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按照prEN ISO 15883标准,评估酶清洁剂和戊二醛基消毒剂在清洗消毒器中对软性内窥镜进行化学热力处理的有效性。

Evaluation of the effectiveness of an enzymatic cleaner and glutaraldehyde-based disinfectant for chemothermal processing of flexible endoscopes in washer-disinfectors in accordance with prEN ISO 15 883.

作者信息

Zühlsdorf B, Kampf G

机构信息

Technische Hygiene, Charité Universitätsmedizin Berlin, Benjamin Franklin Campus, Berlin, Germany.

出版信息

Endoscopy. 2006 Jun;38(6):586-91. doi: 10.1055/s-2006-925133. Epub 2006 Apr 12.

DOI:10.1055/s-2006-925133
PMID:16612746
Abstract

BACKGROUND AND STUDY AIMS

This study evaluated the effectiveness of the cleaning process, the disinfection process, and a combination of the two in accordance with the new international standard, prEN ISO 15 883.

MATERIALS AND METHODS

The cleaning process consisted of a 1-min prerinse at 20 degrees C, followed by a 5-min cleaning step at 45 degrees C (with an enzymatic cleaner, 0.5 %), followed by a 1-min interim rinse from 45 degrees C to 55 degrees C. The disinfection process consisted of a 1-min prerinse at 20 degrees C, followed by a 5-min disinfection step at 55 degrees C (with a glutaraldehyde-based disinfectant, 1 %), followed by two final rinses of 1 min each at 55 degrees C. Transparent test pieces were contaminated with a mixture of blood and ENTEROCOCCUS FAECIUM, and were assessed for visible cleanliness and microbial load.

RESULTS

Cleaning alone, disinfection alone, and the combination of the two always led to visible cleanliness of all test pieces. The cleaning process revealed a mean reduction factor of > or = 4.6 (n = 6); the disinfection process revealed a mean reduction factor of > or = 9.0 (n = 6), and the combination of the two was found to reduce the test organism in the WD440 by 9.0 +/- 0.2 log (10) steps (n = 12) and in the AdaptaScope by 9.3 +/- 0.4 log (10) steps (n = 5).

CONCLUSIONS

Overall, the entire process was found to be very effective and compatible for reprocessing flexible endoscopes in washer-disinfectors. No visible residual blood was found, despite the use of glutaraldehyde in the disinfection phase. These findings once again emphasize the importance of effective cleaning for the overall results when reprocessing flexible endoscopes.

摘要

背景与研究目的

本研究依据新的国际标准prEN ISO 15883评估了清洗过程、消毒过程以及二者结合的有效性。

材料与方法

清洗过程包括在20℃下预冲洗1分钟,接着在45℃下进行5分钟的清洗步骤(使用0.5%的酶清洁剂),随后从45℃至55℃进行1分钟的中间冲洗。消毒过程包括在20℃下预冲洗1分钟,接着在55℃下进行5分钟的消毒步骤(使用1%的戊二醛基消毒剂),随后在55℃下进行两次每次1分钟的最终冲洗。透明测试片被血液和粪肠球菌的混合物污染,并对其可见清洁度和微生物负荷进行评估。

结果

单独清洗、单独消毒以及二者结合均能使所有测试片达到可见清洁度。清洗过程显示平均减少系数≥4.6(n = 6);消毒过程显示平均减少系数≥9.0(n = 6),二者结合在WD440中使测试微生物减少9.0±0.2 log(10)个对数级(n = 12),在AdaptaScope中减少9.3±0.4 log(10)个对数级(n = 5)。

结论

总体而言,整个过程被发现对于在清洗消毒器中对软性内镜进行再处理非常有效且合适。尽管在消毒阶段使用了戊二醛,但未发现可见的残留血液。这些发现再次强调了有效清洗对于软性内镜再处理总体结果的重要性。

相似文献

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Evaluation of the effectiveness of an enzymatic cleaner and glutaraldehyde-based disinfectant for chemothermal processing of flexible endoscopes in washer-disinfectors in accordance with prEN ISO 15 883.按照prEN ISO 15883标准,评估酶清洁剂和戊二醛基消毒剂在清洗消毒器中对软性内窥镜进行化学热力处理的有效性。
Endoscopy. 2006 Jun;38(6):586-91. doi: 10.1055/s-2006-925133. Epub 2006 Apr 12.
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High-level disinfection of gastrointestinal endoscopes: are current guidelines adequate?胃肠内镜的高水平消毒:现行指南是否足够?
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Gut. 1998 Apr;42(4):585-93.
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ESGE/ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer-disinfectors, according to the European Standard prEN ISO 15883 parts 1, 4 and 5.根据欧洲标准prEN ISO 15883第1、4和5部分制定的ESGE/ESGENA关于清洗消毒器中内镜再处理的工艺验证和常规测试指南。
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