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Re: TGA change to listing of 2% CHG in 70% ETOH enquiry

Home Forums Infexion Connexion TGA change to listing of 2% CHG in 70% ETOH enquiry Re: TGA change to listing of 2% CHG in 70% ETOH enquiry

#70170
Beth Bint
Participant

Author:
Beth Bint

Email:
Beth.Bint@SESIAHS.HEALTH.NSW.GOV.AU

Organisation:

State:

Hi All

This is the advice we have received from our pharmacy regarding this matter.

“Chlorhexidine 2% in Alcohol 70% was a hospital only product before but is now available to everybody so labelling was changed to accommodate this broader group. Its still the same product still safe to use on skin. The manufacturer (name available on request) is aware of hospitals concerns and by the end of this month (hopefully) will be rolling out hospital only labelled bottles that will have the original directions on them and would only be available to hospitals.”

We will be seeking written advice from this company regarding this as assurance of safe use under the current labelling until the relabelled product is available.

Regards
Beth

Beth Bint

Infection Prevention and Control Clinical Nurse Consultant | Infection Management and Control Service
Level 1 Lawson House Wollongong Hospital
Tel 02 4222 5898 |beth.bint@SESIAHS.HEALTH.NSW.GOV.AU
http://www.health.nsw.gov.au
________________________________

Hi all,
My understanding is that the TGA has changed its registration processes for skin disinfectants so that they now need to be registered as OTC medicines. This probably involves another cost for manufacturers who may be trying to get around this by simply re-labelling their products. Consumers need to express to the product suppliers that this is not acceptable.
In the meantime, if the product has not changed its formulation, some healthcare facilities are electing to continue to use the products off label.
Clearly not a satisfactory situation.

Regards,
Irene

Irene Wilkinson
Manager, Infection Control Service
SA Health
Irene.wilkinson@health.sa.gov.au

I have emailed the manufacturer of 100ml 2% Chlorhexidine in 70% Alcohol with the same labeling- will share the response when it arrives

I note the 500ml bottle of 0.5% Chlorhexidine in 70% Alcohol also now has this labeling

Have had a look around the TGA website and have not seen anything about category changes

regards
Sue

Sue Borrell
Infection Prevention Nurse Consultant
Infection Prevention & Hospital Epidemiology

t 03 90763139
m 0429 806356
e S.Borrell@alfred.org.au

Alfred Health
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Hi Lindy
our generic branded liquid solution seems to now also have the ‘hospital grade disinfectant and the surface cleaning” directions, however our single use swabs and packets do not. Has anyone contacted the manufacturer yet?
regards
J

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>>> Lindy Ryan <Lindy.Ryan@SWAHS.HEALTH.NSW.GOV.AU> 3/07/13 9:03 >>>
Dear Colleagues

Just wondering if anyone; facilities/ service had been using 2%CHG in 70% ETOH (tinted pink /red/blue) for skin antisepsis for their pt. s for insertions of CVADs or preop skin prep? and if so were you notified of the change to the physical labelling from it previously being labelled for use as skin prep – use as a preoperative treatment of unbroken skin to it at some date being relabelled as a hospital grade disinfectant with the direction of apply to hard surfaces e.g walls and floors

Can I ask then if you were aware can I ask are you still using it as a skin antisepsis even with the label change or have you stopped using for this purpose and if so what are you now using instead?

Any advice or feedback would be grateful

Many thanks

Regards

Lindy

Lindy Ryan
Infection control CNC
Nepean Hospital NBMLHD
Phone 4724 2228
Email lindy.ryan@swahs.health.nsw.gov.au

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