Hypertension kills nearly 10 million people annually worldwide and is the major cause of disability across the globe. In the majority of people with hypertension, blood pressure is inadequately controlled and if blood pressure was controlled and lowered, many millions of deaths, strokes, heart attacks and other cardiovascular events would be prevented. Most adult people do not not know they have high blood pressure and for that reason it has been termed the ‘Silent Killer’.
However, all assumptions relating to the diagnosis and the management of High Blood Pressure (Hypertension) and its treatment is dependent on Blood Pressure Devices that are in fact accurate.
We have therefore concluded that over 80% of all Blood Pressure Monitors sold on the market today are not clinically validated and hence are not proven to be accurate.
Accuracy of Blood Pressure Monitors
All assumptions relating to the diagnosis and management of hypertension are dependent on the accurate measurement of blood pressure.
History of blood pressure measurement
The history of blood pressure measurement makes fascinating reading. For a general history of the beginnings and evolution of blood pressure measurement over the centuries, see references 1 to 5.
Development of blood pressure device validation
All decisions relating to the diagnosis and treatment of high blood pressure are dependent on accurate measurement. The first efforts to have blood pressure devices clinically validated independently was in 1982 , and in 1989 it was proposed that a standardised protocol should be produced for the independent validation of blood pressure measuring devices.  In the late nineteen-eighties, the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) and the Deutsches Institut für Normung (DIN) published standards for blood pressure measuring devices and there have been several revisions since then (see Clinical Validation Protocols for Blood Pressure Monitors below). In 1990 the British Hypertension Society Protocol was published  and revised in 1993.  This protocol was succeeded by the International Protocol of the European Society of Hypertension, in 2002,  and the revised International Protocol published in 2010  became the protocol used most widely in the world for evaluating blood pressure measuring devices.
In 2018, the first universal protocol was published by ISO.  This extended the previous 2013 ANSI/AAMI/ISO protocol to include elements of the 2010 ESH protocol. [13, 14] Validations according to this protocol will be required for compliance with new EU regulations, which come into force in 2020. 
The new universal protocol, called ISO 81060-2:2018 was published in December 2018.  and this has replaced the previous protocols ISO 81060-2:2013  and the European Society of Hypertension International Protocol 2010 (ESH-IP 2010) . However, validation studies according to those protocols will have begun prior to the publication of the universal protocol and will be published throughout 2019. To allow for this transition period, and the fact that those were the current protocols when the validation studies began, Medaval will continue to recognise new validations according to ISO 81060-2:2013 or ESH-IP 2010, as being according to a current protocol as long as the date of publication is no later than 31 December 2019.
New validations with a date of publication from 1 January 2020, must comply with ISO 81060-2:2018. All validations carried out according to ISO 81060-2:2013 or ESH-IP 2010 will cease to be regarded, by Medaval, as being regarded as in accordance to a current protocol on 1 January 2025.
Blood pressure measurement guidelines
National and international societies of hypertension publish guidelines on the management and drug treatment of hypertension but a need to publish guidelines devoted specifically to the measurement of blood pressure has been recognised and addressed by members of the Medaval’s Scientific Panel of experts over a number of years. [17-26]