The FDA released a safety communication in the wake of the outbreak of carbapenem-resistant Enterobacteriaceae linked to duodenoscopes used during ERCP. The statement included recommendations for healthcare providers, patients and reprocessing staff.
Here are six FDA recommendations for ERCP duodenoscope reprocessing.
• Follow all manufacturer instructions for cleaning and reprocessing.
• Report any problems with device reprocessing to the FDA and manufacturer.
• Carefully clean the elevator mechanism and assess the mechanism by hand even when using an automated endoscope reprocessor.
• Raise and lower the elevator mechanism throughout the manual cleaning process.
• Establish a quality control program for reprocessing duodenoscopes including written procedures, training assessment and documentation processes.
• Use the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes.