ORAL HEALTH STERILIZINGASSESSMENT TOOL
District: Oral Health facility: Date:

CRITERIA

/  / RISK RATING &
ACTIONS REQUIRED / REVIEW DATE / BY WHOM
1. OPERATIONS
1.1 CLEANING REUSABLE DENTAL INSTRUMENTS & EQUIPMENT
1.1.1 All reusable items are cleaned in an area physically separate to other areas within the sterilizing processing facilityBuilding and Refurbishment
1.1.2 Before reusable items are returned to the sterilizing 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 must not become dry. QH D&S ICG Section 1
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 & QH D&S ICG Section 1
1.1.4 The collection container/trolley is cleaned at the end of each collection round of used reusable items SOP1 & QH D&S ICG Section 1
1.1.5 All items that have been unwrapped are considered to be contaminated and must undergo a full cleaning processSOP1
1.1.6 All items including specialised items (eg. powered tools, multi-part instruments) are cleaned in accordance with manufactures guidelines and appendix’s B&C of AS/NZS 4187:2003 and 4815:2006 SOP1 &Cleaning Complex instruments
1.1.7 In order to prevent damage to the surfaces of instruments or residual cleaning residue, abrasive cleaners such as steel wool or abrasive cleaning powders are not to be used SOP1
1.1.8 Chemicals are packaged and dispensed in a safe manner which prevents contamination SOP1
1.1.9 Cleaning methods within the department do not generate aerosols nor add to the formation of bioburden SOP1
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
1. OPERATIONS cont.
1.1 CLEANING REUSABLE INSTRUMENTS & EQUIPMENT
1.1.11 Cleaning methods used are appropriate for the design of the items being processed.
1.1.12 Any defective instruments are cleaned, dried and sterilized prior to being sent for repairs SOP1
1.1.13 At the completion of the cleaning process, items are visually inspected to ensure they are clean and free from detergent residue SOP2
1.1.14 All equipment and instruments undergo a mechanical cleaning process appropriate for the item and the items are processed for the complete cycle SOP1
1.1.15 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
  • brackets for hand pieces

1.1.16 Each time the ultrasonic cleaner is filled, water is added first, then the manufacturers recommended detergent followed by degassing of the machine before instruments are placed in the basket for processing SOP1
1.1.17 An ultrasonic cleaner is used to clean jointed, serrated, cannulated instruments not insulated instruments, mirrors or lenses SOP1
1.1.18 When items are removed following being cleaned in an ultrasonic they are rinsed in warm to hot water prior to drying SOP1
1.1.19 The ultrasonic solution is replaced at least daily or when the solution is contaminated SOP1
1.1.20 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
1.1.21 At the end of each cleaning session the manual cleaning equipment is cleaned and thermally disinfected or sterilized SOP1
1.1.22 Powered instruments and hoses are cleaned as follows-
  • kept clean during surgical procedure
  • cleaned with disposable low-lint 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 sterilization
  • damaged tools and hoses sent for repair by a qualified person SOP1

ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 16/22) / INADEQUATE
(<70%)
1.1 OVERALL COMMENTS FOR THIS SECTION:
1. OPERATIONS cont.
1.2 PACKAGING & WRAPPING
1.2.1 Individual packs do not include combinations of hollowware, instruments, dressings, drapes or tubing SOP2
1.2.2 Instruments with hinges or ratchets are opened and unlocked prior to packing SOP2
1.2.3 Instruments with multiple parts are dismantled or loosened prior to being packed in accordance with manufacturers instructions SOP2
1.2.4 When packaging instruments sets with delicate items, these items are protected to prevent damage SOP2
1.2.5 When packaging sharp instruments the tips are protected to prevent the perforation of the flexible packaging material SOP2
1.2.6 When packaging instruments that require lubrication the lubricant is water miscible, compatible with the sterilizing process and used in accordance with manufacturers instructions SOP1
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

1.2.8 When packaging powered instruments and hoses-
  • lubricate only as necessary, not inside the hose and follow manufacturers instructions
  • test prior to sterilization
  • disassemble prior to sterilization
  • hoses are loosely coiled SOP1

