Wednesday, 26 March 2014

The SEM Scanner: The 'Sixth Vital Sign' to Assess Pressure Ulcers

 Bruin Biometrics, LLC ("BBI"), a biometric sensing medical device company today announced significant clinical breakthroughs in the assessment of pressure ulcers using BBI’s SEM Scanner ™, a CE marked medical device.

Bruin Biometrics will present these data in detail during a two - week EU clinical and policy presentation series under the theme, “Making Pressure Ulcer Prevention Possible,” between March 31 and April 11, 2014, including a presentation at the 2nd Focus Meeting of the EPUAP April 7 – 9, 2014.

“We are living through a healthcare transformation that holds the promise of sparing millions of patients from unnecessary pain and potential early mortality. Policy makers across Europe, many of whom consider pressure ulcers to be unacceptable quality events, have crafted and are implementing policies that are increasingly holding healthcare providers financially respo nsible for the billions of Euro required to treat pressure ulcers,” said Martin Burns, CEO of Bruin Biometrics.

“The SEM Scanner TM is coming to market, with breakthrough clinical data, at a critical time for healthcare systems and aging populations.” Interim results (Figures 1 and 2) from BBI’s clinical stud ies show statistically significant SEM Scanner TM readings from patients with confirmed Stage I ulcers, as well as Deep Tissue Injury (DTI).

Three clinical breakthroughs have thus far been observed:

  • SEM readings at the center of a sacral pressure ulcers, where compromised tissue is present, are significantly lower than readings at the periphery of the pressure ulcer;
  • Around the periphery of the pressure ulcers, SEM readings converge toward those ob served over vascularized, viable tissue as indicated by control site readings obtained from subjects’ sternums ; and,
  • SEM readings at the center of existing sacral pressure ulcers are statistically different from SEM readings at the sacra in a population at risk for pressure ulcers and in healthy subjects.

These data pattern s have been independently observed in subjects across two separate study sites under the auspices of two autonomous principal investigators

“These data hold tremendous clinical and economic value for practitioners assessing patients at admission, at discharge and during stay for the existence of pressure ulcers and deep tissue injuries,” Burns said.

The current standard of care in pressure ulcer prevention is based on visual assessment, which focuses on areas where pressure ulcers most commonly d evelop: sacra and heels, for example. Unfortunately, the quality of visual skin inspection is highly dependen t on the skill of the caregiver, and wide and varying resu lts occur.

By the time pressure - induced tissue damage is visually evident at the skin’s surface, significant damage has already occurred. The SEM Scanner can be used by all healthcare practitioners. And SEM Scanner readings – the 6 th vital sign – are readily interpreted and tracked. The device uses integrated sensor technology to assess inflammatory changes associated with pressure - induced tissue damage.

“Pressure ulcers can be aggressively addressed as a problem if healthcare workers use the SEM Scanner TM as a part of their vital signs checks,” Burns said. “Pressure ulcer scanning should be the sixth vital s ign check of all at risk patients.”

Read the full press release.

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