FDA Proposal Targets Surgical Stapler Injuries

Published on April 23, 2019 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) issued new proposals today in a bid to reduce serious injuries associated with the use of internal surgical staplers and implantable staples.

Surgical Stapler Injuries and Deaths

Internal staplers and implantable staples are used in a wide range of surgeries to cut through organs and tissues, and to create connections between structures.

Although the use of such systems can significantly shorten procedure time compared to manual suturing, they were also cited in more than 41,000 individuals FDA adverse event reports from January 1, 2011 through March 31, 2018. According to the agency these reports included 366 patient deaths, over 9,000 serious surgical stapler injuries, and over 32,000 malfunctions.

FDA to Reclassify Internal Surgical Staplers

Internal surgical staplers are currently designated Class I (low risk) medical devices. As a result, manufacturers do not have to seek approval from the FDA prior to bringing the products to market. Earlier today, however, the FDA issued a proposed order that would reclassify internal surgical staplers as Class II (moderate risk) medical devices with special controls.

“Reclassification of surgical staplers for internal use as a Class II device would allow the agency to require premarket review and allow us to establish special controls, such as mandatory performance testing of various mechanical features, demonstration of usability and labeling comprehension such as assessing health care professionals’ ability to properly select and use the device according to the labeling, and specific labeling elements supporting the safe use of the device,” Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health said in a statement.

Surgical Stapler Injuries Subject of FDA Meeting

The agency also issued draft guidance to ensure product labels contain the information surgeons need to avoid surgical stapler injuries and malfunctions, including appropriate warnings, contraindications, and clear technical specifications.

On May 30th, the FDA will convene a public meeting of its General and Plastic Surgery Devices Panel to obtain feedback on the proposed reclassification and draft guidance.

“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,” Shuren continued. “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.”

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