2006年可疑医疗器械不良事件报告质量分析  

Analysis on the qualitys of the Medical Device Adverse Events Reports in 2006

作　　者：杨兆慧[1] 孟永成[1] 

机构地区：[1]北京市药品不良反应监测中心,北京100024

出　　处：《中国药物警戒》2007年第4期222-225,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的分析北京市2006年131例医疗器械不良事件主动报告质量,评价报告的可利用性并探索提高报告质量的有效方法。方法采用定性定量相结合的方法对2006年北京市131例医疗器械不良事件主动报告填写质量进行分析总结。结果北京市2006年医疗器械不良事件报告表依然存在填写不全,事件描述不完整等质量缺陷,不良事件涉及产品可跟踪性有待提高。结论在医疗器械不良事件监测技术工作中,需要进一步加强医疗器械不良事件监测的宣传和培训,提高各报告单位相关人员的有效报告的能力,切实提高可疑医疗器械不良事件报告质量。Objective To evaluate the usability of the reports on suspected Medical Device Adverse Events （MDAE） to explore an effective way to improve the report＇s quality. Methods We analyzed 131 suspected ADE questionnaires, which had been initiatively reported by hospitals to Beijing ADR Monitoring Center in 2006, by using both qualitative and quantitative study methods. Results Incomplete questionnaires and the lack of the detailed description of MDAEs found in the Beijing 2006 MDAE reports. In addition, the traceability of the medical devices involved to MDAEs need to be improved, Conclusion Based on the results of this study, we suggest that further steps should be taken to strengthen the training for medical monitoring professionals to improve the quality of our ADEs＇reports.

关 键 词：医疗器械 不良事件监测 报告质量 再评价 

分 类 号：R197.39[医药卫生—卫生事业管理] R95[医药卫生—公共卫生与预防医学]