How to check whether a blood pressure monitor has been properly validated for accuracy
Open accessAbstract
Hypertension guidelines recommend that blood pressure (BP) should be measured using a monitor that has passed validation testing for accuracy. BP monitors that have not undergone rigorous validation testing can still be cleared by regulatory authorities for marketing and sale. This is the situation for most BP monitors worldwide. Thus, consumers (patients, health professionals, procurement officers, and general public) may unwittingly purchase BP monitors that are non‐validated and more likely to be inaccurate. Without prior knowledge of these issues, it is extremely difficult for consumers to distinguish validated from non‐validated BP monitors. For the above reasons, the aim of this paper is to provide consumers guidance on how to check whether a BP monitor has been properly validated for accuracy. The process involves making an online search of listings of BP monitors that have been assessed for validation status. Only those monitors that have been properly validated are recommended for BP measurement. There are numerous different online listings of BP monitors, several are country‐specific and two are general (international) listings. Because monitors can be marketed using alternative model names in different countries, if a monitor is not found on one listing, it may be worthwhile cross‐checking with a different listing. This information is widely relevant to anyone seeking to purchase a home, clinic, or ambulatory BP monitor, including individual consumers for use personally or policy makers and those procuring monitors for use in healthcare systems, and retailers looking to stock only validated BP monitors.
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Blood pressure readings obtained in nonstandardized clinic practice are usually higher than those obtained by standardized measurement.
“Usually, BP readings obtained in nonstandardized practice in the clinic are higher than those obtained by standardized measurements.15,26,28–30”
From International Consensus on Standardized Clinic Blood Pressure Measurement – A Call to Action (2023) · cites this paper as [26]
The ‘Considerations beyond monitor validation for proper blood pressure measurement’ section says that failing to follow a proper protocol makes inaccurate readings more likely. It does not say that nonstandardized clinic readings are usually higher than standardized readings; searches for that comparison found no supporting passage. (LLM, conf=0.79)
Experimental — accuracy not yet measuredStandardization is essential because many aspects of blood pressure measurement, including the patient's physical condition, the clinic environment and the equipment, can readily produce inaccurate and unreliable values.
“Standardization is essential because there are many aspects of BP measurement, including the patient’s physical condition, clinic environment, and equipment that can readily result in inaccurate and unreliable values.23,25,26”
From International Consensus on Standardized Clinic Blood Pressure Measurement – A Call to Action (2023) · cites this paper as [26]
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- Authors
- Picone, D. S., Padwal, R., Campbell, N. R. C., Boutouyrie, P., Brady, T. M., Olsen, M. H., Delles, C., Lombardi, C., Mahmud, A., Meng, Y., Mokwatsi, G. G., Ordunez, P., Phan, H. T., Pucci, G., Schutte, A. E., Sung, K., Zhang, X., Sharman, J. E., & Collaborative, F. T. A. I. M. O. B. P. (.
- Affiliations
- University of Tasmania (AU)
- University of Alberta (CA)
- University of Calgary (CA)
- Inserm (FR)
- Johns Hopkins University (US)
- University of Southern Denmark (DK)
- University of Glasgow (GB)
- World Health Organization Regional Office for the Americas (US)
- King Saud bin Abdulaziz University for Health Sciences (SA)
- North-West University (ZA)
- Department of Non‐Communicable Diseases and Mental Health Pan American Health Organization Washington DC USA
- University of Perugia (IT)
- Kangbuk Samsung Hospital (KR)
- World Hypertension League Beijing China
- Corresponding author
- Sharman, James E.
- ORCID
- Venue
- The Journal of Clinical Hypertension
- Publisher
- Wiley
- Published
- 2020-10-05
- Volume
- 22
- Issue
- 12
- Pages
- 2167-2174
- ISSN
- 1524-6175 (ISSN-L)
- 1751-7176
- PMC
- PMC8030032
- OpenAlex
- W3089392505
- Cited by
- 52
- References
- 27
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 5 · 2023: 14 · 2022: 20 · 2021: 6
- FWCI
- 6.17
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Hypertension (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, other-oa)
- UTAS Research Repository (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Boloka Institutional Repository (North-west University) (submittedVersion)
- Funders
- Heart and Stroke Foundation of British Columbia and Yukon (RE/18/6/34217)
- 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 › Clinical practice guidelines implementation
- Keywords
- blood pressure monitors, device validation, measurement accuracy, consumer guidance, hypertension, ambulatory blood pressure monitoring, home blood pressure monitoring, regulatory approval
- MeSH terms
- Blood Pressure, Blood Pressure Determination, Humans, Hypertension, Reproducibility of Results, Blood Pressure Monitors, Blood Pressure Monitoring, Ambulatory, Sphygmomanometers
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