澳大利亞超声诊疗消毒技术规范供參考

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Policies and Statements
B2
Statement on the Disinfection of Transducers
May 1996, Reaffirmed September 1999, Revised July 2005, September 2007, April 2011
1. SCOPE
This statement provides recommendations for the cleaning and disinfection of:
• All intracavity ultrasound transducers (including, but not limited to, transvaginal,
transrectal and transoesophageal
• All transducers that are likely to come into contact with broken skin
• All transducers used during ultrasound guided biopsy or injection
• All transducers used in ultrasound guided interventional procedures
• All transducers used within a sterile environment (such as operating theatres).
2. ABBREVIATIONS AND DEFINITIONS
TGA: Therapeutic Goods Administration
MSDS: Material Safety Data Sheet: a form supplied with the product detailing the
properties of the product
TG054 Therapeutic Goods Order No.54
3. BACKGROUND
3.1 GENERAL:
Every patient must be regarded as a potential source of infection and appropriate
precautions should be taken to prevent cross-infection between patient and operator. These
are known as “Universal Precautions” and are promoted as an essential part of all health
care institutions.
Standard precautions that should be undertaken as part of every examination include:
• Washing of hands both before and after direct patient contact
• Use of personal protective equipment where appropriate
• Maintenance of clean and/or disinfected patient equipment (as required)
• Maintenance of a clean working environment
• Correct disposal of waste.
3.2 MEDICAL INSTRUMENT CLASSIFICATION:
The risk of transmitting infections on instruments and equipment is related to the presence
or absence and burden of infectious agents (number and virulence), the type of procedure
(e.g. invasive versus non-invasive) and the body site where the instrument is used (e.g.
submucosal invasion versus intact skin).
The Spaulding classification system1 suggests that contact sites for instruments may be
classified as critical, semicritical or noncritical and that instruments should be classified
accordingly1.
Instruments that come into contact with intact nonsterile mucosa (or nonintact skin) are
considered semi-critical instruments. Semi-critical instruments should preferably be sterile or
must be a minimum of high level disinfected, after each use.
High level disinfection is necessary, even when a single use disposable probe cover is used
routinely, due to the possible rupture or breeching of the transducer cover which could lead
to contamination of the transducer2.
3.3 MICROBIAL REDUCTION:
Sterilisation/disinfection represents a statistical reduction in the number of microbes present
on a surface. Meticulous cleaning of the instrument is the essential key to an initial reduction
of the microbial/organic load by at least 99%.
Every patient must be regarded as a potential source of infection and appropriate
precautions should be taken to prevent cross-infection between patient and operator. These
are known as “Universal Precautions” and are promoted throughout all health care
institutions. Particularly important is the washing of hands both before and after direct
patient contact1. Other precautions will include use of personal protective equipment where
appropriate and correct handling and disposal of waste and maintenance of a clean working
environment.
Potential sources of infection associated with vaginal ultrasound scanning include those
organisms transmitted by blood and genital secretions such as Human Immunodeficiency
Virus, Hepatitis B Virus, Hepatitis C Virus, Cytomegalovirus, Neisseria gonorrhoea,
Chlamydia trachomatis, Trichomonas vaginalis1 and Human Papilloma Virus. It should be
remembered that some organisms, including some viruses, can remain infectious for days
outside the body, particularly if kept moist in blood or serum.
All sterilisation/disinfection represents a statistical reduction in the number of microbes
present on a surface. Meticulous cleaning of the instrument is the essential key to an initial
reduction of the microbial/organic load by at least 99%2.
The following protocol is recommended for the cleaning and preparing of intracavitary
transducers between patients. These will include transvaginal, transrectal, transoesophageal
and endoscopic transducers. The principles are the same for any transducers that may
come into contact with body secretions.

