Sterilization RPN ppt Student Copy. 2023.pdf

Sterilization  Learning Outcomes ▪ Understand sterilization terminology. ▪ Compare and contrast sterilization and High-level disinfection methods. ▪ Apply best practices to confirming the sterility of packages, instruments and sterilization containers. ▪ Understand CJD and sterilizatio...

Sterilization  Learning Outcomes ▪ Understand sterilization terminology. ▪ Compare and contrast sterilization and High-level disinfection methods. ▪ Apply best practices to confirming the sterility of packages, instruments and sterilization containers. ▪ Understand CJD and sterilization protocol.  Medical Device Reprocessing Department MDRD ▪ Also known as Central Sterilization Department (CSD) or Central Processing Department (CPD) ▪ Imperative role to perioperative nursing care ▪ WHY? ▪ Medical Device Reprocessing Technician requires completion of a certification MDRD  Desired Patient Outcome GOAL: Freedom from Infection ▪ All sterilization and disinfection methods are monitored by hospital infection control policies and procedures in accordance with the Canadian Standards Association (CSA) ▪ Sterilization is a critical aspect of infection control. ▪ Sterilization involves the complete elimination or destruction of all forms of microbial life.  Terminology Name Definition Sterile High Level Disinfection Bioburden Spore Prion Bowie Dick Leak Test Biological Indicator Chemical Indicator Immediate Use Steam Flash Sterilization Sterilization *Sterilization methods are monitored by their ability to kill a known population of resistant spores  Environment Sterile Core (Central-Core Area) ▪ Houses sterile items, equipment, and supplies Outer Core (Outside of the Operating Room) ▪ Scrub sinks are located here ▪ Stretchers kept here ▪ Enter and Exit OR room from this door  Preparing For Sterilization Process Before the instruments go to MDRD: Instruments need to be kept as clean as possible during surgery ▪ Always cleaned with sterile water - WHY? At the end of the case: ▪ The scrub nurse will clean as much gross debris (bioburden) off the instruments ▪ Wiping or soaking in sterile water ▪ Some hospitals use an enzymatic spray (unsterile) onto instruments after the case before they are sent to MDRD  The efficacy of the sterilization or high-level disinfection (HLD) process depends on cleaning!!! Limit the amount of bioburden on an item as much as possible!  Processing Instruments and Equipment Spaulding Classification System ▪ How items are reprocessed depends on its intended use ▪ Based on the risk of infection for the patient 1. Critical 2. Semi Critical 3. Noncritical  Spaulding Classification System 1. Critical Items that are in direct contact with the sterile tissue or the vascular system i.e. – surgical instruments, needles, implants 2. Semi Critical Items that are in contact with the sterile tissues but do not penetrate mucus membranes *These instruments require HLD! i.e.- GI endoscopes, laryngoscope blades 3. Noncritical Items that come into contact with skin i.e. non-invasive monitoring, bedpans, etc.  Preparation for Sterilization ▪ Transportation of soiled instruments ▪ Decontamination – Hand cleaning – Mechanical cleaning Washer-sterilizers/disinfectors/decontaminators/ sanitizers Ultrasonic cleaners Utensil washers Example of OR → MDRD Example of MDRD Layout  Quality Control Practices ▪ Mechanical controls – Recording thermometers – Digital readouts ▪ Chemical controls – Indicators ▪ Biologic controls – Geobacillus stearothermophilus  Chemical Indicator ▪ Used to monitor the process parameters in the sterilization cycle (i.e. time, temperature, and steam) ▪ External ▪ Internal  Chemical Indicator ▪ Chemical indicators DO NOT GUARANTEE sterility. ▪ Shows the package has undergone the sterilization cycle and parameters are met ▪ These are checked and verbally confirmed by the scrub and circulating nurse.  