With details on 2,450 blood pressure monitors, 596 blood glucose meters and 152 pulse oximeters, medaval.ie hosts, by far, the web’s largest database on these medical devices and is an invaluable source of information for both the public and professional institutions.
Medaval stresses the importance of accuracy and provides several lists of validated blood pressure monitors, for a wide variety of requirements, and a list of blood glucose meters. While most users take accuracy for granted, the reality is that only 17% of blood pressure monitors and 9% of blood glucose meters have had their measurement technology validated, according to a standard protocol, as published on PubMed, the primary database for medical publications. No such publication could be found for any pulse oximeter.
Even these low figures hide the fact that many of these devices have been on the market for some time and were validated according to protocols that are now obsolete and replaced by protocols with stricter accuracy criteria.
Medaval have launched their own Certification of Accuracy to provide both private and professional users of a guarantee of proven accuracy according to current standards. To achieve this certification, validations must be carried out exactly as required under the relevant protocols and fulfil the criteria. They hope that their single mark will provide a simple way for consumers to recognise accurate devices. With so many different CE, ISO, FDA and other marks for different functions and device types, not to mention spurious and misleading terminology on some packaging and advertisements, it is difficult for any user to know whether a device is accurate or not.
The simplicity of the Medaval stamp will, hopefully, over time provide users with a single indicator of medical device accuracy. Given the percentage of devices listed as validated, the caution they provide “Health care professionals, patients and consumers are cautioned against using any medical device that has not been tested correctly for accuracy” is chilling. The reality is that, if you are using a medical device, the chances are very high that it has not been tested properly for accuracy and that the values you have been assuming are correct may not be so correct after all.
It only takes a few minutes to check your device on their website and full validation information is provided on each one. You can even download the manual, if you need it. They have an excellent filtering and search system to help you find your device easily and speedily. If it is not validated, please send a query. Medaval will collate all queries and present them to the Manufactures.
Medaval awards its first Certificates to 3 manufactures of Accurate Devices at the recent European Society of Hypertension conference in Milan last month. The certificates that Medaval awards are a Certificate of Accreditation for devices that have been proven to be accurate, for a particular function, according to a specified protocol.
The validation is studied, not only for the results but also to ensure the protocol was followed correctly. Devices certified by Medaval can carry a Medaval Certification of accuracy, on its packaging, in its literature and in advertisements for that device for a period of time.
Medaval certifies the measurement technology, rather than the device itself. Medaval also provide a comparative-equivalence service whereby devices that share the same technology can also carry the certification.
Received by and on behalf of custo med GmbH.
Dr Peter Rumm,
Medical Project Consultant
Export Sales Manager
Presented to custo med GmbH.
By Con Creedon, CEO Medaval Ltd.
Received by and on behalf of Omron Healthcare EMEA
Medical Marketing Group Manager,EMEA
Corporate Communications Group Manager,EMEA
Presented to Omron Healthcare.
By Con Creedon, CEO Medaval Ltd
Neil Atkins Chief Analytical Officer, Medaval Ltd.
Received by and on behalf of A&D Instruments Ltd.
Medical Business Development Division
Head of Customer Service & Inside Sales
Presented to A&D Instruments Ltd
By Con Creedon, CEO Medaval
Neil Atkins. Chief Analytical Officer, Medaval Ltd.
Medaval has just posted up on its website (Click Here) approved lists for the following categories of devices:
- Medaval Certified Blood Pressure Devices.
- Accurate Upper Arm Home Blood Pressure Monitors.
- Accurate Wrist Home Blood Pressure Monitors.
- Accurate Monitors for Ambulatory Blood Pressure Measurement.
- Accurate Professional & Hospital Blood Pressure Monitors.
- Accurate Blood Pressure Monitors for Pregnancy, Children and other Groups.
- Accurate Blood Glucose Meters
All the lists are interactive with our database and are free to download in pdf format.
All lists will be updated regularly as devices become awarded accreditation, undergo Comparative Equivalence and or awarded a pass under a validation study.
It is first a foremost a services for manufacturers.
- Where a manufacturer incorporates identical technology in more than one device, Medaval can provide independent assessment of this claim via its Comparative-Equivalence service.
- The Medaval Comparative-Equivalence process involves comparing every feature of the respective devices. Those features required for measurement technology must be identical.
- Devices are then compared according to how they differ in other features, providing practical-use summary comparisons.
- Comparative-Equivalence is independent of validation but, where a device is certified for a particular technology, that certification can be applied to all devices where that technology is proven to be identical.
- Comparative–Equivalence is a full scientific study and the results are subjected to peer review.
On our website under services we have included a brief video to explain its principles and we have also posted the video on the following link here: