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


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.

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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.


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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.

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

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Correspondence to Paul K. Whelton.

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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.

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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).

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