cep Cleaning of Dental Instruments Scottish Dental Clinical Effectiveness Programme

Transcription

Scottish Dental
Clinical Effectiveness Programme SDcep
The Scottish Dental Clinical Effectiveness Programme (SDCEP) is an initiative
of the National Dental Advisory Committee (NDAC) and is supported by the
Scottish Executive and NHS Education for Scotland. The Programme aims
to provide user-friendly, evidence-based guidance for the dental profession
in Scotland.
Cleaning of Dental Instruments
Dental Clinical Guidance
SDCEP guidance is designed to help the dental team provide improved care
for patients by bringing together, in a structured manner, the best available
information that is relevant to priority areas in dentistry, and presenting this
information in a form that can be interpreted easily and implemented.
‘Cleaning of Dental Instruments’ is the first of the SDCEP series
‘Decontamination Into Practice’, which aims to help the evolution towards
compliance with relevant statutory and mandatory requirements and
standards. ‘Cleaning of Dental Instruments’ provides advice on all aspects
of cleaning, including organising the decontamination area, cleaning
methods and testing of equipment.
Scottish Dental Clinical Effectiveness Programme
Dundee Dental Education Centre, Frankland Building,
Small’s Wynd, Dundee DD1 4HN
Email
scottishdental.cep@nes.scot.nhs.uk
Tel
01382 425751 / 425771
Website www.scottishdental.org/cep
March 2007
Scottish Dental
The Scottish Dental Clinical Effectiveness Programme (SDCEP) is an
initiative of the National Dental Advisory Committee (NDAC) and is
supported by the Scottish Executive and NHS Education for Scotland.
The Programme aims to provide user-friendly, evidence-based guidance
for the dental profession in Scotland.
SDCEP guidance is designed to help the dental team provide improved
care for patients by bringing together, in a structured manner, the best
available information that is relevant to priority areas in dentistry, and
presenting this information in a form that can be interpreted easily and
implemented.
‘Supporting the dental team to provide quality patient care’
Scottish Dental
March 2007
© Scottish Dental Clinical Effectiveness Programme
ISBN 978 1 905829 03 3
First published March 2007
Dundee Dental Education Centre, Frankland Building, Small’s Wynd, Dundee DD1 4HN
Email
Tel
01382 425751 / 425771
1
Introduction
1
2
Organising Cleaning Within the Decontamination Area
2
2.1
2.2
2.2.1
2.2.2
2.3
2.4
2.4.1
2
2
3
4
4
4
5
3
Pre-cleaning Procedure
3.1
3.2
3.3
3.4
3.5
3.6
4
5
6
Purchasing Instruments and Training Staff
Setting Up a Decontamination Area
Physical Segregation
Temporal Separation
Ventilation
Hand Hygiene
Good Practice Points
During Treatment
Taking Instruments to the Decontamination Area
Segregating Instruments
Items for Disposal
Re-usable Instruments
Items Unsuitable for Immersion
7
7
7
8
8
10
10
Cleaning Methods
11
4.1
4.2
4.2.1
4.2.2
4.2.3
4.3
4.3.1
4.3.2
4.3.3
4.4
4.4.1
4.4.2
11
12
12
13
13
14
14
15
16
17
18
21
General Requirements for Each Cleaning Method
Manual Cleaning
Workflow and Facilities
Cleaning Procedure
Avoiding Instrument Damage
Ultrasonic Cleaning
Points to Consider Before Purchasing an Ultrasonic Cleaner
Validating the Operating Procedure for Ultrasonic Cleaners
Ultrasonic Cleaning Procedure
Washer-disinfectors
Points to Consider Before Purchasing a Washer-disinfector
Using a Washer-disinfector
Rinsing, Drying, Inspection and Care of Instruments
22
5.1
5.2
5.2.1
5.2.2
5.2.3
5.2.4
5.3
22
22
23
23
23
23
24
Rinsing and Drying of Instruments after Cleaning
Inspection and Care of Instruments before Sterilizing
Inspection for Cleanliness
Functional Inspection
Lubrication
Handpiece Care
Out-of-hours Use of Instruments
Validation, Testing and Maintenance of Cleaning Equipment
25
6.1
6.2
6.2.1
6.2.2
6.3
6.3.1
6.3.2
25
25
25
25
27
27
28
Validation
Maintenance and Testing of an Ultrasonic Cleaner
Maintenance
Testing
Installation and Testing of a Washer-disinfector
Installation
Routine Testing
iii
iv
1
Introduction
Decontamination of dental instruments and
equipment ideally involves cleaning, thermal
disinfection and sterilization and is an important
branch of infection control. Effective cleaning is
essential to enable disinfection and sterilization of
instruments to be carried out reliably. Any organic
material or adherent dental materials left on
instruments can inhibit these processes. This can
also cause corrosion of instruments or impair their
function, and might lead to cross-infection from
one patient to another.
The Scottish Dental Clinical Effectiveness
Programme is providing a series of guidance
documents entitled ‘Decontamination Into Practice’ that addresses different aspects of instrument
decontamination. This series is part of a national initiative to standardise good decontamination
practice.
Aimed specifically at those working in primary care dental services, ‘Cleaning of Dental Instruments’
presents practical advice on the first stage of the decontamination process: how to thoroughly clean
dental instruments. This advice is based on a range of existing guidance documents and has been
developed through consultation with the Health Protection Scotland (HPS) Decontamination Team,
other experts and end-users.
Supplementary advice that relates to the whole decontamination process is provided separately in the
appendices. Decontamination-related weblinks are also included throughout the text for those who
need additional information. Many of these links can be accessed via the Decontamination section of
the ScottishDental website: www.scottishdental.org/decontam. In particular, the following Scottish
Health Technical Memoranda (SHTM) have detailed information on how to choose, use and validate
equipment for decontamination processes:
• SHTM 2010 Sterilization
• SHTM 2030 Washer-Disinfectors (also includes ultrasonic cleaning machines)
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2
Organising Cleaning Within the
Decontamination Area
2.1
Purchasing Instruments and Training Staff
Before buying instruments:
• check the manufacturer’s decontamination instructions to ensure that the
instruments can be decontaminated with the facilities that you have available, or
buy single-use instruments;
• give preference to buying instruments that can be cleaned using automated methods
(e.g. washer-disinfector) that you might adopt in the future.
