Protocols

The traditional approach to determining the accuracy of blood pressure measuring devices has been focused on the measuring equipment — the sphygmomanometer, which in contemporary terms might now be referred to as the "hardware" component. However, with the increasing application of computer technology to blood pressure measuring devices consideration must now be given to other features, such as user friendliness and the "software" component of sphygmomanometers and the means being established for accreditation of software for the analysis of blood pressure data.

Validation of blood pressure measuring devices or sphygmomanometers

The Association for the Advancement of Medical Instrumentation (AAMI) published a standard for Electronic or Aneroid Sphygmomanometers in 1987, which included a protocol for the evaluation of the accuracy of devices, and this was followed in 1990 by the protocol of the British Hypertension Society (BHS); both protocols were revised in 1993. These protocols, which differed in detail, had a common objective, namely the standardisation of validation procedures to establish minimum standards of accuracy and performance, and to facilitate comparison of one device with another. 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 difficult to fulfill and the Working Group on Blood Pressure Monitoring of the European Society of Hypertension recently published a simplified protocol to facilitate manufacturers to submit their products for validation so as to obtain the minimum approval necessary for a device to be used in clinical medicine, and in the hope that in time, most devices on the market will be independently assessed for basic accuracy according to this protocol.

To obtain references for these protocols please refer to the Library.

Assessment of software components of blood pressure measuring devices

Software programs are becoming an important feature of blood pressure measuring devices, especially for devices recording blood pressure over periods of time, such as in operating theatres, intensive care areas, and for self measurement of blood pressure and 24-hour recording of ambulatory blood pressure, and also in the growing area of telemetric transmission of data. Such programs can be purely presentational in that they provide tables, graphs or plots of measurement data, or they can be interpretational in that they provide a computer-generated report on the data recorded.

Criteria for accreditation of the software components of blood pressure monitors are now beginning to be established and one of the functions of the dableducational.org website will be to review these processes and to categorise software accordingly.