Disi n f ection & S t erili z a tion

1. Disinfection& Sterilization

2. Objectives • Define importantcomponentsincleaning, disinfection,andsterilization • Identifymethods for cleaning,disinfection,or • sterilization • Listrisks offailure toproperlyclean,disinfect,or • sterilize equipment • Discuss importance of coordinatedapproach

3. Definitions • Clean-Removevisibleforeignmaterial • “if it isn’t clean it can’t be sterilized or high level disinfected” • Decontamination-Removepathogenicorganisms • andmake equipmentsafe for handling • Sterilization-Killall microbes • Sanitize -Reducemicrobialloadoninanimate objectstorelativelysafe level

4. Important Difference • Disinfection-Killing allmicrobiologicorganisms • with the exceptionof spores • Antisepsis-Killor reducemicrobialloadon livingtissue • Agentsthatcankillmicroorganisms include bothdisinfectantsandantiseptics(cideor cidal) • Disinfectants–inanimateobjects • Antiseptics– livingtissue

5. Regulations • FederalInsecticide,Fungicide,RodenticideAct 1947(FIFRA) • Specified • Use Dilution • ContactTime • Methodof Application • SafetyPrecautions

6. Regulations • EnvironmentalProtectionAgency(EPA) • Disinfectants • IncludingHighLevelDisinfectants • LiquidChemicalSterilants • Food and DrugAdministration(FDA) • Antiseptics

7. Regulations • OccupationalSafety andHealth Administration(OSHA) • BloodbornePathogenRule1991 • RequireEPAregistration • Disinfectantmustbetuberculocidal • Ruleamended in 1997 - disinfectantsmustbe effective • againstHIV& HBV

8. SpauldingClassificationSystem • Critical–objectswhich penetratesterile tissue or bloodmustbeSterile • Semi-critical –objectsthat touchmucous membranes or non-intact skinrequireHigh level disinfection • Non-critical –objects thatonlytouchintact skinrequire Intermediate& Low level disinfection

9. 4 Methods • Sterilization–allmicroorganisms& spores • High-level disinfection–allmicroorganisms • exceptspores • Intermediate-level disinfection–destroys most virusandmost fungibutnot spores • Low-leveldisinfection–destroysvegetative bacteria, some virusesand fungi,butnot sporesormycobacteria

10. InfluencingFactors • Organic andinorganicload • Typeandlevel ofmicrobial contamination • Concentration andexposure • time togermicide • Physical nature of object • Presenceofbiofilms • TemperatureandpH • Relative Humidity

11. Biofilm • Structured communityof microorganisms • Encapsulatedinacomplex matrix • Adherestoa livingorinertsurface • Oftencharacterizedby • surfaceattachment • structuralheterogeneity • geneticdiversity • complexcommunityinteractions • extracellularmatrix ofpolymeric • substances-AKAslime,sludge

12. Biofilm

13. Staphylococcus aureus biofilm

14. CriticalItems • Objectsthatenternormallysteriletissueor vascular • system • Goals • Sterility • Destroyallmicroorganismsincludingspores • Methods • High temp– Steam • Heattolerantitems • Low temp– ETO or H2O2gas • Heatsensitiveitems • Liquidchemicalsterilants– H2O2,paracetic acid • Heatsensitiveitems

15. Ideal SterilizationMethod • Highlyeffective • Rapidaction • Strongpenetration • Materials compatible • Non-toxic • Organic materialresistance • Adaptable • Monitoringrequired • Cost-effective • SchneiderPM. TappiJ.1994;77:115-119

16. Decontaminationof CriticalItems • Dedicatedarea • Negative airflow • Requiredpersonal protective equipment • Presoaktoremoveload • Manualcleaning offragileitems • Automatedcleaning • Ultrasonic • Washers • Detergents (sanitize) • NeutralpH • Enzymes • Decontaminationroom

17. Cleaninstruments • Dried • Inspected • Cleanliness • Maintenance • Repair • Packedor wrapped • AAMIapprovedrigid containers or wrappers • Associationforthe AdvancementofMedical Instrumentation

