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The FDA is warning consumers, patients, caregivers, and health care providers of risks related to using unauthorized devices that claim to measure or estimate blood pressure. Many blood pressure devices currently sold over-the-counter (OTC) do not have FDA marketing authorization, meaning the FDA has not evaluated the safety and effectiveness of those devices.
The agency said inaccurate blood pressure measurements can lead to errors in diagnosing hypertension (high blood pressure) or hypotension (low blood pressure), which may result in delayed treatment or lack of treatment. This can lead to patient harms, such as stroke, heart attack, heart failure, kidney failure, cognitive decline, and early death.
Recommendations for Consumers, Patients, and Caregivers
- Do not use unauthorized blood pressure devices, including software features on wearables, such as smartwatches and smart rings, that claim to measure blood pressure. These devices may be sold through online marketplaces or directly from the seller.
- Be aware that the safety and effectiveness of unauthorized devices have not been reviewed by the FDA, and the use of these devices could result in inaccurate measurements of blood pressure levels.
- To see if a blood pressure device has been evaluated and authorized by the FDA, search the FDA’s 510(k) database using the device name. Devices that have been evaluated and authorized will generally have the product code DXN.
- If your medical care depends on accurate blood pressure measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs.
