Transcript Short Version for Clinicians - CHRISP

Easi-Sterilise
Information session
for Clinicians
“Getting it right, every step of the way”
Why are we here?
 Patient and staff safety
 Directives from QH EMT for rapid implementation of
education and training following incidents
 Implementing a continuous quality improvement
program
 Acknowledge an absence in effective communication
when changes are made
 To build on current level of knowledge in light of ever
changing technology, standards, guidelines, advisories
and legislation
Aim of this workshop
Provide participants with an overview of the
Easi Sterilise Standard Operating Procedures
and outline the responsibility of the clinician
in ensuring that items have been through the
correct reprocessing and are able to be used
safely for patient care.
QH Commitment
Is to:
 Appropriately train and skill staff
 Provide information and resources so that
step-by-step quality processes are
consistently followed
 Assist in identifying gaps in knowledge and
provide opportunities for improvement
SOPs & WSAs
 To assist Oral Health facilities operationalise QH policy
and guidelines
 A resource for staff
 Update and supersede the OH Critical Instrument Tracking
(2003)
 A framework to assist staff identify competence and areas
where education and improvement may be needed
 A resource to identify opportunities for improvement within
the department that will require further education and
training
1.1 Standard Precautions
Standard precautions are applied as a first-line
approach to infection control. These form the
basis for your decision-making and practice.
Standard precautions are a set of guidelines
based on the assumption that all blood and
body fluids are potentially infectious.
1.1 Standard Precautions
In the context of sterilising practice and ALL the Standard
Operating Procedures, standard precautions include:
Hand Hygiene
Hand cream – approved by infection control – not
in packing area or handling of sterile stock
Personal Protective Equipment
• Gloves
• Face shields, hair protection, safety glasses and masks
• Fluid resistant gowns/aprons
OHS Requirements
1.2 Soiled Pickup Collection
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Standard Precautions - PPE
Contaminated items - dedicated collection trolley/container
Keep instrument sets together
Secure sharps
Collection containers are:
 puncture-resistant
 leak-proof and made of either plastic or metal
 with a lid or liner that can be closed
1.3 Sorting Prior To Cleaning
Instruments and items sorted by;
• Type
• Method of cleaning e.g. Manual , ultrasonic,
Instruments and items are checked for;
• Completeness
• Defects
• Sharps or blades that have not been removed
• Heavily soiled items
• Single use only items must not be returned for
reprocessing
Report concerns to supervisor
Cleaning
 Cleaning removes organic and inorganic soil, blood, fats etc
which contain pathogenic micro-organisms
 Gross Debris should be removed chairside
 Cleaning minimises contamination levels of bioburden
(number of micro-organisms) prior to sterilisation
 For sterilisation to occur the aim is to have a low number of
micro-organisms present on instruments
Cleaning
 Steam will not penetrate contamination left
on instruments
 If the item is not clean it won’t be sterilised
1.5 Pre Cleaning
 Pre cleaning (initial cleaning) allows for the removal
of visible blood, body fluids and debris from items
prior to cleaning (definitive cleaning). Pre cleaning
shall be undertaken as soon as possible (e.g. during
and post procedure chairside).
 If blood, proteins and other debris are allowed to dry
or remain in crevices and joints, the instruments
become very difficult to clean and are prone to
stiffness and accelerated corrosion.
