Alcohol swabs for skin preparation

[Anonymous]

Hi everyone,

I seem to recall we had a discussion on the AICA list a while back re the
use of alcohol swabs for skin preparation prior to cannulation or
administration of IM / SC medications and I seem to recall that the
discussion may have touched on whether the swabs themselves need to be
sterile or not. Problem is that I can’t find that discussion point in any of
the threads were this topic was raised.

I have been looking at some of the alcohol swabs being used for IV
cannulation [Day Surgery environments] and there are some brands of swabs
out there that do not have the STERILE symbol [word] on the packaging.

Can anyone please tell me whether the alcohol swabs used for skin
preparation need to be sterile and if so – where this requirement is stated.

Thanks in anticipation.

Kind Regards

Terry McAuley

Sterilisation & Infection Prevention and Control Consultant

STEAM Consulting

E: terry@steamconsulting.com.au

W: http://www.steamconsulting.com.au

A: PO BOX 779

Endeavour Hills

VIC Australia 3802

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[Matthias Maiwald (KKH)]

Terry,

Just returned from a short period of leave, saw your query.

I am not personally aware of a formal requirement, although there may be one.

The concern is bacterial spores; they are not killed by the alcohol. That means, although a sterile manufacturing process is technically not (!) required to achieve a spore-free solution or alcohol swab, it is a definite advantage, in the case of alcohol swabs, to have them produced as sterile.

In the case of alcohol solutions, this is classically achieved by filtering the alcohol disinfectant through a bacterial exclusion filter, by which the spores are held back. In the case of alcohol swabs, manufacturers may have their proprietary ways to exclude spores from the swabs, which I am not familiar with.

In a similar context, the US FDA had a public hearing about a year or so ago, concerning liquid antiseptic products (not: swabs), whether or not they need to be produced technically sterile. The result was, if I remember this correctly, that when liquid antiseptics would be produced appropriately with good manufacturing practices, they would not need to be technically sterile, and conversely, when manufacturers would switch to sterile production, that this would increase costs very significantly.

A few years ago, I wrote a small comment for a literature evaluation service “Faculty of 1000” concerning an article reporting on contaminated alcohol swabs. I am quoting from my own comment below.

The article was:

Dolan SA, Littlehorn C, Glod MP, Dowell E, Xavier K, Nyquist AC, Todd JK. Association of Bacillus cereus Infection with Contaminated Alcohol Prep Pads. Infect Control Hosp Epidemiol. 2012 Jul; 33(7): 666-71. PMID: 22669227. DOI: 10.1086/666334

My comment was:

“This is an interesting report of a small series of infections with Bacillus cereus (a sporeforming bacterium) in one children’s hospital in the United States associated with contaminated alcohol preparation pads from one manufacturer. Two index patients were identified who had clinically relevant Bacillus cereus infections, and these infections were traced back to packaged single-use alcohol pads that were found to be contaminated with Bacillus species by microbiological investigations. These pads had not been specifically labeled as sterile. A possible route of transmission was the disinfection of vascular catheter hubs with these alcohol pads. Cultures from the pads grew a number of diverse Bacillus strains, and although the patients’ isolates did not match the ones from the pads in molecular typing, an origin from the pads appeared highly likely given that 63% of the pads were contaminated and given the diversity of the strains from the pads. The product was subsequently recalled nationwide and the hospital subsequently only used pads that were labeled as sterile. This incident is a reminder of the old microbiological wisdom that alcohol disinfectants are effectively auto-sterile with the notable exception of bacterial spores (and theoretically prions) and that all alcohol antiseptics for use on humans need to be filtered with bacterial exclusion filters during the manufacturing process (and pads would have to be sterilized separately). Of interest, the 2009 World Health Organization Hand Hygiene Guideline proposes an alternative way for end users to make their own alcohol hand rubs, by adding a small quantity of hydrogen peroxide that kills spores during storage of the alcohol hand rub.”

Regards, Matthias.

—
Matthias Maiwald, MD, FRCPA
Consultant in Microbiology
Adj. Assoc. Prof., Natl. Univ. Singapore
Department of Pathology and Laboratory Medicine
KK Women’s and Children’s Hospital
100 Bukit Timah Road
Singapore 229899
Tel. +65 6394 8725 (Office)
Tel. +65 6394 1389 (Laboratory)
Fax +65 6394 1387

Hi everyone,

I seem to recall we had a discussion on the AICA list a while back re the use of alcohol swabs for skin preparation prior to cannulation or administration of IM / SC medications and I seem to recall that the discussion may have touched on whether the swabs themselves need to be sterile or not. Problem is that I can’t find that discussion point in any of the threads were this topic was raised.

I have been looking at some of the alcohol swabs being used for IV cannulation [Day Surgery environments] and there are some brands of swabs out there that do not have the STERILE symbol [word] on the packaging.

Can anyone please tell me whether the alcohol swabs used for skin preparation need to be sterile and if so – where this requirement is stated.

Thanks in anticipation.

Kind Regards
Terry McAuley
Sterilisation & Infection Prevention and Control Consultant
STEAM Consulting
E: terry@steamconsulting.com.au
W: http://www.steamconsulting.com.au
A: PO BOX 779
Endeavour Hills
VIC Australia 3802

CONFIDENTIAL COMMUNICATION: The information contained in this message may contain confidential information intended only for the use of the individual or entity named above. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution or duplication of this transmission is strictly prohibited. If you have received this communication in error, please notify us by telephone or email immediately and return the original message to us or destroy all printed and electronic copies. Nothing in this transmission constitutes an agreement of any kind unless otherwise expressly indicated.

MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.

The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.

Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.

Replies to this message will be directed back to the list. To create a new message send an email to aicalist@aicalist.org.au

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[cid:kkha16.gif]kkh

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