福建省医疗机构医疗设备质量控制检测技术能力比对结果分析与评价

目的评价福建省医疗机构医疗设备质控检测分析仪的准确可靠程度。方法参考实验室间比对能力验证的方法,对21家医疗机构的通用电气安全、高频电刀、呼吸机和多参数监护仪4种检测分析仪共12个参数进行检测,采用稳健统计Z比分数法和实验室偏移估计值法进行评价。结果在四种检测分析仪比对的全部377个参数检测结果中,符合预期的有335个(88.86%);结果可疑26个(6.90%);不符合预期15个(4.24%);四种检测分析仪完全符合预期的比例为:通用电气50.00%、高频电刀50.00%、呼吸机69.23%、多参数监护仪83.33%。结论比对数据分析结果整体情况较好,但检测分析仪整体完全符合预期的比例不高,各医疗机构应予注意,结合具体参数检测结果,自行分析查找原因并改进。

Analysis and Evaluation of Comparison Results of Quality Control Testing Ability for Medical Equipment in Hospitals in Fujian Province

Objective To evaluate the accuracy and reliability of quality control analyzer in hospitals of Fujian Province.Methods Robust statistical Z-score and laboratory offset estimation method was used to analyze 12 parameters of general electric safety,electrosurgical units,ventilator,and multi-parameter monitor analyzer in 21 hospitals based on inter-laboratory comparison method.Results The results of meeting expectations,questionable,and not meeting expectations were 335(88.86%),26(6.90%)and 15(4.24%)respectively in the 377 parameters tested by the four analyzers.The proportion of meeting the expectations were 50.00%,50.00%,69.23%and 83.33%respectively in general electric safety,electrosurgical units,ventilator,and multi-parameter monitor analyzers.Conclusion The results of parameters testing are satisfied,but the proportion of the testing analyzer which meeting expectations is not high.All medical institutions should pay attention to them,analyze and find out the reasons in combination with the specific parameter testing results,and carry out the traceability and calibration reasonably.