FDA Warns Against Use of 24-Hour Multi-Patient Use Endoscope Connectors

By on 1:06 PM

The U.S. Food & Drug Administration (FDA) has issued an alert to healthcare providers and facilities advising them against using "24-hour multi-patient use endoscope connectors" because of the risk of cross-contamination.

These are connectors labeled for use with multiple patients over the course of 24 hours without reprocessing. The FDA says it is recommending against their use because it has not received "acceptable testing to demonstrate the safe use of these products."

Endoscope connectors are accessories that attach the auxiliary water channel of flexible gastrointestinal endoscopes to a water source and irrigation tubing. The FDA recommends using connectors with features that prevent patient fluids from flowing backwards into endoscopes to reduce the risk of cross-contamination and infection between patients.

More specifically, FDA encourages providers to use single-use endoscope connectors with backflow prevention features or reusable endoscope connectors with backflow prevention features, and ensure reusable connectors are reprocessed according to their instructions.

The FDA noted that one manufacturer, Erbe USA, currently markets a 24-hour multi-patient use endoscope connector. Called the ERBEFLO port connector, the FDA stated the accessory does not include a backflow prevention feature.

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.