ELECTRICAL AND MECHANICAL TROUBLESHOOTING IN MEDICAL AND DIAGNOSTIC DEVICE MANUFACTURING: A SYSTEMATIC REVIEW OF INDUSTRY SAFETY AND PERFORMANCE PROTOCOLS

Abstract

The reliability and performance of medical and diagnostic devices are critically dependent on robust troubleshooting methodologies that address both electrical and mechanical system failures. This systematic review investigates the evolving frameworks, diagnostic technologies, and regulatory protocols governing troubleshooting practices in medical device manufacturing, with an emphasis on safety, performance assurance, and compliance. Following the PRISMA 2020 guidelines, a total of 82 peer-reviewed articles, regulatory documents, and technical standards published between 2000 and 2024 were selected from databases including PubMed, IEEE Xplore, Scopus, ScienceDirect, and Google Scholar, as well as official repositories of the FDA, IMDRF, WHO, and the European Commission. Thematic synthesis was conducted across seven core domains: historical foundations of troubleshooting, electrical diagnostics, mechanical failure analysis, risk management integration, diagnostic innovations, technician documentation and training, and global regulatory harmonization. Findings revealed a substantial shift from reactive, experience-based troubleshooting to data-driven, standardized protocols incorporating real-time diagnostics, firmware-based alerts, predictive maintenance models, and comprehensive root cause analysis. Electrical subsystems, particularly power supplies and circuit boards, were identified as the most failure-prone, while mechanical issues such as misalignment, fatigue, and wear remained prevalent in actuators and pump systems. Integration of ISO 14971 and ISO 13485 frameworks was observed across quality assurance systems, with risk-based thinking and Corrective and Preventive Action (CAPA) processes widely embedded in technical workflows. Furthermore, significant advancements in technician training, service documentation, and embedded AI diagnostics have transformed the operational landscape of maintenance teams and OEM service models. Despite these advancements, discrepancies across international regulatory frameworks pose ongoing challenges to harmonized troubleshooting documentation and global compliance. This review underscores the multidimensional nature of fault diagnostics in medical device manufacturing and highlights the interplay between technological innovation, regulatory alignment, and organizational learning in sustaining safe, high-performance medical technologies.