Double high-level disinfection versus liquid chemical sterilization for reprocessing of duodenoscopes used for ERCP: a prospective randomized study.
Double high-level disinfection versus liquid chemical sterilization for reprocessing of duodenoscopes used for ERCP: a prospective randomized study.
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DOI：
10.1016/j.gie.2020.07.057
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发表时间：
2021-04
影响因子：
7.7
通讯作者：
Rex DK
中科院分区：
文献类型：
--
作者：
Gromski MA;Sieber MS;Sherman S;Rex DK
病原微生物传播的可能性是当前可重复使用的十二指肠镜设计所固有的问题。最近爆发的多药耐药病原体通过内窥镜传播，揭示了这一问题的紧迫性。美国食品药品监督管理局已提供内镜微生物培养和重复高水平消毒（HLD）或液体化学灭菌（LCS）再处理作为加强十二指肠镜再处理的补充措施。本研究旨在比较双HLD（DHLD）与LCS再处理内窥镜的有效性。我们前瞻性评价了2017年10月23日至2018年9月24日期间2种不同的十二指肠镜再处理模式。合格的内窥镜被随机隔离，由DHLD或LCS进行再处理。根据内部方案，在再处理后对十二指肠镜进行随机培养以进行监测。在研究期间，共进行了878次再处理后监测培养（DHLD组453次，LCS组425次）。在所有培养物中，17例为任何微生物阳性（1.9%）。当比较接受DHLD的内窥镜（8个阳性培养物，1.8%）与接受LCS的内窥镜（9个阳性培养物，2.1%; P = 0.8）时，阳性培养物无显著差异。两组均有2种培养物生长高度关注的微生物（0.5% vs 0.5%，P = 1.0）。未检出多重耐药微生物，包括耐碳青霉烯类肠杆菌科。对于所有微生物和高度关注的微生物，DHLD和LCS的阳性培养率均较低。然而，两种工艺均未完全消除采用2种不同补充再处理策略再处理的内窥镜中的阳性培养物。
The potential for transmission of pathogenic organisms is a problem inherent to the current reusable duodenoscope design. Recent outbreaks of multidrug-resistant pathogenic organisms transmitted via duodenoscopes has brought to light the urgency of this problem. Microbiologic culturing of duodenoscopes and reprocessing with repeat high-level disinfection (HLD) or liquid chemical sterilization (LCS) have been offered as supplemental measures to enhance duodenoscope reprocessing by the U.S. Food and Drug Administration. This study aims to compare the efficacy of reprocessing duodenoscopes with double HLD (DHLD) versus LCS. We prospectively evaluated 2 different modalities of duodenoscope reprocessing from October 23, 2017 to September 24, 2018. Eligible duodenoscopes were randomly segregated to be reprocessed by either DHLD or LCS. Duodenoscopes were randomly cultured after reprocessing for surveillance based on an internal protocol. During the study period, there were 878 post-reprocessing surveillance cultures (453 in the DHLD group and 425 in the LCS group). Of all cultures, 17 were positive for any organism (1.9%). There was no significant difference of positive cultures when comparing the duodenoscopes undergoing DHLD (8 positive cultures, 1.8%) with duodenoscopes undergoing LCS (9 positive cultures, 2.1%; P = .8). Both groups had 2 cultures that grew high-concern organisms (.5% vs .5%, P = 1.0). No multidrug-resistant organisms, including carbapenem-resistant enterobacteriaceae, were detected. DHLD and LCS both resulted in a low rate of positive cultures, for all organisms and for high-concern organisms. However, neither process completely eliminated positive cultures from duodenoscopes reprocessed with 2 different supplemental reprocessing strategies.
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