t their most severe, pressure ulcers become open wounds. Current diagnostic protocol involves visual observation of erythema, or redness of the skin, and looking for an absence of blanching – the whitening of the skin when pressed. These methods are not failsafe, nor are they effective in all populations. ‘The darker the skin, the harder it is to detect visible signs,’ states Sanna, who explains that darker-skinned patients typically develop the most advanced wounds. Other tests depend on the clinician’s ability to detect a change in skin firmness and temperature. ‘The R.A.S. gives caregivers an objective way to apply the recommended diagnostic evaluation protocol in America and Europe.’ Pressure ulcer treatment includes turning the patient frequently to avoid adding pressure to the area, dressing the wound, removing tissue and even surgery. In 2007, Medicare evaluated that a pressure ulcer added US$43,180 to the cost of a hospital stay in the US. In 2008 it stopped reimbursing hospitals for ‘facility-acquired’ bedsores, i.e. those contracted while in care.
This was the time that Sanna was developing her technology as part of her doctoral research at Carnegie Mellon University. ‘There is a real demand for reliable, objective assessment tools,’ says Sanna. She also cites the costly lawsuits filed by families whose loved ones die or receive amputations due to bedsores – 17,000 claims are made each year – that healthcare institutions have to face. The R.A.S. applies a method called tissue reflectance spectroscopy, ‘which measures and analyses the light reflecting off the tissue.’ The device is low cost and easy to use. ‘There is no need for additional training to interpret the results.’ Just pass the optical reader on the skin, which is protected from contamination or infection thanks to a disposable sterility ‘skirt’ – a cover that slips over the device and is replaced on each use. The results are read on the screen. With a projected classification as a Class I FDA medical device, the R.A.S. should have a quick path to what Sanna estimates is a US$2.9 billion market.