省市医疗器械不良事件监测合作模式探讨

市级医疗器械不良事件监测技术机构是我国医疗器械不良事件监测工作中承上启下的重要组成部分,为医疗器械监管提供了有力的技术支撑。本文重点讨论淄博市药物警戒中心在山东省药品不良反应监测中心的指导下,利用省级平台开展医疗器械不良事件专项监测和风险信号挖掘,探讨省市医疗器械不良事件监测合作新模式,为市级监测技术机构高质量开展不良事件监测工作提供参考。

Discussion on Cooperation Model of Provincial and Municipal Medical Device Adverse Event Monitoring

Municipal technical agencies for medical device adverse event monitoring are an important part of the medical device adverse event monitoring network in China,providing strong technical support for medical device supervision.This paper focuses on the use of provincial platform to carry out targeted medical device monitoring and risk signal detection in Zibo City under the financial support of Shandong Provincial Center for ADR Monitoring.The authors aim to explore a new model of cooperation in provincial and municipal adverse event monitoring,and to provide experience for municipal technical agencies to carry out effective adverse event monitoring.