FDA Center for Devices and Radiological Health Director Jeffrey Shuren, MD, issued a new communication on surgical staplers and implantable staples.
What you should know:
1. The FDA received more than 41,000 individual adverse event reports related to surgical staplers from Jan. 1, 2011, to March 31, 2018. It sent out a public-facing alert to that point in March.
2. The FDA proposed new regulatory requirements for surgical staplers because of the increasing amount of adverse events, Dr. Shuren said. If approved, the FDA would reclassify surgical staplers as class two medical devices, requiring additional clearance before marketing.
When the FDA originally classified surgical staplers, as a class one device, staplers had been in common use for years, and the FDA believed they were generally safe and effective.
3. The FDA also issued draft guidance to manufacturers providing several recommendations around labeling.
4. Finally, the FDA plans to convene its General and Plastic Surgery Devices Panel to discuss whether the current pathway around surgical staplers is appropriate and to discuss the proposed changes.
"Combined, we believe these steps will help better protect patients by ensuring that these devices are safe and effective for their intended use in surgeries," the communication concluded.