At this year’s Association for the Advancement of Medical Instrumentation (AAMI) conference, health technology management (HTM) departments were a core focus. Attendees discussed the blurring lines that separate HTM professionals from IT professionals — and the variety of challenges that come with keeping pace in an evolving health care system.

The FDA's docket on refurbished equipment and service was a central part of that conversation, as professionals from different sectors shared their views on why the FDA is investigating the topic and what it means for the industry. In a session entitled What’s next for the FDA initiative on service, refurbishment, and third-party repair, Dave Francoeur, senior director of brand and quality at Sodexo, moderated a conversation to explore the docket in detail.

The FDA was accepting comments on the docket until May 26, and after reviewing what individuals and companies had to say, the panelists shared their takeaways with attendees.
Mary Logan, president and CEO of AAMI, said that her organization tried to offer a very "big-picture" response in its comment so that its insights could be interpreted neutrally and be useful to the FDA regarding the entire service business. But Logan acknowledges that even with this approach it was difficult to encompass every relevant aspect.

"As to the future of servicing equipment, AAMI encourages the FDA to not develop definitions but rather standards through a consensus-based process," said Logan.

Underreporting from hospital staff members as a roadblock to greater transparency was emphasized by Binseng Wang, vice president of quality and regulatory compliance at Aramark. If organizations reported the problems they are having, the FDA would be more informed about the nature of equipment-related problems as a whole and could “prosecute those who cause trouble.”

Wang also reminded attendees that the FDA is not about cost, but making sure that a patient is safe. If patient care will be affected, that is under mandate for Congress to have the FDA look more into the situation.

AAMI's position that standards are a better solution than regulations was echoed by Dale Munson, manager of service and biomedical training at Medtronic, who said such a solution would ensure the HTM community was not only properly trained, but certified in their ability to service equipment. He believes that as a result of the docket, tiers will be established with maintenance responsibilities that are focused upon patient safety.

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