Open letter: the use of unlicensed products for perioperative skin preparation

Throughout the NHS, there has been increasing concern raised by clinicians over recent years that due to budgetary pressures, clinicians are having to use unlicensed products when preparing skin for surgery putting patient safety at risk. As a result, a group of senior clinicians have written to the Department of Health and Social Care and MHRA to push them to provide greater clarity and leadership on the topic to help improve patient outcomes.

Preet Kaur Gill MP

The use of unlicensed products for perioperative skin preparation

14th July

Dear Minister,

As clinicians working across the NHS, we are writing to express concern about the continued use of unlicensed products for perioperative skin preparation within some NHS organisations.

Preventing surgical site infections (SSIs) is a fundamental component of safe surgical care. Patients should be able to have confidence that products used before surgery have been appropriately assessed, authorised, and regulated for their intended purpose. However, we understand that some NHS Trusts are procuring unlicensed biocidal products in place of licensed medicinal products specifically approved for perioperative use.

While such decisions may be driven by short-term cost pressures, they risk creating unintended consequences for both patients and the wider NHS. The use of unlicensed products raises important questions regarding patient safety, clinical governance, informed consent, and accountability. It also introduces variation in practice across the health service at a time when consistency and quality of care are key priorities.

The implications extend beyond patient outcomes. Surgical site infections can lead to prolonged hospital stays, delayed recovery, and increased demand on NHS services. Any procurement savings must therefore be weighed against the potentially significant costs associated with avoidable complications, additional treatment, and litigation.

We are therefore calling on the MHRA and the Department of Health and Social Care to provide greater clarity and leadership in this area, including:

• Clear national guidance on the use of licensed and unlicensed products for perioperative skin preparation;
• Greater transparency regarding regulatory oversight and enforcement;
• Improved monitoring of patient outcomes and adverse events associated with unlicensed products; and
• Support for procurement decisions that properly reflect patient safety, clinical effectiveness, and whole-system costs.

At a time when the NHS is seeking to improve productivity, reduce waiting lists, and enhance patient safety, it is essential that procurement decisions support these objectives. Patients deserve confidence that the products used in their care meet the highest standards of safety, quality, and regulatory scrutiny.

Yours sincerely,

Mr Andrea Bille
Thoracic Surgeon
Guy’s Hospital

Mr Aziz Momin
Consultant Cardiac Surgeon
St George’s Hospital

Mr Giles Bond-Smith MBBS BSc FRCS
Consultant HPB, AWR & Emergency Surgeon
Clinical Director for Surgery, Women’s and Oncology (SUWON)

Lindsay Keeley RN BSc Hons
Clinical, Patient Safety & Quality Lead
The Association for Perioperative Practice

Oliver Tierney
President and Director
The Association for Perioperative Practice

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