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美国急症医学研究所(Emergency Care Research Institute,ECRI)是独立于FDA的第三方非营利机构,拥有医疗器械不良事件网络报告系统,收集来自医生、患者以及生产商的可疑医疗器械不良事件报告。ECRI制定针对不良事件报告的指南;向报告单位和医生反馈信息;通知并鼓励生产企业对确定的危害和问题采取纠正措施。2009年11月,ECRI在“器械健康”杂志上发表了一篇《2010年前十位的医疗技术危害》(涉及到多种类型的医疗器械)的文章,并针对这些危害提出可能的预防措施,本文特全文翻译,以供参考。
The Emergency Care Research Institute (ECRI), a third-party non-profit organization independent of the FDA, owns the Medical Device Adverse Event Network Reporting System, which collects reports of suspicious medical device adverse events from doctors, patients, and manufacturers. ECRI develops guidelines for reporting adverse events; feeds back information to reporting units and physicians; and encourages manufacturers to take corrective action for identified hazards and problems. In November 2009, ECRI published an article entitled “Top Ten Medical Technology Hazards in 2010” (involving many types of medical devices) in the journal Device Health and proposed possible solutions to these hazards Preventive measures, this article full text translation, for reference.