FDA Database Release Reveals Millions of Medical Device Malfunctions

Release of FDA Database Sheds Light on Millions of Medical Device Malfunctions and Injuries

UNITED STATES – According to an online article published by khn.org, the United States Food and Drug Administration (FDA) released information from a database revealing more than 5 million reports of medical device malfunctions and injuries.

The FDA keeps track of all complaints associated with medical devices. Such complaints may include device malfunction alone, or may include injuries alone, or may include a combination of both device malfunction and injuries.  The FDA recently released what was considered to be a “once hidden” database that documents device malfunctions and injuries from over the past two decades.

An investigation conducted by Kaiser Health News found that some medical device manufacturers were sending details on reported complaints and malfunctions to the FDA as “alternative summary” reports which placed the information in the FDA’s previously hidden database.  As such, the information was not available to the public, making it impossible for doctors and patients to know about potential dangers associated with a medical device.

The newly discovered FDA database includes information on 176 reported deaths associated with potential medical device malfunctions.  Such deaths should have been reported through the proper channels at the FDA and become a part of the public database.  The FDA does allow medical device manufacturers to report certain information as an alternative summary report. However, there are guidelines that manufacturers must follow.  The FDA has revoked some manufacturers’ ability to submit alternative summary reports for failure to follow such guidelines.

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