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评估酒精擦拭在预防一次性药瓶细菌定植中的效果:一项初步研究。

Assessing the Efficacy of Alcohol Swabbing in Preventing Bacterial Colonization of Single-Use Vials: A Pilot Study.

作者信息

Christolias George, Luo Henry, Schneider Byron, Thomas Jerry, Whittier Susan, Singh Jaspal, Chen Allen, Solberg Joseph, Ehsanian Reza

机构信息

Department of Physical Medicine and Rehabilitation, Columbia University Vagelos College of Physicians and Surgeons, New York, USA.

School of Medicine, University of New Mexico School of Medicine, Albuquerque, USA.

出版信息

Cureus. 2025 Aug 19;17(8):e90512. doi: 10.7759/cureus.90512. eCollection 2025 Aug.

DOI:10.7759/cureus.90512
PMID:40978985
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12446881/
Abstract

Introduction Proceduralists who use single-use vials have adopted many of the same techniques for sterilizing multi-use vials, including swabbing the rubber tops with 70% isopropyl alcohol before drawing injectate. However, the lack of literature specific to this sterilization technique for single-use vials brings into question the necessity of this practice. This pilot study aims to establish protocols and determine the feasibility of methods to assess the hypothesis that routine use of disposable alcohol swabs does not affect the risk of bacterial colonization of injectate vials. Methods Forty new injectate vials (n=20, vials with an aluminum cap; n=20, vials with a plastic cap) were randomly assigned to a "swab"/"no-swab" group. Vials assigned to the "swab" group were firmly swabbed once with 70% isopropyl alcohol after cap removal and allowed to air-dry. A blinded researcher sampled the exposed rubber stopper of the injectate vials by firmly swabbing the rubber with a sterile cotton culture swab dipped in sterile 0.9% normal saline. A microbiologist blinded to group assignment assessed the degree of bacterial growth from swabs of the injectate vials' rubber stoppers after incubation on blood agar plates. Results There was no growth in any of the 40 samples in either the "swab" or "no-swab" group on day 5 of plate incubation at 35°C in a CO2 environment. Subgroup analysis by vial cap material (plastic vs. aluminum) also revealed no detectable microbial growth in either group. Statistical testing confirmed no significant differences between groups (two-sided Fisher's exact test; P=1.00), and confidence intervals indicated a wide range of possible undetected effects due to limited power. These findings indicate that the swabbing of single-use vials prior to usage had no measurable impact on sterility under clean clinical conditions. Conclusion The findings of this pilot study provide valuable insights into the efficacy of routine alcohol swabbing in preventing bacterial colonization of single-use injectate vials. Despite the widespread practice of swabbing vial tops with 70% isopropyl alcohol before drawing injectate, the necessity of this protocol has been called into question due to the lack of specific literature supporting its effectiveness for single-use vials. However, our results demonstrate that neither swabbing nor the absence of swabbing resulted in bacterial growth on the rubber stoppers of injectate vials after two and five days of plate incubation. These findings suggest that for the types of vials assessed in this study, routine alcohol swabbing may not be essential for preventing bacterial contamination. Further research involving larger sample sizes and diverse types of injectate vials is warranted to confirm these findings and establish evidence-based guidelines for vial preparation protocols in clinical settings.

摘要

引言

使用一次性小瓶的操作人员采用了许多与对多用途小瓶进行消毒相同的技术,包括在抽取注射液前用70%异丙醇擦拭橡胶瓶塞。然而,缺乏针对一次性小瓶这种消毒技术的文献引发了对这种做法必要性的质疑。这项初步研究旨在制定方案并确定评估以下假设的方法的可行性:常规使用一次性酒精棉签不会影响注射液小瓶细菌定植的风险。

方法

40个新的注射液小瓶(n = 20,铝盖小瓶;n = 20,塑料盖小瓶)被随机分配到“擦拭”/“不擦拭”组。分配到“擦拭”组的小瓶在取下瓶盖后用70%异丙醇牢固擦拭一次,然后晾干。一名不知情的研究人员通过用蘸有无菌0.9%生理盐水的无菌棉培养拭子牢固擦拭注射液小瓶暴露的橡胶塞来取样。一名对分组不知情的微生物学家在血琼脂平板上孵育后评估来自注射液小瓶橡胶塞拭子的细菌生长程度。

结果

在35°C、二氧化碳环境下平板孵育第5天时,“擦拭”组或“不擦拭”组的40个样本中均未生长。按瓶塞材料(塑料与铝)进行的亚组分析也显示两组均未检测到微生物生长。统计检验证实两组之间无显著差异(双侧Fisher精确检验;P = 1.00),置信区间表明由于检验效能有限,可能存在广泛的未检测到的效应。这些发现表明,在清洁临床条件下,使用前对一次性小瓶进行擦拭对无菌性没有可测量的影响。

结论

这项初步研究的结果为常规酒精擦拭预防一次性注射液小瓶细菌定植的效果提供了有价值的见解。尽管在抽取注射液前用70%异丙醇擦拭瓶塞的做法很普遍,但由于缺乏支持其对一次性小瓶有效性的具体文献,该方案的必要性受到质疑。然而,我们的结果表明,在平板孵育两天和五天后,擦拭与否均未导致注射液小瓶橡胶塞上出现细菌生长。这些发现表明,对于本研究中评估的小瓶类型,常规酒精擦拭可能对于预防细菌污染并非必不可少。有必要进行涉及更大样本量和多种类型注射液小瓶的进一步研究,以证实这些发现并为临床环境中的小瓶准备方案建立循证指南。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19d9/12446881/7f381f221271/cureus-0017-00000090512-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19d9/12446881/3e139452ed92/cureus-0017-00000090512-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19d9/12446881/7f381f221271/cureus-0017-00000090512-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19d9/12446881/3e139452ed92/cureus-0017-00000090512-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19d9/12446881/7f381f221271/cureus-0017-00000090512-i02.jpg

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