Validation protocols for blood pressure-measuring devices

Abstract

Hypertension is a major risk factor for cardiovascular morbidity and mortality. Therefore, blood pressure self-measuring devices have emerged as valuable tools in patient care and the accuracy of these instruments is of fundamental importance. For this reason, several validation procedures for assessing the efficacy of blood pressure monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League (Prüfsiegelprotokoll), and the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. In the past, most of the protocols have been reviewed and modified because of experiences gained during the validation studies carried out. However, each shows distinct differences, that is number and characteristics of patients required, blood pressure ranges, and the length of the validation procedure, which may result in unique advantages and/or limitations associated with their use. The continued standardization and evolution of these guidelines is essential to ensure the efficacy of blood pressure-measuring devices marketed for clinical and home use. Here, we aimed to compare four currently used validation protocols and to initiate a discussion on potential future improvements.

Similar cardiometabolic effects of high- and moderate-intensity training among apparently healthy inactive adults: a randomized clinical trial

“…Blood pressure was measured using an electronic oscillometric device (Riester Ri-Champion model, Jungingen, Germany) according to the recommendations of the Association for the Advancement of Medical Instrumentation [45]. Prior to blood pressure monitoring, the accuracy of the device was tested using a standard mercury sphygmomanometer in a random subsample (n = 25) to ensure that there was no consistent difference (>10 mmHg) in blood pressure.…”

Validation of non-invasive central blood pressure devices: ARTERY Society task force consensus statement on protocol standardization

“…Several scientific bodies have developed validation protocols for non-invasive peripheral BP monitors, 54–59 yet they differ on procedural features such as sample size and selection criteria, number of assessment phases, acceptable margin of error, BP range and pass/fail criteria. 52 A ‘universal’ brachial BP validation protocol is under development through collaboration of the American Association for the Advancement of Medical Instrumentation (AAMI), the International Organization for Standardisation (ISO), and the ESH Working Group on Blood Pressure Monitoring and Cardiovascular Variability, and projected to be in effect in 2018. This harmonized protocol is expected to inform many aspects of central BP validation protocols that equally apply to brachial BP (e.g.…”

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“…What this means is that the "standard" to which all devices are manufactured is the "physician's ears." The devices must maintain their accuracy over a broad range of pressures, and the testing protocols are quite rigorous (see Beime et al, 2016 for a list of worldwide standards). For example, the Association for the Advancement of Medical Instrumentation (AAMI) standards (2013) and the British Hypertension Society (BHS) (O'Brien et al, 1993) (most prominent of the standards) specify that there must be 85 subjects evaluated and this sample should be as heterogeneous as possible, providing a wide range of diastolic and systolic pressures as well as arm sizes.…”

“…In addition, there must be two trained listeners making simultaneous and blinded blood pressure determinations along with the device for every subject, with three sets of comparative blood pressure measurements obtained for each subject in the supine, seated, and standing positions. A substantial majority of the automatic devices (ambulatory and stand-alone electronic) currently on the market made by major manufacturers meet or exceed the AAMI and BHS standards, with accuracy assessed over a range of systolic pressures of about 80-220 mm Hg and a range of diastolic pressures of about 50-130 mm Hg (Beime et al, 2016).…”