Global proliferation and clinical consequences of non-validated automated BP devices.

Professional societies, guideline writing committees, and other interested parties emphasize the importance of accurate measurement of blood pressure for clinical and public health decisions related to prevention, treatment, and follow-up of high blood pressure. Use of a clinically validated instrument to measure blood pressure is a central component of measurement accuracy and precision. Despite this, most regulatory authorities do not specify validation requirements that manufacturers must meet to sell their blood pressure measurement devices. Likewise, device validity is not a major area of focus for most consumers and healthcare providers, perhaps because they assume it is a pre-requisite for market approval. This has led to a global proliferation of non-validated blood pressure measurement devices, with only a small minority of blood pressure measurement devices having passed internationally accepted validation protocols. The clinical consequences are likely to be significant because non-validated devices are more likely to provide inaccurate estimates of blood pressure compared with validated devices. Even small inaccuracies in blood pressure measurement can result in substantial misdiagnosis and mistreatment of hypertension. There is an urgent need for clinical validation of blood pressure measurement devices prior to marketing them to consumers. There is also need for simplification of the process for consumers and healthcare providers to determine whether a blood pressure measurement device has successfully met an internationally accepted test of validity.