Managing Cybersecurity as a Patient Safety Function: Business and Governance Challenges in Surgical Sterile Processing Departments

Abstract

Abstract
Emerging networks of medical devices, for remote monitoring and data collection, are advancing efficiencies, while also introducing vulnerabilities in Surgical Sterile Processing Departments (SPDs). Cybersecurity efforts in SPDs should be guided by a new risk treatment paradigm – to be inextricably linked with patient safety risk mitigation, instead of remaining the sole purview of the information technology (IT) governance structures. Security vulnerabilities in sterilizers, washer-disinfectors, and tracking systems have the potential to bring entire operations to a standstill, impact the integrity of patient data, and even increase surgical site infections from the use of instruments processed with suboptimal outcomes. Using a narrative review methodology and assessing literature in academic, regulatory, and industrial spheres, this work aims to characterize the business and governance challenges faced by healthcare organizations in this effort. Such challenges may include the legacy composition of SPD device ecosystems, the budgetary silos of clinical, IT, and cybersecurity funding, the absence of SPD and clinical engineering cybersecurity subject matter experts, and the disconnect between regulatory and voluntary guidance frameworks. The review suggests that successful mitigation of these cybersecurity risks in SPDs will depend on shared accountability across clinical, operational, and IT leaders. Specific recommendations include a patient safety-oriented cybersecurity framework, an SPD-specific risk assessment, and structured communication across disciplines to enable business continuity, clinical outcome, and cyber resiliency alignment.