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Basics of Sterilization

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Presentation on theme: "Basics of Sterilization"— Presentation transcript:

1 Basics of Sterilization
David R. Woodard, MSc, CIC

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3 Dr. Earle Spaulding “You can clean without disinfecting, but you cannot disinfect without cleaning”

4 Decontamination Area The location designated for the collection, retention, & cleaning of soiled instruments Physically separated from all other areas to decrease risk of cross infection Air from decontam area is exhausted to the outside and not recirculated

5 Types of Cleaning Decontamination
Process that removes as many microorganisms as possible by physical, mechanical or chemical means Also known as cleaning Utilizes water, detergent and enzyme soln Enzyme separates blood, bone and tissue from instruments

6 Types of Cleaning Disinfection
Immediate state between physical cleaning & sterilization Uses thermal processes or chemical germicides

7 Manual Cleaning of Instruments
Cleaned under water with nonabrasive neutral PH detergent Low sudsing and & does not leave residue Special attention given to hard to clean areas Items with lumens are cleaned with brushes and flushed with water

8 Inspection of Instruments
Cleanliness, & absence of corrosive substances Free motion of hinged instruments-absence of stiffness Proper alignment of jaws & teeth Proper tension with closed ratchets Sharpness of blades, trocars, absence of burrs, gouges Screws and pins are clean

9 Inspection Con’t General integrity-absence of cracks, dents, chipping, worn areas Intact insulation sheathing, absence of tears Items composed of more than one part are complete & parts fit together securely Powered surgical instruments appropriately lubricated & tested for proper functioning

10 Preparation of Instruments
Remove gross soil at point of use Jaws, blades, serrations, box locks commonly retain high levels of bioburden Remove blood/tissue with water & sponge ↓number of organisms Reduces nutrient material that promotes bacterial growth Minimizes potential for environmental contamination Removes substances that damage the instruments

11 Organization of Instruments
Maximize surface area of instruments Place instruments in a mesh bottom tray to allow for full exposure of cleaning mechanism Open jointed instruments at box locks Disassemble instruments composed of more than one part Separate delicate scissors & microsurgical instruments from heavier instruments to avoid damage

12 Assembly of Items for Sterilization
All hinged instruments must be opened & secured with stringers in a wire mesh basket The weight of an instrument set should be evenly distributed to avoid collection of moisture during sterilization A towel may be positioned in the tray to facilitate revaporization of condensate Delicate instruments require tip guards/foam Count sheet in every tray

13 Packaging Materials Items must be packages in a manner that maintains their sterility Appropriate packaging material Allows effective sterilant penetration Must contain the sterility of the processed items Must allow aseptic presentation of contents

14 Paper-Plastic Package System
Allows for proper sealing to secure contents Remove as much air as possible to facilitate effective sterilization Double peel packages should be sequentially sized & sealed to allow fro proper fit of inner pouch Paper sides of both packages are positioned together to allow adequate penetration of the sterilant

15 Rigid Sterilization Containers
Reduce cost and management of waste Perforations in the lid and bottom are covered with disposable bacterial filters Filters allow sterilant to penetrate Tamperproof locks & ID labels Need to follow recommended weight, density, sterilization cycles & times & loading practices

16 Storage of Packaging Materials
Room temperature Humidity 35% to 70% High humidity Packaging may become over hydrated which can affect integrity of adhesives & seals of peel packages Low humidity Dehydration Brittle and easily tear

17 High Level Disinfection
Uncontrolled process Efficacy is directly affected by the cleanliness of the device, preparation of the device, the level of the active ingredient, temperature of solution and the exposure time Testing the solution according to directions

18 Chemical Disinfection (Cidex OPA) High Level Disinfection
Performed by submersing an item in a covered basin of germicidal solution for a designated length of time to achieve the desired level of microbial kill May eliminate many or all pathogenic microorganisms Will not kill spores

19 Disinfecting Issues Product must be: Test strips expire!
Tested once each day of use or each time used when not used daily. Changed as manufacturer requires Test strips tested for accuracy (high/low) at time of introduction to use Test strips expire! Temperature sensitive

20 Disinfection Improper cleaning and organic debris are among many factors that have been known to nullify or limit the efficacy of this process.

21 Washer Sterilizers Wash, rinse, & use gravity steam sterilization
High temps & steam leads to total destruction but they should not be considered ready or safe for patient use Must clean & remove bioburden Tissue or debris not removed during wash cycle may be baked on during sterilization cycle

22 Advantages of Washer Sterilizer
↑ penetration capability Exposure of higher temps to all surface areas Greatest incidence of microbial lethality Automatic time-released lubrication cycle

23 Sterilization The process of killing all forms of microbial life

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25 Sterilization Indicators
Class I – External, time, temp, pressure indicator, says item went through autoclave (tape, peel packs) Class II – Bowie Dick, checks for air removal Class III – Internal, time & temp, rarely used today Class IV – Internal, reacts to two or more parameters, rarely used today Class V – Integrators, melted chemical pellet, reacts to all parameters, all steam cycles Class VI – Emulating indicators, cycle specific Biological – gold standard, shows kill of organisms Class I- the package, tray, etc. went through the autoclave. DOESN’T indicate sterility. Heat sensitive tape. Class II- Bowie Dick used in vacuum sterilizers to ensure air is removed and steam is penetrating. Run each am. Class III – Checks only two parameters, time and temp, not used in healthcare today Class IV- Reacts to 2 or more parameters, rarely used in healthcare today Class V – Integrator for ALL parameters, can be used in all steam cycles, run WITH a BI. Class VI – Emulating indicator, specific ones for different cycles Biological Indicator – demonstrates kill of organisms.

