Validation of two automatic sphygmomanometers according to the modified International Standardization Organization 81060-2:2018 protocol in adults with a mid-upper arm circumference of 22 centimeters or less

Abstract

Objective A recent International Organization for Standardization (ISO) Task Group report calls for research to investingate potential special populations in validation studies of automated blood pressure (BP) devices. Accordingly, we aimed to determine the accuracy of two previously validated BP monitors passed in a general population when measured in adults with a mid-upper arm circumference (MUAC) ≤ 22 cm. Methods Test device A was the OMRON HEM 7121 equipped with the HEM CS24 cuff designed for an arm circumference of 17–22 cm. Test device B was the YuWell YE660Е with the YuWell ‘360°’ cuff (18–36 cm). Data from 37 participants aged 20.14 ± 2.23 (18–28) years were analyzed according to criterion 1 of ISO Standard 81060-2 : 2018. Results According to criterion 1, the mean ± SD of the BP differences for the device A was −7.81 ± 5.20/−10.66 ± 5.48 mmHg (systolic/diastolic) and for the device B was −8.00 ± 6.30/−16.11 ± 5.15 mmHg (systolic/diastolic), respectively. This means that neither device met the requirements. Conclusion Since devices A and B, which had passed in a general population study, failed in adults aged 18–28 years with an MUAC ≤ 22 cm, such individuals might be considered as new special population for validation studies.