FDA Cracks Down on Surgical Staplers

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...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news