9, 10 Pregnancy and pre-eclampsia have been acknowledged by experts as special populations. 8 However, few studies have tested the accuracy of automated BP monitors in specific populations such as arrhythmia patients, pregnant women, etc. Over the last ten years, several devices have been validated, mostly in the general population. Moreover, to allow new BP devices to be listed as “recommended accurate BP measuring devices” in certain scientific society websites, it is recommended to perform such independent clinical validation and publish its results. 7 Elsewhere, international guidelines recommend submitting any new device for BP measurement to an independent clinical validation.
6 In 2018, members of the AAMI, ESH and ISO committees reached a consensus on an optimal validation standard, the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) which is now considered as the standard protocol for the validation of non-invasive blood pressure measuring devices. 2 Different protocols have been used to validate the accuracy of BP measuring devices such as the international protocol of the European Society of Hypertension (ESH), 3 the British Hypertension Society (BHS) protocol, 4 the Association for the Advancement of Medical Instrumentation (AAMI) protocol 5 and the International Organization for Standardization (ISO). 1 These devices must undergo a validation study by experts in independent centers as recommended by guidelines and societies. Several non-mercury techniques measuring blood pressure (BP) have been developed to supplant the mercury-auscultatory method, such as the hybrid, aneroid and electronic devices using algorithms based principally on the oscillometric technique.