RURAL HOSPITAL

High and Low Temperature Sterilization


Presented by:

Lihua Song - OZONE /GRAVITY AIR DISPLACEMENT STERILIZATION
Lester Fong - ETHYLENE OXIDE
Jennifer Humiwat - STERRAD
Grace Di Cosmo -DYNAMIC AIR REMOVAL STEAM STERILIZER
Gina Dinu -DRY HEAT STERILIZATION
Augustine Thomas -WEB DESIGNER
Shelly-Ann Pollard - PRESENTER

LOW TEMPERATURE STERILIZATION-OZONE


OVERVIEW

Ozone is a powerful oxidizing agent which is a relatively new low temperature sterilization method available to healthcare facilities

Normal cycles:

1.       Preconditioning
2.       Preheating
3.       Add moisture
4.       Vacuum
5.       Humidification
6.       Inject ozone and allow to sterilize by oxidation
7.       Repeat steps 4-6 once 
Correct loading procedure: 

  • Avoid overloading and stacking it will prevent the sterilizing agent from reaching all surfaces of the instrument
  • Avoid contact with chamber walls 
  •    Use dividers, pins, mats when needed to secure instruments in place to avoid damage during sterilization 
  •      Pouches should be placed on edge in wire basket

Routine Monitoring: 

  • ·         Physical monitors: time, temperature, O3 concentration and relative humidity
  • ·         Chemical indicators: inside and outside
  • ·         Biological Indicators: every load 
TROUBLE SHOOTING:

1. The lamp cartridge indicator light on the front of the unit which should remain ON while the unit is operating.

2. The sound or vibration on the aquazone, purifier which would indicate that the air pump is working.

3. Ozone bubbles in the water

4. When the indicator light is off
  • -Check GFCI to see if it has tripped
  • - check lamp connection, for blown lamp or power supply.
5. When Ozone not present in water
  • - Check for filter because a dirty filter will cause a low flow of ozone.
  • - Check for clogged jet, block check valve
  • - check diffuser stone to see that it has not been fouled
6. When cloudy water with ozone present
  • - Check ph balance, clean filter, drain and tanks
  • - Use shock treatment to read water excessive contaminants 

OTHER INFORMATION
  • Uses O2, purified water and electricity
  • Safe for staff and environment
  • Process time 4 1/2hrs. at 35C(only one cycle)
  • Lumen restrictions (12" x 1/4")
  • Anodized rigid containers have been approved

** CAUTION: UNLOADABLE**
·         Natural rubber
·         Latex
·         Textile fabric
·         Copper, brass, bronze, zinc, nickel
·         Implants
·         Flexible endoscope
·         Glass or plastic ampoules
·         Liquid
·         Packaging that creates a solid barrier such as hermetically sealed packs
·         Rigid anodized aluminum 


LOW TEMPERATURE STERILIZATION-STERRAD(ASP)



OVERVIEW
STERRAD (ASP) sterilizer can process many of the items you commonly sterilized as well as instruments that are sensitive to heat and moisture.
  •  Fiber optic light cables
  •  Rigid  endoscopes
  •  Forceps

5 Phases
  •  1.       The vacuum phase- the chamber is evacuated, reducing internal pressure in preparation for the subsequent reaction.

  • 2.       The injection phase- a measured amount of liquid peroxide is injected into the chamber, evaporating the aqueous hydrogen peroxide solution and dispersing it into the chamber, where it kills bacteria on any surface it can reach.

  • 3.       The diffusion phase- the hydrogen peroxide vapor permeates the chamber, exposing all load surfaces to the sterilant and rapidly sterilizes devices and materials without leaving any toxic residues. At the completion of the phase, the chamber pressure is reduced and the plasma discharge is initiated.

  • 4.       The plasma phase- an electromagnetic field is created in which the hydrogen peroxide vapor breaks apart, producing a low-temperature plasma cloud that contains ultraviolet light and free radicals. Following the reaction, the activated components lose their high energy and recombine to form oxygen and water.Phase 1, 2 and 3 are then run a second time for added efficacy. This built-in reprocessing assures optimal sterilization for even the most difficult to sterilize devices.

  •  5.       The vent phase- the chamber is vented to equalize the pressure enabling the chamber door to be open. There is no need for aeration or cool- down. Devices are ready for immediate use.