1.5 Pre Cleaning
 Pre cleaning can be performed by methods
such as dry wiping, damp wiping or use of a
commercially available single use only
instrument sponge
 Place the dry wipe, damp wipe or sponge on
the bracket table and carefully wipe the
instrument across the material
1.6 Hand Cleaning For Immersible Items
Drying – As per manufacturer’s instructions
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Drying cabinet
Disposable low-lint cloth for hose, battery and external
parts
Air pressure gun (for removal of excess moisture)
Disposable syringe
1.6 Hand Cleaning For Immersible Items
Problems associated with incorrect drying
 Items should NOT be air dried/ dripped dry
Good conditions micro-organisms multiply in 20-30 minutes
 Wet packaging result in unsterile item
 Can cause rusting, corrosion, pitting to the item
 handpieces
Handpieces
 outside surfaces cleaned using
detergent wipe,
 rinsed by wiping
 dried
 slow speed motors
 outside surfaces cleaned using
detergent wipe,
 rinsed by wiping,
 dried
 lubricated (manually or automatic)
may need special adaptors
 Dried, wrapped & processed in a
wrapped cycle
Special adaptors may be needed
Special adaptors may be needed
Ideally, handpieces and
slow speed motors are
cleaned and lubricated
using mechanised
cleaning equipment
Special adaptors may be needed
1.8 Ultrasonic Cleaner
Purpose
Ultrasonic cleaning is a form of mechanical cleaning
that uses high frequency ultrasonic waves (cavitation)
that dislodges fine particles from the surfaces of
instruments.
1.8 Ultrasonic cleaner
Ultrasonic cleaning is an effective cleaning method for
instruments prior to the reprocessing
1.9 Washer Disinfector Machines
 Batch and continuous type washer disinfectors clean and
remove bio burden/micro-organisms (blood and debris)
 Thermal (high level) disinfection using time at
temperature – final rinse
 Means the cleaning process is verifiable
 Lumened items still require Flush brush Flush
 Unlock and open items
 Use appropriate washer baskets/inserts
 Keep sets together
1.9 Washer Disinfector Machines
REPORT IMMEDIATELY:
 Cycle parameters not meeting set requirements or
variations to cycle parameters – failed cycles
 Items that appear dirty or stained are returned to the
cleaning area for recleaning/destaining
 Excess water – check the following: the machine
temperature, amount of rinse aid going into the
machine or the way in which the machine was loaded
 Damaged instruments
1.9 Washer Disinfector Machines
Releasing the load and unloading the washer disinfector

Authorising release of the load occurs on completion of
washer disinfector cycle and prior to opening the door.

Check cycle parameters have been met and print out/log (or
equivalent) is signed

Care opening the doors due to heat and moisture

Inspect load not become dislodged or displaced

Avoid injury and damaging the equipment/instruments
Washer disinfector printout
Section 2
Packaging and Wrapping Procedures
2.1 Organisation Of Packing Area
Organised packing area ensures a clean, safe work working area
that reduces the risk of equipment damage/loss and unsafe
work practices.
2.2 Assembly Of Instrument Trays And
Hollowware
Prepare equipment for sterilization:
Check multi-part equipment / instruments
 can be assembled and functioning
 then disassembled or loosely assembled for sterilisation as
per manufacturers instructions
 Hinged or ratchet instruments are opened and unlocked
 Sharp items protected with a tip protector or enclosed in
a cassette
2.2 Assembly Of Instrument Trays And
Hollowware

When packaging hollowware sets:
 Openings are to face in the same direction,
 Hollowware should not be able to move, and
 If hollowware is nestled - insert separators

Individual packs do not include combinations of hollowware,
instruments, gauze dressings, drapes or tubing
2.3 Wrapping and Packaging
Provides a protective barrier against sources of
potential contamination. Wrapping/packaging
methods must facilitate aseptic removal of
contents
2.3 Wrapping, Packaging &
Labelling
 Wrapped items
 The method shall be envelope fold or square fold technique
 The type and method of wrapping and packaging is facility
specific
 Check prior to use the wrapping material is not damaged or
expired
 The class 1 chemical indicator tape used for sealing will be
specific to the mode of sterilisation (pressure sensitive, nontoxic and adhere to clean surface)
 Ensure tape is adhered to wrapping/packaging material
2.3 Wrapping, Packaging &
Labelling
 Flexible packaging materials
 Check for damage and expiry date
 Correct size pouch for contents
 Hollowware openings are against non-laminate
surface
 Any writing required should be done on the outer
parameter of the flexible packaging material.
 Self sealing pouches must be sealed by folding the
flap along perforation/dotted line as indicated by
the manufacturer.
