骨科植入物器械在消毒供应室的安全管理

Safety Management of Orthopedic Implants Equipment in Sterilization and Supply Department

目的探讨骨科植入物器械在消毒供应室的安全灭菌和规范管理。方法采用回顾性分析方式,对122个骨科植入物器械高压蒸汽灭菌过程进行工艺、化学、生物监测,严格掌控放行标准。结果 122件骨科植入物器械出现2件首次生物监测不合格、3件出现湿包经重新灭菌达标,再次生物培养后达到放行标准,122件全部安全放行。结论骨科植入物器械为高度危险性物品,必须强调质量控制,注重过程化管理,建立可追溯管理体系。

OBJECTIVE To investigate the safety sterilization regulation for the orthopedic implants equipment in the sterilization and supply department.METHODS The autoclave sterilization process,chemical and biological monitoring and strict control of the pass criteria of 122 pieces of orthopedic implants equipment possibly unqualified were retrospectively analyzed.RESULTS Two pieces unqualified after first time biological monitoring and three pieces with wet package were re-sterilizied,and as a result the all 122 pieces became qualified.CONCLUSION The orthopedic implants equipment belongs to the for high-risk devices,it must be stressed its quality control and process-oriented management,and established the retrieval management system.