FDA Releases Final Guidance On Endoscope Cross-Contamination

December 28, 2016

Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention.

The guidance, released in draft form in January 2015, calls on makers of gastrointestinal endoscopes to consider risk-mitigation in device design or ensure their devices are reprocessed or discarded after each use to prevent cross-contamination during flexible gastrointestinal endoscopy procedures. The recommendations follow reports of backflow from irritation channels into water bottles and tubing when irrigation channels lacked a backflow-prevention mechanism.

The final guidance states that when testing the performance of a system incorporating backflow-prevention valves or other features for reducing the risk of cross-contamination, manufacturers should use worst-case scenarios for backpressure, pressure cycling, duration, concentration of chemical and microbiological markers, and other conditions. — Jeff Kinney

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