 Pouches shall only be filled up to ¾ of the overall
space, allowing approximately 5 cm seal area
2.3 Wrapping, Packaging &
Labelling
 Labelling of packs:
 All packs, bags, pouches and wrapped items must
be labelled if contents are not visible
 Use a non-toxic, water resistant, felt tipped
marking pens and rubber stamps using similar ink
or pre-printed tape
 Writing on wrapping could damage the integrity
of the material
2.3 Labelling

To occur prior to the sterilizing process utilising:
1. Batch labels (piggyback)
Details on the batch label gun must be checked and updated for
each sterilizer cycle. The minimum information required on each
label must include;
• Date of sterilization
• Sterilizer number
• Sterilizer cycle number
Blue = Unprocessed
Sterilizer
number
Colour interpretation chart
2.4 Using and Reloading Batch Label
Gun
 Upper adjustable print display - Setting the
date and the steriliser number
 Date must appear as DD(space)MM(space)YY
starting from the far left
 The sterilizer number must be positioned to
the far right
White mark
(R) Side - Steriliser
number
(L) Side
Date - dd mm yy
Steriliser cycle number
White mark
Chemical Indicators
 Class 1 – Process indicator – exposure to a sterilisation
process – shows processed/unprocessed e.g sterilising tape,
external chemical indicators.
 Class 2 – Specific tests e.g Bowie Dick type test
 Class 3 – Single parameter – critical parameter e.g. dry heat
 Class 4 – Multi parameter eg. Time at Temp.
 Class 5 – Integrating indicator – time temp and moisture
 Class 6 – Emulating indicator (cycle verification) – eg. 134°C @
3.5 min
Chemical Indicators
do not indicate sterilization
 Written information about the indicators shall be
obtained from the supplier covering:
(a) How to interpret indicator results.
(b) The factors affecting end-point colour change
during storage of sterilized items.
(c) The sterilization conditions that the indicator will
detect.
(d) The storage requirements and shelf-life of the
indicator itself.
Packaging Instruments & Class 1
Chemical Indicators
Packaging Instruments
Dental Instruments
 Sterile at point-of-use
 must be stored to maintain sterile
conditions
 must be tracked when used
Extraction instruments
The
way
we
were……
Section 3
Sterilising
3.1 Batching & Recording of a load prior
to sterilisation
 MUST HAVE DOCUMENTED EVIDENCE OF ALL ITEMS
of a sterilising process = tracking/tracing proof
 Assists in the recall of an item/load
 Recording of load contents assists in compiling of
statistical data on production volume
Warning: Do Not Store Unprocessed
Items In The Sterilizer
 The sterilization cycle shall be commenced immediately after
loading.
 Warm, moist atmosphere of the chamber can lead to—
 (a) release of unprocessed items for use;
 (b) contamination of packaging by condensate;
 (c) an increase in bioburden on unprocessed items; and
 (d) the deterioration of:
 (i) chemical indicators, packaging and labelling; and
 (ii) adhesive of self seal pouches, labelling and sterilizing tape.
Downward Displacement
Validator Plus Steriliser
.
bench top class N
downward
displacement
autoclave capable
of processing both
wrapped and
unwrapped loads
Small Pre vacuum
Lisa 500 series
Large Pre-vacuum Sterilisers
3.2 LOADING AND RECORDING OF ITEMS
FOR STEAM STERILISATION
 Sterilant needs to have contact and/or penetrate all surfaces
of the all items
Do not:
 crush items together
 allow items to touch the floor, top, door or walls of the
chamber
 Allow enough space between each item for:
 air removal,
 steam penetration,
 draining of condensate
 drying to occur
Loading the steriliser
 All loads/cycles must have a chemical
indicator to distinguish between processed
and unprocessed loads
 A “control” pouch containing a class 5 or 6
chemical indicator and batch label attached is
included in all loads as per direction from the
Chief Dental Officer, Jan 2010
Loading of Laminated Packaged
Instruments
Loading hollow ware & pouches
Place hollow ware on a 45 degree angle
Lisa 500 series
Examples of sterilisation cycles
Recognised International
Temperature, Pressure, Time
Relationship
International Units of Pressure
Temp C
kPa
psi
mb
bar
Holding time
(minutes)
121
103
15
1030
1.03
15
126
138
20
1380
1.38
10
132
186
27
1860
1.86
4
134
203
30
2030
2.03
3
Physical checks
Cycle completed check print out for:
 Temperature has reached 134°C
 Time at 134°C > 3 mins + penetration time
 Pressure 203kpa or 2030mb or 30psi
stand alone printer
Other types?
