On November 29, 2016, the FDA issued guidance for “Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.” The objectives of this guidance document are to: (1) highlight the cross-contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes; (2) clarify terminology used to describe these devices; and (3) outline strategies to mitigate the risk of cross-contamination between patients.
During colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use a water bottle to supply irrigation for the procedure. 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/connectors can become contaminated with blood, stool, or other patient fluids that travel back through the endoscope channels and tubing (backflow). The 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.
Flexible gastrointestinal endoscopes and accessories (including valves and other devices used for irrigation) are Class II devices, as described in 21 CFR 876.1500. The FDA uses product codes to identify devices that supply endoscopic irrigation, the most common being FDF (colonoscope and accessories, flexible/rigid), FDS (gastroscope and accessories, flexible/rigid), and OCX (endoscopic irrigation/suction system). These irrigation devices may be submitted to the FDA in pre-market notification (510(k)) applications as part of a flexible gastrointestinal endoscope system or separately as accessories to flexible gastrointestinal endoscopes.
This guidance outlines the recommended mitigation strategies to reduce the risk of cross-contamination from connectors and irrigation accessories, including device design and appropriate labeling. The 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.
The risk of cross-contamination from endoscope connectors during the use of flexible gastrointestinal endoscopes can be mitigated by a combination of device design, labeling, and proper device handling, as described below. 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.
Manufacturers of flexible gastrointestinal endoscopes and accessories (including valves and other devices used for irrigation) must establish and maintain procedures for validating the design of their device, which shall ensure that the device conforms to defined user needs and intended uses (21 CFR 820.30(g)). The FDA interprets this to require manufacturers to validate the design, including instructions for use and associated claims, of such devices to ensure that the device can be safely and effectively used as intended. This data should be kept and maintained at the manufacturer’s facility. The data should be made available for review at the request of FDA or made available during an FDA inspection.
See the FDA Guidance
See also Medical Law Perspectives, June 2016 Report: How Risky Is Going to the Hospital? The Dangers and Liabilities of Healthcare-Associated Infections
See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who is Liable and Why
See the Medical Law Perspectives March 11, 2015, Blog: Uncleanable ERCP Duodenoscopes: Manufacturer, Hospital, and Physician Liability?