对构建省级药械安全性监测网络的思考

Thinking on the Establishment of Provincial Medical-device Security Monitoring Network

目的:为提高省级药械安全性监测网络(MSMN)监测效能,促进药械安全性监测工作健康、持续、快速发展提供理论参考。方法:结合山东省构建与优化MSMN的实践,对省级MSMN的构成要素、特点和优化措施进行了探讨。结果与结论:省级MSMN的构成要素包括机构与人员、法律法规、技术指南与各项管理制度等,具有立体性、广泛性、合理性等特点。优化省级MS-MN措施包括加快机构建设步伐、壮大监测人员队伍等。

OBJECTIVE： To provide theoretical reference for the improvement of monitoring efficiency of provincial medical- device monitoring network （MSMN） and the promotion of medical-device security monitoring to develop healthily and rapidly. METHODS： Based on the construction and optimization of MSMN in Shandong province, the elements, characteristics and optimi- zation measures of provincial MSMN were analyzed. RESULTS ＆ CONCLUSIONS： The elements of provincial MSMN include in- stitution and personnel, legal regulations, technical guidelines and management system with completeness, comprehensiveness, ra- tionality. The optimization measures include speeding up the pace of institution-building and enlarging the team of monitoring per- sonnel.