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For many in the healthcare industry, the most polarizing debate this fall has not been who should win the White House, but how far the Food and Drug Administration (FDA) ought to go in regulating the service and repair of medical devices. Last week, these divergent views came to a head during the agency’s two-day workshop on the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices by third-party entities and original equipment manufacturers (OEMs).
During the forum-held Oct. 27-28 at the FDA’s headquarters in Silver Spring, Md.-OEMs, third-party vendors, and hospital-based healthcare technology management (HTM) professionals all voiced a commitment to patient safety but clashed over fundamental questions related to reporting requirements for device-related incidents, access to information and parts, competition in the marketplace, and even whether there is truly a service problem to debate. For every point offered by one presenter, there was a counterpoint, and the tension in the room was sometimes palpable.
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