Randomized Comparison of 3 High-Level Disinfection and Sterilization Procedures for Duodenoscopes
Randomized Comparison of 3 High-Level Disinfection and Sterilization Procedures for Duodenoscopes
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DOI：
10.1053/j.gastro.2017.06.052
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发表时间：
2017-10-01
期刊：
影响因子：
29.4
通讯作者：
Sawhney, Mandeep S.
中科院分区：
文献类型：
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作者：
Snyder, Graham M.;Wright, Sharon B.;Sawhney, Mandeep S.
背景和目的：十二指肠镜与多药耐药微生物（MDRO）的传播有关。我们比较了三种不同方法消毒或灭菌后十二指肠镜被MDRO或任何其他细菌污染的频率。方法：我们进行了一项单中心前瞻性随机研究，在该研究中，通过标准高水平消毒（sHLD）、双重高水平消毒（dHLD）或标准高水平消毒后环氧乙烷气体灭菌（HLD/ETO）对内窥镜进行随机再处理。从每个十二指肠镜的升降器机构和工作通道中采集样本，并在使用前进行培养。主要结局是具有升降器机制或工作通道培养物显示1个或多个MDRO的十二指肠镜的比例;次要结局包括十二指肠镜污染的频率，其中任一采样位置上的需氧细菌生长菌落形成单位（CFU）超过0和10个或更多。研究结果：入组3个月后，研究因无效而关闭;我们没有观察到足够的事件来评估主要结局。在541例十二指肠镜培养事件中，516例被纳入最终分析。任何组的十二指肠镜培养均未显示MDRO阳性。在sHLD组、dHLD组和HLD/ETO组中分别有16.1%、16.0%和22.5%的内窥镜中观察到细菌生长超过0 CFU（P = 0.21）。在sHLD组、dHLD组和HLD/ETO组中分别有2.3%、4.1%和4.2%的内窥镜中观察到细菌生长或10个或更多CFU（P = 0.36）。从3.2%的术前直肠拭子和2.5%的十二指肠抽吸物中培养MRDO。结论：在比较经sHLD、dHLD或HLD/ETO再处理的内窥镜时，我们发现两组之间的MDRO或细菌污染无显著差异。强化消毒方法（dHLD或HLD/ETO）未提供额外的污染防护。然而，发生的事件不足以评估我们的主要研究终点。
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.