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This paper provides a novel risk cluster approach for healthcare failure mode and effect analysis (FMEA). Considering FMEA team members' vagueness and uncertainty in their evaluations on failure modes, picture fuzzy sets (PFSs) are advised to describe the risk evaluation result of healthcare failure modes. Moreover, clustering failure modes is more adaptable to actual needs especially under tight resources constraint. Therefore, in this paper, a new FMEA model using PFSs and k-means clustering is developed to evaluate and cluster the risk of failure modes, which is more reasonable, effective and practical for healthcare risk management.