S-37-5: HOW TO CHECK WHETHER A BLOOD PRESSURE DEVICE HAS BEEN PROPERLY VALIDATED FOR ACCURACY

Abstract

Accurate measurement of blood pressure (BP) is a fundamental requirement for correct hypertension diagnosis and management. For BP measurement, hypertension guidelines recommend using an automated BP measuring device that has passed accuracy testing in accordance with an internationally-accepted validation protocol. These devices should be used for clinic, home and ambulatory BP monitoring. Automated BP measuring devices confirmed to have been appropriately validated have less measurement variability and are more likely to be accurate compared with non-validated automated BP devices. Unfortunately, regulatory loopholes enable marketing and sale of automated BP measuring devices that have not passed appropriate validation testing. These devices are predominantly available in the online global marketplace, in which there are more than 3,500 different BP device models and where approximately 75% to 80% do not have evidence of being appropriately validated. These non-validated devices are also significantly cheaper and over-represented in terms of sales volume (based on top 100 sales lists internationally). Health practitioners and the public are generally unaware of these issues, and thus widespread education and resources are needed to address. In collaboration with international organisations, the Lancet Commission on Hypertension Group and the World Hypertension League has created resources on how to check that a BP device has been properly tested for accuracy. These resources direct users to registries of validated BP device listings in different world regions with the goal of increasing the clinical use of BP devices that have been appropriately validated for accuracy.