Learning Objectives Differentiate between disinfection and sterilisation Explain different types of sterilisation Outline the process for cleaning patient care items December 1 2013 ID: 1047090
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1. Cleaning, Disinfection,and Sterilisation
2. Learning ObjectivesDifferentiate between disinfection and sterilisation.Explain different types of sterilisation.Outline the process for cleaning patient care items.December 1, 20132
3. Time involved90 minutesDecember 1, 20133
4. Key points - 1Cleaning, disinfection, and sterilisation are the backbone of infection prevention and controlProper cleaning essential before any disinfection or sterilisation processFailure to sterilise or disinfect reusable medical devices properly may spread infectionsThe type and level of device decontamination depends upon the nature of the item and its intended useDecember 1, 20134
5. Key points - 2Steam sterilisation effective only when preceded by Thorough pre-cleaning, proper packaging/loading, and careful monitoring of autoclaves Chemical disinfectants must be selected, used, and discarded to minimise harm Those responsible for processing contaminated items must be fully trained and wear protective clothing when necessaryClearly written policies and procedures must be available on-site for training personnel and for monitoring their performance December 1, 20135
6. DecontaminationA process of treatment that renders a medical device, instrument, or environmental surface safe to handleDoes not necessarily mean that the item is safe for patient reuse6December 1, 2013
7. Pre-Cleaning/CleaningEveryone responsible for handling and reprocessing contaminated items must:Receive adequate training and periodic retrainingWear appropriate personal protective equipment (PPE)Receive adequate prophylactic vaccinationsDecember 1, 20137
8. Spaulding ClassificationDivided hospital instruments into general categories based on the risk of infection involved in their use Critical items Semi critical item Non critical itemsDecember 1, 20138
9. Critical ItemsEnter normally sterile tissues, the vascular system, or equipment through which blood flowsItems must be properly and safely pre-cleaned and sterilised before useDecember 1, 20139
10. Critical Items - ExamplesImplantsProsthetic devicesSurgical instrumentsNeedlesCardiac cathetersUrinary cathetersBiopsy forceps of endoscopeDecember 1, 201310
11. Semi-critical ItemsContact mucous membranes but do not penetrate soft tissue or body surfacesMeticulous physical cleaning followed by appropriate high-level disinfectionDecember 1, 201311
12. Semi-critical Item - ExamplesFlexible fiberoptic endoscopesRespiratory therapy equipmentAnaesthesia equipmentEndotracheal tubesBronchoscopesVaginal speculaCystoscopeHand-pieceDecember 1, 201312
13. Non Critical ItemsDirect contact with the patients intact skin (unbroken skin)Little risk of pathogen transmission directly to patientClean and disinfect using a low to intermediate level disinfectantDecember 1, 201313
14. Examples of Non Critical ItemsItems which are in contact with intact skinBedpansBlood pressure cuffsCrutchesStethoscopesFace maskX-ray machineDecember 1, 201314
15. DisinfectionA process that eliminates many or all pathogenic microorganisms on inanimate objects, with the exception of bacterial spores December 1, 201315
16. Sterilisation - 1The complete elimination or destruction of all forms of microbial lifeIncludes large numbers of highly resistant bacterial sporesDecember 1, 201316
17. Sterilisation - 2Store in clean, dry placeProtect wrappingInspect before useDecember 1, 201317
18. Staff Training and ProtectionWritten and up-to-date policies and procedures must be available on-site for training/monitoring staff responsible for device reprocessingTrain staff fully and retrain as necessary; maintain written records The staff must also be provided with:Personal protective equipment (PPE)Prophylactic vaccinationsDecember 1, 201318
