Background and Aims

Duodenoscopes have been implicated in the transmission of multidrug-resistant organisms (MDRO). We compared the frequency of duodenoscope contamination with MDRO or any other bacteria after disinfection or sterilization by 3 different methods.

Methods

We performed a single-center prospective randomized study in which duodenoscopes were randomly reprocessed by standard high-level disinfection (sHLD), double high-level disinfection (dHLD), or standard high-level disinfection followed by ethylene oxide gas sterilization (HLD/ETO). Samples were collected from the elevator mechanism and working channel of each duodenoscope and cultured before use. The primary outcome was the proportion of duodenoscopes with an elevator mechanism or working channel culture showing 1 or more MDRO; secondary outcomes included the frequency of duodenoscope contamination with more than 0 and 10 or more colony-forming units (CFU) of aerobic bacterial growth on either sampling location.

Results

After 3 months of enrollment, the study was closed because of the futility; we did not observe sufficient events to evaluate the primary outcome. Among 541 duodenoscope culture events, 516 were included in the final analysis. No duodenoscope culture in any group was positive for MDRO. Bacterial growth of more than 0 CFU was noted in 16.1% duodenoscopes in the sHLD group, 16.0% in the dHLD group, and 22.5% in the HLD/ETO group (P = .21). Bacterial growth or 10 or more CFU was noted in 2.3% of duodenoscopes in the sHLD group, 4.1% in the dHLD group, and 4.2% in the HLD/ETO group (P = .36). MRDOs were cultured from 3.2% of pre-procedure rectal swabs and 2.5% of duodenal aspirates.

Conclusions

In a comparison of duodenoscopes reprocessed by sHLD, dHLD, or HLD/ETO, we found no significant differences between groups for MDRO or bacteria contamination. Enhanced disinfection methods (dHLD or HLD/ETO) did not provide additional protection against contamination. However, insufficient events occurred to assess our primary study end-point. ClinicalTrials.gov no: NCT02611648.

中文翻译：

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十二指肠镜的3种高级消毒和灭菌程序的随机比较

背景和目标

十二指肠镜已经牵涉到多重耐药生物体（MDRO）的传播。我们通过3种不同的方法比较了十二指肠镜在MDRO或其他细菌消毒或灭菌后受到十二指肠镜污染的频率。

方法

我们进行了单中心前瞻性随机研究，其中十二指肠镜通过标准高水平消毒（sHLD），双重高水平消毒（dHLD）或标准高水平消毒然后进行环氧乙烷气体消毒（HLD / ETO）进行随机再处理）。从每个十二指肠镜的升降机构和工作通道收集样品，并在使用前进行培养。主要结果是十二指肠镜在具有升降机构或工作通道培养物的情况下所占的比例，显示出1个或多个MDRO。次要结果包括十二个十二指肠镜在两个采样位置上的污染频率，其中有氧细菌生长的菌落形成单位（CFU）大于0和10个或更多。

结果

入组3个月后，由于徒劳无功而关闭了该研究；我们没有观察到足够的事件来评估主要结果。在541个十二指肠镜培养事件中，有516个被纳入了最终分析。任何一组中没有十二指肠镜培养对MDRO呈阳性。sHLD组的十二指肠镜中细菌生长超过0 CFU，在dHLD组中为16.0％，在HLD / ETO组中为22.5％（P = 0.21）。sHLD组中十二指肠镜的细菌生长或CFU≥10，在dHLD组中为4.1％，在HLD / ETO组中为4.2％（P = 0.36）。MRDO由术前直肠拭子的3.2％和十二指肠抽吸物的2.5％进行培养。

结论

在通过sHLD，dHLD或HLD / ETO重新处理的十二指肠镜的比较中，我们发现MDRO或细菌污染的组之间无显着差异。增强的消毒方法（dHLD或HLD / ETO）没有提供防止污染的附加保护。但是，发生的事件不足以评估我们的主要研究终点。ClinicalTrials.gov编号：NCT02611648。