Key result
Weak and fragmented regulatory frameworks on the accuracy of blood pressure-measuring devices exist among countries of the Americas, with only 3 of 13 surveyed countries having specific regulations and only 1 requiring accuracy validation testing.
Why the study?
Accurate blood pressure measurement is essential for the WHO Global HEARTS initiative, but the regulatory frameworks governing device accuracy in participating countries in the Americas had not been determined.
Cross-Sectional (n=13)
The weak and fragmented regulatory frameworks for blood pressure measuring devices in the Americas pose a major barrier to accurate hypertension diagnosis and the successful implementation of the HEARTS initiative.
Answers are grounded in this paper and cite their sources.
Sparse BPMD regulations may impair accurate hypertension diagnosis; leaves open need for mandatory validation policies across the Americas.
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.
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Lombardi et al. (2020) conducted a cross-sectional in Hypertension (Regulatory frameworks for blood pressure-measuring devices) (n=13). Regulatory frameworks for blood pressure-measuring devices was evaluated on Existence and scope of laws and regulations relevant to ensuring the accuracy of blood pressure-measuring devices. Weak and fragmented regulatory frameworks on the accuracy of blood pressure-measuring devices exist among countries of the Americas, with only 3 of 13 surveyed countries having specific regulations and only 1 requiring accuracy validation testing.
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