The Post-Marketing Real-World Outpatient Clinical Validation of Electronic Blood Pressure Monitors

This study evaluated the accuracy of a variety of home upper-arm oscillometric blood pressure monitors (BPMs) from 448 participants against the FDA-certified XYZ110 auscultatory device using simultaneous measurements. Descriptive statistics were used to summarize the key findings of the study. Device performance was evaluated referencing international standards (ISO 81060-2:2013), where a mean absolute difference of ≤5 mmHg was defined as "Accurate." In addition, survey questionnaires completed by a subset of participants were analyzed to provide supplementary insights. A total of 448 consecutive outpatient clinical patients attending a routine clinical visit with their BPMs (male 215 and female 233) were eligible to participate in this study. The overall mean age of the participants was 62.35±12.59 years. Most of the BPMs included in this study were of the Omron brand (79.69%, n = 357), followed by Yuwell (5.8%, n = 26) and others. 76.32% of systolic blood pressure (SBP) measurements and 69.89% of diastolic blood pressure (DBP) measurements from BPMs exhibited differences of ≤5 mmHg compared to the reference calibrator. 70.89% (n = 318) were accurate in measuring SBP, and 60.27% (n = 270) were accurate in measuring DBP. Our study revealed that over 20% of BPMs exhibited discrepancies of more than 5 mmHg compared to a reference calibrator. Overall, the Omron U30, HEM-7211, and U10 models demonstrated relatively higher accuracy in blood pressure measurements. Regular patient to patient validation of BPMs is crucial to ensure accurate measurements for daily use.