1.2.9 When determining size, mass and contents of items, consideration is given to the sterilizers ability to-
  • effectively sterilize the pack
  • facilitate the drying process of the pack
  • establishing the efficiency of air elimination from the load
SOP2
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
1.2.11 Only textile wraps as specified in AS3789.2, AS3789.8, AS1079.2, AS1079.5 are used QH D&S ICG Section 2
1.2.12 Hollowware (gallipots) are placed with opening against the paper side of the flexible wrapping material SOP2
1.2.13 Nylon packaging material is only used with a dry heat sterilizer QH D&S ICG Section 2
1.2.14 Methods used to wrap items complies with AS 4815:2006
1.2.15 The method used to seal packs include heat sealers and sterilizing indicator tape SOP2
1.2.16 Only suitable equipment is used for heat sealing bags and flexible packaging materials SOP2
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
1.2.18 Only non-toxic solvent based felt-tipped marking pens and/or rubber stamps using similar ink are used for labelling packs prior to processing SOP2
1.2.19 Each packaged item labelling includes-
  • contents of pack
  • batch control data - Sterilizer identification number, date of sterilization and cycle or load number
  • an additional batch control label is included in the sterilizer cycle record book
  • the treating clinician places the batch control label or barcode from the packaged item into the individual patients record SOP3

1. OPERATIONS cont.
1.2 PACKAGING & WRAPPING
ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 13/19) / INADEQUATE
(<70%)
1.2 OVERALL COMMENTS FOR THIS SECTION:
1. OPERATIONS cont.
1.3 STERILIZING EQUIPMENT
1.3.1 The methods for processing used in the sterilizing facility includes (please identify)-
  • steam under pressure
  • dry heat

1.3.2 The sterilizing cycle and temperature reflects the type of load and wrapping material QH D&S ICG Section 3
1.3.5 Portable sterilizers without a drying cycle are only used for processing unwrapped items QH D&S ICG Section 3
1.3.6 Portable sterilizers with a drying cycle are used to process small numbers of simple packs QH D&S ICG Section 3
1.3.7 Dry heat sterilizers are used only to sterilize anhydrous items and items sealed in impermeable containers which can not be sterilized by steam under pressure QH D&S ICG Section 3
ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 5/7) / INADEQUATE
(<70%)
1.3 OVERALL COMMENTS FOR THIS SECTION:
1. OPERATIONS cont.
1.4 LOADING A STERILIZER
1.4.1 When loading a sterilizer, space is left between items being processed and the items do not come in contact with the chambers walls SOP3
1.4.2 Loading patterns and loading techniques are consistent with the sterilizers loading pattern during Performance Qualification (PQ) SOP3
1.4.3 Flexible packaging material is loaded on the edge of the laminate or placed flat with the paper surface downwards SOP3
1.4.4 Once the sterilizer is loaded the cycle is commenced and monitored for the entire cycle SOP3
Portable (benchtop), downward displacement and pre-vacuum sterilizers
1.4.5 Hollowware is tilted on its edge at a 45º angle in a draining position and not placed above textile packs QH D&S ICG Section 3
1.4 6 Packs of drapes are loaded with layers vertical
QH D&S ICG Section 3
1.4.7 Only a single layer of packs is placed on the loading tray
QH D&S ICG Section 3
1.4.8 Items to be sterilized unwrapped are placed on a perforated mesh tray flat on the sterilizer shelf with a new chemical indicator placed in the loading tray (dependent on validation of the sterilizer) QH D&S ICG Section 3
1.4.9 A “control” pouch, containing a class 5 or 6 chemical indicator and batch label attached, shall be included in all sterilization cycles. It is not required in test cycles such as vacuum/leak test and air removal steam penetration tests e.g. Bowie Dick type tests (as per direction from the Chief Dental Officer, Jan 2010) SOP 3.2
1. OPERATIONS cont.
1.4 LOADING A STERILIZER
ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 7/9) / INADEQUATE
(<70%)
1.4 OVERALL COMMENTS FOR THIS SECTION:
1. OPERATIONS cont.
1.5 UNLOADING OF STERILIZERS
1.5.1 The sterilizer door is not opened prior to completion of the processing cycle SOP3
1.5.2 Cooling items are placed on racks not solid surfaces SOP3
1.5.3 Processed items are cooled before being place into new polyethylene dust covers and sealed SOP3
1.5.4 The sterilizing parameters are checked prior to a load being released SOP3
1.5.5 A sterilization cycle record is made for each cycle and shows specific contents and signatures of responsible persons SOP3
ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 4/5) / INADEQUATE
(<70%)
1.5 OVERALL COMMENTS FOR THIS SECTION:
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 QH D&S ICG Section 2
1.6.2 All unwrapped medical items (including critical, semi-critical and non-critical) undergo a cleaning and sterilizing process prior to being stored in a clean dedicated container/draw
QH D&S ICG Section 2
1.6.3 Storage containers, trolley and cupboards are clean, dry and in good condition (cardboard boxes are not used) SOP4
1.6.4 Access to the sterile stock area is restricted SOP4
ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 3/4) / INADEQUATE
(<70%)
1.6 OVERALL COMMENTS FOR THIS SECTION:
2. QUALITY ASSURANCE
2.1 CLEANING PROCESS & EQUIPMENT
2.1.1 The water supply is potable and good quality
SOP 5.1 & QH D&S ICG Section 2
2.1.2 The detergents and drying agents used in instrument cleaning are compatible with the quality of clean water supply SOP1.3 &QH D&S ICG Section 2
2.1.3 Cleaning agents are used as recommended by the manufacturer for their intended purpose: acid-based agents are only used for stainless steel surfaces; enzymatic cleaners used for sensitive equipment; household detergents are not used
SOP1.3 & QH D&S ICG Section 2
2.1.4 All mechanical cleaning equipment have daily checks of washer/disinfector function and detergent and rinse additives
SOP1.10 & SOP5.4
2.1.5 Automated washers disinfectors used to process semi-critical items intended for immediate use achieve the following time-temperature combination SOP 1 & SOP5QH D&S ICG Section 5
Surface T° Time
90° C 1min
80° C 10min
75° C 30min
70° C 100min
ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 4/5) / INADEQUATE
(<70%)
2.1 OVERALL COMMENTS FOR THIS SECTION:
2. QUALITY ASSURANCE cont.
2.2 MINIMUM STANDARDS FOR MONITORING OF MECHANICAL CLEANING EQUIPMENT
2.2.1 Automated washer disinfector machines-
  • documented time at temperature
  • check every cycle if thermal disinfection required
  • continuous performance checks for - T° and cleanliness of items to be checked after each load
  • documented daily test for chemical residue SOP5

