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Many blood pressure devices for home monitoring are not validated

A new study published by the American Heart Association has revealed that many blood pressure devices sold for home monitoring have not been sufficiently tested. According to the researchers, inaccurate readings can lead to inappropriate treatment and dangerous consequences.

Study lead author Dr. James E. Sharman is the deputy director of the Menzies Institute for Medical Research at the University of Tasmania.

“Inaccurate blood pressure measuring devices could have a major implication for public health. If blood pressure is incorrectly overestimated it could lead to unnecessary prescriptions or higher doses than needed of blood pressure lowering medications, which are usually prescribed for life,” said Dr. Sharman.

“Medications are costly, have potential side effects and patients incorrectly labeled with high blood pressure could suffer unnecessarily. When blood pressure is incorrectly underestimated, people might remain at increased risk for a heart attack or stroke that could otherwise be avoided with the appropriate medication and dose, and/or lifestyle changes.”

The researchers analyzed the blood pressure devices available online in Australia. More than 90 percent of the devices were sold by large, multinational businesses like Amazon and eBay.

When a blood pressure device is validated, this means it has gone through extensive testing for accuracy. The study showed that only six percent of the 972 models of blood pressure monitoring devices had been validated. 

Wristband monitors made up about half of the devices being sold, and none of them had been validated. Among the upper-arm cuff blood pressure devices examined, just over 18 percent had been rigorously tested and validated. 

“People around the world monitor their blood pressure using home devices to help to effectively manage hypertension and to help determine their risk for heart attacks or strokes,” said Dr. Sharman. 

“If the devices haven’t been properly validated for accuracy, treatment decisions could be based on incorrect information. We found non-validated devices dominate the Australian marketplace, which is a major barrier to accurate blood pressure monitoring and cardiovascular risk management.”

The study was focused solely on devices available in Australia’s online marketplace, so it has some limitations. While the major e-commerce sites sell products worldwide, the team did not investigate where specific blood pressure devices are sold. In the United States, the FDA requires manufacturers to submit documentation that devices have been tested, but the tests are not independently evaluated. 

“International policies need to be strengthened to ensure that home use medical devices are rigorously tested for accuracy before being cleared for sale by regulatory authorities. Currently, manufacturers of blood pressure devices conduct their own accuracy testing, an honor system with potential real-life consequences for patients,” said Dr. Sharman.

The study is published by the American Heart Association in the journal Hypertension.

By Chrissy Sexton, Staff Writer


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