An Observational Cross-Sectional Blind Comparison to Evaluate the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor

Accurate measurement of blood pressure (BP) is a necessity for the reliable diagnosis and proficient management of hypertension. However, validation of blood pressure monitoring devices only began in the 1980's, followed by a series of ad-hoc validation protocols from differing organisations such as the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society (BHS), the German Hypertension League, the European Society of Hypertension (ESH), and the International Organisation for Standardization (ISO) over the subsequent three decades. The need for a universally acceptable protocol was recognised and members of the AAMI, ESH, and ISO committees collaborated to re-examine the aspects of validation to achieve a consensus on an optimal validation standard.

With an increased prevalence of hypertension, causing approximately 9.4 million deaths per year worldwide, the demand for non-invasive arterial pressure monitoring devices has also increased to help patients manage blood pressure (BP). Traditionally, non-invasive BP measurement techniques include auscultatory and oscillometric devices, however, these can present with several limitations in terms of cuff size, instruments' bulky volume, and discomfort caused by external pressure. Advancements in technology has meant that wearable devices are becoming readily available for various health related measurements, including BP. The HUAWEI Technology have developed an automated oscillometric wearable wrist watch-type device for BP measurement that has recently been validated in accordance with the AAMI/ESH/ISO Universal Standard requirements and can be recommended for self-measurement. However, while this research concluded the HUAWEI watch fulfilled the requirements for self-measurement in the general population, it should be noted that the study was conducted within the Chinese population only. Consequently, to ensure generalisation to a wider population, it is important to examine the HUAWEI watch validity within differing populations. Therefore, the aim of this study will be to explore if the HUAWEI D2 watch-type blood pressure monitor meets the AAMI/ESH/ISO Universal Standard requirements in differing populations.