FDA to re-evaluate premarket review procedures for surgical staplers

FDA
The FDA plans to hold a public advisory committee meeting this year to discuss the current regulatory pathway for manufacturers, and will present a comprehensive analysis of medical device reports. (FDA)

The FDA has acknowledged an increasing number of safety reports linked to surgical staplers and plans to re-evaluate whether the commonly used devices should receive more federal oversight and undergo premarket review.

Surgical staplers, used to stitch up tissue faster than manual suturing in a wide range of applications, are categorized as Class I, low-risk devices that do not need to be approved by the agency before being sold. Their implantable staples, however, are designated as Class II devices and require an FDA clearance.

A review of seven years’ worth of medical device reports found more than 41,000 problems linked to surgical staplers and implantable staples—including 32,000 malfunctions, over 9,000 serious injuries and 366 deaths, according to the FDA.

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Misfiring, as well as difficulty or failure in firing staples, ranked among the most-common problems reported, alongside malformed staples or a reopening in the stapled wound. User errors were also reported, such as stapling the wrong tissues or using the wrong staple size during a procedure.

Going forward, the FDA plans to hold a public advisory committee meeting this year to discuss the current regulatory pathway for manufacturers and will present a comprehensive analysis of medical device reports.

“Reclassifying surgical staplers for internal use from Class I to Class II would allow the FDA to establish special controls, such as mandatory performance testing of various mechanical features, demonstration of usability and labeling comprehension (assessing user’s ability to properly select and use the device according to the labeling), and specific labeling elements supporting the safe use of the device,” the FDA said in a statement announcing the meeting, alongside a letter to healthcare providers. A date for the meeting has not been set.

In addition, the FDA plans to issue a new draft guidance for manufacturers, proposing recommendations for product labeling and instructional information—and also reminded surgeons to review device instructions and select the appropriate staple size for a patient’s tissue type and thickness.

The agency’s announcement shortly followed an investigation by Kaiser Health News into a secondary, internal safety report repository managed by the FDA, outside of its more well-known and public MAUDE database. The story focused heavily on the number of malfunctions reported for surgical staplers and the injuries that have happened to patients.

The agency’s alternative summary reporting program is designed for well-known and well-documented issues, the FDA told Kaiser Health News. It has collected information on at least 1.1 million incidents since 2016, linked to about 100 medical devices including surgical staplers as well as products such as endovascular balloon pumps and mechanical breathing machines.

“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,” William Maisel, chief medical officer of the FDA’s Center for Devices and Radiological Health, said in the agency statement.

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