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# Guide on Mitigating Risks With Endoscope Irrigation
- URL: https://www.fdaweb.com/guide-on-mitigating-risks-with-endoscope-irrigation/
- Published: 2016-11-28T12:00:00.000Z
- Updated: 2026-09-14T21:51:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137423

FDA has posted a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM430550.pdf?ref=fdaweb.com) on “Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.” The document is intended to highlight the cross-contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes. It also clarifies terminology used to describe and outline strategies to mitigate the risk of cross-contamination between patients. 

The guidance says the irrigation devices may be submitted in 510(k) applications as part of a flexible gastrointestinal endoscope system or separately as accessories to flexible gastrointestinal endoscopes. “During colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use a water bottle to supply irrigation for the procedure,” it says. Clinicians typically use a single water bottle for multiple patients without reprocessing the water bottle between patients. This practice raises the risk of cross-contamination between patients, because the water bottle and associated tubing/connector can become contaminated with blood, stool, or other patient fluids that travel back through the endoscope channels and tubing.