26 WELCOME TO DECONTAM PASS THRU WINDOW AUTO WASHER WORK TABLE

27 WELCOME TO STERILE PROCESSING WINDOW WASHER

28 READY FOR STERILIZATION AUTOCLAVE WORK TABLES

29 WORK AREA INCUBATOR OBSOLETE EQUIP / INST COUNT SHEETS

30 Steam Sterilization Moist Heat
Most economical & efficient Rapid processing time allows frequent availability Items must be able to tolerate high temps & moisture Works with time, temperature & moisture

31 Steam Sterilization Time, Temperature, Moisture
Steam circulates within the jacket space surrounding chamber Steam enters the chamber & displaces all the air Air and steam do not mix As pressure increases, saturated steam contacts all surfaces , penetrates packages, & forces air out through a drain at the bottom of sterilizer Sterilization is initiated once all air is removed High temp of saturated steam causes microbial destruction Proper loading is crucial to allow the steam to freely circulate

32 Steam Sterilization Con’t
Temperature affects the time of exposure in that the higher the temperature, the less exposure time is required. As pressure ↑ in a closed chamber, so does the temperature If these parameters are not represented in a cycle, sterilization will not occur

33 Cycle Phases Conditioning Exposure Exhaust Drying Air removal
Load is heated to sterilization temp Exhaust Bottom drain opens and steam is exhaused Drying Dry heat revaporizes existing moisture & removes from the load

34 Proper Loading & Unloading
Prevents formation of air pockets & obstructions to the circulation of steam Proper Unloading Hot packages are allowed to cool before being handled Moisture will form upon contact and cause contamination Called strike through Do not place hot items on cool surfaces

35 Sterilization Process Monitors Chemical Monitors (Indicators)
Monitor one or more process parameters of a sterilization cycle Detects failures in packaging, loading or sterilizer function Consist of a sensitive chemical or ink dye that develops a visual change after the exposure to certain physical process conditions (temp & humidity) Placed on the outside of every package Need to be examined after sterilization & before use

36 Chemical Monitors Con’t
Internal monitors placed in the area of greatest challenge within the package Visible once package is opened Both internal l& external indicators reflect exposure of an item to one or more sterilization parameters Do not guarantee sterility If questionable, item is not considered sterile

37 Biologic Monitors Standardized preparation of known microorganisms highly resistant to a specific mode of sterilization. Their purpose is to reveal evidence of the efficacy of a sterilization cycle by utilizing a high number or resistant spores to challenge the function of the sterilizer. Most reliable monitors

38 Biologic Monitors Con’t
After cycle is complete put in incubator to observe microbial growth Negative biologic monitors contain no growth & indicates that conditions necessary for sterilization & microbial kill were met If growth detected: Notify supervisor immediately Further test & evaluate to determine viability of organisms & efficacy of the cycle

39 Biologic Monitors Con’t
Bacillus stearothermophilus Steam sterilization Bacillus subtilis Gas sterilization Impregnated on paper strips or capsules and placed within the chamber Special test packs or Wrapped in items

40 Biologic Monitors Con’t
A control biologic monitor, which has the same lot number, as the test and has not bee exposed to a cycle is also incubated and examined for growth

41 Routine Biologic Monitoring
Frequency of Use: During installation of sterilizer or after major repairs Daily in steam autoclaves Gas-with each load Any load with implants

42 Routine Biologic Monitoring
Placement: Steam In loaded chamber over drain or coolest part of sterilizer Gas In the middle of the loaded chamber Incubation: Usually 48 hours 1 hr incubation monitors available for gravity displacement steam sterilizers

43 Bowie Dick Test Daily air removal test
Insures proper function of the vaccuum and detects any air leaks Monitor is placed on the bottom rack over the drain before the first load Satisfactory test occurs when there is a uniform color change

44 Bowie Dick Test Bowie Dick (steam)
Uniform color change means OK, monitors efficacy of air removal and steam penetration, run daily before 1st load and 1 pk. per load. Also after initial instillation, relocation and sterilizer repair. 44

