Sterility and use patterns of multiple-dose vials.
Sterility and use patterns of multiple-dose vials.
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多剂量小瓶的无菌和使用模式。
DOI：
10.1093/ajhp/39.2.294
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发表时间：
1982
期刊：
影响因子：
--
通讯作者：
J. Burke
中科院分区：
文献类型：
--
作者：
J. C. Bawden;J. Jacobson;J. C. Jackson;R. K. Anderson;J. Burke
研究了多剂量瓶 (MDV) 中微生物的活力以及 MDV 的使用和使用中污染率。将大肠杆菌和铜绿假单胞菌固定培养物的连续十倍稀释液注射到含有抑菌剂的 30 ml MDV 中，并在 1、16、24 和 48 小时以及 7 天时取出样品以测试活生物体。所有打开的 MDV 均从医院的每个患者护理区和药房取出，并使用等分取样方法进行微生物污染测试。每天以随机顺序走访一个护理单位，直到所有单位和药房的所有打开的 MDV 都收集完毕。收集后的第二天，每个单元所有新开的 MDV 都被做了不显眼的标记和统计。在标记后的第一天、第六天和第十三天，对装置上剩余的所有标记的 MDV 进行统计。当以 1-100 菌落形成单位/ml 或更高浓度（在污染后一小时内对样品进行测试）接种时，从故意污染的 MDV 中分离出细菌。 16 小时内只有一种产品呈阳性，超过该时间就没有呈阳性。从31个护理单位和药房共收集928张已打开的MDV；没有一个微生物污染呈阳性，表明污染率可能低于每 1000 个中 4 个。利多卡因、胰岛素、稀释剂和肝素占收集的小瓶的 57%。打开的小瓶在一个单元上保留的时间长度以及每个单元打开的小瓶的数量在单元之间存在很大差异。应客观权衡有关 MDV 使用的控制政策的成本、可行性和有效性与潜在收益。
The viability of microorganisms in multiple-dose vials (MDVs) and the use and in-use contamination rate of MDVs were investigated. Serial tenfold dilutions of stationary cultures of Escherichia coli and Pseudomonas aeruginosa were injected into 30-ml MDVs containing bacteriostatic agents, and samples were removed at 1, 16, 24, and 48 hours, and at seven days to test for viable organisms. All opened MDVs were removed from each patient-care area and the pharmacy in a hospital and tested for microbial contamination using an aliquot-sampling method. One nursing unit was visited each day, in random order, until all opened MDVs from all units and the pharmacy were collected. The day following collection, all newly opened MDVs at each unit were marked inconspicuously and tallied. On the first, sixth, and thirteenth day after marking, all marked MDVs remaining on the unit were tallied. Bacteria were isolated from deliberately contaminated MDVs when inoculated with 1-100 colony-forming units/ml or greater when the sample was tested within one hour after contamination. Only one product was positive in 16 hours, and none was positive beyond that time. A total of 928 opened MDVs was collected from 31 nursing units and the pharmacy; none was positive for microbial contamination, indicating that the contamination rate was probably less than 4 per 1000. Lidocaine, insulin, diluents, and heparin constituted 57% of collected vials. The length of time that opened vials remained on a unit and the number of opened vials per unit varied considerably between units. The cost, feasibility, and effectiveness of control policies regarding use of MDVs should be weighed objectively against potential benefits.