STERILISING SERVICES AUDIT
CRITERIA

1. OPERATIONS
1.1 CLEANING REUSABLE MEDICAL DEVICES
1.1.1 All reusable items are cleaned in an area that is physically
separate to other areas within the sterilising processing facility Building
& Refurbishment
1.1.2 Before reusable items are returned to the sterilising processing
facility gross soil such as blood, body fluids and skin preparation
solutions are removed as close as possible to the point of use by either
dry wiping, damp wiping and rinsing or both. Cannulated instruments
are not allowed to become dry. Disinfection & Sterilization Infection
Control Guidelines
1.1.3 Collection trays/trolleys for the collection of used reusable items
are puncture and leak resistant with a lid or liner that can be securely
closed SOP1.1 & Disinfection & Sterilization Infection Control
Guidelines
1.1.4 The collection container/trolley is cleaned at the end of each
collection round of used reusable items SOP1.1 & Disinfection &
Sterilization Infection Control Guidelines
1.1.5 All items that have been unwrapped are considered to be
contaminated and undergo a full cleaning process SOP1.2
1.1.6 All items including specialised items (eg loan sets, powered tools,
multi-part instruments and flexible and rigid endoscopes) are cleaned in
accordance with manufactures guidelines and appendix’s B&C of
AS/NZS 4187, Easi-Sterilise SOP1.8 & Cleaning of Complex
Instruments
1.1.7 In order to prevent damage to the surfaces of instruments or
residue, abrasive cleaners such as steel wool or abrasive cleaning
powders are not used SOP1.5
1.1.8 Chemicals are packaged and dispensed in a safe manner which
prevents contamination SOP1.3
1.1.9 Cleaning methods within the department do not generate aerosols
nor add to the formation of bioburden SOP1.5 SOP1.4 SOP1.6
1.1.10 Prior to the cleaning, items are sorted according to type and
cleaning method plus instrument trays are checked for completeness
and defects SOP1.2
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RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
STERILISING SERVICES AUDIT
CRITERIA
1.1.11 Cleaning methods used are appropriate for the design of the
items being processed SOP1.2


1. OPERATIONS cont.
1.1 CLEANING REUSABLE MEDICAL DEVICES
1.1.12 Any defective instruments are cleaned, dried and sterilised prior
to being sent for repairs SOP1.2
1.1.13 Loan instruments undergo a cleaning process prior to being
wrapped for sterilisation. Any soil or debris found on the loan
instruments are reported to the supplier SOP1.2
1.1.14 Prior to returning loan instruments to the source they are to
undergo a cleaning and sterilising process Disinfection & Sterilization
Infection Control Guidelines
1.1.15 At the completion of the cleaning process, items are visually
inspected to ensure they are clean and free from detergent residue
SOP2.5
1.1.16 All equipment and instruments undergo a mechanical cleaning
process appropriate for the item and the items are processed for the
complete cycle SOP1.9 to SOP1.11
1.1.17 Automated washer disinfector machines have the following
cycles:
 pre-rinse with water
 wash, in warm water and cleaning agent as per manufacturers
recommendations
 one or more rinses with hot water at 80°C-90°C, with drying agent
added
 drain, leaving contents at a temperature for quick drying
 drying, either by radiant heat from an element or hot air blast
SOP1.9 to SOP1.11
1.1.18 All anaesthetic equipment undergo mechanical cleaning are
disassembled as required prior to processing and care taken to ensure
all surfaces and lumens are exposed to the cleaning process SOP1.13
1.1.19 Each time the ultrasonic cleaner is filled, water is added first,
next the manufacturers recommended detergent followed by degassing
of the machine before instruments are placed in the basket for
processing SOP1.13
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RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
STERILISING SERVICES AUDIT
CRITERIA