Biological Indicator ▪ Most accurate method to GUARANTEE sterility ▪ BI Contains a known population of resistant spores ▪ This spore is resistant to moist heat sterilization ▪ It is used to test the sterilizer’s ability to destroy specific strains of highly resistant spores ▪ This test is done by MDRD daily in the first load of the day Destroying spores renders the item as STERILE!  Types of Biological Indictors ▪ Steam Pressure Sterilizer Bacillus stearothermophilus ▪ Ethylene Oxide Sterilizer (dry heat) Bacillus subtilis ▪ Hydrogen Peroxide Gas Bacillus subtilis Biological Indicator  MDRD Protocol ▪ All staff wear PPE ▪ Disassemble instruments ▪ Wash ▪ Inspect ▪ Reassemble ▪ Package (wrap) including appropriate chemical indicator ▪ Put into sterilizer  The Sterilization Process 1. Decontamination 2. Inspection 3. Testing 4. Packaging 5. Sterilization  Step 1: Decontamination ▪ Cleaning any item that comes into contact with patient or sterile field ▪ Manually: initial rinse ▪ Mechanically: Ultrasonic Washer Sterilizers - Cool rinse - Enzymatic solution soak - Detergent wash - Ultrasonic cleaning - Hot water rinse - Chemical germicide rinse - Lubrication - Drying cycle  Once decontamination occurs… Step 2: Instrument Inspection ▪ Reassembled (if required) ▪ Checked against CPD inventory – correct instrument, counted, and placed in the ‘opened’ position so that all areas can be sterilized. Step 3: Instrument Testing Step 4: Packaging *These steps are done in a clean area separate from the decontamination area.* 26 Step 5: Sterilization  Sterilization Methods 1. Steam Sterilization (Autoclave) 2. Chemical Sterilization Methods a) Ethylene Oxide (EO) b) Gas Plasma Sterilization (*Sterrad) c) Liquid Chemosterilizer: Peracetic Acid (*Steris) d) Irradiation 3. High-Level Disinfection ▪ All Methods have advantages and disadvantages  Method of Choice is Dependent On: ▪ The item itself ▪ Required equipment ▪ Cost involved ▪ Safety factors ▪ Packaging of item ▪ Length of time the process takes ▪ All have advantages and disadvantages Steam Sterilizer Gas Plasma Sterilizer Chemical Sterilizer  Steam Sterilizers 1. Gravity Displacement 2. Pre-Vacuum 3. Immediate-Use Steam Sterilization The principles of steam sterilization are the same with each but how air is removed from the chamber is how they differ.  Important Note There are three important factors to consider for steam sterilization: ▪ Moisture/steam, Heat/Temperature, Time High Temperature is required for the destruction of the microorganisms!! ▪ Instruments with lumens must be flushed with water allowing steam to penetrate and sterilize for steam sterilization  Steam Sterilizers ▪ Oldest, very safe, and economical ▪ Occurs in an Autoclave ▪ Items are exposed to direct steam contract under high pressure. ▪ Steam pressure rises, penetrates the package, and contacts the items to be sterilized (100% wet) ▪ This is the preferred method for items that are not moisture and heat sensitive.  Steam Sterilizer: Gravity Displacement ▪ Steam enters the closed chamber ▪ Air is forced to the bottom of the chamber ▪ Additional steam forces air out the drain ▪ Chamber is filled with steam  Steam Sterilizer: IUSS Immediate-Use Steam Sterilization Formerly known as Flash Sterilization NOT supported by ORNAC ▪ Used only if emergency (last resort) ▪ Shortened cycles; no drying ▪ Instruments are decontaminated and are placed in the IUSS ▪ Unwrapped items ▪ Immediate use ▪ Contraindicated for implantable devices ▪ Daily Bowie Dick Leak test is required ▪ An incident report is complete and printout is put in patient’s chart.  