Train all staff in the basics of infection control procedures, including:
• how infections are transmitted;
• how to prevent transmission of infections;
• what to do in the event of an accident or personal injury;
• your practice policy on infection control.
Ensure staff are fully vaccinated against hepatitis B.
For staff involved in cleaning instruments, give practical training in all stages of the decontamination
process.
Record details of training in the staff training manual or each individual’s personal development
file.
Ensure personal protective equipment (PPE) (i.e. gloves, facemask, eye protection, plastic disposable
aprons and adequate footwear) is available and worn. This provides a protective barrier against
the spread of infections through contact with blood or body fluids either directly or via splatter or
aerosol spray.
2.2
Setting Up a Decontamination Area
Use a dedicated decontamination area, separated from the patient treatment area, preferably in
another room or rooms.
• If, through lack of space, decontamination has to be carried out in a patient treatment
room, minimise the risk to patients by deferring decontamination until the room is
unoccupied and ensure that rigorous environmental cleaning is carried out between
clinical and decontamination activities. As this takes time and will inevitably affect
the frequency of patient appointments, plan to move towards a separate dedicated
decontamination area as soon as possible.
• When setting up new premises or planning significant modification to existing
premises, consider having two rooms for decontamination that are separate from
the patient treatment area(s): one for dirty activity (cleaning instruments) and one
for clean activity (inspection, sterilization and wrapping instruments). This is the
preferred arrangement.
2
2
Irrespective of the specific layout, a tidy working environment makes carrying out decontamination
easier. Therefore, declutter your working environment.
Carry out the decontamination process as a dirty-to-clean workflow that ensures dirty instruments
or splashes or aerosols generated during cleaning do not come into contact with clean instruments.
This is a one-way process that can be achieved by physical segregation or temporal separation.
Advice on environmental cleaning is given in ‘Control of the Environment Policy and Procedure’,
published by Health Protection Scotland (HPS) (available via www.scottishdental.org/decontam).
2.2.1 Physical Segregation
Physical segregation means using different areas for different activities.
Set up a decontamination area that preferably comprises a single run of sealed, easily cleaned
worktop with the following items arranged in the order listed:
• a separate hand-washing sink;
• a setting-down area for dirty instruments;
• a washing sink with detergent for cleaning instruments;
• a setting-down area for washed instruments;
• an ultrasonic cleaner, if appropriate (see Sections 4 and 6);
• a rinsing sink;
• a setting-down area for rinsed instruments;
• an automated washer-disinfector (includes drying cycle);
• a setting-down area with task lighting and magnifier for inspection of all instruments
(to check instruments for visible contamination and functionality or damage, and to
ensure instruments are dry);
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• an area for wrapping instruments (only if a benchtop vacuum sterilizer is to be
used);
• a steam sterilizer;
• an area for setting down and wrapping instruments sterilized in a benchtop nonvacuum (bowl and instrument) sterilizer;
• clean, orderly, enclosed storage for instruments prior to use (not open shelving);
• a dedicated, clean, rigid, labelled box with a lid to transport instruments to the
clinical area safely and securely.
2.2.2 Temporal Separation
Temporal separation means using the same area for two separate activities at different times.
If, through lack of space, a work surface is used for both dirty and clean instruments, ensure that
the surface is thoroughly cleaned, and if necessary disinfected, between the two activities to avoid
recontamination of cleaned instruments.
Regard temporal separation as a temporary arrangement and plan to increase the space for the
decontamination area to enable physical segregation of decontamination activities as soon as
possible.
2.3
Ventilation
Within the decontamination area, ensure that air flow is maintained away from the patient area
and does not carry contaminants from the dirty area to the clean area.
Do not use portable fans in the decontamination area because rapid uncontrolled air circulation
can spread contamination.
More-detailed information on planning decontamination facilities, including basic ventilation
requirements for local decontamination units, is currently under development and will be published
as Scottish Hospital Planning Note 13.
2.4
Hand Hygiene
The term hand hygiene covers not only hand washing, but also alternative and additional measures
such as hand disinfection using alcohol rubs/gels. Hand hygiene is crucial in preventing the spread
of infection.
Gloves are not a substitute for hand hygiene because microorganisms flourish under gloves.
Therefore, clean hands before and after using gloves.
4
2
There are three different levels of hand hygiene. The level required depends on the potential for,
or actual, contamination of the hands. Carry out a risk assessment of the level required before
and after different procedures.
Advice on how and when to employ the three levels of hand hygiene is given in ‘Hand Hygiene Policy
and Procedure’ published by HPS (available via www.scottishdental.org/decontam). A summary of
the three levels is provided in Appendix 2.
2.4.1 Good Practice Points
Staff
Keep nails short and clean. Do not wear artificial nails or extensions or nail varnish if working in
the clinical environment, including decontamination areas.
Remove wrist and hand jewellery, including wrist watches, before working in the clinical
environment or the decontamination area. A plain wedding band is acceptable but this must be
moved or removed when performing hand hygiene to ensure the area under the ring is cleaned
and dried thoroughly.
Facilities and procedures
Ensure that there is a separate sink for hand washing in the decontamination area and that the
sink:
• does not have a plug or an overflow and is fitted with a remote running trap (i.e. the
U bend is not directly under the plughole);
• has an electronic sensor-operated or elbow/wrist lever-operated mixer tap;
• has a tap that runs into the sink basin and not straight
down the drain to avoid aerosol from the drainage
system splashing back onto the user.
Use wall-mounted liquid handwash dispensers with
disposable cartridges and ensure the nozzle is kept clean.
Do not use refillable handwash containers as bacteria can
multiply within many of these products and are therefore a
potential source of contamination.
Apply the handwash to wet hands to reduce the risk of
irritation, and perform hand washing under running water.
• Details of the types of products to be used for different
levels of hand hygiene can be obtained from the HPS
‘Hand Hygiene Policy and Procedure’ (available via
www.scottishdental.org/decontam).
