International Society of Hypertension

International Society of Hypertension and World Hypertension League


Clinical Validations

Medaval Lead Implementation of World Hypertension League and International Society of Hypertension Recommendations

In May 2016, the World Hypertension League, in conjunction with the International Society of Hypertension and other hypertension organisations, published a policy statement in which they made four important recommendations concerning the regulation of the manufacture and marketing of blood pressure monitors and cuffs.¹ The free-access document is available from Wiley here.

Medaval lead the implementation of these recommendations.

With over 3,100 blood pressure monitors, Medaval provides the most comprehensive registry of blood pressure monitors, in the world.

Each device is marked according to how it is tested independently to meet an international validation standard. Each certificate is awarded dependent on the cuffs tested in the validation.

Medaval endorses the calls on the private sector to ensure that only validated devices are sold on the market and marks devices which have not been subjected to validation. Over 2,500 (86%) devices have not been validated.

 

Medaval endorses the calls governmental organisations to develop policies and regulations to allow only the sale of validated blood pressure monitors.

 

Lists of best-rated blood pressure monitors and validated monitors according to several categories are provided.

 

Medaval endorses the recommendation for upper-arm devices.

 

All Medaval lists include the site of measurement.

 

Cautions are provided for wrist devices.

 

Medaval provides a simple easy-to-understand branded symbol to identify clearly the level of validation.

One to five stars are awarded based on the protocol used, when it was validated, multiple validations and certification to ensure independent guarantee of strict adherence to the protocol.

Medaval 5 star Blood Pressure Monitors

Certified by Medaval with multiple validations

Medaval 4 star Best Blood Pressure Monitors

Certified by Medaval with a single validation

Medaval 3 star Blood Pressure Monitors

Multiple validations including using a current protocol and since 2007

Medaval 2 Star Best Blood Pressure Monitor

Two of: validated using a current protocol and, validated since 2007 and multiple validations

Medaval 1 Star Best Blood Pressure Monitor

One of: validated using a current protocol and, validated since 2007 and multiple validations

No validation found-accuracy unknown

No validation information found – Accuracy unknown

Reference

  1. Campbell NR, Gelfer M, Stergiou GS, Alpert BS, Myers MG, Rakotz MK, Padwal R, Schutte AE, O’Brien E, Lackland DT, Niebylski ML, Nilsson PM, Redburn KA, Zhang XH, Burrell L, Horiuchi M, Poulter NR, Prabhakaran D, Ramirez AJ, Schiffrin EL, Touyz RM, Wang JG, Weber MA. A Call to Regulate Manufacture and Marketing of Blood Pressure Devices and Cuffs: A Position Statement From the World Hypertension League, International Society of Hypertension and Supporting Hypertension Organizations. J Clin Hypertens (Greenwich). 2016 May;18(5):378-80. doi: 10.1111/jch.12782. Epub 2016 Feb 8. PMID: 26852890.

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