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Claighen, Christine – GOJO/AU

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  • in reply to: Re: Question on dispensing hand sanitiser #76807
    Claighen, Christine – GOJO/AU
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    Claighen, Christine – GOJO/AU

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    ClaigheC@GOJO.COM

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    Hi Emma,
    Any ABHR use in clinical setting must be TGA registered.
    The exclusion Helen refers to if the supplier makes an ABHR using either of the WHO formula with strict guidance of no fragrance, or colourant or extra moisturisers outside the WHO FORMULA as follows:

    The formulations are based on advice by the World Health Organization and similar decisions by the US Food and Drug Administration. The final formulation of the hand sanitiser must contain only the following ingredients:

    * EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;
    * sterile distilled water or boiled cold water;
    * glycerol 1.45% v/v (pharmacopoeial grade);
    * hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and
    * does not contain any other active or inactive ingredients, including colours, fragrances or emollients.

    Here is the link:
    https://www.tga.gov.au/hand-sanitisers-and-covid-19

    Regards
    Christine Claighen
    Regulatory and Scientific Manager

    On 2 May 2020, at 8:15 am, helen truscott <helentruscott@hotmail.com> wrote:

    Hi Emma,

    I understand that some ABHR companies have distributed larger containers, but this has come with other issues such as how the containers can be decanted without causing manual handling issues and how to get the solution into the pump dispensers.

    If the product has been sent from one of the usual ABHR manufacturing companies, they should be sending a list of ingredients to show that it is still the same product and ideally they would be able to provide some labels for you.

    If it has come from a different source altogether, to be used in healthcare facilities, it would still need to meet TGA approval. The TGA has made a Determination on 27 March 2020 regarding Excluded Goods Hand Sanitisers and states that:

    There should be labels on the 5l container and also the bottles they are being decanted to.

    I can send you the relevant TGA document if you forward me your email address

    Kind regards

    Helen Truscott RN,RM,MPH,GDipTMH,CIPC-A
    Ph:0410 011983
    E:Helentruscott@hotmail.com

    Sent from Outlook Mobile

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    From: ACIPC Infexion Connexion <ACIPCLIST@ACIPC.ORG.AU> on behalf of Sarah Bailey <sarah@QED.COM.AU>
    Sent: Friday, May 1, 2020 2:36:37 PM
    To: ACIPCLIST@ACIPC.ORG.AU <ACIPCLIST@ACIPC.ORG.AU>
    Subject: Re: [ACIPC_Infexion_Connexion] Question on dispensing hand sanitiser

    Hi Emma,

    Im not sure of TGA regulations, but, as the alcohol content of the gel makes the product a hazardous substance, any bottle you decant it into would need to be labelled with the full name of the product and the correct hazard phrases/labels, so that it complies with your state Work Health and Safety legislation.

    This is also so that in the case of a spill or accident, the correct SDS can be used for advice to deal with spillages etc.

    Cheers,

    Sarah Bailey MSc, PGDip Med Myc

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    From: ACIPC Infexion Connexion <ACIPCLIST@ACIPC.ORG.AU> On Behalf Of Jones, Emma
    Sent: Thursday, April 30, 2020 7:09 PM
    To: ACIPCLIST@ACIPC.ORG.AU
    Subject: [ACIPC_Infexion_Connexion] Question on dispensing hand sanitiser

    Hi all

    Looking for some assistance or recommendations around dispensing of hand sanitiser. I have sourced 5ltr hand sanitiser 60% ethanol but concerned around the tga requirement for appropriate labelling.

    These are to be used in the dental channel both clinically and for patients under the current Lv2 requirement.

    My question is can these be dispensed to smaller bottles without labelling but more an identification stating hand sanitiser instead?

    Thanks for your insight and help

    Emma

    Emma Jones
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    in reply to: Re: Non-alcohol based hand sanitisers #76395
    Claighen, Christine – GOJO/AU
    Participant

    Author:
    Claighen, Christine – GOJO/AU

    Email:
    ClaigheC@GOJO.COM

    Organisation:

    State:

    Hi,
    When you use a hand sanitiser in a clinical setting (blood or bodily fluid exposure) the product has to be registered with the TGA. Aside from the the active ingredient, the product is determined to be cosmetic or a therapeutic depending on indication for use.

