should be looking at these deceptive practices as a result of this refusal by the OEM's to participate in the community and act accordingly.
Our health care systems are stressed enough without further needless expense being added by the OEM's. Their actions and the tantrum thrown, withdrawing from the collaborative community effort, is evidence they, the OEM's, had no interest in participating from the outset.
FDA should move immediately to require OEM's to provide the information needed to maintain and repair the equipment they sell or forfeit the right to participate in the marketplace.
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