Transcription
Accessible version: sinfection/Guideline for Disinfection andSterilization in HealthcareFacilities, 2008Update: May 2019William 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)31HospitalEpidemiologyUniversity of North Carolina Health Care SystemChapel Hill, NC 275142Divisionof Infectious DiseasesUniversity of North Carolina School of MedicineChapel Hill, NC 27599-70301 of 163
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)3HICPAC MembersRobert A. Weinstein, MD (Chair)Cook County HospitalChicago, ILJane D. Siegel, MD (Co-Chair)University of Texas Southwestern Medical CenterDallas, TXMichele L. Pearson, MD (Executive Secretary)Centers for Disease Control and PreventionAtlanta, GARaymond Y.W. Chinn, MDSharp Memorial HospitalSan Diego, CAAlfred DeMaria, Jr, MDMassachusetts Department of Public HealthJamaica Plain, MAJames T. Lee, MD, PhDUniversity of MinnesotaMinneapolis, MNWilliam A. Rutala, PhD, MPHUniversity of North Carolina Health Care SystemChapel Hill, NCWilliam E. Scheckler, MDUniversity of WisconsinMadison, WIBeth H. Stover, RNKosair Children’s HospitalLouisville, KYMarjorie A. Underwood, RN, BSN CICMt. Diablo Medical CenterConcord, CAThis guideline discusses use of products by healthcare personnel in healthcare settings such ashospitals, ambulatory care and home care; the recommendations are not intended for consumer use ofthe products discussed.Last update: May 20192 of 163
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Table of ContentsExecutive Summary . 8Introduction. 9Methods. 9Definition of Terms . 9A Rational Approach to Disinfection and Sterilization . 11Critical Items . 11Semicritical Items. 11Noncritical Items . 12Changes in Disinfection and Sterilization Since 1981 . 13Disinfection of Healthcare Equipment . 14Concerns about Implementing the Spaulding Scheme . 14Reprocessing of Endoscopes . 14Laparoscopes and Arthroscopes . 18Tonometers, Cervical Diaphragm Fitting Rings, Cryosurgical Instruments, and EndocavitaryProbes . 19Dental Instruments. 21Disinfection of HBV-, HCV-, HIV- or TB-Contaminated Devices . 22Disinfection in the Hemodialysis Unit . 22Inactivation of Clostridium difficile . 23OSHA Bloodborne Pathogen Standard . 24Emerging Pathogens (Cryptosporidium, Helicobacter pylori, Escherichia coli O157:H7,Rotavirus, Human Papilloma Virus, Norovirus, Severe Acute Respiratory Syndrome[SARS] Coronavirus) . 24Inactivation of Bioterrorist Agents . 26Toxicological, Environmental and Occupational Concerns . 27Disinfection in Ambulatory Care, Home Care, and the Home . 28Susceptibility of Antibiotic-Resistant Bacteria to Disinfectants . 29Surface Disinfection . 30Air Disinfection . 32Microbial Contamination of Disinfectants . 33Factors Affecting the Efficacy of Disinfection and Sterilization . 34Number and Location of Microorganisms . 34Innate Resistance of Microorganisms . 34Concentration and Potency of Disinfectants . 35Physical and Chemical Factors . 35Organic and Inorganic Matter . 35Duration of Exposure . 35Biofilms . 36Cleaning . 37Disinfection . 39Chemical Disinfectants . 39Alcohol. 39Overview. . 39Mode of Action. . 39Microbicidal Activity. . 39Uses. 40Chlorine and Chlorine Compounds . 40Overview. . 40Mode of Action. . 42Last update: May 20193 of 163
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Microbicidal Activity. . 42Uses. 42Formaldehyde . 43Overview. . 43Mode of Action. . 44Microbicidal Activity. . 44Uses. 44Glutaraldehyde . 44Overview. . 44Mode of Action. . 45Microbicidal Activity. . 45Uses. 46Hydrogen Peroxide . 47Overview. . 47Mode of Action. . 47Microbicidal Activity. . 47Uses. 48Iodophors . 48Overview. . 48Mode of Action. . 49Microbicidal Activity. . 49Uses. 49Ortho-phthalaldehyde (OPA) . 49Overview. . 49Mode of Action. . 49Microbicidal Activity. . 49Uses. 50Peracetic Acid . 51Overview. . 51Mode of Action. . 51Microbicidal Activity. . 51Uses. 51Peracetic Acid and Hydrogen Peroxide . 51Overview. . 51Microbicidal Activity. . 51Uses. 52Phenolics . 52Overview. . 52Mode of Action. . 52Microbicidal Activity. . 52Uses. 52Quaternary Ammonium Compounds . 53Overview. . 53Mode of Action. . 53Microbicidal Activity. . 53Uses. 54Miscellaneous Inactivating Agents . 55Other Germicides . 55Metals as Microbicides . 55Ultraviolet Radiation (UV). 55Last update: May 20194 of 163
