医疗设备固定年限报废制度优化研究——基于除颤仪全生命周期质控数据的 C_pk 实证分析

      Research on the Optimization of Fixed-Term Scrapping System for Medical Equipment: An Empirical Analysis of \colorRGB65,99,142C_pk Based on Defibrillator Lifecycle Quality Control Data

      • 摘要:
        目的 针对当前医疗设备管理中普遍存在的按固定年限报废造成的资源浪费问题,研究旨在建立基于真实世界数据(real-world data,RWD)的设备残值科学评估体系,为优化医疗设备配置资源,打破按年限强制报废的传统管理模式提供理论与实证依据。
        方法 选取某大型三甲医院急救类设备除颤仪作为典型实证样本。构建包含过程能力指数( C_pk )的技术评估模型与基于重置成本法的卫生经济学评估模型。回顾性收集在用的85台设备191条有效质控记录,量化评估超期服役设备的实际性能状态与潜在经济价值。
        结果 实证分析显示,除颤仪使用年限与其核心性能无显著相关性。在规范维护下,占比37.6%的超12年服役设备的过程能力依然表现优秀( C_pk> 1.33 )。基于此案例测算,实施基于状态的设备使用期限管理,仅单项设备即可为医院节省重置成本115.2万元。
        结论 现行的固定年限设备报废制度存在显著的资源错配风险。研究验证了技术与经济2个维度的评估模型在识别剩余价值方面的有效性。建议医疗机构实施基于设备特性的分类管理,建立基于 C_pk 指数的分类分级设备使用有效期延长管理目录,在保障医疗安全的前提下实现医院固定资产的精细化管理与降本增效。

         

        Abstract:
        Objective To address the prevalent issue of resource waste caused by the "fixed-term scrapping" policy in medical device management, this study aims to establish a scientific residual value evaluation system based on real-world data (RWD). The goal is to provide theoretical and empirical evidence for optimizing medical resource allocation and breaking the traditional rigid age-based mandatory retirement model.
        Methods Defibrillators, a typical category of emergency equipment in a large tertiary hospital, were selected as the pilot sample. A technical evaluation model incorporating the Process Capability Index ( C_pk ) and a health economic evaluation model based on the replacement cost method were constructed. A retrospective analysis was conducted on 191 valid quality control records from 85 in-use devices to quantitatively evaluate the actual performance status and potential economic value of devices serving beyond their recommended lifespan.
        Results Empirical analysis demonstrated no significant linear correlation between the service life of defibrillators and their core performance. Under standardized maintenance, 37.6% of the devices that had served for over 12 years still exhibited excellent process capability ( C_pk> 1.33 ). Implementing a condition-based service life management strategy for this specific category of equipment alone could theoretically save the hospital approximately \yen 1,152,000 in replacement costs.
        Conclusion The current fixed-term scrapping system for medical equipment poses a significant risk of resource misallocation. This study validates the effectiveness of a dual-dimensional (technical and economic) evaluation model in identifying the residual value of equipment. It is suggested that medical institutions implement classified management based on device characteristics—establishing a hierarchical life-extension management catalog based on the C_pk index—to achieve refined fixed asset management and significant cost efficiency while ensuring medical safety.

         

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