Limitations of current validation protocols for home blood pressure monitors for individual patients.

BACKGROUND Automatic blood pressure monitoring conducted at home is increasingly used in the diagnosis and management of hypertension. We assessed the adequacy of existing British Hypertension Society (BHS) and Association for the Advancement of Medical Instrumentation (AAMI) validation standards for automatic blood pressure monitoring devices. SUBJECT AND METHODS A theoretical study and an empirical test are presented to estimate the proportion of persons for whom a blood pressure monitor validated according to existing BHS and AAMI standards would be inaccurate. RESULTS The results suggest that a major limitation of both protocols is the lack of attention given to the number of individual patients for whom a monitor may be inaccurate. A blood pressure monitor that meets the AAMI and BHS validation criteria may report blood pressures in error by more than 5 mmHg for more than half of the people. CONCLUSIONS A validation standard that does not take account of the person-effects on error will lead to a substantial proportion of persons using self-monitors that are systematically inaccurate for that person.