45 Biological Indicators
Following the autoclave cycle, the BI is placed in an incubator; also a control Length varies with the product; rapid readout 1-3 hours, or 24 hours Positive test = sterilization process has failed due to improperly processed load, failure to meet temperature or exposure parameters, mechanical problems, etc. If rapid testing is used, you can pull instruments before they are used and surgeons don’t have to be notified of failed sterilization of instruments. A major concern if instrument was used: was it an implantable? What type of surgery? Surgeon may feel that patient should be given antibiotics or just be aware and watched for signs of infection. Yellow = pus FAIL Purple = bugs killed, PASS 45

46 Ethylene Oxide Sterilization
Used to sterilize heat-labile and/or moisture-sensitive items Toxic & flammable Lengthly processing /aeration time High cost Environmental concerns

47 ETO Sterilization Gas Colorless, noncorrosive, highly penetrative
For items that are sensitive to high concentrations of moisture and/or heat Appropriate conditions of time, ( min) temp, (low) EO concentration, relative humidity (45%-74%) Appropriate aeration is required to remove residual EO

48 EO Aeration Continuous currents warm filtered air 12 hrs = 120 degrees

49 Hydrogen Peroxide Gas Plasma Sterilization Sterrad
Rapidly destroys microorganisms utilizing low temperatures without toxic residue Used for heat and moisture sensitive items Uses radio frequency energy to vaporize hydrogen peroxide Takes approximately one hour For narrow lumens that are longer than 12” or narrower than ¼ “ , a special adaptor is needed

50 Chemical Sterilization The Steris
Used on items that are heat sensitive Delicate instruments, scopes, cameras Uses a lower temperature & shorter cycles Peracetic Acid

51 Steris Peracetic Acid Sterilization “Just In Time”
Acetic acid, hydrogen peroxide, water Adversely reacts with protein & enzymes of microorganisms penetrating cell wall & causing destruction Sterilant mixes with water, which reduces concentration of the acid Takes about 30 minutes Works by time, temp and concentration

52 Immediate Use Sterilization
Only used in special situations Use open , perforated mesh bottom trays Trays with lids may impede air removal & steam penetration Gravity displacement method Disassemble all instruments Flush lumens with distilled water

53 Flash Sterilization Con’t
Parameters Simple instruments Gravity displacement 270 degrees for 3 minutes Complex instruments Gravity displacement 270 degrees for 10 minutes

54 Flash Sterilization Con’t
Several like instruments can be sterilized together More than 1 instrument tray requires 10 min Lumens must be flushed with water Trays with rubber or cloth run for 10 min

55 Flash Log The same tracking process as for items put up in CS.
Review daily for compliance Report to ICC and department of surgery at regular intervals Use to support additional sets “We need to flash the hyster tray because we only have one”

56 Issues Documentation Recalls Pt name/MR # Items in load User initials
Policies and Procedures

57 Sterility The loss of sterility is related to an event, not to time.
Germs don’t have a calendar that says – “ok it 28 days, lets contaminate the Kockers” Events – Dampness Loss of package integrity Dirt

58 Why Expiration Dates? Why are their expiration dates if we believe that sterility is event related? Commercially prepared products are tested for sterility at time intervals (the guarantee). At some point in time, they stop testing, and that’s as long as the guarantee can be made.

59 Scopes the bane of our existence
Which scope was used on which patient Cross contamination Biological Tissue Disinfection Storage

60 Problems in Ambulatory Infection Control
Many well-publicized outbreaks in ambulatory centers Two main causes: Unsafe injection practices Improper cleaning, disinfection, sterilization of instruments, endoscopes Nevada & Nebraska outbreaks resulted in criminal charges and license revocations Nevada, criminal charges

61 CMS IC Requirements Must list national guidelines being used
Follow them!  CDC/HICPAC Guidelines:  Guideline for Isolation Precautions (CDC/HICPAC)  Hand hygiene (CDC/HICPAC)  Disinfection and Sterilization in Healthcare Facilities (CDC/HICPAC)  Environmental Infection Control in Healthcare Facilities (CDC/HICPAC)  Perioperative Standards and Recommended Practices (AORN)  Guidelines issued by a specialty surgical society / organization (List) Please specify (please print and limit to the space provided):

62 CMS IC Requirements NOTE! If the ASC cannot document that it has designated a qualified professional with training (not necessarily certification) in infection control to direct its infection control program, a deficiency related to 42 CFR (b)(1) must be cited. Lack of a designated professional responsible for infection control should be considered for citation of a condition-level deficiency related to 42 CFR

63 CMS IC Requirements Prefilled syringes- single patient use
IV bags- single patient use, spike just prior to use IV tubing and connectors- single patient use Sharps safety devices, proper disposal

64 The Great Clave Experiment…
15 clave ports from 15 different hospital units were randomly selected and cultured. 11 of the 15 grew Coag-Neg Staph or Staph Epidermidis plus lots of other nasty stuff. Four cultures grew nothing… (but 2 of them were from brand new IV sets…)

65 Scope Processing Written policy and procedure for:
Immediate post-procedure cleaning, leak testing, what to do if it fails Thorough cleaning, brushing channels Proper connections for AERs High-level disinfection/sterilization Manufacturers’ written instructions


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