November 23, 2024

Are All FDA-Approved Blood Pressure Monitors Equally Accurate?

Are All FDA-Approved Blood Pressure Monitors Equally Accurate?

They are not. In fact, not all FDA-cleared blood pressure monitors (BPMs) have been clinically validated for accuracy, evaluated in real-world conditions, or undergone calibration against another valid device.

A study analyzed 3411 devices from 457 unique manufacturers distributed across Asia, Europe, Africa, Oceania, North America, and South America, and found no evidence of validation in 76.3% of devices, with only 8.8% validated and 11.1% deemed equivalent. This is largely because “regulatory authorities mainly focus on ensuring that BP monitors are safe,” which means that these devices may be cleared for sale even if they have not undergone rigorous, independent testing to confirm their accuracy. Furthermore, establishing and enforcing standards for manufacturers across different countries is challenging, since there is no single global institution overseeing this process. 

Users are encouraged to rely on online registries for identifying devices that have been properly tested by independent experts, such as national hypertension societies. For instance, the Validated Device Listing (VDL) is maintained by the American Medical Association (AMA). Most of such directories are based in high-income countries (USA, Canada, UK, Japan, Germany, Greece, and Ireland), and thus they are not so helpful in identifying the validated blood pressure monitors in low-income regions.

Why Are Reliable Blood Pressure Monitoring Methods So Important?

According to a recent review published in Clinical Hypertension, high blood pressure remains “the leading cause of morbidity and mortality worldwide.” Often, hypertension develops without symptoms, meaning regular blood pressure monitoring is essential for early detection and treatment. While finger blood pressure apps and new wearable devices showcase clever smartphone innovations, the American Heart Association emphasizes that proper self-monitoring of blood pressure requires a clinically validated device.

Hypertension guidelines recommend that blood pressure be measured using monitors validated for accuracy. Users can “google” the BPM they have (brand and model name) to learn its validation status. For those looking for a blood pressure monitor to buy it may be worthwhile checking in one or more recognised listing.

List of Trusted Registries of Validated Blood Pressure Monitors

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