National Medical Devices Committee - Summary of Minutes: August 2024

Attendees and apologies

• Gordon James, Board Chief Executive (Chair), NHS Golden Jubilee Hospital
• Paul Campbell, MHRA,
• John Sturgeon, Digital/IT, NHS Lothian 
• Ruth Griffith, COSLA
• Scott Barnett NHS National Services Scotland (NSS)
• Kirsty Brightwell, Medical Director, NHS Shetland
• John Gebbie, Director of Finance, NHS 24
• Malcolm Phillips, Healthcare Science Lead, NHS Lothian
• Eddie Fraser, Chief Executive, Local Authorities via COSLA
• Marc Turner, Director, Scottish National Blood Transfusion Service (SNBTS)
• Chief Medical Officer (CMO) Specialty Advisor for Clinical Physics, Scottish Government
• Steven Friel, Chair, national Incident Safety Officers (Boards and Local Authorities), NHS Golden Jubilee Hospital
• Sulisti Holmes, Head of Incident Reporting Investigation Centre (IRIC)
• Neil Smart, Chair of SHTG, Health Improvement Scotland (HIS)
• Head of Digital Health and Care, Scottish Government
• Chief Scientist Office, Scottish Government
• Kenny Rees, National Procurement, NHS National Services Scotland (NSS)
• Claire Fernie, Public Partner, Health Improvement Scotland (HIS)
• Medical Devices and Legislation Unit, Scottish Government
• Medical Device Policy Officials, Devolved Government

Apologies

• Gregor Smith , Chief Medical Officer (CMO), Scottish Government
• Head of Chief Medical Officer (CMO) Policy Division, Scottish Government
• Amanda Wong, Allied Health Professionals (AHP) Director, NHS Fife
• Lynsay Gracie, Head of Decontamination and chair of the national Reusable Medical Devices Decontamination Expert Group (RMD-DEG), NHS Greater Glasgow and Clyde
• Janette Kennan, Nurse Director, NHS Fife
• Head of Diagnostics and General Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA)
• Ewan Bell, Chair of Board Medical Device Committee, NHS Dumfries and Galloway

Items and actions

Software as a Medical Device (SaMD)

The planned changes in the regulation of SaMD are anticipated to require organisations to have a whole lifecycle inventory of SaMD, a greater understanding of the classification of SaMD and closer working between Digital/IT and Clinical Engineering.

A Short Life Working Group (SLWG) on the Management of SaMD was established to consider the challenges for Boards and Local Authorities and develop an approach to common issues. The work from the SLWG delivered a summary toolkit to capture shared learning, which was issued on 31 May 2024 to NHS Board Digital and Clinical Engineering Leads to assist Boards with developing their approaches locally. The summary report/toolkit can be accessed on Turas.

The Management of SaMD SLWG has been paused to give Boards time to undertake work in the areas described in the summary report. We anticipate the SLWG will meet again in Spring 2025 to review outcomes and to scope potential areas of work, including management of SaMD mobile apps.

 

Board Medical Device Policies Guidance

At the first Medical Devices Committee (MDC) meeting on 15 March 2024, the MDC agreed to the development of an improvement approach to assist Boards to develop their local Board medical device policies by 31 March 2025. Further Guidance including a Checklist, template and example Terms of Reference for a Board MDC has been developed into a draft CMO letter.

To further support Boards, an NHS Board Chairs of Medical Device Committee Group is being established, with the first meeting planned for 1 October 2024. Reporting to this MDC, the aim of this Group will be to share best practice and learning. The distribution of the CMO letter will coincide with the first NHS Board Chairs of Medical Device Committee Group meeting on 1 October 2024.

 

Software

Software for a once for Scotland approach to support NHS Boards and Scottish Government to meet requirements for medical device regulatory compliance as well as the Scottish Public Cyber Resilience Framework (CRF)/Network Information Systems requirements is being used. It will manage the cyber security of connected medical devices and assist in developing an accurate local Board inventory, also provide a national overview of the medical device estate and help mitigate the key cyber risks to NHS Scotland in this critical area.