1. OPERATIONS cont.
1.1 CLEANING REUSABLE MEDICAL DEVICES
1.1.20 Ultrasonic cleaner is used to clean jointed, serrated, cannulated
instruments not insulated instruments, mirrors or lenses SOP1.13
1.1.21 When items are removed following being cleaned in an ultrasonic
they are rinsed in warm to hot water prior to drying SOP1.13
1.1.22 The ultrasonic solution is replaced at least daily or when the
solution is contaminated SOP1.13
1.1.23 On completion of a mechanical cleaning cycle items (including
anaesthetic equipment) are placed in a drying cabinet where the
temperature range is between 65° C to 75° C SOP1.15
1.1.24 Safety instructions are followed during the operation of all
mechanical washers eg mechanical lifters for heavy equipment, lid is
kept closed during ultrasonic operation and no part of the operators
body is submerged inside the water tank of an ultrasonic cleaner during
operation SOP1.13
1.1.25 At the end of each cleaning session the manual cleaning
equipment is cleaned and thermally disinfected or sterilised SOP1.5
1.1.26 Powered instruments and hoses are cleaned as follows kept clean during surgical procedure
 cleaned with low-linting cloth, detergent and water
 not immersed in water
 not placed in a mechanical washer
 hose and handpiece to stay attached during cleaning
 inspect for wear and tear
 detergent rinsed off items
 drying cabinet to dry items
 test prior to sterilisation
 damaged tools and hoses sent for repair by a qualified person
SOP1.8
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RISK RATING &
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
STERILISING SERVICES AUDIT

CRITERIA
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
1. OPERATIONS cont.
1.1 CLEANING REUSABLE MEDICAL DEVICES
1.1.27 Cleaning flexible and ridged endoscopes involves immediately following the procedure the endoscope insertion tube is
to be wiped clean using clean water and an enzymatic cleaning
solution
 enzymatic solution is aspirated through the suction channel and
water and air is fed via the water/air channels (if applicable)
 all endoscopes are leak tested prior to immersion
 the endoscope is dismantled according to manufacturers
instructions
 components are cleaned with an enzymatic solution diluted
according to manufacturers instructions
 all taps are opened
 channels/lumen of the endoscope are brushed to remove any
debris
 cleaning process continues till the item is completely clean
 flush rinsing is carried out to remove traces of enzyme/detergent
 accessory items are placed in an ultrasonic cleaner following
manufactures instructions
 accessory items are flushed and rinsed following cleaning
 brushes used for cleaning the channels and lumens are cleaned
and thermally disinfected after each use
 after flush rinsing the endoscope and accessory item is thoroughly
dried
 internal lumens are purged with air
Endoscopy and Easi-Sterilise Cleaning of Complex Instruments
ADEQUATE
(100%)

OVERALL COMMENTS FOR THIS SECTION:

REQUIRES IMPROVEMENT
(>70% = 19/27)

INADEQUATE
(<70%)

STERILISING SERVICES AUDIT
CRITERIA

1. OPERATIONS cont.
1.2 PACKAGING & WRAPPING
1.2.1 Individual packs do not include combinations of hollowware,
instruments, dressings, drapes or tubing SOP2.5
1.2.2 Instruments with hinges or ratchets are opened and unlocked prior
to packing SOP2.5
1.2.3 Instruments with multiple parts are dismantled or loosened prior to
being packed in accordance with manufacturers instructions SOP2.5
1.2.4 When packaging instruments sets with delicate items, these items
are protected to prevent damage SOP2.5
1.2.5 When packaging sharp instruments the tips are protected to
prevent the perforation of the flexible packaging material SOP2.5
1.2.6 When packaging instruments that require lubrication the lubricant
is water miscible, compatible with the sterilising process and used in
accordance with manufacturers instructions SOP1.3
1.2.7 When packaging hollowware all openings face in the same direction
 non-porus spacers are used to separate each piece of hollowware
 contents cannot move inside the pack SOP2.5
1.2.8 When packaging powered instruments and hoses lubricate only as necessary, not inside the hose and follow
manufacturers instructions
 test prior to sterilisation
 disassemble prior to sterilisation
 hoses are loosely coiled SOP1.8
1.2.9 When determining size, mass and contents of items, consideration
is given to the sterilisers ability to effectively sterilise the pack
 facilitate the drying process of the pack
 establishing the efficiency of air elimination from the load SOP2.6
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ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
STERILISING SERVICES AUDIT
CRITERIA

