Reprocessing of instruments for office based practices including Day surgeries, dental practices and aged care facilities

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Reprocessing of instruments for office based
practices including Day surgeries, dental
practices and aged care facilities
Lynne Noring
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National standards
and State Policy

• Australia/ New Zealand 4815 2006 Office based
  health care facilities Reprocessing of reusable
  medical and surgical instruments and equipment,
  and maintenance of associated environment.
• NSW infection Control policy

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Cleaning and handling of used equipment
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Standard precautions

• Treating all used items as a potential source of
  infection
• Wash hands and cover any skin lesions with
  occlusive dressings
• Wear appropriate personal protection such as
  utility gloves specially designed repellent
  masks/eye protection/face shields and fluid
  resistant aprons or gowns.
• Thermal disinfect the cleaning brushes either at
  the beginning or end of each day.

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why is the pre-requisite to sterilisation the
cleaning process.

• Reduce the microbial contaminates.
• Remove tissue debris, blood and other organic
  material so the sterilant can make contact with
  every part of the item being sterilised.
• To prevent the deterioration of instruments and
  equipment.
• If an item is not clean prior to being placed
  into the steriliser it will not be sterile.

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There are 2 types of soil you will come in
contact with when cleaning reusable equipment.

• Visible contaminates
• including blood,bone.tissue and inorganic soils
  such as dirt or dust.
• Non-visible contaminates Micro organisms,
  bacteria, and virus.

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Water quality for cleaning

• Water supply should be of good quality.
• Water suitable for drinking is suitable for
  cleaning.
• Water with high mineral content is unsuitable
  due to mineral deposits shortening the equipment
  life and interfering with the effect of the
  cleaning agents.

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Collection procedures

• Procedures for the collection of used reusable
  items from treatment areas shall be formulated by
  each office based health care facility.
• Collection equipment shall be puncture and leak
  resistant, and made of a material that is able to
  be cleaned.

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Reprocessing Area

• All used items are to be cleaned in a designated
  area to prevent the possible contamination of
  items processed.
• On receipt in the reprocessing area, items should
  be sorted to type and corresponding cleaning
  method. Example manual, mechanical and cannualted.

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Sorting for reprocessing

• All equipment that is unwrapped is considered to
  be contaminated whether used or not.
• A check for completeness and defects shall be
  made during the sorting process.
• All facilities should have written procedures for
  handling specialized equipment.

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The equipment the facility should ideally include.

• Separate hand washing facilities
• Adequate bench space with smooth surfaces without
  crevices.
• Good lighting
• Efficient ventilation
• Adequate storage space
• Bins for disposal of waste
• Non-slip flooring
• Cleaning sinks and washer /disinfector
• Ultrasonic cleaner
• Drying facilities.

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The four steps to the cleaning process

• Pre-rinse cold water
• Wash- hot water and a cleaning agent
• Rinse 1 or more rinses with hot water
• 80 to 90 c with a drying agent added, in
  accordance with manufacturers recommendations.
• Drying shall be by means of a drying cabinet or
  lint free cloths or disposable lint free cloths.

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Cleaning agents

• Shall be used to remove residual soil and organic
  matter from instruments and equipment. Only those
  intended by the manufacturer for use in cleaning
  medical devices shall be used.

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Safe use of cleaning agents

• Staff should be trained in application, handling
  and safe use of cleaning agents for instrument
  cleaning.
• Product data bulletins and material safety data
  sheets for all cleaning agents shall be obtained,
  read and implemented.

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Cleaning agents should be,

• Biodegradable
• Non-corrosive
• Non-toxic
• Non-abrasive
• Low foaming
• Free rinsing
• Preferably liquid
• mild alkali formation with a ph range 8.0 to 10.8
• However some instruments and equipment maybe made
  of materials where the use of neutral detergents
  are more appropriate.