18. SterilizationMonitoring Mechanical– cycletime,temperature, pressure (steam) Chemical–heatorchemicalsensitiveinksthat changecolorwhengermicidalparameters reached Biological – BacillusorGeobacillusspores thatdirectlymeasuresterilization Bowie-Dick testisfor vacuumanddoneoncea day. Nota sterilizationmonitor

19. Chemical monitor • Chemicalintegrator • Usedfor packcontrol tomonitorconditions • insideeachpack orrigidcontainer • Failedindicator–immediatelyremovepack from procedureandreprocess

20. Biological Monitors Daily Steam– Geobacillus stearothermophilus Dryheat-Geobacillus stearothermophilus ETO – Bacillusatrophaeus Lowtemperature technologies(H2O2 gas)– Geobacillus stearothermophilus Steambiologicmonitor

21. FailedBiologicIndicator • Immediatelytakesterilizeroutofservice • Notify director • Quarantineallloadssincefailureandreprocess • Begininvestigation • Verify integrityof biologicindicator • Verifymechanicalindicator(printout) • Verifyoperator input • Correctcycleselection • Verify correctplantoperations • Lossof steam • Powerloss • Repeatbiologicindicatorin 3consecutiveruns • Ifanypositive– callmanufacturerfor service

22. Immediate Use Sterilization • Designedfor thesteamsterilization of unwrapped • singleitems designatedfor immediateuse • Decontaminateitem • Use rigidcoveredimmediateusecontainer • Donot wrapitem • Allmechanical,biological andchemicalmonitors • apply • Neverusefor any implantableitem

23. Immediate Use Sterilization • Weighcostsofmore instrumentsvs. patientsafety • Do not usefor convenienceor asanalternativeto purchasingmoreinstrumentsets • Establishguidelinesandmonitoruse • Date&time • MD,case • Item • Reason • Use onlywhenthereisinsufficienttimeto process instrumentcompletelyin wrappedor rigid container

24. LowTemperatureSterilization • Usedonheat andmoisturesensitiveequipment • ETO (ethyleneoxide) • Gasconcentration,temperature,humidity • Longcycle,aeration required,toxicity • Hydrogen peroxidegas plasma (Sterrad) • Requiressyntheticpackaging.Nocellulose • Somedeviceswith narrowlonglumenscannot beprocessed(See manufacturer’s recommendationsfor lengthand diameter) • PeraceticAcid (Steris) • Point ofuse.Nostorageallowed. • Smallloads • Immersibleinstrumentsonly

25. Single UseDevice FDA issuedSingleUse DeviceGuidanceinAugust 2000. Hospital orthirdpartyreprocessorisregulated thesameas originalequipment manufacturer Adevicelabeledfor single use isconsidereda newdeviceifreprocessed.Thereprocessoris considered the manufacturer. As a newdevice,allfederal (FDA)controls regarding themanufactureand marketing of thedeviceapply.

26. Storage of SterileItems • Eventrelatedshelflife –considertheproductsterile • until aneventcausesittobecomecontaminated. Packaging evaluatedbeforeusefor integrity • Tearoropeninginpackaging • Waterdamage • Timerelatedshelflife–consideritemsterilefor setperiodbasedon wrapping/packagingmaterial.Once expirationdateis passed,itemmustbe removedfrom service. Discardor reprocess.Ifmanufacturerhas placedexpirationdateon package,itemhastime relatedshelflife.

27. Storage of SterileItems • Segregated,protectedarea • Coveredshelving • Solidsurfacebottom shelf • Temperaturecontrol(68-75) • Humiditycontrol (30%-70%) • Air exchangeperhour • 8-10 inches offfloor • 18 inchesbelowceiling • 2 inchesfromoutsidewall

28. Semi-Critical Items • Objectsthatcomeincontactwithmucous • membranesandnon-intactskin • Goals • Highleveldisinfection • Free ofallmicroorganismsexcepthigh numbersofspores • Methods • Pasteurization • Liquidchemicalsterilants–heatsensitiveitems • Gluteraldehyde • OPA(ortho-pthaldehyde)

29. Semi-CriticalItems • Pasteurization • –700C (1580F)for30minutes • Notjustfor foodanddrink • Used onrespiratory therapy and • anesthesiaequipment

