Are previously validated blood pressure self-measurement devices accepted under the Universal Standard? A systematic review.

This study aimed to analyze whether oscillometric blood pressure devices validated for the general population may be considered approved under Universal Standard criteria. A systematic review was conducted, with searches in nine databases, up to September 2023, including 32 validation studies of noninvasive arm cuff devices for self-measurement. The British Hypertension Society protocol was most common (68%), followed by the Association for the Advancement of Medical Instrumentation (40%). Most devices met Universal Standard criterion 1, but only 17 (53%) met criterion 2. Few studies contained details about the choice of cuffs, the number of participants by arm circumference, or the differences between methods by cuff subgroup. Due to the considerable differences between validation protocols, 53% of the devices analyzed were approved under the Universal Standard. The study contributes to expanding the validated pool of self-measurement devices under the Universal Standard.