Clinical Accuracy of Blood Pressure Monitors
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 device validation
All decisions relating to the diagnosis and treatment of high blood pressure are dependent on accurate measurement. The first efforts to have blood pressure devices clinically validated independently was in 1982 [6] and, in 1989, it was proposed that a standardised protocol should be produced for the independent validation of blood pressure measuring devices [7]. In the late nineteen-eighties, the American National Standards Institute (ANSI), with the Association for the Advancement of Medical Instrumentation (AAMI), and the Deutsches Institut für Normung (DIN) published standards for blood pressure measuring devices and there have been several revisions since then (see Clinical Validation Protocols for Blood Pressure Monitors 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 [11] became the protocol used most widely in the world for evaluating blood pressure measuring devices.
Current Protocols
The first universal protocol, called ISO 81060-2:2018 was published in December 2018 [12]. This extended the previous ISO 81060-2:2013 protocol [13] to include elements of the 2010 ESH protocol [11, 14, 15]. It was adopted by AAMI and ANSI in August 2019 [16] and by the EU and Great Britain in December 2019 [17] before becoming the official EU harmonised protocol on 25 March 2020 [18]. Therefore, this will be the harmonised protocol for blood pressure monitors that will be required for MDR compliance with EU 2017/745 regulations [19]. These regulations were implemented on 26 May 2021 [20].
Electronic Instructions for Medical Devices
In the light of EU MDR, the European Commission as also implemented regulations regarding instructions for medical devices being supplied in electronc form. [21]
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. [22-31]
  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 easurement. 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. ISO/TC 121/SC 3. ISO 81060-2:2018, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Geneva, Switzerland: ISO; 2018 Nov 23. Information here.
  13. 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.
  14. Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, Frick G, Friedman B, Graßl T, Ichikawa T, Ioannidis JP, Lacy P, McManus R, Murray A, Myers M, Palatini P, Parati G, Quinn D, Sarkis J, Shennan A, Usuda T, Wang J, Wu CO, O’Brien E. A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. Hypertension. 2018 Mar; 71 (3):368-374. doi: 10.1161/HYPERTENSIONAHA.117.10237. Epub 2018 Jan 31. PMID: 29386350.
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  16. Association for the Advancement of Medical Instrumentation, American National Standards Institute, International Organization for Standardization. AAMI/ANSI/ISO 81060-2:2019, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Arlington, VA, USA: AAMI; 2019 Aug 20.
  17. British Standards, European Norme, International Organization for Standardization. BS EN ISO 81060-2:2019, Non-invasive Sphygmomanometers – Part 2: Clinical Investigation of Automated Measurement Type. Brussels, Belgium: CEN; 2019 Dec 9.
  18. The European Commission. Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC. Official Journal of the European Union. 2020 Mar 25; C/2020/1901( L 90):1-24. Available from: eur-lex.europa.eu.
  19. The European Parliament and the Council of the European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance). Official Journal of the European Union. 2017 May 05;60(L 117):1-175. Available from: eur-lex.europa.eu.
  20. The European Commission. Public health: Stronger rules on medical devices. (Press release). 2021 May 26;IP/21/2617. Available from: ec.europa.eu.
  21. The European Commission. Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices. Official Journal of the European Union. 2021 Dec 15;64(L 448):32-38. Available from: eur-lex.europa.eu.
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