Unreliable? 76% of world’s blood pressure monitors have not been validated

Seventy-six percent of the world’s blood pressure (BP) monitors have not been properly validated, according to a new analysis published in JAMA.[1] This raises questions as to what does this means for patient care?

“To identify and manage elevated BP, guidelines from hypertension societies recommend BP measurement using automated cuff-based devices that are clinically validated for accuracy,” wrote lead author Dean S. Picone, PhD, of the Menzies Institute for Medical Research at the University of Tasmania in Australia. “Validated devices are more likely to be accurate compared with devices without evidence of validation. However, regulations in most countries permit devices to be cleared for marketing without evidence of validation.”

Picone et al. explored a publicly available Medaval database, gathering information on nearly 4,300 BP monitors. Once exclusions were made for manually operated devices and devices that measure BP somewhere other than the patient’s upper arm or wrist, the group was left with 3,411 devices manufactured by 457 different companies. The devices are distributed throughout North America, South American, Asia, Europe, Africa and Oceania. Many are also sold online.

Researchers then searched for evidence that each device had passed a proper validation protocol. New devices with measurement technology “identical to that of previously validated devices” were viewed as being “equivalent,” meaning a separate validation was not required.