2015-12-28 19:50:02 UTC

Dec. 28, 2015

All facilities using Fuji’s duodenoscopes must train staff on the new instructions and implement them as soon as possible.

If you use Fuji duodenoscopes in your practice, be aware that the manufacturer has issued revised, validated manual reprocessing instructions with added safety measures to prevent the spread of bacteria. These instructions replace those provided in the original device labeling.

All facilities using Fuji’s ED-530XT duodenoscope, as well as Fuji’s 250 and 450 duodenoscope models, must train staff on the new instructions and implement them as soon as possible.

The revised instructions include a more rigorous protocol for pre-cleaning, manual cleaning and high-level disinfection procedures. They also incorporate the use of an additional disposable brush (Model WB1318DE) to manually clean the distal end of the scope. Read the FDA Safety Communication for details of the key changes to the reprocessing procedure and recommended next steps.

FDA reviewed Fuji’s revised reprocessing instructions and the validation data and believes that, when followed, they demonstrate consistent and reliable cleaning and high-level disinfection of the Fuji ED-530XT duodenoscope. FDA also asks facilities to apply the new reprocessing instructions to Fuji’s 250 and 450 duodenoscope models while validation testing continues for those models.

The AGA Center for GI Innovation and Technology has been working closely with FDA, endoscope manufacturers, and other GI, epidemiology and infectious disease experts to develop a path forward to prevent scope-associated infections. The center will continue to keep you updated on how we can enhance the safety of this life-saving procedure.

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