Chapter 10 REVIEW: The Decontamination, Sterilization, and Disinfection

Chemical Indicators

Change color when exposed to specific parameters of the sterilization process. (Temp, chemical sterilant concentration.) Placed in and out of packs to be sterilized. Must be check for color change when distributing.

Insrtuments Exposed to Prion Disease

Creutzfeldt-Jakob Disease (CJD) and Variant CJD are fatal disease caused by prions. They infect the CNS tissue. not destroyed by normal means of mechanical/chemical sterilization. Disposable supplies are used when possible in these cases. Instruments must be kept moist during procedures, prep, and transportation to decontamination. Adheres to s=dry stainless steels, but less viable in moisture. Guideline for instruments with prion contact are published by the Society for Health Epidemiology of America (SHEA) 4 reprocessing methods 1. Prevacuum sterilization at 273° F (134°C)- 18 min 2. Prevacuum sterilization at 273° F (132°C)- 1 hour 3. Immerse in 1 N NaOH - 1 hour, transfer to open pan and AutoClave - 1 hour 4. Immerse in 1 N NaOH - 1 hour, heat in gravity displacement sterilizer at 121°C- 30 min

Removing Items From (IUSS)

Do it in a way that prevents contamination of items. Circulator wear gloves, grasps tray handles, scrub takes instrument from tray, not the tray. Scrub doesn't leave sterile field to retrieve items. Allow cooling time

Storage of Wrapped Sterile Goods

Event related sterility is the accepted standard NO LONGER STERILE WHEN: - Show signs of exposure - Torn wrap - Stored location has no environment control - Transported with soiled or open system

Precautions With EO Sterilization

Exposed to gas burns skin and mucus membrane Prolonged exposure = Respiratory damage. Difficult to remove, level of residue is not the same in all material. Wear dosimeter to measure gas exposure. Goods go under aeration cycle after sterilization in the same chamber.

Sorting and Inspecting

Happens in assembly area Separate from decontamination area to prevent cross contamination. workroom has ample table space to work on. attire: scrub, jacket, head cover. Sterilizer adjacent to work area fro quick transfer of instrument sets and wrapped sets.

Central Processing Department

High Volume Processing Also called Sterile Processing Department Scrubs can fill this position Scrubs are responsible for protecting CP personnel from injury when processing instruments for reprocessing.

Immediate-Use Steam Sterilizer (IUSS)

High speed prevacuum. Used to be called Flash Sterilizer. Located in restricted sub-sterile room just outside the OR. Used only when no alternative is available.

Closed Sterilization Containers

Hold equipment for sterilizaton Safe for vapor, gas, or steam sterilization Not to be used for instrument storage in work area Check filter expiration date before hand Container should match sterilization method

Loading Sterilization (EO)

Packages centered, do not touch top or bottom of the chamber. Place package on its side Preprogrammed exposure time, temp, aeration parameter.

Cleaning

Performed by hand, ultra sonic machine, followed by automated washer/disinfector/sterilizer.

Ultra Sonic Cleaning

Removes debris from instruments by cavitation. recessed sink that is filled by water and enzymatic detergent. The Manufacturer states if it CAN/CAN'T be exposed to this method of cleaning. Open instruments before submerging. Change water frequently to avoid build up. Machine is emptied and dried daily .

The Reprocessing Cycly

Step by step procedure that requires an exact protocol. 1. Starts at point of use cleaning 2. Sorting and disassembly 3. Cleaning the instruments 4. Decontamination 5. Sorting and inspection 6. Assembly 7. Wrapping 8. Storage

Ethylene Oxide Sterilization

Used in 100% pure form blended with carbon dioxide gas, or mixed with hydrochloroflurocarbons (HCFCs) 2016 (EPA) regulated the use of HCFCs which are no longer used in the U.S. HCFC affects Ozone depletion 100% Ethylene Oxide is still used, Sterilizes items that are heat and moisture sensitive. Highly penetrating Low temperature Cold cycle = 85° F to 100° F (29° C to 37.7°C) Warm cycle = 130° to 145° F (54°C to 63°C) Requires humidity to lessen spore resistance to EO gas. 25% to 80% moister content

Vaporized Hydrogen Peroxide (VHP)

Used with or without a plasma cycle on heat and moisture sensitive items. Exposed to vacuum that creates a vaop and forced into central chamber, where the goos are loaded.

Orthiphthalaldehyde

.55% (Cidex OPA) is a non-glutaraldehyde-based, high level disinfectant that can be used on immersible medical devices. Instruments are cleaned, dried, and place in solution for 12min.

Transportation Of Soiled Instruments to Decontamination

All instruments and soiled equipment must be transported to decontamination in closed, containers, closed case cart, or leak proof bags with red/orange bio-hazard labels. Scrub must contain and transports soiled items asap.

