Table 1.

Summary of strengths, challenges and key actions in six countries relating to improving access to validated automated blood pressure measuring devices (BPMDs).

Country	Focus	Strengths and challenges	Lessons to other countries
Brazil	Regulations	Strength: Strong regulatory system, with high technical capacity. Challenges: Compliance and enforcement. Approval of non-validated automated BPMDs of approved by authorities of IMDRF participating countries. Key action: Inclusion of ISO 81060-2:2018 and other accuracy validation standards on automated BPMDs marketing registration requirements.	Regulate acceptance of approval by other countries, including those belonging to the IMDRF. Enforce regulations, including the use of post-market surveillance
Chile	Procurement	Strength: Strong health care and health information system. Challenges: Regulatory bottleneck. Decentralized health system. Key actions: Procurement of a substantial number of validated automated BPMDs for use in PHC. Promotion of accuracy validation through issuing of protocols and recommendations by the MoH.	Ensure that procurement mechanisms are normative and enforceable. Follow regulatory pathway at the same time.
Cuba	Regulations Clinical validation studies	Strength: Domestic manufacturing and technical support to perform accuracy validation studies. Challenge: Budgetary limitations. Regulatory bottleneck. Key action: Performing accuracy validation study of a domestically produced automated BPMD.	Streamline regulatory processes. Obtain technical cooperation to build capacity to perform accuracy validation studies
Dominican Republic	Procurement	Strength: Political will and commitment to ensure exclusive use of validated BPMDs in PHC. Challenge: Resistance to the use of validated, semi-automated BPMDs by the medical profession. Key action: Acquisition of substantial number of validated automated BPMDs for use in PHC.	Foster awareness and knowledge among the medical profession of the importance of using automated or semi-automated BPMDs that have been validated for accuracy.
Ecuador	Procurement	Strengths: Commitment by the MoH to procure automated BPMDs that have been validated for accuracy. Capacity in BP measurement strengthened trough virtual courses. Challenge: Budgetary limitations constraining the purchase of new automated BPMDs Key action: Development of technical specifications for procurement of automated BPMDs.	Strengthen procurement mechanisms through adoption of technical specifications that include accuracy validation to circumvent regulatory bottleneck.
Saint Lucia	Procurement and regulations	Strength: Small population size and flexible administrative structure makes it possible to adopt many creative measures. Challenge: Regulatory changes requiring extensive consultation and therefore time. Key action: Promotion of validated automated BPMDs at the population level using social media.	Find creative ways that respond to reality of the country, including the use of social media and modification of services provided by government. Adopt solutions that take advantage of both strengths and weaknesses.

BP blood pressure, BPMD blood pressure measuring device, IMDRF International Medical Devices Regulations Forum, MoH Ministry of Health, PHC primary health care.