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Surgical Stapler Safety Took Center Stage in 2019 Webinar Offers Advice on Avoiding Stapler Misuse ECRI has conducted investigations on about three to five accidents per year involving staplers, said Scott Lucas, PhD, ECRI’s he FDA, professional medical societies and the media had director of accident and forensic investigation, during a recent their sights set on a common topic in 2019: surgical staplers. webinar on avoiding stapler misuse sponsored by the organizaLast March, the FDA issued a letter to physicians expressing tion. From 2009 to 2019, his group reviewed six cases resulting concern over increasing adverse events associated with surgical in a fatal injury, 15 resulting in a nonfatal injury, and five close staplers and staples for internal use, offering recommendations calls with no injury. for providers to promote safe use. The agency published an anal“In most of our cases, our testing resulted in normal operation ysis of nearly 110,000 stapler incidents of the incident stapler on since 2011, resulting in 412 deaths, 11,181 ‘In most of our cases, our testing resulted in surrogate tissue,” he said, serious injuries and 98,404 malfunctions. “so we think there are Some of the most commonly reported normal operation of the incident stapler many possible contributing problems in these reports included failure on surrogate tissue. So we think factors.” These include to fire or misfire, failure to form a staple, the jaws clamping onto there are many possible and difficulty opening or closing. another instrument, the The agency then kicked things up a notch. contributing factors.’ surgeon selecting too thick tissue or In April, the FDA issued a draft guidance to incorrect staple size, using the wrong vessel, and —Scott Lucas, PhD manufacturers of surgical staplers and statissue disease or necrosis that can cause a staple line to ples about information they should include unravel, or the tissue to pull out the staple. in product labeling, such as procedures for Julie Miller, a senior project engineer of health devices for determining that a tissue is appropriate for staECRI, offered the following suggestions during the webinar to pling. In May, the agency held an open public meeting of the Med- help avoid misuse of staplers: ical Devices Advisory Committee’s General and Plastic Surgery 1. During procurement, materials management staff should Devices Panel to discuss whether surgical staplers for internal use communicate with clinicians so that when possible, surgeons should be reclassified, from Class I to II devices. The panel recomcan work with their preferred devices. mended a reclassification, which would subject staplers to premar- 2. Surgery chiefs and OR directors should arrange for handsket notification, and allow the FDA to establish mandatory special on device training for all surgical team members. Training controls to help mitigate known risks of the device. should be conducted by the manufacturer or a superuser at Meanwhile, in April, Ethicon recalled a number of circular stathe institution, and should be scheduled before the device is plers for insufficient firing and failure to completely form staples, used for the first time. and in May, Medtronic recalled some of its Covidien Endo GIA 3. Before a procedure, surgeons and surgical staff should have staplers over possible missing components. In October, Ethicon an appropriate range of stapler cartridge sizes available; have recalled its Echelon Flex Endopath staplers for failure to form additional staplers and other means of closure available, such as complete staples. manual sutures; and inspect the stapler for damage before use. Also in October, the nonprofit ECRI Institute placed misuse 4. During a procedure, surgeons and staff should not use a staof surgical staplers No. 1 on its top 10 technology hazards list for pler if they are unable to visually confirm a secure closure, 2020, up from the No. 8 spot in 2010. and pause before firing to ensure there are appropriately “This is a legitimate concern,” said pediatric surgeon Romeo sized staples for the intended tissue. If there are any unusuIgnacio Jr., MD, FACS, FAAP, the trauma medical director at al sounds or difficulty squeezing the stapler handle, proceed Rady Children’s Hospital–San Diego, and a co-author of a recent with caution or use another closure method. paper on the history of surgical staplers (Am Surg 2019;85[6]:563As the designs continue to advance, however, surgeons and 566). “Anecdotally in surgery we see stapler errors like bowel industry should work together to present training courses on anastomotic leaks, and sometimes we consider it a technical error, proper use of staplers, and to improve dissemination of informabut at times it is the device itself.” tion about recalls, Dr. Ignacio said. But other surgeons say this could be blown out of proportion. While there are rare occasions where the instruments don’t “I think staplers get a bad rap because they’re easy targets,” said work, surgical judgment remains imperative, Dr. Goldberg said: Ross Goldberg, MD, FACS, the vice chair of surgery at Valley- “You can’t blame the tool for what you did. If the surgeon doesn’t wise Health in Phoenix. “There are a lot of staplers, and we aren’t know what they’re doing with the stapler, they shouldn’t be using seeing that many complications compared to the number of sta- it. You need to have the technical background to understand how plers being sold.” to use it, but applying it appropriately is the bigger issue.” ■ By KAREN BLUM
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