Cleveland—Surgeons who perform colorectal surgery in the United States have canceled elective procedures, moved cases to different hospitals, and returned to hand-sewing anastomoses as they work around a shortage of surgical staplers following a recall of Ethicon’s manual circular stapler.
“The biggest thing people are concerned about is the safety of the patients—making sure that they get taken care of appropriately and that their safety is not impinged upon,” said Tracy L. Hull, MD, FACS, FASCRS, the newly elected president of the American Society of Colon and Rectal Surgeons, in an interview during the ASCRS 2019 annual meeting.
The ASCRS is advising surgeons in hospitals where manual circular staplers are unavailable to postpone cases that can wait and to work with other companies or hospitals to find staplers when needed.
“Colorectal surgeons are a good community and they try to help each other. They have interacted with other hospitals, other practices for patients that can’t wait,” said Dr. Hull, a surgeon at the Cleveland Clinic in Ohio.
Patients with rectal cancer are among those who need urgent care, she said.
Some surgeons have returned to hand-sewing anastomoses when surgical staplers are unavailable. “But if you’re not used to that, that may not be the best option,” she said. “If you can wait, wait.”
Older surgeons may have trained before surgical staplers were available and are comfortable hand-sewing anastomoses. But for younger surgeons, their experience may be limited.
“This reminds me of the days prior to the introduction of surgical staplers. All we had were sutures. It brought back 1978 memories,” said Gary H. Hoffman, MD, the clinical chief of the Division of Colon-Rectal Surgery, Cedars-Sinai Medical Center, in Los Angeles.
On April 11, 2019, Ethicon announced that it was initiating a voluntary recall of specific lots of manual circular staplers, the Intraluminal Stapler. The recall covered staplers manufactured between March 6, 2018, and March 6, 2019, and affected 92,496 devices. The following month, the FDA issued a formal recall for the staplers, warning their use could cause serious injury or death.
After investigating complaints and returned products, Ethicon confirmed that uncut washers in the stapler and malformed staples occur with its intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity. The company said the problem arose from a change in a manufacturing process.
In a statement issued by the FDA, Ethicon confirmed serious injuries to two patients. Misfiring of the stapler resulted in an additional resection—of the middle rectum in one patient and the lower rectum in another patient—during the planned resection of the upper rectum. Potential risks to patients include death, sepsis, bleeding, need for permanent ostomy, lifelong nutritional and digestive issues, anastomotic leak, additional operations, need for anastomoses, need for antibiotics and the need for additional imaging studies.
Ethicon spokesperson Devon Bowers, in an email to General Surgery News, said new manufacturing process controls have been implemented to ensure all devices have sufficient firing stroke. “We encourage any surgeons [who] may have a concern regarding the device performance to contact Ethicon at 1-877-ETHICON.”
On June 4, Ethicon started shipping new manual circular staplers. At press time, Ms. Bowers said hospitals in the United States would start receiving the new product by mid-June. “Ethicon’s top priority has been to return supply of this critical product as quickly as possible.”
Medtronic also produces manual circular staplers used in colorectal procedures. In many hospitals, surgeons switched to the Medtronic product when available. However, this stapler was also in limited supply.
This winter, the Illinois Environmental Protection Agency issued an order to shut down a major sterilization plant belonging to Sterigenics, which sterilizes a variety of medical devices, due to high levels of ethylene oxide in the air around the facility. The closure affected the supply of a number of minimally invasive surgical instruments. Medtronic did not respond to questions about the plant’s closure and its effect on surgical staplers. Several surgeons said they were told by industry representatives that the Sterigenics closure reduced the supply of surgical staplers.
Eric Haas, MD, the head of the ASCRS New Technologies Committee and chief of the Division of Colon and Rectal Surgery at Houston Methodist Hospital, said the sterilization plant closure, along with the stapler recall, created “a perfect storm” that severely limited access to manual circular staplers in the United States. For weeks, surgeons have been discussing the “stapler crisis” on private ASCRS portals, saying their cases were canceled, postponed and/or moved from one facility to another.
The shortage hit home for Dr. Haas. The OR director at one of his admitting hospitals reported that they had no staplers for a rectal case scheduled the next day. “We had to postpone the case until we could schedule it at a neighboring hospital that still had supplies. But we have not been able to go back to that facility, even now.”
Dr. Haas, who has been in contact with Ethicon and Medtronic on behalf of the ASCRS, said delayed recognition of the staple malfunction resulting in patient harm is not associated with the recalled staplers. “I think that’s important to know. If it didn’t work, it didn’t work. You would know it as you are doing the procedure.”
Dr. Haas said he experienced two successive misfirings with Ethicon staplers before the devices were recalled. “The staples formed, but the knife blade didn’t cut all the way through the tissue. It didn’t pop the way it is supposed to. There’s a little bit of tissue that we had to force out by just removing the stapler.” In both cases, which were being done robotically, he hand-sewed the anastomosis and the patients did well.
Ethicon’s recall comes at a time of intense scrutiny for surgical staplers. In March, Kaiser Health News released a major investigative report that found the FDA permitted medical device companies to file reports of injuries and malfunctions in a private internal database. Since 2016, at least 1.1 million incidents were reported internally instead of being described individually in the public database known as MAUDE, it found.
The FDA later acknowledged it received more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions. Some of the most commonly reported problems in these adverse event reports include opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples.
The FDA has proposed reclassifying surgical staplers to add premarket review and special controls to the category devices—a proposal then approved by an FDA advisory panel. It also recommended simplifying labeling and increasing surgeon training with the devices to improve outcomes.
It’s not yet clear what special controls will be added to surgical staplers. The FDA proposal is open for public input until June 24.
The recalled stapler accounts for only 4% of the adverse events associated with surgical staplers, said Madris Tomes, MBA, the founder and CEO of Device Events, a web-based tool that tracks medical device post-market surveillance data and recalls.
The overall risk for adverse events associated with surgical staplers is low, but staplers are used in more than 1 million endoscopic procedures each year in the United States, said Scott Lucas, PhD, the director of accident and forensic investigation at the ECRI Institute. “The total number of injuries and deaths are substantial, so this push (for safety) is appropriate and necessary, and we’ve got to get that number down.”
Dr. Lucas urged surgeons to ensure they report all relevant events to the manufacturers and FDA, and preserve all potentially relevant materials for the purpose of investigation. Stapler cartridges should be saved and numbered in the sequence they were used, he said. For circular staplers, he recommends OR teams preserve the removed tissue “donuts” and any loose staples in cases with a stapler malfunction in order to assess proper staple line formation.
The proposed FDA changes can make surgery safer by improving consistency across devices and manufacturers and offering more guidance for surgeons, he said. “Arguably, the staplers are designed safely. It’s a matter of, can we improve as an industry even more than we already are?”
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