Inadequacy of manual cleaning for reprocessing single-use, triple-lumen sphinctertomes: Simulated-use testing comparing manual with automated cleaning methods

Background and Aims: Despite widespread reuse of single-use sphinctertomes, publications regarding the adequacy of reprocessing are conflicting and the cautery wire channel is seldom evaluated. Our objective was to use thickened artificial test soil containing microorganisms to perform simulated-use tests combined with in-situ and destructive testing to evaluate cleaning efficacy and ethylene oxide sterilization of single-use triple lumen sphinctertomes. Methods: New triple-lumen sphinctertomes were soiled with thickened artificial test soil containing 6 log(10) per milliliter of Enterococcus faecalis and Bacillus stearothermophilus by inoculation through the distal end and dried for I hour, 24 hours, or 7 days before cleaning. The efficacy of manual cleaning was compared with that of automated cleaning with the Medisafe SI-Auto narrow-lumen cleaner After cleaning, Bradford's reagent was injected into the channels as a direct method of detecting residual protein. Destructive testing was done to determine the levels of residual protein, carbohydrate, hemoglobin, endotoxin, and viable bacteria in the cleaned device. Destructive sterility testing of the devices also was performed after ethylene oxide sterilization. Results: Both in-situ and destructive testing demonstrated that manual cleaning and automated washers connected via the luer ports did not remove soil or organisms from the cautery wire channel. Only retro-flushing in the SI-Auto provided adequate cleaning of all 3 channels. If reprocessing was delayed for more than 24 hours, retro-flush cleaning was no longer effective. Ethylene oxide sterilization failure was detected only for devices held for 7 days before cleaning and sterilization. In-use testing showed that patient secretions gained access to the cautery wire channel. Conclusions: Only retro-flushing done within 24 hours of use provided adequate cleaning for multi-lumen, single-use sphinctertomes. Our data validate the efficacy of reprocessing sphinctertomes once with SI-Auto retro-flush cleaning followed by 2 hours of ethylene oxide sterilization.