Devices

FDA Reclassifies Surgical Staplers, Staples

FDA has issued a final order reclassifying surgical staplers for internal use from Class 1 (general controls) to Class 2 (special controls) and requiring them to undergo premarket review. An agency statement says that as a result of the order, surgical staplers for internal use “will be subject to more stringent regulatory requirements, including requiring premarket notification and special controls to help mitigate known risks of the device.” The order is effective 10/8 and FDA says it will not enforce it for 180 days.

The agency also issued a final guidance, Surgical Staplers and Staples for Internal Use — Labeling Recommendations. The document says the recommendations are needed because malfunctions and misuse associated with the devices have resulted in serious adverse events, including death. “FDA believes that the labeling recommendations in this guidance would help promote the safe and effective use of surgical staplers and staples for internal use by helping manufacturers develop labeling with information about specific risks, limitations, and directions for use of the device,” the guidance says.

The agency says that between 1/2011 and 3/2018 it received over 41,000 adverse event reports associated with surgical staplers and staples for internal use, including over 360 deaths. Some of the most commonly reported problems, it says, were opening of the staple line or malfunction of the staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (applying to the wrong tissue or applying a staple of the wrong size).

An updated FDA letter to healthcare providers alerts professionals to information about the safe and effective use of surgical staplers.

“Today’s issuance of a final order and guidance is the result of our continuous and careful evaluation of surgical staplers and staples for internal use,” the FDA statement says. “In 5/2019, FDA convened a public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss whether reclassifying surgical staplers for internal use from Class 1 to Class 2 would be appropriate.” The committee generally agreed with the agency’s recommendations.

“Manufacturers of surgical staplers for internal use will now be required to meet the special controls outlined in the final reclassification order and be required to submit a 510(k) if they do not already have one,” FDA says.

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