5
2
Do not use bar soap.
Do not use scrub or nail brushes because these can cause abrasion of the skin, and can be a
source of infection.
Use paper hand-towels and foot-operated or sensor-operated waste bins.
Ensure your paper towels and drying technique do not damage the skin.
Use a hand cream following hand washing at the end of a session to counteract dryness but do
not use hand cream under gloves because this can encourage growth of microorganisms.
Alcohol-based skin disinfectant hand rubs/gels formulated for use without water can be used on
visibly clean hands instead of hand washing between patients during surgery sessions.
• Follow local infection control guidance or manufacturers’ instructions on the
maximum number of applications of alcohol hand rubs/gels that can be used on
physically clean hands before hand washing is required. Be aware that build-up of
product on the hands occurs with repeated application.
Do not use alcohol-impregnated wipes as a substitute for hand rubs/gels because this is not
effective in hand decontamination.
Moving from dirty to clean areas
When you shift from working in a designated dirty area to a clean area change your gloves and
plastic apron. Wash your hands or use alcohol rub/gel on visibly clean hands when you change
gloves.
Ensure your local infection control policy specifies when PPE is to be worn and changed.
6
3
Review manufacturers’ instructions prior to purchase of instruments to ensure that all devices can
be appropriately decontaminated. Failure to comply with manufacturers’ instructions can affect
product guarantees and warranties.
Train staff in how to prepare properly for decontamination of the range of devices used in your
practice, including transporting contaminated instruments, disposing of single-use items correctly,
dismantling instruments when appropriate and selecting the most appropriate cleaning method
for each instrument (see below and Section 4).
Remember to include new instruments in staff training and keep staff training records up to
date.
Draw up and use a written waste disposal policy. For further information refer to Scottish
Executive Health Department Letter 2006 PCA(D)05 and Health Facilities Scotland (HFS) guidance
on healthcare waste, available via www.scottishdental.org/decontam.
3.1
During Treatment
Keep your standard kits to a minimum. Do not put out instruments you do not need.
Regard all instruments set out for each patient as contaminated after the treatment whether or
not they have been used.
When working with substances that can harden on instruments (i.e. calculus during scaling or
cements), wipe re-usable instruments immediately with a non-linting swab.
• To avoid risk of sharps injuries it is the operator’s responsibility to ensure that
residues are removed from sharp hand instruments used in the patient’s mouth,
such as scalers.
3.2
Taking Instruments to the Decontamination Area
Transport instruments for decontamination as soon as possible after use to the decontamination
area.
Use a rigid, durable, leak-proof container
that has a tight-fitting lid and is easy to clean
and disinfect to transport dirty instruments,
and ensure it is clearly labelled as containing
contaminated instruments.
• It is good practice to place used
instruments in this type of container
even if decontamination is to be
carried out in the same room. This
reduces the risk of inadvertent reuse of contaminated instruments.
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3
• Consider using different coloured containers to transport clean and dirty
instruments.
Ideally, clean containers in a washer-disinfector (WD). If this is not possible, clean containers with
a fresh detergent solution, rinse and dry. Do not use bleach or hypochlorite solution because
residues might damage the instruments.
Further advice on transferring instruments is provided within Health Protection Scotland (HPS) local
decontamination unit (LDU) guidance (available via www.scottishdental.org/decontam).
3.3
Segregating Instruments
A used dental kit contains a wide variety of instruments and contaminated material.
Prior
to
cleaning,
segregate
re-usable
instruments to be
cleaned from items for
disposal.
3.4
Items for Disposal
Shown below is the symbol that identifies single-use items. This label identifies the device as disposable
and not intended to be reprocessed for use on the same or another patient. This will appear on
packaging but might not be present on individual items.
8
3
Always check packaging for the single-use symbol before use and note that it might be difficult
to see, as indicated in the photographs.
Use single-use instruments only on an individual patient during a single procedure and then
discard. The re-use of a single-use device has legal implications. Anyone who reprocesses or
re-uses a device intended for use on a single occasion bears full responsibility for its safety and
effectiveness.
New regulations for clinical waste disposal came into force on 1 February 2007 and new guidance
has been published by Health Facilities Scotland (HFS). All clinical waste (renamed healthcare waste)
is now categorised as special waste and an additional colour-coded stream (Red) has been introduced
for individual potentially toxic products (e.g. dental radiography chemicals, amalgam and amalgamfilled teeth) that require specialized disposal. These new regulations require changes to the labelling
and paperwork associated with clinical waste.
Ensure that appropriate waste containers are
available for all types of waste (i.e. paper, plastic or
special waste, including sharps).
• Assemble all colour-coded waste-disposal
containers correctly before use and ensure
the lids are firmly clicked into place. A large
number of sharps injuries are caused by
containers separating when in use.
• Check with your local waste contractor to
ensure that all your colour-coded waste
containers and labels comply with the latest
HFS guidance.
Dispose of single-use items according to their category (as outlined in your waste disposal
policy).
• Identify and dispose of single-use sharps,
matrix bands, used and partly used local
anaesthetic cartridges and extracted teeth
without amalgam in Yellow Stream wastedisposal containers (formerly known as sharps
bins) kept close to the point of use.
• Dispose of amalgam into a designated Red
Stream waste-disposal container that is clearly
labelled for amalgam waste.
• Dispose of extracted teeth containing
amalgam into a separate Red Stream container that is clearly labelled for extracted
teeth with amalgam.
• Do not fill colour-coded waste-disposal containers above the specified level.
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Recent changes to waste disposal are provided in ‘Interim SHTN 3 Guidance’, published in February
2007 by HFS (available via www.scottishdental.org/decontam). Note that a revised and updated
edition of NHSScotland waste guidance Scottish Hospital Technical Note 3 (SHTN 3) is due to be
published in 2007. For further information refer to local NHS board dental waste guidance.
3.5
Re-usable Instruments
Separate re-usable instruments, according to manufacturers’ instructions, into those that will
require manual cleaning and those that can withstand either ultrasonic cleaning or processing in
a WD.
Some instruments require to be dismantled for
cleaning. Follow manufacturers’ instructions.
