A panel of medical experts voiced overwhelming support for a proposal that, if ultimately enacted, would subject internal surgical staplers and implantable stapler systems to a higher level of regulatory oversight.
Internal surgical staplers and implantable staples are generally used in minimally-invasive procedures to cut and then quickly seal tissue and blood vessels. But if they fail to fire or create a secure seal, patients may suffer massive bleeding or life-threatening infections.
Internal surgical stapler systems are currently categorized Class I (low risk) devices. As such, they do not have to undergo human testing prior to coming to market. Other Class I medical devices include plastic bandages, examination gloves, and handheld manual surgical instruments.
The U.S. Food & Drug Administration’s (FDA) proposed designating internal stapler systems Class II (moderate risk) medical devices after the products were cited in more 41,000 adverse event reports, including 366 patient deaths, 9,000 serious injuries, and 32,000 stapler malfunctions.
Reclassifying internal surgical stapler systems would allow the FDA to require pre-market testing and establish special controls for the devices, such as performance standards, post-market surveillance, patient registries, and the development and distribution of guidance documents.
The FDA convened its General and Plastic Surgery Devices Panel last week to consider the proposal. According to a summary of the meeting, the panel unanimously voted in favor of reclassification.
“Staplers are clearly in a complex environment and probably should have been Class II from the beginning,” panel chairman Dr. Frank Lewis told MassDevice.com shortly after the vote. “It was more a recognition of a misclassification error at the outset of regulation which was in 1976 or ’77 rather than a real change of opinion.”
The FDA is not required to implement advisory panel recommendations, but it usually does so.
Last Thursday’s vote came just days after the agency granted Class I recall designation to a surgical stapler recall recently announced by Ethicon, Inc. Class I is the FDA’s most serious recall category, and indicates that product poses a significant risk of patient injury or death.
At least two patients were harmed by Ethicon’s recalled staplers. The action involved:
More than 92,400 units were sold in the United States from March 15, 2018 through May 8, 2019.