O'Brien E, Atkins N, Staessen J
State of the Market: A review of ambulatory blood pressure monitoring devices

Hypertension (Nov) 26:835-842 1995

With the plethora of automated BP monitoring devices becoming available, the question of verification has been raised. Standards to evaluate automated BP devices have been issued both by AAMI and the British Hypertension Society. A new standard is expected in 1996 from the European Community. Automated BP monitors can use a variety of technologies, including ausculatatory and oscillometric methods, with new methods such as pulse-wave velocity detection and the vascular unloading technique (Finapres) on the horizon. The authors chide that, of 43 devices on the market, only 18 were evaluated according to AAMI or BHS recommendations, and that in 9 cases the "protocol was not adhered to". Their conclusion, which I believe to be overly strict is, that only 9 of these devices can be considered to be reliable. The authors are particularly upset that results of some validation studies, recently published in peer-reviewed journals, did not conform to AAMI or BHS recommendations. The authors name names, and the paper is useful for its extensive list of ABP manufacturers, including those that have jumped through all of the validation hoops required by the authors.

Comment: The authors raise the valid point that validation standards are necessary. Without knowing in detail what the "protocol violations" were in studies affecting 9 of the monitors (which the authors then stigmatize as being "questionable") it is difficult to judge whether the authors are possibly a bit too strict in their regulatory desires. (Daugirdas)

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H: Exam and lab tests : Ambulatory monitoring