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Labelling of cleaning agents should include,

• The name of the product
• The manufacturer
• The purpose of the product
• The directions for dilution and use
• The batch number
• The expiry date
• Advice not to be mixed with other chemicals
• Safety and first aid
• Specific storage
• Hazards nature

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Abrasive cleaners

• Steel wool
• Stainless steel brushes
• Powders and pastes

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Manual cleaning equipment

• Sinks
• Assorted brushes with soft and hard bristles.
  lumen brushes with a variety of diameters and
  lengths.
• Soft lint free cloths

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Mechanical cleaning methods

• Ultrasonic washers
• Indexing/tunnel washer disinfectors
• Stand alone washer/disinfectors
• Cannulised sonic washers

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Thermal disinfection

• Thermal disinfection is not a sterilisation
  process. Items used for critical procedures must
  be sterilised.
• Thermal disinfection uses heat and water at
  temperatures that destroy pathogenic vegetative
  organisms.

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Thermal disinfection 0-100 temp/Celsius100-0.32
time/minutes
Temperature
Time
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Methods of mechanical cleaning

• Washer cycles include, cold pre-rinse
• Hot wash with cleaning agent
• One or more rinses with hot water at a suitable
  temperature for thermal disinfection to be
  achieved.
• Drain, leaving the contents at a temperature for
  quick drying.
• Drying.
• Washer disinfectors need to cleaned and
  maintained regularly to prevent colonizing and
  formation of biofilms which could contaminate the
  instruments processed within.

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Ultrasonic cleaners

• The tank must be filled with cold or tepid water
  add a measured amount of recommended detergent.
  Operate the machine to degas the solution.
• Tested to see if the transducers are functioning
  correctly and the results recorded.
• Rinse the instrument of visible contaminates
  before immersing the instruments.
• The instruments should be placed in a suitable
  basket in an open position before being submerged
  into the water tank close the lid and commence
  the cycle.
• After the specific time, remove the instruments
  and rinse in clean running hot water.

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Method of manual cleaning

• Flush the item with running water.
• Fill the container or bowl with warm water and
  neutral or in some cases enzymatic cleaning
  solution.
• Dismantle all removable parts or open items
  before placing into the cleaning solution.
• Hold the items low in the container and wash all
  surfaces, brush lumens and valves.
• Remove stubborn stains by soaking in an approved
  stain removing solution if the instrument
  manufacturers recommendation permits.

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Method of rinsing and drying for manual cleaning.

• Rinse the item thoroughly in hot running water.
• Dry in a drying cabinet or with lint free cloths
  or disposable lint free cloths. items should
  never be dried in ambient air.
• Then visually inspect the cleanliness of all
  items.

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Manually cleaning of respiratory equipment.

• All items shall be dismantled and thoroughly
  cleaned in detergent and water. Manufactures
  recommendations should be considered, followed by
  thorough rinsing in clean running water to remove
  any residue.
• Where thermal disinfection or sterilisation
  processes are not available for semi-critical
  items, single use devices shall be used.

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Chemical disinfection

• Chemical disinfection can only be used when
  thermal disinfection is unsuitable.
• Any chemical disinfectants that are used must be
  registered with the Therapeutic Goods
  Administration in Australia
• Instruments should not be stored in chemical
  disinfectants before or after any form of
  processing.

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Materials that may inhibit or restrict chemical
disinfection.

• Hard water
• Fibres or lint from cleaning materials
• Food, fluid and fats
• Body fluids and excrements
• Organic materials
• Physical soils

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Instrument Grade Disinfectants

• High level instrument grade disinfectant is the
  minimum level to be used on semi-critical
  instruments which contact unbroken mucous
  membranes that are normally not sterile.

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Instrument grade disinfectants

• Intermediate or low level disinfectants may be
  used for non-critical instruments which are
  normally restricted to contact with unbroken
  skin.
• There may be instances where a hospital grade
  disinfection maybe used in a office based health
  care facility.
• Formal policies and procedures need to be
  developed for the use of hospital grade
  disinfectants.

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General housekeeping

• There needs to be written policies and procedures
  for the routine cleaning of all the sterilising
  and ancillary equipment including
• Method
• Frequency
• Manufacturers instructions
• Cleaning agents and materials.
• All waste should be removed from the
  reprocessing area via designated disposals exits.
  AS4031,AS/NZS4261,NZS4304 should also be
  consulted.

