FDA Issues Safety Recommendations for Providers Using Surgical Staplers

The Food and Drug Administration recently issued recommendations for healthcare providers to reduce the risk of adverse events associated with surgical staplers and staples for internal use. Among other recommendations, FDA recommends providers carefully follow the stapler manufacturer’s instructions for use, have a range of staple sizes available and select the appropriate size cartridge for the tissue. Since 2011, the agency has received more than 41,000 medical device reports for surgical staplers and staples for internal use, including 366 deaths. FDA plans this year to issue draft guidance to manufacturers on information to include in their product labeling and to hold a public meeting on whether to reclassify the staplers as Class II devices, which would allow the agency to establish mandatory special controls to mitigate known risks.

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