FDA Warns of Endoscope Connector Contamination Risk

Posted April 20, 2018

The Food and Drug Administration (FDA) has issued an alert, warning healthcare providers against using a type of endoscope port connector that does not include backflow prevention features due to the risk of cross-contamination.

The connector in question, known as a 24-hour multipatient use endoscope connector, is labeled for use with multiple patients over the course of 24 hours without reprocessing. However, "to date, the FDA has not received acceptable testing to demonstrate the safe use of these products and recommends against their use,” the FDA wrote in a letter to healthcare providers.

These small devices are used during gastrointestinal endoscopy procedures to connect an irrigation water source and tubing to a flexible gastrointestinal endoscope. However, a lack of backflow protection may allow fluids from one patient to enter and contaminate the connector, tubing, and water source. If those contaminated items are then reused without reprocessing, a previous patient’s fluids can flow back into the endoscope during subsequent procedures.

The 24-hour connector’s design and instructions “do not adequately mitigate the risks of cross-contamination for endoscopy patients … 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,” the FDA wrote.

The FDA recommended that healthcare providers and staff who are at a facility that performs endoscopies should not use the 24-hour multipatient-use endoscope connectors. Staff should instead use endoscope connectors that have backflow prevention features, which may be either single-use or reusable. If the facility employs reusable connectors, they should be processed between patients according to the device’s instructions for use, the FDA explained.

Contamination issues due to improper or inadequate reprocessing of endoscopes and their related accessories have been a longstanding issue. To help reduce cross-contamination risks, the FDA provided recommendations to industry in a November 2016 guidance document, Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.

In this guidance, the FDA recommends that at least one device component within an endoscope’s irrigation system should have a backflow-prevention valve or similar feature, which “should be tested with quantitative chemical and/or microbiological assays to demonstrate prevention of the backward flow of fluids under simulated use conditions.”

If the irrigation does not include backflow protection or a similar feature, according to the guidance, “all components of the irrigation system should be reprocessed or discarded after being used during a procedure in one patient and before starting one in the next patient.”