FDA Recommends Steps to Mitigate Duodenoscope Infection Risk

Addressing recent outbreaks of serious, sometimes fatal infections associated with duodenoscopes, the Food and Drug Administration has issued recommendations for taking extra steps to improve the reprocessing of these devices, which “may further help reduce the risk of infection transmission,” the agency said in a statement issued on Aug. 4.

The extra measures are microbiological culturing, ethylene oxide sterilization, the use of a liquid chemical sterilant processing system, and repeated high-level disinfection. “Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices,” according to the FDA’s statement announcing the measures.

^{Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License}

The statement acknowledges that some health care facilities will not be able to implement one or more of these steps, so “it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks.”

And while it is not possible to completely eliminate the risk of transmitting infections, “the benefits of these devices continue to outweigh the risks in appropriately selected patients,” the statement adds.

These recommendations and the statement regarding the risk-benefit profile of these devices, used to perform endoscopic retrograde cholangiopancreatography, reflect comments of panelists at a meeting of the FDA’s s gastroenterology and urology devices panel on May 14 and 15 to address recent concerns about duodenoscopes and several outbreaks in U.S. hospitals of serious infections related to the devices.

The FDA’s statement is available here.

Any infections possibly related to duodenoscopes should be reported to the manufacturer and the FDA’s MedWatch program.