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%).