After these steps, select a cleaning method that is suitable and available (see Section 4).
3.6
Items Unsuitable for Immersion
Identify items that cannot be immersed in aqueous
solution (e.g. electrical and electronic equipment)
and clean them in accordance with manufacturers’
instructions.
• If recommendations include wiping with a detergent solution, use a clean non-linting
cloth and the recommended detergent solution to wipe the instrument. Follow by
wiping with a clean, damp non-linting cloth to remove residues. Dry thoroughly
using a clean non-linting cloth.
• If disinfection with alcohol is advised, first clean as above then wipe with alcoholimpregnated wipes.
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4
Cleaning Methods
Three methods of cleaning re-usable dental instruments are currently available:
• manual cleaning;
• ultrasonic cleaning;
• cleaning using a washer-disinfector (WD).
The use of a WD is the preferred method of cleaning as it includes a thermal disinfection stage
that renders instruments safe for handling and inspection and is an automated process that can be
validated. However, more than one cleaning method will need to be employed in practice.
4.1
General Requirements for Each Cleaning Method
Selecting a method of cleaning: Refer to manufacturers’ instructions for instruments,
equipment, cleaning equipment and cleaning solutions to ensure that instruments can be cleaned
using a method available in your practice. Maintain a list of instruments to be cleaned by each
method.
Staff training: Train all practice staff involved in cleaning dental instruments so that they:
• understand the key principles and importance of effective cleaning;
• are able to use all cleaning methods and decontamination equipment in your
practice properly and safely;
• can perform daily testing and maintenance of the equipment and maintain good
records (see Section 6 for details).
Validation: Validation is the means by which an entire process is documented, tested and able to
be repeated. Ensure ultrasonic and WD cleaning procedures used in your practice are validated. This
is to demonstrate that all instruments and equipment cleaned by these methods are reliably and
consistently cleaned using predetermined and reproducible conditions (see Section 6 for details).
Hepatitis B vaccination: Ensure staff are fully vaccinated against hepatitis B.
Personal protective equipment: Wear appropriate personal protective equipment (PPE) when
cleaning instruments: that is, household
gloves, facemasks, eye protection, plastic
disposable aprons and adequate footwear.
Include this information in the practice’s
COSHH assessment of blood, saliva and
other biological materials. Wash household
gloves with detergent and hot water and
dry after each use to remove visible soil.
Replace these gloves weekly or more
frequently if worn or torn or if there is any
difficulty in removing soil.
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4
Cleaning Methods
4.2
Manual Cleaning
In principle, manual cleaning is the simplest method to set up but it cannot be validated because it
is difficult to ensure that it is carried out effectively on each occasion. Compared with other cleaning
methods, manual cleaning presents a greater risk of sharps injury to staff. However, despite the
limitations of manual cleaning, it is important for each practice to have the facilities, documented
procedures and trained staff to carry out manual cleaning as a backup for when other methods are
not available or are not appropriate. This method must have systems in place to avoid recontamination
of clean instruments.
Put in place an effective system for manual cleaning, as outlined below, and ensure all staff follow
an agreed, written procedure.
Use manual cleaning only when it is required by the instrument manufacturer’s instructions or if
other methods are not available.
Consider routinely using an automated method (e.g. a WD).
Aim to phase in instruments that can be cleaned in a WD.
4.2.1 Workflow and Facilities
Maintain a dirty-to-clean workflow throughout the cleaning procedure.
Preferably, use two sinks: one for manual cleaning and one for rinsing.
• If there is space for only one sink, rinse using a clean plastic basin alongside the sink.
However, this must be regarded as a temporary measure until decontamination
facilities are upgraded to include two sinks.
Preferably, use separate spaces for setting down dirty and clean instruments.
• If lack of space means that a setting-down space has to be used for both dirty and
clean instruments at different times during the decontamination process, thoroughly
clean the surface between stages with a water–detergent solution to minimise the
risks of cross-contamination.
Always use detergents specifically formulated for manual cleaning of instruments. NB: do not
use chlorhexidine handscrub (e.g. Hibiscrub), washing-up liquid, cleaning creams or soap.
Chlorhexidine in particular makes proteins stick to steel. Refer to Appendix 3 for examples of
suitable cleaning products.
Advice on surface cleaning is given in ‘Control of the Environment Policy and Procedure’ published by
Health Protection Scotland (HPS) (available via www.scottishdental.org/decontam).
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4
Cleaning Methods
4.2.2 Cleaning Procedure
Measure the volume of water and detergent to achieve the exact concentration specified by the
detergent manufacturer. A line painted on the sink is useful to indicate the required volume of
water.
Using a thermometer, monitor the temperature of the
water throughout the cleaning procedure to ensure
the temperature is maintained within the range
recommended by the detergent manufacturer.
Where manufacturers’ instructions permit, fully
submerge items to be cleaned in the detergent
solution.
Scrub instruments using long-handled brushes with
soft plastic bristles. To minimise aerosol risk, do not
scrub under running water.
Following cleaning, drain the water, avoiding
splashing.
If the water is heavily soiled, repeat the cleaning
procedure.
Wash brushes with detergent and hot water after each
use to remove visible soil and store dry and head up.
Replace brushes at least weekly or more frequently if
worn or if soil cannot be removed (as shown).
4.2.3 Avoiding Instrument Damage
Most dental instruments are made of high-quality materials designed to minimise corrosion if
reprocessed correctly. The corrosion resistance is based on their alloy composition and structure,
which forms a protective passivation layer on the surface. The ability of the instruments to resist
corrosion depends on the quality and thickness of this layer. It is important to avoid damage to the
passivation layer during cleaning.
Avoid the use of wire brushes as this can compromise the passivation layer and increase the
chance of breakage.
Remove from use any instruments that have rust spots. On no account use wire brushes to
remove rust spots.
Do not use wire pot scourers to clean instruments because these will damage the surface of
instruments.
After manual cleaning, rinse, dry and inspect instruments for cleanliness and, where
possible, check functionality as described in Section 5, before sterilization.
