FDA Assessing Safety of Surgical Staples for Internal Use
The agency plans in the coming months to issue a draft guidance with labeling recommendations for manufacturers and to hold a public advisory committee meeting to discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate.
The U.S. Food and Drug Administration has issued a letter to health care providers expressing concern about the rising number of adverse events associated with surgical staplers and staples for internal use, saying it intends to take several actions to ensure they are used safely.
Because surgical staplers and staples for internal use are used as a system, FDA is analyzing the medical device reports submitted for both surgical staplers and implantable staples to obtain a comprehensive picture of the safety profile for the devices. It has found that from Jan. 1, 2011, to March 31, 2018, FDA received more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions. FDA indicated it believes many of the problems identified in the reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler.
Some of the most commonly reported problems in these adverse event reports include 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). Malfunctions or misuse can result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications, such as bleeding, sepsis, and even death.
The agency plans in the coming months to issue a draft guidance with labeling recommendations for manufacturers and to hold a public advisory committee meeting to discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate. Currently, surgical staplers are regulated as Class I medical devices, which don't require a premarket submission to FDA. Implantable surgical staples are classified as Class II medical devices and require premarket review before marketing.
FDA's recommendations to health care providers are to read and carefully follow the stapler manufacturer's instructions for use, have a range of staple sizes available, and select the appropriate size cartridge for the tissue type and thickness. They should avoid using the stapler on tissue that is too thick or too thin for the selected staple size, as this could result in staple malformation, and should be aware that different companies may use different color schemes on the cartridges to indicate different staple sizes.
The agency also recommends considering other options for certain types of tissue, being familiar with the structures around the intended staple site and checking that unintended structures are not in the staple line, and avoiding using staples on large blood vessels, such as the aorta, and avoiding clamping the stapler on delicate tissue, as clamping can still cause injury even if no staples are fired.
"As part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices," said Dr. William Maisel, M.D., MPH, chief medical officer in FDA's Center for Devices and Radiological Health. "As part of our Medical Device Safety Action Plan, we are committed to streamlining and modernizing how we implement post-market actions to address device safety issues to make our responses to risks more timely and effective. The agency's analysis of adverse events associated with surgical staplers and implantable staples is ongoing, but we know these devices provide important benefits for patients undergoing surgery, so it's important for us to continue to educate providers about the devices' safety and risk. We are asking providers to be aware of the new information and implement the recommendations we're outlining today to help improve the safe use of these devices. Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts."
FDA indicated it will announce the meeting's details on its FDA Advisory Committee calendar website.