【摘要】 目的对239例医疗器械不良事件报告进行分析,为加强医疗器械不良事件监测工作提供建议。方法采用回顾性研究方法,对山东省2006年收集的医疗器械不良事件报告及其质量进行综合分析。结果骨科植入物和宫内节育器引起的不良事件所占比例最高,且程度严重。医疗器械不良事件报告覆盖范围窄,质量有待提高。结论应进一步加强骨科植入物和宫内节育器的监测。建议通过完善法律法规,健全监测网络,开展宣传培训,加强日常监管,推动医疗器械不良事件监测工作,维护公众用械安全。更多还原

【Abstract】 Objective Analyzed 239 cases of medical device adverse events (MDAE) and provide sugg-estion to MDAE monitoring. Methods With retrospective case study,analyze 239 MDAE reports in Shandong province in 2006. Results Orthopedic implants and intrauterine device(IUD) caused the higher proportion of adverse events with serious degree. The scope that the reports covered is narrow and the quality needs to be raised. Conclusion Further focus monitoring on orthopedic implants and IUD should be strengthen. The MDAE monitoring should be promoted by improving laws and reg-ulations,establishing monitoring network,training and publicity,strengthening supervision.更多还原