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//-->.pos {position:absolute; z-index: 0; left: 0px; top: 0px;}HICPAC 2bCDC cleared 2/11/2002/WAR corrected and returned to CDC 2/20/2002Draft Guideline for Disinfection and Sterilizationin Healthcare FacilitiesWilliam A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H.,and the Healthcare Infection Control Practices Advisory CommitteeNOTE: This manuscript is a confidential communication. Do not duplicate, distribute, or quoteuntil it is published.1EXECUTIVE SUMMARY .........................................................................................................7INTRODUCTION........................................................................................................................7METHODS...................................................................................................................................7DEFINITION OF TERMS..........................................................................................................9A RATIONAL APPROACH TO DISINFECTION AND STERILIZATION.....................10CRITICALITEMS........................................................................................................................10SEMICRITICALITEMS................................................................................................................10NONCRITICALITEMS.................................................................................................................11CHANGES INDISINFECTION ANDSTERILIZATIONSINCE1981 (LASTCDC GUIDELINE)............12DISINFECTION OF HEALTHCARE EQUIPMENT...........................................................12CONCERNS WITHSPAULDINGSCHEME......................................................................................12ENDOSCOPES.............................................................................................................................13LAPAROSCOPES, ARTHROSCOPES,ANDCYSTOSCOPES.............................................................15TONOMETERS, DIAPHRAGMFITTINGRINGS, CRYOSURGICALINSTRUMENTS, ENDOCAVITARYPROBES.....................................................................................................................................16DENTALINSTRUMENTS.............................................................................................................18DECONTAMINATION OFBONE...................................................................................................19DISINFECTION OFHBV-, HCV-, HIV-ORTUBERCULOSIS-CONTAMINATEDDEVICES.............19DISINFECTION OFHEMODIALYSISMACHINES...........................................................................20INACTIVATION OFC.DIFFICILE.................................................................................................20INACTIVATION OFCREUTZFELDT-JAKOBDISEASEAGENT........................................................21OSHA BLOODBORNEPATHOGENSTANDARD...........................................................................23EMERGINGPATHOGENS(CRYPTOSPORIDIUM, HELICOBACTER PYLORI, ESCHERICHIA COLIO157:H7, HUMANPAPILLOMAVIRUS, NORWALKVIRUS).......................................................23TOXICOLOGICAL ANDENVIRONMENTALCONCERNS.................................................................25DISINFECTION INAMBULATORYCARE, HOMECARE,AND THEHOME.....................................26SUSCEPTIBILITY OFANTIBIOTIC-RESISTANTBACTERIA TODISINFECTANTS.............................26SURFACEDISINFECTION: SHOULDWEDOIT? ..........................................................................28AIRDISINFECTION....................................................................................................................29MICROBIALCONTAMINATION OFDISINFECTANTS....................................................................29FACTORS AFFECTING THE EFFICACY OF DISINFECTIONAND STERILIZATION ............................................................................................................30NUMBER ANDLOCATION OFMICROORGANISMS.......................................................................30INNATERESISTANCE OFMICROORGANISMS..............................................................................31CONCENTRATION ANDPOTENCY OFDISINFECTANTS................................................................31PHYSICAL ANDCHEMICALFACTORS.........................................................................................31ORGANIC ANDINORGANICMATTER..........................................................................................32DURATION OFEXPOSURE..........................................................................................................32BIOFILMS..................................................................................................................................322CLEANING ................................................................................................................................32DISINFECTION ........................................................................................................................34CHEMICALDISINFECTANTS.......................................................................................................34Alcohol .................................................................................................................................34Overview..........................................................................................................................34Mode of Action ................................................................................................................34Microbicidal Activity.......................................................................................................34Uses..................................................................................................................................35Chlorine and Chlorine Compounds .....................................................................................36Overview..........................................................................................................................36Mode of Action ................................................................................................................36Microbicidal Activity.......................................................................................................36Uses..................................................................................................................................37Formaldehyde.......................................................................................................................38Overview..........................................................................................................................38Mode of Action ................................................................................................................38Microbicidal Activity.......................................................................................................38Uses..................................................................................................................................38Glutaraldehyde.....................................................................................................................39Overview..........................................................................................................................39Mode of Action ................................................................................................................39Microbicidal Activity.......................................................................................................39Uses..................................................................................................................................41Hydrogen Peroxide...............................................................................................................42Overview..........................................................................................................................42Mode of Action ................................................................................................................42Microbicidal Activity.......................................................................................................42Uses..................................................................................................................................42Iodophors..............................................................................................................................43Overview..........................................................................................................................43Mode of Action ................................................................................................................44Microbicidal Activity.......................................................................................................44Uses..................................................................................................................................44Ortho-phthalaldehyde ..........................................................................................................44Overview..........................................................................................................................44Mode of Action ................................................................................................................44Microbicidal Activity.......................................................................................................44Uses..................................................................................................................................45Peracetic Acid ......................................................................................................................45Overview..........................................................................................................................45Mode of Action ................................................................................................................45Microbicidal Activity.......................................................................................................46Uses..................................................................................................................................46Peracetic Acid and Hydrogen Peroxide...............................................................................46Overview..........................................................................................................................463Microbicidal