基于失效模式与影响分析的MRI设备可靠性分析
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摘要
目的探讨失效模式与影响分析(FMEA)在评价MRI设备可靠性中的效果,为提高MRI设备可靠性提供依据。方法成立FMEA管理团队,填写FMEA调查表,对MRI设备6个子系统32种故障类型的可靠性进行分析,计算风险指数(RPN)。结果 (1)国内外MRI设备RPN值排名前6的风险因素相同,均为系统控制部分故障、数据重建模块故障、图像数据库故障、梯度放大器故障、射频放大器故障、计算机硬件故障。(2)场强为1.5T的国内外MRI设备的比较,29个失效模式的差异有统计学意义(P<0.05)。场强为3.0T的国内外MRI设备的比较,22个失效模式的差异有统计学意义(P<0.05)。结论国产MRI设备的风险性高于进口,应针对高风险的系统控制部分故障、数据重建模块故障、图像数据库故障、梯度放大器故障、射频放大器故障、计算机硬件故障这6种失效模式制定相应措施,以达到提高设备可靠性的目的。
Objective To explore the effect of failure mode and impact analysis(FMEA) in evaluating the reliability of MRI equipment, and to provide a basis for improving the reliability of MRI equipment. Methods The FMEA management team was established, and the FMEA questionnaire was filled in. The reliability of 32 fault types in 6 subsystems of MRI equipment was analyzed and the risk index(RPN) was calculated. Results(1) The risk factors in the top 6 of the MRI equipment risk index(RPN) with a field strength of 1.5 T and 3.0 T were the system control part failure, the Gradient amplifiers failure, image databases failure, data reconstruction modules failure, radio frequency amplifier failure and computer hardware failure.(2) Compared with domestic and foreign MRI equipment with a field strength of 1.5 T, the difference of 29 failure modes was statistically significant(P< 0.05). Compared with domestic and foreign MRI equipment with a field intensity of 3.0 T, 22 failure modes showed statistically significant differences(P<0.05). Conclusion The risk of MRI equipment in China was higher than that in foreign countries. Corresponding measures should be developed for the six failure modes of high-risk the system control part failure, the Gradient amplifiers failure, image databases failure, data reconstruction modules failure, radio frequency amplifier failure and computer hardware failure to achieve the purpose of improving MRI equipment reliability.
Objective To explore the effect of failure mode and impact analysis(FMEA) in evaluating the reliability of MRI equipment, and to provide a basis for improving the reliability of MRI equipment. Methods The FMEA management team was established, and the FMEA questionnaire was filled in. The reliability of 32 fault types in 6 subsystems of MRI equipment was analyzed and the risk index(RPN) was calculated. Results(1) The risk factors in the top 6 of the MRI equipment risk index(RPN) with a field strength of 1.5 T and 3.0 T were the system control part failure, the Gradient amplifiers failure, image databases failure, data reconstruction modules failure, radio frequency amplifier failure and computer hardware failure.(2) Compared with domestic and foreign MRI equipment with a field strength of 1.5 T, the difference of 29 failure modes was statistically significant(P< 0.05). Compared with domestic and foreign MRI equipment with a field intensity of 3.0 T, 22 failure modes showed statistically significant differences(P<0.05). Conclusion The risk of MRI equipment in China was higher than that in foreign countries. Corresponding measures should be developed for the six failure modes of high-risk the system control part failure, the Gradient amplifiers failure, image databases failure, data reconstruction modules failure, radio frequency amplifier failure and computer hardware failure to achieve the purpose of improving MRI equipment reliability.
引文
[1]杨正汉,王振常.重视MRI设备临床质量控制——发挥设备最优性能[J].中国医学影像技术,2017,33(11):1605-1606.
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[3] Jain K.Use of failure mode effect analysis(FMEA)to improve medication management process[J]. International journal of health care quality assurance,2017,30(2):175-186.
[4]邱妮娜,武夏明,肖玉良,等.应用失效模式与影响分析方法降低PIVAS危害药品调配中的职业暴露风险[J].中国药房,2018,29(14):1873-1876.
[5]陈淑贤,张赞,桑彤,等.探讨失效模式与效应分析在药品检验机构仪器设备风险管理中的应用与控制[J].中国药学杂志,2018,53(01):72-75.
[6]杨丽,陈玉烛,车良菊,等.失效模式与效应分析对泌尿外科留置导尿患者尿路感染的影响U].中华医院感染学杂志,2018,28(04):610-613.
