Introduction
Medical equipment is key to the delivery of healthcare services across the NHS Golden Jubilee Board. Effective management of these resources minimises risk, ensuring all equipment is:
- Suitable for its intended purpose
- Properly understood by the user
- Appropriately maintained
- Used only for its intended purpose
- Procured in a controlled, co-ordinated way demonstrating best value for the Board taking into account whole-life costs
Specific guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Scottish Government are fundamental to the formation of this policy:
- MHRA Managing Medical Devices (2014)
- Scottish Government CEL 35 (2010) A policy for Property and Asset management in Scotland
- SHTN 00-04 (2021) Guidance on Management of Medical Devices and Equipment in Scotland’s Health and Social Care Services
The Board carries out a range of equipment intensive clinical specialities, each requiring highly complex specialist medical devices. This policy outlines the organisation’s systematic approach to complete medical equipment lifecycle management. It aims to ensure that safety standards and applicable legislation are adhered to at all times.
UK Legislation
The UK-EU Withdrawal Agreement (Brexit) has prevented the planned transition to the revised harmonised EU Medical Device Regulations (EU MDR). The updated EU regulation will NOT be passed into law in Great Britain. Instead, the UK Medical Devices Regulations 2002 (UK MDR) remain in place.
A brief summary of the impact of this change is included in Appendix 2.
