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目的:为了确保复用医疗器械的质量与安全,研究在消毒供应中心建立相应的危害分析关键控制点(HACCP)体系,并且对这种体系的控制效果进行评估和分析。方法:通过了解HACCP原理和操作过程对其控制效果进行研究和分析。结果:医院消毒供应中心医疗器械刷洗、除锈、消毒、检查、装配、打包、灭菌前准备、灭菌操作、无菌物品卸载这些步骤被明确为9个关键控制点。这9个控制过程没有准确实施对压力蒸汽灭菌后医疗器械质量和安全有显著的影响。在明确了9个关键控制点的相关数据、监控手段、补救措施之后,在医院消毒供应中心建立相应完整的HACCP体系,对其运行情况和操作过程进行有效验证。结论:医院消毒供应中心严格实施了卫生行业标准,为了确保复用医疗器械质量安全在消毒技术规范的基础上实施HACCP系统是一种有效的方法。通过对消毒供应中心HACCP运行体系进行了解之后,监督管理员能够重点监督者9个关键控制点,提升监督效率。
OBJECTIVE: In order to ensure the quality and safety of reusable medical devices, a corresponding critical control point (HACCP) system for disinfection and supply was established in the disinfection and supply center, and the control effect of such system was evaluated and analyzed. Methods: By understanding the HACCP principle and operation of the control effect of its research and analysis. Results: The steps of scrubbing, descaling, disinfecting, inspecting, assembling, packing, preparing, sterilizing, sterilizing and unloading the medical devices in the hospital disinfection supply center were identified as 9 key control points. The failure of these nine controls to be accurately implemented has had a significant impact on the quality and safety of medical devices after autoclaving. After defining the relevant data, monitoring measures and remedial measures of 9 key control points, a complete and complete HACCP system was established in the hospital disinfection and supply center, and the operation and operation of the system were validated. Conclusion: The hospital disinfection supply center strictly implements the health industry standard. In order to ensure the quality and safety of the reused medical devices, it is an effective way to implement the HACCP system based on the disinfection technical specifications. After understanding the HACCP operation system of the disinfection supply center, the supervisory administrator can supervise 9 key control points and supervise the supervisors.