Multiple attempts were made to obtain additional information from the user facility and provide instructions in the proper reprocessing steps of the scope.To date, no response from the user facility has been received.The scope instructions for use (ifu) does not provide instructions for the use of "sheaths instead of cold liquid sterilization" in the reprocessing procedures.Per the ifu, "use basins which are at least 40 cm by 40 cm in size and deep enough to allow the endoscope to be completely immersed." for high level disinfection, "fill a basin with disinfectant solution at the temperature and concentration recommended by the disinfectant manufacturer.Use a basin which is at least 40 cm by 40 cm in size and deep enough to allow the endoscope to be completely immersed.Immerse the endoscope in disinfectant solution.If air bubbles adhere to the surfaces of the endoscope, remove them using a clean lint-free cloth.Cover the basin with a tight fitting lid to minimize the release of disinfectant vapor.Soak the endoscope for the amount of time and at the temperature recommended by the disinfectant manufacturer." in addition, the ifu provides the following warning statement: "all disinfection steps should be performed with the endoscope and all equipment completely immersed.If the equipment is connected or disconnected while not immersed, disinfectant solution may not adequately contact all surfaces of the equipment.As a result, the effectiveness of disinfection may be reduced.".
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