Challenges in validation studies of blood pressure measurement devices

Accurate blood pressure (BP) measurement is essential for effective health management. To ensure this, international standards for the validation of BP monitors have been established and revised over time, with ISO 81060-2:2018 being the most recent. While many studies have been published evaluating the accuracy of BP monitors based on this standard, we identified concerns regarding the reliability of some reported results and therefore conducted a comprehensive literature review. Using ISO 81060-2:2018 as the validation framework, we extracted relevant studies from PubMed and collected the SD values for criterion 1 to compare and analyze the reported measurement accuracy. While most SD values ranged from 5 to 8%, we identified six studies reporting values below 4%. On the basis of our experience, such low variability is highly implausible and raises questions about the credibility of these findings. Reports claiming exceptionally high measurement accuracy with unusually low SD values may lead to misconceptions and could potentially be misused for marketing purposes. Therefore, validation studies must be conducted in strict adherence to medical ethics. In addition, there is a need to raise awareness that the current international standards for BP monitor validation require further refinement.