Blood Pressure Monitor, 80% are probably inaccurate.

Blood Pressure Monitor

A Blood Pressure Monitor is used to diagnose Hypertension and Hypotension

An accurate Blood Pressure Monitor is essential but only 1 in 5 have been validated. 

Hypertension (High Blood Pressure) kills nearly 10 million people annually worldwide and is the major cause of disability across the globe. In the majority of people with hypertension, blood pressure is inadequately controlled and if blood pressure was controlled and lowered, many millions of deaths, strokes, heart attacks and other cardiovascular events would be prevented. Most adult people do not not know they have high blood pressure and, for that reason, it has been termed the ‘Silent Killer’.

However, the diagnosis and the management of High Blood Pressure (Hypertension) and its treatment is dependent on accurate measurement. This means that the Blood Pressure Monitor must be validated strictly according to a standard protocol. 

Over 80% of all Blood Pressure Monitors sold on the market today are not proven to be accurate. Check your blood pressure monitor on our registry, the largest in the world to see if it has been validated.

Blood Pressure Monitor Accuracy

Introduction

All assumptions relating to the diagnosis and management of hypertension are dependent on the accurate measurement of blood pressure.

History of blood pressure measurement

The history of blood pressure measurement makes fascinating reading. For a general history of the beginnings and evolution of blood pressure measurement over the centuries, see references 1 to 5.

Development of blood pressure monitor validation

All decisions relating to the diagnosis and treatment of high blood pressure are dependent on accurate measurement. The first efforts to have a blood pressure monitor validated independently was in 1982 [6], and, in 1989, it was proposed that a standardised protocol should be produced for the independent validation of a blood pressure monitor. [7] In the late nineteen-eighties, the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI) and the Deutsches Institut fur Normung (DIN) published standards for blood pressure measuring devices and there have been several revisions since then (see Blood Pressure Monitor Validation Protocols below). In 1990, the British Hypertension Society Protocol was published [8] and revised in 1993. [9] This protocol was succeeded by the International Protocol of the European Society of Hypertension, in 2002, [10] and the revised International Protocol, published in 2010, is the protocol used most widely in the world for evaluating blood pressure measuring devices. [11]

Defiance of blood pressure monitor validation

While hundreds of devices have been validated according to these protocols, they only represent less than 20% of the market. Correct blood pressure monitor validation is still not widespread and spurious claims of “Clinical Validation” are endemic. Indeed, if you check the Medaval Registry, you will observe that many companies ignore blood pressure monitor validation altogether. Many of these non-validated devices are advertised and sold on Amazon, often under unscientific “Top” and “Best” buy lists. Medaval is the only site that star-rates devices based on proven accuracy, according to correct validation with correct protocols. If a blood pressure monitor is not listed on this site as validated, there is no guarantee that it provides accurate measurement.

Blood pressure measurement guidelines

National and international societies of hypertension publish guidelines on the management and drug treatment of hypertension but a need to publish guidelines devoted specifically to the measurement of blood pressure has been recognised and addressed by members of the Medaval’s Scientific Panel of experts over a number of years. [12-21]

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.

Blood Pressure Monitor Validation Protocols

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.

Previous Protocols

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.