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Education and training

• Office - based health care facilities responsible
  for instrument reprocessing are also responsible
  for ensuring the appropriate education and
  training of staff is kept up to date on a regular
  basis .

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Interchange of instruments and equipment.

• Instruments should not be interchanged between
  necropsy, human and animal use.
• Instruments used on animals should not be
  reprocessed in sterilisers and associated
  equipment and environments used for reprocessing
  instruments used for humans.
• Infection transmission hazards exist where these
  requirements are not met.

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Instruments on loan

• On receipt into the health care facility,
  instruments on loan from loan companies or other
  health care facilities or individual clinicians ,
  shall undergo a complete routine cleaning and
  processing prior to sterilisation.
• Perceived lack of time shall not be permit the
  cleaning process to be bypassed.
• There should be a contracted arrangement between
  the health care facility and the loan supplier to
  define the responsibilities of the parties.

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Sterilisation of unwrapped instruments.

• To avoid danger of contamination, use unwrapped
  instruments for critical procedures immediately
  after sterilisation.
• However this is an unacceptable practice and
  should only take place when an item is dropped
  and another one is not available and the item
  must have undergone a full cleaning process prior
  to being placed in the flash sterilising unit.
• Lack of time or equipment is not an acceptable
  excuse for this process to take place.
• The lack of a drying process causes instruments
  to corrode, and jointed instruments to become
  stiff.

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Lubrication

• If lubricants are required for basic instruments
  they need to be,
• Water miscible
• Compatible to the sterilising agent.
• Lubrication is not a way of overcoming inadequate
  cleaning practices.
• Routine lubrication of instruments following the
  cleaning process often results in extremely heavy
  contamination.

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Insulated instruments

• Need to be tested to ensure the integrity of the
  insulation material
• This can be done by trained SSD staff member or a
  bio-medical engineer depending on the frequency
  of the equipment use.

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Handpieces

• Such as those used for ear,nose,oral
  maxillo-facial surgery, dental and oral surgery
  and invasive podiatry shall to be cleaned and
  sterilised after each use.
• The internal surfaces of handpieces may become
  soiled with patient debris during use which can
  be expelled into or onto subsequent patients.

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Processing handpieces.

• Documented cleaning procedure must be followed.
• At the end of the procedure, handpieces need to
  be operated and run to discharge water and air
  for a minimum of 30 seconds. This is to flush out
  any gross debris that may have entered the
  turbine and air or water lines.
• Handpieces maybe hand clean and lubricated
  following manufacturers recommendations or hand
  cleaned and then processed using an automatic
  flush-through and lubricated system.
• Handpieces need to be also packaged and steam
  sterilised and remain in a sterile package before
  each use.
• It is not an acceptable practice wiping or
  soaking handpieces in a chemical disinfectant.
• Handpieces pose a challenge to the downward
  displacement sterilisation process, due to
  limitations to the air removal process and steam
  penetration.

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Air water syringes for dental

• The tip needs to be removed after each use for
  cleaning and sterilisation.
• The air water line needs to be cleared by
  flushing thoroughly with water for 30 seconds.
• If sterilising is not possible, single use tips
  shall be used.
• Ultrasonic scalers for dental procedures the tip
  needs to be cleaned and sterilised and the scaler
  flushed with running water for 30 seconds. And
  the handle hand cleaned.

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Diagnostic ultrasound transducers.

• Intracavity probes such as (transvaginal
  transrectal or transoesophageal ) require
  cleaning in accordance to the manufacturers
  recommendations and either sterilisation if
  possible or high level disinfectant using only
  instrument grade disinfectant should be used.
• Sheaths/ sleeves or protective barriers must not
  be used as a substitute for cleaning,
  disinfection or sterilisation procedures.

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Use of textiles

• Where an office- based health care facility has a
  laundry which is dedicated to processing drapes,
  gowns and other textiles that need to be sterile
  and area needs to be set a side for inspection,
  folding and assembly of these textiles. If this
  is not possible consideration should be given to
  outsourcing textiles or the use of single use.
• Inappropriate textiles and laundering practice
  pose an infection risk.

