Easi-Sterilise Information session for Clinicians. “Getting it right, every step of the way”. Why are we here?. Patient and staff safety Directives from QH EMT for rapid implementation of education and training following incidents Implementing a continuous quality improvement program
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“Getting it right, every step of the way”
Provide participants with an overview of the Easi Sterilise Standard Operating Procedures and outline the responsibility of the clinician in ensuring that items have been through the correct reprocessing and are able to be used safely for patient care.
Appropriately train and skill staff
Provide information and resources so that step-by-step quality processes are consistently followed
Assist in identifying gaps in knowledge and provide opportunities for improvementQH Commitment
Standard precautions are applied as a first-line approach to infection control. These form the basis for your decision-making and practice. Standard precautions are a set of guidelines based on the assumption that all blood and body fluids are potentially infectious.
In the context of sterilising practice and ALL the Standard Operating Procedures, standard precautions include:
Collection containers are:
Instruments and items sorted by;
Instruments and items are checked for;
Report concerns to supervisor
Steam will not penetrate contamination left on instruments
If the item is not clean it won’t be sterilised
Drying – As per manufacturer’s instructions
Disposable low-lint cloth for hose, battery and external parts
Air pressure gun (for removal of excess moisture)
Problems associated with incorrect drying
Good conditions micro-organisms multiply in 20-30 minutes
outside surfaces cleaned using detergent wipe,
rinsed by wiping
slow speed motors
outside surfaces cleaned using detergent wipe,
rinsed by wiping,
lubricated (manually or automatic) may need special adaptors
Dried, wrapped & processed in a wrapped cycle
Ultrasonic cleaning is a form of mechanical cleaning that uses high frequency ultrasonic waves (cavitation) that dislodges fine particles from the surfaces of instruments.
Ultrasonic cleaning is an effective cleaning method for instruments prior to the reprocessing
Cycle parameters not meeting set requirements or variations to cycle parameters – failed cycles
Items that appear dirty or stained are returned to the cleaning area for recleaning/destaining
Excess water – check the following: the machine temperature, amount of rinse aid going into the machine or the way in which the machine was loaded
Releasing the load and unloading the washer disinfector
Authorising release of the load occurs on completion of washer disinfector cycle and prior to opening the door.
Check cycle parameters have been met and print out/log (or equivalent) is signed
Care opening the doors due to heat and moisture
Inspect load not become dislodged or displaced
Avoid injury and damaging the equipment/instruments
Packaging and Wrapping Procedures
Organised packing area ensures a clean, safe work working area that reduces the risk of equipment damage/loss and unsafe work practices.
Prepare equipment for sterilization:
Check multi-part equipment / instruments
Provides a protective barrier against sources of potential contamination. Wrapping/packaging methods must facilitate aseptic removal of contents
To occur prior to the sterilizing process utilising:
(R) Side - Steriliser number
Date - dd mm yy
Steriliser cycle number
(a) How to interpret indicator results.
(b) The factors affecting end-point colour change during storage of sterilized items.
(c) The sterilization conditions that the indicator will detect.
(d) The storage requirements and shelf-life of the indicator itself.
bench top class N downward displacement autoclave capable of processing both wrapped and unwrapped loads
Place hollow ware on a 45 degree angle
Temperature, Pressure, Time
Cycle completed check print out for:
In built printer
W&H Lisa™ Manual
Immediately cycle has completed - Visually check
When releasing and authorising the load for use :
Document in steriliser record/log
Sign the sterilizer cycle printout and attach
Document time of release
Signature or identification of person releasing the load
Ensure the items unloaded correspond with load documentation
Attach the “control” pouch batch label
Attach the control class 5 chemical indicator
Immediately notify the supervisor if not met.
Away from high activity areas
Do not use forced cooling by fans or air con.
Do not place on solid surfaces, as condensation from vapour (still within the pack) can result.
Items dropped on the floor, placed on a dirty surface, compressed, torn, have broken seals, or are wet, are considered non-sterile and shall be reprocessed.
