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Evidence Based Medicine (EBM)

Evidence Based medicine (EBM) is the process of systematically reviewing, appraising and using clinical research findings to aid the delivery of optimum clinical care to patients1. The principle of which emphasises that the foundation of any medical decisions regarding the optimal diagnostic or therapeutic procedures are scientifically evidenced from clinical research, and whilst clinical experience and intuition are of great help, they are not the main basis in decision-making.

At BBI scientific knowledge, methods, and rigor underpin everything we do. They inform our decision-making and drive the actions we take. Externally, we demonstrate valid results to affirm the credibility of our products and claims.

We are committed to ensuring that our technology demonstrates high levels of clinical quality and evidence; enabling Health Care Practitioners (HCPs) to integrate technology into the delivery of healthcare in everyday clinical practice. Through collaboration, we strive to empower HCPs to improve their experience and patient outcomes by adopting innovative technology that modernises care pathways and that makes prevention of Pressure Injuries/Ulcers (PI/PU) real.

1. Rosenberg W, Donald A. (1995) Evidence based medicine: an approach to clinical problem-solving. BMJ 310: 1122–1126.

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Standard of Care Increasing Clinical Utility Device Functionality

International Clinical Practice Guidelines (CPG)2

CPG recommendation 2.6 states that HCPs using their own qualified clinical judgement
should, “Consider using a sub-epidermal moisture/edema measurement device as an
adjunct to routine clinical skin assessment.”

CPG recommendation 2.7 states that HCPs using their own qualified clinical judgement when
assessing darkly pigmented skin should, “Consider assessment of skin temperature and
sub-epidermal moisture as important adjunct assessment strategies.”

2 European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance (2019). Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide. Emily Haesler (Ed.).

Standard of Care

PI/PU Global Care Guidelines

Pressure Ulcers: Prevention and Management Clinical Guideline [CG179]. National Institute for
Health and Care Excellence (NICE). Published date: April 2014

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European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan
Pacific Pressure Injury Alliance (2019). Prevention and Treatment of Pressure Ulcers/Injuries:
Clinical Practice Guideline. The International Guideline. Emily Hasler (Ed.). EPUAP/NPIAP/PPPIA

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NICE MIB: SEM Scanner for pressure ulcer prevention. MedTech Innovation Briefing [MIB182]
Published date: May 2019

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Australian Wound Management Association. Pan Pacific Clinical Practice Guideline For The
Prevention And Management Of Pressure Injury. Cambridge Media Osborne Park, WA:2012

View Here Centers for Medicare & Medicaid Services

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Scafide K., et al. (2020). Bedside Technologies to Enhance the Early Detection of Pressure Injuries. A Systematic Review. Journal of Wound, Ostomy and Continence Nursing. 00(0):1-9

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Increasing Clinical Utility

Systematic Reviews

Moore Z, et al (2022). Measuring sub-epidermal moisture to detect early pressure ulcer development: a systematic review. Journal of Wound Care. Vol 31

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SEM Scanner: HE Outcomes Research (HEOR) Data

Raizman R., et al. (2018). Utility of a sensor-based technology to assist in the prevention of pressure ulcers. A clinical comparison. International Wound Journal. 15(6) 1033-1044

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Smith G. (2019). Improved clinical outcomes in pressure ulcer prevention using the SEM Scanner. Journal of Wound Care. Vol 28(25)

Burns M. (2019). Modelling pressure ulcer prevention and treatment pathways: large cost savings achievable with investment in new technology. Accepted and presented at EPUAP, Lyon, France

BBI (2020) Prevention made real: a system problem, a system solution. Getting serious about pressure injury/ulcer prevention – This is the story of George.

