FMEA在手术部位感染风险管理中的应用
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摘要
手术部位感染已成为全球医院控制与预防的重要项目,是保障患者安全的重要内容之一。失效模式与效应分析(FMEA)作为一种风险分析方法在设计、制造中用以预防、避免差错的应用早已为人们所熟悉。近年来国际上逐步将FMEA应用到医疗风险管理上,起到事前预防和避免医疗风险的方法,来尽可能减少出现风险问题。
本研究首先介绍了FMEA和医疗风险管理的发展过程,分析了FMEA在医疗风险管理中应用的可行性,讨论了应用FMEA进行医疗风险管理的意义;通过分析FMEA风险评价技术,依照风险管理的特点和要求,得到医疗风险管理FMEA的风险评价方法,构建出医疗风险管理FMEA的模式,并通过在手术部位感染风险管理中的实际应用,得出将FMEA应用于医疗风险管理中可有效地达到事前预防的目的,并能降低感染的发生,归纳出实施FMEA管理的要点以及改进措施。
期望通过本次研究,将FMEA应用于手术部位感染风险的管理,来降低感染的发生率,来检验FMEA是否适用于国内医院风险管理,是否具有有效性,可行性和推广性。并力求通过推广FMEA的应用,来完善医院在风险管理问题上的能力,从而尽可能地降低医疗风险以及由此带来的补救赔偿费用,提高病人安全,增加病人对医疗活动的信赖度。
Surgical site infection has become an important project in global hospitals control and prevention, it is one of the important contents to protect patient safety. Failure Mode and Effect Analysis (FMEA) as a method of risk analysis in the design and manufacture ,it has long been familiar with the application which have been used in the prevention and avoid errors. In recent years, it is gradually used FMEA to applied the medical risk management by the international community, and it will play a pre-prevention and avoid of medical risks, so as to reduce the risks.
This study introduces the FMEA and the development of medical risk management process, analysises the FMEA feasibility of the application in medical risk management,discusses the application of FMEA to the significance of medical risk management; through the analysis of FMEA risk assessment technology,in accordance with characteristics and requirements of medical risk management ,it will be get the FMEA risk management medical risk assessment methods, and built a medical model of FMEA risk management, and also through surgical site infection of practical application in risk management,can be effectively used to achieve the purpose of the prevention which applied the FMEA to medical risk management, and can be reduced the incidences of infection, and summarized the main points of the implementation of FMEA and management improvements.
It's hoped that through this study FMEA ,it will be applied to the management of surgical site infection risk, to reduce the incidence of infection, to test the applicability of FMEA to domestic hospital risk management, to test whether the FMEA is effective, feasible, and replicable. Meanwhile, it's seeked to improve the ability of risk management in the hospital through promoting the application of FMEA, thereby reducing the medical risks as much as possible, as well as compensation for the resulting cost of remediation, improving the safety of patients and increasing the reliability of patients in health care activities.
本研究首先介绍了FMEA和医疗风险管理的发展过程,分析了FMEA在医疗风险管理中应用的可行性,讨论了应用FMEA进行医疗风险管理的意义;通过分析FMEA风险评价技术,依照风险管理的特点和要求,得到医疗风险管理FMEA的风险评价方法,构建出医疗风险管理FMEA的模式,并通过在手术部位感染风险管理中的实际应用,得出将FMEA应用于医疗风险管理中可有效地达到事前预防的目的,并能降低感染的发生,归纳出实施FMEA管理的要点以及改进措施。
期望通过本次研究,将FMEA应用于手术部位感染风险的管理,来降低感染的发生率,来检验FMEA是否适用于国内医院风险管理,是否具有有效性,可行性和推广性。并力求通过推广FMEA的应用,来完善医院在风险管理问题上的能力,从而尽可能地降低医疗风险以及由此带来的补救赔偿费用,提高病人安全,增加病人对医疗活动的信赖度。
Surgical site infection has become an important project in global hospitals control and prevention, it is one of the important contents to protect patient safety. Failure Mode and Effect Analysis (FMEA) as a method of risk analysis in the design and manufacture ,it has long been familiar with the application which have been used in the prevention and avoid errors. In recent years, it is gradually used FMEA to applied the medical risk management by the international community, and it will play a pre-prevention and avoid of medical risks, so as to reduce the risks.
This study introduces the FMEA and the development of medical risk management process, analysises the FMEA feasibility of the application in medical risk management,discusses the application of FMEA to the significance of medical risk management; through the analysis of FMEA risk assessment technology,in accordance with characteristics and requirements of medical risk management ,it will be get the FMEA risk management medical risk assessment methods, and built a medical model of FMEA risk management, and also through surgical site infection of practical application in risk management,can be effectively used to achieve the purpose of the prevention which applied the FMEA to medical risk management, and can be reduced the incidences of infection, and summarized the main points of the implementation of FMEA and management improvements.
