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墨西哥合众国的一项疫苗冷链温度监测研究。

A vaccine cold chain temperature monitoring study in the United Mexican States.

作者信息

Falcón Verónica Carrión, Porras Yara Verónica Villalobos, Altamirano César Misael Gómez, Kartoglu Umit

机构信息

Francisco Zarco 2947, Colonia Melchor Ocampo, Ciudad Juarez, Chihuahua CP32380, Mexico.

Area of Personal Property and Specialized Equipment, OPD Jalisco Health Services, Amsterdam #1486 int 15, Arcos Vallarta, C.P 44130 Guadalajara, Jal, Mexico.

出版信息

Vaccine. 2020 Jul 14;38(33):5202-5211. doi: 10.1016/j.vaccine.2020.06.014. Epub 2020 Jun 22.

DOI:10.1016/j.vaccine.2020.06.014
PMID:32586762
Abstract

Vacine cold chain assessments conducted in various parts of the world indicate that maintaining equipment at the temperature range recommended by the World Health Organization (WHO) is not always observed. It has been also the case that staff rather prioritize protecting vaccine from heat damage, thus often exposing vaccines to freezing temperatures. As a result, inadvertent freezing of vaccines is a largely overlooked problem all over the world. In a recent systematic review, comparison of the occurrence of freezing temperatures during storage and transport were found to be a global problem occurring both in the resource-rich as well as the resource-limited settings. A vaccine cold chain temperature monitoring study was conducted using standard WHO study protocol with the objective to document potential problems and to identify appropriate control measures. Multiple temperature monitoring devices were used in the study to evaluate user friendliness of these devices and staff attitudes towards them. In general, majority of the time, temperatures were kept between recommended temperature range of 2-8 °C. Temperature variation got wider when products moved from 3PL Laboratory to service points. The wider variation is found at the service points. High temperature excursions were observed or short periods of time while exposures to freezing temperatures were more both higher in number and duration, however, shake test with these vaccines indicated no freeze damage. 91% of staff believed that they did not have the necessary tools to detect if a vaccine had been damaged by a temperature excursion outside the 2-8 °C range, and all staff believed that inclusion of such devices (e.g. vaccine vial monitor) in the system would improve cold chain operations as they have became aware of problematic areas through this study.

摘要

在世界不同地区进行的疫苗冷链评估表明,并非总能将设备维持在世界卫生组织(WHO)推荐的温度范围内。情况还往往是,工作人员更优先保护疫苗免受热损害,因此常常使疫苗暴露在冷冻温度下。结果,疫苗的意外冻结是一个在全世界很大程度上被忽视的问题。在最近的一项系统评价中,发现储存和运输期间冷冻温度的发生情况在资源丰富和资源有限的环境中都是全球性问题。使用WHO的标准研究方案进行了一项疫苗冷链温度监测研究,目的是记录潜在问题并确定适当的控制措施。该研究中使用了多个温度监测设备,以评估这些设备的用户友好性以及工作人员对它们的态度。总体而言,大多数时候,温度保持在2-8°C的推荐温度范围内。当产品从第三方物流实验室转移到服务点时,温度变化幅度变大。在服务点发现变化幅度更大。观察到有短时间的高温偏差,而暴露于冷冻温度下的情况在数量和持续时间上都更多,然而,对这些疫苗进行的摇瓶试验表明没有冻害。91%的工作人员认为他们没有必要的工具来检测疫苗是否因超出2-8°C范围的温度偏差而受损,并且所有工作人员都认为在系统中纳入此类设备(例如疫苗瓶监测器)将改善冷链运作,因为他们通过这项研究已经意识到了问题所在。

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