Association for the Advancement of Medical Instrumentation (AAMI) –
Provides recommended practices & technical information for the U.S. Medical professions
Develop standards with support of FDA
Association of Surgical Technologist (AST) –
Organization for ST’s that publishes guidelines for many practices in the area of perioperative setting
Centers for Disease Control & Prevention (CDC) –
Federal agency that provides research & protocols in all areas of public health
Centers for Disease Control & Prevention-Healthcare Infection Control Practices Advisory Committee (CDC-HICPAC) –
Federal agency that provides research & protocols in all areas of public health and infection control, including professional environment
ECRI Institute –
Research and consulting organization that applies scientific research to determine which medical procedures, devices, drugs, and processes are best for patient care
The Joint Commission (TJC) –
Accreditation agency for all health care organizations in the United States (oversees compliance with environmental and patient safety regulations and enforces compliance with standards)
Food and Drug Administration (FDA) –
Federal agency responsible for the regulation of medical devices, drugs, food, and cosmetics
Antiseptic –
Chemical that is used to remove microorganisms on the skin or other tissue
Surgical soaps and hand rubs contain antiseptic
Used to cleanse patient’s skin (animate-living surface) prior to surgery to reduce the number of microorganisms
Asepsis –
Process of using soap or hand rub to clean patient’s skin or our OR teams' hand and arms
Bacteriostatic –
Process or chemical that inhibits bacterial colonization, but does not destroy bacteria
Bioburden –
Number of live bacterial colonies on a surface at a given time before it is sterilized (refers to the degree of microbial contamination)
Biofilm –
Composed of dense colonies of microbes that are attached to surfaces
Contaminated –
Any surface or tissue that has come in contact with a potential or actual source of microorganisms
Cleaning (Mechanical Action) –
Physical removal (scrubbing or washing) of blood, body fluids, and/or gross debris from the surface an inanimate object (non-living)
Disinfection –
Process which most but not all microorganisms located on inanimate surfaces are destroyed
Chemical or physical agent used for disinfection is a disinfectant
This is only used on inanimate (nonliving) surfaces
Reprocessing –
All steps necessary to render soiled medical devices safe for use on patients
These are the steps of decontamination, washing, preparing items for sterilization, and sterilization
Sterilization –
Destruction (killing) of all microorganisms, including spores, on inanimate surfaces
Performed by steam, chemical agents, EtO gas, high-velocity electron bombardment, UV radiation, gamma irradiation
Terminal cleaning –
Process of removing organic soil from all exposed surfaces of the critical and semi-critical areas of the operating room
This is performed daily in the operating room
Signifies the end-of-day cleaning and entails a thorough cleaning of OR equipment, rooms and areas outside the OR
Terminal decontamination –
Process in which instruments and supplies are processed to ensure they are safe to handle
This is performed to ensure it is safe for the staff to handle during subsequent stages of reprocessing
Spaulding Classification System:
Allows for selection of the exact method of reprocessing according to where in the body the item will be used
Based on the level of risk for infection associated with that part of the body
Items Classified in the Spaulding Classification System that are CRITICAL are:
Items used for invasive procedures or vascular access (enter what is considered sterile tissue)
Carry high potential for causing SSI
These items must be sterilized
Examples: Instruments or devices that enter the vascular or urinary systems (vascular and urinary catheters), implantable items, needles
Items Classified in the Spaulding Classification System that are SEMI-CRITICAL are:
Items that come in contact with mucous membrane or nonintact skin
