FDA approves Fujifilm's revised duodenoscope reprocessing instructions

FDA approves Fujifilm’s revised duodenoscope reprocessing instructions

Last year, the FDA ordered Fujifilm Medical Systems, Hoya PENTAX and Olympus — the three major manufacturers of duodenoscopes sold in the United States — to study how scopes are reprocessed in healthcare facilities. Now, the FDA has approved Fujifilm’s new manual reprocessing instructions, according to a Mass Device report.

Specifically, the FDA approved Fujifilm’s revised instructions for its ED-530XT duodenoscope. Fujifilm is also undergoing formal validation testing for revised reprocessing instructions for its 250 and 450 duodenoscope models, according to the report.

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