Key result
The Omron BP7450 and BP5450 home blood pressure monitors met the ISO validation criteria for accuracy, whereas the Walmart, Walgreens, and CVS store-brand monitors failed to meet the standard.
Why the study?
Three retail home blood pressure monitors from large US vendors did not have accessible results from validation testing.
Do commercially available home blood pressure monitors provide accurate measurements meeting ISO validation standards compared to a mercury sphygmomanometer in a general adult population?
Cross-Sectional (n=85)
Observer-blinded
No
Do commercially available home blood pressure monitors provide accurate measurements meeting ISO validation standards compared to a mercury sphygmomanometer in a general adult population?
Two Omron home blood pressure monitors met ISO validation criteria for accuracy, while three widely available store-brand monitors did not, highlighting the critical need for consumers to verify device validation status before use.
Omron devices met ISO criteria while three retail monitors failed; supports verifying validation status before recommending home BP monitors.
The accuracy of Omron 10 Series BP7450 (HEM-7342T-Z), Omron Platinum BP5450 (HEM-7343T-Z), Walmart Equate Premium 8000 Series UA-8000WM, Walgreens Premium 15+ WGNBPA-960BT, and CVS Series 800 BP3MW1-4YCVS were assessed in an adult general population compared to a mercury sphygmomanometer standard according to the ISO 81060-2:2018/AMD 1:2020 validation procedure. Omron selected the monitors and included three non-Omron monitors because they were from large retail vendors in the United States and these monitors did not have accessible results from validation testing. The BP7450, N = 85, passed both criteria for the standard. Mean (SD) differences in paired SBP and DBP determinations between the test device and reference were 0.5 (7.7) and 2.5 (6.8) mm Hg. The BP5450, N = 86, passed both criteria. Mean (SD) differences in paired SBP and DBP determinations were 1.9 (7.0) and 3.6 (6.4) mm Hg. The UA-8000WM, N = 85, did not meet the first criterion for the standard. Mean (SD) differences in paired SBP and DBP determinations were 2.5 (8.0) and 5.1 (6.4) mm Hg. The WGNBPA-240BT, N = 85, did not meet the first criterion for the standard. Mean (SD) differences in paired SBP and DBP determinations were 7.9 (8.5) and 5.5 (6.7) mm Hg. The BP3MW1-4YCVS, N = 85, did not meet the first criterion for the standard. Mean (SD) differences in paired SBP and DBP determinations were 5.8 (8.7) and 3.1 (5.6) mm Hg. These findings emphasize the importance of verifying the validation status of home blood pressure monitors before use by consumers.
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Peprah et al. (2023) conducted a cross-sectional in General population (n=85). Home blood pressure monitoring devices vs. Mercury sphygmomanometer was evaluated on Mean difference in paired systolic blood pressure (SBP) determinations between the test device (BP7450) and reference (MD 0.5 mm Hg). The Omron BP7450 and BP5450 home blood pressure monitors met the ISO validation criteria for accuracy, whereas the Walmart, Walgreens, and CVS store-brand monitors failed to meet the standard.
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