[7]李宵,崔赛,安静,等.失效模式和影响分析在医院避光输注药品管理中的应用[J].中国医院药学杂志,2017,37(21):2183-2186,2166.
[8] Younge KC,Wang YZ,Thompson J.PracticalImplementation of Failure Mode and Effects Analysis for Safety and Efficiency in Stereotactic Radiosurgery[J].International journal of radiation oncology biology physics,2015,91(5):1003-1008.
[9]代云萍,邓富秋,陈慧,等.FMEA模式对妇产科住院患者医院感染的防控效果[J].中华医院感染学杂志,2017,27(18)4206-4209.
[10]陈中文,何奔,向泽林,等.综合应用Delphi法、FMEA与Borda序值法评估接种门诊预防接种风险[J].中国疫苗和免疫,2018,24(01):95-100.
[11]归纯漪,孙梅.失效模式与效应分析在我国手术室护理风险管理中的应用[J].中国卫生资源,2016,19(01):30-34
[12] Patil K,Yavalkar S,Ruikar SD,et al.Communication between Different Sub-Systems of MRI[C].2017 International conference on communication and signal processing(ICCSP).2017:2148-2152.
[13] Stumpf C,Malzacher M,Schmidt L-P.Radio Frequency Modeling of Receive Coil Arrays for Magnetic Resonance Imaging[J]. Journal of Imaging,2018,4(5):67.
[14]刘雅文,尹红霞,杨娉娉,等.MRI设备临床质量控制流程和制度的现状与发展趋势[J].中国医学影像技术,2017,33(11):1615-1619.
[15] Andrew Webb.Increasing the Sensitivity of Magnetic Resonance Spectroscopy and Imaging[J].Anal.Chem,2012,84(1):9-16.
[2] Xiao L,Ouyang SM,Li YW,et al.Fault detection method for magnetic resonance imaging spectrometer based on the acquisition and analysis of its output waveforms[J].Concepts in magnetic resonance part:B-magnetic resonance engineering,2017,47B(1).
[3] Jain K.Use of failure mode effect analysis(FMEA)to improve medication management process[J]. International journal of health care quality assurance,2017,30(2):175-186.
[4]邱妮娜,武夏明,肖玉良,等.应用失效模式与影响分析方法降低PIVAS危害药品调配中的职业暴露风险[J].中国药房,2018,29(14):1873-1876.
[5]陈淑贤,张赞,桑彤,等.探讨失效模式与效应分析在药品检验机构仪器设备风险管理中的应用与控制[J].中国药学杂志,2018,53(01):72-75.
[6]杨丽,陈玉烛,车良菊,等.失效模式与效应分析对泌尿外科留置导尿患者尿路感染的影响U].中华医院感染学杂志,2018,28(04):610-613.
[7]李宵,崔赛,安静,等.失效模式和影响分析在医院避光输注药品管理中的应用[J].中国医院药学杂志,2017,37(21):2183-2186,2166.
[8] Younge KC,Wang YZ,Thompson J.PracticalImplementation of Failure Mode and Effects Analysis for Safety and Efficiency in Stereotactic Radiosurgery[J].International journal of radiation oncology biology physics,2015,91(5):1003-1008.
[9]代云萍,邓富秋,陈慧,等.FMEA模式对妇产科住院患者医院感染的防控效果[J].中华医院感染学杂志,2017,27(18)4206-4209.
[10]陈中文,何奔,向泽林,等.综合应用Delphi法、FMEA与Borda序值法评估接种门诊预防接种风险[J].中国疫苗和免疫,2018,24(01):95-100.
[11]归纯漪,孙梅.失效模式与效应分析在我国手术室护理风险管理中的应用[J].中国卫生资源,2016,19(01):30-34
[12] Patil K,Yavalkar S,Ruikar SD,et al.Communication between Different Sub-Systems of MRI[C].2017 International conference on communication and signal processing(ICCSP).2017:2148-2152.
[13] Stumpf C,Malzacher M,Schmidt L-P.Radio Frequency Modeling of Receive Coil Arrays for Magnetic Resonance Imaging[J]. Journal of Imaging,2018,4(5):67.
[14]刘雅文,尹红霞,杨娉娉,等.MRI设备临床质量控制流程和制度的现状与发展趋势[J].中国医学影像技术,2017,33(11):1615-1619.
[15] Andrew Webb.Increasing the Sensitivity of Magnetic Resonance Spectroscopy and Imaging[J].Anal.Chem,2012,84(1):9-16.