Bowie Dick Leak Test ▪ An air removal test ▪ Tests the ability of the Autoclave (Steam Sterilizer) to remove air from the chamber ▪ Ensures that steam is able to penetrate all surfaces of the equipment or item that is loaded into the autoclave ▪ This test is run daily before the first load of the day  5 Phases of Sterilization Phase 1 1. Packing and Loading the Sterilizer/Autoclave Wrappers: Paper, Plastic Peel Packs, Rigid Container  Phase 2 and 3: Heating and Destroying The sterilizer takes time to heat up; ▪ Exposure time for destruction of spores is 2-4 minutes if Temp is 270F (132C) and there is 27 lbs of pressure ▪ Exposure time can take 5,8,15 minutes +++ ▪ Varies depending on the item being sterilized  Phase 2 and 3 cont’d Notice the picture → ▪ This is the print out indicating the pressure, temperature, and the time the sterilization process took. ▪ These printouts are kept as records in MDRD.  Phase 4 Cooling ▪ Packs dry for at least 15- 20 minutes IN the Autoclave ▪ Packs must cool for at least 30-60 minutes, with some variance, on open racks to ensure cooling occurs without condensation resulting. ▪ What happens if packages are wet?  Phase 5: Testing Remember: ▪ Your responsibility is? ▪ External and internal chemical indicators are Scrub packed in MDRD Circulating ▪ Biological indicators are used in all autoclaves at the start of each day including the OR flash autoclave. ▪ Bowie Dick test only proves that air removal is sufficient to achieve steam penetration for sterilization.  Packaging Characteristics Types ▪ Steam permeable ▪ Double wrapping ▪ Tear/puncture ▪ Chemical indicator resistant ▪ Tape/ sticker with ▪ Aseptic delivery load control numbers possible ▪ Sterilization pouches ▪ Toxin/dye-free and ▪ Rigid containers low linting ▪ Cost effective  Storing and Expiry Time ▪ Once any item is wrapped the shelf-life sterility is event-related, not time-related. ▪ Dependent on what happens to the package after the item is sterilized.  Chemical Sterilization Methods 1. Ethylene Oxide (EO Gas) 2. Hydrogen Peroxide Gas Plasma (Sterrad) 3. Liquid Chemosterilizer: Peracetic acid (Steris) 4. Irradiation Glutaraldehyde (Cidex)- liquid – HLD ▪ All will have their own chemical indicators  Chemical Sterilizer Advantages Disadvantages Safe for heat sensitive items EO requires aeration (lengthy time) Quick turnaround (peracetic Exposures to chemical and acid) gas is dangerous Effective in destroying More expensive than steam microbes  Heat Sensitive Process ▪ This is used for materials that cannot be heat- sterilized. ▪ Chemical Sterilization is sometimes referred to as cold or low temperature sterilization ▪ Maximum temperature is 54-60C (130-140F) versus ▪ Steam sterilization at 121-132C (250-270F)  Ethylene Oxide ▪ (EO)(Gas) is used to sterilize items that are heat and moisture sensitive i.e. – flexible GI endoscopes, electrical devices, delicate instruments ▪ EO is a colorless, very toxic and flammable gas. It is considered a harmful, carcinogenic substance that is very explosive at room temperature. ▪ It is a very expensive, lengthy, and difficult process ▪ Materials must be aerated after sterilization. ▪ EO cycle requires a 3-hour exposure time ▪ The minimum time for aeration is 8- 12 hours @ 50 degrees C. ▪ Can take up to 12 hours or more a cycle! EO Sterilizer  Gas Plasma Sterilization: (Sterrad) ▪ Plasma sterilant requires Hydrogen Peroxide (nontoxic) ▪ It works by making a plasma “cloud” around the items to sterilize them. ▪ It uses lower temperatures than steam sterilizer. ▪ Cycle time: 30 minutes. (Total cycle complete in 2-3 hours) ▪ Cannot use fabric for packing items.  Liquid Chemosterilizers (Steris) ▪ Peracetic Acid is used to sterilize endoscopes. ▪ The scopes are placed in a special Steris machine. ▪ Lumens are flushed ▪ “Just-in-time” process – meaning it can’t be stored for future use ▪ The time frame is about 30 minutes ▪ The scopes come out “wet” and must be used within 1-2 hours of sterilization ▪ Print out is attached to patient record  Liquid Chemosterilizers ▪ These process if used to sterilize cystoscopes, bronchoscopes, and some endoscopes ▪ Colonoscopes and gastroscopes are currently often sterilized using High Level Disinfection (HLD) which will not necessarily kill spores.  