Clinical profile of the SEM Scanner — Modernizing pressure injury care pathways using Sub-Epidermal Moisture (SEM) scanning

References

• EPUAP/NPIAP/PPPIA, European pressure ulcer advisory panel, national pressure injury advisory panel and Pan Pacific pressure injury alliance. Prevention and treatment of pressure ulcers/injuries: Clinical Practice Guideline. The International Guideline. EPUAP/NPIAP/PPPIA, 2019.
   Google Scholar
• Degenholtz HB, Rosen J, Castle N, et al. The association between changes in health status and nursing home resident quality of life. Gerontologist. 2008;48(5):584–592.
   PubMed Web of Science ®Google Scholar
• Essex HN, Clark M, Sims J, et al. Health-related quality of life in hospital inpatients with pressure ulceration: assessment using generic health-related quality of life measures. Wound Repair Regen. 2009;17(6):797–805.
   PubMed Web of Science ®Google Scholar
• Jackson DE, Durrant LA, Hutchinson M, et al. Living with multiple losses: insights from patients living with pressure injury. Collegian. 2018;25(4):409–414.
   Web of Science ®Google Scholar
• Padula WV, Delarmente BA. The national cost of hospital-acquired pressure injuries in the United States. Int Wound J. 2019;16(3):634–640.
   PubMed Web of Science ®Google Scholar
• Guest JF, Vowden K, Vowden P. The health economic burden that acute and chronic wounds impose on an average clinical commissioning group/health board in the UK. J Wound Care. 2017;26(6):292–303.
   PubMed Web of Science ®Google Scholar
• Guest JF, Fuller GW, Vowden P. Cohort study evaluating the burden of wounds to the UK’s National Health Service in 2017/2018: update from 2012/2013. BMJ Open. 2020;10(12):e045253.
   PubMed Web of Science ®Google Scholar
• Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004;33(3):230–235.
   PubMed Web of Science ®Google Scholar
• Dealey C, Posnett J, Walker A. The cost of pressure ulcers in the United Kingdom. J Wound Care. 2012;21(6):261–2, 264, 266.
   PubMed Web of Science ®Google Scholar
• Gefen A, Ousey K. COVID-19: pressure ulcers, pain and the cytokine storm. J Wound Care. 2020;29(10):540–542.
   PubMed Web of Science ®Google Scholar
• Team V, Team L, Jones A, et al. Pressure injury prevention in COVID-19 patients with acute respiratory distress syndrome. Front Med (Lausanne). 2020;7:558696.
   PubMed Web of Science ®Google Scholar
• Tang J, Li B, Gong J, et al. Challenges in the management of critical ill COVID-19 patients with pressure ulcer. Int Wound J. 2020;17(5):1523–1524.
   PubMed Web of Science ®Google Scholar
• Gefen A, Ousey K. Update to device-related pressure ulcers: SECURE prevention. COVID-19, face masks and skin damage. J Wound Care. 2020;29(5):245–259.20.
   PubMed Web of Science ®Google Scholar
• Moore Z, Patton D, Avsar P, et al. Prevention of pressure ulcers among individuals cared for in the prone position: lessons for the COVID-19 emergency. J Wound Care. 2020;29(6):312–320.
   PubMed Web of Science ®Google Scholar
• Kim RS, Mullins K. Preventing facial pressure ulcers in acute respiratory distress syndrome (ARDS). J Wound Ostomy Continence Nurs. 2016;43(4):427–429.
   PubMed Web of Science ®Google Scholar
• Clay P, Cruz C, Ayotte K, et al. Device related pressure ulcers pre and post identification and intervention. J Pediatr Nurs. 2018;41:77–79.
   PubMed Web of Science ®Google Scholar
• Zhang W, Liu X, Wang S, et al. Mechanism and prevention of facial pressure injuries: a novel emergent strategy supported by a multicenter controlled study in frontline healthcare professionals fighting COVID-19. Wound Repair Regen. 2021;29(1):45–52.
   PubMed Web of Science ®Google Scholar
• Shelhamer MC, Wesson PD, Solari IL, et al. Prone positioning in moderate to severe acute respiratory distress syndrome due to COVID-19: a cohort study and analysis of physiology. J Intensive Care Med. 2021;36(2):241–252.
   PubMed Web of Science ®Google Scholar
• Padula WV, Cuddigan J, Ruotsi L, et al. Best-Practices for preventing skin injury beneath personal protective equipment during the COVID-19 pandemic: a position paper from the National Pressure Injury Advisory Panel (NPIAP). J Clin Nurs. 2021. Advance online publication. DOI:https://doi.org/10.1111/jocn.15682.
