FDA validates revised reprocessing instructions for Model ED-530XT duodenoscopes

‐

FUJIFILM Medical Systems issued revised reprocessing instructions late last month for Model ED-530XT duodenoscopes, according to a safety communication issued by the FDA. The instructions require exacting pre-cleaning, manual cleaning, and high-level disinfection procedures.

While these revised reprocessing instructions are for Model ED-530XT duodenoscopes, the FDA is encouraging healthcare facilities that use Fuji’s 250 and 450 duodenoscope models, to use the revised reprocessing instructions until the revised instructions for those models are final.

Key changes to the reprocessing procedure for Fuji’s ED-530EXT duodenoscope:

  • Pre-cleaning
    • During immersion of the scope tip in detergent solution, move the forceps elevator back and forth and aspirate detergent solution while the forceps is raised and while lowered.
  • Manual cleaning
    • Additional brushing of the distal tip, forceps elevator and elevator recess first using the existing Fujifilm valve cylinder cleaning brush (Model WB11002FW2) and then using the new disposable (Model WB1318DE) cleaning brush.
    • Additional flushing of detergent and rinse water onto the forceps elevator/recess while the elevator is both raised and lowered.
    • Additional flushing steps and increased channel flushing volumes of detergent and rinse water
  • Manual high-level disinfection
    • Additional flushing of disinfectant and rinse water onto the forceps elevator/recess while the elevator is both raised and lowered. Additional raising and lowering of the elevator while immersed in disinfectant solution and rinse water.
    • Additional flushing steps and increased flushing volumes of disinfectant and rinse water through the duodenoscope’s internal channels.

     

    In October, the FDA ordered the top three manufacturers of duodenoscopes, Olympus America, Inc., Fujifilm Medical Systems, USA, Inc., and Hoya Corp. to submit plans outlining how they were going to conduct studies to understand how the duodenoscopes are being reprocessed in healthcare settings.

    For more information visit the FDA website.