Listing of devices on the market
Devices on the market were identified, together with manufacturer details, user manuals and all published evidence of performance and accuracy. Details for over 2,300 blood pressure devices, over 550 blood glucose monitors and over 100 pulse oximeters are posted on the Medaval website and are available for scrutiny.
Listing of devices with validation studies
Devices, with measurement technology for which a scientific validation study was carried out, were identified and listed separately from those for which it was not possible to find evidence for a reported validation study. Only 441 of the 2,478 blood pressure monitors (18%) and 61 of the 596 blood glucose meters (11%) were identified as having a published validation (as listed in PubMed), of the respective measurement technology, according to a recognised standard protocol. We were unable to find any such validations for pulse oximeters.
Lists of validated devices, divided into categories, including validations in special populations, are provided under the Approved Lists tab.
Medaval’s science is underpinned by scientific experts in device validation across the disciplines of Blood pressure monitors, Blood glucose meters and Pulse oximeters.
All validation and comparative-equivalence reports are peer reviewed by members from our Reviewer Panels.
All procedures are developed and reviewed by members of our Scientific Procedures Panels.
Validations are performed by members of our Validation Panels. Validations are assigned blind to the manufacturer. Validation reports are peer reviewed by members from our corresponding Reviewer Panel. Once reviewed, investigators are free to prepare a scientific paper for publication, should they so wish.
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. Medaval insists that only the most recent standard protocols are used. Older protocols are not recognised for certification, as their requirements, having been superseded, do not meet current standards. In general, technological advances allow error margins to be narrowed over time while, at the same time, clinical research also drives a demand for increased accuracy. Similarly, ad-hoc protocols are not recognised. While they have a role in the development of new standard protocols, the reliability of the results has yet to be proven.
The passing criteria in validation protocols are based on specific sample distributions and on other criteria and can only be applied if all of the instructions are followed correctly. Therefore, in any validation study, Medaval, first tests the hypothesis that the study was not carried out in accordance with the requirements and it is only if that hypothesis is rejected can the results be considered reliable.
As many validation studies have been published despite the fact that the protocols used were not followed properly, Medaval insists on scrutinising all validation studies from scratch 1) to ensure that a suitable protocol, meeting current standards, was used; 2) to ensure that the protocol was followed correctly and 3) to ensure that the measurement technology satisfied the passing criteria. Only when these criteria are satisfied, and the results checked by members of the Medaval Review Panel, can devices using this technology be certified.
Listing of devices with validation studies
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.
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.
Lists of validated devices, divided into categories, including validations in special populations, are provided under the Approved Lists tabs.
Listing of devices without validation studies
Many devices have never been subjected to a validation study and some manufactures appear reluctant to have any of their devices validated.
Medaval provides comprehensive lists of these devices, so that users can check that devices are validated correctly. It is important to make these checks. Many devices are advertised using terms, such as “clinically tested”, that appear to suggest that they have been validated. Certifications cited are often assumed to include clinical validation. However, references to published independent studies are often not provided or, references provided are for different devices without any proof that the technology is the same.
Health care professionals, patients and consumers are cautioned against using any medical device that has not been tested correctly for accuracy.
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. The term for the procedure is based on the requirement both to prove equivalence of the measurement technology and to compare the devices on other features.
Some devices can appear to be very similar, perhaps with a few extra features, and some even look identical except with a different branding. However, it is a mistake to assume that a validation, performed on one of these devices, can be applied to all of them. Just because they look similar on the outside, does not mean they are the same on the inside. The fact is that they are different in some respects. The scientific approach is always sceptical and so the assumption must be that, because they are different, the validation cannot be applied, no matter what is claimed. However, the guide, and Medaval’s comparative-equivalence, is the designed specifically to test this claim and to avoid expensive and unnecessary validations. It may be that the comparative aspect will reveal that it is only the names or models that differ or that there are substantial differences but with equivalent measurement technology. It does not matter, this is what the procedure is designed for and it is incorrect to apply validations otherwise.