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J Hypertens. 2020 Jan;38(1):21-29. doi: 10.1097/HJH.0000000000002246.

Lancet Commission on Hypertension group position statement on the global improvement of accuracy standards for devices that measure blood pressure.

Author information

1
Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.
2
The Conway Institute, University College Dublin, Dublin, Ireland.
3
University of Tennessee Health Science Center, Memphis, Tennessee, USA.
4
Hypertension in Africa Research Team, Medical Research Council Unit for Hypertension and Cardiovascular Disease, North-West University, Potchefstroom, South Africa.
5
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
6
Department of Internal Medicine, Holbaek Hospital, Holbaek.
7
Centre for Individualized Medicine in Arterial Diseases (CIMA), Odense University Hospital, University of Southern Denmark, Odense, Denmark.
8
Foundation-Medical Research Institutes, Geneva, Switzerland.
9
Medaval Ltd., Dublin, Ireland.
10
Hypertension League of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.
11
Vascular Biology and Hypertension Group, University of Alabama at Birmingham, Birmingham, Alabama, USA.
12
Department of Medicine, Physiology and Pharmacology and Community Health Sciences, O'Brien Institute for Public Health and Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, Alberta, Canada.
13
The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
14
American Heart Association, Dallas, Texas, USA.
15
Sydney Medical School, University of Sydney and Baker Heart & Diabetes Institute, Melbourne, Victoria, Australia.
16
Department of Pharmacology, European Georges Pompidou Hospital, Assistance Publique Hôpitaux de Paris, Inserm UMR 970 and University Paris Descartes, Paris, France.
17
FOSCAL, Instituto Masira, Facultad de Ciencias de la Salud, UDES, Bucaramanga, Colombia.
18
Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.
19
Cardiovascular & Hormonal Research Laboratory, Department of Cardiology & Kolling Institute, Royal North Shore Hospital and Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.
20
Department of Non Communicable and Mental Health, Pan American Health Organization, Washington, District of Columbia.
21
Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
22
Studium Patavinum, University of Padova, Padua.
23
Department of Cardiovascular, Neural and Metabolic Sciences, Istituto Auxologico Italiano, IRCCS, San Luca Hospital.
24
Department of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
25
Imperial Clinical Trials Unit, Imperial College London, London, UK.
26
American Medical Association, Improving Health Outcomes, Chicago, Illinois.
27
Department of Medicine (Cardiology), Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York.
28
The James J. Peters VA Medical Center, Bronx, New York, USA.
29
Cardiology Unit, Department of Medicine, University of Padova, Town Hospital of Cittadella, Padova.
30
Department of Medical, Surgical, and Experimental Sciences, University of Sassari, Sassari, Italy.
31
Hypertension League, Department of Cardiology, Federal University of Goiás, Goiânia, Brazil.
32
Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju.
33
Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
34
Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
35
The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
36
Steno Diabetes Center Copenhagen, Gentofte, Denmark.
37
Third Department of Medicine, Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Sotiria Hospital, Athens, Greece.

Abstract

: The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organisation for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.

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