FDA医疗器械设备问题术语集的应用研究  

Application Research of FDA Event Problem Codes about Medical Devices

作　　者：钟玲 王刚[2] 文强 李穗 董放[2] 

机构地区：[1]重庆市药品不良反应监测中心,重庆400014 [2]国家食品药品监督管理局药品评价中心,北京100045 [3]江西省药品不良反应监测中心,江西南昌330046

出　　处：《中国药物警戒》2014年第1期31-34,共4页Chinese Journal of Pharmacovigilance

摘　　要：美国食品药品监督管理局(FDA)于2009年7月开始实施新的设备问题术语集。通过阐述FDA设备问题术语集的实施概况及其术语集结构,基于美国MAUDE数据库论证了该设备问题术语集对医疗器械风险评价的实际意义,分析了FDA设备问题术语集对于我国监测实情的应用难度,并结合监测现状提出了借鉴FDA设备问题术语集的实施建议,以期对我国设备故障术语集的建立提供有益思路。The U.S. Food and Drug Administration（FDA） implemented a new device problem codes in July 2009. In this paper, we presented an overview of the device problem codes and their structure, demonstrated device problem codes＂ practical significance to medical device risk assessment using the Manufacturer and User Facility Device Experience （MAUDE） database, discussed the difficulties in applying the device problem codes to China considering the current conditions of medical device adverse events monitoring, and made suggestions for implementation using the device problem codes for reference. The objective of this paper was to provide some helpful information for establishment of the medical device failure terminology in China.

关 键 词：FDA 设备问题术语集 医疗器械故障 术语集 风险评价 

分 类 号：R197.39[医药卫生—卫生事业管理]