Carry a lesser risk of infection due to properties of resistance of the intact mucosal lining
High-level disinfectants should be used for items in this category, but sterilization may also be preferred following decontamination (EGD)
Examples: laryngoscopes, bronchoscopes, anesthesia and respiratory equip (ETT), some endoscopes
Items Classified in the Spaulding Classification System that are NON-CRITICAL are:
Items that come in contact with intact skin and clean environmental equipment
Does not come in contact with mucous membrane
Pose least risk of infection
Require either intermediate- or low-level disinfection
Examples: blood pressure cuffs, tourniquet cuffs, pulse oximeters, stretchers, or other furniture
High Level Disinfectant:
Effective against all microorganisms except spores
If the instrument is soaked for 10 hours, it is considered sterile
Intermediate Level Disinfectant:
NOT effective on spores
Used on instruments that come in contact with skin
Low Level Disinfectant:
Used on non-critical items, come in contact with skin and environmental surfaces
These factors affect disinfectant efficiency:
Concentration level, bioburden, contact time, physical factors of the solution (i.e. temperature of solution, water hardness, pH level, exposure time)
Glutaraldehyde (Cidex) 2% concentration:
HLD (20 minutes) that could become a sterilant (10 hours)
One of 3 methods that is used to sterilize scopes (Others are EtO and Steris/Peracetic Acid)
Sodium Hypochlorite (Bleach):
Used on surfaces, floors, and equipment
Quaternary Ammonium Compounds (Quats):
Bactericidal, fungicidal, and psudomonacidal
NOT sporicidal, virucidal, or tuberculocidal
Isopropyl and Ethyl Alcohol 60-70%:
Tuberculocidal, bactericidal, viricidal, and fungicidal
NOT sporicidal
Used for cleaning and disinfecting small, noncritical surfaces
NEVER used to clean an endoscope because it breaks down the glue that holds scope camera in place
Decontamination Area:
Never put in the same room as processing
Filtered air is exhausted outside the facility
Minimum air exchange 10 times per hour in decontamination area
Temp 64°F-70°F and humidity 35%-72%
NEGATIVE AIR PRESSURE (not pushing contaminated air out)
Cleaning solutions which may be used for soaking instruments:
Sterile (distilled) water
Enzymatic solution
Detergent solution
Advantages and Limitations of Sterile Water:
Advantages: Keeps organic debris moist
Disadvantages: Ineffective in softening or removing dried debris
Advantages and Limitations of Enzymatic Solution:
Advantages: Removes moistened and dried debris without the need for mechanical action
Disadvantages: Efficiency depends on concentration of solution, temperature, and contact time
Advantages and Limitations of Detergent Solution:
Advantages: Keeps organic debris moist, while loosening dried on debris
Disadvantages: Mechanical action is necessary to completely remove soil
Recommendations for Transporting Instruments to the Decontamination Area:
Place heavy instruments on the bottom of a trays
Instruments with ring handles should be unratcheted
Instruments with multiple parts should be disassembled
Place instrument trays into or on case cart and transport to decontamination room
Can use a table and wrap with table drape
CANNOT transport uncovered – potential for environmental contamination
Chelation:
The process of binding minerals, such as iron or magnesium, in the solution to prevent deposit on the surface of surgical instruments, which causes spotting
Enzymatic:
Catalysts that aid in breaking down organic soil such as blood and tissue into solution
Used as a soaking solution
Emulsification:
Action of dispersing two liquids that are not capable of being mixed
Solubilization:
Action by which the solubility of a substance is increased within a solution
Ultrasonic:
Cleaning solutions are manufactured specifically for use in ultrasonic cleaners
Manual Detergent:
Products usually used for hand cleaning of items and/or for presoaking
Washer Decontaminator:
Liquid solution that is available in three different pH levels
Neutral-pH product:
Least corrosive, less effective at removing organic soil
Moderate-pH product:
Low level of alkaline and may be combined with surfactant and chelating agents