19. Single-Use ItemsSingle-use items must be safely discarded after usee.g., injection needles No reprocessing before carefully considering the following: Is device undamaged and functional? Can it be disassembled for reprocessing? Can its sterility be validated, if needed? Is the reprocessing cost-effective? Is an authorised person onsite willing to be responsible for any negative consequences? December 1, 201319
20. Choice of MethodMethod to be used will depend on: Device’s intended useRisk of infection Degree of soilage Process must not damage the deviceDecember 1, 201320
21. DisinfectionReduction in numbers of pathogens on inanimate surfaces/objects For items that will contact intact skin or mucous membraneUse physical or chemical agents or both Level of disinfectionHigh-levelIntermediate-levelLow-levelDecember 1, 201321
22. High-level Disinfectants - 1Active against vegetative bacteria, viruses (including the non-enveloped ones), fungi, and mycobacteriaMay have some activity against bacterial sporesWith extended contact times HLDs are used to disinfect heat-sensitive and semi-critical devices Such as flexible fibreoptic endoscopes22December 1, 2013
23. High-level disinfectants - 2HLDs typically require 10-45 minutes contact time Depends on the temperature After disinfection, items require thorough rinsing/flushing with sterile or filtered water to remove any chemical residuesThey must then be dried with an alcohol rinse or by blowing clean, filtered air through the device’s channels prior to storage23December 1, 2013
24. Intermediate-level DisinfectantsActive against vegetative bacteria, mycobacteria, fungi and most viruses May fail to kill spores, even after prolonged exposure24December 1, 2013
25. Low-level DisinfectantsActive against vegetative bacteria (except mycobacteria), some fungi, and only enveloped viruses In many cases, washing with unmedicated soap and water would be sufficient in place of LLD25December 1, 2013
26. Chemical disinfectants in health careAgentsSpectrumUsesAdvantagesDisadvantagesAlcohols (60-90%) includingethanol and isopropanolLow- to intermediate-level disinfectant.Used for decontaminating the outside of some semi-critical and noncritical items, e.g., oral and rectal thermometers and stethoscopes. Also to disinfect small surfaces such as rubber stoppers of multi-dose vials. Alcohols with detergent are safe and effective for spot disinfection of countertops, floors, and other surfaces. Also common in handrubs.Fast acting.No residue.Non-staining.Low cost. Widely available in many countries for medicinal and research purposes.Volatile, flammable, and an irritant to mucous membranes.Inactivated by organic matter.May harden rubber, cause glue to deteriorate, or crack acrylate plastic.26December 1, 2013
27. Chemical disinfectants in health careAgentsSpectrumUsesAdvantagesDisadvantagesChlorine and chlorine compounds: the most widely used is an aqueous solution of sodium hypochlorite 5.25-6.15% (domestic bleach) at a concentration of 100-5000 ppm free chlorine Low- to high-level disinfectant. Used for disinfecting tonometers and for spot disinfection of countertops and floors. Can be used for decontaminating blood spills. Concentrated hypochlorite or chlorine gas is used for disinfection of large and small water distribution systems, such as dental appliances, hydrotherapy tanks, and water distribution systems in haemodialysis centres.Low cost, fast acting. Readily available in most settings. Available as liquid, tablets or powders.Corrosive to metals in high concentration (>500 ppm). Inactivated by organic material.Decolourises or bleaches fabrics. Releases toxic chlorine gas when mixed with ammonia. Irritant to skin and mucous membranes. Unstable if left uncovered, exposed to light, or diluted; store in opaque container.27December 1, 2013
28. Chemical disinfectants in health careAgentsSpectrumUsesAdvantagesDisadvantagesAldehydes Glutaraldehyde: ≥2% alkaline or acidic solutions. Also formulated with phenol-sodium-phenate and alcohol. High-level disinfectant. Widely used as high-level disinfectant for heat-sensitive semi-critical items such as endoscopes. Good material compatibility.Allergenic and irritating to skin and respiratory tract. Must be monitored for continuing efficacy levels when reused. 28December 1, 2013
