浅谈医疗器械检测数据的整理与利用——基于口腔铸造合金数据应用实践  

Preliminary Discussion on the Collation and Utilization of Medical Device Testing Data——Application Practice Based on Dental Casting Alloy Data

作　　者：韩建民[1,2] 潘硕 刘斌 徐永祥[1,2] 郭媛媛 马靖 HAN Jianmin;PAN Shuo;LIU Bin;XU Yongxiang;GUO Yuanyuan;MA Jing(Department of Dental Materials, Peking University School/Hospital of Stomatology, Beijing 100081, China;Peking University School of Stomatology, Dental Medical Device Inspection Center, Key Laboratory ofDental Materials of NMPA, Beijing 100081, China;Center for Medical Device Evaluation of NMPA, Beijing 100081, China;Center for Information of NMPA, Beijing 100044, China)

机构地区：[1]北京大学口腔医学院/医院口腔材料研究室,北京100081 [2]北京大学口腔医学院口腔医疗器械检验中心,国家药品监督管理局口腔材料重点实验室,北京100081 [3]国家药品监督管理局医疗器械技术审评中心,北京100081 [4]国家药品监督管理局信息中心,北京100044

出　　处：《中国医药导刊》2020年第6期411-415,共5页Chinese Journal of Medicinal Guide

基　　金：中国食品药品监管数据中心课题研究(项目编号:2017-1038,项目名称:口腔铸造合金性能及安全性现状分析)。

摘　　要：医疗器械科学监管是保障医疗器械产品安全的重要课题,智慧审评和智慧监管是各国监管机构的努力方向,海量数据的有效支撑对于科学监管至为关键。目前,我国虽然已建立了医疗器械审评审批、上市后不良反应、标准等系列相关数据库,并为上市前审评和上市后监管提供有效支撑,但医疗器械产品全生命周期中不同环节的数据尚亟待采集、挖掘和分析。本研究梳理了北京大学口腔医学院口腔医疗器械检验中心的口腔铸造合金数据,关联了中国食品药品监管数据中心医疗器械产品信息,尝试建立医疗器械检测性能数据库,探索医疗器械检测数据的采集、整理、分析和再利用的可行性,以期为我国医疗器械口腔合金的科学监管提供数据支撑,也为探索各类医疗器械检测中心建立相应的数据库提供参考。Scientific supervision of medical devices is an important topic to ensure the safety of medical devices.Many countries make endeavor to intelligent evaluation and intelligent supervision of medical devices.However,intelligent evaluation and intelligent supervision are based on the big data of medical devices.Although China has established a series of databases related to medical devices,such as review and approval database,post-marketing adverse reactions database and standards database,which has provided effective support for pre-market review and post-market supervision,those data from the whole life cycle of medical devices still need to be collected and analysed.This study rearranged the data of dental casting alloy from the Dental Medical Device Inspection Center of Peking University School of Stomatology,combined the medical device product information of China Data Center For Food and Drug Administration,try to establish the medical device test performance database,and explore the feasibility of the medical device test data collecting,sorting,analyzing and reusing,so as to provide data support for the scientific supervision of dental casting alloy,and provide reference for the establishment of corresponding database in medical device inspection centers.

关 键 词：医疗器械 科学监管 口腔铸造合金 检测数据 智慧审评 智慧监管 

分 类 号：R197.39[医药卫生—卫生事业管理] R194.5[医药卫生—公共卫生与预防医学]