The role of medical equipment reliability assessment in improving healthcare service quality: a scoping review.

backgroundWith the rapid advancement of medical technology, medical equipment plays a vital role in diagnosis, treatment, and patient monitoring. Equipment reliability is not merely an engineering concern but a fundamental determinant of healthcare quality, patient safety, and clinical decision-making. This study systematically reviews the existing literature to identify the core parameters constituting medical equipment reliability assessment, empirically link these parameters to specific management decisions, and trace their impact on measurable health service outcomes, with comparative analysis between international frameworks and current Chinese practice.

methodsWe conducted a systematic search of three major electronic databases-PubMed, EMBASE, and Web of Science-from their inception until October 31, 2025. All English-language studies examining the relationship between medical equipment reliability and healthcare service quality were considered. Two reviewers independently performed literature screening, data extraction, and methodological quality assessment (using the Mixed Methods Appraisal Tool) to characterize the strength of evidence supporting parameter-decision-outcome linkages-an approach consistent with scoping review methodology when the research question involves evidence mapping with quality considerations. A rigorous thematic analysis was conducted to synthesize parameter categories and their decision-level linkages.

resultsThe initial search identified 1,852 records, of which 23 studies were included after sequential screening, spanning 12 countries, four continents, > 17,000 devices, and 14 years of research (2011-2025). Thematic analysis of 47 extracted parameters yielded eight core parameter categories: Equipment features, Function, Maintenance requirement, Performance, Risk and safety, Availability and readiness, Utilization, and Cost. These categories demonstrate strong empirical grounding (91.5% inter-rater agreement) and are reproducibly linked to four core management decisions: risk classification (12 studies), maintenance prioritization (18 studies), strategy selection (14 studies), and replacement planning (11 studies). Documented patient safety and operational impacts include 12-39% improvement in equipment functionality, 34-41% reduction in unnecessary maintenance, and 25% cost savings with one-year payback. Comparative analysis reveals that while international frameworks increasingly adopt predictive, data-driven, value-based maintenance, China's current practice remains predominantly compliance- driven, periodic verification-based, with real-time performance monitoring currently limited to 12-18% of high-value equipment in tertiary hospitals.

conclusionMedical device reliability assessment constitutes a multi-dimensional decision science requiring integration of technical, clinical, economic, and human factors. This review provides the first evidence-based, systematically derived eight-category parameter framework with empirically validated linkages to management decisions and patient safety outcomes.

trial registrationINPLASY2025120062. CLINICAL TRIAL NUMBER: Not applicable.