血压监视器

高血压每年在全球范围内死亡人数几乎超过1000万人,并且是导致全球残疾的主要原因。 在大多数高血压患者中,血压控制得不够充分,如果控制和降低血压,可以防止数百万人死亡,中风,心脏病发作和其他心血管事件发生。 大多数成年人不知道自己有高血压,因此被称为’无声杀手’。

然而,与高血压(高血压)及其治疗的诊断和管理有关的所有假设依赖于事实上 准确 的血压设备。

因此,我们得出结论,目前市场上出售的超过80%的血压监测仪未被证明是准确的

血压监视器的准确性

简介

所有关于高血压诊断和治疗的假设都依赖于血压的准确测量。

血压测量的历史

血压测量的历史令人着迷。有关几个世纪以来血压测量的开始和演变的一般历史,请参见参考文献1至5。

开发血压设备验证

所有关于高血压诊断和治疗的决定都依赖于准确的测量。首先独立验证血压装置的努力是在1982年[6],并且在1989年提出应该为血压测量装置的独立验证生成一个标准化的方案。在20世纪80年代后期,美国国家标准学会(ANSI)和医疗器械促进协会(AAMI)和德国皮肤研究所(DIN)发布了血压测量装置的标准,并且已经有此后进行了几次修订(参见下面的血压监测器验证协议)。 1990年,英国高血压社会议定书发表[8]并于1993年修订。[9]该议定书于2002年由欧洲高血压学会国际议定书继承[10],2010年修订的国际议定书为该协议是世界上用于评估血压测量设备最广泛使用的协议。 [11]根据这些协议已经验证了数百个设备。

血压测量准则

国家和国际高血压社会发布了有关高血压管理和药物治疗的指南,但需要出版专门用于测量血压的指南,多年来Medaval的科学专家小组的成员已经认识到并提出了这些指南。 [12-21]

血压监测仪的准确性 - 参考文献

References

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  4. O’Brien E. Ave atque vale: the centenary of clinical sphygmomanometry. Lancet. 1996;348(9041):1569-70. PMID: 8950887.
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  7. O’Brien E, O’Malley K, Sheridan J. The need for a standardized protocol for validating non-invasive blood pressure measuring devices. J Hypertens. 1989;7(3):S19-S20. PMID: 2760713.
  8. O’Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O’Malley K, Jamieson M, Altman D, Bland M, Atkins N. The British Hypertension Society Protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Hypertens. 1990;8(7):607-19. PMID: 2168451.
  9. O’Brien E, Petrie J, Littler WA, de Swiet M, Padfield PL, Altman D, Bland M, Coats A, Atkins N. The British Hypertension Society Protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993;11(suppl 2):S43-S63.
  10. O’Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B, Palatini P, Atkins N, Gerin W; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. Working Group on Blood Pressure Monitoring of the European Society of Hypertension International protocol for validation of blood pressure measuring devices in adults. Blood Press Monit. 2002;7(1):3-17. PMID: 12040236.
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  13. Amery A, Brunner HR, Clement DL, Distler A, Ganten D, Gotzen R, Imai Y, Mancia G, Meyer-Sabellek W, O’Brien E, Pickering T. Consensus document on non-invasive ambulatory blood pressure monitoring. The Scientific Committee. J Hypertens. 1990;8(suppl 6):135-40. PMID: 2081994.
  14. O’Brien E, Coats A, Owens P, Petrie J, Padfield P, Littler WA, de Swiet MA, Mee F. Use and interpretation of ambulatory blood pressure monitoring: recommendations of the British Hypertension Society. BMJ. 2000;320(7242):1128-34. PMID: 10775227.
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  16. O’Brien E, Asmar R, Beilin L, Imai Y, Mallion J-M, Mancia G, Mengden T, Myers M, Padfield P, Palatinin P, Parati G, Pickering T, Redon J, Staessen J, Stergiou G, Verdecchia P; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure measurement. J Hypertens. 2003;21:821-48. PMID: 12714851.
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  18. O’Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G, Clement D, de la Sierra A, de Leeuw P, Dolan E, Fagard R, Graves J, Head GA, Imai Y, Kario K, Lurbe E, Mallion JM, Mancia G, Mengden T, Myers M, Ogedegbe G, Ohkubo T, Omboni S, Palatini P, Redon J, Ruilope LM, Shennan A, Staessen JA, vanMontfrans G, Verdecchia P, Waeber B, Wang J, Zanchetti A, Zhang Y; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013;31(9):1731-68. doi: 10.1097/HJH.0b013e328363e964. PMID: 24029863. Erratum in J Hypertens. 2013;31(12):2467.
  19. Stergiou GS, Parati G, Asmar R, O’Brien E; European Society of Hypertension Working Group on Blood Pressure Monitoring. Requirements for professional office blood pressure monitors. J Hypertens. 2012;30(3):537-42. doi: 10.1097/HJH.0b013e32834fcfa5. PMID 22241143.
  20. Stergiou GS, Karpettas N, Atkins N, O’Brien E. European Society of Hypertension International Protocol for the validation of blood pressure monitors: a critical review of its application and rationale for revision. Blood Press Monit. 2010;15(1):39-48. doi: 10.1097/MBP.0b013e3283360eaf. PMID: 20087174.
  21. Stergiou GS. Office blood pressure measurement with electronic devices: has the time come? Am J Hypertens. 2008;21(3):246. doi: 10.1038/ajh.2007.78. PMID: 18311123.
用于血压监测的验证协议

