National Medical Devices Committee - Summary of Minutes: May 2024

Summary of minutes from the meeting of the group on 29 May 2024.


Attendees and apologies

  • Gordon James (Chair), Board Chief Executive, NHS Golden Jubilee Hospital
  • Kirsty Brightwell, Medical Director, NHS Shetland
  • Head of Diagnostics and General Medical Devices, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Marc Turner, Senior Responsible Officer (SRO) Scan for Safety Programme
  • Clair Fernie, Lay Representative
  • Steven Friel, Chair of Incident Safety Officers (Boards and Local Authorities), NHS Golden Jubilee
  • Head of Digital Health and Care, Scottish Government
  • Simon White, Director, Scan for Safety Programme
  • Lindsey Robertson, Implementation Lead, Scan for Safety Programme
  • Janette Kennan, Nurse Director, NHS Fife
  • Amanda Wong, AHP Director, NHS Fife
  • Neil Smart, Chair of SHTG, Health Improvement Scotland
  • 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
  • Kenny Rees, National Procurement, NHS National Services Scotland
  • Head of CMO Policy Division, Scottish Government
  • Chief Scientist Office, Scottish Government
  • Sulisti Holmes, Head of Incidents and Reporting Investigation Centre (IRIC)
  • CMO Specialty Advisor for Clinical Physics, Scottish Government
  • Medical devices and Legislation Unit, Scottish Government

Apologies

  • Chief Medical Officer (Co-Chair), Scottish Government
  • Eddie Fraser, Chief Executive, Local Authorities via COSLA
  • Medical Devices Policy Officials, Devolved Governments

Items and actions

Post Market Surveillance Legislative Requirements

The Committee received an overview of current Post Market Surveillance (PMS) legislative requirements. The future UK PMS regulation, originally expected to be laid before the UK Parliament on 23 May, has been delayed due to the general election being called.

The importance of ensuring that existing safety system requirements, as set out in CEL (Chief Executive Letter) 43 (2009) (CEL 43 (2009) - Safety of health, social care, estates and facilities equipment: NHS Board and local authority responsibilities), are operating effectively across all NHS Boards and Local Authorities. This includes having a clear written policy for reporting incidents to the national Incident Reporting and Investigation Centre (IRIC), effective processes for cascading safety information and an audit system to demonstrate compliance. The Committee asked IRIC to update CEL 43 to clarify and reinforce these requirements.

 

NHS Scotland Scan for Safety Programme Implementation

The Committee received an update on the NHS Scotland Scan for Safety Programme implementation. Building on the Inventory Management System which has already been implemented in all NHS Boards, the NHS Scotland Scan for Safety Programme is now implementing the additional functionality for Point of Care Scanning to capture data regarding high-risk implantable medical devices. As this is a time limited, centrally funded national programme until March 2026, Chief Executives are asked to support the immediate action required to ensure that their Board has their implementation date confirmed with the Programme Team NSS.ScanForSafetyProgramme@nhs.scot

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