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4
Cleaning Methods
4.3
Ultrasonic Cleaning
Ultrasonic cleaning in a fully functioning machine enhances removal of debris, thereby reducing the
need for scrubbing instruments. Thus, although a WD is preferred and should be incorporated into
new plans or upgrades (see Section 4.4), an ultrasonic cleaner can be used as a cleaning method,
particularly for instruments with hinges and/or intricate parts. However, many ultrasonic cleaners in
regular use have been found to be ineffective in the past because of lack of maintenance and testing
or damage in transit. Therefore, it is essential that ultrasonic cleaners are shown to be effective.
To enable consistent cleaning of instruments, follow the manufacturer’s operating instructions
and ensure all staff use a specified and documented operating procedure (see Section 4.3.2).
Do not use ultrasonic cleaners to clean dental handpieces.
Test your ultrasonic cleaner quarterly to ensure that it is fully functional (see Section 6).
Assess the impact of carrying out these tests in your practice when considering upgrading your
decontamination facilities and bear in mind that the preferred method of cleaning is to use a
WD.
4.3.1 Points to Consider Before Purchasing an Ultrasonic Cleaner
Before purchasing an ultrasonic cleaner ensure that the ultrasonic cleaner complies with the
requirements of Scottish Health Technical Memorandum (SHTM) 2030 and has the following
features:
• control of process variables such as time
and temperature;
• a lid with an interlock to prevent operation
of the cleaner when the lid is open
(ultrasonic cleaners must be operated
with the lid closed);
• a choice of load carrier(s) appropriate
to the nature of the devices to be
processed;
• an irrigation system if devices with lumens
are to be processed;
• a chamber drain-tap to enable the
chamber to be emptied;
• a printer (some ultrasonic cleaners have
integrated printers that give a permanent record of each cleaning cycle).
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Cleaning Methods
4.3.2 Validating the Operating Procedure for Ultrasonic Cleaners
It is important that an operating procedure that cleans instruments effectively is validated, documented
and then used consistently.
To demonstrate valid, reproducible operation of your ultrasonic cleaner:
• ensure your machine is installed and tested to the requirements specified in SHTM
2030;
• follow a written procedure that you know is effective in cleaning your instruments
and includes details of the loading procedures, choice of operating cycle time and
temperature and choice of detergent;
• detail the water-changing regimen in writing and keep records of each change
(change the aqueous solution in the ultrasonic tank at intervals not exceeding
4 hours or earlier if visibly soiled);
• use only those detergents that are specified by the manufacturer as suitable for use
in ultrasonic cleaners (refer to Appendix 3 for suitable products);
• run the ultrasonic cleaner while filled with the water–detergent solution but without
a load for the manufacturer’s specified time to de-gas the solution on start up and
on subsequent re-fillings;
• rinse out the tank after emptying the solution (rinsing will remove soiling before it
is filled up again);
• drain, clean with a neutral detergent solution, rinse and dry the cleaner when not
in use (e.g. overnight).
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Cleaning Methods
4.3.3 Ultrasonic Cleaning Procedure
If instruments are particularly heavily soiled, briefly immerse them in cold water in the washing
sink to remove some of the blood and other visible soil before ultrasonic cleaning.
Follow the manufacturer’s recommendations for the safe operating procedure of your ultrasonic
cleaner and follow the points outlined below regarding filling and emptying the cleaner.
• Ensure that joints or hinges are opened fully and instruments that need taking apart
are fully disassembled before they are immersed in the solution.
• Place instruments in a suspended basket and fully immerse in the cleaning solution
ensuring that all surfaces are in contact with the solution.
• Do not overload the basket or overlap instruments
because this results in poor cleaning and can cause
wear to the instruments.
• Do not place instruments on the floor of the ultrasonic
cleaner because this results in poor cleaning and
excessive instrument movement, which can damage
the instruments.
• To avoid damage to delicate instruments a modified
basket or tray system might also be necessary depending
on operational requirements.
• Set the timer to the correct setting as per the ultrasonic cleaner manufacturer’s
instructions. Close the lid and do not open until the cycle is complete.
• After the cycle is complete, drain the basket of instruments before rinsing.
• Change the solution when it becomes visibly contaminated or otherwise every
4 hours because the build-up of debris will reduce the effectiveness of cleaning.
Ensure staff are aware of the need to assess when a change of solution is necessary
as advised in the operational requirements.
After ultrasonic cleaning, rinse, dry and inspect instruments for cleanliness and,
where possible, check functionality as described in Section 5, before sterilization.
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4
Cleaning Methods
4.4
Washer-disinfectors
Using a washer-disinfector (WD) is the preferred method for cleaning dental instruments because it
offers the best option for the control and reproducibility of cleaning, and the cleaning process can
be validated. WDs are used to carry out the processes of cleaning and disinfection consecutively. A
typical WD cycle for instruments includes the following five stages:
Flush – Removes ‘difficult’ gross contamination, including blood, tissue debris, bone fragments and
other fluid and solid debris. Latest standards indicate that a water temperature of <45°C is used to
prevent protein coagulation and fixing of soil to the instrument.
Wash – Removes any remaining soil. Mechanical and chemical processes loosen and break up
contamination adhering to the instrument surface. Detergents used in this process must be specified
by the manufacturer as suitable for use in a WD.
Rinse – Removes detergent used during the cleaning process. This stage can contain several substages.
Thermal disinfection – The temperature of the load is raised and held at the pre-set disinfection
temperature for the required disinfection holding time: for example, 80˚C for 10 minutes, or 90˚C
for 1 minute.
Drying – Purges the load and chamber with heated air to remove residual moisture.
The cycle time depends on the type of machine purchased, and particularly on whether a drying
stage is available and used. Time per cycle ranges between 20 and 60 minutes, depending on the
model of WD and the wash programme chosen.
Incorporate a WD into any plans to upgrade your facilities (taking note of the points outlined in
Section 4.4.1).
Following installation of a WD, ensure the operating procedure of the WD is validated by a Test
Person, and this validation is verified by an Authorised Person (Sterilizers) (see Section 6).
Clean all instruments that are able to be immersed in water in a WD if available, except when
stated otherwise in manufacturers’ instructions.