    Christine Claighen BSc (Biotech), Dip (Micro)
    Head of Regulatory and Science- Australasia

    GOJO Australasia Pty Ltd
    Suite 1, Level 1
    2B Lord Street
    Botany NSW 2019

    Phone: +61 2 9016 3885
    Mobile: +61 401 098 881
    Email: christine.claighen@gojo.com.au
    Web: http://www.gojo.com.au

    [X]

    On 26 Feb 2020, at 8:43 pm, Michael Wishart wrote:

    Oh well, according to this TGA monograph, it has to be alcohol.

    https://www.tga.gov.au/otc-medicine-monograph-hand-sanitisershttps://www.tga.gov.au/otc-medicine-monograph-hand-sanitisers

    I would think non-alcohol based hand sanitiser is a non-TGA product, then.

    Cheers
    Michael

    Michael Wishart | Infection Control Coordinator, CICP-E

    St Vincents Private Hospital Northside | 627 Rode Road CHERMSIDE QLD 4032
    T +61 7 3326 3068 | F +61 7 3607 2226
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    From: ACIPC Infexion Connexion [mailto:ACIPCLIST@ACIPC.ORG.AU] On Behalf Of marjenes@OPTUSNET.COM.AU
    Sent: Wednesday, 26 February 2020 8:36 PM
    To: ACIPCLIST@ACIPC.ORG.AU
    Subject: Re: [ACIPC_Infexion_Connexion] Non-alcohol based hand sanitisers

    Dear Michael,
    Gosh I certainly wasnt thinking of the supermarket when I wrote common brand – I meant common HCW brand lol. I think everyone knows which brand I mean?

    Regards,

    Margaret Jennings
    Marjen Education Services

    website. http://www.marjenes.com.au
    email. marjenes@optusnet.com.au

    mob. 0404 088 754

    From: ACIPC Infexion Connexion <ACIPCLIST@ACIPC.ORG.AU> On Behalf Of Michael Wishart
    Sent: Wednesday, 26 February 2020 8:27 PM
    To: ACIPCLIST@ACIPC.ORG.AU
    Subject: Re: [ACIPC_Infexion_Connexion] Non-alcohol based hand sanitisers

    Hi Margaret

    I just had a quick look at a major supermarket website (nothing better to do, right? ), and I get grapefruit, lavender, lemon and myrtle, and cherry blossom as ingredients of some of the hand sanitisers available. Some alcohol (listed a denatured), but no actual concentration. Claims that 99.9% of bacteria are removed by the hand sanitiser, which I could probably claim with just soap and water, actually.

    Caveat emptor (buyer beware) is correct, indeed.

    Cheers
    Michael

    Michael Wishart | Infection Control Coordinator, CICP-E

    St Vincents Private Hospital Northside | 627 Rode Road CHERMSIDE QLD 4032
    T +61 7 3326 3068 | F +61 7 3607 2226
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    From: ACIPC Infexion Connexion [mailto:ACIPCLIST@ACIPC.ORG.AU] On Behalf Of marjenes@OPTUSNET.COM.AU
    Sent: Wednesday, 26 February 2020 8:11 PM
    To: ACIPCLIST@ACIPC.ORG.AU
    Subject: Re: [ACIPC_Infexion_Connexion] Non-alcohol based hand sanitisers

    Wed
    Dear Michael,
    I think youll find that the pump mechanism has been altered on the liquid dispensers of one common brand of ABHR and they now spray into the hand and dont drip. I would question why any facility is still using the old pump type as it has been around for a year at least.

    Apart from the TGA issue, I am interested in what product is in a non alcohol handrub?

    Regards,

    Margaret Jennings
    Marjen Education Services

    website. http://www.marjenes.com.au
    email. marjenes@optusnet.com.au

    mob. 0404 088 754

    From: ACIPC Infexion Connexion <ACIPCLIST@ACIPC.ORG.AU> On Behalf Of Michael Wishart
    Sent: Wednesday, 26 February 2020 6:58 PM
    To: ACIPCLIST@ACIPC.ORG.AU
    Subject: Re: [ACIPC_Infexion_Connexion] Non-alcohol based hand sanitisers

    Hi Elena

    Obviously carpeted floors are not the preferred floor coverings in acute care areas, but they are seen to be more attractive floor coverings for public and waiting areas.

    But my understanding is that the requirement for not placing ABHR over carpet was because hand *rubs* are very liquid, and will drip when used onto the floor. I once worked in a hospital that had carpet in its ICU, and we trialled a hand *rub* and the drips stained the carpet very badly! So we switched to a hand *gel* product that did not drip, and the problem went away. You might also find some hand *foam* products are almost non-drip in use as well, so carpeted areas are not an issue.

