Using the FDA’s MedWatch program

By Jennie McKee

Orthopaedic surgeons—unlike medical device manufacturers and facilities such as hospitals and surgical centers—are not legally required to report adverse events associated with medical devices to the U.S. Food and Drug Administration (FDA). And yet, reporting these problems through the FDA’s MedWatch program is something all orthopaedists can do to help improve patient safety, according to the authors of “Reporting and Notification of Adverse Events in Orthopaedics”.

The authors—including William M. Mihalko, MD, PhD—state that orthopaedic surgeons must understand the importance of reporting adverse events involving devices and pharmaceuticals to the FDA.

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