可疑医疗器械不良事件报告表质量分析方法研究

目的根据可疑医疗器械不良事件报告表的特点,结合药品不良反应报告表质量评估标准,探讨可疑医疗器械不良事件报告表质量评估方法。方法采用文献研究、调查问卷、小组讨论方法,根据报告表各项在分析评价中的权重,制定报告表质量评分表,对报告表进行质量分析,综合评价。在此基础上,从国家药品不良反应监测中心医疗器械不良事件数据库2010年1～4月份的报告表中随机抽取5%,对报告表进行质量评分,验证此方法的可行性及优点。结果建立了可疑医疗器械不良事件报告表质量评分法。结论通过验证,可疑医疗器械不良事件报告表质量分析方法科学、有效、易于操作,结果符合实际,有利于不断提高报告表质量,有利于为监管部门采取风险管理措施提供可靠的信息来源。

Study on Quality Analysis of Adverse Events of Medical Device Reports

Objective To explore quality analysis of adverse events of medical device（MDAEs） Reports with characteristic of MDAEs Reports and quality standard of adverse drug reactions Reports.Methods Quality scoring table is prepared with the Weighted Coefficient of each item in Reports by using literature research,questionnaire and small group discussion.MDAEs Reports of a random 5% of MDAEs Reports database from Jan.to Apr.2010 in center for drug deevaluation of SFDA were analysed with the scoring table,that is to validate feasibility and merit of Quality scoring table.Results Quality scoring method of MDAEs Reports is established.Conclusion The quality scoring method is scientific,effective and easy to be operated.The results are accurate.It is propitious to improve quality of MDAEs Reports and to furnish true information for risk management of supervisory board.