FDA Recommends the Reclassification of Surgical Staplers and Staples, Which May Prompt Various Recalls
FDA Recommends Reclassifying Surgical Staplers
Surgical staplers and staples are used for a variety of reasons, both internally and externally. Examples of such uses include, among others, wound closure (typically with scalp or trunk of the body), removal (resection) of part of an organ, cutting through (transection) organs, and creating connections between structures (anastomoses).
Warning to Healthcare Providers
While surgical staplers and staples may be beneficial in certain circumstances, these medical devices have proven to be dangerous for many patients. In a March 8, 2019 letter to healthcare providers, the United States Food and Drug Administration (FDA) warns that surgical staplers and staples used internally have caused patients to sustain injuries and death. Between January 1, 2011 and March 31, 2018, the FDA received more than 41,000 medical device reports for surgical staplers and staples, including the following:
- 366 deaths;
- More than 9,000 serious injuries (including, among others, sepsis, bleeding, fistula formation, tearing of internal tissues and organs, and increased risk of cancer recurrence); and
- More than 32,000 malfunctions.
Examples of common adverse events associated with the use of surgical staplers and staples that have caused injuries and deaths include, but may not be limited to, the following:
- Misfires;
- Failure of the stapler to fire the staple;
- Misapplication of staples (for example, when the user applies staples to the wrong tissue or using the wrong size staples); and
- Difficulty in firing the staplers.
Because of the substantial number of adverse events associated with surgical staplers and staples, the FDA plans to reclassify the medical devices from Class I to Class II, which would require manufacturers to complete a premarket submission to the FDA. As Class I medical devices, surgical staplers and staples can be sold without a premarket submission, which means there is very little regulation to ensure patient safety. Essentially, there are no rules when it comes to surgical staplers and staples, and this is something the FDA wants and needs to change.
Reclassification from a Class I to a Class II Medical Device
After years of patient injuries and deaths linked to surgical staplers and staples, which currently lack essential regulation, the FDA prepared an executive summary that was presented at a May 30, 2019 meeting of the General and Plastic Surgery Devices Panel. The summary outlines the FDA’s plan to reclassify surgical staplers and staples for internal use from Class I to Class II medical devices. By reclassifying surgical staplers and staples for internal use, the FDA can implement requirements that will significantly help to reduce the incidence of injuries and death.
Most Recent Surgical Stapler Recall – Ethicon Circular Staplers
On April 11, 2019, Ethicon, Inc. issued a recall of its circular staplers following complaints of misfiring that harmed at least two patients. Misfiring of staplers has the potential to cause severe injuries, such as sepsis, bleeding, the need for a permanent ostomy bag, life-long nutritional and digestive issues, the need for additional surgeries, leak in the closure (anastomotic leak), the need for additional closures (anastomoses), and death. The FDA had been investigating Ethicon’s manufacturing practices, which proved to be inadequate and dangerous.
The FDA has categorized the Ethicon recall as “Class I,” which is the most serious type of recall available and is only issued when a medical device has the potential to cause serious injuries or death. The specific device information for the Ethicon staplers subject to recall includes the following:
- Product Names: Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples, and Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples.
- Product Codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33AÂ (codes are located on the front of the single unit carton).
- Manufacturing Dates: March 6, 2018 to March 6, 2019
- Distribution Dates: March 15, 2018 to March 9, 2019
- Total Number of Devices Subject to Recall: 92,496
When medical devices have the potential to cause extensive harm, they should undergo review and scrutiny before they are used on patients. While the FDA’s plan to reclassify surgical staplers and staples is a step in the right direction, far too many patients have been harmed over the past decade because of medical devices that should never have been classified as Class I devices to begin with.
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