April 13 (UPI) — Most blood pressure devices sold for home monitoring in Australia, and possibly elsewhere, may not have been validated for accuracy and could lead to misdiagnoses or inappropriate treatment, a new analysis has revealed.
Just 6 percent of 972 devices available in Australia — including those sold by multi-national e-commerce retailers like Amazon and eBay — underwent rigorous testing to verify that they provided accurate readings, a process called validation, according to findings published Monday in the journal Hypertension.
More than half the blood pressure monitors on the market were wristband models, and none had been validated, while just over 18 percent of the upper-arm cuff blood pressure devices had been validated, the authors found.
“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,” Dr. James E. Sharman, deputy director at the Menzies Institute for Medical Research at the University of Tasmania in Australia and co-author of the study, said in a press release.
“If the devices haven’t been properly validated for accuracy, treatment decisions could be based on incorrect information,” he added. “We found non-validated devices dominate the Australian marketplace, which is a major barrier to accurate blood pressure monitoring and cardiovascular risk management.”
In the United States, one out of every three adults has high blood pressure, according to the American Heart Association. Nationally, it has been estimated that home blood pressure monitoring devices generate more than $350 million in sales annually.
The AHA recommends home blood pressure monitoring for people with high blood pressure, or hypertension, because it provides more blood pressure readings rather than the occasional measurement in a doctor’s office or health care clinic. The organization suggests using a blood pressure monitor with an upper-arm cuff that has been independently validated, and taking the device to a healthcare provider to double-check it for accuracy.
For the new study, researchers studied the online blood pressure device marketplace in Australia, where online sales were the source of more than 90 percent of the devices analyzed. In general, non-validated devices were cheaper than those that had been tested for accuracy, the authors found.
However, it should be noted that the authors only reviewed devices purchased via Australia’s online marketplace. While these suppliers also sell products in the United States and worldwide, it is not known if these same blood pressure devices are sold elsewhere.
The U.S. Food and Drug Administration requires manufacturers to submit documentation that the devices are tested for precision before they can be available for sale. However, the devices are not independently evaluated, as manufacturers conduct their own accuracy tests.
“If blood pressure is incorrectly over-estimated it could lead to unnecessary prescriptions or higher doses than needed of blood pressure lowering medications, which are usually prescribed for life,” Sharman said.
“Medications are costly, have potential side effects and patients incorrectly labeled with high blood pressure could suffer unnecessarily,” Sharman said. “When blood pressure is incorrectly under-estimated, people might remain at increased risk for a heart attack or stroke that could otherwise be avoided with the appropriate medication and dose, or lifestyle changes.”