A comparison of the British Hypertension Society and Association for the Advancement of Medical Instrumentation protocols for validating blood pressure measuring devices: can the two be reconciled?

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