Sterile or non-sterile

I am looking at another recall of a 2% chlorhexidine impregnated pad. You don’t have to really read the rest. It is Burkholderia cepacia – a less dangerous relative of pseudomonas aeruginosa – one that colonises rather than infects. It can be found in catheter associated infections and very rarely it can be a problem in patients with immunodeficiency. It is a very naughty little bug that seems to be hit by chlorhexidine and then recovers and grows – actually like is less common and more dangerous relative pseudomonas.

Bugs also survive in alcohol. Many of the Bacillus species (including Bacillus cereus) can survive and occasionally these are associated with serious infections, particularly in neonates. Our old friend C. difficile is another one that is not killed by alcohol.

In 2012 the FDA asked all of the manufacturers of topical antiseptics to update their labels to clearly inform healthcare professionals whether the solution or applicator was sterile or non-sterile. They also asked manufacturers to use single-use packaging to decrease the risk of infection.

Of course a label that says non-sterile does not mean that it is contaminated – it just means that there has been no terminal sterilisation process. But sterile does mean sterile. When a medicine says that it is sterile it means that it has gone through an appropriate sterility checking process and sign-off by a qualified person before that batch is released.

Across the pond we should have been smiling. We have a sophisticated regulatory system that ensures that every new product launched this century to be used on the skin before an intervention as a medicinal product will be sterile and single use. We have a system where all new products used to clean medical devices such as hubs are licensed as medical devices under the control of the MHRA.

It is just a pity that the majority of the UK uses nonsterile bulk bottles of antiseptics and wipes without an appropriate license. Would it be helpful in the UK if the MHRA asked manufacturers to clearly state on their products the words ‘sterile’ or ‘non-sterile’? Would it make us look – would it make us think?



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