Course Access
Fiona
I can’t verify the current status of this information, but there has
been a previous discussion about this product on this list (November
2011). This is one of the more comprehensive messages in that group.
From:AICA Infexion Connexion [mailto:AICALIST@AICALIST.ORG.AU] On
Behalf Of Glenys.Harrington@HEALTH.VIC.GOV.AU
Maree and Robert,
Further to my comments earlier today. I have contacted the TGA for
further clarification.
The particular product under discussion in this thread is categorised
as a “medical device” as it is “intended to be used on medical devices”.
Such products must be included on the Australian Register of
Therapeutic Goods Devices (ARTG) before they can be supplied in
Australia.
The ARTG form will state the following:
“Product type: Medical Device – Class …… – Included”
The key word is “included” which confirms that the product is suitable
for the ” intended purpose” which is also included on the ARTG form.
For this particular products the intended purpose on the ARTG form is as
follows:
“Intended purpose: The Tristel disinfecting wipes system is intended to
decontaminate and disinfect non-lumened medical devices that cannot be
fully immersed in liquid disinfectant or sterilant and cannot be
sterilised by heat. It allows high level disinfection of instruments
where automated dishwashers, sinks and water supplies are unavailable.
The system provides high-level disinfection in less than two minutes.
The Tristel system is not intended for high level disinfection of
critical medical devices which must be sterilised prior to use on
patients”.
The information above is unclear and ideally should have included
information about semi critical devices (ie contacts mucous membranes,
non-intact skin) in addition to critical devices (ie enters normally
sterile tissue or vascular system). It is also unclear in the intended
purpose statement reference to the use of the product “where ….sinks
and water supplies are unavailable” as such devices would before high
level disinfection need to be meticulously pre-cleaned?
I am providing TGA with additional information (ie Methods of
sterilization and disinfection, [Modified Spaulding classification
system]).
All ARTG forms can be found by searching the ARTG database available on
the TGA web page.
https://www.ebs.tga.gov.au/ebs/ANZTPAR/PublicWeb.nsf/cuDevices?OpenView
For disinfectants not used on medical devices (ie for general, outbreak
or isolation cleaning and disinfecting purposes) there are 3 categories:
1. Hospital grade and commercial/household grade disinfectants with
specific claims
2. Hospital grade disinfectants without specific claims
3. Household or commercial grade disinfectant without specific claims
(that do not make disinfectant claims)
1 & 2 must be either “listed” or “registered” on the ARTG.
The ARTG form will include an “ARTG identifier” with either “Aust L”
or Aust R” (listed or registered with the TGA). Generally products need
to be registered to make fungicidal, sporicidal, tuberculocidal and
viricidal claims (ie with specific claims).
If a product is not registered in Australia and the
manufacturer/supplier is making fungicidal, sporicidal, tuberculocidal
and viricidal claims TGA have asked that you let them know via their
on-line “Report a perceived breach or questionable practices” at the
following link and they will follow-up.
http://www.tga.gov.au/about/form-breach-tgact.htm
The manufacturer/supplier may not be fully aware of the TGA
requirements as outlined in the TGA “Guidelines for the Evaluation of
Sterilants and Disinfectants”.
Find below additional information provide by the TGA this morning:
Disinfectants are regulated in a variety of ways in Australia,
depending on the claims made in the instructions for use, labelling and
promotional material.
Type of disinfectant
How is it regulated?
Comments
Sterilants and instrument grade disinfectants (all levels) – intended
to be used on medical devices
An accessory to a medical device – Class IIb Must be included on the
ARTG before they can be supplied in Australia.
In Europe are regulated as Class IIa. Sponsors importing these products
need to ensure that the Australian regulatory requirements have been met
by the manufacturer.
Undergo a mandatory Level 2 Application Audit.
Cleaners intended to be used on medical devices
An accessory to a medical device – Class I
Must be included on the ARTG before they can be supplied in
Australia.
Hospital grade and commercial/household grade disinfectants with
specific claims*
‘Other Therapeutic Goods’ – registered
Must be registered on the ARTG before they can be supplied in
Australia.
Must comply with TGO 54 (
http://www.tga.gov.au/docs/html/tgo/tgo54.htm ).
Information to be submitted for review includes instructions for
use, promotional material, labels, product specifications, and efficacy,
stability and quality control data.
Hospital grade disinfectants without specific claims*
‘Other Therapeutic Goods’ – listed Must be listed on the ARTG before
they can be supplied in Australia.