1. OPERATIONS cont.
1.2 PACKAGING & WRAPPING
1.2.10 Prior to use, textile wraps are laundered and checked for holes
or threadbare patches SOP2.6
1.2.11 Only textile wraps as specified in AS3789.2, AS3789.8,
AS1079.2, AS1079.5 are used Disinfection & Sterilization Infection
Control Guidelines
1.2.12 Hollowware (gallipots) are placed with opening against the paper
side of the flexible wrapping material SOP2.6
1.2.13 Nylon packaging material is only used with a dry heat steriliser
Disinfection & Sterilization Infection Control Guidelines
1.2.14 Methods used to wrap items complies with AS 4187 page 31-32
SOP2.6
1.2.15 The method used to seal packs include heat sealers and
sterilising indicator tape SOP2.6 & SOP2.7
1.2.16 Only suitable equipment is used for heat sealing bags and
flexible packaging materials SOP2.7
1.2.17 After heat sealing packs the seal is checked to ensure that it is
complete (especially over gusset folds of bags or pouches) SOP2.7
1.2.18 Only non-toxic solvent based felt-tipped marking pens and/or
rubber stamps using simular ink are used for labelling packs prior to
processing SOP2.6
1.2.19 Each packaged item labelling includes contents of pack
 batch control data - Steriliser identification number, date of
sterilisation and cycle or load number
 batch control data information is also included in the steriliser log
sheet (eg by an additional label)
 operating suite place the batch control label or barcode from the
packaged item into the individual patients operating suite records
(SOP3.1 & SOP3.2
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ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
STERILISING SERVICES AUDIT

CRITERIA
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
1. OPERATIONS cont.
1.2 PACKAGING & WRAPPING
ADEQUATE
(100%)

REQUIRES IMPROVEMENT
(>70% = 13/19)

OVERALL COMMENTS FOR THIS SECTION:
1.3 STERILISING EQUIPMENT
1.3.1 The methods for processing used in the sterilising facility includes
(please identify) steam under pressure
 dry heat
 low temperature sterilisation Disinfection & Sterilization Infection
Control Guidelines
1.3.2 The sterilising cycle and temperature reflects the type of load and
wrapping material Disinfection & Sterilization Infection Control
Guidelines
1.3.3 Flash sterilisation is only used in situations where a single
instrument has been dropped and there is no duplicate instrument
available Disinfection & Sterilization Infection Control Guidelines
1.3.4 Flash sterilisers are only used for unwrapped non-porus items
NOT used to process cannulated, complex instruments, suction and
other tubing, textiles or paper Disinfection & Sterilization Infection
Control Guidelines
1.3.5 Portable sterilisers without a drying cycle are only used for
processing unwrapped items Disinfection & Sterilization Infection
Control Guidelines
1.3.6 Portable sterilisers with drying cycle are used to process small
numbers of simple packs Disinfection & Sterilization Infection Control
Guidelines
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INADEQUATE
(<70%)

STERILISING SERVICES AUDIT

CRITERIA
1.3.7 Dry heat sterilisers are used only to sterilise anhydrous items and
items sealed in impermeable containers which can not be sterilised by
steam under pressure Disinfection & Sterilization Infection Control
Guidelines
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM

1. OPERATIONS cont
1.3 STERILISING EQUIPMENT
1.3.8 Instruments that have been processed with liquid sterilants are
used immediately following processing Disinfection & Sterilization
Infection Control Guidelines
1.3.9 Non-woven wraps or non-cellulose flexible packaging materials
are used for Hydrogen Peroxide Plasma Sterilisers Disinfection &
Sterilization Infection Control Guidelines
1.3.10 Peracetic acid sterilising equipment –
 all channels of the flexible endoscope are connected in line for both
sterilising and water rinsing cycles,
 next a one minute purge of filtered air
 the unit remains sealed until released by the operator Disinfection &
Sterilization Infection Control Guidelines
ADEQUATE (100%)
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REQUIRES IMPROVEMENT
(>70% = 7/10)

OVERALL COMMENTS FOR THIS SECTION:
1.4 LOADING A STERILISER
1.4.1 When loading a steriliser, space is left between items being
processed and the items do not come in contact with the chambers
walls SOP3.2
1.4.2 Loading patterns and loading techniques are consistent with the
sterilisers loading pattern during Performance Qualification SOP3.2
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
INADEQUATE
(<70%)

