基于自发呈报系统177例脑脊液分流管不良事件预警分析

Analy sis of 177 Cases of Adverse Events of CSF Flow Control Shunts Based on Spontaneous Response System

目的通过自发呈报系统(SRS)进行脑脊液分流管不良事件监测并分析,为安全用械、合理用械提供参考依据。方法回顾分析177份脑脊液分流器不良事件报告,进行数据挖掘分析和预警。结果 177例中170例不良事件明确或可能与脑脊液分流管的使用有关;脑室扩大和感染是最为常见的不良事件表现,分别占21.2%和19.4%;不良事件的发生与产品质量、手术操作、患者病理状态和使用情况等风险因素有关。结论应进一步加强脑脊液分流管不良事件监测,加强风险控制,降低脑脊液分流管不良事件发生率,维护公众用械安全。

Objective Monitoring and Analyzing CSF flow control shunts adverse event reports by SRS provide a reference for the safe and reasonable use. Methods Retrospective analysis of 177 CSF flow control shunts adverse event reports, to proceed data mining analysis and early warning. Results 170 cases of adverse events in 177 cases may be related to the use of CSF flow control shunts. Ventricular dilatation and infection were the most common adverse event performances, according for 21.2% and 19.4% respectively. Adverse events might be relevant to the risk factors of product quality, surgical operation, patient pathological conditions. Conclusion Monitoring should be strengthened in order to reduce the CSF flow control shunts adverse events and maintain public safety.