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FDA workshop: is it servicing or remanufacturing?

by John R. Fischer , Staff Reporter
Stakeholders from all areas of the medical equipment industry gathered Monday and Tuesday in Maryland for the FDA’s Medical Device Servicing and Remanufacturing Activities workshop.

Held at the Hilton Washington, D.C. North Gaithersburg Hotel, the aim of the one-and-a-half-day event was to facilitate an exchange of ideas between diverse parties for the building of a collaborative community dedicated to ensuring that standards of safety, effectiveness and quality are met in the manufacturing and servicing of medical devices. The main intent of this meeting was to discuss what constitutes servicing versus remanufacturing activities, one of many topics to be addressed in a future draft guidance that will be issued by the FDA.

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“We’ve seen these incredible advances in technology, materials, digital health, AI and a list of other innovations,” said Dr. William H. Maisel, deputy director for science and chief scientist of the FDA Center for Devices and Radiological Health, in his welcoming remarks to the roomful of attendees. “Our vision statement isn’t just about getting these devices to patients. It’s about making sure that once they get to patients, they remain of high quality, and are safe and effective.”

The formation of collaborative communities was proposed by the FDA in its May 2018 report which concluded a two-year investigation into the difference between the quality, safety and effectiveness of servicing provided by ISOs and in-house HTM professionals for medical devices, compared to OEMs. The report found no evidence to suggest that servicing by third-party providers leads to potential adverse events that may pose harm to patients.

The first day of the workshop consisted of two-breakout sessions. The first comprised two scenarios for each table that pertained to equipment or components plagued by different challenges, and the practices used to solve the problem.

Participants were tasked with determining if each practice was an example of servicing or remanufacturing, based on a proposed flowchart that the FDA is considering issuing as a visual guide to help address the most common and important considerations in distinguishing the two types of activities. The objective was to create an exchange of thoughts as to what considerations are needed to make such determinations and to suggest any improvements for the flow chart.
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