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4. MINIMUM REQUIRED PROCEDURE
Using these guidelines as a baseline the following recommendations are made for the
procedures listed in section 1 (Scope).
4.1 OPERATOR TRAINING:
Health care workers who clean and disinfect reusable medical instruments must be trained
in all necessary procedures. They should receive formal training in equipment cleaning and
processing, disinfection and/or sterilisation at an appropriate level.
4.2 OPERATOR REQUIREMENTS:
The operator must wear a disposable (non-sterile) glove on the hand used during the
procedure. Care must be taken to ensure that contaminated gloves do not contact the ultrasound
machine or the exposed transducer cable. At the completion of the procedure the glove should be removed and disposed of in the correct receptacle and hands should be
washed thoroughly in warm soap and water.
4.3 PROBE COVERS:
Prior to the use of a transducer cover, specific enquiry should be directed to the patient
regarding latex sensitivity and, if appropriate, special non-latex covers may need to be
utilised3.
The most preferred option is using a cover that is at least 38 microns thick. This may include
condoms, specific probe covers, surgical drapes, or surgical gloves. At the end of the
procedure, using a gloved hand, the disposable cover should be removed and discarded,
taking care not to contaminate the surface of the instrument.
Although the use of a disposable cover reduces the level of risk of transmission of infection
or contamination, covers can be perforated or contain small, unrecognised defects2.
4.4 CLEANING:
Cleaning is an essential prerequisite for all effective disinfection processes because organic
residue may prevent the disinfectant from contacting the item being processed and may also
bind and inactivate chemical disinfectants4.
Utilising running water, all the gel should be removed from the transducer. A free-rinsing,
mild alkali is preferred over neutral detergents. Use a small, soft brush to clean any crevices
or angles. The current Australian standard outlines that standard household-type detergents
and soaps are not a recommended cleaner due to their high foaming properties which
increases the residue left behind and decreases the effectiveness of the clean. The
transducer must be thoroughly cleaned and then dried with a soft, disposable towel.
4.5 DISINFECTION:
Cleaning of the transducer is an essential part of the disinfection process. However, high
level disinfection, with a chemical agent is necessary for further statistical reduction in the
number of infective agents on the transducer. All chemical agents utilised must be TGA
approved for use as a high level disinfectant on medical devices. Sodium hypochlorite (e.g.
Milton) is not TGA approved for high level disinfection of medical equipment and is not
suitable for use in disinfecting transducers.
The definitions given in TGO54 state that, when used as recommended by the manufacturer,
high level disinfectants inactivate all microbial pathogens, except large numbers of bacterial
endospores.
TGA-approved chemical agents that may be used include:
a) 2% glutaraldehyde: Soak the transducer in the glutaraldehyde solution for twenty
minutes, rinse under running tap water then dry. Note: Buffered glutaraldehyde is a
cold disinfectant which has a broad spectrum of activity with rapid microbiocidal action.
It is non-corrosive to most materials, including metals and rubber. Because of potential
irritant effects of glutaraldehyde extreme care must be taken with its use, and
manufacturers’ instructions on usage should be strictly followed. Spent glutaraldehyde
solutions disposed of to the sewer should be flushed with copious amounts of water.
b) Ortho-phthalaldehyde 0.55%. Soak the transducer in the solution for a minimum of ten
minutes at twenty degrees Celsius (20o C) or higher, followed by rinsing under copious
amounts of running tap water before drying. Orthophthalaldehyde has a broad
spectrum of activity with rapid microbiocidal effects, with the exception of some
bacterial endospores; it is non-corrosive to most materials including metals and rubber.
Cidex OPA is a satisfactory preparation. Usual precautions must be taken with its use
with regard to protection from irritant effects. Regular testing needs to be performed to
ensure a minimal effective concentration with the use of test strips. Spent solutions
disposed of to the sewer should be flushed with copious amounts of water.
Manufacturers’ instructions on usage should be strictly followed.
c) Hydrogen peroxide: An approved automated system utilising hydrogen peroxide can be
utilised. No rinsing is required at the completion of the cycle. The manufacturer’s
instructions for use must be carefully followed.
5. FURTHER RECOMMENDATIONS
5.1 The equipment manufacturer must be consulted prior to using any chemical disinfectant on
their transducers and all chemical agents utilised must be TGA approved for use as a high
level disinfectant on medical devices. The requirement for the use of personal protective
equipment, if suggested, for each chemical agent must be followed.
5.2 Ultrasound transducers are heat sensitive items and as such will need to be disinfected
using low-temperature chemical sterilising agents or systems. The ability of chemical
disinfectants to effectively inactivate contaminating infectious agents depends on a number
of factors, including the initial number of agents present, temperature, pH and
concentration5.
Chemical disinfectants intended to cover a range of different levels of disinfection may
specify different exposure and/or temperature combinations on the product label.
The active ingredients of the disinfectant in use must also be closely monitored as
recommended in the manufacturer’s guidelines. However, consideration should be given to
more frequent monitoring when large volumes of items are being processed.
5.3 Where liquid chemicals are used the transducer should be soaked in the solution for the
recommended time and temperature (as recommended by the manufacturer), followed by
rinsing under copious amounts of water and then drying. These products may have
associated toxic issues and as such Personal Protective Equipment must be used along with
fume cabinets and other directions as outlined on the MSDS. Efficacy must be checked
daily, or as recommended by the manufacturer (with the appropriate chemical test strip
indicators) to ensure that it is still at a viable strength to achieve high level disinfection.
Care should be taken to follow each disinfectant’s labelled conditions for the use of their
specific products. Directions for use are not interchangeable between formulations from
either the same or different manufacturers.
It must be noted that the transducer must not be left in the chemical agent for longer than the
recommended time due to the possibility of damage. This means that the soaking period
should be timed.
5.4 It is recommended that post-disinfection rinsing is performed using sterile water as the use of
tap water can reintroduce pseudomonas to the disinfected medical device.

淡淡

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愚人国度

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Mr.beauty

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chuchuhuier

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zx88apple

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babygreen

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wento

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小兵张嘎

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