Validation of the iHealth Track and Omron HEM-9210T automated blood pressure devices for use in pregnancy

Abstract

Objective: Self monitoring of blood pressure in pregnancy is increasingly popular with both health care professionals and patients. We assessed the validity of the iHealth Track and Omron HEM-9210T automated blood pressure devices (with Bluetooth connectivity) for the use in telemonitoring of blood pressure in pregnancy. Methods: In this prospective observational study, the revised 2010 International Protocol of the European Hypertension Society (EHS) was used for the validation of the two devices against auscultatory sphygmomanometry by two independent observers who took 13 same arm measurements in 33 pregnant women, of which 10 were diagnosed with preeclampsia. The measurements were alternated between the test device and a calibrated aneroid sphygmomanometer following the protocol. Both automated devices were assessed sequentially in the same women. Results: In the group of 33 women, the iHealth Track passed the EHS 2010 validation criteria with 86/98/99 of 99 device-observer systolic measurement comparisons and 88/96/98 of 99 device-observer diastolic measurement comparisons within the 5/10/15 mmHg boundaries respectively. The Omron HEM-9210T passed the same criteria with 85/94/99 of 99 device-observer systolic measurement comparisons and 82/95/99 of 99 device-observer diastolic measurement comparisons. Conclusions: The iHealth Track and Omron HEM-9210T automated blood pressure monitors are validated for use in pregnancy. These two devices can now be added to the short list of validated devices in pregnancy and can be used for self-measurement of blood pressure in a telemonitoring setting of pregnant patients with (a high risk of) hypertensive disease.