The US Food and Drug Administration (FDA) is alerting clinicians about an increasing number of medical device reports (MDRs) associated with the use of surgical staplers for internal use and implantable surgical staples and providing additional recommendations to help reduce risks associated with their use.
From January 1, 2011, to March 31, 2018, the FDA received more than 41,000 individual MDRs for surgical staplers and staples for internal use, including 366 deaths, more than 9000 serious injuries, and more than 32,000 malfunctions, the agency said in a March 8 letter to clinicians.
The most commonly reported problems 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 (eg, user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).
Stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications such as bleeding, sepsis, tearing of internal tissues and organs, increased risk for cancer recurrence, and death, the FDA said.
The letter to healthcare providers reminds clinicians of the importance of reviewing labeling instructions and indications for use for surgical staplers and implantable staples, such as choosing the appropriate staple size for the patient’s tissue type and thickness.
The letter also suggests considering alternative options if the patient’s tissues are swollen, prone to bleeding, or necrotic and provides recommendations on how to recognize and manage device malfunction.
“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,” William Maisel, MD, MPH, chief medical officer in the FDA’s Center for Devices and Radiological Health, said in a statement.
“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the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts,” Maisel said.
In the coming months, the FDA plans to issue a new draft guidance with labeling recommendations for manufacturers of surgical staplers and staples to help clinicians better understand the appropriate use and risks of these products.
The agency also plans to hold a public advisory committee meeting to discuss whether the current pathway for manufacturers to market surgical staplers for internal use is appropriate.
Specifically, they’ll discuss whether reclassifying surgical staplers for internal use as Class II devices would be appropriate. Currently, surgical staplers for external and internal use are regulated as Class I medical devices, which do not require a premarket submission to the FDA.
Reclassifying surgical staplers for internal use as a Class II device would subject them to premarket notification and allow the FDA to establish mandatory special controls to help mitigate known risks of the device.
Clinicians and healthcare facilities are encouraged to report adverse events related to these products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting program.