An FDA panel has recommended that surgical staplers for internal use be reclassified to a more highly regulated status.
The General and Plastic Surgery Devices Panel met last week following a March alert the agency issued about internal-use surgical staplers. The devices have seen an uptick in concern over the past few months, with the FDA saying in March that it has received more than 41,000 adverse event reports, including 366 deaths, related to the devices. In addition to the advisory meeting and the proposed regulatory change, the agency also issued draft guidance to stapler makers.
Staplers were also a focus of the recent Kaiser Health News report, also released in March, shedding light on at least 1.1 million adverse event reports that were hidden from public view through an “alternative summary reporting” repository.
“Staplers are clearly in a complex environment and probably should have been Class II from the beginning,” panel chairman Dr. Frank Lewis told MassDevice in an interview following the meeting. “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.”
Surgical staplers for internal use were classified as less-highly regulated Class I devices in 1988. They had been in common use in medical practice for many years, and the FDA said it believed that general controls were sufficient to provide reasonable assurance of the safety and effectiveness of those devices and the devices were exempt from premarket notification the following year.
Reclassification of the staplers as a Class II device would allow the agency to require premarket review and allow 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.
The ECRI Institute, Medtronic and Johnson & Johnson’s Ethicon subsidiary all supported the reclassification, according to an FDA summary of the meeting.
Stapler/staple malfunctions may result in prolonged surgical procedures or unplanned, additional surgical
interventions, which may lead to other complications such as bleeding, sepsis, fistula formation, tearing of
internal tissues and organs, increased risk of cancer recurrence, and death. Common causes for these
complications include the use of incorrectly sized staples, incorrect use of the device by the user and
improper use of the device for the condition of the patient’s tissues, the FDA said. These complications frequently require additional diagnostic studies, invasive procedures and in the need for reoperation resulting in prolonged hospitalization and additional skilled nursing care.
Although the panel’s recommendation is non-binding, Lewis said it appears the FDA will agree.
“The panel decision is entirely advisory. It has no force of law at all,” he said. “My impression is that this is an action that they want to take.”