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Guideline for Disinfection and Sterilization in Healthcare Facilities
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Accessible version: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/Guideline for Disinfection and
Sterilization in
Healthcare
Facilities
, 2008Update: May 2019
William A. Rutala, Ph.D., M.P.H.
1,2 , David J. Weber, M.D., M.P.H. 1,2 , and the HealthcareInfection Control Practices Advisory Committee
(HICPAC) 3 1Hospital Epidemiology
University of North Carolina Health Care System
Chapel Hill, NC
275142
Division of Infectious Diseases
University of North Carolina School of Medicine
Chapel Hill, NC 27599-7030
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Last update:
May 2019 2 of 163
3HICPAC Members
Robert A. Weinstein, MD (Chair)
Cook County Hospital
Chicago, IL
Jane D. Siegel, MD (Co-Chair)
University of Texas Southwestern Medical Center
Dallas, TX
Michele L. Pearson, MD (Executive Secretary)
Centers for Disease Control and Prevention
Atlanta, GA
Raymond Y.W. Chinn, MD
Sharp Memorial Hospital
San Diego, CA
Alfred DeMaria, Jr,
MDMassachusetts Department of Public Health
Jamaica Plain, MA
James T. Lee, MD, PhD
University of Minnesota
Minneapolis, MN
William A. Rutala, PhD, MPH
University of North Carolina Health Care System
Chapel Hill, NC
William E. Scheckler, MD
University of Wisconsin
Madison, WI
Beth H. Stover, RN
Kosair Children's Hospital
Louisville, KY
Marjorie A. Underwood, RN, BSN CIC
Mt. Diablo Medical Center
Concord, CA
This guideline discusses use of products by
healthcare personnel in healthcare settings such as hospitals, ambulatory care and home care; the recommendations are not intended for consumer use of the products discussed. Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Last update:
May 2019 3 of 163
Table of Contents
Executive Summary ...................................................................................................................................... 8
Introduction.................................................................................................................................................... 9
Methods......................................................................................................................................................... 9
Definition of Terms ........................................................................................................................................ 9
A Rational Approach to Disinfection and Sterilization ................................................................................. 11
Critical Items ......................................................................................................................................... 11
Semicritical Items.................................................................................................................................. 11
Noncritical Items ................................................................................................................................... 12
Changes in Disinfection and Sterilization Since 1981 .......................................................................... 13
Disinfection of Healthcare Equipment ......................................................................................................... 14
Concerns about Implementing the Spaulding Scheme ........................................................................ 14
Reprocessing of Endoscopes ............................................................................................................... 14
Laparoscopes and Arthroscopes .......................................................................................................... 18
Tonomete
rs, Cervical Diaphragm Fitting Rings, Cryosurgical Instruments, and EndocavitaryProbes ....................................................................................................................................... 19
Dental Instruments................................................................................................................................ 21
Disinfection of HBV-, HCV-, HIV- or TB-Contaminated Devices .......................................................... 22
Disinfection in the Hemodialysis Unit ................................................................................................... 22
Inactivation of
Clostridium difficile ........................................................................................................ 23
OSHA Bloodborne Pathogen Standard ................................................................................................ 24
Emerging Pathogens (Cryptosporidium, Helicobacter pylori, Escherichia coli O157:H7, Rotavirus, Human Papilloma Virus, Norovirus, Severe Acute Respiratory Syndrome[SARS] Coronavirus) ................................................................................................................. 24
Inactivation of Bioterrorist Agents ......................................................................................................... 26
Toxicological, Environmental and Occupational Concerns .................................................................. 27
Disinfection in Ambulatory Care, Home Care, and the Home .............................................................. 28
Susceptibility of Antibiotic-Resistant Bacteria to Disinfectants ............................................................. 29
Surface Disinfection .............................................................................................................................. 30
Air Disinfection ...................................................................................................................................... 32
Microbial Contaminatio
n of Disinfectants ............................................................................................. 33
Factors Affecting the Efficacy of Disinfection and Sterilization .................................................................. 34
Number and Location of Microorganisms ............................................................................................. 34
Innate Resistance of Microorganisms .................................................................................................. 34
Concentration and Potency of Disinfectants ........................................................................................ 35
Physical and Chemical Factors ............................................................................................................ 35
Organic and Inorganic Matter ............................................................................................................... 35
Duration o
f Exposure ............................................................................................................................ 35
Biofilms ................................................................................................................................................. 36
Cleaning ...................................................................................................................................................... 37
Disinfection .................................................................................................................................................. 39
Chemical Disinfectants ......................................................................................................................... 39
Alcohol............................................................................................................................................ 39
Overview. ................................................................................................................................. 39
Mode of Action. ........................................................................................................................ 39
Microbicidal Activity. ................................................................................................................ 39