In built printer
Top of the printout
New Lisa 500 series manual
W&H Lisa™
Manual
3.3 Releasing & Unloading a Sterilised Load
 To ensure that the staff unloading the
steriliser check that sterilisation has occurred
in accordance with the validated process and
authorises the release of the load
3.3 Releasing & Unloading a Sterilised Load
 Ensures that the sterilant has contact with, and/or penetrates
all surfaces of all items being reprocessed
Immediately cycle has completed - Visually check
 Chemical indicators have changed colour correctly
 No visible wet packs & packs intact
 Printout confirms sterilisation parameters are met – sign
 If no printer, check the class 4,5 or 6 chemical indicator
3.3 Releasing & Unloading a Sterilised Load
 Only in exceptional circumstances (such as
involved in providing direct patient care)
would a delay to removing a completed
sterilization load, be considered acceptable
and no more than 30 minutes from when the
cycle has finished.
3.3 Releasing & Unloading a Sterilised Load
When releasing and authorising the load for use :
 Check items unloaded correspond with load
documentation
 Check and record results of process challenge
devices (if used) on sterilizing log chart
 Check and record results of biological indicator (if
used) on sterilizing log chart
3.3 Releasing & Unloading a Sterilised Load
Document in steriliser record/log
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Sign the sterilizer cycle printout and attach
Document time of release
Signature or identification of person releasing the load
Ensure the items unloaded correspond with load
documentation
 Attach the “control” pouch batch label
 Attach the control class 5 chemical indicator
 Immediately notify the supervisor if not met.
Cooling items

 Away from high activity areas
 Do not use forced cooling by fans or air con.
 Do not place on solid surfaces, as condensation
from vapour (still within the pack) can result.
 Items dropped on the floor, placed on a dirty
surface, compressed, torn, have broken seals,
or are wet, are considered non-sterile and shall
be reprocessed.
The key pieces of legislation relating to
recordkeeping are
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Public Records Act 2002
Public Services Act 1996
Electronic Transactions (Qld) Act 2001
Evidence Act 1977
 See also QH clinical records retention and disposal
schedule
 http://paweb.sth.health.qld.gov.au/sqrm/hims/recor
ds/documents/disposal_retention_sched.pdf
Each Sterilizer’s
information is written
once on the front
page
Found
on
CHRISP
Oral
Health
website
In the case where one or more items (but not all) have failed,
in a successful cycle
Section 4
Stock management
4.1 Dedicated Area For Sterile Goods
 Only those sites that can ensure
environmental control (temperature and
humidity) and meet sterile stock storage
requirements of AS/NZS 4815 can move to
event related sterility. If these storage
requirements can not be met the unused
items must be reprocessed after 3 months
4.1 Dedicated Area For Sterile Goods
Environmental considerations for Event Related Sterility
 Temperatures in this area are in the range 18◦C - 22◦C
with a relative humidity ranging from 35% - 68%
 Secure from public access
 Limited staff thoroughfare/working in this area
 Sterile goods shall always be segregated from nonsterile goods
 Protected from direct sunlight
4.1 Dedicated Area For Sterile Goods
Environmental considerations for Event Related Sterility
 For open shelving store items 250mm above floor level
& at least 400mm from ceiling fixtures
 Surfaces such as walls, floors, ceilings and shelving
shall be non-porous, smooth and easily cleaned
 Air-conditioning & ventilation conditions should be in
accordance with AS1668.2
 New overhead lighting is fitted flush to the ceiling to
minimise dust entrapment
4.1 Dedicated Area For Sterile Goods
 The environment shall be
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Dedicated storage areas
Store in a clean, dry, dust free environment
Insects and vermin free
Protected from direct sunlight
250mm above floor level & at least 400mm from
ceiling fixtures
4.2 Stock Rotation
 The purpose of stock rotation is to use sterile stock
according to the date of manufacture.