It's hoped that through this study FMEA ,it will be applied to the management of surgical site infection risk, to reduce the incidence of infection, to test the applicability of FMEA to domestic hospital risk management, to test whether the FMEA is effective, feasible, and replicable. Meanwhile, it's seeked to improve the ability of risk management in the hospital through promoting the application of FMEA, thereby reducing the medical risks as much as possible, as well as compensation for the resulting cost of remediation, improving the safety of patients and increasing the reliability of patients in health care activities.
引文
1 Centers for Disease Control and Prevention,National Center for Health Statistics.Vital and Health Statistics,Detailed Diagnoses and Procedures,National Hospital Discharge Survey,1994.Vol127.Hyattsville,Maryland:DHHS Publication;1997.
2 Emori TG,Gaynes RP.An overview of nosocomial infections,including the role of the microbiology laboratory.Clin Microbiol Rev 1993;6(4):428-42.
3 Cruse P.Wound infection surveillance.Rev Infect Dis1981;4(3):734-7.
4 Cruse PJ,Foord R.The epidemiology of wound infection:a 10-year prospective study of 62,939 wounds.Surg Clin North Am 1980;60(1):27-40.
5 Martone WJ,Jarvis WR,Culver DH,Haley RW.Incidence and nature of endemic and epidemic nosocomial infections.In:Bennett JV,Brachman PS,eds.Hospital Infections.3rd ed.Boston:Little,Brown and Co;1992.p.577-96.
6 Boyce JM,Potter-Bynoe G,Dziobek L.Hospital reimbursement patterns among patients with surgical wound infections following open heart surgery.Infect Control Hosp Epidemiol 1990;11(2):89-93.
7 Poulsen KB,Bremmelgaard A,Sorensen AI,Raahave D,Petersen JV.Estimated costs of postoperative wound infections.A casecontrol study of marginal hospital and social security costs.Epidemiol Infect 1994;113(2):283-95.
8 113[美]普雷切特.风险管理与保险[M].孙祁祥,译.北京:中国社会科学出版社.1998.
9 张仲明.加强医疗风险管理确保医疗质量.中华医院管理杂志,1999,15(9)569-572.
10 卢仲毅,王兴勇等.医疗风险防范管理的理论与实践.中华现代医院管理杂志,2004,2(8):81-83
11 张宝库.美国医院的风险管理[J].中华医院管理杂志.1992,8(10):638-641.
12 卢祖洵,程峰.风险管理方法及其在医院管理工作中的应用[J].中国卫生事业管理,1996,98(8):395-396.
13 Duwe B,Fuchs BD,Hansen-Flaschen J.Failur mode and effects analysis application to criticalcare medicine.Crit Care Clin,2005;21(1):21-30.
14 Adachi W,Lodolce AE.Use of failure mode and effects analysis in improving the safety of i.v.drug administration.Am J Health Syst Pharm,2005,62:917-920.
15 Tosha B Wetterneck,Kathleen Skibinski,MarkSchroeder,et al.Challenges with the performance of failure mode and effects analysis in healthcare organizations:an Ⅳmedication HFMEA'.The 48th Annual Conference of the Human Factors and Ergonomics Society,2004.
16 Kunac DL,Reith DM.Identification of priorities for medication safety in neonatal intensive care.Drug Saf,2005,28:251-261.
17 Apkon M,Leonard J,Probst L,et al.Design of a safer approach to intravenous drug infusions:failure mode effects analysis.Qual Saf Health Care,2004;13(4):265-271.
18 郝宏恕,杨士梁,郭宜祯等.运用前瞻性风险管理模式提升中医针刺病人安全.华夏医药,2008,3(3):203-205.
19 施雁,阮华英,戴慧珊等.应用6Sigman失效模式降低静脉置管感染率,中华护理杂志,2006,41(10):913-915.
20 Linkin DR(Division of Infectious Diseases,Department of Medicine,Center for Clinical Epidemiology and Biostatistics,University of Pennsylvania),Sausman C,Sausman L,et al.Applicability of Healthcare Failure Mode and Effects Anlaysis to healthcare eidemiology:evaluation of the sterilization and use of surgical instruments.Clin Infect Dis,2005,41(7):1014-9.
