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 past 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 the 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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Because each unique automated BPMD can have different undisclosed algorithms, the accuracy of each BPMD needs to be individually determined by comparison to a BP reference standard using a scientifically accepted validation protocol.
“Since each unique automated BPMD can have different processes, algorithms and fitting functions to derive BPs (none of which are publicly disclosed), the accuracy of each BPMD needs to be individually determined by comparison to a BP reference standard using a scientifically accepted validation protocol [14, 57, 58].”
From Automated 'oscillometric' blood pressure measuring devices: how they work and what they measure (2022) · cites this paper as [57]
The Objective calls for all BP measuring devices to be assessed for accuracy under an agreed validation protocol, and Validation Criteria and Reporting specifies comparison of test-device readings with reference readings. The paper does not say that each automated device uses different, undisclosed algorithms or that this is why individual validation is needed; searches for algorithms and device-model differences did not establish that rationale. Page numbers were not available in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe validation standards used for cuff BP devices are not suitable for cuffless devices.
“Importantly, the established validation standards used to evaluate the accuracy of cuff BP devices are inappropriate for cuffless devices58,59.”
From Blood pressure and its variability: classic and novel measurement techniques (2022) · cites this paper as [59]
The PAT-based blood pressure errors in n = 3 healthy normal subjects meet the tolerable error of 10 mmHg from consensus guidelines for blood pressure measurement systems.
“meeting the tolerable error of 10 mmHg from consensus guidelines (32) for BP measurement systems.”
From Comprehensive pregnancy monitoring with a network of wireless, soft, and flexible sensors in high- and low-resource health settings (2021) · cites this paper as [32]
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Cites
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Flagged first, then by citations
Research works printed but not linked: 3
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- 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 Institutes of Health (US)
- University of Tennessee Health Science Center (US)
- From the Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece (G.S.S.); University of Tennessee Health Science Center (B.A.); Physikalisch-Technische Bundesanstalt, Berlin, Germany (S.M.); Foundation, Medical Research Institutes, Paris, France (R.A.); Medaval, Dublin, Ireland (N.A.); Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany (S.E.);...
- ORCID
- Venue
- Hypertension
- Published
- 2018-03
- Volume
- 71
- Issue
- 3
- Pages
- 368-374
- ISSN
- 0194-911X (ISSN-L)
- 1524-4563
- OpenAlex
- W2790385199
- Semantic Scholar
- f57d717a859803f12872dc98ba842dc8ea0e7077
- Cited by
- 469
- References
- 19
- Citations by year
- 2026: 60 · 2025: 83 · 2024: 71 · 2023: 69 · 2022: 52 · 2021: 47 · 2020: 43 · 2019: 30 · 2018: 14
- FWCI
- 25.24
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Hypertension (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institute for Health and Care Research (NIHR-RP-02-12-015)
- 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 Determination, Europe, Humans, International Cooperation, Reference Standards, Societies, Medical, Reproducibility of Results, Blood Pressure Monitors, Practice Guidelines as Topic, Consensus
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