Current Protocols

ESH

ESH-IP:2010

O’Brien E, Atkins N, Stergiou G, Karpettas N, Parati G, Asmar R, Imai Y, Wang J, Mengden T, Shennan A; Working Group on Blood Pressure Monitoring of the European Society of Hypertension European Society of Hypertension. International Protocol revision 2010 for the validation of blood pressure measuring devices in adults. Blood Press Monit. 2010;15:23-38. doi: 10.1097/MBP.0b013e3283360e98. PMID: 20110786. Erratum in Blood Press Monit. 2010;15(3):171-2.

AAMI/ANSI/ISO and DIN/EN

81060-2:2013

Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-2:2013, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Arlington, VA, USA: AAMI; 2013. Preview available here.

idem quod

Deutsches Institut für Normung. DIN EN ISO 81060-2:2014-10: Nichtinvasive Blutdruckmessgeräte – Teil 2: Klinische Prüfung der automatisierten Bauart (ISO 81060-2:2013); Deutsche Fassung EN ISO 81060-2:2014. Berlin, Deutschland: DIN; 2014.

81060-1:2013

Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-1:2007/(R)2013, Non-Invasive Sphygmomanometers – Part 1: Requirements and Test Methods for Non-Automated Measurement Type. Arlington, VA, USA: AAMI; 2013. Preview available here.

IEEE

1708:2014

IEEE Engineering in Medicine and Biology Society. 1708-2014 – IEEE Standard for Wearable Cuffless Blood Pressure Measuring Devices. Piscataway, New Jersey, USA: IEEE; 2014. Available from here.

DHL

DHL:2016

Deutsche Hochdruckliga e.V. DHL® Deutsche Gesellschaft für Hypertonie und Prävention [German Hypertension League e.V. DHL® German Society for Hypertension and Prevention]. Klinische Prüfung von Blutdruckmessgeräten zur Erlangung eines Prüfsiegels (Prüfsiegel DHL®: 2016-10). [Clinical testing of blood pressure monitors for obtaining a Quality Seal (Quality Seal DHL®: 2016-10).] Heidelberg: DHL; 2016. Download here.

以前的协议

ESH

ESH-IP:2002

O’Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, Mengden T, Imai Y, Waeber B, Palatini P, Atkins N, Gerin W; Working Group on Blood Pressure Monitoring of the European Society of Hypertension. Working Group on Blood Pressure Monitoring of the European Society of Hypertension International protocol for validation of blood pressure measuring devices in adults. Blood Press Monit. 2002;7(1):3-17. PMID: 12040236.

