Lancet Commission on Hypertension group position statement on the global improvement of accuracy standards for devices that measure blood pressure.
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Author(s)
Type
Journal Article
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.
Date Issued
2020-01
Date Acceptance
2019-08-14
Citation
Journal of Hypertension, 2020, 38 (1), pp.21-29
ISSN
0263-6352
Publisher
Lippincott, Williams & Wilkins
Start Page
21
End Page
29
Journal / Book Title
Journal of Hypertension
Volume
38
Issue
1
Copyright Statement
© 2019 The Author(s). Published by Wolters Kluwer
Health, Inc. This is an open access article distributed under the terms of the Creative
Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND),
where it is permissible to download and share the work provided it is properly cited.
The work cannot be changed in any way or used commercially without permission
from the journal.
Health, Inc. This is an open access article distributed under the terms of the Creative
Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND),
where it is permissible to download and share the work provided it is properly cited.
The work cannot be changed in any way or used commercially without permission
from the journal.
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/31790375
PII: 00004872-202001000-00004
Subjects
Lancet Commission on Hypertension Group
Cardiovascular System & Hematology
1103 Clinical Sciences
1102 Cardiorespiratory Medicine and Haematology
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2020-01-01