It is essential for physicians and other health professionals to trust that blood pressure measurement devices produce accurate readings to provide the best care for patients with hypertension. Yet with so many brands and models available on the market, it can be challenging for physicians to determine which BP devices are reliable to use in clinical practice or to recommend for patients to use at home. This is where the US Blood Pressure Validated Device Listing (VDL™) can help.
At the launch of the VDL in 2020, 16 BP-measurement devices met the requirements for being listed as clinically accurate after independent review. Now that number has grown to 57, and includes home and in-office upper arm devices, wrist cuff devices, automated office blood pressure devices, community kiosks and 24-hour ambulatory monitors.
In an interview, Nar Ramkissoon, MPH, senior manager of ecosystem development at the AMA, detailed why patients and physicians can trust the VDL review process and use the devices listed on the website.
In 2015, experts in hypertension began creating a framework for demonstrating that a BP measurement device could produce clinically accurate results. Working closely with these experts, the AMA formalized a set of criteria to aid in determining which BP devices available in the U.S. have been validated for clinical accuracy with testing against the gold standard for blood pressure measurement such as the mercury sphygmomanometer.
The set of criteria “includes essential elements for what would constitute clinical accuracy, such as proof of FDA pre-market clearance, test results from an accepted international validation protocol, and attestation that any device components that can impact accuracy are unchanged in updated or similar models,” said Ramkissoon. “The criteria set a high bar that results in increased level of clinical accuracy that physicians can be confident in and use in clinical decision making with their patients.”
“We put the criteria out for public comment and received supportive feedback from the industry and other clinical groups and associations that see the value in accurate medical devices,” he said, noting the VDL criteria was ratified in 2019 and is used as the basis for ongoing reviews.
The AMA partnered with the National Opinion Research Center (NORC) at the University of Chicago to design and manage an independent process to determine which BP devices meet the VDL criteria. A separate VDL Independent Review Committee (IRC) was formed to be the key part of this process.
“It’s a process where manufacturers submit required documentation to NORC about their devices. Then NORC assigns the submissions to the IRC,” Ramkissoon said. “The IRC members are all physicians with expertise in hypertension management and measurement who can look at each device objectively.”
“Every device is reviewed separately by at least two IRC members to determine whether that device meets the criteria,” he said. “If there are any discrepancies, the IRC co-chairs will review and may request additional information from the manufacturer. Then, the entire committee convenes to vote on whether each submission is approved for listing.”
It is very important to make sure that the VDL is “credible and that there’s high level of integrity throughout the entire process,” Ramkissoon said. “These reviewers must meet a certain level of expertise so that there’s confidence of informed, sound judgments.
“The IRC operates without conflicts from industry, and also operates independently of the AMA,” he added. “Those key principles of credibility and independence are factored into the operating structure created for the VDL.”
Additionally, “all of the reviewers on the IRC are volunteers—they do not receive any compensation,” Ramkissoon said. These physician experts are “doing it because they are very passionate about this work and know that device accuracy is a big problem that they can help to address.”
Meanwhile, “the manufacturers do not pay for submissions, for review or to be listed,” he said.
The members of the Independent Review Committee had to apply to become members and disclose any conflicts of interest that could be disqualifying.
That’s because “it is important to make sure that there aren’t any perceived or real biases if a reviewer works closely with a single manufacturer or has other financial relationships with a manufacturer,” Ramkissoon said.
Ultimately, “we want to increase transparency in which BP devices have undergone validation testing and the results,” he said, noting “the experts who serve on the IRC increase our confidence that more people living with hypertension will get accurate BP readings that their physicians can use to diagnose and treat their hypertension.”