Indicators for Steam Sterilization

-Class 1 (single parameter): these are process indicators. tape or label indicating only that an individual item in unit was directly exposed to the sterilization. -Class 2 (specialty indicator): Used for specific tests that measure parameters. (Bowie-Dick Test). -Class 3 (single parameter): includes indicators that respond to only one critical parameter with an exact value. (Heat sensitive pellet) -Class 4 (multi parameter): these are represented by multi-variable indicators that react to two or more parameters. -Class 5 (integrating parameters): This class includes indicators that react to all critical values over a specified range in the sterilization process. -Class 6 (emulating indicators): Used for internal pack control of each cycle run, not for the overall performance of the sterilizer for all cycles.

AAMI Recommended Practice for Immediate use of Sterilization

1. Never sterilize implants. 2. Follow manufacture specifications for exposure time and temperature. 3. Follow parameter specifications of container and instrument. 4. Some instruments can not go through this process. 5. sterilizers must be located in an area where unwrapped sterile items can be transported directly to sterile field. 6. items for this process are not wrapped 7. Monitors for temperature must be used with every load. 8. single use items can not be sterilized.

Guidelines for instrument Assembly

1. Open hinged instruments go on stringer. 2. Sharp instruments turned downward, can be covered with protectors. 3. Disassembles instrument should be assembled, if they come through decontamination assembled, they are not clean and need to be reprocessed. 4. Make sure instruments are not caught in the perforations of the baskets to avoid damaging them. 5. Heavy instruments go at the bottom. 6. Flush deionized (distilled) water through lumens 7. Instrument trays should not contain peel pouches, or wrapped items. 8. No elastic bands should be used. 9. No synthetic wraps inside instrument trays. 10. Power driven tools (drills, reamers) should be disassembled before sterilization.

Types of Process Monitoring Systems

3 Categories for Monitoring: Physical Chemical Biological Also called Indicators

Gas plasma Sterilization

4 Phases 1. Vacuum phase- air evacuates, which reduces pressure. 2. Injection phase- Liquid hydrogen peroxide injected to chamber, and converted to vapor. 3. Diffusion phase- Vapor disperses throughout the load, radio frequency breaks down vapor. 4. Plasma Phase- Creates plasma cloud containing free radicals and ultra violet light. compound recombined into oxygen and water and are dissipated from chamber Exposure time 30 to 60min No toxic chemicals, no aeration cycle.

Qualities and Types of Wrapping Systems

Accomplishes the following: -Allows the sterilant to penetrate wrapper -Allows complete dissipation of sterilant when process finishes -contains no toxic ingredients or non-fast dyes - No lint - Resists destruction in sterilizer - Permits complete enclosure of contents in package - Convinient to work with - Facilitates a method of opening - Cost effective - Matches the sterilization method

Spaulding Classification

Allows healthcare workers to select the exact method of reprocessing according to where in the body the item will be.

Use of Chemical Disinfectants

Categorized by chemical type. Some destroy some microbes, others destroy them all. FACTORS: -Concentration of solution -Bioburden on the object -Water hardness and PH - Presence or absence of organic matter on item.

Peel Pouch

Combo synthetic and paper wrapper. AKA: Sterilization pouches. Double sided and made from medical grade paper and transparent polypropylene-polymethylene. Comes in rolls or single use pouches. Heat seal device or self seal pouches available. Double pouching is unnecessary. Keep 1 inch barrier. Use for lightweight instruments. No air should be in bag. Check heat seal for air pockets.

High Risk

Critical items Comes in contact with sterile body tissue. EX: organs/vascular system contacted by surgical instrument.

Sterilization

Current methods: - High temperature steam under pressure - Ethylene oxide (EO) - Hydrogen peroxide gas plasma - Hydrogen peroxide vapor - Peracetic acid vapor - Ozone - Dry heat Basic criteria for method must meet safety of process, efficiency, and the economy of the product. Manufacturers recommendations for sterilization process must be followed exactly. Manufacturers liable for injury only if the products are used and reprocessed to the specifications.

DART

Daily air removal test. Wrapped towels taped with heat sensitive chemical monitor tape and stacked to a height of 10 inches (25 to 27.5 cm). Its placed alone in the sterilization chamber and processed. Unsatisfactory DART "Failures" reported to engineering staff. Failure in vacuum pump system or defective gasket.

Method of Reprocessing

Determined by what the instrument or equipment is made of and by the manufactures recommended method.

Equipment Tracking

Each package needs to be labeled with name, date of processing, lot #, batch #, initial, department of receiving package. Lot #: is all items in the same load.

