Quality assessment of flexible endoscope cleaning: a single-center retrospective study based on ATP bioluminescence assay with direct lumen inspection.

BACKGROUND Despite standardized reprocessing protocols, flexible endoscopes remain vulnerable to residual contamination due to their complex channel architecture. Current rapid monitoring methods-ATP bioluminescence assays and visual channel inspection-each present limitations in comprehensive cleanliness assessment when used individually.

AIM The objective of this study was to evaluate the application of a combined method, integrating visual channel inspection with ATP bioluminescence assay, for quality control in flexible endoscope cleaning.

METHODS A total of 540 reusable flexible endoscopes from the Medical Center of the Second Affiliated Hospital of Fujian Medical University were randomly selected between January 2023 and June 2024. Based on the detection method, they were divided into three groups: ATP group, Visualization group, and Combined group, with 180 endoscopes in each group. The ATP group underwent ATP bioluminescence assay, the Visualization group underwent visual channel inspection, and the Combined group underwent both detection methods. The cleaning quality of the flexible endoscopes was assessed before pre-processing, after pre-processing, and after cleaning.

RESULTS No significant differences were found among groups in baseline contamination or most post-pre-processing results (P > 0.05). Duodenoscopes showed the highest scratch rate (97.59%). Scratches positively correlated with ATP values. After cleaning, a statistically significant difference in pass rates was observed among the three groups across all sampling sites (P < 0.05). The combined method achieved a pass rate of 99.44%-100%, which was significantly higher than the rates achieved by either method alone (ATP-only: 89.44%-94.44%; visual-only: 95.00%-97.22%), thereby nearly eliminating the use of non-compliant instruments.

CONCLUSIONS The combined use of visual channel inspection and ATP bioluminescence detection serves as an effective quality control strategy. It enhances the ability to identify non-conforming endoscopes, thereby preventing the use of contaminated endoscopes in clinical procedures and demonstrating potential value in safeguarding patient safety.