   Google Scholar
• Peko L, Barakat-Johnson M, Gefen A. Protecting prone positioned patients from facial pressure ulcers using prophylactic dressings: a timely biomechanical analysis in the context of the COVID-19 pandemic. Int Wound J. 2020;17(6):1595–1606.
   PubMed Web of Science ®Google Scholar
• Nani FS, Stefani KC, Busnardo FF, et al. Ulcer pressure prevention and opportunity for innovation during the COVID-19 crisis. Clinics (Sao Paulo). 2020;75:e2292.
   PubMed Web of Science ®Google Scholar
• Gefen A. The sub-epidermal moisture scanner: the principles of pressure injury prevention using novel early detection technology. Wound Int. 2018;9(3):30–35.23.
   Google Scholar
• Bates-Jensen BM, Mccreath HE, Pongquan V. Subepidermal moisture is associated with early pressure ulcer damage in nursing home residents with dark skin tones: pilot findings. J Wound Ostomy Continence Nurs. 2009;36(3):277–284.
   PubMed Web of Science ®Google Scholar
• Bates-Jensen BM, Mccreath HE, Pongquan V, et al. Subepidermal moisture differentiates erythema and stage I pressure ulcers in nursing home residents. Wound Repair Regen. 2008;16(2):189–197.
   PubMed Web of Science ®Google Scholar
• Oomens CW, Bader DL, Loerakker S, et al. Pressure induced deep tissue injury explained. Ann Biomed Eng. 2015;43(2):297–305.
   PubMed Web of Science ®Google Scholar
• Bouten CV, Oomens CW, Baaijens FP, et al. The etiology of pressure ulcers: skin deep or muscle bound? Arch Phys Med Rehabil. 2003;84(4):616–619.
   PubMed Web of Science ®Google Scholar
• Pieper B, Mott M. Nurses’ knowledge of pressure ulcer prevention, staging, and description. Advances in Wound Care. J Prev Heal. 1995;8(3): 34, 38, 40 passim.
   Google Scholar
• Pancorbo-Hidalgo PL, Garcia-Fernandez FP, Lopez-Medina IM, et al. Risk assessment scales for pressure ulcer prevention: a systematic review. J Adv Nurs. 2006;54(1):94–110.
   PubMed Web of Science ®Google Scholar
• Hiser B, Rochette J, Philbin S, et al. Implementing a pressure ulcer prevention program and enhancing the role of the CWOCN: impact on outcomes. Ostomy Wound Manage. 2006;52(2):48–59.
   PubMedGoogle Scholar
• Moore ZE, Patton D. Risk assessment tools for the prevention of pressure ulcers. Cochrane Database Syst Rev. 2019;1(1):Cd006471.
   PubMedGoogle Scholar
• Waterlow J. From costly treatment to cost-effective prevention: using Waterlow. Br J Community Nurs. 2005;10(Sup3):S25–S30.
   PubMedGoogle Scholar
• Bergstrom N, Braden BJ, Laguzza A, et al. The braden scale for predicting pressure sore risk. Nurs Res. 1987;36(4):205–210.
   PubMed Web of Science ®Google Scholar
• Norton D. Calculating the risk: reflections on the Norton Scale. Decubitus. 1989;2(3):24–31.
   PubMedGoogle Scholar
• EPUAP/NPUAP/PPPIA, European pressure ulcer advisory panel, national pressure ulcer advisory panel and Pan Pacific pressure injury alliance. Prevention and treatment of pressure ulcers/injuries: clinical practice guideline. The international guideline. EPUAP/NPUAP/PPPIA, 2014.
   Google Scholar
• NPUAP, Prevention and treatment of pressure ulcers: Quick Reference Guide. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance, 2014.
   Google Scholar
• World Health Organization. International statistical classification of diseases and related health problems (10th ed). 2016. https://icd.who.int/browse10/2016/en (accessed 14 April 2020).
   Google Scholar
• Scafide KN, Narayan MC, Arundel L. Bedside technologies to enhance the early detection of pressure injuries: a systematic review. J Wound Ostomy Continence Nurs. 2020;47(2):128–136.
   PubMed Web of Science ®Google Scholar
• Gefen A, Cohen L, Amrani G, et al. The roles of infrared thermography in pressure ulcer research with focus on skin microclimate induced by medical devices and prophylactic dressings. Wound Int. 2019;10(1):8–15.
