Contamination of Disposable Distal Cap Duodenoscopes and Detachable Elevator Duodenoscopes After Reprocessing: A Randomized Trial.

Abstract

Background and aim: To reduce bacterial contamination after reprocessing, various new designs of duodenoscopes have been developed to better expose the elevator complex for cleaning. We compared the rates of bacterial contamination and organic residue in disposable distal cap duodenoscopes and detachable elevator duodenoscopes after manual cleaning and high-level disinfection (HLD), as well as their cost-effectiveness.

Methods: A total of 162 duodenoscopes were randomly assigned to either Group A (disposable distal caps; n = 81) or Group B (detachable elevator; n = 81). A total of 324 samples from the elevator were collected for culture following manual cleaning (n = 81 in each group) and HLD (n = 81 in each group), followed by the adenosine triphosphate (ATP) testing for organic residue.

Results: After manual cleaning, there was no difference in bacterial contamination rates (8.6% vs. 8.6%; p = 1.00) and mean ATP levels (164.6 ± 257.5 vs. 158.1 ± 286.1 RLUs; p = 0.88) between Groups A and B. After HLD, no bacterial contamination was observed in either group and the mean ATP levels were very low with no significant difference between the two groups (30.1 ± 45.3 vs. 37.5 ± 51.9 RLUs; p = 0.68). The expense in reprocessing (excluding the scope cost) for Group A was lower (2099 USD) than Group B (3854 USD) in providing comparable scope cleanliness.

Conclusion: After manual cleaning, the bacterial contamination rate and organic residue levels in detachable elevator duodenoscopes and disposable distal caps duodenoscopes were comparable. No bacterial contamination was detected in either type of duodenoscope after reprocessing. Apart from the initial differences in scope cost, the disposable distal cap duodenoscope had lower cost on disposable items to have comparable disinfection result.