超声多普勒胎儿监护仪、心率仪国家监督抽验质量分析

Analysis of Quality Status of Ultrasonic DoppIer Fetal Inonitor& Heartbeat Detector National Supervision and Inspection

通过整理统计2013年、2014年、2017年和2018年超声多普勒胎儿监护仪、心率仪国家医疗器械监督抽验情况,分析了该类产品的整体质量状况,对抽验结果进行了深入分析发掘,特别是产品不合格项目的原因,同时针对生产企业和监管部门存在的问题提出了相应的建议,为提升我国相关产品质量及监管效果提供参考。

In this paper, we analyze the status of the medical device testing and the situation of the unqualified varieties by sorting out the situation of the Ultrasonic Doppler fetal Inonitor& heartbeat detector supervision and inspection from 2013, 2014, 2017 and 2018. We analyze the results of the inspection deeply, and find that the safety risk points exist in the quality of the equipment, especially the reasons for nonconformity. At the same time, the corresponding suggestions are put forward to production companies and regulators respectively on the existing problems, to provide a reference for improving product quality and supervision effects.