April 18, 2018
The FDA is alerting health care 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.
Endoscope connectors are small accessories used to connect the auxiliary water channel of flexible gastrointestinal endoscopes to a water source and irrigation tubing. 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.
One manufacturer, Erbe USA Inc., currently markets a 24-hour multi-patient use endoscope connector, called the ERBEFLO port connector. The ERBEFLO port connector does not include a backflow prevention feature.
The FDA's assessment has found that the recommended instructions and device design for the ERBEFLO 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.
Alternative endoscope connectors that are designed according to FDA recommendations are widely available on the U.S. market. These alternatives include backflow prevention features, and may be reprocessed and reused between procedures, or they may be single-use devices.
RECOMMENDATIONS FOR HEALTH CARE PROVIDERS AND STAFF AT FACILITIES PERFORMING ENDOSCOPY:
- Do not use 24-hour multi-patient use endoscope connectors because they carry a risk of cross-contamination.
- The FDA encourages health care providers and facilities to:
- use single-use endoscope connectors with backflow prevention features, or
- use reusable endoscope connectors with backflow prevention features, and ensure that those reusable connectors are reprocessed according to their instructions for use prior to each patient procedure.
The FDA previously described the recommended testing for endoscope connectors in its November 2016 guidance document, "Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes."
The agency continues to work with endoscope connector manufacturers to ensure that their products are designed and tested to prevent cross-contamination. We will continue to actively monitor this situation, and will update this communication if significant new information becomes available.
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 1-800-638-2041 or 301-796-7100.