医院在用高频电刀的质量控制与数据分析
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摘要
目的对手术室使用频率较高、风险较大的高频电刀进行质量控制,发现造成电刀不合格的因素,及时解决存在问题,保证手术的安全进行。方法根据国家医用电气设备安全要求、国家计量要求以及电刀的产品说明书,利用QA-ES III电刀分析仪和ESA612电气安全分析仪对电刀的相关参数进行检测。结果 38台高频电刀整体合格率为84.2%,使用时间小于5年的合格率为100%,大于5年的合格率为76.9%。A品牌Ⅰ型号电刀合格率为84.6%。结论根据医院在用电刀的质量控制数据,及时发现潜在问题并指导电刀维护维修工作,降低高风险医疗设备的故障率,保证医疗质量与安全。
Objective To find out the factors causing unqualified electric knives, timely solve existing problems, and ensure the safety of the operation via quality control of high-frequency electric knives with high operating frequency and high risk in the operating room. Methods According to the national safety requirements of medical electrical equipment, the national requirements of metrology and the specification of the electrosurgical generator, we used the QA-ES III electric knife analyzer and ESA612 electric safety analyzer to detect the relevant parameters of the electrosurgical generator. Results The overall pass rate of 38 sets of the electrosurgical generator was 84.2%. The pass rate of the using time less than 5 years was 100%, and the using time more than 5 years was 76.9%. The pass rate of the electrosurgical generator was 84.6%. Conclusion According to the quality control data of the electrosurgical generator used by the hospital, the potential problems are discovered in time and the electrosurgical generator maintenance and repair work is guided, so the failure rate of high-risk medical equipment is reduced, and the medical quality and safety are ensured.
Objective To find out the factors causing unqualified electric knives, timely solve existing problems, and ensure the safety of the operation via quality control of high-frequency electric knives with high operating frequency and high risk in the operating room. Methods According to the national safety requirements of medical electrical equipment, the national requirements of metrology and the specification of the electrosurgical generator, we used the QA-ES III electric knife analyzer and ESA612 electric safety analyzer to detect the relevant parameters of the electrosurgical generator. Results The overall pass rate of 38 sets of the electrosurgical generator was 84.2%. The pass rate of the using time less than 5 years was 100%, and the using time more than 5 years was 76.9%. The pass rate of the electrosurgical generator was 84.6%. Conclusion According to the quality control data of the electrosurgical generator used by the hospital, the potential problems are discovered in time and the electrosurgical generator maintenance and repair work is guided, so the failure rate of high-risk medical equipment is reduced, and the medical quality and safety are ensured.
引文
[1]王浩文,骆毅斌.高频电刀的设计原理及其使用中的注意事项[J].医疗装备,2017,30(3):21-22.
[2]刘华斌,宋成利.高频电刀的质量控制与管理[J].生物医学工程学进展,2016,37(1):19-21.
[3]王鹏,刘烨斌.高频电刀的计量检测与质量控制[J].江苏省计量测试学术论文集,2014:112-115.
[4]GB9706.1-2007,医用电气设备(第1部分):安全通用要求[S].北京:中国标准出版社,2007.
[5]GB 9706.4-2009,医用电气设备(第2-2部分):高频手术设备安全专用要求[S].北京:中国标准出版社,2009.
[6]JJF1217-2009,高频电刀校准规范:校准条件[S].
[7]杨嘉文,喻洋.高频电刀质量控制[A].中华医学会医学工程学分会第十五次全国学术年会论文汇编[C].2015.
[8]赵鹏.高频电刀质量控制检测技术[M].北京:中国计量出版社,2011.
[9]张乔冶.高频电刀工作原理及其质量控制要点[J].中国医疗器械信息,2017,13(10):27-29.
[10]邓文艳,徐楚天,周嫱.高频电刀质量控制检测参数的设定及测量方法[J].中国医疗设备,2016,31(11):125-126.
[11]陈聪.高频手术设备的高频漏电流的测试[J]中国医疗器械信息,2016,12:47-50.
[12]李红霞,王晓东,潘文哲.医院在用高频电刀质量控制的探讨[J].中国医疗设备,2017,32(10):169-171.
[13]杨茂林.关于高频电刀质量控制规范的研究[J].标准科学,2016,10:99-100.
[14]苏京昌,苏军昌,王丽.高频电刀质量控制及应用安全的关键因素分析[J].中国医疗器械信息,2016,10(54):113-114.
[15]张文,陈伟健,张惠敏.高频电刀风险分析及安全管理[J].技术装备,2015,10(9):96-97.
[16]杨宇航,朱宏宁.高频电刀不良事件案例分析与探讨[J].中国医学装备,2017,10(14):149.
[2]刘华斌,宋成利.高频电刀的质量控制与管理[J].生物医学工程学进展,2016,37(1):19-21.
[3]王鹏,刘烨斌.高频电刀的计量检测与质量控制[J].江苏省计量测试学术论文集,2014:112-115.
[4]GB9706.1-2007,医用电气设备(第1部分):安全通用要求[S].北京:中国标准出版社,2007.
[5]GB 9706.4-2009,医用电气设备(第2-2部分):高频手术设备安全专用要求[S].北京:中国标准出版社,2009.
[6]JJF1217-2009,高频电刀校准规范:校准条件[S].
[7]杨嘉文,喻洋.高频电刀质量控制[A].中华医学会医学工程学分会第十五次全国学术年会论文汇编[C].2015.
[8]赵鹏.高频电刀质量控制检测技术[M].北京:中国计量出版社,2011.
[9]张乔冶.高频电刀工作原理及其质量控制要点[J].中国医疗器械信息,2017,13(10):27-29.
[10]邓文艳,徐楚天,周嫱.高频电刀质量控制检测参数的设定及测量方法[J].中国医疗设备,2016,31(11):125-126.
[11]陈聪.高频手术设备的高频漏电流的测试[J]中国医疗器械信息,2016,12:47-50.
[12]李红霞,王晓东,潘文哲.医院在用高频电刀质量控制的探讨[J].中国医疗设备,2017,32(10):169-171.
[13]杨茂林.关于高频电刀质量控制规范的研究[J].标准科学,2016,10:99-100.
[14]苏京昌,苏军昌,王丽.高频电刀质量控制及应用安全的关键因素分析[J].中国医疗器械信息,2016,10(54):113-114.
[15]张文,陈伟健,张惠敏.高频电刀风险分析及安全管理[J].技术装备,2015,10(9):96-97.
[16]杨宇航,朱宏宁.高频电刀不良事件案例分析与探讨[J].中国医学装备,2017,10(14):149.