The FDA is alerting healthcare providers and facilities about the risk of cross-contamination with certain connectors that are used in gastrointestinal endoscopy. Endoscope connectors that are labeled for use with multiple patients over the course of 24 hours without reprocessing are known as 24-hour multi-patient use endoscope connectors. To date, the FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their use.
To mitigate the risk of cross-contamination and possible infection between patients, the FDA recommends the use of connectors with features that prevent patient fluids from flowing backwards into the endoscope (backflow prevention features). These connectors may be either single-use connectors that are discarded after each patient, or reusable connectors that are reprocessed according to their instructions for use prior to each patient.