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 In April, the FDA issued a draft guidance to manufacturers of surgical staplers and staples about information they should include in product labeling, such as procedures for determining that a tissue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