High-pH product:
Most effective for removing heavy amounts of soil
Steps of the Instrument Cleaning Process:
Transport to decontamination
Sort instruments by type and weight
Disassemble (if necessary)
Soak with water plus enzymatic solution, followed by disinfection
Sterilization
Rinse
Lubricate
Dry
Inspect and Reassemble
Package and Prepare for Sterilization
Mechanical Decontamination:
The physical removal of blood and body fluid from inanimate objects
Recommendations for Preparing Instruments for Decontamination in a Machine:
Instruments must be placed into a perforated or wire mesh tray
Hinged instruments must be left in open position to allow water, cleaning agent, and steam to contact total surface area
Instruments with attachments must be disassembled
Instruments with concave surfaces should be placed up-side down to allow proper cleaning, rinsing, steam contact, and drainage
Washer-Decontaminator:
Does not incorporate a sterilizing phase
Items exposed to intermediately critical area
Surgically Clean:
Instruments and equipment that is mechanically cleaned and chemically disinfected, but not rendered sterile
Washer-Sterilizer:
Includes steam sterilization cycle, but not considered appropriate for use on patient (not sterile)
Put like metals together to avoid electrolytic conduction reaction (DO NOT let different types of metals touch)
Ultrasonic Cleaner:
Removes small organic particles (debris) from areas of instrumentation that manual or mechanical cleaning cannot reach
Uses cavitation to clean areas
Causes bubbles that implode
Used for delicate instruments
Items requiring special care:
Items with lumens
Powered instruments
Oil powered instruments according to manufacturer’s recommendations
Ridged endoscopes
Flexible endoscopes
Lubrication:
Last step before instruments are reassembled and prepared for sterilization
Surgical instruments must be lubricated to maintain optimal function
Process is commonly referred to as milking
Prior to the first procedure of the day:
Clean all surfaces in the OR
Damp dusting begins with the highest surface
Pads are removed when cleaning the OR table
OR table should be unlocked and moved to facilitate mopping
Intraoperative Decontamination Practices in the OR:
Basin with sterile water should be used for soaking and cleaning instruments
Instruments not cleaned easily should remain in sterile water to prevent drying of the blood if not used again during the procedure
Instruments with a lumen should periodically flushed with sterile water to prevent clogging
Areas that are Terminally Cleaned:
Substerile room
Stretchers
Scrub sinks
Hallway floors
Packaging Material Must Have the Following Performance Characteristics When Used for Sterilization:
Efficiency
Ease of opening
Sterilization suitability
Strength
Barrier efficiency and support impermeability
Seal integrity
Safety
Sterility maintenance
Woven textiles:
Cotton or cotton-blend
Reusable fabric
Double-ply required when wrapping trays to be sterilized
Economical, reusable, easily penetrated by sterilants
Absorbent material may absorb moisture during steam sterilization, which inhibits the necessary contact of the moisture with all surface areas of the items
Not recommended for use with EtO
Must use heat seal patch to fix holes
Woven textiles with barrier properties:
Do not absorb moisture
Muslin:
Made of cotton
Have a thread count 140 - unbleached
Available in single or double ply
Double ply required for sterilization
Have to rehydrate muslin to prevent superheating of fabric, even if it was not used
Must use heat seal patch to fix holes
Nonwoven Materials:
Disposable, thus commonly referred to as disposables
Includes items such as drapes and gowns
Excellent barrier properties
Lint free, impervious to moisture, tear resistant
Costly, as they are single use items and not as “memory-free” as woven materials
Paper Materials:
Nonwoven material that is easily penetrated by steam; single-use items
Does not have the flexibility of other nonwoven materials, becomes brittle in dry conditions, easily torn and ruptured
Peel Pack Pouches:
Paper-plastic and Tyvek-plastic
