由 Gus Iversen
, Editor in Chief | February 17, 2021
The Medical Imaging and Technology Alliance (MITA), a trade group representing the interests of medical equipment manufacturers, issued a white paper last week proposing third-party equipment service providers should be required to register with the FDA and adopt a Quality Management System conformant with the FDA's 21 CFR 820 standard.
Under 21 CFR 820, OEMs must abide by regulations related to design, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices. They also must undergo periodic FDA inspections to prove compliance and develop adequate training curricula for employees to implement and maintain training records that are subject to internal audits.
MITA frames its position around concerns for patient safety, despite a two-year investigation conducted by the FDA, which determined those concerns were unwarranted. In a 2018 report, the FDA found that current objective evidence did not justify the need to regulate third-parties
because it did not find widespread public health concern around medical equipment servicing.
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When asked why MITA is taking a position that seems to contradict the FDA's findings, Peter Weems, MITA's director of policy and strategy, told HCB News that the same FDA report showed that there were between 16,520 and 20,830 firms servicing medical devices in the country. "The best way to determine the magnitude of the problems associated with improper performance of these activities would be through registration and reporting by third-party servicers," he said.
The white paper states that "third-parties are accountable to no entity, and beyond voluntary standards, operate within a regulatory grey area," but advocates for third-party service disagree with that description. Rob Kerwin, general counsel for the International Association of Medical Equipment Remarketers and Servicers (IAMERS), told HCB News that such an analysis does not give "due credit" to HTM professionals and hospital environment of care (EOC) committees that review and require third-party QMS.
The 2018 FDA report concluded that the best way forward for different service entities, (in-house, third-party and OEM) was to form collaborative communities
in which they could address their differences and find a path forward together. MITA, alongside another leading organization representing OEM interests, AdvaMed, pulled out of that collaboration
in May 2020, citing a lack of progress.