Irradiation ▪ Type of sterilization done on large multi-use items by companies for gloves, sutures, etc. ▪ Gamma rays used to sterilize. ▪ Done outside of hospitals ▪ Items are sterile indefinitely, as long as the wrapper is not torn and intact.  Disinfection A process that destroys microorganisms through a liquid chemical or thermal process. Can be used on environmental surfaces or body surfaces Categorized in 3 groups depending on their disinfection capability Disinfectants do NOT kill spores!!  Disinfection in the OR Types of Disinfection Methods 1. Low-Level Disinfection (LLD): ▪ Kills vegetative forms of bacteria, and some viruses and fungi ▪ Used on floors and counter tops ▪ “Surface medical equipment” - BP Cuffs, Stethoscopes, SPO2 probes, ECG lead cords. Laryngoscope handles. **You will see this done in between cases in the OR 2. Intermediate-Level Disinfection: ▪ Kills most vegetative bacteria, viruses, and fungi ▪ Often used now instead of LLD disinfectants. There are microcidal disinfectants, that reduce microorganisms and are used as bactericidal agents on inanimate objects. ▪ Alcohol-Based (Chlorhexidine) ▪ Chlorine Compounds (Javex based) ▪ Hydrogen Peroxide (Cavitron Wipes) Antiseptics Antiseptics are microbial agents that are be used on LIVING tissue ▪ Chlorhexidine/ (Hibitane) ▪ Iodophors Proviodine/Betadine Also used for ________.  Disinfectants in the OR cont’d 3. High-Level Disinfectants (HLD) ▪ Kills all microorganisms except spores ▪ Destruction of bacteria is dependent on exposure time and strength of product ▪ Should be performed in a well ventilated area Glutaraldehyde Solution Dual use: Sterilizer and Disinfectant Dependent on exposure time Used for semi-critical items Chemical sterilizer: 10 hours of exposure = sterile (no spores) HLD: 20-45 mins exposure = disinfected Used for: colonoscopes, gastroscopes, and bronchoscopes  High-Level Disinfection Washer Sterilizers ▪ The most common High Level Disinfectant. It does not necessarily kill all spores. ▪ The fumes are very toxic and a ventilation hood *Remember: The ability to render an item “sterile” is its ability to destroy spores.  Review: Key Sterilization Procedures in the OR ▪ Chemical indicators appropriate to the sterilization method should be internal and external and on each item load ▪ Chemical indicators are verified by both the scrub and circulating nurse ▪ Biological Indicators are verified and documented by MDRD ▪ Maximum size for textile packs is 12x12x20 inches ▪ Packages cannot weigh more than 12 lbs (4.3 kg) or steam will not penetrate. ▪ Instruments with screws and stylets must be disassembled. ▪ Rubber items must be separated from instruments before sterilizing to prevent from sticking together ▪ Scrub Nurse is responsible for ensuring instruments are in the open position in the instrument pan ▪ Double-wrapping and fan folding of drapes must be sequential to protect against microbes (ORNAC) ▪ Lumens of instruments must be flushed with water for steam sterilization. ▪ Lumens of instruments must be dry for EO or plasma gas sterilization.  Creutzfeldt-Jakob Disease (CJD) ▪ CJD is an infectious, debilitating, and fatal neurological disease of the CNS (Human Prion Disease) ▪ Caused from self-replicating prion that affects the brain tissue ▪ Affects normal protein in the brain tissue to form abnormal folds ▪ The incubating period is months to years to decades. ▪ This prion/protein is highly resistant to conventional sterilization methods. ▪ Can occur randomly for unknown reasons. ▪ RESISTANT to sterilization methods  Special Protocol for Instrument Care After exposure; Critical devices/instruments ▪ Rinse instruments for 1 hour in alkaline cleaning agent and vaporized hydrogen peroxide ▪ Continue with normal sterilization methods If impossible to clean… ▪ Discard! ▪ Use disposable equipment if possible!!  References ▪ Rothrock, J. (2022). Alexander’s Care for the Patient in Surgery (17th ed). Elsevier. ▪ Tighe, S. (2015). Instrumentation for the Operating Room (9th ed). Elsevier. ▪ ORNAC Standards 2023