Factors influencing validation of ambulatory blood pressure measuring devices.
With the introduction of 24 h ambulatory blood pressure monitoring into clinical practice a vast market for ambulatory blood pressure monitoring devices has been created. To satisfy this market manufacturers are producing an array of ambulatory blood pressure monitoring devices. There is no obligation on manufacturers to have such devices validated independently, even though two national protocols, one from the British Hypertension Society (BHS) and the other from the Association for the Advancement of Medical Instrumentation (AAMI), call for independent validation and state the means of doing so. However, many factors can influence the validation procedure. They include compliance to the protocol being employed; the accuracy of the standard; establishing precisely the model being validated; the influences of blood pressure level, age and exercise on device accuracy; the provisions necessary for special populations, such as pregnant women, the elderly and children; the influence of oscillometric versus Korotkoff sound detection and electrocardiographic gating on comparative measurements; the assessment of performance as distinct from accuracy; and the relevance of general factors, such as the algorithm being employed and computer compatibility. Forty-three ambulatory blood pressure monitoring devices have been marketed for ambulatory blood pressure measurement and of those only 18 have been validated according to either the BHS or the AAMI protocol. The influence of the factors listed above on the validation studies of those devices will be considered and the relevance of validation procedures to the clinical use of ambulatory blood pressure monitoring devices will be discussed.