Agency proposing higher classification of surgical staplers that will require premarket notification clearance
THURSDAY, April 25, 2019 (HealthDay News) — The U.S. Food and Drug Administration this week announced three new efforts to protect patients from malfunctions, injuries, and deaths associated with the use of surgical staplers for internal use and implantable surgical staples.
Last month, the agency issued a letter to health care providers informing them of an increasing number of medical device reports tied to the use of surgical staplers. An FDA analysis revealed that the agency received more than 41,000 individual adverse event reports related to surgical staplers from Jan. 1, 2011, to March 31, 2018. The reports included more than 32,000 malfunctions, more than 9,000 serious injuries, and 366 deaths. Most of the reports involved an opening of the staple line or malformation of staples, misfiring, firing difficulty, failure of the staple to fire, and misapplied staples.
To increase the regulatory requirements for surgical staplers, this week, the FDA proposed reclassifying them from Class I to Class II medical devices, which requires review and clearance of a premarket notification submission before marketing. The agency also issued a draft guidance for manufacturers to help them ensure stapler labeling provides information on hazards, contraindications, and other information practitioners need to safely use the device.
The agency will also hold a public meeting of the FDA General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on May 30, 2019. During the meeting, a comprehensive analysis of all adverse events related to surgical staplers reported to the FDA will be presented and the panel will hear from experts on the proposed reclassification and draft guidance.
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