National Medical Devices Committee - Summary of Minutes: March 2024

Attendees and apologies

• Chief Medical Officer (CMO), Scottish Government
• Gordon James, Board Chief Executive, NHS Golden Jubilee Hospital
• Kirsty Brightwell, Medical Director, NHS Shetland
• Eddie Fraser, Chief Executive, Local Authorities via COSLA, East Ayrshire Council
• Head of Diagnostics and General Medical Devices, MHRA
• Marc Turner, Senior Responsible Owner (SRO), Scan for Safety Programme
• John Gebbie, Director of Finance, NHS 24
• Steven Friel, Chair of national Incident Safety Officers (Boards and Local Authorities), NHS Golden Jubilee
• Janette Kennan, Nurse Director, NHS Fife
• Amanda Wong, AHP Director, NHS Fife
• Neil Smart, Chair of SHTG, Health Improvement Scotland
• Kenny Rees, National Procurement, NHS National Services Scotland
• Head of CMO Policy Division, Scottish Government
• Medical Devices and Legislation Unit, Scottish Government.

Appologies

• Sulisti Holmes, Head of Incidents and Reporting Investigation Centre (IRIC)
• Malcolm Philips, Healthcare Science Lead, NHS Lothian
• Lynsay Grace, Head of Decontamination and chair of the national Reusable Medical Devices Decontamination Expert Group (RMD-DEG), NHS Greater Glasgow and Clyde
• Andrew Reilly, CMO Specialty Advisor for Clinical Physics, Scottish Government
• Head of Digital Health and Care, Scottish Government
• Medical Device Policy Officials, Devolved Governments

Items and actions

The MHRA (Medicines and Healthcare products Regulatory Agency) Medical Device Regulatory Roadmap which will implement the planned revision of UK Medical Device Regulation. This is being designed to improve patient safety and expected to apply during 2025. Discussions included a high level analysis of the impact areas for NHS Boards and to some extent Local Authorities, with areas including Health Institution Exemption, Software as a Medical Device and the need for the improved understanding of the breadth of medical devices being used by NHS Boards. The Committee will continue to consider these areas as specific requirements of the future Medical Device Regulation become available.

A baseline review of NHS Board Medical Device Policies undertaken by the SG Medical Devices Legislation Unit, as outlined in CMO Letter (2024)1 “MDR Preparedness and Medical Devices Policy Framework and Action Plan 2024-26”. The review summarised that the requirement for Boards to have a Medical Device Policy has been in place for over 10 years. The Committee agreed to: a) the development of an improvement approach that will provide further guidance and templates to be issued around July 2024 to assist Boards to develop local Board policies that provide assurance that the management of medical devices complies with regulatory requirements and integrates with other Board safety and governance structures, and b) that all Boards should have a Medical Device Policy in place by 31 March 2025. The baseline work undertaken will be used as a key measurement indicator and help to inform future work being planned on the development of a monitoring and measurement framework being led by Scotland’s national Incident Reporting Investigation Centre (IRIC) (also outlined in CMO Letter (2024)1)