Guideline

. 2018 Mar;36(3):472-478.

doi: 10.1097/HJH.0000000000001634.

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

George S Stergiou¹, Bruce Alpert², Stephan Mieke³, Roland Asmar⁴, Neil Atkins⁵, Siegfried Eckert⁶, Gerhard Frick⁷, Bruce Friedman⁸, Thomas Graßl⁹, Tsutomu Ichikawa¹⁰, John P Ioannidis¹¹, Peter Lacy¹², Richard McManus¹³, Alan Murray¹⁴, Martin Myers¹⁵, Paolo Palatini¹⁶, Gianfranco Parati¹⁷, David Quinn¹⁸, Josh Sarkis¹⁹, Andrew Shennan²⁰, Takashi Usuda²¹, Jiguang Wang²², Colin O Wu²³, Eoin O'Brien²⁴

Affiliations

¹ Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece.
² University of Tennessee Health Science Center, USA (retired).
³ Physikalisch-Technische Bundesanstalt, Berlin, Germany.
⁴ Foundation, Medical Research Institutes, Paris France.
⁵ Medaval, Dublin, Ireland.
⁶ Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
⁷ Microlife, Switzerland.
⁸ General Electric Healthcare Technologies, USA.
⁹ Dräger, Lübeck, Germany.
¹⁰ Omron Healthcare, Kyoto, Japan.
¹¹ Departments of Medicine and of Health Research and Policy, Stanford University School of Medicine, and Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, USA.
¹² Institute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, UK.
¹³ Green Templeton College, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
¹⁴ Newcastle University, UK.
¹⁵ University of Toronto, Schulich Heart Program. Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Canada.
¹⁶ Department of Medicine. University of Padova, Italy.
¹⁷ Department of Medicine and Surgery, University of Milano-Bicocca.
¹⁸ Welch Allyn, USA.
¹⁹ PharmaSmart International, USA.
²⁰ King's College London, St. Thomas' Hospital, London, UK.
²¹ Nihon Kohden, Tokyo, Japan.
²² Shanghai Institute of Hypertension, Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
²³ Office of Biostatistics Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
²⁴ The Conway Institute, University College Dublin, Ireland.

PMID: 29384983
PMCID: PMC5796427
DOI: 10.1097/HJH.0000000000001634

Guideline

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

George S Stergiou et al. J Hypertens. 2018 Mar.

. 2018 Mar;36(3):472-478.

doi: 10.1097/HJH.0000000000001634.

Authors

Affiliations

¹ Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece.
² University of Tennessee Health Science Center, USA (retired).
³ Physikalisch-Technische Bundesanstalt, Berlin, Germany.
⁴ Foundation, Medical Research Institutes, Paris France.
⁵ Medaval, Dublin, Ireland.
⁶ Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
⁷ Microlife, Switzerland.
⁸ General Electric Healthcare Technologies, USA.
⁹ Dräger, Lübeck, Germany.
¹⁰ Omron Healthcare, Kyoto, Japan.
¹¹ Departments of Medicine and of Health Research and Policy, Stanford University School of Medicine, and Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, USA.
¹² Institute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, UK.
¹³ Green Templeton College, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
¹⁴ Newcastle University, UK.
¹⁵ University of Toronto, Schulich Heart Program. Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Canada.
¹⁶ Department of Medicine. University of Padova, Italy.
¹⁷ Department of Medicine and Surgery, University of Milano-Bicocca.
¹⁸ Welch Allyn, USA.
¹⁹ PharmaSmart International, USA.
²⁰ King's College London, St. Thomas' Hospital, London, UK.
²¹ Nihon Kohden, Tokyo, Japan.
²² Shanghai Institute of Hypertension, Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
²³ Office of Biostatistics Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
²⁴ The Conway Institute, University College Dublin, Ireland.

PMID: 29384983
PMCID: PMC5796427
DOI: 10.1097/HJH.0000000000001634

Abstract

: 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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Conflict of interest statement

Conflict of interest: GS, BA, RA, PP, GP: conducted validation studies for various manufacturers; advised manufacturers on device and software development. NA: Conducted validation studies for various manufacturers; advised manufacturers on device and software development; Medaval employee. GF: Microlife employee. BF: GE Healthcare employee. TG: Dräger employee. TI: Omron employee. RM: Received blood pressure monitoring equipment for research purposes from Omron and Lloyds Pharmacies; Chair of British Hypertension Society Blood Pressure Monitoring Working Party which oversees validation studies for various manufacturers. AM: Patent holder for manual blood pressure device; research grant holder for blood pressure measurement techniques. DQ: Welch Allyn employee, USA. JS: PharmaSmart International employee, USA. AS: Conducted validation studies for various manufacturers; developed the CRADLE VSA. TU: Nihon Kohden employee. JW: Conducted validation studies for various manufacturers. SE, JI, PL, MM, SM, CW: none.

Figures

**Figure 1**
Standardized Bland-Altman scatterplots as shown below will be presented in the AAMI/ESH/ISO validation study report (with permission from ref. [8] modified).

See this image and copyright information in PMC

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References

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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

Affiliations

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

Authors

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Abstract

Conflict of interest statement

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