which was designed to reduce the risk of cross-contamination previously identified by the FDA.
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In a letter published April 18, the FDA had written that the original version of the product, the Erbe USA ERBEFLO port connector, was the only one of its type on the market that did not feature a method of backflow prevention, as recommended by new FDA guidelines. As such, the original ERBEFLO device did not adequately reduce the risk of cross-contamination; blood, stool, or other fluids from previous patients could travel through the endoscopy channels, contaminating the connector, tubing, and water bottle.
The FDA approval of the modified ERBEFLO port connector is based on a review of the functional and simulated use testing of the modified device design. The effectiveness of the device at reducing the risk of backflow and contamination is also supported by simulated testing.
Revised labeling included with the product identifies compatible endoscopes and accessories and provides warnings to ensure proper usage.
“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 said in the May 23 update letter.