Validation up-date

With the increasing marketing of automated and semi-automated devices for the measurement of blood pressure, there is a need for potential purchasers to be able to satisfy themselves that such devices have been evaluated according to agreed criteria. Since their introduction a large number of blood pressure measuring devices have been evaluated according to one or both protocols. However, experience has demonstrated that the conditions demanded by the protocols are extremely difficult to fulfil. The European Society of Hypertension (ESH) protocol, named the International Protocol, which will be published shortly, is based on the data from 19 validation studies performed according to the AAMI and BHS protocols. Critical assessment of this data base of evidence has permitted rationalisation and simplification of validation procedures without loosing the merits of the much more complicated earlier protocols. This has been achieved by elimination of pre-validation phases, improving observer recruitment and training, minimising observer error during validation, reducing the number of subjects recruited, relaxing the range of blood pressures required and eliminating 'hopeless' devices early in the validation procedure.