医疗机构低温灭菌技术(2014.11 成都讲义) (1)

2014/10/20 3M Infection Prevention Solutions 3常 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 案搏/敏 3？73？7-2012 5 5《1《3 5《2《3 : 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 周响周 14 : 2008 75-85% 如剂 器蒸总 如剂 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 1 2014/10/20 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. US CDC 报道 January 3, 2014 Serious multidrug-resistant outbreak tied to contaminated endoscopes 严重的多重耐药菌爆发与污染的内镜有关 The investigation determined that ERCP scopes were carrying the microbe, and about half of the tested patients were found to be colonized (44 identified cases so far). 调查确定ERCP 内镜 携带微生物，被检查病人一半 定植（目前确认44个病 人） Mortality rates with such infections are high. 此感染死亡率很 高 To stop the outbreak, the institution has begun to sterilize their scopes using ETO sterilizer. 用ETO 灭菌内镜停止爆发 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. Journal of Hospital Infection 85 (2013) 118e124 Submit from Taiwan 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. Revised disinfection protocol for ureteroscopes ? To report such an outbreak at a regional teaching hospital in southern Taiwan. From October to December 2010 ? 2010年10月至12月，南台湾区域性教学医院报道 ?15 patients who had undergone ureteroscopy prior to the infection. 感染前15个病人做过输尿管镜 ?The outbreak was caused by a contaminated ureteroscopy 爆发是由输尿管镜污染所致 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. Then, weekly ethylene oxide (ETO) sterilization was added to the disinfection protocol for ureteroscopes. 器敏总 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 2 2014/10/20 低温灭菌 复杂和贵重 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. ( ) 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. - 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3 2014/10/20 – ? ? ? ? ? ? ? 3M Infection Prevention Solut ions © 3M 2012. All Rights Reserved. - 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 2-5% 50-80 : ? ? 周天2总 / : ? ? ? ? ? , 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Right

s Reserved. 化学灭菌剂必须接触 微生物以便有效灭活 穿透性 灭菌成功 匹配性 不损伤 低温灭菌技术必须考虑的关键因素 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 4 2014/10/20 周响周 14 灭菌 : 2008 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 对物 品 不破 坏或 非常 小 由 的管 所有低温灭菌技术 ， 接接触灭菌剂 灭菌有效 是必须的，以 灭菌剂 接接触 污 IB 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 透性 的 ，所以 物 的穿 以穿透微 物 的 被 用 的效 5 穿透0.1mm 的 ，22 穿透0.04mm 的 ，26 穿透0.3mm 的 ，41 穿透0.39mm 的 的 和 以穿透 穿透性 的 用 ， 用 学 © 3M 2012. All Rights Reserved. 的 3M Infection Prevention Solutions ETO和H2O2 ETO ETO ETO : ETO ? ? ? 的 ?物腔O ? 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 5 2014/10/20 穿透性 和效 长度 穿透性 和效 Sterilization, Disinfection and Preservation, S. Block 5th Edition 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. : 带有 的 不 6mm, 不 过30mm, 过 过 化 高 800ppm 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 6 2014/10/20 有 素 的 有管 化 ， 灭菌物 损 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 器总 , , 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 器总 塑卡 27955-2011 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 41 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 7 2014/10/20 Hydrogen Peroxide Sterilization Study : 因 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. HPV 灭菌的 发生 化, 一 Vol.6 No.1 2013 Journal of Healthcare-associated Infection 2013; 6: 19-23. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 44 ? : ? 微镜 ? 1-5个H2O2灭菌 ?H2O2灭菌 致 化 3M Infection Prevention Sol utions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. - 总搏天剂 器总 ? ? (感器L) ? 1 ppm (8 hour TWA) (剂L) ? 0.5 ppm (8 hour TWA) (器L) ? 5 ppm (15 ) ? 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infecti

on Prevention Solutions © 3M 2012. All Rights Reserved. 8 2014/10/20 NIOSH EO Study Results of NIOSH Study Mortality Indices Among Workers Exposed to EO EO (1991-2003) 发病 率 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2010. All Rights Reserved. © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 2005-2012 - 卡如 1 - 坏响剂 149 Hydrogen Peroxide Sterilization Study 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. Source: https://www.jstage.jst.go.jp/article/jsei/26/4/26_4_239/_pdf HPV 高 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 9 2014/10/20 过 化 灭菌的 - 3M 与有效 用的 Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 测试方法 灭菌 化 灭菌 (HP) 人 有 的 , 一人有 性 重复发生. FDA HP 报 . 发 化学 (CI) 灭菌 内, 灭菌前 生 . 过 , 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 测试方法 感 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. , HP 高 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 100PPM 10 2014/10/20 1. 2. 3. ( 排MDA © 3M 2012. All Rights Reserved. 20120322 3M Infection Prevention Solutions ) 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. HPV ， 菌 成， 80ppm 孔排V 高 灭 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. Test Report Personal EO Monitors 报 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 65 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 66 11 2014/10/20 Monitoring For Safety 搏蒸痛草程累物置蒸 器总 总搏天剂 感器L (8 hr. TWA) 1腐腐m 强如总搏天 如响L天 800腐腐m 1.HPV的 2. 不 EO 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 目前 报 被 的 , , 67 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. - EO ANSI/AAMI ST41(1999) Ethylene oxide sterilization in health care facilities: Safety and effectiveness GB/T 19633 a) h EO ECH b) EO c) ECH : 0.1 mg 2 mg 20 mg 12 mg : 30 d 24 h, 2 mg/d 24 ISO 11135 Sterilization of health care products- Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical device GB/T 19633 3M Infection Prev ention Solutions © 3M 2012. All Rights Reserved. 30 d EO ECH 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. （ ETO : (<10 gm) (10-100 gm) (> 100 gm) ） 50 250 100 25 5 25 250 25 250 25 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved

. C ，12 C ，8 的 和 技术 250 100 25 10 25 250 25 250 250 71 5,000 2,000 500 10 500 5,000 250 5,000 500 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 60 内 12 2014/10/20 性穿 过 EO 医用 的内 剂 的 EO EO， 的 功 EO 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 100% 用的EO EO 灭菌 100% 灭菌 灭菌 ( 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. ) © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions 10 / 7《？ m 作99《9% 敏案剂<1 腐腐m 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 13 2014/10/20 , 管镜 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 镜 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. , 44 , ？ ？？, , , 100腐腐m 0《1腐腐m 18-40 10腐腐m 内 灭菌有关 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 性 与 术 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. - 1 接触 过过 化 灭菌 PLLA 有 , 性 的 成 …… PLLA HPGP 过 化 的 ) ( 4 ) / / /PCD (4 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. © 3M 2011. All Rights Reserve d. 14 2014/10/20 性 H2O2 H2O2 1 H2O2 性 性 穿透性 / 24 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 的低 温灭菌 性 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 3M Infection Prevention Solutions © 3M 2012. All Rights Reserved. 87 15