Background and Aims

Newly designed duodenoscopes with disposable distal caps have been developed for better cleaning and preprocessing to reduce the risk of bacterial contamination (BC). We compared BC and organic residue of duodenoscopes with disposable distal caps and duodenoscopes with fixed distal caps after manual cleaning and high-level disinfection (HLD).

Methods

Four hundred duodenoscopes were randomized into group A (fixed distal caps, n = 200) and group B (disposable distal caps, n = 200). After manual cleaning, samples from the elevator were submitted for culture. An adenosine triphosphate (ATP) test was performed for organic residue evaluation. Based on our previous data, ATP < 40 relative light units (RLUs) had 100% sensitivity with 100% negative predictive value to confirm no BC after reprocessing.

Results

After manual cleaning, group A had a higher BC rate (14% vs 7%, P = .02), a higher proportion of duodenoscopes with ATP ≥ 40 RLUs (73.5% vs 57%, P = .001), and a higher mean of ATP level (226.6 vs 82.0 RLUs, P < .001) compared with group B. After HLD, the proportion of potential BC (ATP ≥ 40 RLUs) in group A was 2.7 times higher than group B (4% vs 1.5%, P = .13). Mean ATP level after HLD in the 2 groups was significantly lower than before the HLD procedure (group A, 24.2 vs 226.6 RLUs [P < .001]; group B, 20.4 vs 82.0 RLUs [P < .001], respectively).

Conclusions

After manual cleaning, duodenoscopes with disposable distal caps had significantly lower BC and organic residue than duodenoscopes with fixed distal caps. Only a few duodenoscopes from each group did not pass the ATP threshold after HLD.

中文翻译：

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与带固定远端帽的十二指肠镜相比，带一次性远端帽的十二指肠镜再处理后的细菌污染和有机残留物：一项随机试验

背景和目标

新设计的带有一次性远端盖的十二指肠镜已经开发出来，可以更好地清洁和预处理，以降低细菌污染 (BC) 的风险。我们比较了带有一次性远端帽的十二指肠镜和带有固定远端帽的十二指肠镜在手动清洁和高水平消毒 (HLD) 后的 BC 和有机残留物。

方法

400 个十二指肠镜被随机分为 A 组（固定远端帽，n = 200）和 B 组（一次性远端帽，n = 200）。人工清洁后，电梯的样本被送去培养。进行三磷酸腺苷 (ATP) 测试以评估有机残留物。根据我们之前的数据，ATP < 40 相对光单位 (RLU) 具有 100% 的灵敏度和 100% 的阴性预测值，以确认再处理后没有 BC。

结果

人工清洗后，A 组的 BC 率更高（14% vs 7%，P  = .02），ATP ≥ 40 RLUs 的十二指肠镜比例更高（73.5% vs 57%，P  = .001），以及更高的 与 B 组相比，ATP 水平的平均值（226.6 vs 82.0 RLUs，P < .001）。HLD 后，A 组潜在 BC（ATP ≥ 40 RLUs）的比例是 B 组的 2.7 倍（4% vs 1.5%） , P  = .13). 两组 HLD 后的平均 ATP 水平显着低于 HLD 手术前（A 组分别为 24.2 和 226.6 RLUs [ P  < .001]；B 组分别为 20.4 和 82.0 RLUs [ P  < .001]。

结论

手动清洁后，带有一次性远侧盖的十二指肠镜的 BC 和有机残留物明显低于带有固定远侧盖的十二指肠镜。HLD 后，每组只有少数十二指肠镜未超过 ATP 阈值。