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DISINFECTION & STERILIZATION
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Outline • Cleaning & Decontamination • Disinfection • Prep & Pack • Sterilization • Terminal • Point of Use • Quality Assurance & Monitoring • Sterilization Process Failure
Good old Dr. Earle Spaulding • The selection of a disinfection or sterilization method depends on the intended use of the item. • Non-critical requires low level disinfection • Semi-critical requires high level disinfection • Critical requires sterilization
Definitions • Cleaning—Removal of contamination from an item to the extent necessary for further processing or for intended use. • Decontamination—The use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infection and the item is rendered safe to handle with the ungloved hand.
Definitions • Disinfection—The process that kills pathogenic and other microorganisms by physical or chemical means. • Low • Intermediate • High Level • Sterilization—Free from viable microorganisms. • This is actually just a probability. • Sterility Assurance Level (SAL)= 10 -6 th power, or 1: 1, 000 chance that a single viable microorganism is present on a “sterilized” item.
AORN Standards & Recommended Practices Recommendation #1 “Items to be processed should be categorized as critical, semicritical, and noncritical. ” • Non. Critical: Contact with intact skin but not mucous membranes • Clean with low-level disinfectant : kill bacteria, fungi and some viruses, won’t kill spores • Ex Alcohol, quaternary ammonium (virex)
• Intermediate level disinfection is also mainly for environmental surfaces • Used on noncritical items that have been exposed to pathogens that aren’t killed by low level disinfection. • Examples: Halogens (chlorine, iodine), Phenolics (carbolic acid) • Relatively fast acting • Relatively broad spectrum
Semi-Critical: Contact with mucous membranes or broken skin • Require high level disinfection but do not have to be sterile at point of use • Examples: Gluteraldehyde, Ortho-Phthaldehyde (OPA), Formaldehyde, Cidex OPA • All have a use life after opening package • May have an obnoxious odor • Use test strips to ensure MEC • Need proper venting • Need copious rinsing—particularly with OPA • Need documentation
Critical Items Object that carry a high risk for infection if contaminated, things that will enter sterile tissue. High level disinfection +sterilization
It all starts with cleaning • Items can’t be disinfected or sterilized unless they are properly cleaned. • AORN: “Cleaning and decontamination are the initial and most critical steps in breaking the chain of disease transmission. ” 2011 pg 401
Cleaning & Decontamination • Cleaning begins at the point of use. • AORN RP: Care of Instruments Recommendation #4— Instruments should be kept free of gross soils during surgical procedures • Use enzymatic spray at the end of the procedure
Flush lumens & cannulas!!!
Cleaning & Decontamination • Soiled instruments need to be contained and confined for transportation to the soiled utility room or to SPD.
Cleaning & Decontamination—after the procedure • The first step is to remove all visible and invisible soils • Must be done according to manufacturer’s guidelines • Neutral PH enzymatic detergent, mechanical friction • Next step is generally the mechanical washer
Cleaning & Decontamination • AORN RP: Care of Instruments, Recommendation #5— Cleaning and decontamination should occur as soon as possible after the instruments are used. • AAMI: Instruments are decontaminated within 15 -60 minutes after use.
How fast do microorganisms reproduce? ? • 12: 00 • 12: 20 • 12: 40 • 13: 00 • 14: 00 • 15: 00 • 16: 00 • 17: 00 • 18: 00 • 19: 00 1 2 4 8 64 512 4, 096 32, 768 262, 144 2, 097, 152
Final point on cleaning and decontamination • Anything that can be disassembled must be disassembled for cleaning, decontamination, and sterilization • Copious rinse with RO, DI or distilled water
What’s next? • Disinfection • Use a germicidal solution • Follow manufacturer’s guidelines regarding dilution • Must come in contact with all surfaces • Must remain in wet contact for the prescribed amount of time—read the label
Disinfection • Thermal!!! Using Mechanical Washer-Sterilizer • Washes with cold water then fills chamber with steam • Heat denatures proteins at lower temperatures if steam is present • Pressure is used to achieve temp of 270 deg. • Goal is steam saturation of 100%
Inspect & Assemble • Regardless of who is processing the instruments, they need to be inspected to make sure they’re clean and in good working order before they go into a sterilizer
Packaging • Instruments that are terminally sterilized are placed into some kind of package before they go into a sterilizer • Rigid container • Flat wrapped • Peel pouch
Sterilization • Terminal Sterilization—sterilized in a package, has a shelf life • Point of Use Sterilization—no shelf life, needs to be delivered to the sterile field at the completion of the sterilization cycle.
Steam Sterilization • Most common method of sterilization • Has been used for many years • Relatively safe • Relatively inexpensive • Can be used for the majority of surgical instruments
Steam Sterilization • Phases • Condition • Sterilize • Exhaust • Dry—needs to cool to room temperature before handling (sterility assurance and condensation) • Need to make sure all parameters for sterilization have been met prior to releasing the instruments for patient use.
