To the Editor:
[Re: “Surgical Stapler Safety Took Center Stage,” by Karen Blum, February 2020, page 1]

Internal surgical staplers are used for transection, resection and creation of anastomosis. The internal staplers of 2020 are very different technologically than the staplers used prior to 1990. This is especially true with the staplers designed for minimally invasive endoscopic and robotic surgery. Furthermore, the reliance on internal surgical staplers has increased with these surgical advances. With the advent of powered staplers, there has been the addition of software issues, new questions regarding the reliability of motors driving stapler action to replace human variability, and the introduction of new LED messages to mitigate stapler malfunctions. 

All these design advances increase the need for the user to find the time to learn and understand the new technologies and to seamlessly be able to initiate countermeasures to error messages. The newer staplers have lockout mechanisms to prevent use on inappropriate tissue thickness and are programmed to achieve appropriate tissue gaps with ideal prefire compression times and pressures. The intended end result of these innovations is improved stapler safety. However, regardless of the advances made in modern internal surgical staplers, ECRI data suggest that staplers consistently remain in the top 10 medical devices (No. 1 in 2020), causing patient adverse events and mortality. The majority of these adverse events seem to be related to user judgment error or lack of understanding of stapler function, whereas 10% or more are estimated to occur because of actual stapler malfunction. 

Julie Miller, a senior project engineer of health devices for ECRI, was quoted in the General Surgery News article stating, “Surgery chiefs and OR directors should arrange for hands-on 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.” The increased reliance on staplers with minimally invasive procedures, and the decreased exposure of surgery residents on alternative surgical techniques such as hand-sewn bowel anastomoses, further highlight the need for training. 

The FDA has proposed that additional regulation of these devices is necessary in order to provide a reasonable assurance of safety and effectiveness. As proposed, internal surgical staplers would be regulated as Class II devices with special controls. If finalized, the proposed special controls would require testing to evaluate the quality of staple lines and help ensure atraumatic stapler/ tissue interaction. The proposed special controls also include requirements for the evaluation of the capacity of staple lines to maintain hemostasis and other performance testing; development of clear and informative labeling; testing of device usability; and label comprehension. If the proposed reclassification were finalized, as Class II devices reviewed under premarket notification, clinical studies may be requested prior to marketing for those staplers with different indications for use or technological characteristics that cannot be adequately evaluated with bench and animal testing. FDA encourages surgical training not only in residency programs but also for surgeons who have been in practice in various clinical settings. All surgeons have a professional responsibility to demonstrate an understanding of novel stapler technology, its application and safety features prior to using the device on patients. 

The majority of surgeons in the United States have either experienced or know another surgeon who has experienced a stapler malfunction. These include locking of the stapler on tissue requiring conversion from a minimally invasive to an open surgery and tissue injury sometimes resulting in bleeding or bowel leaks. While bleeding and leaks from suture lines and hand-sewn anastomoses do also occur, when these events occur in a minimally invasive surgical scenario due to stapler malfunction they are frequently more difficult to recognize and correct. Bleeding from a staple line can occur freely into the abdominal cavity or within the lumen of the bowel and occur as acute uncontrolled hemorrhage from a vascular staple line or as a slower bleed presenting postoperatively. Both modes of this adverse event have been reported to cause patient mortality or emergent return to the OR. In some cases, these events have been shown to be the result of malformed or loosely formed staples resulting in inadequate hemostasis. Additionally, staple cartridges have been discovered to be completely void of staples and, when fired, cut tissue without approximation also leading to severe morbidity and mortality. Industry has mitigated this adverse event by instructing users through labeling to look at the face of the cartridge; if color is detected then there are no staples in the cartridge but only exposed drivers, and it should not be used. The FDA’s proposal to reclassify internal staplers into Class II, if finalized, would provide additional requirements to help ensure that stapler labeling consistently provides such information. While the absence of staples in a cartridge should be an event that never occurs, it does in fact occur, and surgeons may not be aware of how to detect this manufacturing flaw unless they read the label. 

The FDA has also published a draft labeling guidance providing further recommendations related to the proposed labeling special controls. Currently, the FDA is evaluating comments from industry, expert surgeons and others received to the public docket. Internal surgical staplers, when used appropriately, can provide improved and more efficient surgical care for patients; nevertheless, the FDA believes that changes to the current regulatory process are needed to improve stapler safety. Some commenters have stated that the proposed labeling recommendations may seem impractical, such as the warning to establish a strategy for proximal vascular control prior to division of a blood vessel with a surgical stapler. However, from the FDA’s perspective, the purpose of including such a warning is to promote stapler safety without dictating practice of medicine by reminding users that serious injury and mortality continue to occur at a consistent rate from failed vascular pedicle staple lines despite safety improvements in stapler design. 

To conclude, internal surgical stapler safety necessitates collaboration of many stakeholders including surgeons, industry, professional societies, surgical educational institutions and the FDA. Reporting all stapler malfunctions and adverse events to the FDA MedWatch website is encouraged to assist with the FDA’s post-market surveillance of these devices, which are essential to the practice of surgery. 

https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting

—George J. Gibeily MD, Medical Officer, Division of Infection Control and Plastic Surgery Devices, Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, FDA’s Center for Devices and Radiological Health

—R. Dale Rimmer, PhD, Lead Reviewer/Chemist Division of Infection Control and Plastic Surgery Devices, Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, FDA’s Center for Devices and Radiological Health