Post-CRE 'superbug' outbreak: 6 FDA recommendations for duodenoscope reprocessing

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.

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