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Hi Gemma and Kylie,
Find below the relevant information from the TGA web page in relation to the
TGA registration or listing requirements for disinfectants and sterilants
which includes detergent/disinfectant or disinfectant wipes.
Note that only those with specific biocidal claims (virucidal, sporicidal,
tuberculocidal, fungicidal or other) must be registered, whereas those
without specific biocidal claims are only required to be listed.
In terms of the Australian Guidelines for the Prevention and Control of
Infection in Healthcare (2010), Section B1.4.2 Routine environmental
cleaning, Use of disinfectants that you quote to be consistent with the TGA
regulations it should read as follows:
“In acute-care settings where there is uncertainty about the nature of
soiling on the surface (e.g. blood or body fluid contamination versus
routine dust or dirt) or the presence of MROs (including C. difficile) or
other infectious agents requiring transmission-based precautions (e.g.
pulmonary tuberculosis) is known or suspected, surfaces should be physically
cleaned with a detergent solution, followed or combined with a
TGA-registered or listed disinfectant with label claims specifying its
effectiveness against specific infectious organisms.
Perhaps you should flag this with the NHMRC? There is an email link under
“More information” where you can direct enquires in relation relating to the
guideline http://www.nhmrc.gov.au/node/30290
TGA online information – see below
“TGA – The regulation of disinfectants and sterilants
http://www.tga.gov.au/industry/disinfectants-regulation.htm
Hard surface disinfectants
Hard surface disinfectants are regulated by the TGA and form part of the
group of products referred to as “other therapeutic goods” (OTGs). OTGs are
subject to the requirements for registered or listed goods under Chapter 3
of the Therapeutic Goods Act
1989. For guidance on the regulation of OTGs, please refer to
Australian Medical Device
Requirements Version 4 (DR4).
Disinfectants that are OTGs are subject to
Therapeutic Goods Order 54
(Standard for Disinfectants and Sterilants) as a mandatory requirement.
Hard surface disinfectants include hospital, household and commercial grade
disinfectants.
Hospital grade disinfectants
Hospital grade disinfectants are suitable for general purpose disinfection
of building and fitting surfaces, and purposes not involving instruments or
surfaces likely to come into contact with broken skin:
*in premises used for:
*the investigation or treatment of a disease, ailment or injury; or
*procedures that are carried out involving the penetration of the
human skin;
*or in connection with:
*the business of beauty therapy or hairdressing; or
*the practice of podiatry;
but do not include:
*instrument grade disinfectants
*antibacterial clothes preparations
*sanitary fluids
*sanitary powder
*sanitisers.
Hospital grade disinfectants are currently either listed or registered on
the ARTG. Those with specific biocidal claims (virucidal, sporicidal,
tuberculocidal, fungicidal or other) must be registered, whereas those
without specific biocidal claims are listed.
The Therapeutic Goods
Regulations 1990 are to be changed so that registered disinfectants become
listed on the ARTG. However, disinfectants with specific biocidal claims and
those containing new chemical entities will still undergo a pre-market
review.
I have also included a link to a table from the TGA Guidelines for the
Evaluation of Sterilants and Disinfectants (pages 62-65) which you may find
useful.
http://www.tga.gov.au/industry/disinfectants-evaluation-guidelines.htm
As you will see in the table only those that are making a specific claim
that covers virucidal, sporicidal, tuberculocidal, fungicidal are required
to be registered.
regards
Glenys
Glenys Harrington
Consultant
Infection Control Consultancy (ICC)
PO Box 5202
Middle Park
Victoria, 3206
Australia
H: +61 3 96902216
M: +61 404 816 434
ABN 47533508426
Of Kylie McCarthy
Hi Gemma,
We are currently using a combined detergent/disinfectant wipe, it was
introduced with the aim of reducing workload and increasing cleaning
compliance amongst staff. The one ‘small’ issue I have with using the
combined product is that as far as I am aware, there is not a combined
product on the market that is TGA ‘Registered’, the products are ‘Listed’
only.
The Australian Guidelines for the prevention and control of infection in
healthcare state the following;
B1.4.2 Routine environmental cleaning
Use of disinfectants
In acute-care settings where there is uncertainty about the nature of
soiling on the surface (e.g. blood or body fluid contamination versus
routine dust or dirt) or the presence of MROs (including C. difficile) or
other infectious agents requiring transmission-based precautions (e.g.
pulmonary tuberculosis) is known or suspected, surfaces should be physically
cleaned with a detergent solution, followed or combined with a
TGA-registered disinfectant with label claims specifying its effectiveness
against specific infectious organisms.
http://www.nhmrc.gov.au/book/australian-guidelines-prevention-and-control-in
fection-healthcare-2010/b1-4-2-routine-environme
Regards
Kylie
Kylie McCarthy
Infection control coordinator
Prince of Wales Private Hospital
Phone 02 9650 4034
Fax 02 9650 4688
Please consider the environment before printing this message
>>> “Klintworth, Gemma” 23/08/2012 11:27 am >>>
Hi all,
We are in the process of putting together a case for the introduction of
detergent/disinfectant wipes into our organisation. I am wondering if most
other hospitals are using these wipes and if so, how they were brought into
your organisations.
Any advice would be much appreciated.
Thanks
Gemma
Gemma Klintworth
CLABSI Project Coordinator
Infection Prevention and Healthcare Epidemiology
t 03 90762250 e G.Klintworth@alfred.org.au
Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Alfred Health incorporates The Alfred, Caulfield Hospital and Sandringham
Hospital
http://www.alfredhealth.org.au
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