Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO)

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Blood pressure (BP) is a vital sign and the essential measurement for the diagnosis of hypertension. Therefore, its accurate measurement is a key element for the evaluation of many medical conditions and for the reliable diagnosis and efficient treatment of hypertension. In the last 3 decades prestigious organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on BP Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. All these initiatives aim to standardize validation procedures and establish minimum accuracy standards for BP monitors. Unfortunately, only a few of the BP measuring devices available on the market have been subjected to independent validation using one of these protocols. Recently, the AAMI, ESH, and ISO experts agreed to develop a single universally acceptable standard (AAMI/ESH/ISO), which will replace all previous protocols. This major international initiative has been undertaken to best serve the needs of patients with hypertension, a public interested in cardiovascular health, practicing physicians, scientific researchers, regulatory bodies, and manufacturers. There is an urgent need to influence regulatory authorities throughout the world to make it mandatory for all BP measuring devices to have undergone independent validation before approval for marketing. Efforts need to be intensified to improve the accuracy of BP measuring devices, further optimize the validation procedure, and ensure that objective and unbiased validation data become available.

Section: Comparison Of Validation Proceduresmentioning

confidence: 99%

Validation protocols for blood pressure measuring devices in the 21st century

Stergiou

Alpert

Mieke

et al. 2018

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“…Devices for ABPM must be validated independently according to the internationally accepted validation protocols, and specific validation may be required in special patient populations. There is now agreement that an international protocol for validation should apply for all BP measuring devices . The software should present ABPM data in a standardized single‐page report that should include: (1) a BP plot showing different windows of the 24‐h period identified and normal bands clearly demarcated showing the individual’s awake and asleep time intervals as reported by each individual; (2) summary statistics for BP and heart rate separately for the 24 h, the daytime (awake), the night‐time (asleep), and the white‐coat window periods; and (3) the raw BP data.…”

Section: General Principles Governing the Use Of Abpm In Practicementioning

confidence: 99%

Ambulatory blood pressure monitoring in the 21st century

O’Brien

White

Parati

et al. 2018

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In clinical practice, ambulatory blood pressure monitoring (ABPM) tends to be used solely for diagnosing hypertension, especially to identify white-coat and masked hypertension. However, ABPM can provide additional information to guide the management and drug treatment of hypertension. In this brief review, the general principles governing the use of ABPM in clinical practice, such as the devices and software, recording requirements, the thresholds for the day, night and 24-hour periods and how often to repeat ABPM are summarized. The use of ABPM for diagnosing, determining the efficacy of treatment, and assessing the long-term control of hypertension are discussed.

“…evaluation, the only one to fulfil the criteria of the 2010 European Society of Hypertension International Protocol was categorized in the “Don't Buy” category. This example illustrates the difference between consumer and scientific processes of evaluation and highlights the need for closer collaboration to achieve the common goal of providing users with the most accurate BP‐measuring device Regulatory bodies: There are many national and international regulatory bodies for medical devices and it is outside the scope of this review to examine these in detail.…”

Section: Recipient Audiencementioning

confidence: 99%

“…Hence, devices appearing on the market must fulfill stringent safety requirements but are not required to have undergone accuracy testing according to one of the above‐mentioned protocols. The collaboration already noted between the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization bodies is, therefore, a critical initiative that will result in the internationally accepted “universal” protocol for the assessment of BP device accuracy …”

Section: Recipient Audiencementioning

confidence: 99%

“…It is often forgotten that these daunting statistics, and indeed all surveys, guidelines, and recommendations are based on a measurement—a measurement that is assumed (erroneously) to be accurate . Many protocols have been developed over the past 50 years to improve the accuracy of BP‐measuring devices, and the leading bodies involved in device validation have recently agreed to develop a universal protocol for the evaluation of future BP‐measuring devices . Desirable and commendable though this initiative will be, a universal protocol to evaluate the accuracy of BP‐measuring devices is of little practical use unless the results of the validation procedures leading to accuracy recommendations are communicated effectively to the desired recipient community.…”

Section: Introductionmentioning

confidence: 99%

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

O’Brien

Alpert

Stergiou

2018

Self Cite

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.