Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Global proliferation and clinical consequences of non-validated automated BP devices

Journal of Human Hypertension volume 37, pages 115–119 (2023)Cite this article

Subjects

Abstract

Professional societies, guideline writing committees, and other interested parties emphasize the importance of accurate measurement of blood pressure for clinical and public health decisions related to prevention, treatment, and follow-up of high blood pressure. Use of a clinically validated instrument to measure blood pressure is a central component of measurement accuracy and precision. Despite this, most regulatory authorities do not specify validation requirements that manufacturers must meet to sell their blood pressure measurement devices. Likewise, device validity is not a major area of focus for most consumers and healthcare providers, perhaps because they assume it is a pre-requisite for market approval. This has led to a global proliferation of non-validated blood pressure measurement devices, with only a small minority of blood pressure measurement devices having passed internationally accepted validation protocols. The clinical consequences are likely to be significant because non-validated devices are more likely to provide inaccurate estimates of blood pressure compared with validated devices. Even small inaccuracies in blood pressure measurement can result in substantial misdiagnosis and mistreatment of hypertension. There is an urgent need for clinical validation of blood pressure measurement devices prior to marketing them to consumers. There is also need for simplification of the process for consumers and healthcare providers to determine whether a blood pressure measurement device has successfully met an internationally accepted test of validity.

This is a preview of subscription content, access via your institution

Relevant articles

Open Access articles citing this article.

Access options

Rent or buy this article

Prices vary by article type

from$1.95

to$39.95

Learn more

Prices may be subject to local taxes which are calculated during checkout

Fig. 1: Comparison of research quality (trial) and routine (clinic) blood pressure measurements in 4,796 Systolic Blood Pressure Intervention Trial (SPRINT) participants.
Fig. 2: Effect of errors in blood pressure measurement on the prevalence of hypertension.
Fig. 3: Effect of errors in blood pressure measurement on the prevalence of hypertension.

References

  1. Whelton SP, McEvoy JW, Shaw L, Psaty BM, Lima JAC, Budoff M, et al. Association of normal systolic blood pressure level with cardiovascular disease in the absence of risk factors. JAMA Cardiol. 2020;5:1011–8.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R, Prospective Studies C. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360:1903–13.

    Article  PubMed  Google Scholar 

  3. Rapsomaniki E, Timmis A, George J, Pujades-Rodriguez M, Shah AD, Denaxas S, et al. Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1.25 million people. Lancet. 2014;383:1899–911.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Fuchs FD, Whelton PK. High blood pressure and cardiovascular disease. Hypertension. 2020;75:285–92.

    Article  CAS  PubMed  Google Scholar 

  5. Whelton PK. Evolution of blood pressure clinical practice guidelines: a personal perspective. Can J Cardiol. 2019;35:570–81.

    Article  PubMed  Google Scholar 

  6. Armitage P, Rose GA. The variability of measurements of casual blood pressure. I. A laboratory study. Clin Sci. 1966;30:325–35.

    CAS  PubMed  Google Scholar 

  7. Armitage P, Fox W, Rose GA, Tinker CM. The variability of measurements of casual blood pressure. II. Survey experience. Clin Sci. 1966;30:337–44.

    CAS  PubMed  Google Scholar 

  8. Rakotz MK, Townsend RR, Yang J, Alpert BS, Heneghan KA, Wynia M, et al. Medical students and measuring blood pressure: results from the American Medical Association Blood Pressure Check Challenge. J Clin Hypertens. 2017;19:614–9.

    Article  Google Scholar 

  9. Campbell NRC, Padwal R, Picone DS, Su H, Sharman JE. The impact of small to moderate inaccuracies in assessing blood pressure on hypertension prevalence and control rates. J Clin Hypertens. 2020;22:939–42.

    Article  Google Scholar 

  10. Roerecke M, Kaczorowski J, Myers MG. Comparing automated office blood pressure readings with other methods of blood pressure measurement for identifying patients with possible hypertension: a systematic review and meta-analysis. JAMA Intern Med. 2019;179:351–62.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Drawz PE, Agarwal A, Dwyer JP, Horwitz E, Lash J, Lenoir K, et al. Concordance between blood pressure in the systolic blood pressure intervention trial and in routine clinical practice. JAMA Intern Med. 2020;180:1655–63.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13–e115.

    CAS  PubMed  Google Scholar 

  13. Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J. 2018;39:3021–104.

    Article  PubMed  Google Scholar 

  14. Muntner P, Shimbo D, Carey RM, Charleston JB, Gaillard T, Misra S, et al. Measurement of blood pressure in humans: a scientific statement from the American Heart Association. Hypertension. 2019;73:e35–e66.

    Article  CAS  PubMed  Google Scholar 

  15. International Standards Organization. ISO 81060-2:2018. Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type. 2020. https://www.iso.org/standard/73339.html.

  16. International Standards Organization. ISO 81060-2:2018/AMD 1:2020Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated measurement type—Amendment 1 2020. https://www.iso.org/standard/75432.html.

  17. Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, et al. 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;71:368–74.

    Article  CAS  PubMed  Google Scholar 

  18. Akpolat T, Dilek M, Aydogdu T, Adibelli Z, Erdem DG, Erdem E. Home sphygmomanometers: validation versus accuracy. Blood Press Monit. 2009;14:26–31.

