医疗器械的软件相关召回分析  

Analysis of software-related recalls of medical devices

作　　者：彭亮[1] 于一[2] 

机构地区：[1]国家食品药品监督管理总局医疗器械技术审评中心,北京100044 [2]国家食品药品监督管理总局药品评价中心(国家药品不良反应监测中心),北京100045

出　　处：《中国医学装备》2016年第7期97-100,共4页China Medical Equipment

摘　　要：目的:基于软件相关召回分析,探讨医疗器械的软件监管要求。方法:收集整理美国软件相关召回数据,分析软件相关召回的类型、情形、原因和发展趋势,提供医疗器械的软件监管对策。结果:自1983-2011年的4个时期内,美国软件相关召回在医疗器械召回所占比重由6%增至19%,同比增长由47%增至164%,明显高于同期医疗器械的整体水平(由13%增至54%),尤其是放射类医疗器械的软件相关召回,其问题最为严重。结论:软件监管形势较为复杂和严峻,需要针对软件特殊性进一步加强医疗器械的软件监管工作,包括软件确认、不良事件监测和可用性设计。Objective：To discuss the regulation requirements of software based on the analysis of software-related recalls of medical devices. Methods：The data of software-related recalls of medical devices in America were collected and processed, and the type, situation, cause and trend of software-related recalls were analyzed, then the suggestions on the regulation requirements of software were proposed. Results：During the four periods from 1983 to 2011, the percentage of software-related recalls vs medical device recalls in America increased from 6%to 19%, and the year-on-year growth rate of software-related recalls rose by 47%to 164%, significantly higher than medical device recalls in the same period （from 13%to 54%）. Especially, the problem of software-related recalls in radiology medical devices was the most serious. Conclusion： The regulatory situation of software is more complicated and severe, so the regulation requirements of software, including software validation, adverse event monitoring and usability design, need to be further strengthened according to the particularity of software.

关 键 词：医疗器械召回 软件相关召回 软件确认 不良事件 可用性 

分 类 号：R194[医药卫生—卫生事业管理]