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(Hypertension. 2000;35:1037.)
© 2000 American Heart Association, Inc.

Scientific Contributions

Blood Pressure–Measuring Devices

Time to Open Pandora’s Box and Regulate

Jan A. Staessen

From the Study Coordinating Center, Hypertension and Cardiovascular Rehabilitation Unit, Department of Molecular and Cardiovascular Research, University of Leuven (Belgium).

Correspondence to Jan A. Staessen, MD, PhD, Study Coordinating Center, Hypertension and Cardiovascular Rehabilitation Unit, Department of Molecular and Cardiovascular Research, University of Leuven, Campus Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium. E-mail jan.staessen@med.kuleuven.ac.be

	Introduction

 
Rose and colleagues¹ found that the DINAMAP models 1846-SX and 1846-SX/P (Critikon Corp) systematically skip 14 values of systolic blood pressure, of which some (140 and 160 mm Hg) are critical in the diagnosis and treatment of hypertension. The findings of Rose and colleagues¹ come as no surprise. The DINAMAP 8100 failed to pass validation.² Furthermore, to protect their intellectual and commercial interests, most-if not all-manufacturers of blood pressure monitors operate in secrecy. Against current recommendations,³ they modify the technical specifications and software of devices without notice or fail to subject new or modified devices to independent peer-reviewed validation in a timely manner.⁴ Guideline committees^{3 5 6} have repeatedly demanded that producers submit their algorithms to expert panels, so that the underlying physiological and physical principles can be verified and so that the proprietary software can be checked for accuracy. Too many companies mislead doctors and the general public by marketing nonvalidated devices, which sometimes measure blood pressure at anatomic sites other than the brachial artery, a procedure that is prone to error and far from generally endorsed.⁶ Other commercial groups, regardless of validation, sell machines for blood pressure self-measurement through public outlets without providing buyers any proper training or information on the limitations of their use. Instructions for professionals as well as other consumers also should be better standardized; they should include guidelines for calibration and state a guaranteed lifetime of accurate use.

Over the past decade, blood pressure measurement by ambulatory monitoring or self-measurement gained wide acceptance in clinical and . . . [Full Text of this Article]

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