The Food and Drug Administration (FDA) has issued a letter to announce the FDA clearance of a modified Erbe USA Inc. (Erbe) ERBEFLO port connector designed to help reduce the risk of cross-contamination. The modified ERBEFLO 24-hour use port connector now has a backflow prevention feature per FDA recommendation. The new feature is designed to reduce the risk of backflow and cross-contamination of the irrigation system. 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.
The revised labeling identifies compatible endoscopes and accessories, as the FDA guidance recommends, by specifying that the modified ERBEFLO 24-hour use port connector should only be used with Erbe irrigation tubing. In addition, clear and specific new warnings help assure proper use of the device.
For example, the revised labeling:
· warns against disrupting the irrigation pathway during a clinical procedure by disconnecting the port connector from the endoscope or the irrigation tubing while the scope is inside a patient, and
· warns against connecting the port connector to an endoscope once the scope is inside a patient.
As noted in the FDA’s April 18, 2018 Letter to healthcare providers and staff at healthcare facilities, Erbe USA Inc., was the only manufacturer marketing a 24-hour multi-patient use endoscope connector that did not include a backflow prevention feature as recommended in the guidance. The FDA's assessment found that the device design and labeling for the original ERBEFLO port connector did not adequately mitigate the risks of cross-contamination for patients. This was because the connector, tubing, and water bottle could become contaminated with blood, stool, or other fluids from previous patients that might travel back through the endoscope channels into the connector and tubing.
In the April 18, 2018 letter, the FDA recommended healthcare facilities use single-use endoscope connectors or reusable endoscope connectors that are reprocessed according to their instructions for use prior to each patient procedure. The clearance of the modified ERBEFLO 24-hour use port connector provides another option for healthcare facilities whose staff understand and can fully implement the instructions for use to reduce the risk of cross-contamination and infection.
The FDA will continue to keep the public informed as any new information or recommendations become available.
