摘要
对医疗器械严重不良事件的调查是评价医疗器械与不良事件关联性的重要过程,是向监管部门提供医疗器械严重不良事件评价报告的关键环节。通过对医疗器械不良事件监测和评价现状的回顾,建议在完善立法基础上,明确技术监测机构、生产经营企业和使用单位在医疗器械严重不良事件中的调查责任,并探讨医疗器械严重不良事件调查机制。
Investigating serious adverse events of medical devices is the important process of evaluating the relevance between medical devices and adverse events, and is the key to provid the evaluation report about serious adverse events of medical devices for the supervision and management department. By reviewing the current situation of medical devices adverse events monitoring and reevaluating, improving the legislation has been proposed to identify the investigation duty of serious adverse events of medical devices, and the investigation mechanism of serious adverse events of medical devices has been discussed .
出处
《中国药物警戒》
2010年第3期178-180,共3页
Chinese Journal of Pharmacovigilance
关键词
医疗器械严重不良事件
调查机制
探讨
serious adverse events of medical devices
investigation mechanism
discussion
