Backflow in irrigation channels used with flexible gastrointestinal endoscopes can pose an infection risk to patients, warns the U.S. Food and Drug Administration (FDA) in new draft guidance issued January 20, 2015. The guidance, Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation through Flexible Gastrointestinal Endoscopes, highlights the cross-contamination risks associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes and outlines strategies to mitigate the risk of cross-contamination between patients. The guidance explains that clinicians often use a water bottle to supply irrigation during colonoscopy or esophagogastroduodenoscopy and typically use a single water bottle for multiple patients without reprocessing it between patients. According to FDA, this practice raises the risk of cross-contamination between patients because, with some devices, the water bottle and associated tubing and connectors can become contaminated with blood or stool in a phenomenon referred to as "backflow." Other channels, such as air and biopsy channels, can also present a potential source for cross-contamination. FDA recommends that, in the absence of valves to prevent backflow, the water bottle and any associated tubing and connectors should be reprocessed or discarded after every patient use. For auxiliary water channels with external valves, any device that is directly connected to the auxiliary water inlet (up to and including the distal valve in the fluid pathway) should be considered contaminated and should be reprocessed or replaced after every patient use.

HRC Recommends: Healthcare organizations that use gastrointestinal endoscopes should review the draft guidance but note that it is not for implementation and is being distributed for comment purposes only. ECRI Institute has identified reprocessing failures as a top 10 health technology hazard for the last several years, including in its most recent list for 2015. Those that wish to submit comments should do so by April 20, 2015.