医疗器械不良事件报告质量分析及改善对策

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

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。

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 normal-ization, 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 sum-marized. 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.