The U.S. Food and Drug Administration (FDA) has released guidance recommending mitigation strategies to reduce the risk of cross-contamination from irrigation tubing and accessories that are part of a flexible gastrointestinal endoscope system.
During colonoscopy or esophagogastroduodenoscopy (EGD), a single water bottle for irrigation is used typically between multiple patients, raising the risk of cross-contamination with blood, stool, and other body fluids that travel back through the endoscope channels and tubing.
In order to prevent backflow, FDA recommends that at least one device component within the irrigation system have a backflow-prevention valve or other feature, which should be tested with quantitative chemical and/or microbiological assays to test their ability to prevent backflow under simulated conditions, according to Regulatory Focus.
The FDA provides a definition for a "backflow-prevention valve", along with other specific terms used to describe components of flexible gastrointestinal endoscopes and accessories, for manufacturers to follow in their device labeling and 510(k) applications.
Mitigation strategies involving device design, labeling, and proper device handling also are discussed in detail in the 12-page guidance document.
On device design, the aforementioned backflow-prevention valve or other feature to prevent backflow is recommended. Performance testing of the valve should include – besides chemical/microbiological tests – testing the valve under worst-case conditions, including worst case backpressure, and pressure cycling to simulate periodic changes in fluid pressure and flow.
Device manufacturers are enjoined to provide performance data of said valve, used among multiple patients over a proposed time frame of 24 hours or less, to demonstrate that the valve or feature can adequately mitigate risk of cross-contamination.
FDA says recommendations regarding the device design are limited to irrigation systems for flexible gastrointestinal endoscopy, because irrigation systems for other devices, such as arthroscopes, may require different risk mitigation strategies due to the need to aseptically handle those irrigation systems.
"If the irrigation system does not include a backflow-prevention valve or other feature demonstrated to prevent backflow of contaminated fluids into the proximal irrigation system, then all components of the irrigation system should be reprocessed or discarded after being used during a procedure in one patient and before starting one in the next patient," states the guidance.
FDA provides a reference table for appropriate labels depending whether intended for distal/proximal irrigation systems or consumable/reusable devices. For further clarity, FDA refers manufacturers to complementary guidance on labeling reprocessed medical devices.
Following a spate of “superbug” outbreaks related to reusable duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures, FDA last year issued final guidance for manufacturers to thoroughly test and label new devices to clearly indicate appropriate reprocessing procedures. It also released updated guidelines for hospitals on how to improve existing methods of cleaning duodenoscopes.
FDA is also encouraging medical device designers to consider easier-to-clean materials and components for reprocessed, reusable, and refurbished devices.