Uses. ........................................................................................................................................ 40
Chlorine and Chlorine Compounds ................................................................................................ 40
Overview. ................................................................................................................................. 40
Mode of Action. ........................................................................................................................ 42
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Last update:
May 2019 4 of 163
Microbicidal Activity. ................................................................................................................ 42
Uses. ........................................................................................................................................ 42
Formaldehyde ................................................................................................................................ 43
Overview. ................................................................................................................................. 43
Mode of Action. ........................................................................................................................ 44
Microbicidal Activity. ................................................................................................................ 44
Uses. ........................................................................................................................................ 44
Glutaraldehyde ............................................................................................................................... 44
Overview. ................................................................................................................................. 44
Mode of Action. ........................................................................................................................ 45
Microbicidal Activity. ................................................................................................................ 45
Uses. ........................................................................................................................................ 46
Hydrogen Peroxide ........................................................................................................................ 47
Overview. ................................................................................................................................. 47
Mode of Action. ........................................................................................................................ 47
Microbicidal Activity. ................................................................................................................ 47
Uses. ........................................................................................................................................ 48
Iodophors ....................................................................................................................................... 48
Overview. ................................................................................................................................. 48
Mode of Action. ........................................................................................................................ 49
Microbicidal Activity. ................................................................................................................ 49
Uses. ........................................................................................................................................ 49
Ortho-phthalaldehyde (OPA) ......................................................................................................... 49
Overview. ................................................................................................................................. 49
Mode of Action. ........................................................................................................................ 49
Microbicidal Activity. ................................................................................................................ 49
Uses. ........................................................................................................................................ 50
Peracetic Acid ................................................................................................................................ 51
Overview. ................................................................................................................................. 51
Mode of Action. ........................................................................................................................ 51
Microbicidal Activity. ................................................................................................................ 51
Uses. ........................................................................................................................................ 51
Peracetic Acid and Hydrogen Peroxide ......................................................................................... 51
Overview. ................................................................................................................................. 51
Microbicidal Activity. ................................................................................................................ 51
Uses. ........................................................................................................................................ 52
Phenolics ........................................................................................................................................ 52
Overview. ................................................................................................................................. 52
Mode of Action. ........................................................................................................................ 52
Microbicidal Activity. ................................................................................................................ 52
Uses. ........................................................................................................................................ 52
Quaternary Ammonium Compounds ............................................................................................. 53
Overview. ................................................................................................................................. 53
Mode of Action. ........................................................................................................................ 53
Microbicidal Activity. ................................................................................................................ 53
Uses. ........................................................................................................................................ 54
Miscellaneous Inactivating Agents ....................................................................................................... 55
Other Germicides ........................................................................................................................... 55
Metals as Microbicides ................................................................................................................... 55
Ultraviolet Radiation (UV)............................................................................................................... 55
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Last update:
May 2019 5 of 163
Pasteurization ................................................................................................................................ 56
Flushing
- and Washer-Disinfectors ................................................................................................ 56
The Regulatory Framework for Disinfectants and Sterilants ................................................................ 57