29. Chemical disinfectants in health careAgentsSpectrumUsesAdvantagesDisadvantagesOrtho-phthalaldehyde (OPA) 0.55%High-level disinfectant.High-level disinfectant for endoscopes.Excellent stability over wide pH range. Superior mycobactericidal activity compared to glutaraldehyde. Does not require activation.Expensive. Stains skin and mucous membranes; may stain items not thoroughly cleaned. Eye irritation. Poor sporicide. Must be monitored for efficacy during reuse. Contraindicated for reprocessing certain urological instruments.29December 1, 2013
30. Chemical disinfectants in health careAgentsSpectrumUsesAdvantagesDisadvantagesPeracetic acid 0.2-0.35% and other stabilised organic acids.High-level disinfectant/sterilant.Used in automated endoscope reprocessors. Can be used for cold sterilisation of heat-sensitive critical items, e.g., haemodialysers. Also suitable for manual instrument processing when properly formulated.Rapid sterilisation cycle time at low temperature (30-45 min. at 50-55oC). Active in presence of organic matter. Environmentally-friendly by-products (oxygen, water, acetic acid).Corrosive to some metals.Unstable when activated. May be irritating to skin, conjunctivae and mucous membranes.30December 1, 2013
31. Chemical disinfectants in health careAgentsSpectrumUsesAdvantagesDisadvantagesHydrogen peroxide 7.5%.High-level disinfectant/sterilant.Can be used for cold sterilisation of heat-sensitive critical items. Requires 30 minutes at 20oC. No activation. No odour.Environmentally-friendly by-products (oxygen, water).Not compatible with brass, copper, zinc, nickel/silver plating. Hydrogen peroxide 7.5% and peracetic acid 0.23%High-level disinfectant/sterilant.For disinfecting haemodialysers.Fast-acting (high-level disinfection in 15 min.). No activation required. No odour. Not compatible with brass, copper, zinc, and lead. Potential for eye and skin damage.31December 1, 2013
32. Chemical disinfectants in health careAgentsSpectrumUsesAdvantagesDisadvantagesPhenolicsLow- to intermediate-level disinfectant.Has been used for decontaminating environmental surfaces and non-critical items. Concerns with toxicity and narrow spectrum of microbicidal activity. Not inactivated by organic matter.Leaves residual film on surfaces. Harmful to the environment. No activity against viruses. Not recommended for use in nurseries and food contact surfaces. 32December 1, 2013
33. Chemical disinfectants in health careAgentsSpectrumUsesAdvantagesDisadvantagesIodophores (30-50 ppm free iodine)Low-level disinfectant.Used on some non-critical items, e.g., hydrotherapy tanks; however, main use is as an antiseptic. Relatively free of toxicity or irritancy. Inactivated by organic matter. Adversely affects silicone tubing. May stain some fabrics.Quaternary ammonium compoundsLow-level disinfectant unless combined with other agents.Used mainly on environmental surfaces. Can be used on skin.Stable with good detergent properties (cationic detergent). Usually non-irritating.Relatively narrow microbicidal spectrum, but range of activity can be expanded when combined with other agents, e.g., alcohols.33December 1, 2013
34. Practical Tips - 1Develop a policy for chemical disinfectionDisinfectants may be supplied ready to use or may need to be dilutedLabel bottles or containers with the name and concentration of disinfectant and, for diluted disinfectants, the date of dilution/preparationPrepare dilutions with clean waterPrepare small amounts at a time to avoid wastageDecember 1, 201334
35. Practical Tips - 2Do not mix freshly made diluted solution with old solutionWash and dry the container before filling with new solutionClean, rinse and dry items thoroughly before disinfectingAfter disinfection, rinse thoroughly with clean water to remove all chemical residuesAlcohol solutions can be allowed to dry without rinsingDecember 1, 201335
36. Steam SterilisationRequires direct contact of an item with steam at a required temperature and pressure for a specified timeMost reliableNon-toxic Has broad-spectrum microbiocidal activityGood penetrating abilityCheap and easy to monitor for efficacy2 main types: gravity and pre-vacuum36December 1, 2013
