Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to monitor patient outcomes and adverse events associated with unlicensed perioperative skin preparation products including their potential impact on surgical site infections and wider NHS costs.
Skin antisepsis products approved for use in the United Kingdom by the National Health Service are outlined in the British National Formulary. Guidance on skin antisepsis and surgical site infections is outlined by the National Institute for Health and Care Excellence. Further joint guidance from the Royal College of Surgeons and Medicines and Healthcare products Regulatory Agency covers the importance of using medicinally licensed products for perioperative skin preparation.
Adverse events associated with the use of specific medicines and devices in the UK are monitored and recorded via the yellow card scheme. This scheme would apply in the event of adverse events associated with use of an unlicensed product.