Kaiser Health News reported “the Food and Drug Administration announced a sweeping plan on Friday to review and address the safety of surgical staplers, including a new examination of seven years’ worth of hidden reports highlighted Thursday in a Kaiser Health News investigation.” In a letter to healthcare providers, “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.”
Medscape reported that “from January 1, 2011, to March 31, 2018, the FDA received more than 41,000 individual [medical device reports] MDRs for surgical staplers and staples for internal use, including 366 deaths, more than 9000 serious injuries, and more than 32,000 malfunctions.” William Maisel, MD, MPH, chief medical officer of the agency’s Center for Devices and Radiological Health, said in a statement, “The agency’s analysis of adverse events associated with surgical staplers and implantable staples is ongoing, but we know these devices provide important benefits for patients undergoing surgery, so it’s important for us to continue to educate providers about the devices’ safety and risk.”
Additional coverage is provided by MedPage Today and Medical Device and Diagnostic Industry.
