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 Mieke², Roland Asmar², Neil Atkins², Siegfried Eckert², Gerhard Frick², Bruce Friedman², Thomas Graßl², Tsutomu Ichikawa², John P Ioannidis², Peter Lacy², Richard McManus², Alan Murray², Martin Myers², Paolo Palatini², Gianfranco Parati², David Quinn², Josh Sarkis², Andrew Shennan², Takashi Usuda², Jiguang Wang², Colin O Wu², Eoin O'Brien²

Affiliations

¹ 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.); Microlife, Switzerland (G.F.); General Electric Healthcare Technologies, USA (B.F.); Dräger, Lübeck, Germany (T.G.); Omron Healthcare, Kyoto, Japan (T.I.); 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 (J.P.I); Institute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, United Kingdom (P.L.); Nuffield Department of Primary Care Health Sciences, Green Templeton College, University of Oxford, United Kingdom (R.M.); Newcastle University, United Kingdom (A.M.); Schulich Heart Program, Division of Cardiology, Sunnybrook Health Sciences Centre, University of Toronto, Canada (M.M.); Department of Medicine, University of Padova, Italy (P.P.); Department of Medicine and Surgery, University of Milano-Bicocca; Cardiology Unit and Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, Istituto Auxologco Italiano, Milano, Italy (G.P.); Welch Allyn, USA (D.Q.); PharmaSmart International, USA (J.S.); St. Thomas' Hospital, King's College London, United Kingdom (A.S.); Nihon Kohden, Tokyo, Japan (T.U.); Shanghai Institute of Hypertension, Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China (J.W.); Office of Biostatistics Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD (C.O.W.); and The Conway Institute, University College Dublin, Ireland (E.O.B.). gstergi@med.uoa.gr.
² 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.); Microlife, Switzerland (G.F.); General Electric Healthcare Technologies, USA (B.F.); Dräger, Lübeck, Germany (T.G.); Omron Healthcare, Kyoto, Japan (T.I.); 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 (J.P.I); Institute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, United Kingdom (P.L.); Nuffield Department of Primary Care Health Sciences, Green Templeton College, University of Oxford, United Kingdom (R.M.); Newcastle University, United Kingdom (A.M.); Schulich Heart Program, Division of Cardiology, Sunnybrook Health Sciences Centre, University of Toronto, Canada (M.M.); Department of Medicine, University of Padova, Italy (P.P.); Department of Medicine and Surgery, University of Milano-Bicocca; Cardiology Unit and Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, Istituto Auxologco Italiano, Milano, Italy (G.P.); Welch Allyn, USA (D.Q.); PharmaSmart International, USA (J.S.); St. Thomas' Hospital, King's College London, United Kingdom (A.S.); Nihon Kohden, Tokyo, Japan (T.U.); Shanghai Institute of Hypertension, Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China (J.W.); Office of Biostatistics Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD (C.O.W.); and The Conway Institute, University College Dublin, Ireland (E.O.B.).

PMID: 29386350
DOI: 10.1161/HYPERTENSIONAHA.117.10237

Review

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. Hypertension. 2018 Mar.

. 2018 Mar;71(3):368-374.

doi: 10.1161/HYPERTENSIONAHA.117.10237. Epub 2018 Jan 31.

Authors

Affiliations

¹ 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.); Microlife, Switzerland (G.F.); General Electric Healthcare Technologies, USA (B.F.); Dräger, Lübeck, Germany (T.G.); Omron Healthcare, Kyoto, Japan (T.I.); 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 (J.P.I); Institute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, United Kingdom (P.L.); Nuffield Department of Primary Care Health Sciences, Green Templeton College, University of Oxford, United Kingdom (R.M.); Newcastle University, United Kingdom (A.M.); Schulich Heart Program, Division of Cardiology, Sunnybrook Health Sciences Centre, University of Toronto, Canada (M.M.); Department of Medicine, University of Padova, Italy (P.P.); Department of Medicine and Surgery, University of Milano-Bicocca; Cardiology Unit and Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, Istituto Auxologco Italiano, Milano, Italy (G.P.); Welch Allyn, USA (D.Q.); PharmaSmart International, USA (J.S.); St. Thomas' Hospital, King's College London, United Kingdom (A.S.); Nihon Kohden, Tokyo, Japan (T.U.); Shanghai Institute of Hypertension, Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China (J.W.); Office of Biostatistics Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD (C.O.W.); and The Conway Institute, University College Dublin, Ireland (E.O.B.). gstergi@med.uoa.gr.
² 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.); Microlife, Switzerland (G.F.); General Electric Healthcare Technologies, USA (B.F.); Dräger, Lübeck, Germany (T.G.); Omron Healthcare, Kyoto, Japan (T.I.); 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 (J.P.I); Institute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, United Kingdom (P.L.); Nuffield Department of Primary Care Health Sciences, Green Templeton College, University of Oxford, United Kingdom (R.M.); Newcastle University, United Kingdom (A.M.); Schulich Heart Program, Division of Cardiology, Sunnybrook Health Sciences Centre, University of Toronto, Canada (M.M.); Department of Medicine, University of Padova, Italy (P.P.); Department of Medicine and Surgery, University of Milano-Bicocca; Cardiology Unit and Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, Istituto Auxologco Italiano, Milano, Italy (G.P.); Welch Allyn, USA (D.Q.); PharmaSmart International, USA (J.S.); St. Thomas' Hospital, King's College London, United Kingdom (A.S.); Nihon Kohden, Tokyo, Japan (T.U.); Shanghai Institute of Hypertension, Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China (J.W.); Office of Biostatistics Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD (C.O.W.); and The Conway Institute, University College Dublin, Ireland (E.O.B.).

PMID: 29386350
DOI: 10.1161/HYPERTENSIONAHA.117.10237

Abstract

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.

Keywords: accuracy; blood pressure measurement; device; monitor; protocol; standard; validation.

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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

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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

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