National Medical Devices Committee - Summary of Minutes: March 2025

Attendees and apologies

• Gordon James (Chair), Board Chief Executive, NHS Golden Jubilee
• Joseph Burt, Head of Diagnostics and General Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA)
• Greig Chalmers, Head of Chief Medical Officer Policy Division, Scottish Government
• Kirsty Brightwell, Medical Director, NHS Shetland
• Malcolm Phillips, Healthcare Science Representative, NHS Lothian
• Sharon Hilton-Christie, Senior Responsible Officer (SRO), Scan for Safety Programme       
• John Gebbie, Director of Finance, NHS 24
• Lynsay Gracie, Head of Decontamination and chair of the national Reusable Medical Devices Decontamination Expert Group (RMD-DEG), NHS Greater Glasgow and Clyde
• Andrew Reilly, Chief Medical Officer Specialty Advisor for Clinical Physics, Scottish Government,
• Steven Friel, Chair, national Incident Safety Officers (Boards and Local Authorities), NHS Golden Jubilee
• Amanda Wong, Allied Health Professional (AHP) Director, NHS Fife
• Sulisti Holmes, Head of Incidents and Reporting Investigation Centre (IRIC)
• Neil Smart, Chair of Scottish Health Technologies Group (SHTG), Health Improvement Scotland
• Deputy Director, Digital Health and Care, Scottish Government
• Kenny Rees, National Procurement, NHS National Services Scotland
• Claire Fernie, Public Partner, Health Improvement Scotland
• Ewan Bell, Chair of Board Medical Devices Committee, NHS Dumfries and Galloway
• Stephen Roberts, Chair of Scottish Technical Managers and Head of Medical Physics, NHS Dumfries and Galloway
• Medical Devices and Legislation Unit, Scottish Government
• Medical devices Policy Officials, Devolved Governments

Apologies

• Professor Sir Gregor Smith, Chief Medical Officer, Scottish Government
• Eddie Fraser, Chief Executive, Local Authorities, COSLA
• Marc Turner, Director Scottish National Blood Transfusion Service (SNBTS), NHS National Services Scotland
• Janette Kennan, Nurse Director, NHS Fife
• Head of Innovation Adoption, Scottish Government

Items and actions

Following discussion with the NHS Scotland Executive Group in January 2025, a Scan for Safety Medical Device Regulation (MDR) Compliance Dashboard (implants) has been developed for regular reporting on Board implementation and will be discussed with Board Chief Executives at their next meeting on 08 April 2025. 

A Monitoring and Improvement Self-Assessment tool for Boards and Local Authorities, developed by Incident Reporting and Investigations Centre (IRIC) with Boards and Local Authorities is being piloted. The self-assessment tool can be used to measure an organisation’s compliance with national guidance including Safe Management of Medical Devices, known as SHTN 00-04 which includes current regulatory requirements. Following the pilot the MDC will consider if this can be used as a tool to provide a baseline across NHS Boards and Local Authorities in Scotland.

Patient Yellow Card Reporting: There is a need to improve reporting rates by patients on medical device safety events to the MHRA Yellow Card scheme. In the period 2024 only 18 direct reports by patients were submitted. A range of actions will be planned to support patients to report any issues in addition to their health or care professional to the MHRA Yellow Card scheme in order to support Post Market Surveillance. The Health Improvement Scotland (HIS) Gathering Views Report on Implanted Medical Devices highlights the need for clearer patient information to support informed consent.