Follow manufacturers’ instructions to ensure instruments are cleaned effectively and to protect
your rights should any clinical or decontamination equipment fail.
Train staff in how to use a WD correctly, including testing of equipment.
Conduct daily and weekly tests and arrange quarterly tests and re-validation tests (annually and
after repair) to ensure your WD is cleaning effectively (see Section 6).
17
4
Cleaning Methods
4.4.1 Points to Consider Before Purchasing a Washer-disinfector
Different models of WDs are available to suit use on a worktop or on the floor under a worktop. Passthrough machines have doors on two sides, which can facilitate the dirty-to-clean work-flow within
a room or between ‘dirty’ and ‘clean’ rooms.
When purchasing a WD, obtain advice on model features and the facilities you will require from
an Authorised Person (Sterilizers), who can be contacted through HPS.
Limitations associated with manufacturers’ instructions
Currently, there is a lack of clear guidance or cohesive strategies between manufacturers of cleaning
equipment and manufacturers of instruments.
Be aware that recommendations from instrument manufacturers might not be fully compatible
with those of the WD or detergent manufacturer.
If any instruments you are considering buying cannot be satisfactorily decontaminated using a
WD, source alternative instruments that can be decontaminated using this method.
Considerations for cleaning handpieces
There is currently no WD adapted to clean handpieces that has been validated independently as
being effective, although at least one manufacturer has done its own validation procedure. If WDs
have a handpiece irrigation system then some models require that a special filter is fitted to protect
the internal mechanism of the handpiece from extraneous debris during the operating cycle. These
filters need to be replaced at regular intervals.
18
4
Cleaning Methods
An automated alternative to a WD is to use a dedicated handpiece
cleaning machine. This uses a pressurised system to clean and lubricate
handpieces. However, unlike a WD it does not disinfect.
Check with your handpiece manufacturer that you can use a WD to
clean your handpieces. However, note that there is little published
research to demonstrate the efficacy of the cleaning of the internal
mechanism of handpieces by this method.
Consult the WD manufacturer for operating details (e.g. whether
filters are required) and running costs before purchase.
WDs might remove all lubricant during the cleaning cycle and so
handpieces might require further lubrication after cleaning. Follow
the handpiece manufacturer’s recommendations for lubrication.
Practice resources
Using a WD requires several resources, including:
• appropriate staff training (on installation of the WD), and
maintenance, testing and commissioning of the WD;
Some manufacturers
mark handpieces with
the symbol on the left
to indicate that they can
be cleaned in a washerdisinfector
• adequate space and provision of utilities (drainage, water,
electricity) and possibly significant modification of premises;
• compatible instruments and tray systems;
• specified types of water for rinsing (if tap water is not suitable) and a mechanism for
producing and/or space for storing the water.
Check whether your practice can accommodate the training, maintenance, testing, space and
utilities required to run a WD (see Section 6 for guidance on testing and maintenance of WDs).
Tray systems for cleaning dental instruments in WDs are recommended where possible. Their use
can minimise instrument handling and the risk of sharps injuries. Obtain recommendations from
the WD manufacturer for the most efficient
design of cassettes for use in your chosen
machine and assess whether extra instruments
are required (particularly as processing times
for WDs are longer than for manual cleaning).
• Instruments must be loaded correctly
to ensure adequate cleaning. This will
be determined at commissioning and
testing. Ensure that a written statement
of compatibility is obtained from the
manufacturer.
19
4
Cleaning Methods
Use a suitable quality of water for rinsing instruments that is as recommended in the WD
manufacturer’s instructions.
• Where the mains water supply is soft water of good quality (i.e. free from humic and
fulvic acids) freshly drawn drinking water might be allowed for rinsing.
• In hard water areas, or where the water is discoloured, use purified water [e.g.
Sterile Water for Irrigation BP, freshly produced reverse osmosis (RO) water, freshly
produced distilled water]. Softening alone is insufficient because this does not
reduce the level of total dissolved solids, which can be left on the instruments as a
residue.
If purified water is required, choose a type that is suitable for both the WD and the sterilizer in the
practice.
• Distillation and RO units are a practical option for producing purified water but be
aware that these require proper installation, testing and routine maintenance to
consistently produce good quality water. Distilled or RO water quality can deteriorate
rapidly at a rate that is dependent on the temperature and other local factors. Use
within 24 hours of production, and preferably within 4 hours.
• Consider buying a distillation or RO unit that can produce purified water at a rate
that will avoid the need for prolonged (e.g. overnight) storage.
• Advice on water quality can be obtained from an Authorised Person (Sterilizers) (see
Appendix 5 for contact details).
Commissioning a washer-disinfector
When purchasing a WD, specify that installation and commissioning to SHTM 2030 and
EN ISO 15883 is part of the contract. Refer to ‘SHTM 2030 Washer-Disinfectors Part 3 Validation
and Verification’ for details of what to ask for; Section 4 of this document contains a schedule
of installation tests. This information can be accessed via weblinks in the Reference List of
‘Decontamination Into Practice’.
Obtaining a validation certificate
Following purchase of a WD, ensure that it is validated on site, prior to use, by a Test Person (see
Appendix 4).
Obtain a validation certificate that is signed by the Authorised Person (Sterilizers) for your records
(see Appendix 5 for contact details). An Authorised Person (Sterilizers) is an independent advisor
and requires payment for this service.
20
4
Cleaning Methods
4.4.2 Using a Washer-disinfector
For details of all operational aspects of using a WD, follow the manufacturer’s instructions.
Train staff in the correct operation of a WD, including how to perform daily test and housekeeping
tasks. An overview of routine testing, including daily tests, is given in Section 6.
It is crucial to load a WD correctly because incorrectly loaded instruments will not be cleaned
effectively. Therefore, follow an instrument loading procedure that has been shown to achieve
effective cleaning in the WD used in your practice. To do this:
• do not overload instrument carriers or overlap instruments;
• open instrument hinges and joints fully;
• attach instruments that require irrigation to the irrigation system correctly,
ensuring filters are in place if required (e.g. for handpieces, if specified by the
manufacturer).
After cleaning, inspect instruments for cleanliness and, where possible,
check functionality as described in Section 5, before sterilization.
