MedWatch: FDA's New Medical Products Reporting Program

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Abstract

MedWatch, the Food and Drug Administration's new medical product reporting program, is a partnership between healthcare professionals, industry and the FDA that is dedicated to the postmarketing surveillance of all FDA-regulated medical products. FDA is committed to educating health professionals about the vital role they play in the detection of adverse events and product problems and facilitating the reporting of those events. Clinical engineers and biomedical equipment technicians (BMETs) are important to MedWatch as a “front line” in signaling potential device-related adverse events and malfunctions or defects. MedWatch encompasses both voluntary reporting by all health professionals and mandatory device reporting by user facilities and others under the Safe Medical Devices Act of 1990 (SMDA). The program simplifies reporting by using a single form that is available in two versions (voluntary form 3500 and mandatory form 3500A for reporting required under the SMDA). Clinical engineers and BMETs should work with user facilities to train staff members on SMDA reporting requirements.

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