Unfortunately, because your browser version is too low to get the best browsing experience, it is recommended to download and install Google Chrome!
Vaccine is a relatively special commodity. It has strict requirements on the ambient temperature for storage and transportation. Many vaccine failures are difficult to identify directly from the senses. This condemns the concealment of the problem and the difficulty of identification. At present, China still lacks effective cold chain logistics management methods. The original monitoring technology lags behind, manifesting itself in manual measurements and paper records; without a unified data system support; poor real-time performance, disconnected supervision; difficulty in obtaining evidence, inability to determine responsibility, and inability to provide early warning. At present, the laws and regulations related to the cold chain technical specifications and regulatory standards for pharmaceuticals in China are in the process of being formulated. It is already a general trend for vaccine cold chains to enter the regulatory field.
The content of cold chain data contains basic information of vaccines, basic information of cold chain equipment and their maintenance records, basic information and maintenance records of monitoring equipment, and basic information of cold chain managers. According to the running direction of the vaccine cold chain, starting from the manufacturer's production, it moves to the recipient population in a branched distribution and finally reaches the recipient. According to the current status and management characteristics of the vaccine cold chain, the entire cold chain can be divided into three sections, namely the first section, the middle section and the last section.
The first paragraph starts from the products produced by the manufacturer's production line and ends at the provincial and municipal medical and health institutions. This cold chain segment contains the inventory, wholesale, and transportation of units at all levels. Generally speaking, the cold chain data in the first section of the cold chain is complete, and the management quality can be guaranteed.
The starting point of the middle section is the outbound node when the provincial and municipal medical and health institutions distribute vaccines downwards, until the medical and health institutions in the districts, cities, and counties receive the storage. The data in the middle of the cold chain is also relatively complete, but it lacks efficiency. The quality guarantee of the cold chain of transportation vehicles is defective in some areas. Most of the cold chain monitoring tools are manually registered. The cold chain management in the vaccine transportation process depends on the cold chain transportation tools of medical and health institutions or the transportation services provided by third-party logistics providers. The integrity of the cold chain data obtained may be affected by complex factors, so This cold chain needs to improve monitoring methods.
The data of the last segment can also be subdivided into two segments before and after, first from the inventory of the medical and health institutions in the district, city and county to the inventory of the community health service center (vaccination point), and then to the recipient to complete the vaccination. The data integrity of the last paragraph is prone to blankness, which is characterized by large uncertainties in time and temperature and difficult data acquisition.
Continuous vaccine cold chain data is important. Continuous cold chain data is a source of information needed for vaccine cold chain management. The key to obtaining continuous data lies in two aspects: the data collection of each cold link and the transfer between the cold links.
The temperature information in the cold chain of the vaccine is the core data, and the other information is the subsidiary data. According to the core data, the quality change of the vaccine is judged, and the external environment status and the person responsible for the temperature change are judged according to the other data. If the cold chain data of the vaccine is found to be incomplete or out of the cold chain during immunization at the end of the cold chain, there is a basis for judging whether the vaccine is damaged. And the responsibility can be determined according to the data such as the time, place and responsible person, which provides basic guarantee for the entire cold chain management.
Therefore, the complete and continuous data supports the traceability of cold chain management and the occurrence of cold chain time, provides effective information for regulatory evidence collection and responsibility determination, and creates the conditions for systematic guarantee from the legal level.
August 9, 2017
Chengdu Xinxin Electronic Technology Co., Ltd. Editorial Department
Editor: Little Devil in Gourd