30 April 2019
FDA Adopts New Requirements for Marketing Surgical Staplers
Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced on 23 April new steps to reduce the risks associated with surgical staplers for internal use, along with the implantable staples used with those devices.
Surgical staplers are used in a wide range of surgical applications. However, the FDA has found a significant number of adverse event reports associated with these devices, including 32,000 malfunctions, 9,000 serious injuries and 366 patient deaths. The most commonly reported problems in the adverse event reports include an opening of the staple line, malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple and misapplied staples.
In light of these findings, the FDA is reclassifying surgical staplers from Class I (low risk) to Class II (moderate risk) medical devices with special controls. This reclassification allows the FDA to require mandatory performance testing of the mechanical features, demonstration of usability, and required testing of labelling comprehension prior to marketing.
The FDA has also issued draft guidance on its website to help manufacturers ensure that surgical stapler labelling provides clear information for use, including relevant hazards, contraindications and other information to ensure safe use. The guidance recommends that manufacturers include (i) contraindications for use, such as not using on necrotic (dead) tissue, and (ii) warnings, such as avoiding use on large blood vessels. The guidance recommends that the directions contain clear instructions on how to evaluate staple line formation and integrity. The FDA will hold a follow-up meeting on 30 May to discuss surgical stapler policy and hear from stakeholders.