Re: Non-alcohol based hand sanitisers

[Greg Whiteley]

Dear Donna and all,
Please be advised that the primary indicator for selection of any hand hygiene product for use within healthcare settings is in fact a TGA PRODUCT registration. All antibacterial/antimicrobial hand rubs and handwashes sold in Australia to Healthcare facilities must be registered with the TGA. This group of products are regulated as Over The Counter (OTC) medicines. They are subject to both in vitro and in vivo performance testing, amd also subject to manufacturing controls under the Code of Good Manufacturing Practice (GMP).
The performance criteria include standardised bactericidal tests, and hand application tests.

This is regarded as a low risk product category, but the controls are strictly supervised by the TGA.

Virucidal claims are forbidden on this product category, and no advertising claims are allowed with respect to virucidal capacity.

However, for products which are not sold into healthcare there are no equivalent regulatory controls. This includes both Alcohol Based Hand Rubs (ABHR) and non alcohol products.

If healthcare facilities choose to purchase and use unregulated products, then they are free to do so. But you should all be aware that you are out into an unregulated market and the quality and legitimacy of the data should be thoroughly considered. Companies who have a good reputation and who manufacture under another quality control environment should be preferred to those operating without regard to an independantly audited quality manufacturing system (e.g. ISO 13485 or ISO 9000).

There may be instances where a non-alcohol based product may be the only appropriate alternative to a fully registered ABHR. But it is a situation of buyer beware, and the presence of or lack of test reports is not the only matter to take into consideration.

Kindly
Dr Greg Whiteley
Chairman, Whiteley Corporation
Adjunct Fellow, Western Sydney University

On Wednesday, 26 February 2020 Donna Cameron wrote:

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
doherty.edu.au

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