37. Gravity Displacement AutoclavesSteam introduced to purge out air and build pressure Raise temperature normally to 121°C at 15 pounds/square inch and maintain it for 15-45 minutesFor sterilising liquids and items in wraps that steam can penetrate37December 1, 2013
38. High-Vacuum AutoclavesAir is first vacuumed out and then steam introduced Faster and better penetration throughout the load Pressure and temperature higher; 134°C at about at 30 pounds/inch2 Processing time about three minutes Not suited for liquids due to need for vacuum 38December 1, 2013
39. Factors Influencing Steam SterilisationProper loading must occurAll items in load must have contact with steamItems in load must be free from grease and oil39December 1, 2013
40. Practical TipsA wide range of sterilisers is availableAlways sterilise items for the correct time using a clock or timerAir in the steriliser and load results in inadequate steam penetrationNever sterilise single use itemsDecember 1, 201340
41. Low-TemperatureMixture of steam (50-80°C) and formaldehyde vapour To process heat-resistant or heat-sensitive medical devices in specialised equipmentDevices pre-cleaned and wrapped in standard material and processed in a three-hour cycleCannot be used for liquidsFormaldehyde must be purged/ neutralised well41December 1, 2013
42. Flash SterilisationOnly to process a critical surgical item:in an emergencywhen accidentally contaminated, or when other means of sterilisation unavailable Never to be used for implantable items or to compensate for shortage of key instruments42December 1, 2013
43. Dry Heat Sterilisation - 1Require hot-air ovensFor glassware, metallic items, powders and oil/grease Time two hours at 160°C and one hour at 180°CPlastics, rubber, paper and cloth cannot be placed in them due to fire risk 43December 1, 2013
44. Dry Heat Sterilisation - 2AdvantagesCan be used for powders, anhydrous oilsInexpensiveNo corrosive effect on instrumentsDisadvantagesHigh temperature damages some itemsPenetration of heat slow, unevenDecember 1, 201344
45. Ethylene Oxide (EO) Colourless, flammable, explosive and toxic gas Processing cycles overnight or longerParametric release is not possibleEO and relative humidity cannot readily be measuredSpores of Bacillus atrophaeus used as biological indicators to monitor process45December 1, 2013
46. Ethylene Oxide (EO) Gas SterilisationUsed for heat or moisture sensitive itemsPrevents normal cellular metabolism and replication46December 1, 2013
47. EO SterilisationAdvantagesItems not damaged by heat or moistureNot corrosive, not damaging to delicate instruments, scopesPermeates porous materialsDissipates from materialDisadvantagesCostToxic properties of ethylene oxideAeration requiredLonger processDecember 1, 201347
48. Hydrogen Peroxide Gas Plasma Highly reactive/charged particles from hydrogen peroxide generated under vacuum Can be used to sterilise heat- and moisture-sensitive items Some plastics, electrical/electronic devices, and corrosion-susceptible metal alloysNot compatible with cellulose (linen, paper), devices with dead-end lumens, powders and liquidsSpecial wrapping required48December 1, 2013
49. FumigationFor rooms contaminated with some pathogens Such as MRSA and Clostridium difficileRelease of hydrogen peroxide, chlorine dioxide gas or possibly ozone in sealed roomsSpore strips (biological indicators) placed strategically to monitor processSpecial equipment requiredRisk of damage to sensitive items 49December 1, 2013
50. Pasteurisation and Boiling Semi-critical items can be pasteurised 65-77°C, 30 minExample: respiratory therapy equipment Must be retrieved carefully for safe transport and storage50December 1, 2013
51. FiltrationRemoval of microbes from air or heat-sensitive liquidsDisinfectant-impregnated filters may inactivate trapped microorganismsExample: High-efficiency particulate air (HEPA) filters All filters must be checked for integrity and replaced as necessary December 1, 201351
52. Automated Endoscope ReprocessorsAlternative to manual reprocessing of heat-sensitive devicesMinimise exposure of staff to pathogens and disinfectantsRequire access to reliable electric and water supplies, specific chemicals, regular maintenanceBiofilm build-up must be avoided 52December 1, 2013
