FDA Advisors Call For New Cleaning Methods, Sterilization For Duodenoscopes

18 May 2015

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.

FDA advisors say changes are need to reprocessing methods used by most hospitals for duodenoscopes, but that the devices involved in contamination incidents should stay on the market for life-saving endoscopic retrograde cholangiopancreatograpy (ERCP) procedures.

A majority of the FDA Gastroenterology-Urology Devices panel – about two-thirds – called for enhanced cleaning of the duodenoscopes, followed...