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Biovigilance for the Quality and Safety of Medical Products of Human Origin

机译：生物警惕人类来源医疗产品的质量和安全

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Progress in science and technology in the health services has led to the development of methods of regenerating and replacing solid organs, tissues and cells, using human body components to create medical products of human origin intended for clinical use. In the activities in which products of human origin are used, however, from the point of donation and harvesting to the subsequent care of the recipient, medical products of human origin are exposed to the risk of specific complications related to the transmission of infectious diseases, and further side-effects. Biovigilance system application is a basic requirement for ensuring the quality and safety of tissues and cells intended for human use. The quality system focuses on error prevention, maintaining a consistent pattern of agreed assays for tissues and cells intended for clinical use. The implementation of quality and safety standards, the development of medical protocols and cooperation protocols between member states, the implementation of Single European Code (SEC), and the development of electronic traceability systems, all aim at vigilance and the surveillance of medical products of human origin from donation to transplantation.
机译：卫生服务领域科学技术的进步导致了利用人体成分制造用于临床用途的人类起源的医疗产品来再生和替代实体器官，组织和细胞的方法的发展。但是，在使用人类起源产品的活动中，从捐赠和收获到接受者的后续护理，人类起源的医疗产品都面临与传染病传播相关的特定并发症的风险，以及其他副作用。生物警戒系统的应用是确保供人类使用的组织和细胞的质量和安全的基本要求。质量体系专注于错误预防，维持用于临床用途的组织和细胞的一致检测方法的一致模式。实施质量和安全标准，制定成员国之间的医疗协议和合作协议，实施单一欧洲法规（SEC）以及开发电子可追溯性系统，所有这些都旨在提高对人类医疗产品的警惕和监视从捐赠到移植

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