Js-whl-ish-lancet-4: validity of automated bpmd in clinical practice and public health. a global need for hypertension management

HEARTS in the Americas is the flagship program to improve population hypertension control and to reduce the CVD burden. Currently, the initiative is being implemented in 2095 primary health care facilities in 24 countries. Accurate BP measurement is key to effective management of hypertension and is one of the six strategic pillars of HEARTS. A pivotal action to facilitate the progress of the agenda was to examine the regulatory frameworks related to BPMDs in participating countries. Study found that most countries had an existing medical devices law, or the foundation for such a law, that stipulated a regulatory bodies responsibilities. However, only six countries had regulations that applied explicitly to BPMDs, and just two had regulations that mandated accuracy and precision validation criteria as a condition of premarket approval. Seven countries had government bodies responsible for enforcing medical device regulations, and seven had mechanisms to remove devices from the market that did not comply with regulations. Seven countries had a centralized system of acquiring BPMDs, but the acquisition was only regulated in six of these countries. In summary, BPMDs can be approved for sale in most countries without the manufacturer providing evidence of passing an internationally accepted clinical validation standard. The efforts to improve access to validated automated BPMDs are different for each country, in line with its priorities, health system maturity including regulatory, economic, and political conditions. Indeed, most of the facilities implementing HEARTS began to use accuracy-validated automated BPMDs. The general achievements showed in concrete actions are twofold: sectors of governments have been investing politically and administratively in modifications to regulations that do not require a substantive legislative process; and improved procurement toward exclusive access of validated automated BPMDs has been at least partially achieved. The improvement of procurement mechanisms has focused on defining technical specifications that include accuracy validation. The challenges that the countries face to reach the goal of exclusive use of validated BPMDs in PHC are enormous and multifactorial. This confirms the need for a robust regulatory framework and comprehensive strategic approach to exclusive use of clinically validated automated BPMDs at regional level. The successful implementation of the initiative depends on a coordinated effort across government and other stakeholders that will contribute to better diagnosis and management of hypertension in the Americas.