Must ensure all air is forced out prior to sealing
Never staple or rubber band together
Rigid Instrument Containers:
Provide containment
Provide assurance of sterility
Can be used for returning contaminated items
Disposable chemical indicator use
Available in a variety of sizes and designs
Should not exceed 25 lbs
General Principles of Packaging:
After laundering, woven fabrics should be stored for at least two hours at a t emperature of 64-72°F and h umidity of 35-70%
Recommended size: 12 inches high x 12 inches wide x 20 inches long
Linen packs should not exceed 12lbs
Instrument trays should not exceed 25lbs
Preparation for sterilization of instruments begins after decontamination and involves the following steps:
Inspection (Includes demagnetizing needle holders)
Reassembly
Preparation
Functional Testing Guidelines for Instrument Inspection:
Cutting edges of scissors
Instruments ratchets
Jaws or clamps
Needle holders
Forceps
Self-retaining retractors
Non-disposable trocars
Powered instruments
Preparation of Instrument Trays for Sterilization:
Items must be properly prepared for effective sterilization
Proper preparation will ensure that:
Sterilant contacts all surface area
The instruments are positioned in a protective manner until they are used
The instruments are evenly distributed
Power driven instruments should be disassembled before steam sterilization process
Basins sets should have a towel placed between the nested basins to:
Absorb the condensate
To aid in air removal
To create an adequate space for the penetration of steam
Specialty Procedure Trays:
Surgical instruments may be prepared for procedures on trays that are designated for a specific procedure
Examples: Cut-down trays, Suture trays, Tracheotomy/tracheostomy trays
Label information:
Package contents
Shelf-life indication
Date of sterilization
Identification of the sterilizer
Cycle or load number
Initials of person preparing package
Department to which the package is to be returned to
Sterilization:
The compete destruction of all living organisms in or about an object
Process that assures all microorganisms, including spores, are killed
Complete Destruction of All Living Organisms in or About an Object can be Accomplished with the Use Of:
Steam
Chemical agents
High-velocity electron bombardment
Ultraviolet radiation
These processes are monitored using mechanical, chemical, and biological indicators to ensure sterility
Steam Sterilization:
Utilizes moist heat in the form of saturated steam under pressure within an enclosed environment
Most common thermal sterilization method and most dependable method of sterilization
BIOLOGICAL INDICATOR IS GEOBACILLUS STEAROTHERMOPHILUS
MINIMAL TEMPERATURE FOR THERMAL DEATH (kill bacterial spores) is 121°C / 250°F
Five Factors Critical to the Outcome of the Sterilization Process:
Time - Length of time the sterilant must remain in contact with the items to render them sterile
Contact - Sterilant must have contact with all surfaces of the items in order to render them sterile
Temperature - Must be achieved in order to kill all microbes, including spores
Moisture (humidity) - Specific amount of moisture that must be present to aid in the destruction of microbes
Pressure - Increases the temperature of steam to the level where it can destroy all microbes
Gravity Displacement Sterilizer Cycle Includes:
Condition Phase
Exposure Phase
Exhaust Phase
Dry Phase (REQUIRED)
Gravity DIsplacement MINIMUM Exposure Standards:
Instrument set, wrapped – 250°F for 30 minutes
Instrument set, unwrapped and Set with no lumen instruments – 250°F for 15 minutes; 270°F for 3 minutes
Set with lumen instruments, and Instruments with tape – 250°F for 20 minutes ; 270°F for 10 minutes
Prevacuum Steam Sterilizer (Dynamic Air Removal) Cycle Includes:
Air Removal Phase
Conditioning Phase
Second Air Removal Phase
Exposure Phase
Exhaust Phase
Drying Phase (REQUIRED)
Prevacuum (Dynamic Air Removal) Minimum Steam Sterilization Exposure Cycle Standards:
Instrument set, wrapped - 270°F for 4 minutes
Instrument set, unwrapped and Set with no lumen instruments - 270°F for 3 min
Set with lumen instruments - 270°F for 4 min
