中美对医院医疗器械不良事件监测制度比较及启示.docVIP

  中美对医院医疗器械不良事件监测制度比 较及启示 刘清峰* 5 （上海医疗器械高等专科学校管理系，上海市 200093） 摘要：比较了中美两国对医院医疗器械不良事件报告制度的差异，结果表明中美都要求医院 上报医疗器械不良事件,建立不良事件报告程序和保存文档记录，都对上报信息的格式做出 了明确的要求；但在监管手段、组织结构设计以及涉及术语解释方面美国都优于中国，而中 10 15 20 国在政府监测部门内部具有更多的环节，导致效率下降。提出中国应对医疗器械监督管理进 行立法，医疗器械管理体制实行垂直管理，对现行不良事件管理制度进行完善。 关键词：卫生事业管理；医疗器械不良事件监测；医院；比较 中图分类号：R19 Comparison and Inspiration on Medical Device Adverse Event System for Hospital between China and America Liu Qingfeng (Shanghai Medical Instrumentation College Management Department,200093,China) Abstract: In this paper，similarities and differences were compared on hospital between China and America on medical device adverse event monitoring system so as to be given enlighten in designing system of medical device adverse event monitoring system in China. The results showed that both of China and America explicitly required hospital to report adverse medical 25 30 35 40 events and require hospital to establish and preserve adverse Event Reporting program documentation and the reporting format of information was to be required clearly. But America were superior to China in the regulatory tools, organizational structure designing, and related terminology, and more internal links in Chinese government monitoring system resulted in reduced performance. The conclusion was that Chinas response to legislative supervision and management to medical device, medical device management system should be implemented the vertical management and it was imperative to improve the existing adverse event monitoring system. Key words: Health Management; medical device adverse event monitoring；system; comparison 为保证医疗器械产品的安全，各国政府都对上市后的医疗器械进行着严格的监督，以保 证和促进公众健康。本文拟通过对比中美两国对医院不良事件监测制度，给我国对医疗器械 不良事件监测制度以借鉴和启示。本文中，我们用美国 FDA（或 FDA）表示美国食品药品 监督管理局，用中国 CFDA（或 CFDA）表示中国食品药品监督管理局；同时，中国的“医 疗器械使用单位”和美国的“医疗器械用户”两词的含义基本相同，都是以医院为主体的组 织，因此，本文统一用“医院”表示。  作者简介：刘清峰，（1968 年-  ），男，籍贯：河南开封，博士（后），教授，硕士研究生导师，医疗器 械监督管理专业主任，美国明尼苏达大学高级研究学者，研究方向为医疗器械监督管理. liuqf@ -1-   1.医疗器械不良事件及不良事件监测的意义 医疗器械不