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.
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.
In-house and independent service groups, on the other hand, generally argue that the biggest threat to safety is the lack of cooperation they get from OEMs regarding access to manuals, passcodes and other necessary information. In a response to Hope's article
, Arif Subhan, then president of the American College of Clinical Engineering (ACCE), observed that reporting of adverse events is the job of facilities (not servicers) and asserted, "it is grossly misleading to suggest servicers are held to a lower standard when clearly it makes no sense to hold servicers to manufacturing-specific regulations."
The clashing viewpoints are comparable to high-profile right-to-repair controversies concerning consumer products like smartphones and tractor-trailers, where manufacturers like Apple and John Deere have argued that a robust service market for their products would open the door to safety and security concerns.
"In reality, AdvaMed and MITA have been stalemating progress in the collaborative communities for over a year," said Francoeur. "They couldn't agree on antitrust-focused language, and they couldn't agree on voting rights."
Although COVID-19 has put the MDSCC on hold, Francoeur said that "mini groups" have been formed within the alliance to concentrate on specific topics (training materials, definitions, QMS solutions, and key performance indicators) and he expects those groups to continue their work despite the departure of MITA and AdvaMed.
The International Association of Medical Equipment Remarketers and Servicers (IAMERS), another MDSCC member representing non-OEM viewpoints, echoed that sentiment. "IAMERS is disappointed that AdvaMed and MITA will not be continuing with the Medical Device Servicing Collaborative Communities initiative," Robert Kerwin, general counsel for the organization, told HCB News. "Like other stakeholders, we have devoted many hours to the MDSCC initiative and will continue to pursue this and other collaborative initiatives."
The need for better partnerships between medical equipment OEMs and service teams has been highlighted by the COVID-19 pandemic. In April, five state treasurers called upon device manufacturers to increase the availability of ventilator service manuals for service technicians on the front lines.
“In a public health crisis, every second counts. There shouldn’t be a single ventilator sitting in a closet because a hospital, already under extreme pressure, isn’t able to make necessary repairs to it," wrote Pennsylvania State Treasurer, Joe Torsella
. "I call on manufacturers of this lifesaving equipment to release this information and remove this barrier that hospitals are facing.”