医疗器械生产企业智慧监管赋能路径研究  

Research on empowerment path of intelligent regulation of medical device manufacturers

作　　者：徐勤 孙文明 司圣源 王敏慧 谢世朋[2] XU Qin;SUN Wen-ming;SI Sheng-yuan(Division of Supervision of Medical Device Production,Jiangsu Medical Products Administration,Nanjing 210001,China;不详)

机构地区：[1]江苏省药品监督管理局医疗器械生产监管处,江苏南京210001 [2]南京邮电大学通信与信息工程学院,江苏南京210000 [3]中国药科大学国际医药商学院,江苏南京210000

出　　处：《中国医学装备》2023年第3期136-140,共5页China Medical Equipment

基　　金：江苏省药品监督管理局药品监管科学科研计划课题(001)“医疗器械生产企业智慧监管赋能路径研究”。

摘　　要：目的:研究医疗器械生产企业智慧监管赋能路径,助推医疗器械生产监管智慧化。方法:分析传统医疗器械生产企业监管方式存在问题及企业数字监管的必要性,采用静态、实时、过程、导入和学习5种路径进行智慧监管赋能,建设包含企业基础数据库、监督检查模块、政企通及数据对接4大基础功能的江苏省医疗器械生产监管平台,规范医疗器械市场秩序。结果:医疗器械生产监管平台能够监管人(人员)、机(设备)、料(材料)、法(规范)、环(环境)、测(检测)、安(安全)和流(流程)8类要素,实现生产管理规范化、生产流程立体化、生产状态可视化、监管上报自动化、监管模型数字化智慧化和运行机制合理化功能。分析平台已收录处置的10979条不良事件数据,有助于提高医疗器械性能;已有介入人工生物心脏瓣膜等17项创新产品被国家药监局认定为创新医疗器械。结论:医疗器械生产监管平台能够实时动态地进行医疗器械企业生产相关质量控制,降低虚假记录产生的可能性,使医疗器械质量管理体系真正发挥控制产品质量的作用。Objective:To study the empowerment path of intelligent regulation of medical device manufacturers,and to promote the intelligentization of medical device production regulation.Methods:The problems existing in the regulation mode of traditional medical device manufacturers and the necessity of digital supervision and administration of enterprises were analyzed.5 paths of static,real-time,process,import and learning were adopted to carry out intelligent supervision and empowerment.A medical device production regulation platform of Jiangsu Province was established,which included four basic functions of enterprises'basic database,supervision and inspection module,government-enterprise connection and data connection,to regulate the order of the medical device market.Results:The medical device production regulation platform could supervise 8 elements of people(personnel),machine(equipment),material(material),law(standard),environment(environment),test(inspection),safety(safety)and flow(procedure)for realization of standardized production management,three-dimensional production process,visualization of production status,automatic supervision reporting,digitalization and intelligence of regulation model and rationalization of operating mechanism.The analysis platform had included 10,979 adverse event data of disposal,which contributed to the improvement of medical device performance;17 innovative products,including interventional bioprosthetic heart valves,had been recognized as innovative medical devices by the State FDA.Conclusion:The medical device production regulation platform can conduct real-time and dynamic quality control related to the production of medical device enterprises,reduce the possibility of false records,and enable the medical device quality management system to truly play a role in controlling product quality.

关 键 词：医疗器械 智慧监管 医疗监管 数字医疗 

分 类 号：R197.39[医药卫生—卫生事业管理]