Key Findings

• 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.
• The quantifiable benefits of a UDI system in healthcare cannot be directly evidenced from the available literature. There is limited, published, indirect evidence suggesting that a UDI system may improve patient safety; for example, using barcode scanning technology to aid medication administration, or a reduced burden on clinical staff to trace implanted devices.
• The literature demonstrates the potential of a UDI system to improve patient safety outcomes and increase efficiency in health systems through complete traceability of medical devices. If the UDI system is interconnected with relevant healthcare databases, there may be wider benefits from post-market device surveillance and research.
• In the event of high-risk field safety notice (FSN) or medical device recall, where affected patients need to be identified and contacted, using a paper-based record system has been shown to be inefficient and time consuming.
• 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. Speciality case studies included cardiology (pacemakers FSN), plastic surgery (breast implant recall) and orthopaedics (hip implant recall). The results demonstrated that a functioning UDI system is likely be cost-effective for NHSScotland, with savings of between £20,000 -£80,000 per recall (based on the breast implant recall case study and the pacemaker recall case study).
• 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.

What were we asked to look at?

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.

Why is this important?

The ability to trace medical devices is an important safety consideration, especially in the event of high-risk field safety notices (FSN) or product recalls. The new UK Medicines and Medical Devices Act 2021 includes powers to establish a medical device information system for managing and tracking high risk medical devices. From January 2021, as part of the Medical and Healthcare Products Regulatory Agency’s (MHRA) Medical Devices Register, manufacturers have been required to register all medical devices before they are placed on the market, with associated UDI information expected to become mandatory in due course.

NHSScotland boards are expected to record the UDI on implantable medical devices in patients’ records for reference and in case of an FSN or recall.  Implantable device information is recorded manually and across boards there is a lack of consistency of approach to recording.  Boards either use bespoke (generally unsupported) databases to record and retrieve device information, or use physical case notes and theatre logbooks. This makes management of medical device recall situations time and resource intensive for clinical staff and raises risks about ability to comply completely with an FSN or recall. 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.

Referred by

Scottish Government