Steam Sterilization • Cycle selection needs to be in accordance with manufacturer’s guidelines • Terminal sterilization cycles all take around an hour. • Common Cycles • Prevacuum 270’ 4 minutes • Prevacuum 270’ 8 minutes • Gravity 250’ 30 minutes
Hydrogen Peroxide Gas Plasma • Used for heat and pressure sensitive instruments • Relatively safe • More expensive than steam sterilization • Fast cycle times— 48 -75 minutes • Good for batteries, shavers, fiber optic scopes • Not for use with paper or cloth
Hydrogen Peroxide Gas Plasma Sterilizer
Hydrogen Peroxide Gas Plasma • Cycles: • Non-lumen: 20 -40 minute cycle for batteries & other non-lumened items. • Lumen cycle: 55 -75 minutes for items containing lumens, mixed loads, complex items • Flexible scope cycle: 75 minutes, allows for terminal sterilization of selected flexible endoscopes
Point of Use Sterilization • Immediate use steam (“Flash”) sterilization • Paracetic Acid Sterilizers • Hydrogen Peroxide Sterilizers • Automated Endoscope Reprocessors
Immediate Use Steam Sterilization • Will sterilize an item in 10 minutes. • Item will come out of the sterilizer hot and wet; • need to be transported to the sterile field at the end of the cycle in a manner that doesn’t compromise sterility • Items need to cool before coming in contact with the patient—force cooling can cause instruments to crack & break
Immediate Use Steam Sterilization • Need to review load printout to make sure all parameters for sterilization were met • Processing implants in an immediate use sterilizer should be avoided at all costs. • If using a “Flashguard” container, read instructions carefully!
Paracetic Acid Sterilizer • Steris System 1 E • Relatively safe for staff • Relatively fast— 38 -43 minutes • Sensitive to water temperature & pressure fluctuations • Use for choledochoscope, bronchoscope, etc.
Steris System 1 E
Point of Use Hydrogen Peroxide Gas Sterilization • Sterrad NX • Used for terminal sterilization of scopes • Able to use for instruments that are moisture sensitive • Cycle time: 28 minutes • Requires packaging • Chamber is small
Automated Endoscope Reprocessor • Automated equipment designed to clean, disinfect, and rinse flexible scopes • “High level decontam”, not sterile • AER’s are a chemical process; Gluteraldehyde, OPA, and Paracetic acid are the most common chemicals
Automated Endoscope Reprocessor
Sterilization Quality Control • How do I know my item is safe for the patient? ? ?
Sterilization Quality Control • Physical monitoring—instruments within the sterilizer that tell us the temperature, pressure, and duration of a sterilization cycle. • Process indicators—let us know whether or not the item has been processed
External Chemical Indicator Tape Before Processing After Processing
Sterilization Quality Control • Tamper evident device—container locks, tape, arrows • Internal Pack Control—chemical indicators placed inside the tray, let us know that several parameters for sterilization have been met
Examples of Internal Chemical Indicators
Sterilization Quality Control • Biological Monitoring—spores inside a test package that measure the lethality of a sterilization cycle • Always run a BI with implants
Biological Indicators • Contain Geobacillus stearothermophillus- Highly heat resistant, spore-forming bacteria does not produce toxins and is non-pathogenic.
Sterilization Quality Control • Bowie Dick Test—used to assure the air removal system is working properly in a prevacuum sterilizer • Daily
Sterilization Quality Control • Lot control number—includes sterilizer identification, cycle number, date of sterilization • This is how we achieve lot traceability • It’s up to the clinical staff to record lot control number in the patient’s record.
Load Control Information* Sterilizer Number S-1 L-5 05 -03 -07 Load Number Date Sterilized *Must be placed on each item Sterilized in the Central Service Department.
Sterilization Quality Control • In order for a sterilizer load to be released for patient use: • Sterilizer tests complete • Parameters for sterilization must be met • Process indicator (tape) must pass • Tamper evident devices present • Lot control present & accurate • Packages cooled to room temperature if terminally sterilized • If implants, BI must pass
Sterilization Quality Control • What can go wrong? ? ?
Parameters for sterilization not met • Parameters: Time, Temperature, Pressure, Concentration • Reprocess the load in another sterilizer • Take the sterilizer out of service until the cause can be identified and corrected • Usually something has gone wrong with the sterilizer & sometimes the plant
Sterilization Process Failure • Positive Biological Indicator • Need to recall back to the last negative biological • Take the device out of service until the cause of the problem can be identified and corrected • Most of the time it’s user error • The rest of the time it’s caused by a problem with the sterilizer or the plant
Sterilization Process Failure • Wet load/wet pack • May be inside the chamber • User error—improper loading of the chamber • Sterilizer—valve or trap problem • Plant—steam too wet • Reprocess the load in another sterilizer; take the sterilizer out of service until the cause can be identified and corrected
Sterilization Process Failure • Wet load/wet pack • May be inside the packages—can’t tell until they are opened. • Usually a condensation issue • Items moved before they have cooled to room temperature • Improper configuration of tray • Improper configuration of sterilizer load • Excessively heavy tray • Mixed metals and plastic • Trays with moisture are considered contaminated—notify SPD and replace the tray. SPD needs lot control # in order to conduct a recall
Internal Pack Moisture
Other things that can go wrong • Hole in wrapper • Items get handled many times and every time they are touched, there’s a chance the wrapper may get damaged • Lift—don’t drag • Watch out for trays that have feet or are very heavy • Rigid Container Defect • All parts have to be intact
Other things that can go wrong • Peel pack has wrinkles in the seal • Tamper evident device comes off • Indicators missing • Item falls on the floor
• Questions? ?