Development and validation of a FMEA-based medical equipment maintenance framework using Industry 4.0

PurposeThis research develops a comprehensive framework to enhance the functionality of medical equipment in hospitals, focusing on disease diagnosis contexts. By leveraging failure mode and effects analysis (FMEA) and Industry 4.0 tools, it aims to optimize healthcare services and patient treatment outcomes, particularly during crises like pandemics.Design/methodology/approachAdopting a mixed-methods approach, the research integrates Industry 4.0 and automation principles to develop and validate the framework. Utilizing a four-year failure database analyzed with R Programming, it implements preventive maintenance strategies such as the Preventive Maintenance Management System (PMMS) with FMEA. FMEA is implemented to systematically identify, assess and prioritize failure modes, enabling targeted mitigation strategies and improving equipment reliability. The framework is validated through empirical analysis and case studies, assessing operational efficiency, equipment importance and societal impact, with recommendations for future research on advanced maintenance methodologies.FindingsThe framework significantly reduces equipment failure rates (FR) and mean time to repair (MTTR), enhancing maintenance efficiency. Downtime decreases, especially for critical medical equipment like life-saving and diagnostic devices, resulting in a remarkable 95% increase in maintenance efficiency. The framework prioritizes and optimizes interventions for vital equipment, ultimately improving patient care and healthcare services.Practical implicationsThe research presents a practical framework for enhancing medical equipment maintenance in Indian hospitals, particularly during disease diagnosis. Leveraging automation technologies, it reduces equipment failure risks, ensuring operational continuity even during pandemics. Improvements in diagnostic accuracy directly benefit patient care, with recommendations aimed at further advancing maintenance methodologies and enhancing healthcare delivery.Originality/valueThe research develops and validates the framework, employing FMEA to identify critical failures and integrating automation (Industry 4.0) to prioritize maintenance tasks. Post-implementation outcomes validate significant improvement, addressing existing gaps in medical equipment maintenance practices. This contributes to optimizing healthcare services and patient outcomes, particularly during critical disease diagnosis scenarios.