Revised Reprocessing Instructions
FUJIFILM Medical Systems, U.S.A., Inc. has validated revised reprocessing instructions for the ED-530XT duodenoscope, which includes additional pre-cleaning, manual cleaning, and high-level disinfection steps.
The revised instructions aim to increase the safety margin of the device by ensuring consistent and reliable cleaning and high-level disinfection.
Key Changes to Reprocessing Procedure
Pre-cleaning: Immersion of the scope tip in detergent solution with movement of the forceps elevator back and forth and aspiration of detergent solution.
Manual Cleaning: Additional brushing of the distal tip, forceps elevator, and elevator recess using a new disposable brush (Model WB1318DE).
Manual High-Level Disinfection: Additional flushing of disinfectant and rinse water onto the forceps elevator/recess while the elevator is both raised and lowered.
FDA recommends implementing the revised reprocessing instructions as soon as possible and applying them to other Fuji duodenoscope models (250 and 450) while validation testing continues.
Manual:
Download: FUJIFILM Medical Systems, U.S.A., Inc. ED-530XT Duodenoscope User Manual
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