FDA approves revised cleaning instructions for duodenoscopes

duodenoscope 210x210 FDA approves revised cleaning instructions for duodenoscopesFUJIFILM Medical Systems, U.S.A., Inc. (Fuji) has issued revised, validated manual reprocessing instructions for its ED-530XT duodenoscope after the devices were linked to outbreaks of deadly drug resistant bacterial infections. The revised reprocessing instructions and validation data has been reviewed and approved by the Food and Drug Administration (FDA), and the agency is recommending that medical facilities using Fuji’s ED-530 duodenoscopes train staff on the new instructions and implement them as soon as possible.

Duodenoscopes are specialized endoscopes involving a flexible tube that is fed down a patient’s esophagus to treat or diagnose various gastrointestinal conditions. The surgical tools are considered key in illness detection and treatment. They are used in about a half million procedures each year.

In February 2015, the FDA issued a Safety Communication warning that the complex design of duodenoscopes may allow bacteria to harbor in the devices’ small nooks and crannies even after the devices have been cleaned and disinfected. In the past two years, patients have become infected with antibiotic resistant bacteria after undergoing duodenoscope procedures at hospitals in California, Connecticut, Illinois, Pennsylvania, and Washington.

The FDA has been working with three manufacturers of duodenoscopes – Fuji, Olympus America, and Pentax Medical – to clarify and confirm that their cleaning and high-level disinfection instructions meet the agency’s expectations. Even with the revised reprocessing instructions, the FDA says duodenoscopes could still harbor bacteria and spread disease.

The revised instructions for the Fuji duodenoscopes include a more rigorous protocol for pre-cleaning, manual cleaning and high-level disinfection procedures. They also incorporate the use of an additional disposable brush to manually clean the distal end of the scope.

Formal validation testing with the revised reprocessing instructions for Fuji’s 250 and 450 duodenoscope models is currently underway.

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