【国外指南】美国CDC ‖ 医疗机构消毒灭菌指南

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Guideline for Disinfection and Sterilization in Healthcare Facilities

医疗机构消毒灭菌指南

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This guideline provides recommendations for disinfection and sterilization in healthcare facilities.                                               

本指南为医疗机构的消毒和灭菌提供建议。

（JUNE 12, 2024 UPDATES ）

TABLE OF CONTENTS | DISINFECTION AND STERILIZATION GUIDELINE目录 | 消毒灭菌指南

• Updates 更新内容
• Authors 作者
• Summary of Recommendations建议摘要
• Introduction 简介
• Rational Approach 合理的方法
• Healthcare Equipment 医疗设备
• Efficacy Factors 功效因子
• Cleaning 清洗
• Disinfection 消毒
• Chemical Disinfectants 化学消毒剂
• Miscellaneous Inactivating Agents其他灭活剂
• Regulatory Framework 监管框架
• Neutralization of Germicides中和杀菌剂
• Sterilization 灭菌
• Steam Sterilization 蒸汽灭菌
• Flash Sterilization 快速灭菌
• Low-Temperature Sterilization低温灭菌
• Ethylene Oxide "Gas" Sterilization环氧乙烷气体灭菌
• Hydrogen Peroxide Gas Plasma过氧化氢气体等离子体
• Peracetic Acid Sterilization过氧乙酸灭菌
• Microbicidal Activity of Low-Temperature Sterilization低温灭菌的杀菌活性
• Bioburden of Surgical Devices手术器械的生物负荷
• Cleaning Effect on Sterilization清洗对杀菌的影响
• Other Sterilization Methods其他灭菌方法
• Sterilizing Practices 灭菌实践
• Reuse of Single-Use Medical Devices一次性医疗器械的再利用
• Conclusion 结论
• Performance Indicators 评价指标
• Glossary 词汇表
• References 参考文献
• Executive Summary 执行摘要
• Tables and Figure 表格和图表
• Sterilization and Disinfection Methods灭菌和消毒方法
• Properties of an ideal disinfectant理想消毒剂的特性
• Epidemiologic Evidence 流行病学证据
• Resistance of Microorganisms微生物的耐药性
• Comparison of Selected Chemicals所选化学品的比较
• Chemical Advantages and Disadvantages化学消毒的优点和缺点
• Sterilization Advantages & Disadvantages灭菌的优点和缺点
• Minimum Steam Sterilization Cycle Times最短蒸汽灭菌周期时间
• Flash Steam Sterilization Parameters快速灭菌参数
• Ideal Low-Temperature Sterilization理想的低温灭菌技术
• Sterilization Efficacy 杀菌功效
• Evaluation of Microbicidal Activity微生物杀灭活性的评价
• Positive Biological Indicator阳性生物指示剂
  
  

Edits and Changes 更新历史

1.Changes to this guideline: [June 2024]本指南最新更新：[2024 年 6 月]

• Content edits made to Vaporized Hydrogen Peroxide (VHP®) section for clarification.对过氧化氢雾化 （VHP®） 部分进行的内容编辑以进行澄清。
  
  

2.Changes to this guideline: [February 2017]本指南的变更：[2017 年 2 月]

• Minor content edits were made to improve clarity.为了提高清晰度，我们进行了一些小的内容编辑。
• Spelling and punctuation were corrected.拼写和标点符号已更正。
• Tables were formatted to be easily read by screen readers in compliance with the Americans with Disabilities Act (ADA).表格的格式符合《美国残疾人法案》（ADA） 的规定，以便屏幕阅读器轻松阅读。
• Numbered or itemized items in paragraph format were converted to vertical numbered or bulleted lists in compliance with ADA.按照《反倾销法》，以段落格式编号或逐项的项目被转换为垂直编号或项目符号列表。
• Link text was changed to comply with ADA.链接文本已更改以符合 ADA。
• Live links were updated; dead links are indicated.实时链接已更新;标明了死链接。
  
  

3.Ebola Virus Disease [August 2014]埃博拉[2014年8月]

Update: The recommendations in this guideline for Ebola has been superseded by these CDC documents:更新：本指南中针对埃博拉的建议已被以下CDC文件所取代：

• Infection Prevention and Control Recommendations for Hospitalized Patients with Known or Suspected Ebola Virus Disease in U.S. Hospitals美国医院对已知或疑似埃博拉病毒病住院患者的感染预防和控制建议
• Interim Guidance for Environmental Infection Control in Hospitals for Ebola Virus埃博拉病毒医院环境感染控制临时指导方针
  
  

See CDC's Ebola Virus Disease website for current information on how Ebola virus is transmitted.有关埃博拉病毒如何传播的最新信息，请参阅CDC的埃博拉病毒病网站。

4.Flexible GI Endoscope Reprocessing [June 2011]软式胃肠道内窥镜再处理 [2011 年 6 月]

Update: Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011 更新：2011 年多学会胃肠软内窥镜再处理指南

5.Environmental Fogging [December 2009]环境消毒剂雾化 [2009 年 12 月]

