The FDA has sent a letter to health care providers to advise of the multiplying medical device reports about the use of implantable surgical staples and surgical staplers for internal use, and what it intends to do about it. Draft guidance will be issued with labelling recommendations for manufacturers amongst other things, and a public advisory committee meeting will be held to review the current pathway for manufacturers to market surgical staplers for internal use. Surgical staplers are regulated as class I medical devices that do not need a premarket submission to the FDA, and implantable surgical staples are classified as class II medical devices and do need premarket review before commercialization.
The FDA has already raised the issue of the risks associated with surgical staplers and implantable staples and has been carrying out an ongoing assessment of medical device reports it has received. An analysis of that information between 1 January 2011 and 31 March 2018 found more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including around 32,000 malfunctions, approximately 9,000 serious injuries and 366 deaths.
“Risks of surgical and implantable staplers to be reviewed“
Dr William Maisel, the FDA’s Center for Devices and Radiological Health chief medical officer, said: “As part of our Medical Device Safety Action Plan, we are committed to streamlining and modernizing how we implement post-market actions to address device safety issues to make our responses to risks more timely and effective. 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.”