53. Ultraviolet (UV) Light UV lamps useful for chemical-free disinfection of air and water and also possibly for decontamination of environmental surfacesBroad-spectrum microbicidal action Require regular cleaning and periodic replacement53December 1, 2013
54. MicrowavesHeating from rapid rotation of water moleculesLimited use except for disinfecting soft contact lenses and urinary catheters for intermittent self-catheterisation May be used in emergencies to treat water for drinking or to ‘disinfect’ small water-immersible plastic or glass items54December 1, 2013
55. Sterilisation Process Monitoring Recommended practices state that both biological and chemical indicators shall be used to monitor the sterilisation processMechanical monitoringChemical monitoringBiological monitoring55December 1, 2013
56. Chemical IndicatorsExternal Chemical Indicatorprocess indicator - autoclave tapedistinguishes processed from unprocessed medical devicessecures packlabels packCheck external indicator to ensure it has changed color before using any packageIf the indicator did not change, do not use56December 1, 2013
57. Biological IndicatorsRequires routine monitoring dailyTest must be dated and labeledOnce removed from the steriliser the test pack opened, BI labeled, crushed and incubated in the incubatorRecords of time, date of incubation and staff initials is required and then time and date and initials of the staff reading the final BI result 57December 1, 2013
58. Biological MonitoringSteam Geobacillus stearothermophilusDry heat B.atrophaeus (formerly B.subtilis)EO B.atrophaeus New low temperature sterilisation technologiesPlasma sterilisation (Sterrad) B.atrophaeusPeracetic acid - Geobacillus stearothermophilus58December 1, 2013
59. Main IP&C priorities Development of reprocessing protocols for instruments and equipment based on generally recognised standards and manufacturer's recommendationsUse of clean water for cleaning items thoroughlyMaintenance, use, and monitoring of equipment, e.g., autoclavesDiscarding items that cannot be cleaned or reprocessed adequatelyStoring reprocessed items away from potential sources of contamination59December 1, 2013
60. References - 1Guidelines for Environmental Infection Control in Health-Care Facilities. MMWR 2003; 52(RR10):1-42. http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdfOntario Ministry of Health & Long-Term Care. Provincial Infectious Diseases Advisory Committee (PIDAC) Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings, 2010. http://www.publichealthontario.ca/en/BrowseByTopic/InfectiousDiseases/PIDAC/Pages/PIDAC_Documents.aspx December 1, 201360
61. References - 2Rutala WA, Weber DJ. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Centers for Disease Control and Prevention, Atlanta, GA. http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdfSnyder, OP. Calibrating thermometers in boiling water: Boiling Point / Atmospheric Pressure / Altitude Tables. http://www.hi-tm.com/Documents/Calib-boil.html Sattar A. Allen Denver Russell Memorial Lecture, 2006. The use of microbicides in infection control: a critical look at safety, testing and applications. J Appl Microbiol 2006; 101:743-753.December 1, 201361
62. QuizDecontamination results in an item that is safe for patient reuse. True/False.Disinfection:Is used for items that will contact intact skinInvolves chemical agentsReduces the numbers of microorganismsAll of the above The most reliable means of sterilisation is:Ethylene oxideSteamDry heatPlasmaDecember 1, 201362
63. International Federation of Infection ControlIFIC’s mission is to facilitate international networking in order to improve the prevention and control of healthcare associated infections worldwide. It is an umbrella organisation of societies and associations of healthcare professionals in infection control and related fields across the globe . The goal of IFIC is to minimise the risk of infection within healthcare settings through development of a network of infection control organisations for communication, consensus building, education and sharing expertise. For more information go to http://theific.org/December 1, 201363