Biomedical/Clinical Engineers Improve Patient Safety by Reporting Medical Device Problems to the Food and Drug Administration


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Abstract

The biomedical/clinical engineering community is an integral part of helping to keep medical devices safe and effective through voluntary adverse event reports submitted to the MedWatch Food and Drug Administration Safety Information and Adverse Event Report Program (link is provided at end of article). These voluntary reports foster an important partnership between the biomedical engineering community and the Food and Drug Administration. Engineers have unique perspective and knowledge, as well as the ability, to test many different types of devices to determine "what went wrong" after a device may have malfunctioned. An engineering perspective greatly enhances medical device reports when the device postevent test results are submitted along with the report.

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