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

INTRODUCTION: 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. AREAS COVERED: 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. EXPERT OPINION: 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).

Perspectives on Patient and Family Engagement With Reduction in Harm: The Forgotten Voice.

BACKGROUND: Despite continued efforts to improve safety in hospitals, hospital-acquired harm persists. Strategies have been identified to establish patient-centered care and improve patient engagement with care. However, the relationship of patient and family engagement to reduction of harm is not well understood, with limited findings available in current literature. PURPOSE: This qualitative study explored the perceptions and attitudes of patients and family members and several clinical disciplines toward patient engagement in reducing preventable harm in hospitalized patients. METHODS: We conducted 8 focus groups at 2 nonprofit hospitals with several constituencies: patients/families, registered nurses, physician hospitalists, and pharmacists/physical therapists. RESULTS: Thematic analysis of transcripts revealed multiple themes from different perspectives, including: family presence increases safety, the hospital environment is intimidating, and communication is essential, but I am not being heard. CONCLUSIONS: The rich data suggest a significant opportunity for reducing risk and harm by more actively engaging patients and families in the effort. Increasing patient acuity and complexity of care furthers the need for partnering with patients and families more intentionally for increased safety.

Developing an Intervention to Reduce Harm in Hospitalized Patients: Patients and Families in Research.

BACKGROUND: Patient safety-focused research may be strengthened by the inclusion of patients and family members in research design; yet, published methodologies for doing so are scarce. PURPOSE: This study engaged patients and families in research design of an intervention to increase patient/family engagement, with reduction of harm in hospitalized patients. METHODS: The study design team convened a Patient Safety Advisory Panel to explore potential testable interventions to increase patient/family engagement with safety. They explored the preferred intervention, Speak Up-My Advocate for Patient Safety (MAPS), through multistakeholder focus groups. RESULTS: Participants emphasized the importance of including patient/family when designing interventions. Regarding the Speak Up-MAPS intervention, perceptions from stakeholders were mixed, including the value and potential complexity, role confusion, and cost of the proposed advocate role. CONCLUSION: Intentional inclusion of the patient/family in research is important and practical. Both strengths and challenges of the proposed intervention were identified, indicating the need for further study.