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What to expect at the annual CEAI clinical engineering conference in Illinois Discussing the event with the organization's president and vice president

Biomedical perspectives: Q&A with Andrew Rich Discussing the ways biomedical engineering is evolving and the advantages major hospitals have when negotiating with OEMs

Tips for responding efficiently to equipment downtime Experts at AAMI discuss strategies to get back up and running

GE debuts VR HTM training technology at AAMI Lowers costs and eliminates need to travel to facilities for training

Glassbeam unveils AI anomaly detection for imaging modality maintenance Allowing better awareness for tube temperature, waterflow changes

Q&A with Christine V. Emery, the new executive director for the AAMI Foundation Changing the way we think about aging and staying healthy

Testing equipment gets modern upgrades, connectivity Touch screens and other enhancements make critical devices more user-friendly

How passive RFID for asset tracking can improve care delivery Insights from the front lines at Northern Westchester Hospital

Planning a better future for OEMs and ISOs Can they co-exist and thrive in the Age of Accelerations?

FDA report opposes regulating third-party servicers Evidence for public health concern deemed 'not sufficient'

The panel of speakers at the HealthCare
Business News Breakfast Symposium

Experts talk third-party service and other HTM issues at AAMI

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.
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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.

Robert Kerwin
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.
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