21
5
Rinsing, Drying, Inspection and
Care of Instruments
Ensure staff are trained in how to rinse, dry and inspect instruments in accordance with the
manufacturer’s instructions.
5.1
Rinsing and Drying of Instruments after Cleaning
After cleaning either manually or in an ultrasonic cleaner, instruments must be rinsed thoroughly to
remove residual soil and detergents and then dried thoroughly. Instruments must not be allowed
to air dry as inadequate drying might enable moisture to be trapped, promoting corrosion and/or
microbial growth.
Immerse clean instruments in clean water in a separate
sink or basin dedicated for rinsing clean instruments.
Preferably, use the same quality of water for rinsing as
is used for sterilization. However, it is acceptable to use
freshly drawn soft tap water. In hard-water areas use
purified water for rinsing.
Use disposable, non-linting towels to dry instruments
immediately after rinsing.
5.2
Inspection and Care of Instruments before Sterilizing
Inspect all instruments that have been through any
cleaning procedure, including processing by a washerdisinfector (WD), to ensure they are clean, functional
and in good condition. An illuminated magnifier is
recommended because it makes it much easier to see
residual contamination, debris or damage.
22
5
Care of Instruments
5.2.1 Inspection for Cleanliness
Inspect instruments for any visible soiling such as blood or lining materials. It is especially important
to check joints, hinges or the serrated surfaces of jaws, which are difficult to clean. If there is
any residual contamination, reject the instrument and ensure it undergoes another cycle of the
cleaning process.
5.2.2 Functional Inspection
Check all instruments that have been through any cleaning procedure, including processing by a
WD, to ensure that they are in good working order.
Dispose of instruments that are blunt, bent or damaged or show any signs of pitting or other
corrosion.
Include certification that instruments have been decontaminated with any instruments sent for
repair.
5.2.3 Lubrication
Lubricate the joints and hinges of instruments before sterilizing to prevent seizing and corrosion.
The lubricant used for this purpose must be permeable to steam, water soluble and suitable for
sterilization. Follow manufacturers’ recommendations.
5.2.4 Handpiece Care
Lubricate handpieces according to the manufacturer’s instructions. Those that have been processed
in a WD might have had the lubricant removed and require lubrication again before going into
the sterilizer. Use a separate canister for cleaned instruments. Label the canisters so that it is clear
which canister is used for unclean instruments, and which is used for instruments that have been
cleaned in a WD. Another canister for use with handpieces after sterilization might be required if
the manufacturer recommends it. Inadequate lubrication can lead to unnecessary damage to the
internal mechanism.
The cleaning process is now complete and the dry instruments are ready for sterilization.
23
5
Care of Instruments
5.3
Out-of-hours Use of Instruments
Preferably, fully decontaminate instruments as soon as possible after use. However, if a patient is
seen late or out of normal working hours, clean and dry instruments at the end of the treatment
session.
Clearly label these instruments as unsafe for handling or use, and continue reprocessing the next
working day.
• Ideally, this involves reprocessing these instruments through the complete
decontamination process, starting with cleaning, because microorganisms can
accumulate during storage.
Put together written policies for staff regarding out-of-hours use of instruments and ensure the
details of these policies are included in staff training.
24
6
Validation, Testing and
Maintenance of Cleaning Equipment
6.1
Validation
Validation is a documented quality assurance procedure applied to each stage of the decontamination
process to ensure that decontamination within the dental practice is consistently carried out to the
required standard. Validation enables results to be obtained, recorded and interpreted to show
that a process will consistently yield instruments that comply with a predetermined specification.
This includes a review of the specification against which decontamination equipment [e.g. washerdisinfector (WD), ultrasonic cleaner or steam sterilizer] is purchased to ensure that it will meet the
user’s requirements and satisfactory commissioning of the equipment (i.e. installation, operational
and performance qualification).
Detailed information is available in the Scottish Health Technical Memoranda:
• SHTM 2030 Washer-disinfectors, Part 3 ‘Validation and Verification’
• SHTM 2010 Sterilization, Part 3 ‘Validation and Verification’
• SHTM 2010 Sterilization, Part 6 ‘Testing and Validation Protocols’
• SHTM 2031 Clean Steam for Sterilization, Appendix 2 ‘Operation and Maintenance
of Clean Steam Generators’
6.2
Maintenance and Testing of an Ultrasonic Cleaner
6.2.1 Maintenance
Always leave the ultrasonic tank clean and dry when not in use to ensure that the surfaces are
undamaged and the inlets and drains are free from obstructions, and test regularly.
Ensure regular checks of electrical safety are made and keep a logbook of these checks.
6.2.2 Testing
Tests to ensure instruments are cleaned effectively in ultrasonic cleaners are obligatory. To test the
efficiency of an ultrasonic cleaner an aluminium foil ablation test (SHTM 2030, Part 3, Section 17)
is recommended. Tests carried out during commissioning are intended to establish the variation in
activity at different positions and levels within the bath and the time required for each test.
Repeat a test of cleaning effectiveness as part of your quarterly maintenance programme.
Electronic testers
Ultrasonic energy meters are now available to monitor efficiency and operating frequency of ultrasonic
baths. They are much quicker and more convenient than the classic foil ablation test but currently
none have been independently validated.
25
6
The foil ablation test
Using a foil ablation test, the activity of the ultrasonic cleaner is verified by the erosion pattern, which
is created on aluminium foil exposed in the bath for a short period. Although practice staff can
perform this test, it would usually be carried out by a Maintenance Person.
Equipment and material
• Aluminium foil of the type sold as aluminium foil wrap for cooking.
• Adhesive tape (e.g. autoclave indicator tape or masking tape).
• A watch or clock with a second hand.
Method
• Cut strips of aluminium foil 15–20 mm wide and 12 cm longer than the bath is deep
(the rolled end acts as a weight to keep foil vertical in the bath).
• Ensure that the water in the tank is at the required level, that the required amount
of any chemical additive specified by the manufacturer has been added and that the
water in the tank is at the specified operating temperature.
