Background: Experience with the original protocols of the Association for the Advancement of Medical Instrumentation (AAMI) and the British Hypertension Society (BHS) for validating blood pressure has provided valuable insight into the methodological problems associated with device validation and has influenced both the BHS and the AAMI in revising their protocols.
Objectives: To review the revisions of the original BHS and AAMI protocols; to compare the protocols; and, using the BHS protocol as a framework for validation, to determine how it should be modified to a protocol that will fulfil the criteria of both the AAMI and the BHS.
Conclusions: The revised protocols have many similarities but there are some important differences. These differences merit consideration so as to facilitate manufacturers seeking to validate devices for acceptance in both Europe and the United States. Of the two protocols, the BHS protocol is the more elaborate in that (1) it takes particular care to ensure that observers are trained to a very high standard, (2) it makes provision for special group validation and (3) it recommends in-use validation of all devices. By modifying the BHS protocol, it is possible to validate blood pressure measuring devices (ambulatory devices require special consideration) to satisfy the criteria of both protocols.