Accurate blood pressure measuring devices: Influencing users in the 21st century

Abstract

Hypertension is now recognized as a major global cause of morbidity and death. All decisions relating to the epidemiology, diagnosis, and management of hypertension are dependent on being able to measure blood pressure accurately. Scientists have developed protocols to assess the accuracy of blood pressure-measuring devices, but little attention has been given to informing users which devices are accurate and inaccurate. This article identifies a recipient audience of researchers, clinicians, and scientists, the public, healthcare executives and administrators, and consumer and regulatory bodies, and discusses how best to communicate the results of device accuracy to these groups with the aim of improving the accurate measurement of blood pressure.

Achieving reliable blood pressure measurements in clinical practice: It's time to meet the challenge

“…One of the dominant themes to emerge from this review is the past failure to communicate the findings of science to those people and authoritative bodies most likely to be affected by inaccuracy of BP measurement . Many hundreds of important papers on BP measurement have been published over more than a half‐century in scientific journals.…”

“…Regulatory authorities, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), concentrate on the safety features of BP measuring devices but with inadequate attention being given to accuracy and performance characteristics. Moreover, recommendations from regulatory bodies can occasionally be so complex and ambiguous as to be unenforceable . Recommendations from consumer organizations are often based on cost and cosmetic features rather than on the all‐important feature of accuracy …”

“…A need for clarity in the recommendations from these bodies is now considered to be imperative . First and foremost, regulatory authorities, such as the FDA and EMA, must now seriously consider accuracy and performance of BP measuring devices, rather than focusing solely on the safety requirements, as is the practice at present.…”

“…One of the dominant themes to emerge from this review is the past failure to communicate the findings of science to those people and authoritative bodies most likely to be affected by inaccuracy of BP measurement. 3,[5][6][7] Many hundreds of important papers on BP measurement have been published over more than a half-century in scientific journals. However, in terms of disseminating information, this often merely amounts to the authors of such papers sharing knowledge with scientists, researchers, and interested clinicians who are already familiar with the shortcomings of BP measurement.…”

“…7 Recommendations from consumer organizations are often based on cost and cosmetic features rather than on the all-important feature of accuracy. 7 So, how can communication be improved? Traditionally, the results of successful validation studies of BP monitors have been published in peer-reviewed scientific journals or presented at scientific meetings, which serve as a durable reference source, but such publications have little impact on most of the groups listed previously.…”