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.
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.
"In order to further their business interests, ISOs have made expansive demands for proprietary servicing materials such as service manuals, software keys, schematics, and tools," Weems said. "These same businesses have consistently refused to implement even basic quality or safety controls."
MITA has long sought to mandate third-party servicer regulation. In 2017, the group endorsed legislation
called the “Medical Device Servicing Safety and Accountability Act", which would require independent servicers of medical devices to register with the FDA. The group continued to support
the legislation after the FDA's 2018 report was published.
"This act would create regulations that would, by design, burden third-party servicers with paperwork and costs without producing any commensurate safety benefit, not to mention duplicating an adverse reporting system already in place," Arif Subhan, FACCE, president of the American College of Clinical Engineering, wrote in an editorial for HCB News at the time
. "The only real beneficiaries of the act are MITA's members, who stand to gain an additional share of the medical device service market when burdensome regulations force third-party servicers to raise costs."
"If third-party servicers were not being held accountable, why are so many working successfully with manufacturers in the multi-vendor programs they operate for hospitals?," Kerwin said. "If MITA is truly concerned about safety, why not issue a white paper encouraging manufacturer equipment training programs and access to service keys?"
Weems, on behalf of MITA, has questions of his own.
"Why do third-party medical device servicers refuse to make themselves known to the FDA?" he said. "Why do they resist adoption of quality controls and remain unwilling to report deaths, serious injuries, or major malfunctions? Patients, physicians and technologists deserve safe servicing."