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预防中心静脉导管相关血流感染:无针连接器抗菌屏障帽的研制

Preventing central venous catheter-associated bloodstream infections: development of an antiseptic barrier cap for needleless connectors.

作者信息

Menyhay Steve Z, Maki Dennis G

机构信息

Menyhay Healthcare Systems LLC, Fresno, CA, USA.

出版信息

Am J Infect Control. 2008 Dec;36(10):S174.e1-5. doi: 10.1016/j.ajic.2008.10.006.

DOI:10.1016/j.ajic.2008.10.006
PMID:19084153
Abstract

BACKGROUND

Reports of outbreaks associated with the use of needle-free valve connectors suggest 2 common risk factors: (1) poor adherence to disinfection practices before use and (2) a design that allows contamination when not in use. Swabbing a membranous septum with 70% isopropyl alcohol may not eliminate septal surface contamination. Frequent access through and handling of needle-free connectors also puts patients at increased risk of central venous catheter-related bloodstream infections (CR-BSIs). A novel antiseptic barrier cap has been designed to maintain health care worker safety and eliminate the vulnerabilities of existing systems to contamination and CR-BSIs for patients at risk.

METHODS

A prospective in vitro study compared the effectiveness of standard disinfection of needleless luer-activated valve connectors with 70% isopropyl alcohol and the effectiveness of an antiseptic barrier cap that, when threaded onto a luer-activated connector, rapidly sterilizes a heavily contaminated surface. Standard disinfection was done by 3- to 5-second swabbing using a sterile commercial pledget of 70% isopropyl alcohol. The antiseptic barrier cap comprises an outer cap with internal female threads and a spike inside the closed end, a capsule containing 0.25 mL of 2% chlorhexidine gluconate in 70% isopropyl alcohol, and a sponge between the septum and the capsule. When the cap is threaded onto a luer-adaptable needleless connector, the spike ruptures the capsule, saturating the sponge with the antiseptic.

RESULTS

All 15 (100%) of the precontaminated positive control connectors not disinfected before entry showed transmission of Enterococcus faecalis across the membranous septum (4500-28,000 colony-forming units), and 20 (67%) of 30 connectors disinfected with 70% alcohol showed transmission (442-25,000 colony-forming units). Of 60 needle-free connectors disinfected with the antiseptic barrier cap, 1 (1.6%) showed transmission (P < .001).

CONCLUSION

An antiseptic barrier cap was highly effective in sterilizing the septum of a needle-free valve connector and preventing entry of any microorganisms, even with heavy contamination of the septum. This new technology should now be evaluated in a clinical trial with CR-BSI as the primary outcome measure.

摘要

背景

与无针阀连接器使用相关的暴发报告提示了两个常见风险因素:(1)使用前对消毒操作依从性差;(2)一种在未使用时允许污染的设计。用70%异丙醇擦拭膜状隔膜可能无法消除隔膜表面污染。频繁通过和操作无针连接器也使患者发生中心静脉导管相关血流感染(CR-BSI)的风险增加。一种新型抗菌屏障帽已被设计出来,以维护医护人员安全,并消除现有系统对有风险患者的污染和CR-BSI易感性。

方法

一项前瞻性体外研究比较了用70%异丙醇对无针鲁尔激活阀连接器进行标准消毒的效果,以及一种抗菌屏障帽的效果,该屏障帽拧到鲁尔激活连接器上时能快速对严重污染的表面进行消毒。标准消毒通过使用无菌的70%异丙醇商业药签擦拭3至5秒来完成。抗菌屏障帽包括一个带有内螺纹的外帽和封闭端内的一个尖刺、一个装有0.25 mL 2%葡萄糖酸氯己定的70%异丙醇的胶囊,以及隔膜和胶囊之间的一块海绵。当该帽拧到适用于鲁尔的无针连接器上时,尖刺会刺破胶囊,使海绵被消毒剂浸透。

结果

所有15个(100%)进入前未消毒的预污染阳性对照连接器均显示粪肠球菌穿过膜状隔膜传播(4500 - 28000个菌落形成单位),30个用70%酒精消毒的连接器中有20个(67%)显示有传播(442 - 25000个菌落形成单位)。在用抗菌屏障帽消毒的60个无针连接器中,1个(1.6%)显示有传播(P < .001)。

结论

抗菌屏障帽在对无针阀连接器的隔膜进行消毒并防止任何微生物进入方面非常有效,即使隔膜受到严重污染。现在应以CR-BSI作为主要结局指标在一项临床试验中对这项新技术进行评估。

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