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MITA continues to push for FDA regulation of third-party servicers

by Gus Iversen, Editor in Chief | February 17, 2021
HTM Parts And Service

"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.

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"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."

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Steve Arey

MITA push for FDA Regulation

February 22, 2021 11:04

Manufacturers of Medical Devices should be required by Law, to perform a "safety inspection" annually on ALL of their Medical Devices.

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