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Published on: August 11, 2017
Evaluation of a rapid quality control method for endoscope cleaning
Background:
Over the past 30 years, endoscope processing has improved significantly, guided by various standards and recommendations. None the less, contamination remains an issue, with 21.1% of endoscopes exceeding acceptable thresholds in 2021. Cleaning, including pre-treatment, is identified as critical for successful endoscope processing. ISO 15883-5 and AAMI guidelines provide frameworks for evaluating cleaning efficacy, with ANSI/AAMI ST91 recommending verification of cleanliness for high-risk and complex-design endoscopes after each cycle. This study assesses the EndoCheck protein detection kit (HEALTHMARK) as a rapid test for evaluating cleaning quality in endoscope channels.
Methods:
The study was conducted in two phases: (1) performance testing (detection limit, extraction efficiency, and sensitivity), and (2) real-use testing (comparison with a standard flush sampling method).
Results:
The EndoCheck kit consistently detected ≥5 μg of bovine serum albumin (BSA) in polytetrafluoroethylene (PTFE) tubes, equivalent to 0.4 μg/cm2, and recovered an average of 68 ± 11% of the initial soil. Under real-use conditions, it identified 51% of endoscopes as non-compliant, compared with 14% with the flush method. This discrepancy was more pronounced in bronchoscopes, likely due to the nature of the residual soil.
Conclusion:
The EndoCheck kit is a highly sensitive, easy-to-use method for detecting residual protein in biopsy channels. Its greater stringency compared with current flush methods makes it a reliable tool for confirming cleanliness when results are negative. Positive results can serve as early indicators, prompting further investigation.
