FDA Warns About 24-Hour Multipatient Endoscope Connectors

Megan Brooks

April 18, 2018

There is a risk of cross-contamination with certain endoscope connectors used in gastrointestinal endoscopy, the US Food and Drug Administration (FDA) cautions in an alert to healthcare providers today.

The concern is with "24-hour multi-patient use endoscope connectors" — endoscope connectors that are labeled for use with multiple patients over the course of 24 hours without reprocessing. "To date, the FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their use," the FDA said.

To help lessen the risk of cross-contamination and possible infection between patients, the FDA recommends the use of connectors with features that prevent fluids from the patient from flowing backward into the endoscope (backflow prevention features).

According to the FDA, one manufacturer, Erbe USA Inc, currently markets a 24-hour, multipatient-use endoscope connector called the Erbeflow port connector, which does not include a backflow prevention feature.

An FDA assessment found that the recommended instructions and device design for the Erbeflow port connector "do not adequately mitigate the risks of cross-contamination for endoscopy patients. This is because the connector, tubing, and/or water bottle can become contaminated with blood, stool, or other fluids from previous patients that travel back through the endoscope channels into the connector and tubing," the agency said.

Alternative endoscope connectors that included backflow prevention features are widely available in the United States, the agency said.

They encourage providers and facilities to use single-use and reusable endoscope connectors with backflow prevention features and ensure that reusable connectors are reprocessed according to their instructions for use prior to each patient procedure.

Healthcare professionals are encouraged to report problems related to use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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