Unreliable? 76% of blood pressure monitors worldwide have not been validated

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Overall, 8.8% of the devices had been validated, 11.1% were equivalent and there was “no proof of validation” for 76.3%. The remaining devices were either being audited by Medaval or failed validation.

Considering only the 2,486 cuffs in the study, 10% had been validated, 13.2% were equivalent and there was “no proof of validation” for 73%. Of the 925 wrist devices in the study, 5.6% had been validated, 5.5% were equivalent, and there was “no proof of validation” for 85%.

“A minority of automated cuff and wrist devices worldwide have evidence of accuracy validation,” the authors wrote. “Lack of validation may compromise optimal medical practice due to increased potential for incorrect diagnosis of hypertension and inappropriate care. Global and national policy frameworks, including regulations with enforcement, are needed, with the aim that all devices meet minimum requirements for independent validation prior to pre-marketing approval.

The Menzies Institute for Medical Research has published a guide that can help patients determine if a blood pressure monitor has been properly tested for accuracy. Click on here for the complete breakdown.

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Reference:

1. Dean S. Picone, PhD, Norm RC Campbell, MD, PhD, Aletta E. Schutte, PhD, et al. Validation status of blood pressure measuring devices sold worldwide. JAMA. 2022;327(7):680-681. doi:10.1001/jama.2021.24464.

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