A Review of Human Factors, Training Deficiencies, and Error Pathways in Surgical Instrument Sterilization: Implications for U.S. Patient Safety

Abstract

Abstract
Surgical instrument sterilization, a routine yet vital and high-risk procedure in contemporary medicine, often culminates in surgical site infections, device failures, and patient injuries when errors occur. As a comprehensive review, this paper navigates the expanse of literature regarding the human and systemic contributors that precipitate these errors and, by extension, bolster sterilization successes in the United States (U.S.). This review challenges the reductionist perspective of errors as isolated "human error," instead providing insights into complex human-machine-system interactions. These encompass cognitive workload, design, system culture, and, most prominently, inconsistent training paradigms which often create vulnerabilities in sterile processing departments (SPDs). This review details that errors in decontamination, inspection, assembly, and sterilization load preparation and management have been identified as recurring factors and likely failure pathways in the literature. When these errors lead to sterilization failure, they often implicate systemic issues over individual negligence. This review advances the position that the paradigm shift necessary to improve patient safety in the U.S. healthcare landscape can be enabled by heeding foundational tenets of human factors engineering in rethinking the system design, standardization, and focus on consistent training and certification, as well as encouraging a shift in safety culture to acknowledge SPD as a safety-critical department, a shift from blame-based systems to systems-based analysis.