    I would encourage you to look at various alcohol based hand sanitiser products in different formulations, and test them in your carpeted areas to see if they do, indeed, create a stain issue or not. But I would also encourage you to also pursue use of a TGA approved product for use in healthcare, rather than an unregulated supermarket product, for the reasons outlined by a previous poster.

    Cheers
    Michael

    Michael Wishart | Infection Control Coordinator, CICP-E

    St Vincents Private Hospital Northside | 627 Rode Road CHERMSIDE QLD 4032
    T +61 7 3326 3068 | F +61 7 3607 2226
    E michael.wishart@svha.org.au |
    W https://www.svphn.org.au

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    From: ACIPC Infexion Connexion [mailto:ACIPCLIST@ACIPC.ORG.AU] On Behalf Of Elena Donaghy
    Sent: Wednesday, 26 February 2020 5:27 PM
    To: ACIPCLIST@ACIPC.ORG.AU
    Subject: Re: [ACIPC_Infexion_Connexion] Non-alcohol based hand sanitisers

    Hi Donna,
    I am very interested in non – alcohol based hand rubs as we have a hand hygiene station within our foyer. The flooring is carpet and I am aware Hand hygiene Australia recommend ABHR dispensers should not be located over carpeted areas, unless the area is protected by active sprinklers. Sprinklers have not been installed.
    We would like to encourage hand hygiene upon entering the building.
    Any advice would be appreciated.

    Elena Donaghy
    Manager of Clinical Education & Infection Control
    e: Elena.Donaghy@shq.org.au | ph: 08 9227 6177 | f: 08 9227 6871
    shq.org.au

    From: ACIPC Infexion Connexion <ACIPCLIST@ACIPC.ORG.AU> On Behalf Of Rebecca Curr
    Sent: Wednesday, February 26, 2020 12:31 PM
    To: ACIPCLIST@ACIPC.ORG.AU
    Subject: Re: [ACIPC_Infexion_Connexion] Non-alcohol based hand sanitisers

    Hi Donna,
    Thank you for this. I am also interested to find a supplier of non-alcohol based hand rub, (brand names would be useful) to use within the correctional facility as alcohol based hand rubs are not permitted.

    Regards

    Rebecca Curr | Clinical Nurse Specialist Immunisation
    Public Health Unit | Central Australia Health Service

    Northern Territory Government
    Demountable Buiding, 6 Gap Rd, Alice Springs
    GPO Box 721 Alice Springs, NT 0871.

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    From: ACIPC Infexion Connexion <ACIPCLIST@ACIPC.ORG.AU> On Behalf Of Donna Cameron
    Sent: Wednesday, 26 February 2020 11:17 AM
    To: ACIPCLIST@ACIPC.ORG.AU
    Subject: [ACIPC_Infexion_Connexion] Non-alcohol based hand sanitisers

    Hi Everyone,

    I have been asked by two different groups this week about non-alcohol based hand sanitisers. My initial thoughts were that, in accordance with all hand hygiene guidance for healthcare settings that I can find, alcohol-based hand rubs are the only acceptable products available. That non-alcohol based hand rubs havent undergone EN1500 testing and therefore shouldnt be used.

    I have subsequently been advised by one of the groups asking me about the product they current use (a non-alcohol based hand rub) that the product has achieved EN1500 certification. They will be providing me with this product information next week.

    In the interim, I was interested to know if any other ICPs etc have either experience or knowledge of non-alcohol based hand rubs, their use (in a healthcare setting) and efficacy.

    I realise we cant use product names (I am happy for you to contact me directly (email below) if you wish to), but I am very interested to hear peoples thoughts/advice/experience on this topic. One of the groups was particularly keen to know about appropriateness in relation to coronavirus so your thoughts on that would also be appreciated.

    Regards,
    Donna

    Donna Cameron
    Infection Control Consultant
    T +61 (0) 3 8344 3574 (Monday, Wednesday & Friday); +61 (0) 3 9096 5233 (Tuesday & Thursday)
    donna.cameron@unimelb.edu.au
    Microbiological Diagnostic Unit Public Health Laboratory
    The Peter Doherty Institute for Infection and Immunity
    792 Elizabeth Street | Melbourne | Victoria | Australia | 3000
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