With details on 2,244 blood pressure monitors, 559 blood glucose meters and 130 pulse oximeters, www.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 manufacturers.
Link: Medaval…