Biological Indicators

Harmless bacteria encased in self contained unit. Placed in selected loads After sterilization it is retrieved and placed in incubator. Determines whether the parameters were effective in the destruction of microbes in the load. Administered at least weekly. Always use for implants or prosthesis sterilization. If the results are positive results show the whole load needs to be reprocessed starting with decontamination. Uses enzyme that binds to spores. Enzyme measured after sterilization. Used for high pressure steam and ETO sterilization. Results obtained in 1 to 4 hours. *The bacteria used during biological monitoring differs according to the sterilization - Steam: Geobacillus Stearothermophilus - Dry Heat and EO Sterilization: Bacilllus - Vaporized gas plasma: Bacillus subtilis - Peracetic acid : According to manufacturers specification. - Immediate use Steam Sterilizer: Geobacillus stearothermophilus enzyme. (fluorescence testing) - Ozone Sterilization: Geobaacillus Stearothermophilus.

Assembling Instruments Sets

Inspect instruments for soil, stains, corrosion, function, and structural soundness. After inspection instruments are stored in the repossessing area as single instruments or wrapped in sets ready for sterilization. Instruments count sheets are consulted to be sure all instruments are accounted for.

Hand Cleaning

Instruments that could be damages in automated washer are soaked in enzymatic detergent. Use warm water and enzymatic cleaner. Temp determined by the detergent manufacturer. Enzymatic detergents are deactivated at temps over 140°f (90°c) Keep instruments underwater while cleaning to avoid splashing that release airborne droplets. Scrub difficult areas with a brush. Suction tips cleared with stylet After cleaning, rinse in distilled or deionixed water to remove traces of detergent and debris.

Single-Use Non-woven Materials

Intended for one time use Material: Spun, heat-bonded fibers such as polypropylene Light weight fabrics require the same treatment as woven wrappers. (4 thickness for complete protection) Valuable for wrapping heavy items, flat basins, or trays. Don't use paper derived from cellulose because it breaks down during sterilization and makes it hard to open and distribute goods.

Cobalt-60 Raditation

Ionizing radiation sterilization. Single use items must never be resterilized, the item might change in composition or deteriorate and become hazardous.

Liquid Peracetic Acid

Liquid chemical made up of 35% peracetic acid, hydrogen peroxide, acetic acid, sulfuric acid, and water. Alternative to cold sterilization. During sterilization peracetic acid inactivates many cell systems through oxidation. Peracetic acid converts to acetic acid (vinegar) after sterilization. Doesn't leave chemical residue, but must be rinsed.

Suffix -cidal

Means to kill

Digital Monitors

Modern sterilizers provide immediate feedback of time, temp, and moisture. Recorded by printouts, gauges, digital readings. Need to know how to spot malfunction by knowing what the normal reads should be.

Wrapping Methods Using Textile

Most common methods: Envelope and square technique single wrap or double wrap according to wrapper specification Basin envelope wrapped Place surgical towel between basin and nested containers never wrap peel packs

Preparation of Items for Gas Sterilization

Must be clean and dry Water bonds with Eo gas and produces a toxic residue that causes burns or toxic reaction with those it contacts. Loaded loosely to allow gas to circulate loosely. Disassemble instruments and keep parts together. WRAPPING NOT suitable for this sterilization: -Wrappers made of natural fiber combines with nylon and rayon, polyester and polyvinyl chloride. (PVC) -Double wrapped peel pouch Follow manufacturer specifications.

Decontamination Attire PPE

Must wear PPE in this area (OSHA Regulations) Protects from infection from splashes and any skin contact. PPE Includes: Eyewear Face shield Mask Cuffed gloves Gown Shoe covers

Low Risk

NON-Critical items Contact only with intact skin EX: Blood pressure cuffs, stethoscope

Disinfection

Not sterilization because does not destroy all microbes. 2 levels 1. high level disinfection (HLD) - most effective - doesn't destroy bacterial spores - used for instruments usedin semi-critical areas of the body. EX: anesthesia equipment, Gastrointestinal endoscopes, respiratory therapy equipment. 2. Low level disinfection - performed on equipment that comes in contact with intact skin. EX: pressure cuffs, stethoscopes

Standards and Regulations

Organizations responsible for performing research or validating standards or validating standards based on evidence. These are the Organizations: AAMI AORN AST CDC CDC_HICPAC FDA ECRI INSTITUTE FDA TJC

Quality Control Monitoring

Procedures and methods for reprocessing medical devices must be monitored to ensure patient safety. monitors the technology used in reprocessing and human factors.. Monitoring means: checking recording and reporting.

