Three incidents during scope procedures at three separate U.S. hospitals potentially have exposed some patients to HIV and hepatitis, reigniting the discussion around scope safety in endoscopy units.
Vanderbilt University Medical Center (VUMC) has released scant information on an incident that occurred in its Gastroenterology Endoscopy Lab but confirmed the situation involved an issue with how a solution was administered through an endoscope during some procedures. Local media reported the story in October after a patient who was potentially exposed came forward.
“We have determined this issue was limited in scope, and the risk to patients is very low. The number of affected patients is less than 4% of endoscopy patients over the last six months,” John Howser, the chief communications officer at VUMC, in Nashville, Tenn., told GEN Priority Report in an emailed statement.
“When such an infection control breach is identified, we generally want to know the details of what happened and how the error was corrected,” wrote healthcare-associated infection expert Lawrence Muscarella, PhD, on his website. However, the “disclosure of the risk of infection from exposure to potentially contaminated medical equipment is often discretionary and neither a foregone outcome nor necessarily an established policy or law,” despite the fact many experts and organizations, including the American Society for Gastrointestinal Endoscopy, have advised that institutions have an ethical duty to inform affected patients in a timely manner when a breach is discovered or an infection is suspected.
Published cases and data analysis suggest that patient exposure to inadequately cleaned, potentially contaminated endoscopes is both underrecognized and underreported, Mr. Muscarella said. He told GEN Priority Report that “FDA has not advised the public of the risk of ‘reprocessed’ gastroscopes exposing patients to infectious materials, including multidrug-resistant organisms, which I think is a significant omission and mistake by the FDA to the potential detriment of public health and patient safety.”
In another incident at Legacy Mount Hood Medical Center, in Portland, Ore., 2,200 patients were potentially exposed to hepatitis B and C and HIV. The health system did not indicate whether a scope was involved but said that infection control practices may not have been followed by an anesthesiologist. The provider was immediately suspended, an investigation was launched and patients were notified, hospital representatives told local media in July, adding that the provider was contracted by the Oregon Anesthesiology Group for approximately six months beginning in December 2023.
A hospital spokesperson told GEN Priority Report they are unable to discuss the matter because it’s currently being litigated.
A third incident reportedly occurred at Salem Hospital, in Massachusetts. The hospital’s parent company, Mass General Brigham, did not respond to GEN Priority Report’s request for comment as of press time. In that alleged incident, reported by the hospital in November 2023, about 450 endoscopy patients were potentially exposed to HIV and hepatitis B and C over a two-year period due to incorrect IV administration.
“Any facility can have problems with reprocessing incidents, even elite facilities. We need to make sure that everyone, whatever role they play in caring for patients in GI care, makes sure they are constantly vigilant,” said Casey Czarnowski, BA, CRCST, CSPDT, CIS, CER, a perioperative consultant in Rochester, Minn., who specializes in sterile processing.
With little information about what went wrong, experts can only speculate. “Ultimately, it is a learning opportunity,” said Harish Gagneja, MD, the chief medical officer at Austin Gastroenterology, in Texas.
Technology May Provide Solutions
Since the major outbreaks of infections related to duodenoscopes in 2013, safety conversations have centered on whether disposable models are imperative to patient safety.
According to Klaus Mergener, MD, an affiliate professor of medicine at the University of Washington, in Seattle, disposable models may provide superior patient safety, but the cost and amount of medical waste fully disposable scopes would create makes the option “unrealistic.”
However, new designs likely do have a place in eliminating rare incidents of scope-related infection, he said. “Technology could be the answer,” Dr. Mergener explained. “Not fully disposable but something in between, such as just a disposable tip, which is hard to clean.” Some scope manufacturers are also exploring the possibility of lining the interior parts of scopes, especially the difficult-to-clean channels, with antimicrobial films, he added.
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“Even under the best scenario, the margin of error for cleaning these endoscopes is quite low,” Dr. Mergener said, adding that low pay and high turnover of scope reprocessors make solving the problem with ongoing training an uphill battle.
Another approach could be automating human-led parts of cleaning, which could significantly reduce potential infection incidents since most contamination occurs as a result of human error.
“Replacing mechanical cleaning with automated cleaning is one of the holy grails of improving the reliability of endoscopy reprocessing,” Dr. Mergener said. “The machine does not take shortcuts. It does things the same way every time. It does away with human error.”
Potential Consequences
Dr. Gagneja agreed that moving to fully disposable scopes is not the answer but said he worries that with each scope-related incident that occurs, the chorus calling for single-use scopes will grow louder. “Single-use endoscopes are impractical due to extreme cost and a never-ending supply of medical waste,” he said.
In addition, Dr. Mergener fears incidents that sacrifice patient safety also may cause people to shy away from procedures. “No one is saying we should ignore the issue of infection transmission, but when you talk about it, in the same breath you also have to remind everyone that endoscopy is lifesaving and overall, extremely safe,” he said.
Although scope procedures are not sterile procedures, treating them as such could also reduce errors that occur in the endoscopy room, whether those incidents involve a scope or not, Mr. Czarnowski said. “We can take universal precautions in how we set up the room and how we set up the scope itself, as if we are going to be doing a sterile procedure, as much as possible.”
—Kaitlin Sullivan
Drs. Gagneja and Mergener are members of the Gastroenterology & Endoscopy News editorial board.
This article is from the December 2024 Priority Report print issue.