U.S. Compliance:
FDA Activities
Last Updated: Mar 20, 2008
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FDA Issues Notification on Unretrieved Device Fragments
Mar 20, 2008
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The U.S. Food and Drug Administration (FDA) has issued a public health notification for healthcare practitioners regarding fragments from medical devices left in patients following procedures.
As required under FDA regulations, nearly 1000 adverse events related to unretrieved device fragments (UDFs) are reported each year to the FDA’s Center for Devices and Radiological Health (CDRH). The consequences include local tissue reaction, infection, perforation and obstruction of blood vessels, and death.
Among other recommendations, the FDA’s notification advises medical professionals to inspect medical devices immediately prior to use for any evidence of defects that might increase the likelihood of fragmentation during a medical procedure, as well as immediately after the device is removed from the patient for any signs of breakage or fragmentation.
Our readers can view the complete text of the FDA’s notification at
this link.
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