LOADING PROCEDURE:
 
  •    First load of the day must include a Biological Indicator.
  •    Place peel pouches loosely on edge, arrange them so that the transparent side of a pouch faces the opaque side of the next pouch. Do not stack pouches on top of the other.
  •   Arrange the items in a tray to ensure that the hydrogen peroxide and plasma can surround them. Do not stack basins within the trays. 
  •    The sterrad should only be loaded with items and instruments as per manufacturer’s recommendation.
  •   When loading ensure that nothing touches the walls of the chamber. 
  •   Place trays flat on the tier shelf. 
  • CSD technicians should consult the MSDS when handling H2O2 cassette and chemical indicator    to prevent burning accidents. 
  •   The load must not project above the top or beyond the edge of the two- tier. 
  •  Provide at least 25mm (1inch) of space between the electrode and the top of the load. 
  •  CDS technicians should wear PPE.
CAUTION: UNLOADABLE ITEMS
  • Liquid, powder, linen, cellulose, paper, towels, devices with channels or lumens longer than 31cm or narrow than 6mm.
  • Foam pads in instrument trays
PROCEDURE FOR MONITORING:
  
  1.        Physical Indicator -  it is achieved through the use of microchip that is installed in the machine. This processor monitors the cycle during sterilization and provides a read out at the end. During the cycle the machine will be cancelled if the parameters of proper sterilization were not met.
  2.   Chemical Indicator – are used on the outside to signal that the pack has been processed and inside to measure efficacy of the sterile penetration of the package.
  3.     Biological Indicator – it is most commonly used and it should be placed in the first cycle of each day. It is used to indicate that microorganisms like spores have been destroyed.

TROUBLESHOOTING: 
  
  1.     Reset barcode
  2.       The system store barcode information in a file called a buffer. It retain too much data and produce a false bar-code error.
  3.    If you have inserted two new cassettes and received a barcode error messages, you should,-Access the cassette functions Press reset if successful and run a cycle as usual-If the reset is unsuccessful, there is a problem within the system. Many systems messages are the result of problems with the materials in the load.
  4. If you received error messages, be sure to inspect the load be sure to replace all the cycle indicators and Biological indicator

By products of plasma sterilization are primarily water and oxygen and because these by- products are harmless there is no need for aeration or environment hazard concerns.

LOW TEMPERATURE STERILIZATION-ETHYLENE OXIDE (ETO)


Sterilizer
Aerator

THE ETO SYSTEM 

OVERVIEW

Ethylene oxide(ETO) has been the primary sterilant of choice for items that cannot tolerate steam steam sterilization.It has an exceptional ability to penetrate and compatibility with numerous materials that provide broad sterilization applications.ETO uses a process call Alkyation where it destroys microorganisms by preventing it from normaly metabolizing or reprducing.

The ETO STERILIZATION CYCLE CONSISTS OF THREE STAGES.

The first stage is preconditioning stage to make the microorganisms grow.The batch goes through a dwell time under a controlled environment of temperature and humidity.

Second stage:sterilization

A heating jacket is used in this cycle to keep a accurate temperature control. After the doors are locked the cycle starts and goes through a numerous of phases which are
  • Cycle start delay to enable the system to start in stable conditions
  • General cell temperature check
  • Initial vacuum phase
  • Leak rate test
  • First flush
  • Second flush
  • DEC (Dynamic Environmental Conditioning)
  • ETO gas injection
  • sterilization dwell time period under Eto
  • Post dwell vacuum level
  • First wash
  • Second wash
  • Final air admission
  • Final chamber re-evacuation delay
 During these phases a batch report will be generated which includes tolerance ckecks,phase changes,alarm and critical process values. If any abnormal conditions occur the batch will automatically
stop and cause of stoppage will be identified. If there is no stoppage it will automatically carry on to the degassing stage.Batch files includes batch ID,Customer name,product type,start and stop times.

Final stage Degassed stage
In this stage the product goes through a dwell time in a temperature controlled environment to 
rid of any ETO residue(aeration).

LOADING 

  • Items must not overload because it will impede proper air removal,load humidification sterilant, sterilant penetration, and degassing.
  • Items must be properly spaced and do not stack.
  • Metal does not absorb ETO therefore it is ideal to use metal carts or baskets
  • Make sure items do not come into contact with chamber walls

UNLOADABLE

  • Liquids should not be combined with ETO as it will produce harmful chemical by products.
  • Leather items should not be use with ETO because if combined chemicals in the leather may produce chlorohydrins.
  • Excessively wet items should be avoided because ETO is unable to penetrate water layers.
     

MONITORING

Personal monitoring-involves the use of devices affixed directly to the employees clothing.
Area monitoring-that provide real-time,and continuous monitoring of airborne.

Sterilizer Performance Monitors

Physical indicators- Is  what you can see on the system itself on the screen.Eg.pressure gauges,timing
recorders charts and more


Chemical indicators(CI)- Should be placed in every load inside the pack in the center.This will show if all parameters have been met.


Biological indicators(BI)- Here we use a spore called Bacillusatrophaeus. If the cycle is capable of killing this spore then it is a successful cycle.