21 Jan S Krouwer.An improved failure mode effects analysis for hospitals.Arch Pathol Lab Med,2004;128(6):663-667
22 Reiling John G,Knutzen Barbara L,Stoecklein Mike.FME A-the care for medical errors.Quality Progress,2003;36(8):67-71.
23 Singh R,Servoss T,Kalsman M,et al.Estimating impacts on safety caused by the introduction of electronic medical records in primary care[j].Inform Prim Care,2004,(12):235-242.
24 徐秀华.临床医院感染学.湖南科学技术出版社.2005,8
25 应用抗菌防治外科感染的指导意见撰写协作组.应用抗菌防治外科感染的指导意见(草案)Ⅱ。中华外科杂志,2003,41(7):552-554
1.Linda T Kohn,Janet Corrigan,J Corrigan,et al.To err is human:Building a safer healthsystem,Washington,DC:National Academy Press,2000.153.
2.Eric Goodman.When doctors make mistakes.Good Housekeeping,2001;232(4): 103-105.
3.Tosha B Wetterneck,Kathleen Skibinski,MarkSchroeder,et al.Challenges with the performance of failure mode and effects analysis in healthcare organizations:an Ⅳmedication HFMEA'.The 48th Annual Conference of the Human Factors and Ergonomics Society,2004.
4.Duwe B,Fuchs BD,Hansen-Flaschen J.Failur mode and effects analysis application to criticalcare medicine.Crit Care Clin,2005;21(1):21-30.
5.Adachi W,Lodolce AE.Use of failure mode and effects analysis in improving the safety of i.v,drug administration.Am J Health Syst Pharm,2005,62:917-920.
6.Kunac DL,Reith DM.Identification of priorities for medication safety in neonatal intensive care.Drug Saf,2005,28:251-261.
7.Apkon M,Leonard J,Probst L,et al.Design of a safer approach to intravenous drug infusions:failure mode effects analysis.Qual Saf Health Care,2004;13(4):265-271.
8.郝宏恕,杨士梁,郭宜祯等.运用前瞻性风险管理模式提升中医针刺病人安全.华夏医药,2008,3(3):203-205.
9.施雁,阮华英,戴慧珊等.应用6Sigman失效模式降低静脉置管感染率,中华护理杂志,2006,41(10):913-915.
10.Linkin DR(Division of Infectious Diseases,Department of Medicine,Center for Clinical Epidemiology and Biostatistics,University of Pennsylvania),Sausman C,Sausman L,et al.Applicability of Healthcare Failure Mode and Effects Anlaysis to healthcare eidemiology:evaluation of the sterilization and use of surgical instruments.Clin Infect Dis,2005,41(7):1014-9.
11.Jan S Krouwer.An improved failure mode effects analysis for hospitals.Arch Pathol Lab Med,2004;128(6):663-667
12.Reiling John G,Knutzen Barbara L,Stoecklein Mike.FME A-the care for medical errors.Quality Progress,2003;36(8):67-71.
13.Singh R,Servoss T,Kalsman M,et al.Estimating impacts on safety caused by the introduction of electronic medical records in primary care[j].Inform Prim Care,2004,(12):235-242.
14.DeRosier J,Stalhandske E,Bagian JP,et al.Using health care Failure Mode and Effect Analysis:the VA National Center for Patient Safety's prospective risk analysis system Jt Comm J Qual Improv,2002;28(5):248-67,209.
15.Nichols JH,Bartholomew C,Brunton M,et al.Reducing medical errors through barcoding atthe point of care.Clin Leadersh Manag Rev,2004;18(6):328-334.
16.Blanchard J,Clinton P,De Lorimier K,et al.FME A utilization as part of the implementation process of computerized physician order entry in a procedure area Medinfo,2004;2004(CD):1529
17.Capunzo M,Cavallo P,Boccia G,et al.A FME A clinical laboratory case study:how to make problems and improvements measurable.Clin Leadersh Manag Rev,2004;18(1):37-41.
18.Precidential&Congressional Commission on Risk Assessment and Risk Management[R].Final Report;Framework for Environmental Health Risk Management Vol.1,Risk Assessment and Risk Management in Regulatory decision -Making Vol.2,Posted in RiskWorld on March 1997,27.
19.Reiling John G,Knutzen Barbara L,Stoecklein Mike.FMEA-the care for medical errors[J].Quality Progress,2003,36(8):67-71.
20.Kohn LT,Corrigan JM,Donaklson MS.Institute of Medicine To Err is Human:Building a Safer Health System[M].Waxhington.DC:National Academy Press,1999.
21.刘碧瑶,沈毅.“失效模式和效果分析”降低医院医疗风险的研究进展.国外医学,2005.2:73-76.
