Validation status of digital blood pressure monitors in Peru: A comprehensive assessment with a validation-process algorithm proposal

Background In Latin America and the Caribbean (LAC), hypertension is the leading cause of death and disability. Accurate diagnosis requires validated blood pressure measurement devices (BPMD). This study aimed to assess the characteristics and validation status of blood pressure measuring devices available for online purchase within Peru. Methods Between September and November 2023, we performed an electronic search of major retailers and online pharmacies. Devices were classified as validated if they were listed in databases recommended by the 2023 European Society of Hypertension (ESH) Guidelines for the Management of Arterial Hypertension or deemed equivalent by the manufacturer. Validation status was verified using a proposed algorithm. Results We identified 13 retailers and 12 pharmacies selling BPMDs online, yielding 530 devices. Of these, 176 were assessed for validation, with 15 devices (8.5%) considered as validated and two (1.1%) as equivalent. Among validated devices, seven used the ESH 2010 protocol, and four each used the ISO 81060-2:2018 standard [adopted by the Association for the Advancement of Medical Instrumentation (AAMI) and ESH] and the ESH 2002 protocol. Six validated devices were from Omron, with two each from Andon, Beurer and Microlife. Prices ranged from 30.1 USD to 351.5 USD. Conclusion The high prevalence of nonvalidated BPMDs available online in Peru underscores the risk of inaccurate blood pressure readings, potentially compromising patient monitoring and treatment. These findings highlight the need for BPMD education for physicians and patients, and advocate for regulatory policies mandating BPMD validation to improve hypertension management in Peru and potentially the LAC region.