Validation of automatic devices for self blood pressure measurement is a ne
cessity, as the mercury columns are no longer available. The European conse
nsus meeting organized by the Group for blood pressure measurement and eval
uation (GEM), from French Society of Hypertension held last June 1999 has d
efined a new international protocol for clinical validation of these device
s.
The main parts of this protocol are the following: the blood pressure is me
asured at the same arm with two observers simultaneously and then with the
automatic device sequentially seven times among 38 patients. The evaluation
is interrupted after the 15th patient if the pre-analysis fails defined cr
iteria. Technical supports are available :A CD-rom from French society of H
TA for the training and certification of observers, a special kit for the e
valuation (2 mercury column's and a double stethoscope) and a specific soft
ware for data analysis created by the GEM.