By John R. Fischer and Gus Iversen

The 2018 AAMI meeting arrived on the heels of a report from the FDA indicating insufficient evidence that third-party medical equipment service providers should face stricter regulations.

The long-awaited 27-page report, entitled "Quality, Safety and Effectiveness of Servicing of Medical Devices” was mandated by Congress last year and could have big implications for the equipment stakeholders who convened in Long Beach, California for the biggest health technology management event of the year.

On Monday morning, June 4, HealthCare Business News hosted a breakfast symposium to discuss the report as well as other current events and top-of-mind concerns facing equipment servicers.

The new report is hardly the final word on the subject, and the debate over regulating third-party services is still “not done,” Robert J. Kerwin, general counsel for IAMERS, told the roughly 180 attendees, most of whom were biomedical engineers and HTM professionals. His observation was in reference to H.R. 2118, a bill that is separate from the FDA’s investigation and proposes that medical equipment servicers must register and submit reports to the FDA to ensure safety and effectiveness.

“Millions of dollars have been spent in this matter and still we see one manufacturer’s trade association issuing an editorial saying that the FDA has a blind spot and that one needs to proceed with H.R. 2118” Kerwin told the room. “We think the FDA carefully considered things. We think that when Congress had the initial discussion on this, they needed to hear more from the HTM community. Respectfully, they didn’t seem to be considering the great job that you all do and how important you are to the healthcare ecosystem.”

Other panel participants included Mike Busdicker, system director of clinical engineering for Intermountain Healthcare; Pat Fitzgerald, executive VP and GM for Richardson Healthcare; Aaron Goryl, GM of in-house and on-demand for GE Healthcare; and Sheila O'Donnell, VP of the technical resource group for Crothall Healthcare.

In a discussion moderated by DOTmed.com president and publisher of HealthCare Business News, Philip Jacobus, the five panelists shared their reactions to the findings of the FDA report and also addressed the need for standards and ways to implement them collaboratively.

HTM Homepage