单一欧洲法规在多组织库中的实施。
Implementation of the Single European Code in a Multi-Tissue Bank.
作者信息
Schroeter Jan, Schulz Tino, Schroeter Bernard, Fleischhauer Katrin, Pruß Axel
机构信息
University Tissue Bank, Institute of Transfusion Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.
出版信息
Transfus Med Hemother. 2017 Nov;44(6):396-400. doi: 10.1159/000481145. Epub 2017 Nov 22.
INTRODUCTION
The traceability of tissue and cells transplants is important to ensure a high level of safety for the recipients. With the final introduction of the Single European Code (SEC) in April 2017 in the EU a consistent system among all member states became mandatory.
METHODS
The regulations for the SEC on EU and national level were evaluated. An overview on the different parts of the SEC with detailed explanations is given. Our own experiences with the implementation of the SEC in our multi-tissue bank are reported in addition.
RESULTS
The implementation of the SEC in our multi-tissue bank could be successfully realized. However, it revealed a number of difficulties, especially the sterile labeling of certain tissue transplants and the complex update of the existing database.
CONCLUSION
The introduction of the SEC has made a contribution to the safety of recipients of tissue and cells transplants through a system of comprehensive and transparent traceability.
引言
组织和细胞移植的可追溯性对于确保接受者的高度安全性至关重要。随着2017年4月单一欧洲编码（SEC）在欧盟的最终引入，所有成员国之间的统一系统成为强制性要求。
方法
评估了欧盟和国家层面关于SEC的法规。对SEC的不同部分进行了概述并给出详细解释。此外还报告了我们在多组织库中实施SEC的自身经验。
结果
我们的多组织库成功实现了SEC的实施。然而，它揭示了一些困难，特别是某些组织移植的无菌标记以及现有数据库的复杂更新。
结论
SEC的引入通过全面且透明的可追溯性系统，为组织和细胞移植接受者的安全做出了贡献。
Zotero 插件