Contamination on duodenoscopes after reprocessing continues to be a major concern in the United States. FDA recently reported that up to 5.4% of samples in postmarket studies tested positive for "high concern" organisms (those more often associated with disease, such as E. coli, and Pseudomonas aeruginosa), updated culturing results show that up to 5.4% of samples testing positive.
On the bright side, at least two medical device manufacturers are actively trying to combat the issue.
During Boston Scientific's first-quarter earnings call, CEO Mike Mahoney said the company is on track to launch its Exalt-D single-use duodenoscope, which is used in endoscopic retrograde cholangio-pancreatography (ERCP) procedures.
"We believe the Exalt-D can help meet a significant unmet need for hospitals and patients," Mahoney said. "The Exalt model D single-use scope has been designed to address this exact issue by eliminating scope disinfection challenges completely. This platform represents a significant opportunity in 2020 and beyond."
Pentax Medical is attacking the issue from a different angle by promoting a new hygiene solution designed to enhance patient safety in endoscopy. Last year Pentax acquired a controlling interest in Paris, France-based PlasmaBiotics, a company that makes devices for drying and storing endoscopes.
Pentax touted the PlasmaTyphoon at the European Society of Gastrointestinal Endoscopy (ESGE) Days in Prague in April. The device is designed to minimize the risk of bacterial contamination through a highly effective drying mechanism and active storing of the endoscopes with plasma, via the PlasmaBag, for up to 31 days.
"The focus is usually on the cleaning of endoscopes, but if you do not dry properly at the end of the whole procedure, then you make all your work for nothing," Ulrike Beilenhoff, former president of the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA), said during a video Pentax Medical provided to journalists following ESGE Days.
In 2017, FDA cleared the first duodenoscope designed with a disposable distal cap. The agency said at the time it was optimistic that disposable distal caps on devices such as the Pentax ED34-i10T would improve access for cleaning and reprocessing the devices.
“We believe the new disposable distal caps represents a major step towards lowering the risk of future infections associated with these devices,” said William Maisel, MD, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health.