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Padula, W., (2019). The national cost of hospital acquired pressure injuries in the United States. International Wound Journal. 16(3):634-640

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Gefen, A., et al. (2020). Modelling the cost-benefits arising from technology-aided early detection of pressure ulcers. Wounds International Vol 11(1) 12-17

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Padula, W., et al. (2020). The cost-effectiveness of sub-epidermal moisture (SEM) scanning to assess pressure injury risk in U.S. health systems. Journal of Patient Safety and Management. 0(0) 1-9

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Wood, Z., (2020). Reducing Pressure Injury (PI) Incidence through the Introduction of Technology. Accepted and presented at NPIAP, Houston, USA

SEM Scanner Real World Evidence

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Evaluation of Novel Sub-Epidermal Moisture (SEM) Technology in Early Pressure Ulcer Detection Versus Conventional Techniques Sharon O’Keeffe, CNS Tissue Viability & Pat McCluskey, Advanced Nurse Practitioner, Cork University Hospital, Ireland. Tissue Viability Conference, Southampton, UK, 2019

Striving for Perfect Care – Preventing Skin Breakdown in the Community Setting in the UK Nicky Ore. et al. Head of Clinical Governance, Mersey Care NHS Foundation Trust, EPUAP, Lyon, France, 2019

Utility of a Sensor-based Technology to Assist in the Prevention of Pressure Ulcers: A Clinical Comparison Rose Raizman. et al. Scarborough Health Network, Canada. International Wound Journal, 2018, 1-12

Improved Clinical Outcomes in Pressure Ulcer Prevention using the SEM Scanner Glenn Smith, Formerly Clinical Nurse Specialist, Nutrition & Tissue Viability, St Mary’s Hospital, Isle of White. Journal of Wound Care, 2019, Vol 28:5

Prevention, Prevention, Prevention - Tackling the No 1 Patient Safety Issue Gillian Raine, Lead Nurse, Marie Curie, Newcastle upon Tyne, UK. Patient Safety Congress, Manchester, UK, 2018

Results from a New Pressure Ulcer Prevention Bundle Simon Littlefield. et al. Private Healthcare Provider. EWMA, Bremen, Germany, 2016

Evaluating the impact on hospital acquired pressure injury/ulcer incidence in a United Kingdom NHS Acute Trust from use of sub-epidermal scanning technology. Journal of Clinical Nursing. 2021;00:1-10

Nightingale, P., et al. (2021)

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The benefits of a first-generation SEM scanner versus an equipment selection pathway in preventing HAPU’s. British Journal of Nursing, Tissue Viability Supplement. Vol 30, No 15; S12-S20

Roper R. (2021)

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Is it time to re-evaluate the inevitability of SCALE ulcers?

Raine G. (2021). Lead Nurse, Marie Curie Hospice, Newcastle upon Tyne International Journal of Palliative Nursing, Vol 27, No 9

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Sub-epidermal moisture assessment as an adjunct to visual assessment in the reduction of pressure ulcer incidence.

Ousey K., et al. (2022). Journal of Wound Care; Vol 31; No 3

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Sub-epidermal moisture assessment as a prompt for clinical action in treatment of pressure ulcers in at-risk hospital patients

Ousey K., et al. (2022). Journal of Wound Care; Vol 31; No 4

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SEM Scanner: Foundational Research

Gershon S., et al. (2014). “SEM Scanner readings to assess pressure induced tissue damage.” Manuscript Submitted for Publication. Abstract accepted and presented at EPUAP , Stockholm, Sweden, August 27-29

Gefen A., et al. (2018). An Observational, Prospective Cohort Pilot Study to Compare the Use of Subepidermal Moisture Measurements Versus Ultrasound and Visual Skin Assessments for Early Detection of Pressure Injury

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Okonkwo H., et al. (2020). A blinded clinical study using a subepidermal moisture biocapacitance measurement device for early detection of pressure injuries. Wound Repair and Regeneration. 1-11

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Gershon, S., (2020). Using sub-epidermal moisture (SEM) level as an indicator of early pressure damage to local skin and tissue. Advances in Wound Care. 1-7

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SEM Scanner: Machine Learning Algorithm

A machine learning algorithm for early detection of heel deep tissue injuries based on a daily history of sub-epidermal moisture measurements

Maayan Lustig, Dafna Schwartz, Ruth Bryant, Amit Gefen (2022)

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SEM Scanner: Surgical Patients

Sub-epidermal moisture versus traditional and visual skin assessment to assess pressure ulcer risk in surgery patients.