Clarification Statement: CDC and HICPAC have recommendations in both 2003 Guidelines for Environmental Infection Control in Health-Care Facilities and the 2008 Guideline for Disinfection and Sterilization in Healthcare Facilities that state that the CDC does not support disinfectant fogging. Specifically, the 2003 and 2008 Guidelines state:

澄清声明：CDC 和 HICPAC 在 2003 年《医疗机构环境感染控制指南》和 2008 年《医疗机构消毒和灭菌指南》中都有建议，指出 CDC 不支持消毒剂雾化。具体而言，2003 年和 2008 年指南指出：

• 2003: "Do not perform disinfectant fogging for routine purposes in patient-care areas. Category IB"2003 年：“不要在患者护理区域出于常规目的进行消毒剂雾化。IB类”
• 2008: "Do not perform disinfectant fogging in patient-care areas. Category II"2008 年：“不要在患者护理区域进行消毒剂雾化。第二类”
  
  

These recommendations refer to the spraying or fogging of chemicals (e.g., formaldehyde, phenol-based agents, or quaternary ammonium compounds) as a way to decontaminate environmental surfaces or disinfect the air in patient rooms. The recommendation against fogging was based on studies in the 1970's that reported a lack of microbicidal efficacy (e.g., use of quaternary ammonium compounds in mist applications) but also adverse effects on healthcare workers and others in facilities where these methods were utilized. Furthermore, some of these chemicals are not EPA-registered for use in fogging-type applications.

这些建议书提到了喷洒或雾化化学品（例如甲醛、苯酚基制剂或季铵化合物）作为净化环境表面或对病房空气进行消毒的一种方式。反对雾化的建议是基于 1970 年代的研究，该研究报告了缺乏杀微生物功效（例如，在雾化应用中使用季铵化合物），但也对使用这些方法的医疗机构中的医护人员和其他人产生不利影响。此外，其中一些化学品未在 EPA 注册，无法用于雾化型应用。

These recommendations do not apply to newer technologies involving fogging for room decontamination (e.g., ozone mists, vaporized hydrogen peroxide) that have become available since the 2003 and 2008 recommendations were made. These newer technologies were assessed by CDC and HICPAC in the 2011 Guideline for the Prevention and Control of Norovirus Gastroenteritis Outbreaks in Healthcare Settings, which makes the recommendation:

这些建议不适用于自2003年和2008年提出以来出现的涉及进行室内净化的新雾化技术（例如，臭氧气体、过氧化氢雾化）。CDC 和 HICPAC 在 2011 年《医疗机构诺如病毒胃肠炎暴发预防和控制指南》中对这些新技术进行了评估，该指南建议：

"More research is required to clarify the effectiveness and reliability of fogging, UV irradiation, and ozone mists to reduce norovirus environmental contamination. (No recommendation/unresolved issue)"“

需要更多的研究来阐明雾化、紫外线照射和臭氧气体在减少诺如病毒环境污染方面的有效性和可靠性。（无建议/未解决的问题）”

The 2003 and 2008 recommendations still apply; however, CDC does not yet make a recommendation regarding these newer technologies. This issue will be revisited as additional evidence becomes available.

2003年和2008年的建议仍然适用。但是，CDC尚未就这些新技术提出建议。随着更多证据的获得，将重新讨论这个问题。

6.New Categorization Scheme for Recommendations [November 2018]新的推荐建议分类方案 [2018 年 11 月]

In November 2018, HICPAC voted to approve an updated recommendation scheme. The category Recommendation means that we are confident that the benefits of the recommended approach clearly exceed the harms (or, in the case of a negative recommendation, that the harms clearly exceed the benefits). In general, Recommendations should be supported by high- to moderate-quality evidence. In some circumstances, however, Recommendations may be made based on lesser evidence or even expert opinion when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms or when then Recommendation is required by federal law.

2018 年 11 月，HICPAC 投票批准了更新的建议方案。“推荐”类别意味着我们确信，推荐方法的好处明显大于坏处（或者，在否定建议的情况下，危害明显超过好处）。一般来说，建议应得到高质量至中等质量证据的支持。然而，在某些情况下，当无法获得高质量的证据并且预期的收益大大超过危害时，或者当联邦法律要求提出建议时，可能会根据较少的证据甚至专家意见提出建议。

This new categorization scheme applies to recommendations made after November 2018. For more information, see November 2018 HICPAC Meeting Minutes.

此新分类方案适用于 2018 年 11 月之后提出的建议。有关更多信息，请参阅 2018 年 11 月 HICPAC 会议纪要。

7.C. difficile Update [April 2019]艰难梭菌更新 [2019 年 4 月]

Update: Recommendation 5.q. and the supporting text were updated to reflect changes in Federal regulatory approvals: LIST K: EPA's Registered Antimicrobial Products Effective against Clostridium difficile Spores

更新：建议 5.q. 和支持文本已更新，以反映联邦监管批准的变化： 清单 K：EPA 注册的抗菌产品对艰难梭菌孢子有效。