What Exactly Does "Validation" of Home Blood Pressure Devices Mean?
The Canadian Hypertension Society recommends that self-measurement blood pressure devices be independently validated according to known international protocols. Self-measurement blood pressure machines are more and more accepted as serious medical devices, but proof of actual accuracy is an obvious requirement in order for these devices to be taken seriously.
There is a common misconception that the organizations which provide protocols for testing the accuracy of these devices actually test and either pass or fail them. For instance, it is not uncommon to hear statements like, "The British Hypertension Society has passed this model." There are three organizations which provide protocols for testing these devices. Probably the best known is The British Hypertension Society (BHS) but the European Society of Hypertension (ESH) and the Association for the Advancement of Medical Instrumentation (AAMI) also have protocols.
What is the purpose of validation protocols?
The purpose of these protocols is to provide any clinical group who is interested in doing an accuracy study a standard, known protocol for the study. If anyone can be said to pass or fail blood pressure monitors, it is the clinical group in question. Generally, these studies are considered to be accepted by health care professionals when they have been published in a peer reviewed journal. The most popular peer reviewed journal in which these types of studies appear is called Blood Pressure Monitoring.
Self-measurement models have been known to fail validation trials. There are no guarantees that models will necessarily be found acceptable. This is why we feel so strongly that un-substantiated validation claims should be rejected.
We are proud to be associated with LifeSource, a manufacturer who understands the importance of accuracy validation and is willing to make the investment to assure both the quality and the investigator independence of such studies.
The studies which have been published to date are available upon request.
How do I know what is validated?
Perhaps unfortunately, there is no Health Canada requirement for home blood pressure devices to be shown to be accurate before they can be sold in Canada.
A “validated” blood pressure monitor is one whose accuracy is endorsed by the caption “Recommended by the Canadian Hypertension Society”, which appears on the Canadian retail package, inside the yellow triangle along with the heart-check logo. All of our most popular models have earned that validation, which is what keeps LifeSource® as Canada’s #1 selling brand of BP monitors (source ACNielsen). This is an important feature for you and your customers since many brands that claim to be “clinically validated” in fact have no published accuracy tests. Always look for the heart-check logo in the yellow triangle.
Why aren't all models validated?
One reason is new models need to be introduced on a timely basis and can't always wait for independent studies to be completed and then expected delays for publishing. A&D Medical, makers of LifeSource, have been leaders at ensuring that clinical studies are performed on their models in order to reassure the market about their clinical reliability.