2.2.2 Ultrasonic cleaner-
  • daily performance testing and documentation – aluminium foil test or pencil load or other test methods as per manufacturers instructions SOP5

2.2.3 Monitoring item cleaning and daily routine cleaning, checking cleaning equipment
  • efficiency testing SOP5
  • daily surface cleaning
  • checking and cleaning filters, door seals, jets, doors, door gaskets, base plates
  • detergent and rinse dispensers are clear and functioning
  • detergent and rinse additives are checked daily and replenished as necessary
  • continuous checks of switches, gauges and lights SOP5

ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 2/3) / INADEQUATE
(<70%)
2.2 OVERALL COMMENTS FOR THIS SECTION:
2. QUALITY ASSURANCE cont.
2.3 PACKAGING & WRAPPING
2.3.1 Each packaging and wrapping material used has been tested to establish penetration rates and drying characteristics
QH D&S ICG Section 2
2.3.2 All packaging and wrapping materials selected are compatible with the item being sterilized and the sterilizing process QH D&S ICG Section 2
2.3.3 Sterilizing indicator tape used for packaging has the following
  • is compatible with the selected wrapping material used
  • when processed changes colour which is uniform
  • distinctly different from the unprocessed tape
  • has the name of the manufacturer, batch number and date of manufacturer clearly marked on its core
  • is heat, moisture stable and permeable to sterilizing agents
  • only used to seal bags or laminating pouches in the event of breakdown of heat sealing equipment as per figure 3.3 page 34 AS/NZS 4815:2006 SOP2 & QHD&S ICG Section 2

2.3.4 Heat sealer-
  • daily check for seal integrity pre and post sterilizing
QH D&S ICG Section 2
2.3.5 The rigid containers used to pack items for sterilization allows for steam penetration and the removal of sterilizing agents plus has the ability to ensure sterility QH D&S ICG Section 2
2.3.6 Rigid containers have the following properties-
  • all components are easily disassembled for cleaning, drying and storage
  • for benchtop steam sterilizers, the base and lids are perforated
  • containers are compatible with cleaning and sterilization methods and equipment
  • adequate trials have been undertaken to assess use of the container system
  • onsite testing using physical & biological testing, & efficiency of drying cycle have been established during Performance Qualification
  • containers are not damaged QH D&S ICG Section 2

