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新型水基自动内镜清洗流程与传统手动清洗在减少十二指肠镜污染方面的比较

Novel water-based automated endoscope cleaning process vs conventional manual cleaning for reducing duodenoscope contamination.

作者信息

van der Ploeg Koen, Severin Juliëtte A, Vos Margreet C, Erler Nicole S, Bulkmans Adriana J C, Bruno Marco, Mason-Slingerland Bibi C G C

机构信息

Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, Netherlands.

Department of Medical Microbiology and Infectious Diseases, Erasmus MC, Rotterdam, Netherlands.

出版信息

Endosc Int Open. 2025 Mar 14;13:a25368061. doi: 10.1055/a-2536-8061. eCollection 2025.

Abstract

BACKGROUND AND STUDY AIMS

Duodenoscope contamination remains a persistent problem, exposing patients to infection risks. Automation in reprocessing may limit human error, reduce workload, and increase uniformity and traceability. However, its effectiveness should be evaluated before implementation. This study assessed the impact of implementing a novel water-based automated endoscope cleaning process on duodenoscope contamination.

METHODS

This before-and-after intervention study compared duodenoscope cleaning methods. From January 2022 to December 2023, conventional manual cleaning was used. From January 2024 to June 2024, the AquaTYPHOON system (AT) replaced manual cleaning. Cultures from Pentax ED34-i10T2 patient-ready duodenoscopes were collected. The main outcome was the contamination rate with microorganisms of gut or oral origin (MGO). Secondary outcomes included contamination with solely gut bacteria. Non-inferiority of the AT was tested using a generalized estimating equation with a non-inferiority margin of 5%.

RESULTS

During the manual cleaning period, 333 duodenoscope cultures of eight duodenoscopes were collected; during the AT period, 100 cultures were collected. Pre-introduction of the AT, the contamination rate with MGO was 21.6%, which fell to 16% post-introduction (risk difference: -5.6%, upper bound 90% confidence interval [CI] 6.8%). For gut bacteria, the contamination rate decreased from 14.4% to 9% (risk difference: -5.4%, upper bound 90% CI 3.9%), indicating non-inferiority.

CONCLUSIONS

AT reduced the contamination rate with MGO, but non-inferiority was not demonstrated. For gut bacteria, AT was non-inferior to manual cleaning. These results are promising. However, future studies should confirm these findings in larger samples and explore other advantages of using the AT in duodenoscope cleaning.

摘要

背景与研究目的

十二指肠镜污染仍是一个长期存在的问题,使患者面临感染风险。再处理过程的自动化可能会减少人为错误、减轻工作量,并提高一致性和可追溯性。然而,在实施之前应评估其有效性。本研究评估了实施一种新型水基自动内镜清洗流程对十二指肠镜污染的影响。

方法

这项干预前后的研究比较了十二指肠镜清洗方法。2022年1月至2023年12月使用传统的手动清洗。2024年1月至2024年6月,AquaTYPHOON系统(AT)取代了手动清洗。收集了宾得ED34-i10T2型已准备好供患者使用的十二指肠镜的培养物。主要结果是肠道或口腔来源微生物(MGO)的污染率。次要结果包括仅被肠道细菌污染的情况。使用广义估计方程检验AT的非劣效性,非劣效界值为5%。

结果

在手动清洗期间,收集了8台十二指肠镜的333份十二指肠镜培养物;在AT期间,收集了100份培养物。引入AT之前,MGO的污染率为21.6%,引入后降至16%(风险差异:-5.6%,90%置信区间[CI]上限6.8%)。对于肠道细菌,污染率从14.4%降至9%(风险差异:-5.4%,90%CI上限3.9%),表明具有非劣效性。

结论

AT降低了MGO的污染率,但未证明其具有非劣效性。对于肠道细菌,AT不劣于手动清洗。这些结果很有前景。然而,未来的研究应在更大样本中证实这些发现,并探索在十二指肠镜清洗中使用AT的其他优势。

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