FDA MedWatch – ED-530XT Duodenoscopes by FUJIFILM Medical Systems, U.S.A.: Safety Communication – FUJIFILM Medical Systems Validates Revised Reprocessing Instructions
AUDIENCE: Risk Manager, Gastroenterology, Surgery, Infectious Disease, Nursing ISSUE: FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) issued revised, validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. The FDA reviewed the revised reprocessing instructions and the validation data and determined they meet the . . . Read more