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Regulatory News | 29 November 2016 | By Zachary Brennan
During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories.
The 12-page guidance, first proposed in January 2015, notes that the risk of cross-contamination between patients can be heightened during such procedures because the water bottle and associated tubing and connectors can become contaminated with patient fluids and materials (e.g., blood, stool) that travel back through the irrigation system channels and tubing during the procedure, FDA says.
“FDA has received reports of backflow from irrigation channels into the water bottle and tubing when the irrigation channel did not have a backflow-prevention mechanism in place,” the guidance says. “Although FDA has not yet received reports of infection that can be attributed to backflow, the risk of cross-contamination should be mitigated by following the measures recommended.”
FDA recommends that at least one device component within the irrigation system have a backflow-prevention valve or other feature to prevent the backflow of fluids contaminated with microorganisms into the system.
The agency also recommends this backflow-prevention valve or other feature be tested with quantitative chemical and/or microbiological assays to demonstrate prevention of the backward flow of fluids under simulated use conditions.
The recommendations regarding the device design are limited to irrigation systems for flexible gastrointestinal endoscopy because, FDA says, irrigation systems for other devices, such as arthroscopes, may require different risk mitigation strategies due to the need to aseptically handle those irrigation systems.
FDA also clarifies terminology used to describe irrigation system components and outlines recommended mitigation strategies (e.g., device design, labeling) that aim to reduce the risk of cross-contamination between patients from the use of irrigation system tubing, valves and accessories.
Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes: Guidance for Industry and Food and Drug Administration Staff
Tags: colonoscopy, cross-contamination of medical devices, medical device safety, device irrigation systems