Olympus America Inc. has issued new, validated manual reprocessing instructions for a specific duodenoscope model to replace those provided in the original labeling, the Food and Drug Administration announced yesterday. The company has a pending 510(k) application for the device (the TJF-Q180V). “The FDA has reviewed these new reprocessing instructions and the validation data as part of its ongoing review of the 510(k), and recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible,” the agency said. The company has sent letters to users of the device outlining the new reprocessing instructions and will soon distribute revised manuals, FDA said. The agency last month issued safety recommendations to prevent possible microbial infections from reprocessed reusable duodenoscopes – flexible, lighted tubes that are threaded through the mouth into the small intestine to drain fluids from blocked pancreatic and biliary ducts. According to the advisory, the agency has received in the past two years 75 reports involving possible microbial transmission from reprocessed duodenoscopes, including multidrug-resistant bacterial infections.