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National Institute for Health and Care Excellence (NICE) Releases Medtech Innovation Briefing (MIB) on BBI’s SEM Scanner

BBI’s SEM Scanner

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The SEM Scanner from BBI Europe Ltd (BBI), has received a Medtech Innovation Briefing (MIB) {MIB182}, part of National Institute for Health and Care Excellence (NICE) advice. The SEM Scanner objectively alerts clinicians to specific anatomical areas of a patient’s body at increased risk for developing pressure damage, meaning patient risk assessments are performed before visible damage manifests at the skin surface – a world and clinical first.3

MIBs are commissioned by NHS England and are designed to support NHS and social care commissioners and staff who are considering using new medical devices. The Briefing includes a description of the SEM Scanner technology, how it is used, its potential role in the pressure ulcer care pathway and also includes a review of relevant published evidence and the likely costs of using the technology.

BBI CEO Martin Burns welcomed the NICE decision: “Around 95% of pressure ulcers are preventable4. Our singular objective is to reduce pressure injury incidence by helping clinicians make prevention real. Where we have seen our SEM Scanner in use, the results have been dramatic. This briefing will help avoid the need for organisations to produce similar information locally, saving staff time and resources. When you consider that the average prevention cost of using the SEM Scanner works out at just £1.50 per patient per day5, we believe that we have game-changer technology available now in the UK.”

2018 data from NHS Improvement showed that treating pressure damage costs the NHS more than £3.8m per day; with 1,700-2,000 patients per month developing pressure ulcers1.

Figures obtained under a Freedom of Information request2 from NHS Resolution (formerly the NHS Litigation Authority) reveal the increasing financial impact of pressure ulcer claims against NHS Trusts from the year 2014/15 to 2017/18 (latest figures available):

• 43% increase in the number of claims received for pressure ulcers from 279 to 399
• A total of £72,404,574 paid in claims during these four years and an increase of 53% from £13,618,669 (2014/15) to £20,828,669 (2017/18)
In terms of claims in 2017/18 these were spread across 12 specialities (including Obstetrics, Rehabilitation and Casualty).

In terms of cost in claims to the NHS, the highest was Orthopaedic Surgery (£4,531,003), followed by General Medicine (£4,295,440), District Nursing (£2,898,400) and General Surgery (£1,522,581).2

The SEM Scanner received European CE Mark approval in 2014, Health Canada clearance in 2016 and the US Food and Drug Administration (FDA) granted marketing authorisation in December 2018 under its De Novo review process for novel low-to moderate-risk devices that are not substantially equivalent to an already legally marketed device.

Glenn Smith, Nurse Prescriber at St Helen’s Medical Centre was contacted by NICE as an expert adviser. Smith was the Tissue Viability and Nutrition Senior CNS/Patient Safety Lead in 2017 when the SEM Scanner was in use at the Isle of Wight NHS Trust. Smith commented that: “I am aware that the SEM Scanner has been available in the UK now for a few years and that BBI have been gradually building their clinical evidence – this review from NICE, which is one of the highest health technology assessments in the UK, now supports the fact that the SEM Scanner could be a frontline technology that could transform how we care for patients at risk of pressure ulcers.”

The Marie Curie Hospice, Newcastle was the first to deploy the SEM Scanner in a hospice setting, starting with a six-month trial in November 2017 which helped reduce incidences of pressure ulcers by nearly 50%6. This led to them winning an Innovation in Care Award 2018 from Hospice UK.

The SEM Scanner has received numerous industry awards including the Journal of Wound Care’s Most Innovative Product (2018) and the Health Service Journal’s Partnership Award for Best Innovation in Medical Technology (2018).

Two members of BBI’s European Scientific Advisory Board commented on the NICE Briefing. Professor Karen Ousey, Director for the Institute of Skin Integrity and Infection Prevention, University of Huddersfield, an authority on wound care commented: "I'm delighted to hear that a Medtech Innovation Briefing has been issued by NICE on the SEM Scanner in support of the prevention of pressure ulcers. This is such an important issue that is not always front of mind, so it is pleasing to see the challenges of pressure ulcer prevention being addressed.”

Jacqui Fletcher, Independent Healthcare and Wound Care Consultant, agrees with Professor Ousey and also added: “it shows great commitment from BBI to pursue this level of endorsement as NICE requires substantial evidence reviews.”

1. NHS Improvement (2018). Pressure ulcers: revised definition and measurement
2. Information obtained under the FOI Act from NHS Resolution (3630) March 2019
3. Okonkwo H. Milne et al. (2018). Evaluation of a Novel Device Using Capacitance of the Detection of Early Pressure Ulcers (PU), a Multi-Site Longitudinal Study. Accepted and presented at NPUAP
4. Findlay D. (1996) Practical management of pressure ulcers. American Family Physician. 54(5), 1519-28, 1533
5. BBI Data on File (2019)
6. Raine G. (2018). Prevention, Prevention, Prevention; Tackling the Number One Patient Safety Issue. Presented at Patient Safety Conference, Manchester, UK