首页|过氧化氢低温等离子灭菌包装袋损坏因素及环节质量控制研究

过氧化氢低温等离子灭菌包装袋损坏因素及环节质量控制研究

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目的:探讨过氧化氢低温等离子灭菌包装袋(以下简称特卫强包装袋)损坏的影响因素,通过环节质量控制的实施,降低特卫强包装袋的损坏率,确保无菌包质量,保障患者安全.方法:设计调查表或登记表,调查分析2019年1月~2019年12月过氧化氢低温等离子灭菌的8606个器械包损坏情况,并从器械包装、灭菌、转运、储存4个方面分析特卫强包装袋损坏的可控因素,采取针对性干预措施,评价2020年1月~2020年12月灭菌的8155个器械包破损关键环节和破损率的干预效果.结果:特卫强包装袋损坏的主要影响因素为器械包转运不当,储存、管理不当,器械盒使用不当,灭菌装载、卸载操作不当,包装袋大小不合适.针对这些影响因素,采取相应的干预措施,进行环节质量控制,使损坏率从干预前3.54%降至干预后的0.20%,损坏率差异有统计学意义(P<0.01).结论:特卫强包装袋损坏受可控因素的影响,通过合理的环节控制,规范操作行为,可以使无菌包从灭菌结束至给患者使用前保持无菌状态,确保患者安全,并降低医院灭菌成本.
Research on the Factors Damaging Hydrogen Peroxide Low-Temperature Plasma Sterile Packaging Bags and the Control of Link Quality
Objective:After discussing the factors damaging hydrogen peroxide low-temperature plasma sterile packaging bags(hereinafter referred to as Tyvek packaging bags),the damage rate of Tyvek packaging bags is lowered through the control of link quality,so as to guarantee the quality of sterile packing bags and the safety of patients.Methods:Design questionnaire and registration form By investigating 8606 instrument packaging bags sterilized by hydrogen peroxide low-temperature plasma from January 2019 to December 2019,the controllable factors damaging Tyvek packaging bags are analyzed from four aspects:instrument packaging sterilization,transfer and storage.By taking targeted interventions on 8155 instrument packaging bags sterilized from January 2020 to December 2020,the intervention effects of the key links and the damage rate are evaluated.Results:The main factors damaging Tyvek packaging bags mainly include improper transfer,storage and management of instrument packing bags,improper use of instrument boxes,improper loading and uploading operations of sterilization and wrong size of packaging bags.For these factors,related intervention measures shall be adopted to control the link quality,so as to lower the damage rate from 3.54%in the control group to 0.20%in the experimental group.The differences in damage rate are of statistical significance(P<0.01).Conclusion:Tyvek packaging bags are influenced by controllable factors.Through reasonable link control and standard operations,the sterile packing bags can keep sterile from the end of sterilization to the usage by patients,which guarantees the safety of patients.

hydrogen peroxide low-temperature plasmaTyvek packaging bagsdamagefactorscontrol of link quality

沈艳芬、吴颖、孙海娟、汪胜傲

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苏州大学附属第一医院消毒供应中心(江苏苏州 215006)

过氧化氢低温等离子 特卫强包装袋 损坏因素 环节质量控制

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(3)
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