血压监测仪,80%可能不准确。

blood pressure Measurement

血压计用于诊断高血压和低血压

一个准确的血压监测器是必不可少的,但只有五分之一已被验证。 

高血压(高血压)每年在全球范围内杀死近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,就会阻止数百万的死亡,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,高血压(Hypertension)的诊断和治疗及其治疗依赖于准确的测量。 这意味着血压监测仪必须严格按照标准协议进行验证。

目前市场上销售的血压监视器中超过80%未被证明是准确的。 检查我们的注册表上的血压监视器,这是世界上最大的注册表,以查看它是否已被验证。

血压监视器准确度

介绍

与高血压的诊断和管理有关的所有假设都取决于准确的血压测量。

血压测量史

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,请参阅参考文献1至5。

开发血压监测仪验证

所有与高血压诊断和治疗相关的决定都取决于准确的测量。第一次独立验证血压监测器的努力是在1982年[6],并且在1989年,提出应该为血压监测器的独立验证制定标准化的方案。 [7]在20世纪80年代末,美国国家标准协会(ANSI),医疗器械促进协会(AAMI)和德国研究所皮革Normung(DIN)公布了血压测量装置的标准,并且自那时以来的一些修订(见下面的血压监测验证协议)。 1990年,英国高血压协会议定书[8]出版并于1993年修订。[9]该议定书于2002年由欧洲高血压协会国际议定书[10]和修订后的国际议定书继承。 2010年,是世界上用于评估血压测量装置的最广泛的协议。 [11]

蔑视血压监测验证

虽然已经根据这些协议验证了数百种设备,但它们仅占市场的不到20%。正确的血压监测验证仍然不普遍,虚假声称的“临床验证”是地方性的。实际上,如果您检查Medaval Registry,您会发现许多公司完全忽略了血压监测器的验证。许多这些未经验证的设备在亚马逊上进行广告宣传和销售,通常采用不科学的“顶级”和“最佳”购买清单。根据正确协议的正确验证,Medaval是唯一基于经过验证的准确性对设备进行评级的网站。如果本网站未列出血压监测器已经过验证,则无法保证其提供准确的测量结果。

血压测量指南

国家和国际高血压学会发布了关于高血压管理和药物治疗的指南,但多年来,Medaval科学专家小组的成员已经认识到并且需要发布专门用于测量血压的指南。 [12-21]

血压监视器验证协议

当前协议

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.

先前的协议

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.

References

  1. Laher M, O’Brien E. In search of Korotkoff. Br Med J (Clin Res Ed). 1982;285(6357):1796-8. PMID: 6816372.
  2. O’Brien E, Fitzgerald D. The history of indirect blood pressure measurement. In Blood Pressure Measurement. Eds. E. O’Brien and K. O’Malley. Handbook of Hypertension. Eds. WH Birkenhager and JL Reid. Elsevier. Amsterdam. 1991. pp. 1-54.
  3. O’Brien E, Fitzgerald D. The history of blood pressure measurement. J Human Hypertens. 1994;8(2):73-84. PMID: 8207743.
  4. O’Brien E. Ave atque vale: the centenary of clinical sphygmomanometry. Lancet. 1996;348(9041):1569-70. PMID: 8950887.
  5. O’Brien E. History of the Blood Pressure Unit at the Charitable Infirmary and Beaumont Hospital 1978-2006. Heartwise. Winter 2006. 12-18. Download here.
  6. Fitzgerald DJ, O’Malley K, O’Brien ET. Inaccuracy of London School of Hygiene sphygmomanometer. Br Med J (Clin Res Ed). 1982;284(6308):18-9. PMID: 6797622.
  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.
  11. 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.
  12. Stergiou GS, Karpettas N, Atkins N, O’Brien E. Impact of applying the more stringent validation criteria of the revised European Society of Hypertension International Protocol 2010 on earlier validation studies. Blood Press Monit. 2011;16:67–73. doi: 10.1097/MBP.0b013e32834331e7. PMID: 21258237.
  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.
  15. O’Brien E, Waeber B, Parati G, Staessen G, Myers MG. Blood pressure measuring devices: recommendations of the European Society of Hypertension. BMJ. 2001:322(7285):531-6. PMID: 11230071.
  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.
  17. Parati G ,Stergiou GS, Asmar R, Bilo G, de Leeuw P, Imai Y, Kario K, Lurbe E, Manolis A, Mengden T, O’Brien E, Ohkubo T, Padfield P, Palatini P, Pickering T, Redon J, Revera M, Ruilope LM, Shennan A, Staessen JA, Tisler A, Waeber B, Zanchetti A, Mancia G; ESH Working Group on Blood Pressure Monitoring. European Society of Hypertension guidelines for blood pressure monitoring at home: a summary report of the Second International Consensus Conference on Home Blood Pressure Monitoring. J Hypertens. 2008;26:1505-26. doi: 10.1097/HJH.0b013e328308da66. PMID: 18622223.
  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.

最佳血压监测仪4和5星级