The purpose of designing an anti-suffocation pillow is to maximise air flow should someone suffering from epilepsy, or any other condition resulting in temporary paralysis, end up face down in their pillow/mattress and be unable to move sufficiently enough to breathe regularly. To us here at Carousel this was a challenge about physics and we have spent many hours developing a product that meets that challenge.
Our innovative design has been registered as a CLASS 1 MEDICAL DEVICE with the Medicines and Healthcare Products Regulatory Agency. The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
However this is a ‘self-certifying’ certificate. We have to provide the MHRA with a technical file containing all the details, drawings and composition of our pillow and upon their approval we can proceed to sell our pillow bearing the CE mark. This is all done pretty much on trust and no testing is involved. Whilst this may be fine for other products we felt that, with the prevention of SUDEP being of paramount importance, we should carry out our own tests.
We engaged BTTG (www.bttg.co.uk) to carry out an air flow test. The results are extremely encouraging and are available via the main menu. You can see from the results that our pillow is 10 times more breathable than a regular pillow and up to 7 times more breathable than our nearest competitors’ pillow, depending on which part of their pillow was tested!
The porousness of our pillow has another very important benefit. And that is, when other pillows are breathed into for any length of time they can retain carbon dioxide that is exhaled from the user. This can then be re-breathed reducing their oxygen intake which in turn endangers their well-being. The Breathe-zy pillow provides for a constant flow of oxygen should an episode become prolonged and help prevent re-breathed carbon dioxide.