Ana Lucia Martins de Oliveira., et al. (2022). Journal of Wound Care; Vol 31; No 3

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Device Functionality

SEM Scanner: Validating the Device

Clendenin M., et al. (2015). Inter-operator and inter-device agreement and reliability of the
SEM Scanner. Journal of Tissue Viability. 24(1):pp 17-23

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Moore Z., et al. (2016). Subepidermal moisture (SEM) and bioimpedance: a literature review of a
novel method for early detection of pressure induced damage (pressure ulcers). International
Wound Journal. 14(2):pp 331-337

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O’Brien G., et al. (2018). The relationship between nurse’s assessment of early pressure ulcer
damage and subepidermal moisture measurement: A prospective explorative study. Journal
of Tissue Viability. 27(4): 232-237

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Cohen L., et al. (2019). Phantom testing of the sensitivity and precision of a sub-epidermal
moisture scanner. International Wounds Journal. Vol 9:No 3

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Moore Z., et al. (2019). Risk assessment tools for the prevention of Pressure Ulcers. Cochrane
Database of Systematic Reviews 2019, Issue 1 Art No: CD006471.

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Budri, A et al. (2020). Impaired mobility and pressure ulcer development in older adults: excess movement and too little movement – two sides of the one coin? Journal of Clinical Nursing. 00: 1– 18

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Evans, P., et al. (2020). The impact of skin barrier cream on variation in sub-epidermal moisture readings. Wounds UK 16(2) 29-35

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Cohen, L., et al. (2020). Sensitivity and laboratory performances of a second-generation sub-epidermal moisture measurement device. International Wound Journal. 1-6

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SEM Scanner: Proving the Concept

Gefen A. (2018). The future of pressure ulcer prevention is already here: Early detection and
targeting inflammation to halt damage. EWMA Journal. Vol 19(2):7-11

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Van Damme N., et al. (2019). Physiological processes of inflammation and oedema initiated by
sustained mechanical loading in subcutaneous tissues: a scoping review.
Wound Repair and Regeneration

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Ross, G., et al. (2019). Assessment of sub-epidermal moisture by direct measurement of tissue
biocapacitance. Medical Engineering & Physics. 73:92–99

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Gefen, A., et al. (2020). The Subepidermal Moisture Scanner: the technology explained. Journal of Wound Care 1;29 (Sup2c):S10-S16

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Concept of SEM: Foundational Science

Bates-Jensen B., et al. (2009). Sub-epidermal moisture is associated with early pressure ulcer
damage in nursing home residents with dark skin tones: Pilot findings. Journal of Wound,
Ostomy and Continence Nursing. 36(3):pp 277-284

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Guihan M., et al. (2012). Assessing the feasibility of subepidermal moisture to predict erythema
and stage 1 pressure ulcers in persons with spinal cord injury. A pilot study. The Journal of
Spinal Cord Medicine. 35(1):pp 46-52

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Swisher S. L., et al. (2015). Impedance sensing device enables early detection of pressure
ulcers in vivo. Nature Communications. 6(1)

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Oliveira A.L., et al. (2017). Accuracy of ultrasound, thermography and subepidermal moisture in
predicting pressure ulcers: a systematic review. Journal of Wound Care. 26(5):pp 502-511

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SEM Scanner: Clinical Profile

Bryant R. et al. (2021). Clinical Profile of the SEM Scanner – Modernizing Pressure Injury Care Pathways Using Sub-Epidermal Moisture (SEM) Scanning. Expert Review of Medical Device

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