Accuracy of the Withings BPM Connect Device for Self-Blood Pressure Measurements in General Population - Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

Abstract

BackgroundAs recommended by various authorities and scientific societies, electronic devices for blood pressure (BP) measurements must undergo independent clinical validations for accuracy assessment.ObjectiveTo assess the accuracy of the Withings BPM Connect device in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization “AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018)”.MethodsThe Withings BPM Connect device measures BP at the brachial level using the oscillometric method. According to this protocol using the same-arm sequential BP measurement method, subjects (n ≥ 85) fulfilling the age, gender, BP and cuff distribution criteria must be included. Two criteria are used for the analysis: Criterion 1: differences between observers’ mercury sphygmomanometer reference measurements and test device BP values (test versus reference) and their standard deviation (SD) must be ≤5 ± 8 mmHg for both systolic (SBP) and diastolic BP (DBP). Criterion 2: the SD of the mean BP differences between the test device and reference BP per subject must be ≤6.91/6.62 mmHg for SBP/DBP.ResultsNinety-two subjects were selected, 85 of whom were included. For validation criterion 1, the mean difference ± SD between the reference and device BP values was 0.6 ± 5.3 mmHg for SBP and 2.1 ± 4.3 mmHg for DBP. For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 4.2/3.6 mmHg (SBP/DBP). These results fulfilled the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018) protocol requirements.ConclusionThe Withings BPM Connect oscillometric device for home BP measurement fulfilled all of the accuracy requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060–2:2018) in general population and consequently can be recommended for home BP measurements.