TY - JOUR
T1 - Declaración de posición del Grupo de la Comisión Lancet de Hipertensión con respecto a la mejora mundial de las normas de exactitud para los dispositivos de medición de la presión arterial
AU - Grupo de la Comisión Lancet de Hipertensión
AU - Sharman, James E.
AU - O'Brien, Eoin
AU - Alpert, Bruce
AU - Schutte, Aletta E.
AU - Delles, Christian
AU - Olsen, Michael Hecht
AU - Asmar, Roland
AU - Atkins, Neil
AU - Barbosa, Eduardo
AU - Calhoun, David
AU - Campbell, Norm R.C.
AU - Chalmers, John
AU - Benjamin, Ivor
AU - Jennings, Garry
AU - Laurent, Stéphane
AU - Boutouyrie, Pierre
AU - Lopez-Jaramillo, Patricio
AU - McManus, Richard J.
AU - Mihailidou, Anastasia S.
AU - Ordunez, Pedro
AU - Padwal, Raj
AU - Palatini, Paolo
AU - Parati, Gianfranco
AU - Poulter, Neil
AU - Rakotz, Michael K.
AU - Rosendorff, Clive
AU - Saladini, Francesca
AU - Scuteri, Angelo
AU - Barroso, Weimar Sebba
AU - Cho, Myeong Chan
AU - Sung, Ki Chul
AU - Townsend, Raymond R.
AU - Wang, Ji Guang
AU - Hansen, Tine Willum
AU - Wozniak, Gregory
AU - Stergiou, George
N1 - Publisher Copyright:
© 2020 Pan American Health Organization. All rights reserved.
PY - 2020
Y1 - 2020
N2 - 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 3 000 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 Organization 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.
AB - 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 3 000 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 Organization 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.
KW - Biomedical technology
KW - Diagnostic equipment
KW - International health
KW - Reference standard
UR - http://www.scopus.com/inward/record.url?scp=85088924128&partnerID=8YFLogxK
U2 - 10.26633/RPSP.2020.21
DO - 10.26633/RPSP.2020.21
M3 - Article
AN - SCOPUS:85088924128
SN - 1020-4989
VL - 44
JO - Revista Panamericana de Salud Publica/Pan American Journal of Public Health
JF - Revista Panamericana de Salud Publica/Pan American Journal of Public Health
M1 - e21
ER -