‘No Plans’ To Change Duodenoscope Cleaning Guide, But Cooperating With FDA, Pentax Says
This article was originally published in The Gray Sheet
While Olympus has already updated its cleaning protocol in response to outbreak of bacterial infections and FDA recommendations, another duodenoscope maker, Pentax, says it has no specific plans to change instructions or designs for its devices. An FDA panel met May 14-15 to discuss duodenoscope safety and make recommendations.
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Current reprocessing methods for duodenoscopes provide no reasonable assurance of safety and effectiveness, and manual cleaning steps need improvement, an FDA panel said. Most panelists called for upgrading manual cleaning, followed by lengthy sterilization of the products until they can be redesigned.
Olympus and FDA sent new reprocessing instruction notices to users of the company’s duodenoscopes requiring use of a small bristle brush and additional flushing rounds. The scopes were involved in bacterial contamination incidents in California, Illinois and other states in recent years.
The agency sped up release of a final guidance on reprocessing reusable devices, including a strict set of protocols for endoscope cleaning, disinfection data, and design guidelines, following reports of serious bacterial infections linked to duodenoscopes.