Must comply with TGO 54 ( http://www.tga.gov.au/docs/html/tgo/tgo54.htm
).
Information to be submitted for review includes instructions for use,
promotional material and labels.
Household or commercial grade disinfectant without specific claims*
‘Other Therapeutic Goods’ – exempt from listing or registration
Exempt disinfectants are not required to be entered on the ARTG
however they still must comply with certain parts of TGO 54 (
http://www.tga.gov.au/docs/html/tgo/tgo54.htm ), including the
labelling requirements, and are expected to comply with performance
requirements.
Antibacterial cleaning wipes
Sanitisers
Sanitary fluids/powders
(that do not make disinfectant claims)
Exempt or excluded depending on claims
Claims determine if exempt from entry on the ARTG or excluded from
the Therapeutic Goods Act 1989.
* ‘specific claims’ cover virucidal, sporicidal, tuberculocidal,
fungicidal or other biocidal activity. Except where claims of activity
against fungi (yeast and mould) for excluded products are concerned,
these claims mean a product is registered.
http://www.tga.gov.au/industry/disinfectants-regulation.htmhttp://www.tga.gov.au/industry/disinfectants-hard-surface.htm
A hospital grade disinfectant with non-specific claims is a listable
product
A hospital grade disinfectant with specific claims is a registerable
product
A “non-specific claim” is a claim which includes general antibacterial
action or activity against bacteria covered by the battery of test
organisms included in the specified test, or bacteria of the same
family. Claims for bacteria other than these are allowable and do not
cause the product to become registerable, but the specific organism
against which activity is claimed must be included as an extra organism
in the test battery e.g. E. coli O157, Salmonella spp, Streptococcus
spp, etc.
A “specific claim” is one which covers virucidal, sporicidal,
tuberculocidal, fungicidal or other biocidal activity. Except where
claims of activity against fungi (yeast and mould) for excluded products
are concerned, such claims lift a product into the registerable category
of goods.
For information on disinfectants:
Please see TGO 54/54A/54B, which can be accessed at
http://www.comlaw.gov.au/Details/F2009C00327
Please see the “Guidelines for evaluation of sterilants and
disinfectants”, which can be accessed at
http://www.tga.gov.au/industry/disinfectants-evaluation-guidelines.htm.
These guidelines describe the information to be supplied to the TGA for
the registration or listing of disinfectants on the ARTG.
Yours sincerely,
Medical Devices Information Line
Information http://www.tga.gov.au/devices/devices.htm (
http://aicalist.org.au/scripts/www.tga.gov.au/devices/devices.htm )
e-Business http://www.ebs.tga.gov.au (
http://aicalist.org.au/scripts/www.ebs.tga.gov.au )
Hope this clarifies further.
regards
Glenys
Glenys Harrington, Infection Control Consultant |Communicable Disease
Prevention and Control | Public Health
Department of Health | Level 14 50 Lonsdale Street Melbourne Victoria
3000 Australia
t. 03 909 65094 | f. 1300 651 170 | e.
glenys.harrington@health.vic.gov.au | http://www.health.vic.gov.au/ (
http://aicalist.org.au/scripts/www.health.vic.gov.au/ideas )
Based on the above, it may be prudent to contact TGA to discuses the
status of this product prior to approving it’s use within your
facility.
Cheers
Michael Wishart
ACIPC Infexion Connexion Administrator
Michael Wishart
Public Health Nurse,Communicable Disease Control
Logan West Moreton PHU
Ph 34131200 Fax 34131221
To contact Nursing team:
LWM_PHN@health.qld.gov.au
>>> Fiona de Sousa 17/05/2012 1:09 pm >>>
Hi All,
I have been asked to review a new cleaning and disinfection system for
reprocessing transvaginal ultrasound probes especially those used in IVF
related pregnancies where chemical residues are a high concern.
The system consists of three separate pre-packaged wipes (a cleaner, a
disinfectant and a rinse wipe) which I believe is currently used in he
UK. The active ingredient in the disinfectant wipe is chlorine dioxide
in aqueous solution.
Has anyone got any experience with this type of system that they would
be willing to share with me?
Kind Regards,
Fiona De Sousa
Infection Prevention & Control Coordinator
Sydney Adventist Hospital
( blocked::blocked::mailto:Fiona.Desousa@sah.org.au
)Fiona.Desousa@sah.org.au ( blocked::mailto:Fiona.Desousa@sah.org.au
)
185 Fox Valley Road, Wahroonga, NSW, 2076
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