FDA: Providers should use revised reprocessing instructions for Fuji duodenoscopes
AHA News Now
Jan 5, 2016
Fuji has issued revised manual reprocessing instructions for its ED-530XT duodenoscope to replace those provided in the original device labeling, the Food and Drug Administration reports. Health care facilities using the duodenoscope should train staff on the new validated instructions and implement them as soon as possible, the agency said. FDA also encourages facilities to apply the revised reprocessing instructions to Fuji’s 250 and 450 duodenoscope models. “While formal validation testing with the revised reprocessing instructions is ongoing for Fuji’s 250 and 450 duodenoscope models, FDA…believes that the revised reprocessing instructions for the ED-530XT duodenoscope are more robust because of additional pre-cleaning, cleaning and high-level disinfection steps and, for that reason, should increase the safety margin of the 250 and 450 duodenoscope models,” the agency said.
Topic: Quality and Patient Safety
Tags: quality, patient safety, regulation