Duodenoscopes With Disposable Caps Led to Less Microbial Contamination

Use of duodenoscopes with disposable elevator caps during endoscopic retrograde cholangiopancreatography (ERCP) led to lower rates of contamination following high-level disinfection compared with standard scope designs, and did not affect the technical performance and safety of ERCP, the randomized ICECAP trial showed.

Among over 500 patients undergoing ERCP, persistent microbial contamination was detected in 3.8% of disposable elevator cap duodenoscopes compared with 11.2% of standard duodenoscopes (P=0.004), corresponding to a relative risk of 0.34 (95% CI 0.16-0.75), reported Nauzer Forbes, MD, MSc, of the University of Calgary in Canada, and co-authors.

That difference translated to a number needed to treat of 13.6 (95% CI 8.1-42.7) to avoid one case of persistent contamination, they noted in JAMA Internal Medicine.

Furthermore, technical success using the disposable elevator cap duodenoscopes was noninferior to that of the standard scopes (94.6% vs 90.7%, P=0.13).

"There has been a sharp increase in global reporting of duodenoscope-related infectious outbreaks, with the majority unrelated to identifiable breaches in disinfection protocols," Forbes and team wrote, noting that a recent study from The Netherlands found that 22% of duodenoscopes were persistently contaminated after high-level disinfection.

"As the mortality associated with duodenoscope-related sepsis can approach 29%, several organizations have declared this issue a priority," they added.

To deal with this long-standing problem in the U.S., the FDA has encouraged transitioning away from fixed end cap duodenoscopes to duodenoscopes with more "innovative" designs, which included a focus on disposable parts.

"Duodenoscopes with disposable caps address both the concern about persistent microbial contamination associated with standard duodenoscopes and the performance limitations of disposable duodenoscopes," noted Graham M. Snyder, MD, SM, of the University of Pittsburgh Medical Center, and Melinda Wang, MD, of the University of California San Francisco, in an invited commentary.

"The findings of the ICECAP trial support the FDA's recommendations for endoscopists to transition to the use of duodenoscopes with novel designs for diagnostic and therapeutic ERCP procedures, such as instruments with disposable elevator caps," they concluded.

Forbes and team also suggested that disposable elevator caps pose a potentially more affordable solution to reducing microbial contamination.

"Duodenoscopes with a disposable elevator cap offer a potential solution for substantially reducing persistent microbial contamination that is scalable, with an incremental cost of approximately $50, or 3% to 7% of overall procedural costs," they wrote. "A 2022 cost utility analysis also supports the use of disposable elevator cap duodenoscopes. The prevention of duodenoscope-related infections, however, also requires consideration of additional factors, including personnel training and communication between those involved in the procedures."

The commentators also noted that the study demonstrated the limitations of high-level disinfection: all nine standard duodenoscopes used in the study had at least one positive persistent microbial contamination result, as did five of the eight duodenoscopes with disposable elevator caps.

For this parallel-arm study, Forbes and colleagues included 518 patients undergoing ERCP at two tertiary centers in Canada from December 2019 to February 2022, split evenly between use of disposable elevator cap duodenoscopes and standard duodenoscopes. Mean age was 60.7 years, and 49.8% were women.

Persistent microbial contamination after disinfection was defined as growth of 10 or more colony-forming units of any organism, or any growth of gram-negative bacteria, within 72 hours of plating.

Technical success of ERCP was determined according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers.

As for safety, there were no significant differences between the disposable group and the standard group in infectious outcomes including cholangitis (0.8% vs 1.2%), as well as other adverse events, including pancreatitis (3.1% vs 3.5%), bleeding (1.9% vs 1.2%), perforation (0.4% vs 0.0%), cardiorespiratory adverse events (1.5% vs 0.8%), or 30-day mortality (0.4% vs 0.4%).

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