Automated blood pressure measurement: state of the market in 1998 and the need for an international validation protocol for blood pressure measuring devices.

The market for blood pressure measuring devices is increasing rapidly. A vast market for self-measuring devices has existed for many years and this continues to grow. There is also a large market for autoated devices in specialized hospital areas, such as operating theatres and intensive care units. Since the introduction of ambulatory blood pressure monitoring into clinical practice, a growing market for devices to measure blood pressure over time has been created. The states of these three markets are reviewed in this paper. With the likely banning of mercury from clinical use, the traditional sphygmomanometer will disappear and it is inevitable that a new and large market will be created by the demand for an automated alternative to the mercury sphygmomanometer in hospitals and in general practice. It is mandatory that such automated devices are validated independently for accuracy and performance. At present two validation protocols are widely used to test the accuracy of blood pressure measuring devices - the British Hypertension Society and the Association for the Advancement of Medical Instrumentation protocols. These protocols have a common purpose and many similarities. It is proposed that a common protocol should be devised for international use. Experience with these protocols allows one to make suggestions concerning how such an international protocol might be simplified and improved.