Prevention Strategies

Opinion: Single-Use for Europe, Too

If patient safety is compromised due to the current design of gastrointestinal endoscopes, it is necessary to take action, including in Europe.

On a 2021 Digestive Disease Week panel about single-use endoscopy in endoscopic retrograde cholangiopancreatography (ERCP), Dr. Mark Gromski of the Indiana University School of Medicine explained why his high-volume practice has adopted single-use duodenoscopes for high-risk patients.

“Gone are the days when we are doing ERCPs without any thought or regard to the infection risk,” he said.

As the plethora of single-use duodenoscope research at the virtual conference would suggest, how new duodenoscope technologies can impact infection control in ERCP is a hot topic in the GI community.

But some researchers are arguing that many European countries have chosen to focus less on these issues compared with the U.S.

A recently published opinion piece in the Journal of Infectious Diseases and Medicine argues that device-related cross-contamination in ERCP is a global phenomenon and should be treated as such. While the U.S. Food and Drug Administration has updated safety guidance in ERCP to include adoption of partially disposable or fully disposable duodenoscopes, there has not been an equivalent focus in European institutions, according to the op-ed, titled “Cross-Contamination in Gastrointestinal Endoscopy: Why is Less Attention Paid in Europe than the U.S.?”

Authors Nikolaj Birk Larsen, Sara Larsen, and Sven Adamsen, all based in Denmark, argue that device-related cross-contamination in ERCP is not limited to the U.S. and cite studies that have linked outbreaks to contaminated duodenoscopes in Europe.

“If patient safety is compromised due to the current design of gastrointestinal endoscopes, it is necessary to take action, including in Europe,” they write.

The authors also note fewer studies have been conducted on duodenoscope-associated infection in Europe than in the U.S. This does not, however, mean outbreaks are any less common on the continent, they say.

Documented cases of multidrug-resistant bacterial outbreaks have been linked back to contaminated duodenoscopes, despite reported adherence to reprocessing protocols, in both the U.S. and Europe. This, the authors write, suggests there is a need for new disposable technologies to address cross-contamination risk in ERCP, as reprocessing is not 100 percent effective in eliminating infection risk. 

“It seems unlikely that there is a difference in the rate of post-endoscopy infections between Europe and the U.S.,” the authors argue. “As post-ERCP outbreaks of multidrug-resistant microorganisms have been reported in Europe, it is highly unlikely that gastrointestinal endoscopes in Europe are completely clean and contamination-free.”

Earlier research from S. Larsen, presented at the American College of Gastroenterology annual conference in October 2020, showed that surveyed GI endoscopists in Europe were willing to transition to single-use duodenoscopes for 39 percent of ERCP procedures. Surveyed endoscopists in the U.S. reported a willingness to transition to single-use for up to half of ERCPs.

S. Larsen and Adamsen were Ambu A/S employees at the time of publication of this article. Ambu received FDA 510(k) approval for a single-use duodenoscope in July 2020.

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