The College notes that the medical technology manufacturing company Becton Dickinson (BD) has issued a recall of their IV Infusion medical products. In that regard, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a national alert.

It follows an investigation by Becton Dickinson which found that the sterilisation process of their products undertaken by a third party supplier did not meet required standards. To ensure the quality of their products, Becton Dickinson has, since mid-February, placed a shipping hold on all products, while they put in place alternative measures. New supplies will begin to be available in the UK later in March.

Becton Dickinson have not reported any patient safety issues in relation to the lack of standardised sterilisation process.

Infusion sets, including those manufactured by Becton Dickinson, are used in NHS hospitals and form the tubing used with an infusion pump to deliver fluids including medications, blood or blood products into a patient in a controlled manner. Becton Dickinson is a substantial supplier to the NHS in the UK.

Scotland’s Chief Medical Officer, Dr Gregor Smith said:

In our management of this situation, patient safety and quality of care are of paramount importance. 

The Scottish Government is working closely with the MHRA and the other UK Health Departments to mitigate any disruption to services, to support clinicians and to ensure that there is no negative impact on patients.

We are also working closely with NHS National Services Scotland and National Procurement to provide support to NHS Boards to put in place measures to alleviate any disruption that this supply issue may cause.

Professor Angela Thomas, Acting President of the Royal College of Physicians of Edinburgh added:

As we understand it, a risk balance assessment must be undertaken regarding this scenario. Clinical consensus has been reached which concurs that it is reasonable not to have a discussion with every patient – that there is no specific reason why any competent practitioner should inform individual patients as risk is so low.

We are advised that if a patient is at particular risk, where treatment could be delayed, then a choice could be made in discussion with that patient.


1. For further information, please visit the UK Government website: