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目的探讨PDCA循环在CSSD管理植入型器械中的应用，进一步加强植入型器械的质量管理，保证零缺陷。方法运用PDCA循环管理模式，设定质量管理重点，将2011年7月~2012年12月180例植入型器械设为对照组；2013年1月~2014年5月180例实施PDCA循环管理后的植入型器械设为观察组。在器械准入、清洗消毒、器械交接、监测追溯、临床科室满意度等方面进行比较。结果实施PDCA循环管理后，观察组器械准入制100%、规范清洗消毒合格率99.44%、器械交接规范率98.88%、监测追溯健全100%，、临床科室满意度科室满意度99.44%。明显高于对照组。(<0.05)结论通过PDCA循环加强医院植入型器械的管理，实施质量持续改进，进一步提高医院物品无菌保证水平和实现植入物零风险。“,”Objective To explore the application of PDCA circulation in the implanted CSSD management instruments, further strengthen the quality management of implantable devices, to ensure zero defect. Methods Using PDCA cycle management mode, set up quality management focus, the 2011.07-2012.12 of 180 patients with implantable devices as control group; 2013.01-2014.05 180 patients with implantable devices in the PDCA cycle management after the set to the observation group. Compared in terms of equipment access, cleaning disinfection, equipment handover, traceability, satisfaction of clinical departments. Results The implementation of PDCA cycle management, the observation group equipment access system 100%, standardize the pass rate of 99.44%, over standard rate 98.88%, monitoring equipment back sound 100%, clinical departments, 99.44%departments satisfaction satisfaction. Significantly higher than control group. ( <0.05). Conclusion Strengthen the implantable device management through the PDCA cycle, the implementation of continuous quality improvement, further improve hospital goods sterility assurance level and realize the implant zero risk.