FW: [ACIPC_Infexion_Connexion] hand soaps for healthcare areas

[Glenys Harrington]

Hi Louisa,

Any antibacterial skin preparations that are to be used in clinics or
hospitals or make claims further than bacteria are Therapeutic Goods.

Hand sanitisers or antibacterial skin preparations can be classified as
cosmetic if they only claim to be active against bacteria and are for
general household use. See cosmetic guidelines pages 12 – 17 which details
when a hand sanitiser become a therapeutic goods (extract below)
http://www.nicnas.gov.au/Current_Issues/Cosmetics/Cosmetic_Guidelines_PDF.pd
f

In general, products making therapeutic claims must be manufactured by
TGA-licensed manufacturers in accordance with the principles of Good
Manufacturing Practice (GMP), and must be included in the Australian
Register of Therapeutic Goods (ARTG) before being supplied in Australia.

In order to get a product included in the ARTG, a sponsor must submit an
application to the TGA, together with relevant supporting data. The sponsor
of a therapeutic good included in the ARTG must be an Australian resident
and/or carrying on business in Australia.

Extract:

Antibacterial skin products where information is presented on the label, or
by other promotional means (e.g. advertising, internet site, point of sale
material) to indicate the products:

– are active against viruses, fungi or other microbial organisms other than
bacteria; or

– are to be used in connection with a specific disease, disorder or medical
condition; or

– are active against a named bacterium that is known to be associated with a
specific disease, disorder or medical condition.

– are to be used in connection with piercing of the skin or mucous membrane
whether for cosmetic or any other purpose; or

– are to be used in connection with any procedure associated with the risk
of transmission of disease from contact with blood or other bodily fluids;
or

– are to be used before any physical contact with any person who is
accessing medical or health services, or who is undergoing any medical or
health care procedure; or

– are to be used in connection with any procedure involving venepuncture or
delivery of an injection.

What to do –

1. Ask the supplier/manufacturer if their HH product is included in the
Australian Register of Therapeutic Goods (ARTG)

2. Ask for a copy of the copy of the “Public ARTG Summary” or

3. Search the Australian Register of Therapeutic Goods (ARTG) by product
name or company https://www.ebs.tga.gov.au/

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
infexion@ozemail.com.au
ABN 47533508426

—–Original Message—–
Of Louisa Sasko

Hi all,

I am currently desperate for some information regarding hand soaps being
used in the clinical setting. Are there any guidelines that stipulate what
soaps are allowed to be used by Healthcare Workers for instance it must be a
hospital grade soap or TGA registered/approved soap for clinical use.

Thanks in advance

Regards
Louisa

CNC Infection Control
Ryde Hospital Sydney
Ph 985 87664
M 0434323266
Pager 54581

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