FDA issues supplemental guidance on duodenoscope reprocessing

The Food and Drug Administration today released guidance on supplemental reprocessing measures that may further reduce the risk of infection associated with the use of duodenoscopes. The measures, which emerged from an FDA-led expert panel meeting, are intended to supplement strict adherence to the manufacturer’s reprocessing instructions. “We recognize that not all health care facilities can implement one or more of these measures, which require specific resources, training and expertise,” the guidance states. “Therefore, 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. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients.” In February, the FDA 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.