22.陈春梅,朱秀文,刘江南.FMEA在项目风险管理中的应用研究[J].河北建筑科技学院学报,2004,21(3):83-87
23.王文旭.FMEA技术在危险源辨识、风险评价、风险控制策划中的应用[J]。中国质量认证,2004,8:49-51.
24.丁志新,陈晓彤.使用软件实现FMEA数据管理与分析[J]。电子质量,2004,8:54-56
25.敖景.失效模式及后果影响分析.电子质量,1999,10:39-42.
2 Emori TG,Gaynes RP.An overview of nosocomial infections,including the role of the microbiology laboratory.Clin Microbiol Rev 1993;6(4):428-42.
3 Cruse P.Wound infection surveillance.Rev Infect Dis1981;4(3):734-7.
4 Cruse PJ,Foord R.The epidemiology of wound infection:a 10-year prospective study of 62,939 wounds.Surg Clin North Am 1980;60(1):27-40.
5 Martone WJ,Jarvis WR,Culver DH,Haley RW.Incidence and nature of endemic and epidemic nosocomial infections.In:Bennett JV,Brachman PS,eds.Hospital Infections.3rd ed.Boston:Little,Brown and Co;1992.p.577-96.
6 Boyce JM,Potter-Bynoe G,Dziobek L.Hospital reimbursement patterns among patients with surgical wound infections following open heart surgery.Infect Control Hosp Epidemiol 1990;11(2):89-93.
7 Poulsen KB,Bremmelgaard A,Sorensen AI,Raahave D,Petersen JV.Estimated costs of postoperative wound infections.A casecontrol study of marginal hospital and social security costs.Epidemiol Infect 1994;113(2):283-95.
8 113[美]普雷切特.风险管理与保险[M].孙祁祥,译.北京:中国社会科学出版社.1998.
9 张仲明.加强医疗风险管理确保医疗质量.中华医院管理杂志,1999,15(9)569-572.
10 卢仲毅,王兴勇等.医疗风险防范管理的理论与实践.中华现代医院管理杂志,2004,2(8):81-83
11 张宝库.美国医院的风险管理[J].中华医院管理杂志.1992,8(10):638-641.
12 卢祖洵,程峰.风险管理方法及其在医院管理工作中的应用[J].中国卫生事业管理,1996,98(8):395-396.
13 Duwe B,Fuchs BD,Hansen-Flaschen J.Failur mode and effects analysis application to criticalcare medicine.Crit Care Clin,2005;21(1):21-30.
14 Adachi W,Lodolce AE.Use of failure mode and effects analysis in improving the safety of i.v.drug administration.Am J Health Syst Pharm,2005,62:917-920.
15 Tosha B Wetterneck,Kathleen Skibinski,MarkSchroeder,et al.Challenges with the performance of failure mode and effects analysis in healthcare organizations:an Ⅳmedication HFMEA'.The 48th Annual Conference of the Human Factors and Ergonomics Society,2004.
16 Kunac DL,Reith DM.Identification of priorities for medication safety in neonatal intensive care.Drug Saf,2005,28:251-261.
17 Apkon M,Leonard J,Probst L,et al.Design of a safer approach to intravenous drug infusions:failure mode effects analysis.Qual Saf Health Care,2004;13(4):265-271.
18 郝宏恕,杨士梁,郭宜祯等.运用前瞻性风险管理模式提升中医针刺病人安全.华夏医药,2008,3(3):203-205.
19 施雁,阮华英,戴慧珊等.应用6Sigman失效模式降低静脉置管感染率,中华护理杂志,2006,41(10):913-915.
20 Linkin DR(Division of Infectious Diseases,Department of Medicine,Center for Clinical Epidemiology and Biostatistics,University of Pennsylvania),Sausman C,Sausman L,et al.Applicability of Healthcare Failure Mode and Effects Anlaysis to healthcare eidemiology:evaluation of the sterilization and use of surgical instruments.Clin Infect Dis,2005,41(7):1014-9.
21 Jan S Krouwer.An improved failure mode effects analysis for hospitals.Arch Pathol Lab Med,2004;128(6):663-667
22 Reiling John G,Knutzen Barbara L,Stoecklein Mike.FME A-the care for medical errors.Quality Progress,2003;36(8):67-71.
23 Singh R,Servoss T,Kalsman M,et al.Estimating impacts on safety caused by the introduction of electronic medical records in primary care[j].Inform Prim Care,2004,(12):235-242.
