Principal Research Scientist/Nursing, President, Association for the Advancement of Wound Care (AAWC), Abbott Northwestern Hospital, Minneapolis, MN, United States of America.
Director of the Skin Wounds and Trauma (Swat)research Centre, MSc (Leadership in Health Professionals Education), MSc (Wound Healing & Tissue Repair), FFNMRCSI, Professor and Head of the School of Nursing and Midwifery, RCSI University of Medicine and Health Sciences, Ireland.
Expert Rev Med Devices. 2021 Sep;18(9):833-847. doi: 10.1080/17434440.2021.1960505. Epub 2021 Sep 3.
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).
压力性损伤（PI）是一个全球性的健康问题。目前的 PI 护理标准，包括皮肤组织评估（STA）和医疗保健专业人员（HCP）的临床判断，仅能诊断皮肤表面可见的 PI，即在损伤已经发生之后。然而，在当前的护理标准下，对早期、非可见的、压力引起的组织损伤进行客观评估在临床上是不可能的。SEMSCAN 是第一个获得美国食品和药物管理局（FDA）授权的设备，可以满足这一未满足的临床需求。
本文描述了该设备新颖的表皮下水分（SEM）扫描技术，并总结了支持在常规 PI 护理实践中使用该扫描仪的临床安全性和疗效数据。
开发 SEMScan 设备的临床策略值得关注。SEM 技术使用特定解剖结构的数据，使 HCP 能够在组织损伤可见迹象出现之前提供早期 PI 预防干预措施，此时损伤仍然是可逆的。当该设备被常规应用于临床时，其能够比 STA 更早地（中位数为 5 天）识别出发生 PI 的风险增加。FDA 的批准是基于基础研究和三项基础试验的数据，这些数据表明设备算法的诊断准确性明显优于临床判断（p<0.001）。
