Abstract: The current methods for reliability evaluation are disconnected from the actual clinical use scenarios. This service life derived from these methods poses a serious challenge to continuing to use expired active medical device safely and effectively. This article reviews the concept of clinical reliability, introduces advances in relevant evaluation methods, and analyzes current difficulties and challenges in evaluation. Based on the real-world clinical needs, this paper presents the development trend of clinical reliability evaluation methods for active medical devices, introducing a new approach that integrates risk analysis with the Fuzzy Analytic Hierarchy Process. This method establishes a direct mapping between clinical reliability evaluation indicators and clinical use risk levels, enabling the dynamic quantitative assessment of clinical use risks. The feasibility and applicability of this method were verified through simulated evaluation data. The introduction of the new method can provide a reference for the dynamic evaluation of the service life of in-use active medical devices, the determination of the renewal of expired devices, and subsequent supervision.