/sterilisation
 Rotate stock so previously sterilised and stored items
will be used first
 Take from left & replace to the right
 Handle only when necessary
 Do not overstock – damage & compromise
Time-Related Sterility
 based upon an arbitrary date allocated to sterilised
packs/pouches etc by which they should undergo reprocessing and sterilisation if they have not been
used
 if storage & handling conditions are not ideal, or if
the packages are frequently handled, items may
need to be reprocessed more frequently
Event-Related Sterility
 This process is a method of determining if an item is
still sterile by assessing whether it has undergone any
events, which may have compromised its sterility,
such as
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Incorrect cleaning in storage areas
Moisture and condensation
Exposure to harsh as well as external climatic conditions
Dust, Vermin and insects
torn/soiled wrapping or poor storage
Maintain sterile stock
Do Not
 Handle without washing and drying hands
 Pack in a manner that could damage the wrapping
 Bundle using rubber bands or similar
 Stack on top of each other - they should be stored
vertically
 Place on or near potentially wet surfaces
 Exposed to aerosolising procedures – only take to
chairside what is needed.
Section 5
Quality
5.1 Water Quality
 To ensure water used in cleaning of re-usable
medical devices is of optimum quality for
effective and efficient processing
Water quality for cleaning
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Water quality affects cleaning procedures
Water must be potable (drinking quality)
Hard water = calcium and magnesium
Damages instruments
Damages equipment
May prevent chemicals working as intended
Unfiltered tap water may contain excessive amounts of
microorganisms depending on source
5.3 Ultrasonic Machine Testing
 Ensures that the machine is functioning effectively.
 Testing can be accomplished using validated test
methods to prove that the transducers are working
effectively soil is able to be removed – new test
methods in development
 Daily test or each day of use
 Document results
 Report test failures
5.4 Mechanical Washer Cycle Monitoring
Proof that the mechanical washer disinfector
attains the correct parameters for the set
cycle and thus enables the conditions for
effective cleaning and/or thermal disinfection
5.4 Mechanical Washer Cycle Monitoring
Washer/disinfectors usually operate within the following
temperature ranges
Rinsing:
40°C - 50°C
Washing:
50°C - 60°C
Disinfecting:
70º for 100mins
75º for 30 mins
80º for 10 mins
90º for 1 min
Final rinsing: 80°C - 90°C
All results shall be checked prior to the release of each load and
the printout signed
5.5 Internal & External Chemical Control
External and or internal chemical control
(indicators) shall be used to identify that an
item has been through a sterilising process.
The indicators are specific to the sterilising
process being used eg. Steam, hydrogen
peroxide, ethylene oxide, peracetic acid
5.5 Internal & External Chemical Control
Control Pouch (Mandatory)
 A separate sterilising pouch with a 'control'
Class 1 chemical indicator and batch label
attached and a Class 5 or 6 Chemical Indicator
inside, must be placed onto a sterilizer tray
and used in every sterilization cycle.
5.5 Internal & External Chemical Control
Internal
 An appropriate internal multi parameter time and
temperature chemical indicator (Class 5 or 6) is used
in the following circumstances:
 In the mandatory OH Control pouch
 Where delays to access to on-site technical support
to undertake calibration, operational qualification
and performance qualification for new sterilizers or
temporarily loaned sterilizers occur.
5.5 Internal & External Chemical Control
External (Mandatory) – Class 1 chemical indicator
Examples include;
 sterilizer indicator tape
 chemical indicators found on commercially
manufactured packs/pouches
5.6 Biological Indicators
Biological indicators are used to verify the
microbial killing power of 10-6 of the
sterilisation process by using a population of
calibrated bacterial spores, on, or in, a carrier
and packaged in a manner that the integrity of
the inoculated carrier is maintained.
 Routine biological testing is not mandatory
for steam sterilisers if process is validated
5.7 Leak Rate (Vacuum) Test
 To verify that air has not leaked into the sterilising chamber.
