FDA Gives Thumbs Up to Fuji’s Revised Duodenoscope Instructions

Following a rash of infections related to duodenoscopes, the FDA has given its blessing to Fujifilm Medical Systems’ updated manual reprocessing instructions for its ED-530XT model.

The revised instructions for the ED-530XT duodenoscope provide a more intense procedure for pre-cleaning, manual cleaning and high-level disinfection procedures, and include the use of a new disposable brush for manual cleaning.

In addition, the instructions call for increased brushing of the forceps elevator and elevator recess first using the existing Fujifilm valve cylinder cleaning brush, followed by a new disposable cleaning brush during manual cleaning. They also call for additional flushing of disinfectant and rinse water onto the forceps elevator and recess while the elevator is raised and lowered for high-level disinfections.

“The agency reviewed the validation data and believes that when followed, the revised, validated reprocessing instructions demonstrate consistent and reliable cleaning and high-level disinfection of the Fuji ED-530XT duodenoscope,” the FDA says in a safety communication.

The agency also is encouraging healthcare facilities to apply the instructions for the ED-530XT devices to Fuji’s 250 and 450 models even though formal validation testing with revised reprocessing instructions for those models is ongoing.

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