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.
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.”2
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
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.). EPUAP/NPIAP/PPPIA
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
NICE MIB: SEM Scanner for pressure ulcer prevention. MedTech Innovation Briefing [MIB182] Published date: May 2019
Australian Wound Management Association. Pan Pacific Clinical Practice Guideline For The Prevention And Management Of Pressure Injury. Cambridge Media Osborne Park, WA:2012
CMS.gov. Centers for Medicare & Medicaid Services
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
Moore Z, et al (2022). Measuring sub-epidermal moisture to detect early pressure ulcer development: a systematic review. Journal of Wound Care. Vol 31
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
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.
Padula, W., (2019). The national cost of hospital acquired pressure injuries in the United States. International Wound Journal. 16(3):634-640
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
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
Wood, Z., (2020). Reducing Pressure Injury (PI) Incidence through the Introduction of Technology. Accepted and presented at NPIAP, Houston, USA
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)
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)
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
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
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
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
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
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
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)
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
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
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
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
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
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.
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
Evans, P., et al. (2020). The impact of skin barrier cream on variation in sub-epidermal moisture readings. Wounds UK 16(2) 29-35
Cohen, L., et al. (2020). Sensitivity and laboratory performances of a second-generation sub-epidermal moisture measurement device. International Wound Journal. 1-6
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
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
Ross, G., et al. (2019). Assessment of sub-epidermal moisture by direct measurement of tissue biocapacitance. Medical Engineering & Physics. 73:92–99
Gefen, A., et al. (2020). The Subepidermal Moisture Scanner: the technology explained. Journal of Wound Care 1;29 (Sup2c):S10-S16
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
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
Swisher S. L., et al. (2015). Impedance sensing device enables early detection of pressure ulcers in vivo. Nature Communications. 6(1)
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
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
November 2022 Update
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Bruin Biometrics LLC Journey
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