30. High Level Disinfection • Endoscopes • Bronchoscopes • LaryngoscopeBlades • Tonometers • Cryosurgicalinstruments • Endocavitary probes • Transesophageal • Transvaginal • Nasopharyngoscopes

31. HighLevel Disinfection 0.55% OPA 12minuteprocess Well ventilatedarea with coveredcontainers Nodeactivatorrequired NoOSHAlimit Weakodor 3x$ Contraindicatedforurological instrumentsusedon patients with historyofbladdercancer >2.0% Glutaraldehyde 45minuteprocess Wellventilated area withcoveredcontainers Deactivatorrequired beforedisposal OSHAlimitof0.05ppm Strongodor $

32. Scopes • Preclean • Remove visiblesoiling • Disinfect • Manual • Automated • Rinse • Freshwater • No recommendationforsterilevs.potable • Manuallyrinselumens • Flushwith 70%isopropylalcohol ? • Dry • Air dry • Store • Hangingfreely (no touching) • In ventilatedcabinet

33. EmergingPathogens “Standarddisinfectionandsterilizationproceduresfor patientcareequipmentareadequateto sterilizeor disinfectinstrumentsordevicescontaminatedwith bloodand otherbodyfluidsfrompersonsinfected withemerging pathogens.” (Rutala, W.A,Ph.D.,MPH.,2004) One exception–Creutzfeldt-JakobDisease

34. Non-Critical Items • Objectsthatwill not comeincontactwith • mucous membranesandnon-intactskin • Goals • Intermediateandlowleveldisinfection • Free ofallvegetativebacteriaand somefungi and viruses • Methods • EPAregisteredhospital disinfectant • Chlorine-based • Phenolics • Quaternary ammonium • HydrogenPeroxide • 70-90% alcohol

35. Non-Critical Items • EnvironmentalSurfaces • Medicalequipment • Furniture • Buildingenvironment • Risks • High touchareas • Doorhandles • IVpoles • Phones • Computers • Lowtouch areas • Toiletseats

36. RoomdisinfectionTechnologies • EPA registered • Sanitizespecific surfaces • Copperalloy • Sanitizeentire room • UV irradiation • Ozone • Somecansanitizeroomandcontentsof • supplydrawers • Hydrogenperoxidevapor

37. Bacteriapersquareinch 49 3,295 25,127

38. Survival Rates • Influenza24-48hrs • MRSA63days • VRE58days • • • • • • • HepatitisB • Norovirus • SARS • Candidasp. • • 7days 12days 24-72hrs 3days Acinetobacter C.diffspore Pseudomonas 33days 5 months 7hours Parainfluenza 10hrs

39. Staff Competencies • Provide comprehensivetraining for all staff • assignedto processmedical/surgical instruments • Toachieveandmaintaincompetency • Handson training • All worksuperviseduntil documentedcompetency • Includesreviewof writteninstruction to assure complianceanduniformity • Conductedat hireandannually

40. InfectionPreventionRole • Periodicreview of policiesand procedures • Annualreviewof disinfectants • Regularreview • Expireditems • Flashsterilizationlogs • Sterilizationmonitor logs • HLDlogs • Observations • Hand hygiene • Properpersonalprotectiveequipment

41. Study Question # 1 All the following statements are true concerning steam sterilization EXCEPT: The temperature inside the autoclave is raised in proportion to the pressure Steam must be superheated for effective sterilization Steam must be saturated for effective sterilization Pressure, temperature, time and moisture are the four parameters of steam sterilization

42. ANSWER: b. Steam must be superheated for effective sterilization

43. Study Question #2 A leak test on endoscopes is performed between each patient use because: It can detect damage to the channel It can detect damage to the exterior Perforated channels are an infection control risk All of the above

44. Answer: d. All of the above

45. References • CentersforDiseaseControland Prevention • http://www.cdc.gov/ncidod/dhqp/guidelines.html • EnvironmentalProtectionAgency • http://www/epa.gov • Foodand DrugAdministration • http://www.fda.gov • Universityof NorthCarolina • http://www.disinfectionandsterilization.org