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