Activity.......................................................................................................46Uses..................................................................................................................................46Phenolics ..............................................................................................................................47Overview..........................................................................................................................47Mode of Action ................................................................................................................47Microbicidal Activity.......................................................................................................47Uses..................................................................................................................................47Quaternary Ammonium Compounds ....................................................................................48Overview..........................................................................................................................48Mode of Action ................................................................................................................48Microbicidal Activity.......................................................................................................48Uses..................................................................................................................................48MISCELLANEOUSINACTIVATINGAGENTS.................................................................................49Other Germicides .................................................................................................................49Superoxidized Water.............................................................................................................49Metals as Microbicides ........................................................................................................49Ultraviolet Radiation............................................................................................................50Pasteurization.......................................................................................................................51Flushing- and Washer-Disinfectors .....................................................................................51EVALUATION ANDNEUTRALIZATION OFGERMICIDES..............................................................51STERILIZATION......................................................................................................................52Steam Sterilization................................................................................................................53Overview..........................................................................................................................53Microbicidal Activity.......................................................................................................54Mode of Action ................................................................................................................54Uses..................................................................................................................................54Flash Sterilization ................................................................................................................55Overview..........................................................................................................................55Uses..................................................................................................................................55Low-Temperature Sterilization Technologies ......................................................................55Ethylene Oxide "Gas" Sterilization ......................................................................................56Overview..........................................................................................................................56Mode of Action ................................................................................................................57Microbicidal Activity.......................................................................................................57Uses..................................................................................................................................58Hydrogen Peroxide Gas Plasma ..........................................................................................58Overview..........................................................................................................................58Mode of Action ................................................................................................................59Microbicidal Activity.......................................................................................................59Uses..................................................................................................................................59Peracetic Acid Sterilization..................................................................................................59Overview..........................................................................................................................59Mode of Action ................................................................................................................60Microbicidal Activity.......................................................................................................60Uses..................................................................................................................................604Microbicidal Activity of Low-Temperature Sterilization Technologies...............................60Bioburden of Surgical Devices.............................................................................................62Effect of Cleaning on Sterilization Efficacy .........................................................................62Other Sterilization Methods .................................................................................................63Ionizing Radiation............................................................................................................63Dry-Heat Sterilizers .........................................................................................................63Liquid Chemicals .............................................................................................................63Performic Acid.................................................................................................................64Filtration...........................................................................................................................64Microwave .......................................................................................................................64Glass Bead “Sterilizer” ....................................................................................................64Vaporized Hydrogen Peroxide (VHP) .............................................................................64Ozone ...............................................................................................................................65Formaldehyde Steam .......................................................................................................65Gaseous chlorine dioxide.................................................................................................66Vaporized Peracetic Acid ................................................................................................66Sterilizing Practices .............................................................................................................66Overview..........................................................................................................................66Sterilization Cycle Validation..........................................................................................66Physical Facilities ............................................................................................................67Cleaning ...........................................................................................................................67Packaging.........................................................................................................................68Loading ............................................................................................................................68Storage .............................................................................................................................68Monitoring (Mechanical, Chemical, Biological Indicators)............................................69REUSE OF MEDICAL DEVICES...........................................................................................72CONCLUSION ..........................................................................................................................73RECOMMENDATIONS FOR DISINFECTION AND STERILIZATION INHEALTHCARE FACILITIES .................................................................................................74A. RATIONALE..........................................................................................................................74B. RANKINGS............................................................................................................................74C. RECOMMENDATIONS............................................................................................................751.Cleaning of Patient-Care Equipment ....................................................................752.Indications for Sterilization, High-Level Disinfection, and Low-Level Disinfection...............................................................................................................................753.Selection and Use of Disinfectants for Noncritical Patient-Care Items.................754.Disinfecting Environmental Surfaces in Healthcare Facilities ..............................765.Disinfectant Fogging ..............................................................................................776.Management of Equipment and Surfaces in Dentistry ...........................................777.High-Level Disinfection of Endoscopes..................................................................778.Processing Patient-Care Equipment Contaminated with Bloodborne Pathogens 799.Processing Creutzfeldt Jakob Disease (CJD)-Contaminated Patient-CareEquipment and Environmental Surfaces ...............................................................795
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