Medaval and more

About Medaval

Incorporated in 1989 as Medical Device Assessment Ltd, the company abbreviated its name to Medaval (Med from medical, from assessment and val from validations) in 2015.

The purpose of the site is to provide, for all purchasers of medical devices, an identifiable mark, the Medaval Certificate of Accreditation and its Brand logo, Certified as Accurate, indicating proven measurement accuracy to current standards.

Best and most accurate device you can buy

 

Medaval Site Description

The site provides, for the first time, a unique and comprehensive resource for information on medical devices that will provide the user, whether a health professional or lay patient, with an up-to-date assessment of the accuracy and quality of all devices providing measurements or indices of health and disease.

As a first step, Medaval completed a comprehensive survey of blood pressure monitors, blood glucose meters and pulse oximeters available on the market. In assessing the many thousands of devices available, a range of services were developed based on international scientific principles and procedures.

Scientific Panels

Medaval’s science is underpinned by scientific experts in device validation across the disciplines of Blood pressure monitors, Blood glucose meters and Pulse oximeters.

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 by clicking here.

Certification by Medaval

Medaval certification is awarded, on application by manufacturers, only to devices with the most accurate measurement technology. The first consideration is the validation protocol. 

Comparative Equivalence

It is important to understand that, when a “device” is said to be validated, it is in fact a measurement technology used in that device that is validated and the results of that validation should be applied to all devices using that technology. However, they cannot just be applied without proof that the technologies are the same.

The most comprehensive instructions on how to do this are described in a guide by the European Commission called MEDDEV 2.7/1 rev 4 and Medaval has developed a procedure, founded on this guide

Comparative Equivalence Video

Comparative Equivalence explained further, in this short video

Device Registration Forms (DPF)

Device Registration Forms (DRF). These are Medaval’s standard forms containing the required device details to enable equivalence comparisons according to MEDDEV 2.7/1 rev 4 requirements.

Listing of devices that are Clinically Validated

Medaval recognises that many devices have been validated over the years, often using protocols which were the most recent at that time. As such, where devices have passed a standard protocol, with the results published in a recognised peer-reviewed journal, these, and other devices proven to use the same measurement technology, are listed, as validated, on the website.

Equivalence (Derivative)

Two devices are said to be equivalent, for a particular measurement technology, if it is proven that all of the hardware and firmware components used in the determination of that measurement are identical for both devices. Components may differ provided that they are also proven to be equivalent.

 

Health care professionals, patients and consumers are cautioned against using any medical device that has not been tested correctly for accuracy.

Listing of devices that are NOT Clinically Validated

From our research, less than 20% of blood pressure monitors, less than 15% of blood glucose meters and no pulse oximeters were identified as having a published validation (as listed in PubMed), of the respective measurement technology, according to a recognised standard protocol

 

Health care professionals, patients and consumers are cautioned against using any medical device that has not been tested correctly for accuracy.