Clinical profile of the SEM Scanner — Modernizing pressure injury care pathways using Sub-Epidermal Moisture (SEM) scanning
| Autor: | Ruth A Bryant, Vignesh Iyer, Zena Eh Moore |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Pressure Ulcer
medicine.medical_specialty Pressure injury business.industry Biomedical Engineering MEDLINE Early detection General Medicine Clinical judgment United States humanities Care Standards Skin tissue Health care Emergency medicine Global health Humans Medicine Surgery Epidermis business Algorithms Skin |
| Zdroj: | Expert Review of Medical Devices. 18:833-847 |
| ISSN: | 1745-2422 1743-4440 |
| DOI: | 10.1080/17434440.2021.1960505 |
| Popis: | Pressure injuries (PIs) are a global health concern. Current PI care standards, including skin tissue assessments (STA) and health care professional (HCP) clinical judgment, diagnose visibly manifested PIs on the skin's surface, i.e. after the damage has already occurred. However, objective assessment of early-stage, non-visible, pressure-induced tissue damage is clinically impossible within the current standard of care. The SEM Scanner is the first device authorized by the Food and Drug Administration (FDA) that addresses this unmet clinical need.This review describes the novel sub-epidermal moisture (SEM) scanning technology of the device and summarizes the clinical safety and efficacy data that support the use of the scanner in routine PI care practice.The clinical strategy for developing the SEM Scanner is noteworthy. SEM technology using anatomy-specific data enables HCPs to provide early PI prevention interventions before visible signs of tissue damage develop while the damage is still reversible. When adopted into routine practice, the device identifies an increased risk of developing PIs 5 days (median) earlier than STA. FDA clearance was based on bench studies and data from three foundational trials that demonstrate the diagnostic accuracy of the device algorithm significantly exceeding clinical judgment (p 0.001). |
| Databáze: | OpenAIRE |
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