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Weak and fragmented regulatory frameworks on the accuracy of blood pressure-measuring devices pose a major impediment for the implementation of HEARTS in the Americas

Lombardi, C, Sharman, JE ORCID: 0000-0003-2792-0811, Padwal, R, Picone, D ORCID: 0000-0002-4760-1634, Alcolea, E, Ayala, R, Gittens, A, Lawrence-Williams, P, Malcolm, T, Neira, C, Perez, V, Rosende, A, Tesser, J, Villacres, N, Campbell, NRC and Ordunez, P 2020 , 'Weak and fragmented regulatory frameworks on the accuracy of blood pressure-measuring devices pose a major impediment for the implementation of HEARTS in the Americas' , Journal of Clinical Hypertension, no. Octobe , pp. 1-8 , doi: 10.1111/jch.14058.

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Abstract

Global HEARTS is a WHO initiative for cardiovascular disease prevention and control. Accurate blood pressure (BP) measurement is an essential component of the initiative. This study aimed to determine the regulatory frameworks governing the accuracy of BPMDs in countries of the Americas participating in the HEARTS initiative. Quantitative and qualitative analysis of the laws and regulations relevant to ensuring the accuracy of BPMDs were determined from the Ministries of Health/Regulatory Agencies among 13 countries in Latin America and the Caribbean. Analysis included characterizing the scope of regulations (ie, pre-market approval, sales and promotion, labeling, cuff sizes, and procurement), information systems for monitoring the models of BPMDs used in primary health care (PHC), and systems to enforce compliance with regulations. Ten of the 13 countries had medical device laws, but regulations that specifically address BPMDs only existed in three countries. Only one country (Brazil) had regulations for mandatory accuracy validation testing and only two countries regulated internet sales of BPMDs. Labeling and cuff size regulations existed in four and two countries, respectively. Less than half the countries reported having a data repository on the BPMD models being used in PHC facilities (four countries) or sold (five countries). Weak and fragmented regulatory frameworks on the accuracy of BPMDs exist among countries of the Americas. This will adversely affect the accuracy of blood pressure assessment and hence poses a major impediment for successful implementation of HEARTS initiative.

Item Type: Article
Authors/Creators:Lombardi, C and Sharman, JE and Padwal, R and Picone, D and Alcolea, E and Ayala, R and Gittens, A and Lawrence-Williams, P and Malcolm, T and Neira, C and Perez, V and Rosende, A and Tesser, J and Villacres, N and Campbell, NRC and Ordunez, P
Keywords: cardiovascular disease risk management, diagnosis, health policy, hypertension
Journal or Publication Title: Journal of Clinical Hypertension
Publisher: Le Jacq Communications, Inc.
ISSN: 1524-6175
DOI / ID Number: 10.1111/jch.14058
Copyright Information:

© 2020 Wiley Periodicals LLC. The Pan American Health Organization (PAHO) retains copyright and all other rights in the manuscript of this article assubmitted for publication.

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