Bowie-Dick Test:
Test used in the prevacuum sterilization cycle to check for air entrapment
NEVER performed on a gravity displaced sterilizer, ONLY on dynamic air removal sterilizer (prevac)
Immediate Use Steam Sterilization (IUSS):
Items to be immediate-use steam sterilized must be decontaminated and cleaned with detergent and water
Only used when no other method is available
Implants are NOT flash sterilized except in an emergency and must be monitored with a Biological Indicator control system
IUSS Exposure Cycle Standards:
Metal, nonporous, and no lumens - Gravity 3 minutes; Prevac 3 minutes
Metal, porous, with lumens - Gravity 10 minutes; Prevac 4 minutes
Gravity Sterilization Exposure Temperature, Pressure, and Time:
250°F – 275°F (121°C – 132°C)
15–17 psi
Minimum exposure time – 15 minutes
Prevacuum/Dynamic Air Removal Sterilization Exposure, Temperature, Pressure, and Time:
270°F – 276°F (132°C – 135°C)
27–30 psi
Minimum exposure time – 4 minutes for wrapped items
Class 1 Chemical Indicators:
External and Process indicators
Examples: Tape, paper indicator strips, labels, locking devices (arrow)
Class 2 Chemical Indicators:
Indicators used for specific tests
Examples: Bowie-Dick, DART
Class 3 Chemical Indicators:
Variable indicators
Example: Heat-sensitive pellet encased in a glass tube
Class 4 Chemical Indicators:
Multivariable indicators designed to react to two or more parameters of sterilization
Example: Paper strips
Class 5 Chemical Indicators:
Integrating indicators designed to react to all sterilization parameters
Most accurate (exacting) of the internal chemical indicators
Example: Biological Indicator
Class 6 Chemical Indicators:
Emulating indicators
Example: Internal pack control of each cycle run
Incubation Periods for Biological Indicators:
Steam Sterilizers – Recorded at 24 hours, rapid read at 3 hours
EtO Sterilizers – Recorded 48 hours, rapid read at 24 hours
Ethylene Oxide (EtO):
Used to sterilize items that cannot tolerate the heat, moisture, and pressure of the steam sterilizer
Must remain in an aerator for 8 hours at 140°F or for 12 hours at 120°F
Temperature Range: Cold 85°F – 100°F; Warm 130°F – 145°F
2-3 hours for sterilization cycle
BIOLOGICAL INDICATOR IS BACILLUS ATROPHAEUS and BACILLUS SUBTILIS
One of three methods recommended for sterilization of endoscopes (others: Cidex [Glutaraldehyde], Steris/Peracetic Acid)
Hydrogen Peroxide Gas Plasma (Sterrad):
Uses gas at low temperatures to sterilize heat or moisture sensitive materials
Cannot be used for narrow lumens or long cannulated instruments
Cycle time ranges from 28-38 minutes
Biological Indicator is Bacillus atrophaeus
The minimum amount of air exchanges per hour in the OR is:
20 per hour
(4 of the 20 are fresh air)
Peracetic Acid Sterilization (Steris):
Kills by oxidation to denature proteins
One of 3 methods to terminally decontaminate endoscopes
Items cannot be stored following sterilization; THEY DO NOT MAINTAIN STERILITY IF THEY ARE NOT USED IMMEDIATELY
Ionizing Radiation:
Uses Cobalt-60 radioactive isotopes
Primary Source of risk to the Patient of SSI are:
Endogenous flora encountered in contaminated procedures (Ex. Bowel case with spillage, appendix rupture during removal, cutting into the bladder during a C-section
Risk to the patient of developing and infection postoperatively may be influenced by:
Age
Obesity
General health
Carriers of S. aureus
Remote infections
Preoperative hospitalization
Preexisting illness and related treatment
Surgical Conscience is:
The basis for the practice of strict adherence to sterile technique by all surgical team members
Three Principles of Asepsis:
A Sterile Field is Created for Each Surgical Procedure
Sterile Team Members Must be Appropriately Attired Prior to Entering Sterile Field
Movement in and Around the Sterile Field Must Not Compromise the Sterile Field
Surgical gown is considered sterile where:
In front of gown, 2 inches below the neckline to table level (OR table, not back table), and sterile gloved hands and gown sleeves up to 2 inches above the elbows
A draped patient is considered the ______ of the sterile field during the surgical procedure
Center