构建我国医疗器械安全警戒系统的探讨  

An Exploratory Discussion on Setting up a Medical Devices Vigilance System in China

作　　者：严樑 黄亦武[1] 杜文民[1] 朱晓文[1] 

机构地区：[1]上海市食品药品监督管理局医疗器械注册处,上海200021

出　　处：《中国医疗器械杂志》2003年第6期435-438,共4页Chinese Journal of Medical Instrumentation

摘　　要：引入医疗器械警戒系统的概念,建立我国医疗器械警戒制度是当前加强医疗器械监管的一项紧迫的工作。我国的制度建 设应定位于国际接轨高度,尽可能直接采用国际市场中成熟的经验。根据国内的具体情况,讨论了不良事件的报告范围 和各责任主体的关系,强调了这一制度的核心应围绕如何发现不良事件,将不良事件纳入属地化监管的体系并与现有其 他法规的挂钩,在建立医疗器械不良事件报告制度的同时,应充分重视不良事件的处理。对植入器械的追踪在我国应尽 快推广条形码技术。It is our urgent mission at present to introduce a concept of a vigilance system for medical devices and to establish the medical devices vigilance regulation in China in strengthening the supervision and administration. Our systems and regulations should be instituted at the international level while directly adopting the ripe experiences in world markets. In the light of domestic specific conditions, this paper discusses the reporting scope of adverse events of medical devices and the relations among the main responsible bodies, laying emphasis upon how to find adverse events and how to deal with them. Adverse events should be brought into a localized supervision system and should be also linked with other laws and regulations now available. While establishing a reporting system for medical devices' adverse events, great importance should be attached to the handling of these events. In regard to the tracing back of implantable medical devices, the bar code technology should be adopted as early as possible.

关 键 词：医疗器械 安全警戒系统 不良事件 责任主体 植入器械 

分 类 号：R197.39[医药卫生—卫生事业管理]