Clinical engineering as a strategic component of hospital governance: implications for patient safety and technological risk management

Abstract

Background: Hospitals increasingly operate as technologyintensive environments in which medical devices, digital platforms, and diagnostic systems constitute essential infrastructure for safe and effective care delivery. The traditional scope of clinical engineering, historically associated with equipment maintenance and technical support, has progressively expanded toward broader responsibilities involving technology governance, regulatory compliance, risk management, and strategic institutional planning. This study investigates how clinical engineering has been incorporated into hospital governance structures and examines the organizational implications associated with this integration. Methods: A systematic literature review was conducted according to PRISMA 2020 guidelines. Searches were performed in Scopus, Web of Science, PubMed/MEDLINE, Embase, SciELO, and the Virtual Health Library. The search period covered January 2000 to December 2025. Eligible studies included peerreviewed publications addressing governance, management, or institutional roles of clinical engineering and medical technology management. A twostage screening process was applied (title/abstract and fulltext review). Methodological quality was assessed using CASP and Joanna Briggs Institute appraisal tools. Results: A total of 742 records were identified. After duplicate removal and eligibility screening, 25 studies were included in the qualitative synthesis. Three analytical domains emerged from the literature: integration of clinical engineering into executive governance structures; interaction with patient safety systems; and institutional accountability associated with medical technology management. Evidence suggests increasing recognition of clinical engineering as a governancerelevant function, although organizational models remain heterogeneous. Conclusions: Formal integration of clinical engineering into hospital governance contributes to improved technological traceability, enhanced patient safety practices, and stronger institutional accountability. However, standardized governance indicators and multicenter empirical validation remain limited. Future research should focus on developing comparative frameworks capable of evaluating technological governance maturity across healthcare systems.