Clinical Validation

What is Clinical Validaion ?

It is essential that medical diagnostic products used by professionals and the public alike, should not only be reliable but must be consistently accurate. All digital blood pressure monitors on sale in the UK must comply with minimum CE and MHRA requirements but a true evaluation of clinical accuracy can only be determined through a clinical validation study. This must be carried out at an appropriately recognised medical institution such as a University Hospital and then conducted following strict criteria or protocol set out by organisations such as the British Hypertension Society (BHS) or the European Society of Hypertension (ESH). In the USA validations are also completed to the Association for the Advancement of Medical Instrumentation (AAMI) where products must also meet FDA requirements and adherence is strictly enforced. The protocols of all these esteemed organizations have become recognised standards throughout the World.

A validation study must be published in a recognised medical publication to receive full accreditation and it is re-assuring for A&D Medical customers to know that we offer the broadest range of clinically validated BP monitors on the market. The TM-2430 Ambulatory monitor (ABPM) was validated in Italy in 1998 and has set the standard in Primary Care in the UK. The TM-2655P Surgery monitor that is being used extensively in GP waiting rooms in the UK has recently also gained full BHS validation.

Keep a Check on Your Blood Pressure with a Clinically Validated A&D Monitor

The top selling UA-767 achieved the BHS grade of “A/A” which was published in 2000 and this monitor is used extensively replacing environmentally challenged mercury sphygmomanometers within the NHS in the UK. The “A” grade refers to accuracy within 5mmHg so “A/A” is the highest grade on both systolic and diastolic measurement and has set the standard for all A&D digital BP monitors.

The UA-767 is so user friendly that it has also been recommended for use in the home and achieved a 10/10 rating in the Daily Mail in 2006. Many GPs now recognise the value of home BP readings with the public better equipped and empowered to determine their own health to agreed standards. All of the A&D upper arm BP Monitors - UA range – are now clinically validated and can be seen on the www.bhsoc.org website and details of the relevant validation studies are shown in the table overleaf. Whereas some High Street stores cannot display clinical accuracy of their own brand Blood Pressure monitors, A&D Medical is happy to share the details of our validation reports with any interested professional or domestic users.

Table of Clinically Validated Monitors

Please click here to see details of the relevant validation studies.

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Clinical Validation

• What is Clinical Validation ?
• Keep a check on your blood pressure with a clinically validated A&D monitor.
• List of Clinically Validated Monitors

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A&D Instruments can test and certify all products in their range that are approved for trade use by the National Weights & Measures Laboraroy (NWML) or Nederlands Meetinstituut (NMi). See our Certifications Page.

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