May 23, 2019
The U.S. Food and Drug Administration (FDA) is issuing this 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 that was identified in FDA’s April 18, 2018 Letter to Health Care Providers and Staff at Health Care Facilities.
The design of the modified ERBEFLO 24-hour use port connector added a backflow prevention feature as recommended in FDA guidance. The guidance recommends that devices of this type have a backflow prevention feature to reduce the risk of backflow and cross-contamination of the irrigation system that might result.
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 guidance.
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 Health Care Providers and Staff at Health Care 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 health care 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 health care 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.
If you have questions about this letter, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 1-800-638-2041 or 301-796-7100.