数字化医用X射线摄影设备质量控制检测结果分析

Quality control performance of digital radiography devices for medical use in Guangzhou

目的了解广州市数字化医用X射线摄影设备(DR)的质量控制情况,探讨质量控制存在的问题,为监管部门提供参考。方法根据WS 521-2017、WS76-2017的方法要求,采用分层随机抽样方法,对广州市40家各级医疗机构共54台DR设备进行状态检测。结果三级医疗机构的合格率高于一级、二级,其中三级与一级比较,差异有统计学意义(χ^(2)=4.28,P<0.05)。中心六城区(越秀、荔湾、天河、番禺、海珠、白云)的合格率高于非中心六城区(黄埔、南沙、增城、花都、从化),差异有统计学意义(χ^(2)=5.73,P<0.05)。进口设备合格率高于国产设备,差异有统计学意义(χ^(2)=4.43,P<0.05),进口设备能获取预处理影像的占比高于国产设备,差异有统计学意义(χ^(2)=7.51,P<0.05)。通用检测项目的有用线束垂直度偏离、光野与照射野四边偏离合格率分别为96.3%、88.9%,专用检测项目的测距误差、极限空间分辨力、低对比度细节的合格率分别为94.3%、92.6%、98.2%,其余检测项目为100%。暗噪声、探测器剂量指示(DDI)、极限空间分辨力、低对比度细节、自动曝光控制(AEC)灵敏度、AEC管电压变化一致性等项目的基线值建立率分别为86.1%、86.1%、85.2%、79.6%、85.4%、85.4%。结论广州市应加强数字化医用X射线摄影设备影像质量控制,根据标准要求进一步规范专用检测项目的检测。

Objective To investigate the quality control performance of digital radiography(DR)devices for medical use in Guangzhou,thereby identify the potential problems in quality control for the reference of regulatory authorities.Methods According to the requirements of the standards criteria documents WS 521-2017 and WS76-2017,a stratified random sampling method was used to conduct the status inspection of 54 DR devices in 40 medical institutions at various levels in Guangzhou.Results The qualification rates were higher with tertiary medical institutions than with primary or secondary institutions,displaying statistically significant difference between the tertiary and primary institutions(χ^(2)=4.28,P<0.05).Six central urban districts(Yuexiu,Liwan,Tianhe,Panyu,Haizhu and Baiyun)were with a higher qualification rate(94.1%vs 65.0%)compared with non-central urban districts(Huangpu,Nansha,Zengcheng,Huadu,and Conghua),showing statistically significant difference(χ^(2)=5.73,P<0.05).The qualification rate was also higher with imported devices higher than with domestic devices,with statistically significant difference(χ^(2)=4.43,P<0.05).Image acquisition and pre-processing was available more with imported devices than with domestic devices,with statistically significant difference(χ^(2)=7.51,P<0.05).Among the general quality control items,the qualification rates were 96.3%and 88.9%for useful beam deviation from perpendicularity and the quadrilateral deviation between the light field and radiation field,respectively.Among the specific quality control items,the qualification rates were 94.3%,92.6%,and 98.2%for the ranging error,spatial resolution limits,and low-contrast details,respectively.The remaining quality control items were 100%qualified.Baseline values of quality control items including dark noise,detector dose indicator(DDI),spatial resolution limits,low-contrast details,automated exposure control(AEC)sensitivity,and standard variations in AEC tube voltage,were established for 86.1%,86.1%,85.2%,79.6%,85.3%,and 85.3%of all DR devices.Conclusions For digital radiography devices for medical use in Guangzhou,quality control should be reinforced.Efforts need to be exerted for standardization of specific quality control items in accordance with the requirements of the standards criteria documents.