UPDATE On Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors - Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures

Today, the U.S. Food and Drug Administration (FDA) issued an updated Letter to Health Care Provider announcing clearance of a modified Erbe USA Inc. (ERBE) ERBEFLO port connector designed to help reduce the risk of cross-contamination. The FDA’s clearance of the modified ERBEFLO 24-hour use port connector is based on our review of the functional and simulated use testing of the modified device design, as noted in the 510k Summary. The effectiveness of the Erbe system (the ERBEFLO 24-hour use port connector and Erbe irrigation tubing) at reducing the risk of backflow and contamination of the irrigation system is supported by simulated use testing, as recommended in the FDA guidance.

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