2019年天津市医用X射线诊断设备质量控制检测结果分析

Analyses of quality control testing results of medical X-ray diagnostic equipm ent in T ianjin in 2019

目的掌握天津市医用X射线诊断设备质量控制基本情况,探讨设备质量控制存在的问题,并为监管部门提供技术依据。方法采用分层随机抽样的方式,选择天津市111家医疗机构中的401台医用X射线诊断设备作为研究对象,使用X射线多功能剂量仪等设备,按卫生行业标准等要求进行质量控制状态检测与评价。结果401台医用X射线诊断设备初检合格率为90.0%,X射线摄影机的初检合格率低于X射线透视机、数字减影血管造影机(DSA)和X射线计算机体层摄影机(CT机)(χ^2=9.203、3.383、5.754,P<0.05)。摄影机中合格率最低的为屏片X射线机,其次为乳腺X射线机和数字X射线摄影机(DR),主要不合格指标分别为输出量重复性、管电压指示的偏离和极限空间分辨力。X射线摄影机中无基线值占比最高的是DR。X射线摄影机不满足检测条件占比高于X射线透视机(χ^2=8.216,P<0.05)。摄影机中屏片X射线机不满足检测条件的占比最高,其次为计算机X射线摄影机(CR)。此项研究401台设备中,私立医疗机构的初检合格率与公立医疗机构差异无统计学意义(P>0.05),国产设备的初检合格率低于进口设备(χ^2=4.576,P<0.05)。结论天津市的医用X射线诊断设备质量控制有待进一步加强,医疗机构应重视医用X射线诊断设备的质量控制检测,监管部门应重点加强含有不合格项目、无基线值和不满足检测条件设备的监督管理。

Objective To understand the current status of quality control of medical X-ray diagnostic equipment in Tianjin,discuss the problems existing in the process of quality control,and provide technical basis for the relevant regulatory agencies.Methods Using stratified random sampling,a total of 401 pieces of medical X-ray diagnostic equipment distributed over 111 medical institutions in Tianjin was used for this study.X-ray multifunctional dosimeters and other types of equipment were used to perform quality control testing and evaluation under the relevant health industry standards.Results The initial testing pass rate of these equipment was 90.0%,with the pass rates of X-ray imaging equipment lower than those of X-ray fluoroscopy equipment,digital subtraction angiography(DSA)and X-ray computed tomography(CT)(χ^2=9.203,3.383,5.754,P<0.05).Among the imaging equipment,the screen X-ray equipment had the lowest pass rate,followed by the breast X-ray equipment and medical digital radiography(DR).The main unqualified items were output repeatability,deviation of tube voltage indication and limit spatial resolution.DR accounted for the highest percentage of X-ray equipment that were below testing condition.The unqualified proportion of X-ray imaging equipment was higher than that of X-ray fluoroscopy equipment(χ^2=8.216,P<0.05).Among the imaging equipment,the screen X-ray equipment was seen to have the highest unaqualified proportion,followed by computed radiography(CR).Among the 401 devices in this study,the initial testing pass rates of private medical institutions was not statistically different from those of public medical institutions(P>0.05).The initial pass rates of domestic equipment was lower than those of imported equipment(χ^2=4.576,P<0.05).Conclusions The performance of medical X-ray diagnostic equipment in Tianjin needs to be further improved.Medical institutions should pay attention to the quality control testing of medical X-ray diagnostic equipment.The relevant regulatory agencies should strengthen oversight and management of equipment that contains unqualified items,no baseline values and below the testing conditions.