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A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement
Open accessAbstract
: In the last 30 years, several 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 Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.
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“in the last three decades, 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 [88].”
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In the citing paper
“Using a small bladder (undercuffing) is common in obese adults and leads to overestimation of BP”
From Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension (2021) · cites this paper as [90]
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“whereas using a larger cuff (overcuffing) is common in children and leads to BP underestimation [4,90,98,99].”
From Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension (2021) · cites this paper as [90]
Experimental — accuracy not yet measuredThe check wasn’t confident either way, so it gives no verdict — never disputed.
In the citing paper
“Unfortunately, most of the devices available on the market have not been subjected to independent validation using one of these protocols [69,87–89].”
From Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension (2021) · cites this paper as [88]
Experimental — accuracy not yet measured
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Research works printed but not linked: 1
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Metadata
- Authors
- Stergiou, G. S., Alpert, B., Mieke, S., Asmar, R., Atkins, N., Eckert, S., Frick, G., Friedman, B., Graßl, T., Ichikawa, T., Ioannidis, J. P., Lacy, P., McManus, R., Murray, A., Myers, M., Palatini, P., Parati, G., Quinn, D., Sarkis, J., Shennan, A., Usuda, T., Wang, J., Wu, C. O., & O’Brien, E.
- Affiliations
- National and Kapodistrian University of Athens (GR)
- University of Tennessee Health Science Center (US)
- Physikalisch-Technische Bundesanstalt (DE)
- Heart and Diabetes Center North Rhine-Westphalia (DE)
- General Electric (United States) (US)
- Dräger (Germany) (DE)
- Omron (Japan) (JP)
- Stanford Medicine (US)
- National Institute for Health and Care Research (GB)
- University of Oxford (GB)
- Newcastle University (GB)
- Sunnybrook Health Science Centre (CA)
- University of Padua (IT)
- IRCCS Istituto Auxologico Italiano (IT)
- Welch Allyn (United States) (US)
- St Thomas' Hospital (GB)
- Nihon Kohden (Japan) (JP)
- National Institutes of Health (US)
- Corresponding author
- Stergiou, George S.
- Asmar, Roland
- Atkins, Neil
- Ioannidis, John P.
- Myers, Martin
- Palatini, Paolo
- Parati, Gianfranco
- Shennan, Andrew
- ORCID
- Venue
- Journal of Hypertension
- Published
- 2018-03
- Volume
- 36
- Issue
- 3
- Pages
- 472-478
- ISSN
- 0263-6352 (ISSN-L)
- PMC
- PMC5796427
- OpenAlex
- W2787867538
- Cited by
- 278
- References
- 19
- Citations by year
- 2026: 49 · 2025: 42 · 2024: 38 · 2023: 31 · 2022: 39 · 2021: 27 · 2020: 24 · 2019: 17 · 2018: 10
- FWCI
- 14.75
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Hypertension (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion)
- Research Portal (King's College London) (submittedVersion)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- National Institute for Health and Care Research (NIHR-RP-02-12-015)
- National Institutes of Health (Z99 HL999999)
- Engineering and Physical Sciences Research Council (EP/N025342/1)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Health Sciences › Medicine › Surgery › Hemodynamic Monitoring and Therapy
- Keywords
- blood pressure measuring devices, device validation, validation protocol, measurement accuracy, international standardization, AAMI, European Society of Hypertension, ISO, hypertension monitoring
- MeSH terms
- Blood Pressure, Blood Pressure Determination, Humans, Hypertension, International Cooperation, Research Design, Reproducibility of Results, Sphygmomanometers, Consensus, Validation Studies as Topic
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