In the case where one or more items (but not all) have failed, in a successful cycle
Environmental considerations for Event Related Sterility
Environmental considerations for Event Related Sterility
The environment shall be
Dedicated storage areas
Store in a clean, dry, dust free environment
Insects and vermin free
Protected from direct sunlight
250mm above floor level & at least 400mm from ceiling fixtures
This process is a method of determining if an item is still sterile by assessing whether it has undergone any events, which may have compromised its sterility, such as
Incorrect cleaning in storage areas
Moisture and condensation
Exposure to harsh as well as external climatic conditions
Dust, Vermin and insects
torn/soiled wrapping or poor storage
To ensure water used in cleaning of re-usable medical devices is of optimum quality for effective and efficient processing
Water quality affects cleaning procedures
Water must be potable (drinking quality)
Hard water = calcium and magnesium
May prevent chemicals working as intended
Unfiltered tap water may contain excessive amounts of microorganisms depending on source
Proof that the mechanical washer disinfector attains the correct parameters for the set cycle and thus enables the conditions for effective cleaning and/or thermal disinfection
Washer/disinfectors usually operate within the following temperature ranges
Rinsing: 40°C - 50°C
Washing: 50°C - 60°C
Disinfecting: 70º for 100mins
75º for 30 mins
80º for 10 mins
90º for 1 min
Final rinsing: 80°C - 90°C
All results shall be checked prior to the release of each load and the printout signed
External and or internal chemical control (indicators) shall be used to identify that an item has been through a sterilising process. The indicators are specific to the sterilising process being used eg. Steam, hydrogen peroxide, ethylene oxide, peracetic acid
Control Pouch (Mandatory)
External (Mandatory) – Class 1 chemical indicator
Biological indicators are used to verify the microbial killing power of 10-6 of the sterilisation process by using a population of calibrated bacterial spores, on, or in, a carrier and packaged in a manner that the integrity of the inoculated carrier is maintained.
To verify that air has not leaked into the sterilising chamber.
The leak rate/vacuum test is not a sterilisation cycle.
It is a special programmed cycle that draws a vacuum and holds the vacuum for a minimum of 10 minutes. If the rate of air that leaks into the chamber via a leaking chamber seal or hole in piping, a pressure rise will be measured that is greater than 1.3 kPa/min over 10 minutes, a fault indicator and printout.
The level of vacuum will be different for each machine. The important thing is that it remains within 1.3kPa/min of the vacuum over the 10 minute period.
Class B and Class S sterilisers with air detector – weekly
Class B and Class S sterilisers without air detector – daily
Record the results.
5.8 BOWIE DICK TYPE TEST failed, in a successful cycle5.8 Bowie Dick Type Test
To detect air entrapment and evaluate the ability of a pre-vacuum steriliser to remove residual air that will then allow the steam penetration and attainment of the correct conditions for steam sterilisation.
Needs a special cycle
Daily on a warmed up steriliser before loads
Different types on the market
Important to document all the procedures!
What is validation?
A documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.
What does this mean?
The entire process is documented, challenged and repeatable, and establishes the efficacy (or not) of the sterilising process, that is monitored by the measurement of the critical requirements of time, temperature and pressure and parameters during each cycle.
Installation Qualification (IQ)
Proves that the steriliser and the where installed comply with the manufacturer’s specifications
Operational Qualifications (OQ)
Determines that the installed steriliser and equipment is working within the defined limits when used as per manufacturer’s procedures.
These shall documented and recorded and include calibration of all gauges, parameter monitoring, the recording device, specific performance tests (eg leak test) and process indicator tests (bowie dick tests)
Heat distribution study
Temperature profile “Cold Spot”
Time at temperature and pressure testing
Thermocouple testing to ensure the inside of the packs of your challenge load has reached the selected temperature x 3 times with BI’s
Hold at or slightly above this temperature and at the correct pressure
Must be done at every validation
Whole load that will be considered your “validated, challenged load” needs to be available.
Validation shall be repeated annually and every time significant changes are made.
Examples of such changes include, but are not limited to, the following:
(a) Any change to the sterilization parameters
(b) Changes in packaging or loading specification which would provide a greater challenge to the sterilization process.
(c) Changes in the items or types of instruments to be sterilized, such as the addition of a new complex medical item which would provide a greater challenge to the sterilization process.