摘要
目的通过收集分析PET-CT不良事件报告,发现该产品安全性特点。方法收集2007~2016年FDA MAUDE数据库以及2006~2017年中国知网数据库,并对不良事件数据进行汇总标注,使用描述性方法对数据进行统计分析。结果PET-CT不良事件主要表现为机械损伤对患者造成的伤害以及数据采集与图像重建的故障表现。结论该产品在临床使用以及产品设计过程中应当关注上述风险。
Objective To collect and analyze the adverse events reports of PET-CT so as to find the safety profiles.Methods The adverse events reports of PET-CT from FDA MAUDE database from 2007 to 2016 and the CNKI database from 2006 to 2016 and tag the data were collected.Descriptive methods were used for statistical analysis.Results Adverse events of PET-CT were mainly manifested in the injuries caused by mechanical injuries to patients and the failure manifestations of data acquisition and image reconstruction.Conclusion The risks mentioned above should be taken into account in clinical use and product design.
作者
王瑜歆
王立刚
WANG Yuxin;WANG Ligang(Liaoning Inspection,Examination&Certification Centre,Liaoning Institute for Certification and Evaluation,Shenyang Liaoning 110036,China)
出处
《中国医疗设备》
2019年第11期138-140,共3页
China Medical Devices
基金
“十三五”国家药品安全规划——技术支撑能力建设项目
关键词
PET-CT
医疗设备不良事件
机械损伤
图像重建
PET-CT
adverse events of medical equipment
mechanical damage
image reconstruction