• Carry out the manufacturer’s recommended start-up procedure. This will normally
include a period of operation to eliminate dissolved gases from the solution in the
bath (the de-gassing procedure).
• Using strips of adhesive tape across the
top of bath, suspend nine strips of the
prepared foil in the bath in a 3 x 3 grid.
Ensure that the rolled bottom end of
each foil strip is no more that 10 mm
above, but not touching, the bottom
of the bath.
• Operate the bath for the predetermined
exposure time. This varies typically
between 30 seconds and 10 minutes
depending on the power rating of the
ultrasonic transducers.
• Remove the strips from the bath, blot
dry and examine. The strips can be filed conveniently by sticking them to a sheet of
plain paper using a transparent adhesive tape.
• Drain the bath and clean to remove debris of eroded aluminium foil.
26
6
Results and interpretation
• When the foil strips are inspected, the
areas that show maximum erosion
should be at similar positions on all
nine foils and each should be eroded
to a similar extent. On re-testing the
extent of erosion, the erosion pattern
should remain consistent. If the zones
of erosion are markedly different
on the nine foils it indicates poor
uniformity of cleaning.
• Poor uniformity of cleaning might be
due to failure of one or more of the
transducers that produce the ultrasonic
vibration in the base of the bath.
Result strips taped to paper showing inadequate
or uneven erosion patterns
A significant change between tests
indicates a deterioration or failure in
the transducers. If there is no erosion,
this indicates complete failure. In the event of any of these findings, withdraw the
ultrasonic cleaner from use and send it for repair or replace it.
6.3
Installation and Testing of a Washer-disinfector
6.3.1 Installation
Before installation contact the manufacturer to obtain drawings and layouts to help local
tradesmen install your machine correctly to conform to specifications.
On delivery of the WD the contractor is expected to carry out the installation checks included in the
contract as specified in SHTM 2030 to establish that the WD:
• has been provided and installed correctly;
• is safe to operate;
• performs as it should (i.e. according to the purchase specification);
• does not interfere with other equipment;
• all connected services are satisfactory and do not prevent attainment of the designed
cleaning and disinfection performance of the WD.
27
6
6.3.2 Routine Testing
Periodic testing is required to ensure WDs still meet the validated parameters established on
installation. Details of these tests are in SHTM 2030 and include daily, weekly, quarterly and yearly
re-validation tests.
Conduct the following daily and weekly tests, and ensure that the other testing schedules outlined
in SHTM 2030, which involve more detail, are conducted by a Maintenance Person or Test Person,
and re-validation is verified by an Authorised Person (Sterilizers).
Daily tests
• Conduct an automatic control test (see below).
• Check spray arm for rotation.
• Check spray nozzles for blockage.
• Remove and clean strainers and filters.
• Inspect instruments visually for cleaning efficacy, using a magnifier to help.
Automatic control test
This is the main test for ensuring that the WD continues to function correctly.
Test procedure
• Place a normal standard load, typical of what is used throughout the day, in the
chamber of the WD. This can be a routine batch of used instruments that need
processing. The important point to note is that this ‘test load’ should be identical
each day.
• For WDs equipped with multiple cycle capability, select the operating cycle to be
tested. If you use more than one cycle routinely then select one operating cycle one
day, and the following day select the second operating cycle and so on. This enables
the test procedure to fit in as a straightforward routine within the daily workflow.
• Start the cycle.
• Ensure that a batch process record is made by the recording instrument fitted to the
WD. Purchase a machine that has an independent recorder fitted. If the WD does
not have a recorder someone has to observe and note the elapsed time, indicated
chamber temperatures and pressures at the beginning and end of each stage or
sub-stage, and the maximum values during the holding time. Check the printout to
ensure that the required parameters have been met.
28
6
The test is to be considered satisfactory if the following requirements are met:
• a visual display indicating ‘cycle complete‘ occurs;
• during the whole operational cycle the values of the cycle variables as indicated by
the instruments on the WD or shown on the batch process record are within the
limits established as giving satisfactory results either by the manufacturer or during
performance qualification;
• during the disinfection hold period (determined from the indicated and/or recorded
chamber temperature) the indicated and recorded chamber temperatures are within
the appropriate disinfection temperature band specified; the time for which the
disinfection temperature is maintained is not less than previously established, by
either the manufacturer or the performance qualification tests, to ensure that the
load is maintained at temperatures within the disinfection temperature band for the
time specified in SHTM 2030;
• the door cannot be opened until the cycle is complete;
• the person conducting the test does not observe any mechanical or other anomaly.
Weekly test – cleaning efficacy
Cleaning efficacy tests are used to demonstrate the ability of the WD to remove soiling and
contamination. Methods to determine whether instruments are being cleaned effectively include:
• visual inspection (as above; conducted routinely each day);
• chemical testing.
Chemical testing involves testing, at least once a week, items that are processed in WDs for residual
protein after cleaning.
A list of tests is available in SHTM 2030 or from the Authorised Person (Sterlizers) who provides the
validation certificate for your WD.
29
Notes
30
31
Notes
32
Scottish Dental
The Scottish Dental Clinical Effectiveness Programme (SDCEP) is an initiative
of the National Dental Advisory Committee (NDAC) and is supported by the
Scottish Executive and NHS Education for Scotland. The Programme aims
to provide user-friendly, evidence-based guidance for the dental profession
in Scotland.
SDCEP guidance is designed to help the dental team provide improved care
for patients by bringing together, in a structured manner, the best available
information that is relevant to priority areas in dentistry, and presenting this
information in a form that can be interpreted easily and implemented.
‘Cleaning of Dental Instruments’ is the first of the SDCEP series
‘Decontamination Into Practice’, which aims to help the evolution towards
compliance with relevant statutory and mandatory requirements and
standards. ‘Cleaning of Dental Instruments’ provides advice on all aspects
of cleaning, including organising the decontamination area, cleaning
methods and testing of equipment.
Dundee Dental Education Centre, Frankland Building,
Small’s Wynd, Dundee DD1 4HN
Email
Tel
01382 425751 / 425771
March 2007

cep Cleaning of Dental Instruments Scottish Dental Clinical Effectiveness Programme

Transcription

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