EPA and FDA ................................................................................................................................. 57
CDC................................................................................................................................................ 57
Test Methods ................................................................................................................................. 58
Neutralization of Germicides ................................................................................................... 58
Sterilization .................................................................................................................................................. 59
Steam Sterilization ................................................................................................................................ 59
Overview. ....................................................................................................................................... 59
Microbicidal Activity. ....................................................................................................................... 61
Mode of Action. .............................................................................................................................. 61
Uses. .............................................................................................................................................. 61
Flash Sterilization ................................................................................................................................. 61
Overview. ....................................................................................................................................... 61
Uses. .............................................................................................................................................. 62
Low-Temperature Sterilization Technologies ....................................................................................... 62
Ethylene Oxide "Gas" Sterilization ....................................................................................................... 63
Overview. ....................................................................................................................................... 63
Mode of Action. .............................................................................................................................. 64
Microbicidal Activity. ....................................................................................................................... 64
Uses. .............................................................................................................................................. 64
Hydrogen Peroxide Gas Plasma
.......................................................................................................... 64
Overview. ....................................................................................................................................... 64
Mode of Action. .............................................................................................................................. 65
Microbicidal Activity. ....................................................................................................................... 65
Uses. .............................................................................................................................................. 65
Peracetic Acid Sterilization ................................................................................................................... 65
Overview. ....................................................................................................................................... 65
Mode of Action. .............................................................................................................................. 66
Microbicidal Activity. ....................................................................................................................... 66
Uses. .............................................................................................................................................. 66
Microbicidal Activity of Low-Temperature Sterilization Technologies .................................................. 67
Bioburden of Surgical Devices ............................................................................................................. 68
Effect of Cleaning on Sterilization Efficacy ........................................................................................... 69
Other Sterilization Methods .................................................................................................................. 69
Ionizing Radiation. .......................................................................................................................... 69
Dry-Heat Sterilizers. ....................................................................................................................... 69
Liquid Chemicals. ........................................................................................................................... 70
Performic Acid. ............................................................................................................................... 70
Filtration. ........................................................................................................................................ 70
Microwave. ..................................................................................................................................... 71
Glass Bead "Sterilizer". .................................................................................................................. 71
Vaporized Hydrogen Peroxide (VHP). ........................................................................................ 71
Ozone. ............................................................................................................................................ 72
Formaldehyde Steam. .................................................................................................................... 72
Gaseous chlorine dioxide. .............................................................................................................. 73
Vaporized Peracetic Acid. .............................................................................................................. 73
Infrared rad
iation. ........................................................................................................................... 73
Sterilizing Practices .............................................................................................................................. 73
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Last update:
May 2019 6 of 163
Overview. ....................................................................................................................................... 73
Sterilization Cycle Verification. ....................................................................................................... 74
Physical Facilities. .......................................................................................................................... 74
Cleaning. ........................................................................................................................................ 74
Packaging. ..................................................................................................................................... 75
Loading. ......................................................................................................................................... 76
Storage. .......................................................................................................................................... 76
Monitoring. ..................................................................................................................................... 77
Reuse of Single
