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.

Hypertension

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.).

Published: March 2018

In the last three decades, various organizations have created protocols for verifying the accuracy of blood pressure (BP) measuring devices.
Experts from AAMI, ESH, and ISO have proposed an international initiative to establish a universal validation standard that all devices would follow.
Once finalized, this new AAMI/ESH/ISO standard will become the single accepted protocol, replacing all previous standards.

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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http://dx.doi.org/10.1161/HYPERTENSIONAHA.117.10237	DOI Listing

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