Blood pressure is an important upstream indicator of overall patient health, and high blood pressure can be a precursor to more serious medical conditions like cardiovascular disease, kidney disease, and stroke. Measuring blood pressure frequently is the best way to stay on top of any changes, but as telehealth and at-home monitoring gain in popularity, how can you be sure your patients are getting accurate measurements outside of a physician’s office?
Treatment plans can only be as good as the data that informs them, and while the mercury sphygmomanometer has been recognized as the gold standard in blood pressure measurement since the 1800s, advances in technology, the rise of telehealth and a growing commitment to patient empowerment and self-measured blood pressure (SMBP) have contributed to a wide variety of blood pressure devices in the marketplace.
Increased accessibility is a double-edged sword. While simple design and reasonable price points have democratized blood pressure management, this robust marketplace of devices has also raised concerns about the accuracy of these devices without standards in place to ensure these at-home monitors provide reliable readings.
A recent study in the Journal of Hypertension reported that out of the 100 best-selling blood pressure devices on Amazon, 81 percent had not undergone adequate clinical validation testing. This means that potentially 3-in-4 patients working with their clinical teams to actively manage their blood pressure from home, and even some medical practices themselves, may not be getting accurate readings. Eighty-one percent of the blood pressure measurement devices accessible to the average consumer have not been vetted for accuracy or reliability and therefore could be providing inaccurate readings. In order to avoid the worst effects of cardiovascular disease, early intervention is critical and inaccurate blood pressure readings can lead to undertreatment, overtreatment or missed diagnoses.
A group of physicians from across the country recognized this problem in 2015. Together they developed a set of criteria for evaluating the accuracy of different blood pressure measuring devices, and these criteria are the basis of the VDL™, U.S. Blood Pressure Validated Device Listing. Manufacturers can voluntarily submit their devices to be evaluated, and if they are determined to be accurate, the device is included on the listing. This working database functions similarly to a consumer reports page, published publicly and updated regularly so that both physicians and patients can be better informed when selecting a blood pressure measurement device.
The VDL was first released in 2020, at a time when the COVID-19 pandemic was causing a boom in telehealth services and more patients were purchasing medical devices for at-home use. Initially, just 16 BP measurement devices had been submitted by their manufacturers and proven clinically accurate. Today, that list has expanded to feature 57 clinically accurate devices, including at-home and in-office upper arm devices, wrist cuff devices, community kiosks and 24-hour ambulatory monitors.
Devices that make it onto the VDL™ undergo a rigorous independent review process, conducted by a panel of 13 physician experts. To ensure objectivity during the validation review, it is a free service – no application fees are required. While the American Medical Association (AMA) was a partner in the development of VDL™, they play no role in the review or approval of devices for the listing.
As at-home care and telehealth become more common, it is all the more critical to ensure that patients can get accurate readings from medical devices outside of a controlled clinical setting. States like Michigan and Maryland recently passed legislation to ensure Medicaid coverage of self-measured blood pressure devices, referencing the VDL™ as an important resource for implementation.
Device accuracy is just one of many important factors in creating real, sustainable change in hypertension control throughout the U.S., but it’s hard to do much else if you can’t get accurate data. Better data leads to better treatment plans, better outcomes and a better state of health for future generations.
Jordana Cohen is an internal medicine physician.