Consumers need to question, what in fact, are the best or top rated, Blood Pressure Monitors, or Blood Glucose Meters and Pulse Oximeters, as the consumer side of the medical device industry has become a lottery.
Certification by Medaval
Medaval Accreditation & 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 Older protocols are not recognised for certification, as their requirements, having been superseded, do not meet current standards.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
- to ensure that a suitable protocol, meeting current standards, was used
- to ensure that the protocol was followed correctly and
- to ensure that the measurement technology satisfied the passing criteria.
Graphical View of Accreditation
Only when these criteria are satisfied, and the results checked by members of the Medaval Review Panel, can devices using this technology be certified.