Accurate measurement of BP—in the physician office and in patients’ homes—is essential for the diagnosis and management of hypertension. But which blood-pressure measurement devices have been validated to help deliver that accurate measurement? One list of such devices just got bigger.
At the launch of the US Blood Pressure Validated Device Listing (VDL™), 16 BP measurement devices were submitted for review by their manufactures and met the requirements to be listed as clinically accurate. Now that number has grown to 25.
The expansion of the VDL adds nine new device models, two manufacturers and three BP device types: ambulatory blood-pressure monitoring, automated office blood pressure, and community kiosk.
In 2015, hypertension experts started meeting to create a framework for what would be needed to create a list of BP measurement devices that meet criteria for demonstrating validation for clinical accuracy. Together, with this group and others, the AMA formalized a set of criteria to aid in determining which BP devices have been validated for clinical accuracy in the U.S.
With criteria established, the AMA provided funding to the National Opinion Research Center (NORC) at the University of Chicago to assist in the design and management of an independent process to determine which BP devices meet the VDL criteria. This independent process resulted in a preliminary list of BP devices that have been validated for clinical accuracy.
“This is more important than ever amid the COVID-19 pandemic, as an increased number of patients are measuring and monitoring their blood pressure at home,” said AMA President Susan R. Bailey, MD.
“Major device manufacturers must be willing to share their testing data and results for independent review to ensure physicians and their patients can trust readings from these devices,” added Dr. Bailey. “We believe these steps can help reduce the devastating impact hypertension has on vulnerable communities.”
New listings add to BP accuracy
The VDL supports the need for accurate and actionable BP measurements that can lead to appropriate hypertension treatment and improved blood pressure control, reducing the risk for cardiovascular disease. With the expansion, the VDL now features five manufacturers, A&D Medical, Hillrom-Welch Allyn, Microlife, Omron and PharmaSmart.
These additional BP measurement devices have been approved for listing on the VDL, and can be viewed at ValidateBP.org. Additional manufacturer submissions will be reviewed by the IRC on an ongoing basis.
Manufacturers interested in submitting a BP device for inclusion in the VDL can review the VDL Criteria and email NORC at [email protected] for additional information. Submissions are reviewed and accepted on a rolling basis. The AMA does not receive funding from any device manufacturer or other third party in relation to the development of the VDL criteria or VDL process.