Washer/Sterilizer/Disinfector

Process comes after hand washing. Has a single front load chamber or tunnel system. Load metal baskets with instruments securely to prevent damage Instruments should be opened specific detergent used Full cycle includes: Immersion in water bath and forceful water spray and possible ultrasonic phase Process basin,bowls, containers separately After cleaning and disinfecting instruments are lubricated according to the manufacturer steel instruments can be dipped in "instrument milk" (lubrication/protective)

Parameter for Steam Sterilization

Requires specific concentration of moisture. Too little moisture = Super heated item that can burn. Too much moisture = Leaves items wet and are considered contaminated. Water converted to steam @ 212° F (100° C) Steam that contains 97% water is necessary for sterilization to be achieved. Steam quality = The amount of moisture in steam.

Intermediate Risk

Semi-Critical items Used on NON-Intact skin or mucus membrane Requires high level disinfection EX: Endotracheal tubes, airways, rectal/vaginal instruments.

Reprocessing Disposable Devices

Single use, disposable, medical devices and products have come into widespread use in he last 2 decades. Has created a need for regulations and recommendations covering the reprocessing of these items.

Sorting Instruments

Sort and Break down instruments in decontamination. They are separated by weight and complexity to prevent damage or injury. Keep all instruments that are broken down with their pieces. Items grouped together by category EX: NON-Immersible, heavy instruments, basins and cups, delicate instruments. Sort, Clean, then Disinfect instruments

Special Handling of OPHTHALMIC Instruments

Special reprocessing to [revent toxic anterior segment syndrome (TASS) TASS is a condition associated with instrument reprocessing TASS PREVENTION: Wipe instruments clean with water and sponge submerse instruments in sterile water after procedure. Use single use cannulas or flush it with sterile water More on page 187 Box 10.1

Steam Sterilization

Steam enters, air is removed, internal pressure increases. Steam under pressure coagulates the nucleic acids and protein that makes up cell genetic and enzymatic material. Destroys cells resilient puter wall and bacterial spores Achieved according to temp, pressure, and exposure time. 3 Phases Conditioning Exposure/holding time Exhaust and drying 2 Types: 1. Gravity displacement- injects steam, displaces air. 2. Dynamic high vacuum- employs high volume system, quickly and forcefully evacuate air from the chamber and replace it with bursts or pulses of steam. (most common Type of sterilization). DO NOT PROCESS the following in STEAM: -Power instruments -Ones that contain optical system -Microprocessor -Synthetic materials

Safety Guidelines for Disinfection

Stored in well ventilated rooms. Containers should be kept covered. Must wear PPE when handling The dilution ratio should never be changed except by hospital protocol. Use device designated for mixing chemical. Don't mix two chemicals, could creat toxic fumes. Dispose of properly follow hospital policy Don't use if missing label and discard.

Guidelines for Storage

Stored separate from NON-sterile instruments Never store near sink Placed loosely on shelf If stored in bins they must be shallow Never stack heavy items on lighter ones. Seldom used items can be wrapped in a dust cover. inspect wrapper

Air Detection

Tests and monitors the efficiency of the high vacuum steam sterilizer, a test called DART is performed using a Bowie-Dick monitor. Air detection during exposure time.

Precautions and Hazards

Unsafe for use on human tissue and skin. don't be mislead by low/mild odor. Law requires facility to provide employees with information on work hazards. Every chemical has a material safety data sheet (MSDS)

Environmental Disinfectant

Used for routine low-level disinfection and environmental decontamination. Contains enzymes and other chemicals that destroy microbes (Denaturation) by changing cell proteins, or by drying (desiccation).

Water Quality

Water used during steam sterilization is treated to remove minerals. Contaminants remaining in the system results in instrument stains of the following color are indicators of contaminants orange, white, brown,black.

Cloth Wrappers

Woven for high quality cotton or a combo of cotton and polyester. Woven wrappers are dense to protect goods from contamination, but porous enough to allow gas/steam penetration. Thread count is at least 140 for effectiveness. One double thickness wrapper of 280 thread count is used to wrap items. laundered before use for minimum level of moisture in cloth to prevent over heating during sterilization. Inspect wrappers for integrity before sterilization.

Glutarldehyde

chemical commonly used in high level disinfectant that is sporicidal, bactericidal, viricidal. turberculocidal in 20 min. Weakened by wet instruments due to dilution. Weakened by presence or organic matter. When mixed, solution must be renewed after 14 days because it become ineffective. Evaluate frequently with test stripes. Should maintain 2% Glutarldehyde. safe levels in the air under 0.2 ppm. if more is in the air it causes irritation of the eyes and nasal passages toxic to tissue rinse instruments that have been cleaned with this with distilled water.

Ozone Sterilization

utilizes a molecular form of oxygen at low heat. For sterilization of moisture and heat sensitive instruments through oxidation. Has 4 phases Sterilizes rigid diagnostic instruments, stainless steel, synthetic substances (PVC, silicone, and polythetrafluoroethylene. (PTFE{Teflon}) Sterilization time exceeds 4 hours.