OTHER INFORMATION:
  • sterilization by alkylation - 3 hrs
  • aeration - 12 hrs at 120 F or 8 hrs at 140 F
  • humidity 50 %
  • BI placed in the center of the load


      =============CAUTION===============                 

  - ETO KNOWN AS CARCINOGEN
     - CAN CAUSE DIZZINESS,VOMITING
        RESPIRATORY IRRITATIONS,NAUSEA     
  













     

HIGH TEMPERATURE- DRY HEAT STERILIZATION

OVERVIEW
  • Dry heat  used for sterilizing items that cannot be processed through steam sterilization.Functions differently from moist heat (steam). Generally requires a high temperature setting than other sterilization methods.Slow acting agent.There are two types,Gravity convention and Mechanical convection.
NORMAL CYCLES
  • Accomplished by a method called conduction
  • Conduction process: the heat is absorbed by the exterior of an item is passed inward to the next layer allowing the saturation of heat to the entire item.
  • The process depend on the right temperature time,how well the heat penetrates the packages,the bio-burden that is associated with the product and free circulation of hot air throughout the chamber

LOADABLE ITEMS
  •  Oil and powder
  • Gauze impregnated with oil
  • Needles

LOADING PROCEDURES
  • Manufactures instruction must always be followed
  • All items must be clean and free of soil prior to loading
  • The chamber must be never be overloaded,and ample space must be allowed between each item.
  • Packages should not touch the chamber walls.
  • The quantity of a liquid (oil) or powder to be sterilized should be limited to that required for a single-use application.
  • Only heat resistant items loaded
  • Gauze strips should be placed in a stainless steel container and covered with petroleum jelly .
  • Glass syringes and needle must be thoroughly dry,and may sterilized fully assembled
  • Instruments must be thoroughly dry. The ratchets and box locks may be closed.
  • Technicians should always use insulated gloves,when removing items packs from the machine.
  • It is recommended to let items cool before removing.
CAUTION: UNLOAD ABLE ITEMS
  • Fabric
  • Rubber items
  • Delicate items that cannot go through hot air
  • Disposable rubbers

PROCEDURES FOR ROUTINE MONITORING
  •  Indicators are used to determine the progress of each load

THE PROCESS INDICATORS
  • Helps confirm that packages have been properly exposed to the sterilization process
  • May be the first sign of processing error
  • Internal and external types of processing indicators

THE CHEMICAL INDICATOR
  • Visual evidence of the successful completion of a sterilized process
  • Provide instant result and are usually the performance test the users see upon opening a sterile package
  • The biological indicator is placed in the center of every load pack. The type of BI is Bacillus atrocious

TROUBLE SHOOTING INFORMATION
After a major repair to a dry heat sterilizer, three consecutive test cycles with a process challenge device (PCD ; previously known as a BI challenge test pack) should be run immediately after on an empty chamber

OTHER INFORMATION
  •  sterilization is a minimum of 320F (160C) for 2 hrs
  • up to 250F for 6 hrs; 356F for 1/2 hr

Packaging materials
  • Heat resistant glass
  • Stainless steel trays
  • Aluminum foil
  • Nylon film
  • Cellophane
Metal instruments represent ideal for dry heat sterilization because of the heat conducting properties of metal

MAINTENANCE
  • Keep the over clean
  • Check the temperature gauge regularly using appropriate thermometer and checking the gauge vs the thermometer
  • It is mostly used in industry



HIGH TEMPERATURE-DYNAMIC AIR REMOVAL STEAM STERILIZER


OVERVIEW

Dynamic air removal stream sterilizer (Pre -Vaccum) is a high volume processing of heat and moisture. Stable materials such as fabrics and wrapped hard goods

NORMAL CYCLE 

Conditioning (Air removal);  At the beginning when the door closed, the doors gasket forms and maintains a high seal to prevent steam from escaping air from entering.

Exposure(Sterilization);As steam continues to enter the sterilizer chamber that is now a closed space. The pressure begins to rise as does the steam temperature. After the needed temperature is reached the sterilizers control system begins timing the cycles exposure phase.

Exhaust; At the end of the exposure phase, the chambers drain is opened and the steam is removed through the discharge line.

Drying; The drying begins at the end of the exhaust phase when packaged items are in the load, if not the contents will be wet and they will be considered contaminated.

