The Food and Drug Administration has announced proposals to increase regulations on surgical staplers for internal use and implantable surgical staples, which are used in many surgical procedures, including gastrointestinal, gynecologic and thoracic surgeries to remove part of an organ, to cut through organs and tissues, and to create connections between structures. In March, the agency issued an alert about the risks these devices pose and provided safety recommendations to keep them in use due to the important benefits they provide.
FDA said that more than 41,000 individual adverse event reports including 32,000-plus malfunctions, 9,000-plus serious injuries and 366 patient deaths were reported from January 1, 2011 to March 31, 2018. Problems included an opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).
FDA says it will now take additional actions by imposing regulatory requirements.
In the announcement, FDA’s Director of the Center for Devices and Radiological Health Jeffrey Shuren said surgical staplers for internal use would be reclassified from its current low-risk Class I category into the higher-risk Class II (moderate risk) category for medical devices with special controls. This means the staplers would require the review and clearance of a premarket notification submission prior to marketing.
“At the time of the device’s original classification in 1988, surgical staplers had been in common use in medical practice for many years, and the FDA believed, based on the available information, 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,” Shuran said in the announcement. “Reclassification of surgical staplers for internal use as a Class II device would allow the agency to require premarket review and allow us to 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.”
FDA said it also released the draft guidance, “Surgical Staplers and Staples for Internal Use - Labeling Recommendations,” to help manufacturers ensure their labeling provides adequate information for use, including relevant hazards, contraindications, and other information under which practitioners can use the device safely and for its intended purpose. The guidance recommends that manufacturers include contraindications for use, such as not using on necrotic (dead) tissue, and warnings, such as avoiding use on large blood vessels.
It also includes clear instructions for use, such as how to evaluate staple line formation and integrity and that the product labeling for surgical staplers and staples for internal use clearly identify key technical characteristics and performance parameters, such as the types of tissues on which the device may be used. Helping manufacturers identify appropriate information to include in their product labeling will ultimately help better protect patients by helping healthcare professionals better understand the appropriate use and the risks of these devices.
FDA will hold a public meeting of the agency’s General and Plastic Surgery Devices Panel of its Medical Devices Advisory Committee on May 30, 2019 to discuss whether the current proposal is appropriate, along with a comprehensive analysis of all the medical device reports (MDRs) received for surgical staplers for internal use and implantable staples, as well as other relevant information.