   Google Scholar
• Bader DL, Worsley PR. Technologies to monitor the health of loaded skin tissues. Biomed Eng Online. 2018;17(1):40.
   PubMedGoogle Scholar
• Ross G, Gefen A. Assessment of sub-epidermal moisture by direct measurement of tissue biocapacitance. Med Eng Phys. 2019;73:92–99.
   PubMed Web of Science ®Google Scholar
• FDA. De Novo Classification Decision Summary For SEM Scanner (MODEL 200) 2018. [cited 2021 Apr 08]. Available from: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170021.pdf.
   Google Scholar
• Li L, Li C, Zhang Z, et al. On the dielectric “constant” of proteins: smooth dielectric function for macromolecular modeling and its implementation in DelPhi. J Chem Theory Comput. 2013;9(4):2126–2136.
   PubMed Web of Science ®Google Scholar
• Tomaselli VP, Shamos MH. Electrical properties of hydrated collagen. I. Dielectric properties. Biopolymers. 1973;12(2):353–366.
   Web of Science ®Google Scholar
• Okonkwo H, Bryant R, Milne J, et al. A blinded clinical study using a subepidermal moisture biocapacitance measurement device for early detection of pressure injuries. Wound Repair Regen. 2020;28(3):364–374.
   PubMed Web of Science ®Google Scholar
• Gershon S, Okonkwo H. Evaluating the sensitivity, specificity and clinical utility of algorithms of spatial variation in sub-epidermal moisture (SEM) for the diagnosis of deep and early-stage pressure-induced tissue damage. J Wound Care. 2021;30(1):41–53.
   PubMed Web of Science ®Google Scholar
• Gefen A, Gershon S. 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. Ostomy Wound Manage. 2018;64(9):12–27.
   PubMedGoogle Scholar
• Gershon S. Using subepidermal moisture level as an indicator of early pressure damage to local skin and tissue. Adv Skin Wound Care. 2020;33(9):469–475.
   PubMed Web of Science ®Google Scholar
• Peko L, Gefen A. Sensitivity and laboratory performances of a second-generation sub-epidermal moisture measurement device. Int Wound J. 2020;17(3):864–867.
   PubMed Web of Science ®Google Scholar
• Gefen A, Kolsi J, King T, et al. Modelling the cost-benefits arising from technology-aided early detection of pressure ulcers. Wound Int. 2020;11(1):22–29.
   Google Scholar
• Padula WV, Malaviya S, Hu E, et al. The cost-effectiveness of sub-epidermal moisture scanning to assess pressure injury risk in U.S. health systems. J Patient Saf Risk Manag. 2020;25(4):147–155.
   Google Scholar
• Clendenin M, Jaradeh K, Shamirian A, et al. Inter-operator and inter-device agreement and reliability of the SEM Scanner. J Tissue Viability. 2015;24(1):17–23.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process.” Issued by CDRH:2020.
   Google Scholar
• Park S, Kim CG, Ko JW. The use of sub-epidermal moisture measurement in predicting blanching erythema in jaundice patients. J Wound Care. 2018;27(5):342–349.
   PubMed Web of Science ®Google Scholar
• Kim CG, Park S, Ko JW, et al. The relationship of subepidermal moisture and early stage pressure injury by visual skin assessment. J Tissue Viability. 2018;27(3):130–134.
   PubMed Web of Science ®Google Scholar
• Bates-Jensen BM, Mccreath HE, Patlan A. Subepidermal moisture detection of pressure induced tissue damage on the trunk: the pressure ulcer detection study outcomes. Wound Repair Regen. 2017;25(3):502–511.
   PubMed Web of Science ®Google Scholar
• Swisher SL, Lin MC, Liao A, et al. Impedance sensing device enables early detection of pressure ulcers in vivo. Nat Commun. 2015;6(1):6575.
   PubMedGoogle Scholar
• Zhang L, Liu P, Dong X, et al. A method for in vivo detection of abnormal subepidermal tissues based on dielectric properties. Biomed Mater Eng. 2014;24(6):3455–3462.
   PubMed Web of Science ®Google Scholar
• Bates-Jensen BM, Mccreath HE, Nakagami G, et al. Subepidermal moisture detection of heel pressure injury: the pressure ulcer detection study outcomes. Int Wound J. 2018;15(2):297–309.
   PubMed Web of Science ®Google Scholar
• Bates-Jensen BM, Mccreath HE, Kono A, et al. Subepidermal moisture predicts erythema and stage 1 pressure ulcers in nursing home residents: a pilot study. J Am Geriatr Soc. 2007;55(8):1199–1205.
