Nonvalidated Home Blood Pressure Devices Dominate the Online Marketplace in Australia: Major Implications for Cardiovascular Risk Management
Open accessAbstract
Self-home blood pressure (BP) monitoring is recommended to guide clinical decisions on hypertension and is used worldwide for cardiovascular risk management. People usually make their own decisions when purchasing BP devices, which can be made online. If patients purchase nonvalidated devices (those not proven accurate according to internationally accepted standards), hypertension management may be based on inaccurate readings resulting in under- or over-diagnosis or treatment. This study aimed to evaluate the number, type, percentage validated, and cost of home BP devices available online. A search of online businesses selling devices for home BP monitoring was conducted. Multinational companies make worldwide deliveries, so searches were restricted to BP devices available for one nation (Australia) as an example of device availability through the global online marketplace. Validation status of BP devices was determined according to established protocols. Fifty nine online businesses, selling 972 unique BP devices were identified. These included 278 upper-arm cuff devices (18.3% validated), 162 wrist-cuff devices (8.0% validated), and 532 wrist-band wearables (0% validated). Most BP devices (92.4%) were stocked by international e-commerce businesses (eg, eBay, Amazon), but only 5.5% were validated. Validated cuff BP devices were more expensive than nonvalidated devices: median (interquartile range) of 101.1 (75.0–151.5) versus 67.4 (30.4–112.8) Australian Dollars. Nonvalidated BP devices dominate the online marketplace and are sold at lower cost than validated ones, which is a major barrier to accurate home BP monitoring and cardiovascular risk management. Before purchasing a BP device, people should check it has been validated at https://www.stridebp.org .
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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 [28]
The Results (p. 7) found that only 6.6% of 972 unique devices surveyed were validated or claimed equivalence, supporting the point that many lacked validation evidence. The Discussion (p. 11) also reports Medaval data for more than 3,000 devices, but the paper does not establish the claimed figure of more than 3,500 models. (LLM, conf=0.88)
Experimental — accuracy not yet measuredAn evaluation of home BP monitors sold online in Australia found that only 18.3% of upper-arm-cuff devices had been validated for accuracy, and validated cuff devices cost more than non-validated ones.
“A detailed evaluation of home BP monitoring (HBPM) devices available online in Australia reported that only 18.3% of upper-arm-cuff devices have been validated for accuracy, and that validated cuff BP devices are more expensive than non-validated devices17.”
From Blood pressure and its variability: classic and novel measurement techniques (2022) · cites this paper as [17]
Most cuffless BP devices require initial calibration for each user and periodic recalibration over time.
“Most of these devices require initial calibration in each user, which is usually performed by inputting a BP value measured using an upper-arm-cuff device or by inputting simple demographic data that are known to correlate with BP level (such as age and sex), with periodic recalibration required over time (every few hours, days or weeks).”
From Blood pressure and its variability: classic and novel measurement techniques (2022) · cites this paper as [17]
The Results (p. 7) and Discussion (p. 11) address the types and validation status of BP devices sold online, not how users calibrate them. Searches for cuffless-device calibration, demographic inputs, and periodic recalibration found no passage supporting the claim. (LLM, conf=0.76)
Experimental — accuracy not yet measuredMost wearable PPG BP devices are not validated, although some have recently been certified for medical use.
“Most devices are not validated [163] although some have recently been certified for medical use [164]–[166].”
From Wearable Photoplethysmography for Cardiovascular Monitoring (2022) · cites this paper as [163]
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Cites
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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 · see citing works
Self-citationHow to check whether a blood pressure monitor has been properly validated for accuracy
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., et al. (2020) · The Journal of Clinical Hypertension · doi:10.1111/jch.14065 · Cited by 52 · see citing works
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Self-citationMeasurements of arterial pressure and flow in vivo
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Self-citation
- Authors
- Picone, D. S., Deshpande, R. A., Schultz, M. G., Fonseca, R., Campbell, N. R. C., Delles, C., Hecht Olsen, M., Schutte, A. E., Stergiou, G., Padwal, R., Zhang, X.-H., & Sharman, J. E.
- Affiliations
- University of Tasmania (AU)
- University of Calgary (CA)
- University of Glasgow (GB)
- Department of Internal Medicine, Holbaek Hospital, Denmark (M.H.-O.)
- North-West University (ZA)
- National and Kapodistrian University of Athens (GR)
- University of Alberta (CA)
- World Hypertension League (X.-H.Z.).
- ORCID
- Venue
- Hypertension
- Published
- 2020-06
- Volume
- 75
- Issue
- 6
- Pages
- 1593-1599
- ISSN
- 0194-911X (ISSN-L)
- 1524-4563
- OpenAlex
- W3015951060
- Cited by
- 118
- References
- 2
- Citations by year
- 2026: 4 · 2025: 24 · 2024: 17 · 2023: 17 · 2022: 31 · 2021: 12 · 2020: 13
- FWCI
- 11.28
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Hypertension (publishedVersion)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- UTAS Research Repository (submittedVersion)
- Figshare (submittedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, other-oa)
- Funders
- British Heart Foundation (18/6/34217, RE/18/6/34217)
- National Research Foundation (86895, GUN 86895)
- South African Medical Research Council (GUN 86895, 86895)
- Medical Research Council
- National Health and Medical Research Council (1104731, 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 › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- home blood pressure monitoring, online marketplaces, antihypertensive therapy, device accuracy, cardiovascular risk management, device cost
- MeSH terms
- Australia, Cardiovascular Diseases, Humans, Hypertension, Risk Management, Reproducibility of Results, Blood Pressure Monitoring, Ambulatory, Device Approval, Sphygmomanometers, Marketing, Diagnostic Self Evaluation, Dimensional Measurement Accuracy
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