STERILIZATION HEALTHCARE

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STERILIZATIONHEALTHCARE
Steam Sterilizers Operation and Preventative
Maintenance
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Sterilization Fundamentals

• 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)

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General Terminology Review
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.
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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

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What is a Steam Sterilizer ?
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Technology Fundamentals

• Steam sterilizers for healthcare have one primary
  purpose

Render instruments sterile for re-use in a
surgical setting
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Sterilization Fundamentals

• Steam Sterilizers
• Temperatures ranging from 121-134?C at pressures
  of 15-30 psi are generally recommended to
  sterilize wrapped or unwrapped surgical
  instruments.
• Why Steam?

Highly Effective
Easy to Control
Non Toxic
Readily Available
Inexpensive
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Sterilization Fundamentals
Two Types of Steam Sterilizers Vacuum used for
large volumes of wrapped surgical
instruments Gravity used for individual
unwrapped surgical instruments
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Sterilization Fundamentals
Alternate Sterilization Technologies ETO
(Ethylene oxide) Gas Plasma Ozone Dry Heat
Sterilizers
Low temp.
Ultra High temp.
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Sterilization Fundamentals

• 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

small
medium
large
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Sterilization Fundamentals

• 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

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Factors Affecting Sterilization
Sterilization Fundamentals

• 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

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Steam Quality Through RO Water
Sterilization Fundamentals

• 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.

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Benefits of RO in Steam Generation ( Clean Steam)
Sterilization Fundamentals

• Balances pH
• Reduces downtime
• Reduces costly repairs
• Extends useful equipment life
• Removes hardness
• Improves equipment reliability

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Other Factors Affecting Sterilization
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

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Sterilization Fundamentals
Why is air removal important?

• 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

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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

SAL
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More about D-Value and SAL...
Sterilization Fundamentals

• 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

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Sterilization Fundamentals

• 3 Primary Factors of Sterility Assurance
• Process Control - Reproducible and controlled
  conditions
• Process Monitoring - Biological indicators,
  chemical indicators, mechanical gauges, cycle
  charts or printouts, etc.
• Good Manufacturing Practices (GMP) - Includes
  record keeping, inspection of materials, process
  validation and equipment maintenance and
  calibration

Complete sterility assurance can only be achieved
by testing each item processed - a destructive
and impractical procedure.
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Sterilization Cycle Talk Getinge Vacuum Cycle
Sterilization Fundamentals
The actual sterilizer cycle as logged in our
digital software solution, T-Doc
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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?

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Sterilizer Maintenance

• Why should we have preventative maintenance on a
  sterilizer?
• Keeps the machine running to manufactures
  recommended specifications
• Minimizes the amount of downtime
• Provides assurance that the unit is running
  optimally
• Extends the life of the sterilizer
• Ensures the unit is safe for operating- no
  chamber cracks, faulty valves etc
• Ensures the appropriate sterility is met by the
  system as it was intended to provide at time of
  manufacturing

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Sterilizer Maintenance

• Sterilizer Video - What Happens during a
  sterilization cycle

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Sterilizer Maintenance

• What should I look for when start of my shift?
• 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.
• Check gasket for wear and tear on the machines
  you are using
• Check chamber and drains to ensure no paper or
  items are obstructing the drain
• Check the printer paper to ensure you have enough
• Verify you have appropriate materials for
  logging, biological tests and bowie dick tests if
  required for your shift
• Check to see if youll be required to process
  stat loads etc during your work period to allow
  you to manage the flow

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Sterilizer Maintenance

• What can effect the sterilization process that I
  can control?
• The proper loading and spacing of the sterilizer
  cart/trolley
• Using the proper packaging material
• Checking to ensure drain is not plugged and is
  cleaned at regular intervals
• Cleaning of the chamber and carts at regular
  intervals
• Proper cool down area away from air conditioning
• Items being sterilized are dry, containers, blue
  silicone liners dry as well as plastic bowls etc
• Being able to properly read the tests BD,
  Biological, Indicators, Integrators etc
• Prequalification of the units after a major
  repair of the sterilizer

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Sterilizer Maintenance

• What can effect the sterilization process that I
  can not control directly?
• The sterilizer malfunctioning
• Steam supply staturation drops below 97
• Water pressure drops
• Electrical power failure
• Failure of BD Test redo test and check results
  2nd failure contact service for repair
• 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.
• 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

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Sterilization Fundamentals
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
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Summary - Key Learnings

• Reviewed General Terminology
• Reviewed the Sterilization Fundamentals
• Reviewed Sterilizer Maintenance and areas that
  can be controlled by MDRD employee

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Sterilizer Maintenance
Questions? Thank you for your Time
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