A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing
A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing
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DOI：
10.1016/j.gie.2018.02.016
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发表时间：
2018-08-01
影响因子：
7.7
通讯作者：
Brandabur, Jack J.
中科院分区：
文献类型：
--
作者：
Bartles, Rebecca L.;Leggett, James E.;Brandabur, Jack J.
背景和目的：在一项初步研究中，我们证明了在自动再处理机中使用单周期高水平消毒（HLD）对十二指肠镜和线性回声内窥镜（DLE）进行再处理的现行指南可能是不充分的。2015年8月，美国食品和药物管理局提供了双重HLD作为解决这一问题的可能回应。因此，普罗维登斯健康与服务中心采用双重HLD作为le的标准程序，但没有严格的临床研究支持这种做法。我们在34家医院中的4家进行了一项质量改进研究，以比较单一HLD和双重HLD。方法：在每个设施中，将DLE患者的HLD随机分为工作日的单HLD或双HLD，周末或节假日的标准双HLD。随机化方案的依从性为99.7%。每天收集干燥后hld的定性监测培养物，为期6个月（每次接触电梯机构1个拭子样本，每次接触吸入和工作通道1个联合刷样），每个样本孵育48小时。比较两个研究组中任何微生物生长和高度关注病原体（潜在致病性肠道菌群）生长的阳性率。结果：在参与医院临床使用的45名小护士中，共获得2925次接触监测培养标本5850份。其中3052例（52.2%）来自双HLD清洗的内窥镜。双HLD与单HLD相比没有益处，因为观察到相似的阳性率（均P < 0.05）。电梯机构比活检通道更频繁地定植(5.2% vs 2.9%， P
Background and Aims: In a pilot study, we demonstrated that current guidelines for duodenoscope and linear echoendoscope (DLE) reprocessing using a single cycle of high-level disinfection (HLD) in an automated reprocessor may be inadequate. In August 2015, the U.S. Food and Drug Administration offered double HLD as a possible response to address this concern. As a result, Providence Health and Services adopted double HLD as standard procedure for DLEs, but no rigorous clinical studies supported this practice. We undertook a quality improvement study to compare single HLD versus double HLD at 4 of our 34 hospitals.Methods: HLD of DLE was randomized, separately in each facility, to either single HLD or double HLD on weekdays, with standard double HLD on weekends or holidays. There was 99.7% compliance with the randomization scheme. Daily qualitative surveillance cultures of dried, post-HLD DLEs were collected for 6 months (1 swab sample from the elevator mechanism and 1 combined brush sample from the suction and working channels for each encounter), and each sample was incubated for 48 hours. Positivity rates of any microbial growth and growth of high-concern pathogens (potentially pathogenic enteric flora) were compared between the 2 study arms.Results: Altogether, 5850 surveillance culture specimens were obtained during 2925 encounters from the 45 DLEs in clinical use in the participating hospitals. Of these, 3052 (52.2%) were from endoscopes cleaned by double HLD. Double HLD demonstrated no benefit over single HLD because similar positivity rates were observed (all P>.05). The elevator mechanism was more frequently colonized than the biopsy channel (5.2% vs 2.9%, P