中国医疗设备2011,Vol.26Issue(3):45-48,4.DOI:10.3969/j.issn.1674-1633.2011.03.016
对比ADR监测分析《医疗器械不良事件监测和再评价管理办法(试行)》的实施障碍
Analysis on the Implementation Obstruction of Medical Device Adverse Event Monitoring and Re-evaluation Management Regulations(on Trial)Contrasting with ADR Monitoring
郑小溪 1李怡勇 1陆庆生1
作者信息
- 1. 广州军区武汉总医院,医学工程科,湖北,武汉,430070
- 折叠
摘要
Abstract
This paper clarifies the similarity of drugs and medical devices, specifies the development and successful practices of ADR monitoring, emphatically analyzes the macroscopic implementation obstruction and detailed influence factors of Medical Device Adverse Event Monitoring and Re-evaluation Management Regulations (on Trial), and then proposes improvement suggestions, so as to consummates the implementation tache of Medical Device Adverse Event Monitoring and Re-evaluation Management Regulations (on Trial), and ensure its implementation effect.关键词
药品不良反应监测/医疗器械不良事件监测/数据信息分类
医药卫生引用本文复制引用
郑小溪,李怡勇,陆庆生..对比ADR监测分析《医疗器械不良事件监测和再评价管理办法(试行)》的实施障碍[J].中国医疗设备,2011,26(3):45-48,4.