Makers of surgical staplers and the implantable staples they’re loaded with will now need to jump through extra hoops before their products can be used to divide, seal and connect internal tissues for post-op healing.
The FDA finalized a new order and guidance for the devices this week. Under the terms of the order, the staplers have been upgraded from Class I to Class II devices, meaning they’ll now need to undergo premarket review before they can be sold.
Class II devices—which already include surgical staples—are also subject to what the agency calls “special controls,” which may require them to maintain any combination of specified performance standards, postmarket surveillance, patient registries, labeling requirements or other guidelines.
With the new order, even those manufacturers with staplers already on the market will need to apply for 510(k) clearance if they haven’t already been cleared. The FDA will begin enforcing the order 180 days after its Oct. 8 publication date.
The finalized guidance, meanwhile, offers devicemakers recommendations for the labeling of both surgical staplers and implantable staples. Detailing the devices’ risks, limitations and explicit instructions for use, according to the agency, may significantly improve their safety and efficacy.
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Surgical staples are used as an alternative to manual sutures for removing parts of organs, cutting through and sealing organs and tissues and connecting anatomical structures. They’re commonly used in gastrointestinal, gynecologic and thoracic surgeries.
When used correctly and exactly as directed, surgical staplers and staples can outperform manual sutures by offering easier placement, more secure closures, minimal risk of tissue reaction or infection and a faster healing process. With unclear labeling and instructions for use, however, the devices carry a sizable risk of causing adverse events.
The FDA’s updated classification and guidance came after a 2019 analysis found that between January 2011 and March 2018 alone, the agency had received more than 41,000 medical device reports for the devices. Those included more than 32,000 malfunctions and 9,000 serious injuries, as well as 366 deaths linked to internal use of surgical staplers and staples.
“The increasing reliance on surgical staplers by surgeons to perform more procedures that are minimally invasive, together with the agency’s analysis of adverse events associated with surgical staplers and implantable staples, prompted the FDA to increase regulatory oversight of these devices while continuing to educate healthcare providers and patients about their benefits and risks,” William Maisel, M.D., chief medical officer and director of the product evaluation and quality office in the FDA’s Center for Devices and Radiological Health, said in a statement.
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In a letter issued alongside the new order and guidance, the FDA offered healthcare providers a set of recommendations to ensure they’re using the devices as safely and effectively as possible. It also noted that the agency is working with hospitals and professional clinical societies to promote increased physician training for the use of surgical staples and staplers.
The recommendations include keeping multiple types and sizes of staples on hand so surgeons can use the ones most compatible with certain staplers or tissues. They also advise physicians to be more selective in their usage of implantable staples and to seek other suturing options if a tissue is damaged or delicate.