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Packaging and wrapping prior to sterilisation

• The purpose of packaging is to provide an
  effective bacteria barrier against potential
  contamination and to maintain sterility.
• Materials should permit the removal of air from
  the pack and allow penetration of the sterilising
  agent and removal of the sterilising agent and
  water vapour.
• Materials need to be compatible to the
  sterilising method selected.
• Sharp instruments should be packaged in such a
  way the tips cannot pierce the packaging
  material.

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Pack size

• The principle determining the size, mass and
  contents of packs is that the contents are dry
  and sterile immediately on completion of the
  sterilisation cycle.
• This is usually established when the performance
  qualifications are conducted on your sterilisers,
  using thermocouples and biological indicators.

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Labelling packs

• Labelling should always be done prior to
  sterilisation so the packaging material integrity
  is not compromised.
• All Packaged items for sterilisation needs labels
  for identification of the contents
• The following is the only methods that should be
  used for labelling packages for sterilisation,
• Soft tipped alcohol-based felt marking pens.
• Pre-printed tapes
• Pre-printed bags
• Stamping systems
• Pre-printed labels
• Computerized generated labels.

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Sealing of packs and bags

• The purpose of sealing is to maintain pack
  integrity ,to ensure the package will remain
  sealed during the sterilisation process.
• Sealing is usually achieved by the use of heat
  seals, self sealing pouches or sterilising
  indicator tape.

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Methods which compromise pack integrity.

• String
• Non-adhesive tape
• Staples
• Elastic bands
• Paperclips
• Ball point pens or pencils

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Sterilisation equipment

• Methods of sterilisation in office -based health
  care facilities are steam under pressure and dry
  heat.
• Steam kills micro-organisms by coagulation of the
  cell protein.
• Dry heat kills micro organisms by oxidation this
  causes the continuous loss of moisture by the
  micro-organism in the heated environment.

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Steam sterilisation

• Steam possess three important qualities that make
  it an effective sterilant.
• Latent heat
• Moisture
• Penetration

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Types of Steam

• Saturated steam
• Wet saturated steam
• Superheated steam
• Saturated steam is the
• only steam suitable for steam sterilisation.
• The maximum allowable steam wetness is 3 which
  is equivalent to 97 dry saturated steam.

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Small steam sterilisers.

• In Australia and New Zealand small steam
  sterilisers are known as bench top or portable.
• AS2182 specifies the manufacturers requirements
  for this type of steriliser.

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Types of sterilising cycles and their intended
use.

• Type N the sterilisation of unwrapped, solid
  items.
• Type B The sterilisation of all wrapped (single
  or double) or unwrapped items, including porous
  and cannulated items that do not exceed the
  specifications of hollow load type A from the
  AS4815 2006
• Type S the sterilisation of items as specified
  by the manufacturer of the steriliser. The
  available cycles needs to be capable of
  sterilising unwrapped solid items and at least
  one other of the following types
• Porous items
• Small porous items
• Hollow load type A
• Hollow load type B
• Single layer wrapped items
• Double wrapped items.

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Tubing

• Tubing poses a challenge to the sterilisation
  process due to the inability of effective
  cleaning. There is also a risk of air entrapment
  during sterilisation. Therefore it is wise to use
  sterile single use tubing.

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Dry heat sterilisers

• The portable dry heat type steriliser is
  different from the steam because air removal is
  not part of the process.
• Items need to be sealed within impermeable
  containers. And can withstand a temperature of
  160c for a minimum holding time of 120 mins plus
  penetration time.
• Dry heat steriliser (hot air Type) are specified
  in AS2487 appliances that do not meet the
  requirements of this standard should not be used
  under any circumstances.
• This type of steriliser is not designed to
  sterilised liquids therefore this should not be
  attempted.

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Peracetic acid liquid chemical sterilisation

• Peracetic acid (PAA) is generally used in
  operating theatres or endoscopy units.
• When used correctly it provides them with a
  sterile product rather than a chemically
  disinfected product.
• PAA is an effective biocide and for sterilisation
  35 peracetic acid is mixed with 10 litres of
  warm water rendering a final concentration of
  0.2.

