摘要
目的通过在消毒供应中心建立危害分析关键控制点(HACCP)体系,保证压力蒸汽灭菌后复用医疗器械的质量和安全。方法应用HACCP原理和程序进行研究分析。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9个操作步骤执行不到位将显著影响压力蒸汽灭菌后医疗器械质量和安全,被确认为9个关键控制点。确定了9个关键控制点阈值、监控手段、纠偏措施,在医院消毒供应中心完整的建立了HACCP体系,并对其运行情况进行了有效验证。结论医院消毒供应中心在切实实行卫生行业标准、《消毒技术规范》的基础上实施HACCP系统是保证复用医疗器械质量安全的有效方法。通过了解消毒供应中心HACCP体系后,监督员可以重点监督关键控制点,提高监督效率。
Objective To establish the hazard analysis and critical control point (HACCP) system in central sterile supply department(CSSD) and ensure the quality and safety of multiplexing apparatuses which were sterilized by high -pressure sterilizer. Methods Principle and method of HACCP analysis. Results The main reasons and factors which seriously affected sterilized apparatuses' quality and safety in CSSD of hospital were water scrubbing, rust cleaning, disinfection, inspection, assembly, packaging, sterilization including preparation, operation and unloading. These were 9 critical steps identified as the 9 key control points, we defined 9 critical control points' thresholds, monitoring methods, corrective actions and setted up HACCP system in CSSD of hospital which was verified. Conclusion Running HACCP system is effective method to assure the quality and safety of multiplexing apparatuses in CSSDwhen we effectively execute the hygiene standards, technical standards for disinfection. After learning the HACCP system in CSSD, supervisors can focus on the operation of critical control points and supervision efficiency can be improved.
出处
《中国卫生监督杂志》
2013年第1期25-29,共5页
Chinese Journal of Health Inspection
基金
广东省医学科研基金立项资助项目(A2011105)