-Use Medical Devices ........................................................................................................ 81
Conclusion................................................................................................................................................... 82
Web-Based Disinfection and Sterilization Resources ................................................................................. 83
Recommendations for Disinfection and Sterilization in Healthcare Facilities ............................................. 84
A. Rationale
.......................................................................................................................................... 84
B. Rankings .......................................................................................................................................... 84
New Categorization Scheme for Updated Recommendations [November 2018] ................... 84C. Recommendations ........................................................................................................................... 84
1. Occupational Health and Exposure ......................................................................................... 84
2. Cleaning of Patient-Care Devices ........................................................................................... 85
3. Indications for Sterilization, High-Level Disinfection, and Low-Level Disinfection .................. 85
4. Selection and Use of Low-Level Disinfectants for Noncritical Patient-Care Devices .............. 85
5. Cleaning and Disinfecting Environmental Surfaces in Healthcare Facilities ........................... 86
6. Disinfectant Fogging ................................................................................................................ 87
7. High-Level Disinfection of Endoscopes ................................................................................... 88
8. Management of Equipment and Surfaces in Dentistry ............................................................ 91
9. Processing Patient-Care Equipment Contaminated with Bloodborne Pathogens
(HBV, Hepatitis C Virus, HIV), Antibiotic-Resistant Bacteria (e.g., Vancomycin- Resistant Enterococci, Methicillin-Resistant Staphylococcus aureus, Multidrug Resistant Tuberculosis), or Emerging Pathogens (e.g., Cryptosporidium, Helicobacter pylori, Escherichia coli O157:H7, Clostridium difficile, Mycobacterium tuberculosis,Severe Acute Re
spiratory Syndrome Coronavirus), or Bioterrorist Agents ............................ 9110. Disinfection Strategies for Other Semicritical Devices ............................................................ 91
11. Disinfection by Healthcare Personnel in Ambulatory Care and Home Care ........................... 92
12. Microbial Contamination of Disinfectants ................................................................................ 92
13. Flash Sterilization .................................................................................................................... 92
14. Methods of Sterilization ........................................................................................................... 93
15. Packaging ................................................................................................................................ 93
16. Monitoring of Sterilizers ........................................................................................................... 93
17. Load Configuration. ................................................................................................................. 94
18. Storage of Sterile Items ........................................................................................................... 94
19. Quality Control ......................................................................................................................... 94
20. Reuse of Single-Use Medical Devices .................................................................................... 95
Performance Indicators ............................................................................................................................... 96
Acknowledgements ..................................................................................................................................... 97
Glossary ...................................................................................................................................................... 98
Tables and Figure ..................................................................................................................................... 106
Table 1. Methods of sterilization and disinfection ............................................................................... 106
Table 1A. Smooth, Hard Surface
1,4 .............................................................................................. 106Table 1B. Rubber tubing and catheters
3,4 .................................................................................... 107Table 1C. Polyethylene tubing and catheters
3,4,7 ......................................................................... 108Table 1D. Lensed instruments
4.................................................................................................... 109
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Last update:
May 2019 7 of 163
Table 1E. Thermometers (Oral and Rectal)
8 ............................................................................... 110Table 1F. Hinged Instruments
4.................................................................................................... 111
Table 2. Properties of an ideal disinfectant ........................................................................................ 113
Table 3. Epidemiologic evidence associated with the use of surface disinfectants ordetergents on noncritical environmental surfaces................................................................... 114
Figure 1. Decreasing order of resistance of microorganisms to disinfection and sterilization (with thedisinfection levels indicated) ..................................................................................... 115
Table 4. Comparison of the characteristics of selected chemicals used as high -leveldisinfectants or chemical Sterilants ......................................................................................... 116
Table 5. Summary of advantages and disadvantages of chemical agents used as chemical sterilants 1or as high-level disinfectants .................................................................................. 117
Table 6. Summary of advantages and disadvantages of commonly used sterilizationtechnologies ............................................................................................................................ 118
Table 7. Minimum cycle times for steam sterilization cycles .............................................................. 119
Table 8. Examples of flash steam sterilization parameters ................................................................ 120
Table 9. Characteristics of an ideal low-temperature sterilization process ........................................ 121
Table 10. Factors affecting the efficacy of sterilization....................................................................... 122
Table 11. Comparative evaluation of
the microbicidal activity of low-temperature sterilizationtechnology (based on tests of inoculated carriers in lab setting) ............................................ 123
Table 12. Suggested protocol for management of positive biological indicator in a steamsterilizer ................................................................................................................................... 124
Disclosure of Financial Interests and
Relationships (2000
- July 2004) ................................................... 124References ................................................................................................................................................ 125
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Last update:
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