FDA Issues Warning On Multi-Patient Endoscope Connectors

The U.S. Food and Drug Administration (FDA) recently released a public alert that warned about the risk of cross-contamination from the use of certain endoscope connectors commonly seen in gastrointestinal endoscopy. The alert primarily points out the risks associated with the use of 24-hour multi-patient use endoscope connectors that are labeled for use with multiple patients over the course of 24 hours without reprocessing.

As of the date of the alert, the FDA had not received enough evidence to demonstrate the safe use of these products, and recommends against the use of the connectors. As the release from the FDA continues:

“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.

FDA Actions

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.”

Read the entire release here: Risk of Cross-Contamination From 24-Hour Multi-Patient Use Endoscope Connectors – Letter to Health Care Providers and Staff at Health Care Facilities Performing Gastrointestinal Endoscopy Procedures

The infection risk with endoscopes and connectors continues to be an issue for hospitals.  Hospitals must continue to be vigilant in their use of endoscopes and must ensure safety protocols are followed strictly to minimize infection risk. Where strong processes are missing, hospitals must work to ensure the proper people and systems are in place to upgrade processes to the highest standards. Software systems such as iRIScope have been introduced in recent years to help hospitals ensure that each of their flexible endoscopes is reprocessed the proper way each time, and documentation of their reprocessing is kept electronically using advanced RFID technology.