医疗机构高频电刀的质量评价研究  

Research on quality evaluation of high-frequency electro knife equipment

作　　者：屈媛媛 李明 李振涛[2] 李妍达 QU Yuan-yuan;LI Ming;LI Zhen-tao;LI Yan-da(Beijing Institute of Medical Device Testing,Beijing 101111,China;Peking University People's Hospital,Beijing 100034,China)

机构地区：[1]北京市医疗器械检测所,北京101111 [2]北京大学人民医院,北京100034

出　　处：《医疗卫生装备》2020年第9期43-47,共5页Chinese Medical Equipment Journal

摘　　要：目的:开展高频电刀的安全性检测,控制和提高高频电刀使用的安全性。方法:对多家医疗机构的43台高频电刀设备(A品牌7台、B品牌31台、C品牌5台)进行检测,分析高频漏电流的热作用、控制器件和仪表的准确度与品牌及使用年限的关系,合格率的影响因素。采用SPSS 25.0软件对检测结果进行分析。结果:43台高频电刀高频漏电流的热作用全部合格,控制器件和仪表的准确度合格率为58.1%。高频漏电流测试结果在不同品牌间存在显著差异(P<0.05),在不同使用年限间无显著差异(P>0.05);控制器件和仪表的准确度测试结果在不同品牌间差异较大(P<0.05),在不同使用年限间无显著差异(P>0.05);在合格率影响因素方面,手术附件的使用以及说明书的及时更新对合格率影响较大。结论:定期开展高频电刀质量评价检测,针对问题制订预防措施,可以提高设备的安全性、有效性,保障患者及使用人员的生命安全。Objective To test the safety of high frequency surgical electro knife equipment and improve its safety performance.Methods Forty-three sets of high-frequency electro knife equipment(including 7 sets of brand A,31 sets of brand B and 5 sets of brand C)from several medical institutions were tested to explore the factors influencing the pass rate and to analyze the relationships respectively between the brands and the thermal effects of high-frequency leakage current and the accuracies of control devices and instruments and between the service lives and the thermal effects and accuracies.SPSS 25.0 software was used to analyze the test results.Results All of the 43 sets of high frequency electrodes were qualified in the thermal effect of high frequency leakage current,and the pass rates of the accuracies of control devices and instruments was 58.1%.The results of high frequency leakage current tests were significantly different for the brands(P<0.05),while not statistically different for the service lives(P>0.05);the accuracy test results of control devices and instruments differed greatly between the brands(P<0.05)while had no obvious differences between the service lives(P>0.05);the surgical accessories and timely updating of the instructions were found to influence the pass rate greatly.Conclusion Conducting high-frequency surgical equipment quality control test regularly and formulating preventive measures for problems can improve the safety and effectiveness of the equipment and ensure the safety of patients and users.

关 键 词：高频电刀 高频漏电流 控制器件和仪表的准确度 手术附件 质量评价 

分 类 号：R318.6[医药卫生—生物医学工程] TH777[医药卫生—基础医学]