    Article  PubMed  Google Scholar 

  19. Jung MH, Kim GH, Kim JH, Moon KW, Yoo KD, Rho TH, et al. Reliability of home blood pressure monitoring: in the context of validation and accuracy. Blood Press Monit. 2015;20:215–20.

    Article  PubMed  Google Scholar 

  20. Sharman JE, Padwal R, Campbell NRC. Global marketing and sale of accurate cuff blood pressure measurement devices. Circulation. 2020;142:321–3.

    Article  PubMed  Google Scholar 

  21. Alpert BS. Can ‘FDA-cleared’ blood pressure devices be trusted? A call to action. Blood Press Monit. 2017;22:179–81.

    Article  PubMed  Google Scholar 

  22. Picone DS, Deshpande RA, Schultz MG, Fonseca R, Campbell NRC, Delles C, et al. Nonvalidated home blood pressure devices dominate the online marketplace in Australia: major implications for cardiovascular risk management. Hypertension. 2020;75:1593–9.

    Article  CAS  PubMed  Google Scholar 

  23. John O, Campbell NRC, Brady TM, Farrell M, Varghese C, Velazquez Berumen A, et al. The 2020 “WHO technical specifications for automated non-invasive blood pressure measuring devices with cuff”. Hypertension. 2021;77:806–12.

    Article  CAS  PubMed  Google Scholar 

  24. Shimbo D, Artinian NT, Basile JN, Krakoff LR, Margolis KL, Rakotz MK, et al. Self-measured blood pressure monitoring at home: a joint policy statement from the American Heart Association and American Medical Association. Circulation. 2020;142:e42–e63.

    Article  PubMed  Google Scholar 

  25. Fan WG, Xie F, Wan YR, Campbell NRC, Su H. The impact of changes in population blood pressure on hypertension prevalence and control in China. J Clin Hypertens. 2020;22:150–6.

    Article  Google Scholar 

  26. Sakhuja S, Jaeger BC, Akinyelure OP, Bress AP, Shimbo D, Schwartz JE, et al. Potential impact of systematic and random errors in blood pressure measurement on the prevalence of high office blood pressure in the United States. J Clin Hypertens (Greenwich). 2022. https://doi.org/10.1111/jch.14418. Online ahead of print.

  27. Picone DS, Padwal R, Campbell NRC, Boutouyrie P, Brady TM, Olsen MH, et al. How to check whether a blood pressure monitor has been properly validated for accuracy. J Clin Hypertens. 2020;22:2167–74.

    Article  Google Scholar 

  28. Graves JW. A survey of validated automated home blood pressure monitors available for the Internet shopper. Blood Press Monit. 2005;10:103–7.

    Article  PubMed  Google Scholar 

  29. Pan American Health Organization. HEARTS in the America’s regulatory pathway to the exclusive use of validated blood pressure measuring devices. PAHO IRIS General Publications [Internet]. 2021. https://iris.paho.org/handle/10665.2/55382.

Download references

Funding

PKW was supported by a Centers for Research Excellence grant from the National Institute of General Medical Sciences, National Institutes of Health (P20GM109036). DSP was supported by a Postdoctoral Fellowship (Reference 104774) from the National Heart Foundation of Australia.

Author information

Authors and Affiliations

  1. Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA

    Paul K. Whelton

  2. Menzies institute for Medical Research, University of Tasmania, Hobart, TAS, Australia

    Dean S. Picone & James E. Sharman

  3. Department of Medicine, University of Alberta, Edmonton, AB, Canada

    Raj Padwal

  4. Department of Medicine, University of Calgary, Calgary, AB, Canada

    Norm R. C. Campbell

  5. Department of Medicine, University of Minnesota, Minneapolis, MN, USA

    Paul Drawz

  6. American Medical Association, Chicago, IL, USA

    Michael K. Rakotz

  7. Department of Medicine and Surgery, University of Milano-Bicocca, and Istituto Auxologico Italiano, IRCCS, Milan, Italy

    Gianfranco Parati

  8. Beijing Hypertension League Institute, Beijing, China

    Xin-Hua Zhang

Authors
  1. Paul K. Whelton
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Dean S. Picone
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Raj Padwal
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Norm R. C. Campbell
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Paul Drawz
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Michael K. Rakotz
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Gianfranco Parati
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Xin-Hua Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. James E. Sharman
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

PKW wrote the initial draft and DSP, RP, NRCC, PD, MKR, GP, X-H Z, and JES provided modifications to the text.

Corresponding author

Correspondence to Paul K. Whelton.

Ethics declarations

Competing interests

None for PKW, PD, MKR, and XHZ. DSP and JES are consultants for HEARTS in the Americas, an initiative of the Pan American Health Organization. JES is principal investigator of a National Health and Medical Research Council partnership grant (S0026615) that includes a medical technology company that manufactures a central blood pressure monitor. RP is CEO of mmHg Inc., a digital health company and provider of BP telemonitoring software. NRCC reports personal fees from Resolve to Save Lives (RTSL), the Pan American Health Organization and the World Bank, unrelated to the current manuscript content; and serving as an unpaid consultant on dietary sodium and hypertension control for numerous governmental and nongovernmental organizations. GP reports honoraria for lectures supported by Omron HealthCare.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Whelton, P.K., Picone, D.S., Padwal, R. et al. Global proliferation and clinical consequences of non-validated automated BP devices. J Hum Hypertens 37, 115–119 (2023). https://doi.org/10.1038/s41371-022-00667-z

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41371-022-00667-z

This article is cited by

Search

Advanced search

Quick links