The DOI matches its Crossref record.
Validation Status of Blood Pressure Measuring Devices Sold Globally
Open accessAbstract
This study uses data from the publicly available Medaval database to determine the number of upper arm cuff and wrist cuff blood pressure measuring devices sold globally as well as the percentages of those devices that have been clinically validated for accuracy.
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Many of the more than 3500 automated BPMD models are without evidence of having passed validation testing.
“hundreds of companies manufacturing more than 3500 different models of automated BPMDs, many of which are without evidence of having passed validation testing [25–29].”
From Automated 'oscillometric' blood pressure measuring devices: how they work and what they measure (2022) · cites this paper as [25]
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Research works printed but not linked: 5
- Murray, 2020, Global burden of 87 risk factors in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019., Lancet, 396, 1223, 10.1016/S0140-6736(20)30752-2 · DOI · Paper page
- Akpolat, 2011, Inaccuracy of home sphygmomanometers: a perspective from clinical practice., Blood Press Monit, 16, 168, 10.1097/MBP.0b013e328348ca52 · DOI
- Picone, 2020, Nonvalidated home blood pressure devices dominate the online marketplace in Australia: major implications for cardiovascular risk management., Hypertension, 75, 1593, 10.1161/HYPERTENSIONAHA.120.14719 · DOI · Paper page
- Stergiou, 2018, Validation protocols for blood pressure measuring devices in the 21st century., J Clin Hypertens (Greenwich), 20, 1096, 10.1111/jch.2018.20.issue-7 · DOI
- Picone, 2020, How to check whether a blood pressure monitor has been properly validated for accuracy., J Clin Hypertens (Greenwich), 22, 2167, 10.1111/jch.v22.12 · DOI
Cited by
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2024 ESC Guidelines for the management of elevated blood pressure and hypertension
McEvoy, J. W., McCarthy, C. P., Bruno, R. M., Brouwers, S., Canavan, M. D., Ceconi, C., Christodorescu, R. M., Daskalopoulou, S. S., Ferro, C. J., Gerdts, E., et al. (2024) · European Heart Journal · doi:10.1093/eurheartj/ehae178 · Cited by 2,298
Self-citationAutomated 'oscillometric' blood pressure measuring devices: how they work and what they measure
Sharman, J. E., Tan, I., Stergiou, G. S., Lombardi, C., Saladini, F., Butlin, M., Padwal, R., Asayama, K., Avolio, A., Brady, T. M., et al. (2022) · Journal of Human Hypertension · doi:10.1038/s41371-022-00693-x · Cited by 84
Self-citationGoupil, R., Tsuyuki, R. T., Santesso, N., Terenzi, K. A., Habert, J., Cheng, G., Gysel, S. C., Bruneau, J., Leung, A. A., Campbell, N. R. C., et al. (2025) · Canadian Medical Association Journal · doi:10.1503/cmaj.241770 · Cited by 60
“17 In Canada, 90% of BP devices sold at pharmacies are validated compared with only 45% of BP devices sold by online retailers.”
Self-citationSharman, J. E., Ordunez, P., Brady, T., Parati, G., Stergiou, G., Whelton, P. K., Padwal, R., Olsen, M. H., Delles, C., Schutte, A. E., et al. (2022) · Journal of Human Hypertension · doi:10.1038/s41371-022-00747-0 · Cited by 31
Self-citation
Metadata
- Authors
- Picone, D. S., Campbell, N. R. C., Schutte, A. E., Olsen, M. H., Ordunez, P., Whelton, P. K., & Sharman, J. E.
- Affiliations
- University of Tasmania (AU)
- University of Calgary (CA)
- UNSW Sydney (AU)
- University of Southern Denmark (DK)
- Department of Non-communicable Diseases and Mental Health, Pan American Health Organization, Washington, DC
- Tulane University (US)
- Corresponding author
- Sharman, James E.
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2022-02-15
- Volume
- 327
- Issue
- 7
- Pages
- 680
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC8848194
- OpenAlex
- W4213270728
- Cited by
- 66
- References
- 0
- Citations by year
- 2026: 8 · 2025: 27 · 2024: 9 · 2023: 13 · 2022: 8
- FWCI
- 9.92
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Figshare (submittedVersion, cc-by)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
- Funders
- Sanofi
- World Bank Group
- World Health Organization
- National Heart Foundation of Australia (104774)
- Servier
- National Institutes of Health (UL1TR002548, AG061388, AG062272)
- Pan American Health Organization
- Clinical and Translational Science Collaborative of Cleveland, School of Medicine, Case Western Reserve University (1UL1TR002548, 1UL1TR002548-01)
- Medical Research Council
- National Health and Medical Research Council
- National Institute on Alcohol Abuse and Alcoholism (R01AA029831)
- National Institute on Aging (AG062272, AG057557, AG061388, R01AG057557)
- National Institute on Drug Abuse (UG1DA049435)
- National Cancer Institute (R25CA221718)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
- Keywords
- blood pressure measuring devices, upper arm cuff, clinical validation, device accuracy, consumer health devices
- MeSH terms
- Self-Testing, Blood Pressure Determination, Humans, Hypertension, Self Care
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