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Pasteurization . 56Flushing- and Washer-Disinfectors . 56The Regulatory Framework for Disinfectants and Sterilants . 57EPA and FDA . 57CDC. 57Test Methods . 58Neutralization of Germicides . 58Sterilization . 59Steam Sterilization . 59Overview. . 59Microbicidal Activity. . 61Mode of Action. . 61Uses. . 61Flash Sterilization . 61Overview. . 61Uses. . 62Low-Temperature Sterilization Technologies . 62Ethylene Oxide "Gas" Sterilization . 63Overview. . 63Mode of Action. . 64Microbicidal Activity. . 64Uses. . 64Hydrogen Peroxide Gas Plasma . 64Overview. . 64Mode of Action. . 65Microbicidal Activity. . 65Uses. . 65Peracetic Acid Sterilization . 65Overview. . 65Mode of Action. . 66Microbicidal Activity. . 66Uses. . 66Microbicidal Activity of Low-Temperature Sterilization Technologies . 67Bioburden of Surgical Devices . 68Effect of Cleaning on Sterilization Efficacy . 69Other Sterilization Methods . 69Ionizing Radiation. 69Dry-Heat Sterilizers. . 69Liquid Chemicals. . 70Performic Acid. . 70Filtration. . 70Microwave. . 71Glass Bead “Sterilizer”. . 71Vaporized Hydrogen Peroxide (VHP ). . 71Ozone. . 72Formaldehyde Steam. . 72Gaseous chlorine dioxide. . 73Vaporized Peracetic Acid. . 73Infrared radiation. . 73Sterilizing Practices . 73Last update: May 20195 of 163
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Overview. . 73Sterilization Cycle Verification. . 74Physical Facilities. . 74Cleaning. . 74Packaging. . 75Loading. . 76Storage. . 76Monitoring. . 77Reuse of Single-Use Medical Devices . 81Conclusion. 82Web-Based Disinfection and Sterilization Resources . 83Recommendations for Disinfection and Sterilization in Healthcare Facilities . 84A. Rationale . 84B. Rankings . 84New Categorization Scheme for Updated Recommendations [November 2018] . 84C. Recommendations . 841. Occupational Health and Exposure . 842. Cleaning of Patient-Care Devices . 853. Indications for Sterilization, High-Level Disinfection, and Low-Level Disinfection . 854. Selection and Use of Low-Level Disinfectants for Noncritical Patient-Care Devices . 855. Cleaning and Disinfecting Environmental Surfaces in Healthcare Facilities . 866. Disinfectant Fogging . 877. High-Level Disinfection of Endoscopes . 888. Management of Equipment and Surfaces in Dentistry . 919. Processing Patient-Care Equipment Contaminated with Bloodborne Pathogens(HBV, Hepatitis C Virus, HIV), Antibiotic-Resistant Bacteria (e.g., VancomycinResistant Enterococci, Methicillin-Resistant Staphylococcus aureus, MultidrugResistant Tuberculosis), or Emerging Pathogens (e.g., Cryptosporidium, Helicobacterpylori, Escherichia coli O157:H7, Clostridium difficile, Mycobacterium tuberculosis,Severe Acute Respiratory Syndrome Coronavirus), or Bioterrorist Agents . 9110. Disinfection Strategies for Other Semicritical Devices . 9111. Disinfection by Healthcare Personnel in Ambulatory Care and Home Care . 9212. Microbial Contamination of Disinfectants . 9213. Flash Sterilization . 9214. Methods of Sterilization . 9315. Packaging . 9316. Monitoring of Sterilizers . 9317. Load Configuration. . 9418. Storage of Sterile Items . 9419. Quality Control . 9420. Reuse of Single-Use Medical Devices . 95Performance Indicators . 96Acknowledgements . 97Glossary . 98Tables and Figure . 106Table 1. Methods of sterilization and disinfection. 106Table 1A. Smooth, Hard Surface1,4 . 106Table 1B. Rubber tubing and catheters3,4 . 107Table 1C. Polyethylene tubing and catheters3,4,7 . 108Table 1D. Lensed instruments4 . 109Last update: May 20196 of 163
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)Table 1E. Thermometers (Oral and Rectal)8 . 110Table 1F. Hinged Instruments4 . 111Table 2. Properties of an ideal disinfectant .
Dental Instruments . Disinfection and sterilization are essential for ensuring that medical and surgical instruments do not transmit infectious pathogens to patients. Because ster
