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新型电子BD测试技术应用效果研究

Research on the application effect of new electronic Bowie&Dick test technology
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摘要 目的:探讨电子Bowie&Dick测试技术(BD测试)的应用效果,为保证脉动预真空蒸汽灭菌器BD测试结果准确性、灵敏性、便利性及灭菌安全提供科学依据。方法:于2023年7月至10月,采用电子BD测试仪与3种一次性化学BD测试包,分别对编号为6号及7号脉动预真空蒸汽灭菌器进行BD测试,分析同一台灭菌器不同BD测试类型的结果以及同一种BD测试类型在2台灭菌器的测试结果,分析电子BD测试设备的测试温度数据及使用效率。结果:电子BD测试6号灭菌器的不合格率与化学BD测试1、测试2和测试3之间的不合格率比较,差异均有统计学意义(χ^(2)=16.68、22.20、0.27;P<0.05)。2台灭菌器之间化学BD测试1、测试3的测试结果比较,差异均无统计学意义(χ^(2)=0.55、0.00,P>0.05)。2台灭菌器电子BD测试仪内外温差比较,差异均有统计学意义(t=45.44,P<0.05),电子BD测试结果的显示时间以及测试数据的保存时间均短于化学BD测试,差异均有统计学意义(t=-29.80、t=-37.12,P<0.05)。2台灭菌器自身物理参数监测记录均全部合格。结论:电子BD测试灵敏性及使用便利性均优于传统化学BD测试,能够增加灭菌安全性及可靠性,还可提高工作效率,提升追溯信息保存的安全性及查找便利性。 Objective:To explore the application effect of electronic Bowie&Dick test technology and to provide a scientific basis for ensuring the accuracy,sensitivity,convenience and sterilization safety of Bowie&Dick test results of pulsation pre-vacuum steam sterilizer.Methods:From July and October of 2023,Bowie&Dick test were performed on pulsating pre-vacuum steam sterilizers No.6 and No.7 using an electronic Bowie&Dick tester and three disposable chemical Bowie&Dick test kits.The test results of different Bowie&Dick tests for the same sterilizer and the same Bowie&Dick test type on two sterilizers were analyzed,the test temperature data and usage efficiency of electronic Bowie&Dick test equipment were analyzed.Results:The unqualified rate of sterilizer No.6 in the electronic Bowie&Dick test was compared with the unqualified rate of chemical Bowie&Dick test 1,test 2 and test 3,and the difference was statistically significant(χ^(2)=16.68,22.20,0.27,P<0.05).There was no significant difference in the test results of chemical Bowie&Dick test 1 and test 3 between the two sterilizers(χ^(2)=0.55,0.00,P>0.05).The temperature difference between inside and outside of the two sterilizers electronic Bowie&Dick testers was compared,and the difference was statistically significant(t=45.44,P<0.05).The display time of electronic Bowie&Dick test results and the storage time of test data were shorter than those of chemical BD test,and the differences were statistically significant(t=-29.80,t=-37.12,P<0.05).The physical parameter monitoring records of the two sterilizers were all qualified.Conclusion:The sensitivity and convenience of electronic Bowie&Dick testing are better than those of traditional chemical Bowie&Dick testing,which can increase the safety and reliability of sterilization,improve work efficiency,improve the safety of traceability information storage and the convenience of searching,which is a new trend of Bowie&Dick testing.
作者 刘杰英 张以梅 谢红洁 Liu Jieying;Zhang Yimei;Xie Hongjie(Central Sterile Services Department,Beijing Tiantan Hospital,Capital Medical University,Beijing 100160,China;Central Sterile Services Department,Beijing Children's Hospital,Capital Medical University,Beijing 100045,China)
出处 《中国医学装备》 2024年第6期200-204,208,共6页 China Medical Equipment
关键词 电子BD测试 化学BD测试 空气排除 蒸汽穿透 Electronic Bowie&Dick test Chemical Bowie&Dick test Air removal Steam penetration
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  • 1AAMI/ISO 11140-05:2006-12-14,Sterilization of health care products-Chemical indicators-Part 5: Class 2 indicators for Bowie and Dick test sheets and packs.
  • 2EN285.Sterlization-Steam sterilizers-Large sterlizers.2006-05.
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  • 4Stuart J.Line and J.K.Pickerill,J.Clin.Path., 1973,26,716-720.
  • 5AAMI/ISO 11140-04:2006-12-14,Sterilization of health care products-Chemical indicators-Part 4: Class 2 indicators as an alternative to Bowie-Dick test fjor detection of steam penetration.
  • 6中华人民共和国卫生部.医院消毒供应中心管理规范[s].北京:中华人民共和国卫生部,2009;2.
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  • 8ISO.ISO11140-4:2005 Sterilization of Health Care Products—Chemical Indicators—Part 4:Class 2 Indicators As an Al-ternative to the Bowie and Dick-type Test for Detection of Steam Penetration[S].Geneva:ISO,2006:4-6.
  • 9ISO.ISO11140-5:2005 Sterilization of Health Care Products—Chemical Indicators—Part 5:Class 2 Indicators for Bowieand Dick Type Air Removal Tests[S].Geniva:ISO,2006:3-5.
  • 10ISO.BS EN 285:2006 Sterilization-Steam Sterilizers-Large Sterilizers[S].Geneva:ISO,2006:36.

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