UPDATED April 24, 2019, with further detail on the FDA’s actions.
The FDA today scheduled an advisory committee meeting next month to consider its proposal to strengthen the regulation of surgical staplers.
During the meeting, set to take place May 30-31, the FDA will seek the committee’s input on its plan to shift surgical staplers from Class I to Class II. Surgical staplers 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 In addition to the advisory meeting and the proposed regulatory change, the agency also issued draft guidance to stapler makers.
“Alerting the public and health care professionals was an important step, but as we shared at that time, we believe additional actions must be taken to better ensure the safe and effective use of these devices. To that end, today we are announcing three new efforts with the goal of better protecting patients from the malfunctions, injuries and deaths associated with these devices,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in a prepared statement.
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.
The general & plastic surgery devices panel is slated to discuss surgical stapler reclassification May 30 and is due to take up the reclassification of certain absorbable hemostatic agents from Class III to Class II the next day, according to the FDA said.
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