2009年,原国家卫生部颁布了《医院消毒供应中心管理规范》,其中第3部分《清洗消毒及灭菌效果监测标准》明确规定“医院消毒供应中心(CSSD)应建立质量管理追溯制度,完善质量控制过程的相关记录,保证供应的物品安全”〔1〕的规范要求,每台灭菌器均应做相应的监测,灭菌监测记录应存档3年。而《医疗事故处理条例》〔3〕和《中华人民共和国侵权责任法》的实施,使详细、客观、真实地记录医 In 2009, the former Ministry of Health promulgated the “Code for Management of Hospital Disinfection Supply Center”, and the third part, “Monitoring Standards for Cleaning, Sterilization and Sterilization” clearly states that “CSSD should establish a quality management retrospective system, Improve the quality control process-related records to ensure the safety of supplies ”[1] of the regulatory requirements, each sterilizer should be monitored accordingly, sterilization monitoring records should be filed for 3 years. The “Medical Malpractice Ordinance” 〔3〕 and “People’s Republic of China Tort Liability Act,” the implementation of a detailed, objective and true record of medical