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.
aHypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece
bUniversity of Tennessee Health Science Center, USA (retired)
cPhysikalisch-Technische Bundesanstalt, Berlin, Germany
dFoundation, Medical Research Institutes, Paris France
eMedaval, Dublin, Ireland
fClinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany
gMicrolife, Switzerland
hGeneral Electric Healthcare Technologies, USA
iDräger, Lübeck, Germany
jOmron Healthcare, Kyoto, Japan
kDepartments 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
lInstitute of Cardiovascular Science, University College London and the National Institute for Health Research University College London Hospitals Biomedical Research Centre, UK
mGreen Templeton College, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
nNewcastle University, UK
oUniversity of Toronto, Schulich Heart Program. Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Canada
pDepartment of Medicine. University of Padova, Italy
qDepartment 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
rWelch Allyn, USA
sPharmaSmart International, USA
tKing's College London, St. Thomas’ Hospital, London, UK
uNihon Kohden, Tokyo, Japan
vShanghai Institute of Hypertension, Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
wOffice of Biostatistics Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA
xThe Conway Institute, University College Dublin, Ireland
Correspondence to Professor George S. Stergiou, Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, 152 Mesogion Avenue, Athens 11527, Greece. Tel: +30 2107763117; fax: +30 2107719981; e-mail: gstergi@med.uoa.gr
Abbreviations: AAMI, Association for the Advancement of Medical Instrumentation; ANSI, American National Standards Institute; BHS, British Hypertension Society; ESH, European Society of Hypertension; ESH-IP, European Society of Hypertension International Protocol; ISO, International Organization for Standardization
Received 23 August, 2017
Revised 31 October, 2017
Accepted 3 November, 2017
