Regulatory Focus™ > News Articles > FDA Takes Aim at Cross-Contamination in Colonoscopies

FDA Takes Aim at Cross-Contamination in Colonoscopies

Posted 19 January 2015 | By Alexander Gaffney, RAC

FDA Takes Aim at Cross-Contamination in Colonoscopies

US regulators are hoping a new set of recommendations will cut down on cross-contamination caused by flexible gastrointestinal (GI) endoscopes, a type of medical device.

Background

In a new draft guidance document issued by the US Food and Drug Administration (FDA) on 16 January 2015, regulators take aim at cross-contamination, which they note is often caused by improper use of flexible GI endoscopes.

"During colonoscopy or esophagogastroduodenoscopy, clinicians often use a water bottle to supply irrigation for the procedure," FDA explained. "Clinicians typically use a single water bottle for multiple patients without reprocessing the water bottle between patients."

"This practice raises the risk of cross-contamination between patients, because the water bottle and associated tubing/connectors can become contaminated with blood or stool that travels up through the endoscope channels and tubing (a phenomenon referred to as “backflow”)," FDA observed.

"The length and narrow diameters of channels in GI endoscopes may not be sufficient to prevent contamination of the irrigation system," the regulator explains in the guidance. Other sources of contamination include the air and water channels of the device and the instrument/biopsy channel, FDA wrote.

FDA Recommendations

FDA's guidance recommends several changes meant to cut down on backflow and other causes of cross-contamination.

For example, manufacturers are advised to design their devices in such a way as to prevent backflow. "There should be at least one device component within the fluid pathway that has a one-way valve or other feature that prevents the backflow of fluids into the irrigation system," FDA writes in the guidance. "In the absence of a one-way valve or other feature demonstrated to prevent backflow and contamination, the water bottle and associated tubing should be designed to be reprocessed or discarded after every patient use to reduce the risk of patient infection."

Other device components should be designed to be discarded or reprocessed after every use, FDA advised. Devices capable of being cleaned must be shown to be capable of withstanding multiple cleanings and sterilizations.

FDA also advises that devices be clearly labeled regarding their proper use. For example, devices should be labeled as a "single-use device" or a "24-hour multi-patient use device." In addition, devices should include any reprocessing instructions, instructions for discarding the device and whether the device is reusable.

 

Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes (FR)


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