April 19, 2018

FDA issues letter to healthcare providers on risks of endoscope connectors

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on April 18 alerted healthcare providers and facilities about the risk of cross-contamination with 24-hour, multipatient use connectors used in gastrointestinal (GI) endoscopy.

Endoscope connectors are small accessories used to connect the auxiliary water channel to a water source and irrigation tubing. To mitigate the risk of cross-contamination, the FDA recommends the use of connectors that prevent patient fluids from flowing backwards into the endoscope.

One manufacturer, Erbe USA Inc, markets a 24-hour, multipatient use endoscope connector (ERBEFLO port connector) that does not include a backflow prevention feature.

To date, the FDA has not received acceptable testing to demonstrate the safe use of these products and recommends against their use.

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