 The leak rate/vacuum test is not a sterilisation cycle.
 It is a special programmed cycle that draws a vacuum and
holds the vacuum for a minimum of 10 minutes. If the rate of
air that leaks into the chamber via a leaking chamber seal or
hole in piping, a pressure rise will be measured that is greater
than 1.3 kPa/min over 10 minutes, a fault indicator and
printout.
 The level of vacuum will be different for each machine. The
important thing is that it remains within 1.3kPa/min of the
vacuum over the 10 minute period.
5.7 Leak Rate (vacuum) Test
Class B and Class S sterilisers with air detector – weekly
Class B and Class S sterilisers without air detector – daily
Record the results.
5.8 BOWIE DICK TYPE TEST
5.8 Bowie Dick Type Test
To detect air entrapment and evaluate the
ability of a pre-vacuum steriliser to remove
residual air that will then allow the steam
penetration and attainment of the correct
conditions for steam sterilisation.
Needs a special cycle
Daily on a warmed up steriliser before loads
Different types on the market
5.9 Routine Cleaning of Reprocessing
Equipment
Equipment
Maintenance
example
Daily
Ultrasonic
All internal and
external surfaces
Washer
disinfector
Filters, spray arms,
drains, door seals,
gaskets,
Weekly
3 Monthly
6 monthly
Clean
chamber
Replace air
filter
clean water
chambers
Drying cabinet All surfaces
Filters, door seals,
vents, door gaskets.
Steam
sterilisers
Drain, floor of
steriliser, door seal,
Validation Documentation
Important to document all the procedures!
1. pre-cleaning
2. cleaning
3. drying of instruments
4. packaging
5. loading steriliser
6. unloading steriliser
7. physical checks
8. sterilisation log book
9. storage of sterile items
10.validation of YOUR sterilisation process
Annual validation
performance qualification (PQ)
What is validation?
A documented procedure for obtaining, recording and
interpreting the results required to establish that a process
will consistently yield product complying with predetermined
specifications.
What does this mean?
The entire process is documented, challenged and
repeatable, and establishes the efficacy (or not) of the
sterilising process, that is monitored by the measurement of
the critical requirements of time, temperature and pressure
and parameters during each cycle.
Commissioning of sterilisers
Installation Qualification (IQ)
Proves that the steriliser and the where installed
comply with the manufacturer’s specifications
Operational Qualifications (OQ)
Determines that the installed steriliser and
equipment is working within the defined limits
when used as per manufacturer’s procedures.
These shall documented and recorded and include
calibration of all gauges, parameter monitoring, the
recording device, specific performance tests (eg leak
test) and process indicator tests (bowie dick tests)
Validation
IQ+OQ+PQ
Commissioning
(IQ) + (OQ)
Installation
Qualification (IQ)
Operational
Qualification (OQ)
Performance
qualification (PQ)
Physical qualification &
testing
Microbiological
qualification & testing
Installation qualification (IQ)
Heat distribution study
Temperature profile “Cold Spot”
 Service technician performs (empty chamber)
whilst calibrating the temperature gauge.
 Or may be provided by the manufacturer.
 Doesn’t need to be routinely checked every time.
Performance qualification (PQ)
physical qualification
 Time at temperature and pressure testing
 Thermocouple testing to ensure the inside of the
packs of your challenge load has reached the
selected temperature x 3 times with BI’s
 Hold at or slightly above this temperature and at the
correct pressure
 Must be done at every validation
 Whole load that will be considered your “validated,
challenged load” needs to be available.
When
Validation shall be repeated annually and every time significant
changes are made.
Examples of such changes include, but are not limited to, the
following:
(a) Any change to the sterilization parameters
(b) Changes in packaging or loading specification which would
provide a greater challenge to the sterilization process.
(c) Changes in the items or types of instruments to be sterilized,
such as the addition of a new complex medical item which
would provide a greater challenge to the sterilization process.
More Information
 Contact:
 Email: [email protected]
 Intranet for SOP & WSA:
http://www.health.qld.gov.au/chrisp/sterilising/oral_health
_SOP.asp