个例医疗器械不良事件报告评价工作中存在的问题与对策

Discussion on the Existing Problem s and Counterm easures in the Evaluation of Adverse Event Reports of M edical Devices

目的 探讨个例医疗器械不良事件报告评价对产品质量管理的作用和影响,提出改进建议,为提升医疗器械安全性监测与评价工作提供参考。方法 通过实践研究和基层调研归纳影响个例报告评价的原因,深入探讨改善对策。结果 个例医疗器械不良事件报告评价存在风险意识不到位、评价结果不准确等问题。结论 通过完善法规、加强审核、严格监管、优化系统、深化应用等措施,可以提升监测效能,确保主体责任落实到位。

Objective The role and impact of individual medical device adverse event report evaluation on product quality management were discussed, and improvement suggestions were put forward, which provided a reference for improving the safety monitoring and evaluation of medical devices. Methods The improvement measures are discussed in depth by summarizing the influencing reasons for the evaluation of individual case reports in the way of practical research and field investigation. Results Some problems, such as insufficient risk awareness and inaccurate evaluation results, exist in the evaluation of individual adverse event reports of medical devices. Conclusion By improving laws and regulations, strengthening audit, strict supervision, optimizing system and deepening application, the monitoring efficiency can be improved to ensure that the main responsibility is implemented.