   PubMed Web of Science ®Google Scholar
• Harrow JJ, Mayrovitz HN. Subepidermal moisture surrounding pressure ulcers in persons with a spinal cord injury: a pilot study. J Spinal Cord Med. 2014;37(6):719–728.
   PubMed Web of Science ®Google Scholar
• Guihan M, Bates-Jenson BM, Chun S, et al. Assessing the feasibility of subepidermal moisture to predict erythema and stage 1 pressure ulcers in persons with spinal cord injury: a pilot study. J Spinal Cord Med. 2012;35(1):46–52.
   PubMed Web of Science ®Google Scholar
• Budri AMV, Moore Z, Patton D, et al. Sub-epidermal moisture measurement: an evidence-based approach to the assessment for early evidence of pressure ulcer presence. Int Wound J. 2020;17(6):1615–1623.
   PubMed Web of Science ®Google Scholar
• Moore ZE, Cowman S. Risk assessment tools for the prevention of pressure ulcers. Cochrane Database Syst Rev. 2014 Feb 5;(2):CD006471.
   PubMed Web of Science ®Google Scholar
• O’Brien G, Moore Z, Patton D, et al. The relationship between nurses assessment of early pressure ulcer damage and sub epidermal moisture measurement: a prospective explorative study. J Tissue Viability. 2018;27(4):232–237.
   PubMed Web of Science ®Google Scholar
• Moore Z, Patton D, Rhodes SL, et al. Subepidermal moisture (SEM) and bioimpedance: a literature review of a novel method for early detection of pressure-induced tissue damage (pressure ulcers). Int Wound J. 2017;14(2):331–337.
   PubMed Web of Science ®Google Scholar
• Raizman R, Macneil M, Rappl L. Utility of a sensor-based technology to assist in the prevention of pressure ulcers: a clinical comparison. Int Wound J. 2018;15(6):1033–1044.
   PubMed Web of Science ®Google Scholar
• Smith G. Improved clinical outcomes in pressure ulcer prevention using the SEM scanner. J Wound Care. 2019;28(5):278–282.
   PubMed Web of Science ®Google Scholar
• Ore N, Carver T. Implementing a new approach to pressure ulcer prevention. J Clin Nurs. 2020;34(4):52–57.
   Google Scholar
• O’Connor R, Moore ZE, O’Connor T. Pressure ulcer detection and risk assessment: the use of sub-epidermal moisture scanning versus existing methodologies, in European Wound Management Association 2016. Bremen, Germany; EWMA. 2016.
   Google Scholar
• Ana Lucia M. DO, The role of sub-epidermal moisture measurement versus traditional risk assessment and visual skin assessment in the prediction of pressure ulcer risk among adults undergoing surgery. Royal College of Surgeons in Ireland, Thesis, 2018. DOI:https://doi.org/10.25419/rcsi.10763948.v1.
   Google Scholar
• Musa L, Ore N, Raine G, et al. Clinical impact of a sub-epidermal moisture scanner: what is the real-world use? J Wound Care. 2021;30(3):198–208.
   PubMed Web of Science ®Google Scholar
• Padula WV, Mishra MK, Makic MB, et al. Improving the quality of pressure ulcer care with prevention: a cost-effectiveness analysis. Med Care. 2011;49(4):385–392.
   PubMed Web of Science ®Google Scholar
• GDPR. REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - General data protection regulation. Official Journal of the European Union; 2016.
   Google Scholar
• FDA. Gov, Use of real-world evidence to support regulatory decision-making for medical devices, C.f.D.a.R.H. U.S. Department of Health and Human Services Food and Drug Administration, Center for Biologics Evaluation and Research, Editor. 2017.
   Google Scholar
• Burns M, Reducing pressure injury/ulcer (PI/U) ulcer through the introduction of technology, in European Wound Management Association. 2020, EWMA: Virtual.
   Google Scholar
• Defloor T, Maria FHG. Validation of pressure ulcer risk assessment scales: a critique. J Adv Nurs. 2004;48(6):613–621.
   PubMed Web of Science ®Google Scholar
• Padula W, Berke C, Bryant R, NPIAP-WOCN-AAWC Joint Policy Task Force. A collaborative call for changes in reimbursement policies to achieve improvements in hospital safety related to pressure injuries. J Patient Saf. 2021;17(4):e268.
   PubMed Web of Science ®Google Scholar