FDA Panel Recommends Reclassifying Surgical Staplers

Troy Brown, RN

June 03, 2019

The US Food and Drug Administration's (FDA's) General and Plastic Surgery Devices Panel recommended reclassifying surgical staplers from class I (subject to general controls only) to class II (subject to general and special controls) medical devices.

Thursday's meeting came in the midst of growing concerns about safety risks associated with the use of internal surgical staplers. Although surgical staplers and staples are used together, the panel was not asked to make a recommendation about internal staples, which are already designated class II medical devices, nor about external staplers used on the skin.

Class II classification requires premarket review of the devices as well as the use of special controls, including performance testing, usability testing, and labeling requirements.

Favorable Risk-Benefit Ratio

"The risk-benefit ratio is strongly in favor of using the device," voting member Michael J. Miller, MD, professor of plastic and reconstructive surgery and founding chair, Department of Plastic and Reconstructive Surgery, the Ohio State University, Columbus, said at the meeting.

"I think a class II device, with special controls, is probably very adequate for this, and I'm very comfortable with that," he said.

Benefits of surgical staplers include the ability to place staples quickly, minimal reaction of tissues, low risk for infection, and secure wound closure. However, stapler and staple malfunctions may lead to the prolongation of surgical procedures or unexpected, additional surgical interventions. These can result in complications, including bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk for cancer recurrence, and death.

Such complications are often caused by incorrect sizing of staples, incorrect use of staplers by the user, and inappropriate use of the stapler with respect to "the condition of the patient's tissues," the FDA explained in a briefing document.

As a result of these complications, patients often require further diagnostic studies, invasive procedures, and reoperation that leads to lengthy hospitalization and further skilled nursing care.

Over a period of more than 7 years, the FDA received more than 41,000 reports of problems with surgical staplers and staples used internally, Medscape Medical News has reported. Among reported incidents regarding medical devices, 366 deaths occurred, and there were more than 9000 serious injuries and more than 32,000 device malfunctions, according to a March 8 letter from the FDA to clinicians.

Label Revisions Suggested

The committee discussed labeling for surgical staplers, and several panel members suggested simplifying the label.

Temporary nonvoting member Walter Pories, MD, professor of surgery, Brody School of Medicine, East Carolina University, Greenville, North Carolina, said the current label information is so detailed that he doubts people read it. "Perhaps the FDA could be encouraged to work with SAGES [the Society of American Gastrointestinal and Endoscopic Surgeons] and the ATC [the American Thoracic Society] and SVS [the Society for Vascular Surgery] to develop simple, clearly defined labels, perhaps with some illustrations," Pories suggested.

Temporary nonvoting member Terry Hicks, MD, associate chairman, Department of Colon and Rectal Surgery, Ochsner Health System, New Orleans, Louisiana, said the label should be simple and limited to "the meat."

"There seems to be unanimous opinion that class II with general and special controls are adequate for the regulation of staplers," committee chair Frank R. Lewis Jr, MD, said.

Class I medical devices have the least potential for harm to the user. They include elastic bandages, examination gloves, and handheld manual surgical instruments, according to the FDA's briefing document. Class I devices are subject to the least restrictive regulatory controls and do not require premarket review.

Special controls may include performance standards, postmarket surveillance, patient registries, and the development and distribution of guidance documents.

"The panel feels that class II classification would provide reasonable assurance of safety and effectiveness. Regarding the question of a registry, there's a divergence of opinion on the panel, and there's no unanimous opinion about the use of that. There are some dissenting voices regarding the difficulties of implementing a registry, particularly given the extremely low incidence of adverse reactions, so there's no uniform recommendation for that, no consensus opinion, and the FDA will need to evaluate further the practicality of doing that," Lewis concluded.

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