BHS

BHS:1993

O’Brien E, Petrie J, Littler WA, de Swiet M, Padfield PL, Altman D, Bland M, Coats A, Atkins N. The British Hypertension Society Protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993;11(suppl 2):S43-S63. Download here.

BHS:1990

O’Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O’Malley K, Jamieson M, Altman D, Bland M, Atkins N. The British Hypertension Society Protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Hypertens. 1990;8(7):607-19. PMID: 2168451.

AAMI/ANSI/ISO

81060-2:2009

Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-2:2009, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Arlington, VA, USA: AAMI; 2009.

81060-1:2007

Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-1:2007, Non-Invasive Sphygmomanometers – Part 1: Requirements and Test Methods for Non-Automated Measurement Type. Arlington, VA, USA: AAMI; 2008.

idem quod

Deutsches Institut für Normung, DIN EN ISO 81060-1:2012-08: Nicht invasive Blutdruckmessgeräte – Teil 1: Anforderungen und Prüfverfahren der nicht-automatisierten Bauart (ISO 81060-1:2007); Deutsche Fassung EN ISO 81060-1:2012. Berlin, Deutschland: DIN; 2012.

SP10:2006

American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:2002/A2:2006, Manual, electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 2006.

SP10:2003

American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:2002/A1:2003, Manual, electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 2003.

SP10:2002

American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:2002, Manual, electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 2003.

SP10:1996

American National Standards Institute, ANSI/AAMI SP10:1992/A1:1996, Association for the Advancement of Medical Instrumentation. American National Standard. Electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 1996.

SP10:1992

American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:1992, Electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 1993.

SP10:1987

American National Standards Institute, Association for the Advancement of Medical Instrumentation. ANSI/AAMI SP10:1987, Electronic or automated sphygmomanometers. Arlington, VA, USA: AAMI; 1987.

EN

1060-3:2009

CEN Technical Committee 205. EN 1060-3:1997+A2:2009: Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems. Brussels, Belgium: CEN; 2009. CEN information here.

1060-4:2004

CEN Technical Committee 205. EN 1060-4:2004: Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers. Brussels, Belgium: CEN; 2004. CEN information here.

idem quod

Deutsches Institut für Normung. DIN EN 1060-4:2004-12: Nichtinvasive Blutdruckmessgeräte – Teil 4: Prüfverfahren zur Bestimmung der Messgenauigkeit von automatischen nichtinvasiven Blutdruckmessgeräten; Deutsche Fassung EN 1060-4:2004. Berlin, Deutschland: DIN; 2004.

DIN

58130:1996

Deutsches Institut für Normung. DIN 58130:1996-12: Nichtinvasive Blutdruckmeßgeräte – Klinische Prüfung [Non-invasive sphygmomanometers – Clinical investigation]. Berlin, Deutschland: DIN; 1996.

58130:1995

Deutsches Institut für Normung. DIN 58130:1995-01: Nichtinvasive Blutdruckmeßgeräte – Klinische Prüfung [Non-invasive sphygmomanometers – Clinical investigation]. Berlin, Deutschland: DIN; 1995.

DHL

DHL:2007

Deutsche Hochdruckliga (DHL) [German Hypertension League]. Klinische Prüfung von Blutdruckmessgeräten zur Erlangung eines Prüfsiegels der Deutschen Liga Hochdruckliga. [Clinical testing of blood pressure monitors for obtaining a German Hypertension League Quality Seal.] Heidelberg: DHL; 1999/A1:2007.

DHL:1999

Deutsche Hochdruckliga (DHL) [German Hypertension League]. Klinische Prüfung von Blutdruckmessgeräten zur Erlangung eines Prüfsiegels der Deutschen Liga Hochdruckliga. [Clinical testing of blood pressure monitors for obtaining a German Hypertension League Quality Seal.] Heidelberg: DHL; 1999.