FDA to reclassify surgical staplers as Class II devices requiring premarket review

Going forward, surgical staplers could fall under special regulatory controls such as mandatory mechanical testing and assessments of their labeling and instructions for use. (Andrew Harnik, Associated Press)

The FDA has proposed to reclassify surgical staplers as higher-risk medical devices—therefore requiring premarket reviews, agency clearance and performance studies—following an increasing number of safety reports in recent years.

Used to stitch together tissues faster than manual suturing, surgical staplers have been categorized as Class I devices since 1988, as part of a group of low-risk “manual surgical instruments for general use.”

By then the staplers had been in common use for many years, and the FDA later exempted manufacturers from premarket notifications. Meanwhile, the internal staples themselves were deemed Class II devices with a moderate level of risk.

Going forward, the stapling devices may also be considered Class II hardware—and could fall under special regulatory controls, such as mandatory testing of mechanical features and assessments of their labeling and instructions for correct use, according to the FDA.

An agency review spanning seven years of device reports found more than 32,000 malfunctions, over 9,000 serious injuries and 366 deaths related to surgical staplers. This included misfirings and device failures, as well as malformed staples or reopenings in the wound. User errors were also reported, such as selecting the wrong size cartridge during a procedure. Last month, the FDA notified the industry of these concerns and its intent to take regulatory action.

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The FDA has also issued a draft guidance (PDF) for manufacturers, offering labeling recommendations covering usage instructions, contraindications, hazards and other safety information. For example, the agency advocated for including warnings against using staples on large blood vessels, and guides on evaluating closure formation and the selection of appropriate staple sizes.

In addition, the FDA plans to receive expert input on its reclassification proposal, as well as the draft guidance, at an advisory panel meeting scheduled for May 30. There the agency plans to present an analysis of all the medical device reports it has received for surgical staplers and their use.

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“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,” said the FDA’s Jeffrey Shuren, director of the Center for Devices and Radiological Health, in an agency statement. “We remain dedicated to closely monitoring reports of adverse events associated with surgical staplers for internal use and implanted staples and will take additional action, as needed, to protect patients.”