A Unique Device Identifier (UDI) system for recording, identifying and recalling medical devices

Anand NP, Dimitrova M, Brown J, Stewart J, Kandulu J, Clifton E
Record ID 32018001663
Authors' objectives: The Unique Device Identifier Programme Board (UDIPB), on behalf of Scottish Government, requested a review of the cost effectiveness and cost implications of a Unique Device Identifier (UDI) system compared with existing health board-level processes for recording, identifying and recalling medical devices.
Authors' results and conclusions: Currently NHSScotland does not have a standard and consistent practice for recording and safekeeping of UDI and patient information for implanted devices. This has resulted in the adoption of ad hoc practices both between clinical specialities and across health boards. The most common approaches are paper-based recording systems. For the first time, economic analyses were undertaken to illustrate, quantify and cost the resource use and staff burden in Scotland when recording medical device information and addressing a FSN or medical device recall. Scenario analysis that varied the adoption rate of a UDI system showed that even at a low adoption rate (for example, only a 25% reduction in time spent by staff to manually identify patients affected by recall) the system could offer substantial resource savings per recall.
Authors' recomendations: A nationally accessible UDI system to capture and recall implantable medical devices provides a way to identify every patient quickly and safely along with minimising the risk of significant harm.
Authors' methods: The Scottish Health Technologies Group (SHTG) carried out a rapid review of the published literature for evidence surrounding the cost effectiveness and long-term benefits of UDI system implementation. A bespoke costing analysis was conducted using available Scottish data from three specialties - cardiology, orthopaedics and plastic surgery - to demonstrate the cost implications of introducing a nationally accessible UDI system to record, track and trace class III medical devices.
Project Status: Completed
Year Published: 2021
Requestor: Scottish Government
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Scotland
MeSH Terms
  • Equipment and Supplies
  • Product Labeling
  • Product Surveillance, Postmarketing
  • Medical Device Legislation
  • Prostheses and Implants
  • Costs and Cost Analysis
  • Medical Device Recalls
  • Health service organisation and delivery
  • pacemaker
  • hip replacement
  • breast implant
Organisation Name: Scottish Health Technologies Group
Contact Address: Scottish Health Technologies Group, Delta House, 50 West Nile Street, Glasgow, G1 2NP Tel: 0141 225 6998
Contact Name: his.shtg@nhs.scot
Contact Email: his.shtg@nhs.scot
Copyright: Scottish Health Technologies Group
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.