sterilization healthcare
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STERILIZATION HEALTHCARE. Steam Sterilizers Operation and Preventative Maintenance. Sterilization F undamentals. Sterilization: A process by which all forms of microbial life including bacteria, viruses, spores, and fungi are destroyed - PowerPoint PPT PresentationTRANSCRIPT
STERILIZATIONHEALTHCARE
Steam Sterilizers Operation and Preventative
Maintenance
Sterilization: A process by which all forms of microbial life including bacteria, viruses, spores, and fungi are destroyed
Note: In a sterilization process, the nature of microbial death is described by an exponential function. Therefore, the presence of microorganisms on any individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero. (ANSI/AAMI ST46)
Sterilization Fundamentals
Sterility Testing: Product is inoculated directly into growth medium.
Process Monitoring: Use of mechanical, biological and chemical indicators to monitor critical sterilization parameters.
Parametric release: Declaring product sterile based on records demonstrating that the process parameters were delivered within specified tolerances. This method does not include the use of Biological Indicators.
General Terminology Review
General Terminology Review
• Bio Burden– # of microorganisms on a contaminated item
• Reduction of Bio Burden:– Hand washing; soap and water
– Chemical; high level disinfection
– Sanitization
– Decontamination
– Disinfection
What is a Steam Sterilizer ?
Steam sterilizers for healthcare have one primary purpose:
Technology Fundamentals
Render instruments sterile for re-use in a
surgical setting
Steam Sterilizers– Temperatures ranging from 121-134C at pressures of 15-30
psi are generally recommended to sterilize wrapped or unwrapped surgical instruments.
– Why Steam?
Sterilization Fundamentals
HighlyEffectiveNon
Toxic
Readily Available
Easy to Control
Inexpensive
Two Types of Steam Sterilizers:
Vacuum: used for large volumes of wrapped surgical instruments
Gravity: used for individual unwrapped surgical instruments
Sterilization Fundamentals
Sterilization Fundamentals
Alternate Sterilization Technologies:ETO (Ethylene oxide)
Gas PlasmaOzone
Dry Heat Sterilizers
Low temp.
Ultra High temp.
• Healthcare Steam Sterilizers– Typical Dimensions:
• 16“ wide x 16" high x 16" long (gravity or vacuum)
• 20“ wide x 20" high x 38" long (gravity or vacuum)
• 24“ wide x 36" high x 36" long (usually vacuum)• 24“ wide x 36" high x 48" long (usually vacuum)• 24“ wide x 36" high x 60" long (usually vacuum)• Floor loader: 26.5 x 62 x up to 76”
Sterilization Fundamentals
small
medium
large
• Steam Sterilizers– Smaller sterilizers: instruments
inserted individually for quick sterilization
– Larger sterilizers (36" or larger): can hold entire “carriage” of instruments for sterilizing
– Floor loader: rises to floor level where entire cart and carriage of instruments are inserted for sterilization
Sterilization Fundamentals
Factors Affecting Sterilization
• Time
– Sterility Assurance Level (SAL) 10-6
– One survivor out of a million (infectious organisms)
• Temperature
– 250F/270F/275F
• Moisture
– Required to coagulate protein
– However, steam quality requires a maximum vapor content of 3%
Sterilization Fundamentals
Steam Quality Through RO Water
• Reverse-Osmosis (RO): the process of squeezing water through a semi-permeable membrane.
• RO will separate pure water molecules from dissolved solids such as Calcium, Sodium and Iron
• Chlorine, Nitrates and Nitrites are removed in the pre-filtration process.
Sterilization Fundamentals
Benefits of RO in Steam Generation ( Clean Steam)
Balances pH
Reduces downtime
Reduces costly repairs
Extends useful equipment life
Removes hardness
Improves equipment reliability
Sterilization Fundamentals
Proper sterilizer design and use to achieve time and temperature
Sterilizer area design and quality utilities feeding unit
Bio Burden reduced prior to sterilization
Adequate contact of the sterilant for all surfaces
Other Factors Affecting Sterilization
Sterilization Fundamentals
Air and steam do not mix
Air inhibits steam contact
Air is 1.6 times denser than steam
Steam condenses on cool goods
Loading and load size
Packs must be dry
Why is air removal important?
Sterilization Fundamentals
• Decimal Reduction Value (D-Value)• The exposure to sterilant
required to reduce the population of test organism by 90% (one logarithm) under stated conditions.
