JS-WHL-ISH-LANCET-5: HOW TO ENSURE THE SALE OF CLINICALLY VALIDATED BP DEVICES IN LOW-AND MIDDLE-INCOME COUNTRIES

Abstract

We now know that not only in high-income countries, but also in low- and middle-income countries there is a major challenge in ensuring that BP devices are accurate. When evaluating the global availability of devices online for sale, there was no evidence of validation for 73% of all devices (2486 devices listed on the Medaval database). This global availability may refer largely to high-income countries, but the crux of the challenge is in fact in lower income regions. In fact, more than an estimated 1 billion people with hypertension reside in low- and middle-income countries compared to approximately 350 million in high-income countries based on data from 2010. A major factor that comes into play in low- and middle-income countries are cost. The health systems of lower income countries are plagued by several challenges, such as managing both infectious and non-communicable diseases. While balancing the management and cost of HIV, COVID-19, malaria and a major rise in obesity and hypertension in an environment with a low physician-to-patient ratio, it is not hard to understand that the cost of a medical device will be a major consideration when deciding on purchasing devices. It has been demonstrated before that non-validated BP devices are cheaper than validated ones in a high-income country, and it is very likely to be the case on lower income regions too. While many clinicians and hospitals may not be aware that the majority of available devices are not validated for accuracy, this may not even be a major consideration in the face of financial challenges. But to ensure better detection, diagnosis and management of hypertension in these settings, perhaps the only intervention to overcome this challenge is to require regulatory approvals of only BP devices that have been validated for accuracy. This is not a simple solution, as effort is required across a range of stakeholders including government regulatory organisations, non-government organisations, manufacturers, researchers, health professionals, and consumers. Only once mandatory validation of BP devices is legislated, the availability of non-validated devices would be stopped.