The urgency to regulate validation of automated blood pressure measuring devices: a policy statement and call to action from the world hypertension league
James E. Sharman, Pedro Ordúñez, Tammy M. Brady, Gianfranco Parati, George S. Stergiou, Paul K. Whelton, Raj Padwal, Michael Hecht Olsen, Christian Delles, Aletta E. Schutte, Maciej Tomaszewski, Daniel T. Lackland, Nadia Khan, Richard J. McManus, Ross T. Tsuyuki, Xinhua Zhang, Lisa Murphy, Andrew E. Moran, Markus P. Schlaich, Norm R.C. Campbell
Abstract
This policy statement is intended to be used as a resource for all health professionals and civil society, including regulatory agencies, Ministries of Health and healthcare organizations, to accelerate the availability, affordability, and exclusive use of automated blood pressure measuring devices (BPMDs) that have passed adequate clinical validation testing. In line with guidance from the World Health Organization (WHO) medical device technical series [ 1 ], the term clinical validation is the process by which devices are tested for accuracy in healthy people and patients with hypertension, and a clinically validated BPMD is one that has “undergone rigorous, standardized testing against a gold standard [properly calibrated manual auscultatory measurement] to ensure that the device produces accurate measurements” [ 1 ] to an internationally accepted standard.