Re: Use of alcoholic CHG wipes in relation to Epidurals

[Matthias Maiwald (KKH)]

P.S. Forgot to add. Here is an article that investigates over 12000 spinal/epidural anaesthesias and does not seem to find an increased rate of complications related to chlorhexidine-containing skin antiseptics:

Sviggum HP, Jacob AK, Arendt KW, Mauermann ML, Horlocker TT, Hebl JR. Neurologic complications after chlorhexidine antisepsis for spinal anesthesia. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):139-44.
http://www.ncbi.nlm.nih.gov/pubmed/22286519

Matthias.

Dear Rachel,

In response to your question, I would first like to address the primary question, then go on to skin antisepsis for spinal procedures.

If the vials are indeed contained within a sterile package, and the sterility of the packaging can be verified, then there is absolutely no need to swab the tops of the vials, unless there is a potential contamination between unpackaging and use.

For most vials (that I know — that are NOT contained within sterile packaging) I would exactly support the TGA’s statement as cited in italics in your e-mail.

But please bear in mind that the addition of chlorhexidine to the alcohol for swabbing the vial tops is absolutely unnecessary. The chlorhexidine adds next to nothing for the purpose of disinfecting vial tops, and pure alcohol (e.g. 70% isopropanol such in sterile prepackaged alcohol pads) is all that is needed. What the chlorhexine would add would be persistency, which is an advantage for skin antisepsis for longer procedures, but you don’t need persistent antiseptic action on vial tops.

The use of skin antiseptics before spinal/epidural anaesthesia is another issue. There are a handful of reported cases of severe adhesive arachnoiditis (and permanent disability) following the use of chlorhexidine/alcohol skin antiseptic before spinal/epidural anaesthesia, some of which are discussed in Bogod’s editorial that you have attached.

As Bogod is discussing, in some cases the causation is obvious. The CHG/ALC has been confused with the anaesthetic and a significant quantity been injected in the spinal canal. The pathogenesis in these cases is very obvious. CHG is known to be neurotoxic, and 70% alcohol is a very aggressive substance when coming into contact with mucous membranes or when entering body cavities. In this regard, the alcohol probably contributed significantly to the pathogenesis. What this means is that in the cases where CHG/ALC was injected, the pathogenesis is clear, biological plausibility is established, and this would have happened with any (not just CHG-containing) skin antiseptic.

Several other cases remain unclear, where it is NOT obvious and/or has not been able to be clarified whether any skin antiseptic has actually been injected in the spinal canal, or whether the skin antiseptic was just (!) present on the skin surface before injection, mainly because the events leading up to the incident would not be properly reconstructed. In one of the cases (cited by Bogod) it was reconstructed that about 0.1 mL (100 uL, a non-trivial amount) was apparently accidentally injected.

For cases where CHG/ALC has been properly applied and dried (as per usual recommendations) before spinal/epidural injections, biological plausibility for linking CHG/ALC with the pathogenesis is — in my personal opinion — not clearly established.

In a hypothetical scenario where the skin antiseptic has not yet dried, I have calculated previously (that was in an earlier Infexion Connexion e-mail concerning skin antisepsis before injections) that the amount that can be brought in with a needle bore would be in the nanolitre range (one nanolitre is 0.000001 mL).

In another hypothetical scenario where the skin antiseptic has dried, the amount should be orders of magnitude lower than that.

A similar calculation (but with a bigger epidural needle bore) has been made by Tilakaratna in a letter to the editor in 2009:

http://bja.oxfordjournals.org/content/103/3/456.full/reply#brjana_el_5066

As an unexplored issue remains whether potential capillary action along the sides of the needles could suck in a solution, but this would only apply if the antiseptic has not dried.

So, these are some of my points.

Some additional points regarding CHG + ALC and/or persistency requirements on skin (see also above, concerning persistency required on vial tops) are made in our recent commentary article in JAC:

Maiwald M, Chan ESY (2014) Pitfalls in evidence assessment: the case of chlorhexidine and alcohol in skin antisepsis (Leading Article). J. Antimicrob. Chemother 69: 2017-21.
http://dx.doi.org/10.1093/jac/dku121

It would in turn be interesting to hear what you briefly touch upon, what recommendations ANTT frameworks have in terms of alcohol + CHG, and what ANTT recommends concerning epidural/ nerve infusion management.

Best 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 all,

I am very interested in input from list subscribers to the issue surrounding use of wipes containing 70% alcohol and 2% CHG to clean the tops of vials prior to injecting or drawing up. Most subscribers would be aware of the adverse events reported in relation to injection of alcoholic CHG into an epidural that has altered practices in relation to insertion and management of epidurals. This concern has resulted; it appears, in a real concern in relation to the use of wipes on any equipment used in the management of epidurals. Please refer to the attached editorial. As the bottles of solution used are presented in a sterile form (sealed sterile packaging) we have recommended that the tops of these vials do not need swabbing prior to use. There do appear, however, to other real concerns relating to the potential for adverse events relating to both epidural and nerve infusions and possible contamination with chlorhexidine residues.

Can I ask if anyone would like to make comment on your approach to this concern?

I flag for those who may not be aware the information provided from the TGA in July 2014 when the TGA investigated a number of reported cases of an unusual infection that were associated with propofol (Ralstonia spp.). As a result of this specific investigation the TGA issued a statement which included the following general information;

“The exterior surfaces of injection vials are not intended to be sterile. Most protective lids do not guarantee sterility of the outer surface of a vial rubber stopper/aluminium crimp seal. This lid is intended to act as a shield for the rubber stopper and to keep dust and other physical contaminants away from it.
Noting this, health professionals are reminded that proper aseptic technique must be strictly followed when administering intravenous injections to a patient. This includes wiping the outer surface of the rubber stopper and its injection site with a suitable disinfectant wipe/swab and allowing it to dry before inserting any device into the vial.

http://www.tga.gov.au/safety/alerts-medicine-provive-mct-lct-140707.htm#.U8h3DZSSxQE

As ANTT frameworks recommend the use of alcohol + CHG, any comments or advice pertaining to ANTT and epidural/ nerve infusion management and your organisations/ health service risk management approach would be most appreciated .

Many thanks in advance
Kind regards
Rachel

……………………………………………………………………………..
Rachel Thomson
Nurse Unit Manager

Infection Prevention & Control Unit
Royal Hobart Hospital
Tasmanian Health Organisation-South
*: 03 62227882/8658

Level 4, H Block
48 Liverpool Street
Hobart, 7000

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