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PAA as a Sterilant

• Concentration 0.2
• Temperature range 50 56 c
• Holding Time 12 minutes
• The cycle time is between 20-35 minutes and is
  dependant on the initial water temperature and
  water pressure.
• Items need to be thoroughly cleaned before being
  loaded into purpose built trays that sit into the
  chamber. As it is a wet process the items are
  immersed for 12minutes followed four rinses with
  filtered portable water. At the end of the cycle
  filtered air is purged into the chamber to remove
  excess water. The unit remains sealed until
  released by the operator.
• The PAA system is designed for just in time
  processing as items cannot be stored following
  the process.

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(LTP) Low Temperature Hydrogen peroxide plasma
sterilisation.

• LTP is a relatively new process when compared to
  other sterilisation methods.
• The plasma is created in ambient temperature. The
  substance used for the sterilisation process is
  hydrogen peroxide (58). This is in liquid form
  originally and is vaporised in the chamber then
  converted to plasma by the addition of an energy
  field which in this case is created by the
  turning on of a radio frequency within the
  chamber during deep vacuum.

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LTP how it kills micro-organisms.

• LTP destroys micro-organisms by creating a plasma
  cloud. This cloud contains free radicals known to
  have a biochemical interaction with cell
  membranes, enzymes or nucleic acids to disrupt
  the life functions of micro-organisms.

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Loading the sterilisers

• Correct loading is essential for successful
  sterilisation.
• Because the sterilant must contact the surface
  for sterilisation to be achieved loading trays
  shall be loosely loaded to capacity. only a
  single layer of packs shall be loaded on each
  tray.
• Packs must remain in the confines of the chamber
  and not touch the walls, floor or door.

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Unloading sterilisers

• The load must be removed immediately on
  completion and visual inspection shall be made to
  ascertain that the load is dry, packaging is
  intact and that the sterilising indicators colour
  change has taken place.
• Directly after the sterilisation process items
  are very vulnerable to contamination by moisture
  or improper handling.
• After sterilisation the loading trays shall be
  kept away from high activity areas.

61
Unloading procedures

• Procedures for unloading each type of steriliser
  shall be developed and documented and ongoing
  compliance with such procedures need to be
  monitored.

62
Performance qualification

• After commissioning performance qualification is
  preformed annually or when significant changes
  are made to any aspect of reprocessing activities
  e.g. changes to packaging material, loading
  configurations and sterilisation process
  parameters.
• Also after major repairs to the steriliser.

63
Performance testing

• Leak rate vacuum test
• Air removal and steam penetration test.
• Air detector test (where applicable)
• Note sterilisers that use downward displacement
  as a method of air removal cannot be effectively
  performance tested prior to use.

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Monitoring

• Chemical indicators
• biological indicators
• enzymatic indicators
• Process challenge devices.
• Data loggers
• Thermocouples and digital readout thermometers.

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Monitoring of packaging following sterilisation.

• Integrity of the outer wrap
• Integrity of seals
• Correct labelling including
• Date of manufacture
• Batch number
• Steriliser cycle or run number
• Steriliser number
• Contents of pack and operators identification
• Correct colour change of chemical indicator.

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Criteria for release of processed items

• To release the processed items, there should be
  evidence that the process has compiled with all
  specific requirements, therefore achieving the
  sterility assurance level or the level of
  disinfection required.
• The person responsible for authorizing the
  release must have full knowledge of all aspects
  of the validated process and be satisfied that
  monitoring and control of the entire process has
  met specifications.

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Storage of sterile stock.

• Storage areas for sterile stock should be
  controlled to prevent contamination and shall be
  dedicated for that purpose only.
• The storage environment should be free of dust,
  insects and vermin.
• Storage containers, trolleys and cupboards need
  to be kept clean and dry and in good condition
  cardboard boxes should not be used as they are
  porous and cannot be cleaned and will harbour
  organisms.

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Summary

• Staff health infection control
• Cleaning , disinfection and chemical disinfection
  
• Inspect, prepare and packaging
• Loading for sterilisation
• Steam
• Sterilisation
• Unloading of sterile items
• Monitoring
• Release of sterile stock
• Storage of sterile stock.

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Thank you