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An increasing number of problems have been reported with surgical staplers and staples, according to a warning issued last week by federal health care providers, which indicates more than 41,000 reports have been received involving complications.
The FDA issued a “Dear Healthcare Provider” letter to U.S. doctors on March 8, raising concerns about surgical staplers for internal use and indicating that the agency will issue draft guidance designed to reduce the risk of complications later this year.
Between January 1, 2011 and March 31, 2018, the FDA has received more than 41,000 adverse event reports. In addition to reports of device malfunctions, the agency indicates that more than 9,000 involved serious injuries and 366 resulted in patient deaths.
The most commonly reported problems linked to surgical staplers involve an opening of the staple line, malformation of staples, staplers misfiring, staplers being too difficult to fire, staplers failing to fire and staplers that were misapplied. The FDA warning indicates that stapler malfunctions or misuse can cause prolonged surgical procedures, the need for additional surgeries, and other complications; such as bleeding, sepsis, internal organ damage, and death.
“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,” Dr. William Maisel, chief medical officer of the FDA’s Center for Devices and Radiological Health, said in a press release. “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the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts.”
The agency is providing the following recommendations to health care providers using surgical staplers:
- Read and carefully follow the stapler manufacturer’s instructions
- Have a range of staple sizes available and select the appropriate cartridge for tissue type and thickness
- Consider other options for patients with tissue that is swollen with fluid, readily tears, bleeds, or is necrotic.
- Be familiar with organs around the intended staple site and ensure that unintended structures like the urinary bladder or objects like clips are not in the staple line.
- Avoid using staples on large blood vessels, like the aorta
- Avoid clamping delicate tissue, which can be damaged even if the stapler isn’t fired
- In cases where the stapler malfunctions, clamp or ligate any damaged blood vessel before releasing the stapler.
The FDA will issue a draft guidance on this issue in 2019, proposing recommendations to manufacturers about the design of surgical staplers and staples and what instructions should be included in product labeling.
The agency also announced it will hold an open public meting of its General and Plastic Surgery Devices advisory committee this year on whether surgical staplers should be reclassified as class II medical devices. Currently, they are class I medical devices, which is the same category as tongue depressors. A Class II classification would require premarket notification and approval by the agency before they hit the market.
The date of the meeting and the draft notice will be announced at a later date.
In the interim, the FDA is continuing to analyze data and review reports of surgical stapler incidents. The agency requests that any doctors or patients who have experienced problems or complications with surgical staplers submit a report through the MedWatch Adverse Event Reporting Program.