Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the US Food and Drug Administration safety communication Evaluating Plastic Syringes Made in China for Potential Device Failures, issued on 30 November 2023, whether her Department is undertaking a similar evaluation of syringes.

The Medicines and Healthcare products Regulatory Agency (MHRA) is aware of the issues raised by the US Food and Drug Administration (FDA) concerning quality control and design problems with plastic syringes manufactured in China. Whist the MHRA works on the basis that CE or UKCA marked plastic syringes originally produced in China are in use within the United Kingdom healthcare system, one of the main suppliers of plastic syringes into the UK healthcare system, Becton, Dickinson and Company, has confirmed that their products are not affected by this issue.

Medical device safety issues may affect different global regions to varying extents. Whilst awareness and active information exchange between regulators is critical to focus national investigations, regulatory action is taken based on UK relevant evidence. Device safety corrective actions communicated via so-called Field Safety Notices (FSNs) related to the specific problems highlighted in the FDA alert have not been issued in the UK. FSNs issued in the UK are available at the following link:

https://www.gov.uk/drug-device-alerts

The MHRA is an active member of the International Medical Device Safety group. Representatives of regulatory authorities across the world meet on a regular basis to discuss emerging safety issues related to medical devices. The current issue was identified and MHRA are closely monitoring the situation. At this stage, there is insufficient evidence to justify actions against specific manufacturers of these products supplying into the UK.