FDA Issues Warning Over 24-Hour Multipatient Endoscope Connectors

Celiac.com 05/08/2018 - The US Food and Drug Administration (FDA) has issued an alert to healthcare providers about the risk of cross-contamination with certain endoscope connectors used in gastrointestinal endoscopy. 

The FDA warns that ”24-hour multi-patient use endoscope connectors,” carry cross-contamination risks. To help reduce the risk of cross-contamination and possible infection between patients, the FDA recommends that providers use connectors with backflow prevention features that prevent patient fluids from flowing back into the endoscope. 

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The FDA warns that these connectors carry cross-contamination risks. "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 reduce the risk of cross-contamination and possible infection between patients, the FDA recommends that providers use connectors with backflow prevention features that prevent patient fluids from flowing back into the endoscope.

Erbe USA Inc’s Erbeflow port connector is currently the only 24-hour, multi-patient-use endoscope connector with no back-flow prevention feature, so the FDA warning is clearly targeted at that device.

According to an FDA assessment, because “the connector, tubing, and/or water bottle can become contaminated with blood, stool, or other fluids from previous patients,” the Erbeflow port connector does not “adequately mitigate the risks of cross-contamination for endoscopy patients.”

The agency is encouraging health providers to use single-use and reusable endoscope connectors with backflow prevention features, and to make certain that reusable connectors are processed properly for each procedure.

The agency is also encouraging healthcare professionals to report problems with these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Read more at FDA.gov.