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Experts report good performance of single use duodenoscopes
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SAN ANTONIO — New, single use duodenoscopes received overall good marks for use in endoscopic retrograde cholangiopancreatography from a group of expert endoscopists, according to study results presented at the American College of Gastroenterology Annual Meeting.
V. Raman Muthusamy, MD, FACG, from the University of California, Los Angeles, said these new scopes are still in the early stages, but the FDA recently recommended that health care centers start to transition to duodenoscopes with disposable components to address the potential for bacterial transmission.
“The U.S. Food and Drug Administration reported reusable duodenoscope culture rates recently on a microbial surveillance study that reached 5.4% for high-concern organisms, including E. coli and Pseudomonas aeruginosa,” he said in his presentation. “They had anticipated the rate to be less than 0.4%, so this constitutes a 13.5-times increase compared to what they had expected.”
While a new single-use duodenoscope has recently been developed and tested in a bench model simulation, Muthusamy said tests done in a clinical setting are needed before they can move forward.
A group of seven experts across six academic centers rated the new EXALT single-use Model D duodenoscope (Boston Scientific) in ERCP procedures in a number of categories, including overall satisfaction, preference to reusable scopes for 17 potential ERCP maneuvers and a qualitative comparison.
They conducted the procedures in 60 patients (61.7% men; mean age 64.4 years). The experts reported that all 60 procedures were done successfully, with just two needing to crossover to a reusable scope.
The median overall satisfaction on a scale of 1 to 10 was 9, and the overall satisfaction was at least 7 in 93.3% of the procedures. All three ratings were also at or above the midpoint.
Of 177 total ratings for 14 maneuvers, the experts rated 90.4% as neutral or comparable to reusable scopes, 1.7% as preferred and 7.9% as not preferred to the endoscopist’s usual duodenoscope.
Experts also reported four procedures at low satisfaction because of inadequate pushability of the instruments due to suboptimal positioning of the scope in front of the papilla. However, these ERCPs were in a subset of procedures that included biliary or pancreatic duct strictures that were dilated or stented.
“Low ratings on select ERCP maneuvers suggest areas for improvement, including navigation and pushability, elevator function and image quality,” Muthusamy said. “Based on these observations, detailed design improvements to the device have already been initiated, in fact there is an entirely new model that has actually been produced in 4 months and will be used in the next trial.” – by Alex Young
Reference:
Muthusamy VR, et al. Abstract 16. Presented at: American College of Gastroenterology Annual Meeting; Oct. 25-30, 2019; San Antonio.
Disclosures: Muthusamy reports consulting for and receiving grant and research support from Boston Scientific. Please see the study abstract for all other authors’ relevant financial disclosures.
Perspective
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John Vargo, MD, MPH
This prospective case series showcases the potential for disposable duodenoscopes. Currently, having an instrument that is 100% free of contamination is the goal for our patient care. The iterative power of rapid design refinement is a distinct advantage in today’s device environment.
In expert hands, with this innovative device, there was high satisfaction except in the setting of more complicated cases. We look forward to further trials with progressively more refined instruments and in the hands of a larger cohort of ERCP experts.
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