National standard for measurement of resting and ambulatory blood pressures with automated sphygmomanometers.

Abstract

The Association for the Advancement of Medical Instrumentation develops voluntary standards for medical devices so that manufacturers might provide information on their product and basic safety and performance criteria that should be considered in qualifying the instrument for clinical use. American national standards are generated through a consensus process by committees consisting of experts in research, development, and design from user, industry, and government communities. Draft standards are made available for public review and may become American national standards after review by the American National Standards Institute. The first American national standard for electronic and automated sphygmomanometers was published in monograph form in 1987. The objective of the revised 1992 standard for electronic and automated sphygmomanometers is to provide updated labeling, safety, and performance requirements that help ensure that consumers and health care professionals are supplied with safe, accurate devices for the indirect measurement of blood pressure, including ambulatory blood pressure recorders. This standard permits validation of the automatic or electronic device by comparison with either direct, intra-arterial blood pressure measurements or the noninvasive cuff/ stethoscope technique, based on Korotkoff sounds identified by individuals trained in auscultation. This summary report of the 1992 American national standard for automatic sphygmomanometers provides recommendations for the methods of comparison, statistical analysis of the data, presentation of the results, and criteria for acceptability. Users, researchers, and instrument designers should refer to the American national standard monograph for detailed requirements. (Hypertension 1993^1^04-509) KEY WORDS • blood pressure determination • blood pressure monitors H ypertension, or high blood pressure, is one of the leading causes of cardiovascular morbidity and mortality. 1 An elevated blood pressure has become a surrogate for hypertensive vascular disease, and the measurement of blood pressure is a regular occurrence in hypertension detection and fol-

Unreliable oscillometric blood pressure measurement: prevalence, repeatability and characteristics of the phenomenon

“…o8 mm Hg. 7 Furthermore, the 85% of the total of BP readings lying within 10 mm Hg from the reference method (Figure 1) also complies with the ESH-IP phase 2.1 criteria. 9 Despite the use of a successfully validated professional oscillometric device, the prevalence of the UOBP phenomenon in this study is striking.…”

“…On the other hand, in order to increase the accuracy of the study in detecting the UOBP phenomenon, carefully standardized observers obtained three pairs of measurements and the threshold for UOBP was set at 410 mm Hg difference between the oscillometric and the auscultatory BP measurement instead of the conventional 5 mm Hg threshold. [7][8][9] The latter aimed to eliminate the expected underestimation of auscultatory systolic and overestimation of diastolic BP because of the faster deflation rate of the electronic device (3.5-4.0 mm/s) compared with that recommended for auscultatory BP measurement (2-3 mm/s). 15 Furthermore, at least two of the triplicate measurements were required to define an UOBP visit, and two such visits were required to define persistent UOBP that was used to investigate predictors of this phenomenon.…”

“…For the assessment of the accuracy of oscillometric devices, validation protocols have been developed by the American Association for the Advancement of Medical Instrumentation, 7 the British Hypertension Society 8 and the European Society of Hypertension. 9 In the last two decades several oscillometric BP monitors have successfully fulfilled the validation criteria of one or more of these protocols.…”

Night-time blood pressure load is associated with higher left ventricular mass index in renal transplant recipients

“…Monitors were calibrated against a mercury sphygmomanometer at the beginning of each session, and monitoring practice was in accordance with the guideline. 16 All recipients completed a sleep and activity diary during ABPM and night times were defined as self-reported actual patient sleep times. Subjects were then classified as 'dippers' and 'nondippers'.…”

Rapid estimation of the accuracy of automatic blood pressure measuring devices (READ)

“…The total number of BP measurements for both the READ and for validation studies is comparable, and covers the spectrum of low, medium and high BP in similar proportions for both methods. 2,4,9 Since discrepancies between automatic devices and the mercury standard are influenced by age, 10 subjects covering a spectrum of ages from 23 to 74 years were chosen for the READ.…”