Hypertension

3 ways to address validation problems with BP-measurement devices

Accurate blood pressure measurement and hypertension diagnosis are crucial because misclassification can have serious clinical consequences for patients. But with more than 3,000 commercially available BP devices that do not have published data on accuracy testing, there is no formal validation, which leads to inaccurate hypertension diagnosis and management, according to a recent peer-reviewed publication.

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The AMA has developed online tools and resources created using the latest evidence-based information to support physicians to help manage their patients’ high BP. These resources are available to all physicians and health systems as part of Target: BP™, a national initiative co-led by the AMA and American Heart Association (AHA).  

Target: BP offers annual, recurring gold-level recognition for all participating sites that achieve hypertension control rates of 70% or higher among their adult patient population, and participation level recognition for those sites that prioritize improving BP control each year and submit data. In 2019, nearly 1,200 organizations were recognized for their efforts focusing on BP control within the populations they serve.

The paper, published in the Journal of Hypertension, was written by members of the Lancet Commission on Hypertension Group, which includes AMA Vice President of Health Outcomes Michael Rakotz, MD, and Gregory Wozniak, PhD, director of outcomes analytics in Improving Health Outcomes at the AMA.

“Due to a host of well-known problems, the global marketplace has been inundated with BP devices that are either known to be inaccurate or are of unknown accuracy,” says the paper. “This can have serious implications for being able to achieve best-practice care of people related to BP control.”

These diverse BP technologies pose new regulatory challenges in providing oversight regarding performance, accuracy, safety and utility. To overcome these, the Lancet Commission on Hypertension Group offered three recommendations.

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Converge with global regulatory requirements

Validated BP devices are indispensable for effective universal health care delivery, according to the World Health Organization (WHO). The WHO’s Global Model Regulatory Framework for Medical Devices offers a step-by-step approach to implementing and enforcing regulatory controls.

Regulatory convergence ensures requirements can expand across all regions to become aligned. Adopting internationally recognized technical documents or regulatory mechanisms help with achieving a common public health goal. There is a need for a single, universally accepted protocol for BP device validation.

While the standard has been adopted in the U.S. and other countries, it is not widely accepted. If a global mandate is required for BP device validation, it can rectify most problems relating to accuracy that is associated with current frameworks.

Develop standards for new device validation

New technology that claims to measure blood pressure poses challenges to regulations. But there is a way to get ahead of these complications.

“Rather than repeating past regulatory problems experienced with standard cuff BP devices, there is an opportunity for developing international standards that are specific to new BP technologies, and that appropriately evaluate accuracy and clinical validity,” says the paper.

Both government and nongovernment organizations need to work together to develop specific standards while legislating for their mandatory use before approval for sale. These stakeholders should also “endorse, regulate and monitor compliance with the new standards.”

Health professionals should also avoid using new technology for BP measurement until it is proven to enhance patient care.

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Accredited online lists of validated BP devices

“There is an urgent need to establish means of informing the scientific and general community as to which BP devices have been tested and found to have acceptable accuracy,” says the paper. “This can be achieved through online lists of BP devices that detail the results of validation studies carried out according to international standards.”

Organizations with sufficient expertise should develop and maintain those lists to ensure scientific rigor while also remaining independent from BP device manufacturers.