医疗器械不良事件报告质量分析及改善对策

中国药物警戒 ›› 2015, Vol. 12 ›› Issue (8): 479-482.

医疗器械不良事件报告质量分析及改善对策

张学宁¹, 王玲², 王刚², 蔺旭东³, 杜红阳⁴

1. 江苏省计划生育科学技术研究所,国家人口计生委计划生育药具不良反应监测中心,江苏南京 210036;
2. 国家食品药品监督管理总局药品评价中心,北京 100045;
3. 河北省药品不良反应监测中心,河北石家庄 050091;
4. 菏泽市药品不良反应监测中心,山东菏泽 274000

收稿日期:2015-09-02 修回日期:2015-09-02 出版日期:2015-08-08 发布日期:2015-09-02
通讯作者: 王玲,女,硕士,主任技师。E-mail：wangling@cdr-adr.org.cn
作者简介:张学宁,男,硕士,流行病与卫生统计学。

Discussion on Quality and Improvement of Medical Device Adverse Event Monitoring Reports

ZHANG Xue-ning¹, WANG Ling², WANG Gang², LIN Xu-dong³, DU Hong-yang⁴

1. Jiangsu Institute of Planned Parenthood Research, Nanjing, NPFPC. Center for Contraceptives Adverse Reaction Surveillance, Jiangsu Nanjing 210036, China;
2. Center for Drug Reevaluation, CFDA, Beijing 100045, China;
3. Hebei Center for ADR Monitoring, Hebei Shijiazhuang 050091, China;
4. Heze Center for ADR Monitoring, Shandong Heze 274000, China

Received:2015-09-02 Revised:2015-09-02 Online:2015-08-08 Published:2015-09-02

摘要/Abstract

摘要： 目的探讨医疗器械不良事件监测与评价工作各个环节对报告质量的作用和影响,提出改进报告质量的有关建议,为进一步提高我国医疗器械安全性监测与评价工作提供参考。方法立足国家中心层面,在对全国医疗器械不良事件报告数据库开展数据规整工作的基础上,对报告系统内的数据进行研究,针对报告质量问题进行总结、梳理;对国内、外文献进行研究分析,归纳并提出报告质量影响因素。结果与结论报告质量是开展医疗器械安全性监测与评价工作的基础,创新报告和监测模式可以从源头提高报告质量,法规和技术标准的建设与完善、监测技术机构审核评价职能的有效落实、相关机构建立数据共享与风险沟通机制可促进提升报告质量。

关键词: 医疗器械, 不良事件, 报告质量

Abstract: Objective To explore the impact of all aspects of medical device adverse event(MDAE) monitoring and evaluation on the quality of MDAE reports, so as to provide references for upgrading the reporting quality and further improving the MDAE monitoring and evaluation. Methods Based on real working practices in MDAE data normalization, the quality of MDAE reports was analyzed by studying the data from national MDAE monitoring information system. Compared with related researches home and abroad, the factors influencing the reporting quality were summarized. Results and Conclusion The reporting quality is the foundation of the MDAE monitoring and evaluation, It can be improved at source by innovating reporting method and monitoring mode. Meanwhile, strengthening the construction and improvement of related regulations and technical standards, implementing the review and evaluation effectively by monitoring technology institutions, establishing data sharing and risk communication mechanism within relevant institutions might be powerful approaches to upgrade the reporting quality.

Key words: medical device, adverse event, reporting quality

中图分类号:

张学宁, 王玲, 王刚, 蔺旭东, 杜红阳. 医疗器械不良事件报告质量分析及改善对策[J]. 中国药物警戒, 2015, 12(8): 479-482.

ZHANG Xue-ning, WANG Ling, WANG Gang, LIN Xu-dong, DU Hong-yang. Discussion on Quality and Improvement of Medical Device Adverse Event Monitoring Reports[J]. Chinese Journal of Pharmacovigilance, 2015, 12(8): 479-482.

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