STERILISING SERVICES AUDIT
CRITERIA
1.4.3 Flexible packaging material is loaded on the edge of the laminate
or placed flat with the paper surface downwards SOP3.2
1.4.4 Flexible endoscopes are processed with the buttons and valves
removed Endoscopy and Disinfection & Sterilization Infection Control
Guidelines
1.4.5 Accessory items for flexible endoscopes are sterilised using
chemical sterilant or packaged and sterilised Endoscopy and
Disinfection & Sterilization Infection Control Guidelines

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1. OPERATIONS cont.
1.4 LOADING A STERILISER
1.4.6 Once the steriliser is loaded the cycle is commenced SOP3.2
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Portable (benchtop), downward displacement and pre-vacuum sterilisers
1.4.7 Hollowware is tilted on its edge at a 45º angle in a draining
position and not placed above textile packs Disinfection & Sterilization
Infection Control Guidelines
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1.4 8 Packs of drapes are loaded with layers vertical Disinfection &
Sterilization Infection Control Guidelines
1.4.9 Only a single layer of packs is placed on the loading tray
Disinfection & Sterilization Infection Control Guidelines
1.4.10 Items to be sterilised unwrapped are placed on a perforated
mesh tray flat on the steriliser shelf with a new chemical indicator
placed in the loading tray Disinfection & Sterilization Infection Control
Guidelines
Hydrogen Peroxide Plasma Sterilisation
1.4.11 Consideration is given to the balance of metal and plastic items
being processed together to prevent inadequate processing SOP3.3
1.4.12 Adaptors/boosters are used for lumen instruments SOP3.3
Peracetic Acid Liquid Chemical Sterilisation
1.4.13 Care is taken when loading a machine with a direct flow
processing container/tray so that all surfaces are penetrated by the
liquid sterilant Endoscopy and Disinfection & Sterilization Infection
Control Guidelines
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ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
STERILISING SERVICES AUDIT

CRITERIA
1.4.14 In machines with flexible processing trays each instrument
channel is directly connected to machines fluid pathways via purposedesigned tubing adaptor kit Endoscopy and Disinfection & Sterilization
Infection Control Guidelines
ADEQUATE
(100%)

ACTIONS REQUIRED
REVIEW
DATE
BY WHOM

REQUIRES IMPROVEMENT
(>70% = 10/14)

INADEQUATE
(<70%)

OVERALL COMMENTS FOR THIS SECTION:
1. OPERATIONS cont.
1.5 UNLOADING OF STERILISERS
1.5.1 The steriliser door is not opened prior to completion of the
processing cycle SOP3.2
1.5.2 Cooling items are placed on racks not solid surfaces SOP3.4
1.5.3 Processed items are cooled before being place into new
polyethylene dust covers and sealed SOP3.4
1.5.4 When instruments are sterilised in an unwrapped cycle for a
sterile set up, the items are unloaded and used immediately using
aseptic technique Disinfection & Sterilization Infection Control
Guidelines
1.5.5 Peracetic acid liquid chemical sterilisation system – air seal is only
released when the cycle is completed Disinfection & Sterilization
Infection Control Guidelines
1.5.6 The sterilising parameters are checked prior to a load being
released SOP3.4
ADEQUATE
(100%)

OVERALL COMMENTS FOR THIS SECTION:

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
REQUIRES IMPROVEMENT
(>70% = 4/6)

INADEQUATE
(<70%)

STERILISING SERVICES AUDIT

CRITERIA
ACTIONS REQUIRED
REVIEW
DATE
BY WHOM
1. OPERATIONS cont.
1.6 STORAGE AND HANDLING OF PROCESSED ITEMS
1.6.1 Sterile items are not stored in ultraviolet cabinets or in
disinfectants Disinfection & Sterilization Infection Control Guidelines
1.6.2 All unwrapped medical items (including critical, semi-critical and
non-critical) undergo a cleaning and sterilising process prior to being
stored in a clean dedicated container/draw Disinfection & Sterilization
Infection Control Guidelines
1.6.3 Storage containers, trolley and cupboards are clean, dry and in
good condition (cardboard boxes are not used) SOP4.2
1.6.4 Access to the sterile stock area is restricted SOP4.2
ADEQUATE
(100%)

OVERALL COMMENTS FOR THIS SECTION:




REQUIRES IMPROVEMENT
(>70% = 3/4)

INADEQUATE
(<70%)
