Joint RCS/MHRA Statement on use of Topical Chlorhexidine for Skin Preparation Prior to Surgery

Statement on the use of topical chlorhexidine for skin preparation prior to surgery

Topical chlorhexidine is a common disinfectant used to prepare the skin prior to surgery in order to prevent surgical site infection. However, it has been reported to the College that some operating theatres may be using biocidal chlorhexidine, a form of the chemical registered with the Health and Safety Executive (HSE), rather than products registered as medicines with the Medicines and Healthcare Products Regulatory Agency (MHRA).

While NICE recommends either chlorhexidine or povidone-iodine for pre-operative antisepsis, operating theatres should be using the medicinally licensed product over those which are classed as a general disinfectant.

The Royal College of Surgeons and the MHRA recommends the use of licensed medicines to prepare the skin prior to surgery. The MHRA has issued the following clarification, which the College fully endorses:

Chlorhexidine - MHRA position

The manufacture and supply of a medicinal product containing chlorhexidine should be in accordance with Human Medicines Regulations. The product should have a marketing authorisation and there are restrictions on how it may be used.

Chlorhexidine is also available in a non-medicinal form which is extensively and legitimately used for non-medicinal purposes, including in a clinical setting.  These versions of the product are not subject to regulation under the Human Medicines Regulations 2012.

The MHRA view is that chlorhexidine is classified differently for different presentations. These are:

• Medical Use: Topical disinfectant for clinical use. (e.g. pre-operatively).
• Medical Device: Disinfectant for medical equipment.
• Biocide: General use as disinfectant (e.g. washing hands).

Where an authorised product exists this should be used in preference to another product as only it will be fully supported by risk-benefit analyses as to its use for that specific purpose.

MHRA would like to highlight that there are health risks associated with using chlorhexidine. Using the appropriately authorised product for its specific intended use, in accordance with the manufacturer’s instructions for use, is the best way of minimising harm.