The accuracy of the majority of medical devices is not regulated and consumers often take device accuracy for granted. We provide essential advice to consumers, healthcare professionals and the industry, as to the accuracy of the devices we list.
Users of devices and potential purchasers can check the accuracy of devices through the range of accuracy from the most accurate with Medaval certification to those that have never has their accuracy checked properly.
The site provides for the first time a fully comprehensive resource for the 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 has completed a survey of all the blood pressure and blood glucose, available on the market, and is now applying the same principles to devices that measure blood glucose.In assessing the many thousands of devices on the market for measuring blood pressure and blood glucose, the following procedures were carried out and posted on the Medaval website:
- Listing of all devices on the market
- All devices on the market were identified, together with manufacturer details, information booklets and all published evidence of performance and accuracy. The details for over 1,500 blood pressure devices and over 500 blood glucose monitors were posted on the Medaval website and are available for scrutiny.
- Listing of devices with validation studies
- From these devices, the number that had had a scientific validation study carried out were identified and listed separately from those for which it was not possible to find evidence for a reported validation study. From 1,536 blood pressure monitors (BPMs) and 515 blood glucose monitors available to the public, 159 & 80 no respectively were identified that had had validation studies performed.
- Listing of blood pressure devices certified by Medaval
- Medaval certification is awarded only to the most accurate devices. 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 Older protocols are not recognised for certification, as there must have been some reason for them being superseded. In general, technological advances allow error margins to be narrowed 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 the sample, and other criteria, being 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 was used for today’s requirements, to ensure that the protocol was followed correctly and to ensure that the device satisfied the passing criteria. Only when these criteria are satisfied, and the results checked by members of the Medaval Review Panel, can a device be certified.
However, Medaval does recognise 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 are listed, as validated, on the website.
Many devices have never been subjected to a validation study and some manufactures appear reluctant to have any of their devices validated. Both health care professionals and patients are cautioned against using any medical device that has not been tested for accuracy.