MONITORING FUNCTIONS

                                         Physical monitoring of the machine

Bowie Dick Test(D.A.R.T)-It is used to detect air leaks and identify ineffective air removal.It is the first test done at the beginning of the day,on an empty load.Above the drain on the bottom shelf ( the coolest part of the machine).
Leak Test- In this cycle, the sterilizer automatically checks for vacuum leaks in the piping and door seal.It is used for testing the vacuum integrity of the sterilizer. A vacuum leak test cycle should be run on the sterilizer at least once a week, it should be one of the first cycles run for the day.
Biological Monitoring-BI test packs are processed to ensure that microorganisms contained in the pack are really dead.The  spore that should be used for this testing is Geo-bacillus stea rothemophiles.BI done in a full load-once a day.
Chemical monitoring-Gives immediate visual assurance that the item has been through the sterilization process.Eg: Autoclave  tape/chemical indicators.
Mechanical Monitoring- Machine print out, gives assurance that all parameters were met:Temperature 270F,Exposure time 4 min. Drying Time 30 min

TROUBLE SHOOTING
    • Wet packs - Incorrect loading of the sterilizer.
                         - Incorrect packing materials or method

                         - Sets of trays are to heavy
CAUTION: 

  •  wrapping instrument trays to loosely will cause the instruments inside to move around to much
  •  wrapping instrument trays too tightly will cause strike through
  •  peel pouches must be sealed properly, arranged paper to plastic never plastic to plastic or paper to paper when loading them for sterilization, this will not allow proper penetration of steam sterilization and will cause moisture build up in the pouches.
  • specific felt markers must also be used for peel pouches,and never write on the paper part of the pouch. This will cause strike through and render the pouch contaminated.


   At the end of each sterilization load, it is important to keep and log all of above information for
   accountability. and to provide sterilization records,if a recall is necessary or an audit is required                                                                                        

LOADING PROCEDURES 

-Place all packages on edge and arrange load to allow for maximum  steam exposure.
-Do not overload ,this will not allow proper steam penetration between items properly.
-Avoid contact of load components with the wall of the chamber (if this happens it will result in tearing of  the instruments sets)

Rigid containers

-Rigid containers should be placed flat with a small space between each container
-Containers should not be stacked unless the manufacturer specify

Textile packs

-Should be placed on their side to help air removed and steam penetration
-Textiles should be vertical in relation to cart.


UNLOADING THE STERILIZER

-Open sterilizer door once load is finished, do not remove cart from the machine, this will allow sterile
   packs to dry completely.( Although this practice has come into question)
- Once the items have reached room temperature carefully remove items from cart
-Move items to storage

                                                                CAUTION 
   REMOVE CART FROM THE MACHINE USING PROTECTIVE GLOVES TO
   GUARD AGAINST BURNS




HIGH TEMPERATURE-GRAVITY AIR DISPLACEMENT STERILIZERS

OVERVIEW
  • Type of  steam sterilization
  • Slowest of the steam sterilizer
  • Required for certain items such as liquids
  • Most use high temperature method
  • Low cost, faster cycles,simple technology and leaves no chemical residue or by-products 
CYCLE PHASES
  1. Conditioning
    • Hot air to the top of  the machine
    • Cool air is forced to the bottom and out the drain
  2. Exposure
    • Prepares the machine for the next stage
    • Pressure and steam temperature to maximum of 250F
    • Time is based upon the time-temperature relationship
  3.  Exhaust
    • Removal of the steam through the discharge line
 
   4. Drying Phase
  • ·         Starts at the end of the exhaust phase
  • ·       Heated,  filtered fresh air and heat from the chamber walls re-vaporize and remove any liquid      and remove any liquid from the chamber
Loading Procedure
  • ·         Avoid overloading
  • ·         Avoid too tight packaging
  • ·         Use an absorbent shelf cover to line the sterilizer cart’s shelf
  • ·         Solid containers must be positioned
  • ·         Small items should be loosely placed in wire baskets
  • ·         Allow visible space between packs
  • ·         When combining loads, place hard goods on the bottom
  • ·         Packages must not touch chamber walls
  • ·         Basin sets should stand on edge
  • ·         Position textile packs so the layers within them are perpendicular to the shelf
  • ·         When possible, sterilize textiles and hard goods in separate loads
  • ·         Other than lumen, the items in the package must be completely dry
  • ·         Surgical instruments trays with perforated bottoms should sit flat on the shelf to maintain even instrument distribution, and to facilitate proper drainage
**CAUTION: NO SPUNBOND-POLYOLEFIN COMBINATIONS FOR PACKAGING**

Routine Monitoring
  • ·         External chemical indicator tape
  • ·         Internal chemical indicator strip
  • ·         BI
  • ·         The leak test
Trouble Shooting 
  •       If steam escapes from the safety valve or under the lid, the autoclave is not working correctly and it is merely steaming items at low pressure ( HLD, not sterilization)
  •   If steam escapes from the safety valve instead of the pressure valve, the pressure valve must be cleaned and inspected 
  •       If steam escapes form under the lid, the gasket (rubber ring) must be cleaned and dried or replaced.