Vascular Health and Risk Management (Mar 2022)
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
Jirar Topouchian,1 Parounak Zelveian,2 Zoya Hakobyan,2 Heghine Gharibyan,2 Roland Asmar3 1Diagnosis and Therapeutic Center, Hôtel Dieu Hospital, Paris, France; 2Preventive Cardiology Dept, Institute of Cardiology Named After Levon Hovhannisyan, Yerevan, Armenia; 3Foundation-Medical Research Institutes (F-MRI)®, Geneva, SwitzerlandCorrespondence: Roland Asmar, Foundation-Medical Research Institutes ®, Place St Gervais 1, Geneva, Switzerland, Tel +33640142239, Email [email protected]: As recommended by various authorities and scientific societies, electronic devices for blood pressure (BP) measurements must undergo independent clinical validations for accuracy assessment.Objective: To 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)”.Methods: The 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.Results: Ninety-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.Conclusion: The 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.Keywords: blood pressure measurements, accuracy, validation, home blood pressure, oscillometric, Withings
