After analyzing more than 41,000 adverse event reports logged between January 2011 and March 31, 2018, FDA found that the most commonly reported problems involve problems with surgical staplers and staples designed for internal use.
The reports include 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 (for example, the user may have applied staples to the wrong tissue or they may have applied staples of the wrong size to the tissue).
Now, as part of the Medical Device Safety Action Plan, first revealed in April 2018, FDA is now taking action to better protect patients from malfunctions, injuries, and deaths associated with surgical staplers. The agency announced three specific new efforts on Tuesday that align with that purpose.
1. Tougher Regulation of Surgical Staplers
FDA proposed reclassifying the staplers into a higher-risk category that requires the review and clearance of a premarket notification submission prior to marketing. Currently, manufacturers of surgical staplers for internal use are not required to submit a premarket notification to FDA because the devices are in the low-risk category, or Class I. The proposed order would bump the devices to Class II (moderate risk) medical devices with special controls, such as mandatory performance testing on various mechanical features, demonstration of usability and labeling comprehension, and specific labeling elements to support safer use of the device.
2. New Labeling Recommendations for Surgical Staplers and Staples
FDA also issued new draft guidance aimed at helping manufacturers ensure their labeling provides adequate information for use, including relevant hazards, contraindications, and other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. The new guidance also recommends that the directions contain clear instructions, such as how to evaluate staple line formation and integrity and that the product labeling clearly identifies key technical characteristics and performance parameters, such as the types of tissues on which the device may be used.
3. Public Advisory Committee Meeting Scheduled for May
FDA has scheduled a public advisory committee meeting for May 30 to receive expert input on the proposed reclassification and draft guidance. As part of the panel meeting, the agency plans to present a comprehensive analysis of all the medical device reports received for surgical staplers for internal use and implantable staples, as well as other relevant information.