Non-Validated BP Monitors Are a Global Problem

— Thousands of device models don’t meet international standards
by Nicole Lou, Staff Writer, MedPage Today February 15, 2022

Automatic blood pressure (BP) monitors that are clinically validated for accuracy turned out to be few and far between in terms of worldwide distribution, despite guideline recommendations that patients use validated models, researchers found.

Devices lacking any evidence of validation made up 76.3% of the 3,411 home BP monitors listed in the commercial Medaval database, with the remainder consisting of the 8.8% known to be validated and the 11.1% deemed equivalent to a previously validated device, said James Sharman, PhD, of the University of Tasmania in Australia, and colleagues.

The problem seemed particularly dire for wrist-based devices, of which 85.0% lacked evidence of having passed any internationally accepted validation protocol, the group reported in JAMA.

This is all possible because the FDA and other regulators allow devices to enter the market without rigorous evidence of validation.

“Global and national policy frameworks, including regulations with enforcement, are needed, with the goal that all devices meet minimum requirements for independent validation before premarket clearance,” the study authors urged.

“Most of the hypertension guidelines in the U.S. and around the globe have placed an emphasis on out-of-office BP monitoring for diagnosis and treatment of hypertension. Thus, it is very important for the patients to use accurate devices. Otherwise, it may lead to either undertreatment or overtreatment of hypertension,” said hypertension specialist Wanpen Vongpatanasin, MD, of UT Southwestern Medical Center in Dallas.

The study counted 457 unique BP device manufacturers, each with a median number of three upper arm cuff devices and two wrist-based devices on the Medaval list. Several dozen devices were in the middle of Medaval audit at the time of the study.

Vongpatanasin recommended that consumers refer to validatebp.org for the short list of validated BP monitors. Before buying, consumers should pay attention to the exact model numbers, as validated and non-validated devices can come from the same manufacturers and may appear very similar, she advised.

“In terms of encouraging the use of the validated devices, the challenge is that it’s not necessarily obvious that some devices have been validated, and others have not. That information has to be disseminated more widely, and this article should help within the medical community. But we still need to get that message out more widely to the users of these home BP measurement devices,” commented J. Brian Byrd, MD, of the University of Michigan in Ann Arbor, who is also a specialist in hypertension.

He said that he personally found some conflicting information between Medaval listings and validatebp.org. “So, although I think the general idea is right, at the level of individual devices, I’m not sure that the Medaval database is the final word,” he cautioned.