24 徐秀华.临床医院感染学.湖南科学技术出版社.2005,8
25 应用抗菌防治外科感染的指导意见撰写协作组.应用抗菌防治外科感染的指导意见(草案)Ⅱ。中华外科杂志,2003,41(7):552-554
1.Linda T Kohn,Janet Corrigan,J Corrigan,et al.To err is human:Building a safer healthsystem,Washington,DC:National Academy Press,2000.153.
2.Eric Goodman.When doctors make mistakes.Good Housekeeping,2001;232(4): 103-105.
3.Tosha B Wetterneck,Kathleen Skibinski,MarkSchroeder,et al.Challenges with the performance of failure mode and effects analysis in healthcare organizations:an Ⅳmedication HFMEA'.The 48th Annual Conference of the Human Factors and Ergonomics Society,2004.
4.Duwe B,Fuchs BD,Hansen-Flaschen J.Failur mode and effects analysis application to criticalcare medicine.Crit Care Clin,2005;21(1):21-30.
5.Adachi W,Lodolce AE.Use of failure mode and effects analysis in improving the safety of i.v,drug administration.Am J Health Syst Pharm,2005,62:917-920.
6.Kunac DL,Reith DM.Identification of priorities for medication safety in neonatal intensive care.Drug Saf,2005,28:251-261.
7.Apkon M,Leonard J,Probst L,et al.Design of a safer approach to intravenous drug infusions:failure mode effects analysis.Qual Saf Health Care,2004;13(4):265-271.
8.郝宏恕,杨士梁,郭宜祯等.运用前瞻性风险管理模式提升中医针刺病人安全.华夏医药,2008,3(3):203-205.
9.施雁,阮华英,戴慧珊等.应用6Sigman失效模式降低静脉置管感染率,中华护理杂志,2006,41(10):913-915.
10.Linkin DR(Division of Infectious Diseases,Department of Medicine,Center for Clinical Epidemiology and Biostatistics,University of Pennsylvania),Sausman C,Sausman L,et al.Applicability of Healthcare Failure Mode and Effects Anlaysis to healthcare eidemiology:evaluation of the sterilization and use of surgical instruments.Clin Infect Dis,2005,41(7):1014-9.
11.Jan S Krouwer.An improved failure mode effects analysis for hospitals.Arch Pathol Lab Med,2004;128(6):663-667
12.Reiling John G,Knutzen Barbara L,Stoecklein Mike.FME A-the care for medical errors.Quality Progress,2003;36(8):67-71.
13.Singh R,Servoss T,Kalsman M,et al.Estimating impacts on safety caused by the introduction of electronic medical records in primary care[j].Inform Prim Care,2004,(12):235-242.
14.DeRosier J,Stalhandske E,Bagian JP,et al.Using health care Failure Mode and Effect Analysis:the VA National Center for Patient Safety's prospective risk analysis system Jt Comm J Qual Improv,2002;28(5):248-67,209.
15.Nichols JH,Bartholomew C,Brunton M,et al.Reducing medical errors through barcoding atthe point of care.Clin Leadersh Manag Rev,2004;18(6):328-334.
16.Blanchard J,Clinton P,De Lorimier K,et al.FME A utilization as part of the implementation process of computerized physician order entry in a procedure area Medinfo,2004;2004(CD):1529
17.Capunzo M,Cavallo P,Boccia G,et al.A FME A clinical laboratory case study:how to make problems and improvements measurable.Clin Leadersh Manag Rev,2004;18(1):37-41.
18.Precidential&Congressional Commission on Risk Assessment and Risk Management[R].Final Report;Framework for Environmental Health Risk Management Vol.1,Risk Assessment and Risk Management in Regulatory decision -Making Vol.2,Posted in RiskWorld on March 1997,27.
19.Reiling John G,Knutzen Barbara L,Stoecklein Mike.FMEA-the care for medical errors[J].Quality Progress,2003,36(8):67-71.
20.Kohn LT,Corrigan JM,Donaklson MS.Institute of Medicine To Err is Human:Building a Safer Health System[M].Waxhington.DC:National Academy Press,1999.
21.刘碧瑶,沈毅.“失效模式和效果分析”降低医院医疗风险的研究进展.国外医学,2005.2:73-76.
22.陈春梅,朱秀文,刘江南.FMEA在项目风险管理中的应用研究[J].河北建筑科技学院学报,2004,21(3):83-87
23.王文旭.FMEA技术在危险源辨识、风险评价、风险控制策划中的应用[J]。中国质量认证,2004,8:49-51.
24.丁志新,陈晓彤.使用软件实现FMEA数据管理与分析[J]。电子质量,2004,8:54-56
25.敖景.失效模式及后果影响分析.电子质量,1999,10:39-42.