Validation testing of five home blood pressure monitoring devices for the upper arm according to the ISO 81060-2:2018/AMD 1:2020 protocol

Abstract

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.