摘要
目的通过在用的数字X线摄影(Digital Radiography,DR)设备的应用质量与使用状况的实证调研、分析和客观评价,促进国产医疗器械创新发展,为示范应用推广提供客观的依据。方法本文采用实证调研方式,现场数据采集,使用客观评价的方法,自动计算图像质量因子。对国产DR设备的影像质量进行评价。通过现场调研,对DR设备可靠性、使用状况进行分析研究。结果调研结果表明,国产常规DR产品影像质量已经达到进口同类产品水平。但不同品牌产品影像质量存在一定差距;在可靠性方面,国产DR在配套使用的核心部件(平板探测器)与进口DR可靠性没有差异;在制造工艺、机械可靠性、电气可靠性方面与进口产品相比差距较大。使用状况调查结果发现,DR图像伪影问题相当普遍,在基层医疗机构比例接近30%,缺乏日常维护、定期校正,操作不规范等问题比较严重。结论国产常规DR的技术发展已经相对成熟,从综合影像质量数据看,已经可以替代进口产品,但在可靠性以及规范化使用方面,有待提高,尤其基层医院的使用管理存在较大问题,会对国产医疗设备应用推广造成了负面影响。
Objective The paper aims to promote the innovation and development of domestic medical devices, and to provide objective basis for demonstration application promotion through the empirical investigation, analysis and objective evaluation of the application quality and use status of the in-use digital radiography(DR) equipment. Methods This paper adopted the method of empirical investigation, field data collection and objective evaluation to automatically calculate the image quality factor and evaluatethe image quality of domestic DR equipment. Through the field investigation, the reliability and use of DR equipment were analyzed and studied. Results Research results showed that the image quality of domestic conventional DR products had reached the level of imported similar products. However, there was a gap in image quality between different brands. In terms of reliability, there was no difference between the core components(flat plate detector) of domestic DR and imported DR. In manufacturing process, mechanical reliability, electrical reliability and imported products compared with the gap. The results of the survey on the use of DR image artifact showed that the problem of DR image artifact was quite common, and the proportion of DR image artifact was close to 30% in primary medical institutions. Cunclusion Domestic conventional DR equipment technology has been relatively mature. From the perspective of comprehensive image quality data, it has been able to replace imported products, but in terms of reliability and standardized use, it will have a negative impact on the application promotion of domestic medical equipments.
作者
金肖青
谢松城
张吉
邱晓力
郑焜
JIN Xiaoqing;XIE Songcheng;ZHANG Ji;QIU Xiaoli;ZHENG Kun(Department of Medical Engineering,Zhejiang Hospital,Hangzhou Zhejiang 310013,China;Zhejiang Development Centre for Modern Biological Technology,Hangzhou Zhejiang 310000,China;Department of Logistic Support,The Children’s Hospital,Zhejiang University School of Medicine,Hangzhou Zhejiang 310052,China)
出处
《中国医疗设备》
2019年第12期1-4,17,共5页
China Medical Devices
关键词
数字X线摄影
国产医疗器械
平板探测器
基层医疗机构
digital radiography
domestic medical devices
plate detector
primary medical institutes