2. QUALITY ASSURANCE cont.
2.3 PACKAGING & WRAPPING
ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 4/6) / INADEQUATE
(<70%)
2.3 OVERALL COMMENTS FOR THIS SECTION:
2. QUALITY ASSURANCE cont.
2.4 STERILIZING EQUIPMENT
2.4.1 Dryness fraction of the sterilizers is 97% or above (a dryness fraction below 97% is associated with wet packs in steam sterilization) - for large sterilizers only QH D&S ICG Section 3
2.4.2 Steam is not superheated i.e. not heated beyond 2°C above the sterilizing temperature QH D&S ICG Section 3
2.4.3 Penetration times have been established and added to the holding times (121°C - 15mins, 132°C – 4 mins, 134°C – 3 mins) see page 36, AS/NZS 4815 QH D&S ICG Section 3
2.4.4 On completion of the sterilizer drying stage the load is immediately removed from the sterilizer and the following actions occur:
  • visual inspection of load occurs noting that the load is dry, seals are intact, correct labelling of the items and the sterilizing indicators have changed to the required colour
  • recording charts and print outs are checked and the sterilizers recording sheets are signed
  • loading cars with cooling items are not placed in a high activity area
  • recently processed items are not assisted to cool by means such as fans or boosted air-conditioning SOP3

ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 3/4) / INADEQUATE
(<70%)
2.4 OVERALL COMMENTS FOR THIS SECTION:
2. QUALITY ASSURANCE cont.
2.5 STERILIZER MONITORING & RECORDS
2.5.1 Daily routine checking and cleaning program for each type of sterilizer-
  • floor of sterilizer is free of debris
  • recording devices are functioning correctly
  • door gasket is undamaged
  • air filter is clean- if applicable
  • chamber drain (if present and applicable)
  • humidity reservoir, if externally fitted and applicable
  • distilled water container, if fitted- and applicable
  • lid seal and carrier undamaged
  • vaporizer system (if applicable) SOP5

2.5.2 Records are kept for each sterilizing cycle, which includes
  • date of cycle
  • sterilizer number or code
  • exposure time, temperature and pressure
  • name or identification of loading operator
  • name or identification of person authorised to release load contents form the sterilizing processing facility
  • specific contents of load including all packs, all items and all trays/cassettes
  • readout results of physical, chemical or biological/enzymatic indicators used SOP3

2.5.3 Pre-vacuum sterilizer-
  • every pack has an external chemical indicator
  • each cycle has an electronic printout
  • daily leak rate test where no air detector
  • daily Bowie Dick test
  • weekly leak rate test if air detector SOP5

2.5.4 Downward displacement (Jacketed) and portable bench-top sterilizers with drying cycle-
  • every pack has an external chemical indicator
  • every cycle has an electronic printout QH D&S ICG Section 3

2. QUALITY ASSURANCE cont.
2.5 STERILIZER MONITORING & RECORDS
ADEQUATE
(100%) / REQUIRES IMPROVEMENT
(>70% = 6/8) / INADEQUATE
(<70%)
2.5 OVERALL COMMENTS FOR THIS SECTION:
2. QUALITY ASSURANCE cont.
2.6 STERILIZER COMMISSIONING & VALIDATION
2.6.1 On commissioning of a sterilizer the following tests and checks are performed-
  • installation qualification
  • operational qualification
  • performance qualification of the sterilizer
  • certification of performance qualification of the sterilizer
QH D&S ICG Section 4
2.6.2 Recommissioning is performed when
  • engineering work that may have altered the performance of the sterilizer
when routine monitoring records, testing and performance prequalification indicates data outside the original parameters determined during validation QH D&S ICG Section 4
2.6.3 Performance qualification (PQ) is performed when-
  • after commissioning
  • whenever change to product, package to be processed or changes to loading pattern
  • 12 months (depending on calibration history)
QH D&S ICG Section 4
2.6.4 Installation qualification consists of -
  • environmental temperature and humidity is maintained within specified limits
  • there is no evidence of interference from or to other equipment during the sterilizing cycle
  • accuracy of T° and/or pressure measurement are within specified limits when verified by calibration
QH D&S ICG Section 4
2.6.5 Operational qualification consists of-