• Situation: Recent newspaper articles, medical publications, and adverse event reports associate
multidrug-resistant bacterial infections caused by CRE with patients who have undergone ERCP.
Duodenoscopes used to perform ERCP are difficult to clean and disinfect, even when manufacturer
reprocessing instructions are followed correctly, and have been implicated in these outbreaks.
The U.S. Food and Drug Administration (FDA) has issued a Safety Communication warning, with related
updates, that the design of duodenoscopes may impede effective cleaning.
• Expectations for Reprocessing Duodenoscopes: Hospitals, critical access hospitals (CAHs), and
ambulatory surgical centers (ASCs) are expected to meticulously follow the manufacturer’s
instructions for reprocessing duodenoscopes, as well as adhere to the nationally recognized
Multisociety consensus guidelines developed by multiple expert organizations and issued in 2011.