Experts Demand Validation of Automatic Blood Pressure Devices

In line with recommendations by the World Health Organization, the World Hypertension League published a consensus document that calls for the “urgent” strengthening of regulations to ensure that all automated blood pressure measurement devices that are available for sale or are used in health centers are clinically validated. The document was signed by 20 experts from 10 countries. They state that validation ensures device accuracy and reduces the risk of errors and deficiencies in the diagnosis and medical management of arterial hypertension.

“Accelerating the adoption of well-validated automated blood pressure devices in routine clinical use is important for national and global strategies to improve the monitoring of hypertension, cardiovascular disease, and noncommunicable diseases,” the authors note in an article published in Journal of Human Hypertension.

A Prevalent Problem

It is estimated that 75% to 80% of the more than 3500 models of automatic devices (sphygmomanometers) for measuring blood pressure that are marketed in the world have not been clinically validated. Validation entails testing in a rigorous and standardized process involving healthy people and patients with hypertension to ensure that the measurements are accurate.

The situation could be even worse in Latin America. “If globally only 20% of the devices are validated, imagine in countries with weaker or nonexistent regulatory systems,” signatory Pedro Orduñez, PhD, regional advisor for the prevention and control of cardiovascular diseases of the Pan American Health Organization (PAHO) and leader of the HEARTS initiative in the Americas, told Medscape Spanish Edition.

In Brazil, for example, only 16.7% of 137 devices promoted on popular internet pages had been clinically validated, according to a recent study conducted by Estefanie Siqueira Vigato, MS, health sciences teacher, assistant professor, and doctoral student in nursing at the State University of Campinas (UNICAMP), in Campinas, Brazil.

For Orduñez, the proportion of validated devices must be urgently increased. “It is crazy to continue measuring pressure with equipment that is known to be inaccurate, with the risk for patients and the costs for the health system that this implies,” he said.

The consensus signatories cited a Canadian study that demonstrated that nonvalidated devices were associated with clinically significant discrepancies in blood pressure measurement, compared with accurate measurements. The discrepancies have been >5 mm Hg in 69% of patients and >10 mm Hg in 36%.

“At population level, even small errors — for example, 5 mm Hg — in the measurement of systolic or diastolic blood pressure can lead to the misclassification of millions of people,” they note.

They add that inaccurate blood pressure measurement can result in unnecessary treatments for patients without hypertension, as well as lack of treatment for patients incorrectly classified as normotensive.

The Proper Procedure

The article’s lead author, James Sharman, PhD, deputy director of the Menzies Institute for Medical Research at the University of Tasmania in Hobart, Australia, acknowledged that having a properly validated blood pressure device is just one of many factors necessary for an accurate measurement of blood pressure.

“If the professionals performing the blood pressure measurement do not follow the proper procedure, this can lead to misdiagnosis and poor medical management. It is therefore a high priority that healthcare professionals be trained in correct measurement and employ out-of-office assessment when available, such as multiday home blood pressure monitoring or 24-hour ambulatory monitoring,” Sharman told Medscape Spanish Edition.

Hypertension is the main risk factor for dying, although the general population and doctors themselves ignore or minimize it, said Orduñez. Many healthcare professionals “overestimate their knowledge and skills in taking blood pressure, even when they know they don’t spend time on this matter,” he added.

Another factor that can conspire against a greater use of validated automated devices is economic. On average, the cost of validated devices in the international internet market is double that of nonvalidated equipment.

“This is a problem in itself, as it is likely to entice consumers to buy cheaper, nonvalidated devices, especially since the topic of validation is not something people generally know about. So, we need to prevent this from being a barrier for healthcare providers in countries with fewer resources. This problem is being addressed, at least in part, through the PAHO Strategic Fund, which is a mechanism that allows for the large-scale purchase of essential health supplies, including validated blood pressure devices,” said Sharman. In 2020, he led the Lancet Commission on Hypertension group, which made a similar claim.

In the new consensus document, the signatories emphasize the need for governments to build a strong regulatory capacity to ensure a quick and smooth transition to the exclusive use of validated automated blood pressure measurement devices. “It is urgent and a technical imperative,” they stress.

“Professionals must be educated, but you also have to regulate. It’s like traffic: drivers and pedestrians must be educated, but stricter regulations and signs must be put in place for guiding,” said Orduñez.

Lists on a webpage on the official PAHO site indicate which models of automated blood pressure measurement devices are clinically validated.

The World Hypertension League document is supported by the following groups and organizations: the Lancet Commission on Hypertension Group, the International Society of Hypertension, Hypertension Canada, the British and Irish Hypertension Society, t Stroke Foundation–Australia, the High Blood Pressure Research Council of Australia, and Resolve to Save Lives.

Orduñez is a PAHO official, but the position of the authors of the consensus document does not necessarily reflect that of the organization. Sharman has disclosed no relevant financial relationships.

Follow Matías A. Loewy of Medscape Spanish Edition on Twitter @MLoewy.

This article was translated from the Medscape Spanish edition.

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