Experts asked to weigh in on the debate regarding single-use accessories for duodenoscopes agreed that the complex design of reusable duodenoscopes make them too difficult to clean, necessitating the disposable components.
“It was almost impossible to clean the gunk from inside the shaft of reusable biopsy forceps or other types of accessories after a patient procedure,” Michelle Alfa, a certified clinical microbiologist and the CEO of AlfaMed Consulting, told Gastroenterology & Endoscopy News.
Alfa added that such devices were “never designed to be reprocessed.”
Lawrence Muscarella, president of LFM Healthcare Solutions, added that single-use components perform well while reducing infection risk and reducing reprocessing expenses, including the costs of staff, transportation and materials.
“The market [has] really carved out not even just a niche but a real presence for the single-use accessories,” he told G&E News.
Muscarella is a consultant for Ambu Inc., a single-use endoscope manufacturer and publisher of Single-Use Endoscopy.
Alfa said the majority of duodenoscope manufacturers make scopes with at least a disposable endcap, but there has been “little progress to change the complex design of the reusable duodenoscopes that would make their narrow channels easier to clean and high-level disinfect or ideally sterilize.”
The U.S. Food and Drug Administration has weighed in on multiple occasions on the need for duodenoscopes to incorporate disposable components or become fully single-use. Last year, the agency updated its existing safety communication because emerging data “suggests that the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary.”