FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers

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The FDA Food and Drug Administration announced a sweeping plan on March 8, 2019, to review and address the safety of surgical staplers.

In a letter sent to health-care providers Friday, the FDA said it will convene an advisory meeting on the safety of the devices and signaled that it might reclassify surgical staplers to put them under tighter control. The agency also said it plans to issue proposed recommendations to companies that make the devices, which are used in countless surgeries.

The FDA also acknowledged in its letter that “we are aware that many more device malfunction reports during this time frame” were submitted as “summary reports,” which go to the FDA but are not included in the public database known as MAUDE (the Manufacturer and User Facility Device Experience). The agency said it “is conducting an analysis” of those summary reports and the results will be made available to the public.

Stapler maker Medtronic confirmed that its reporting exemption for surgical staples ended in mid-2017. FDA records show that its public reports of injuries and malfunctions soared, from about 1,000 in 2015 to 11,000 last year. Ethicon, which also makes staplers, said it has not used the reporting exemption.

Read the letter here.