• Sterility Assurance Level (SAL) • Probability of a non-sterile unit.
As a minimum sterilization cycles are designed to provide a 1 in a million chance of a non-sterile unit. SAL = 10-6
0.0000010.000010.00010.0010.010.1
110
1001000
10000100000
1000000
exposure10-6
SAL
S K
No
D-value
SAL
Sterilization Fundamentals
More about D-Value and SAL...
The SAL is extrapolated from the survivor curve based on the D-value of the Biological Indicator and exposure time.
Traditional cycle development is driven by determining the time for complete kill of a 106 BI and double the cycle time to achieve SAL of 10-6
Sterilization Fundamentals
3 Primary Factors of Sterility Assurance
1. Process Control - Reproducible and controlled conditions
2. Process Monitoring - Biological indicators, chemical indicators, mechanical gauges, cycle charts or printouts, etc.
3. Good Manufacturing Practices (GMP) - Includes record keeping, inspection of materials, process validation and equipment maintenance and calibration
Sterilization Fundamentals
Complete sterility assurance can only be achieved by testing each item processed - a destructive and impractical
procedure.
Sterilization Cycle Talk: Getinge Vacuum Cycle
Sterilization Fundamentals
The actual sterilizer cycle as logged in our digital software solution, T-Doc
Sterilizer Maintenance
• Why should we have preventative maintenance on a sterilizer?
• What happens in the sterilizer during a cycle?
• What should I look for the start of my shift?
• What can effect the sterilization process that I can control?
• What can effect the sterilization process that I can not control directly?
Sterilizer Maintenance
Why should we have preventative maintenance on a sterilizer?
1. Keeps the machine running to manufactures recommended specifications
2. Minimizes the amount of downtime
3. Provides assurance that the unit is running optimally
4. Extends the life of the sterilizer
5. Ensures the unit is safe for operating- no chamber cracks, faulty valves etc
6. Ensures the appropriate sterility is met by the system as it was intended to provide at time of manufacturing
Sterilizer Maintenance
Sterilizer Video - What Happens during a sterilization cycle
Sterilizer Maintenance
What should I look for when start of my shift?
1. Ask the person who you are replacing if there have been any autoclave problems during their shift. Keep a log book of events for of date, time, unit number, copy of print out and what occurred.
2. Check gasket for wear and tear on the machines you are using
3. Check chamber and drains to ensure no paper or items are obstructing the drain
4. Check the printer paper to ensure you have enough
5. Verify you have appropriate materials for logging, biological tests and bowie dick tests if required for your shift
6. Check to see if you’ll be required to process stat loads etc during your work period to allow you to manage the flow
Sterilizer Maintenance
What can effect the sterilization process that I can control?1. The proper loading and spacing of the sterilizer cart/trolley
2. Using the proper packaging material
3. Checking to ensure drain is not plugged and is cleaned at regular intervals
4. Cleaning of the chamber and carts at regular intervals
5. Proper cool down area away from air conditioning
6. Items being sterilized are dry, containers, blue silicone liners dry as well as plastic bowls etc
7. Being able to properly read the tests – BD, Biological, Indicators, Integrators etc
8. Prequalification of the units after a major repair of the sterilizer
Sterilizer Maintenance
What can effect the sterilization process that I can not control directly?
1. The sterilizer malfunctioning
2. Steam supply staturation drops below 97%
3. Water pressure drops
4. Electrical power failure
5. Failure of BD Test – redo test and check results – 2nd failure contact service for repair
6. Consistently wet steam or dirty steam – (tea effect) – You can perform a warm-up prior to the bowie dick test and this will help remove as much moister from the lines as possible.
7. Dirty steam – you can have filters placed at the feed of the units to filter out debris and some of the chemicals used by maintenance to clean the steam lines
Who establishes the proper sterilization parameters for reusable medical devices?
Who establishes the proper sterilization parameters for reusable medical devices?
Answer: The responsibility for safe and effective sterilization of reusable medical devices is the shared responsibility of both manufacturers, and users of the devices. Reichert & Young, p. 132
Sterilization Fundamentals
Summary - Key Learnings
• Reviewed General Terminology
• Reviewed the Sterilization Fundamentals
• Reviewed Sterilizer Maintenance and areas that can be controlled by MDRD employee
Sterilizer Maintenance
Questions?
Thank you for your Time
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