The US Food and Drug Administration (FDA) has taken measures to help reduce risks associated with surgical staplers and implantable staples.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
The regulator has issued a letter to health care providers to alert them that it is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples.
FDA’s letter is also includes information about additional steps that it is planning to take in the coming months to solve the safety of devices.
The actions include issuing draft guidance with labeling recommendations for manufacturers and holding public advisory committee meeting to review whether the current pathway for manufacturers to market surgical staplers for internal use is convenient.
Surgical staplers and staples are used in range of surgical applications, including gastrointestinal, gynecologic, and thoracic surgeries, to remove part of an organ, cut through organs and tissues and form connections between structures.
The devices are designed to use in surgical procedures and reduce surgical procedure time compared against manual suturing.
At present, surgical staplers are regulated as class I medical devices that does not need a premarket submission to the FDA. Implantable surgical staples are classified as class II medical devices and need premarket review before commercialization.
FDA also said it has issued earlier communications about the risks engaged with surgical staplers and implantable staples and has been carrying out an ongoing assessment of medical device reports (MDRs) filed with the agency.
Form the analysis between 1 January 2011 and 31 March 2018, the regulator found over 41,000 individual MDRs for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries and over 32,000 malfunctions.
FDA’s Center for Devices and Radiological Health chief medical officer Dr William Maisel said: “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.”