GS1 recently hosted a Scan4Safety UDI focussed webinar. Advena were present at that webinar, here are some top-level highlights from this webinar:
- Standards are the enabler. The adoption GS1 standards by manufacturers enables multiple processes throughout the supply chain, leading to improved patient safety, reducing unwanted clinical variation and improved operational efficiencies.
- Success of Scan4Safety initiatives across UK achieved because manufacturers are implementing GS1 standards.
- Adoption of a single 2D matrix barcode allows:
- Multiple data sets (e.g. product information, IFU, marketing) to be included and accessed with the correct scanner.
- Saves space and avoids potential confusion compared with use of multiple barcodes
- If multiple barcodes cannot be avoided, then UDI symbol must be present next to the UDI barcode.
- Majority of devices have appropriate barcoding, and processes in place to handle instances when products are without GTINs.
- Manufacturers should communicate changes of GTINs to all people in supply chain including logistics so that systems can be updated.
- Continual engagement between NHS and manufacturers to align requirements according to how and when scanning is conducted, especially when rolled out to more devices.
- Information from databases used to collect product information e.g. patient administration systems or medical devices outcomes register (MDOR) could ultimately be made available to manufacturers to help with collection of Post Market Surveillance data.
How much do you know about GMDN?
- GMDN is non-profit organisation based in the UK, founded in 1991 by the European Standards Organisation (CEN) and then support by IMDRF.
- 25,000 terms grouped by categories (2600) and arranged in a multi-hierarchical structure according to device function, anatomical speciality etc.
- Each GMDN has a name, definition (intended use, technology/material, form/components and significant attributes) and Code (ID)
- Access GMDN by becoming a member
- 70 regulatory systems use GMDN across the world
- GMDN enables traceability
- Where is GMDN used?
- Pre-market approval / registrations i.e. FDA, MHRA, TGA, ANIVISA and as part of UDI
- Tendering and market analysis
- Inventory/purchasing management
- Used for PMS/vigilance database searches
What is Scan4Safety?
- Initiative launched in 2016 by Department for Health and Social Care with aim improving operational efficiency.
- Pilot study demonstrated use of barcoding technology in hospital to streamline tracking and management of medical supplies, equipment and medications.
- In 2020 driven by Ian Paterson inquiry and Baroness Cumberledge reports brought new focus within NHS for tracking of medical instruments and implants.
- Purpose was to enhance patient safety by implementing scanning procedures in surgical theatres.
- In 2023 new mandatory registry was launched to collect information on high risk (class III/IIb) devices. Barcode scanning mandated for high-risk medical devices in all NHS England trusts by March 2024.
- Examples of current initiatives
- Verification of patient identity via wristbands
- Point of care matching of patient and product for blood transfusions
- Matching patient with prescription electronic record to enable robotic dispensing systems
- Implant registries
- Asset management
What is PIMSs?
- PIMs stands for Product Information Management system
- The initiative is driven by the Department of Health & Social Care and originated 10 years ago from the NHS eProcurement strategy.
- The goal of PIMS is to centralise product related data into a single database and allow the process of updating information to be streamlined.
- Requirements of the system
- Currently time consuming to get basic, essential and good quality data about medical devices for users across the health system
- Pockets of rich data but no central reference point or easy to access or connect datasets
- Existing products, platforms and services that exist that PIMs needs to intersect with.
- Collect once use often approach
- Longer term aim of the system to include historic and current data
- The project was divided into phases with alpha phase of project now completed was divided into 3 parts
- User research – interviews, surveys workshops with consumers, providers and wider stakeholders
- Data exploration – reviewed and appraised data sources including MHRA product register, Eudamed, NHS SC catalogue. Base data taken from MHRA product register with additional information taken from other systems or uploaded by manufacturers. Consumer to be able to request missing information.
- Content design – prototype of system to find, review and request data
- Timelines for next phases
- Private Beta Nov 24 – April 25
- Public Beta May 25 – Oct25
- Live Nov 25+
- Seeking interested parties to join PIM stakeholder group and/or participate in beta phase.
Supplier case study of UDI and traceability in action
- Problem: significant atmospheric release of anaesthetic gases contributing to greenhouse gas emissions in human and veterinary healthcare.
- Solution: achieve a circular economy approach to capture, recover, purify and reuse anaesthetic gases.
- Product: system consists of cannisters that collect the anaesthetic gases at the point of use, waste carbon bulked up in carbon exchange units and bulk storage vessels transport to waste processing facility.
- Reasons why GTINS used for traceability
- Customers require data on site specific waste capture (cannister) and associated carbon savings.
- Full cradle to grave traceability needed as waste is classified as hazardous.
- The purified waste becomes a raw material for a new pharmaceutical.
- Each docking station and cannister is given a GS1 GTIN (UDI-DI) and a unique serial number (UDI-PI) combined into 2D data matrix barcode. Future goal to expand GTINs to bulk waste.
Application of Scan4Safety in NHS England
- Scan4Safety initiatives started in 2016
- Initiatives that capture UDI data cover 5 areas (3 in use and 2 in build/design):
- UDI data capture in use
- Patient admission – given wrist band printed from information taken from Patient Administration System (PAS) or A&E system (Symphony). Information displayed in both human readable and barcode format.
- Patient location / ward stay – all locations (organisation, site, block, level, rooms, bed space) are bar coded. Links patient with location and assists with new allocation and ward transfers.
- Patient and Product – Links patient with (UDI) product information for procedure or operation. For a given procedure code, products can be pre-picked using GTIN. Once products selected from inventory system, lot/serial or batch number gathered and linked to patient at point of care. Systems can automatically order stock to replace used items. In the event of product recalls easier identification and notification of all affected patients. Most significant challenge is the integration of PAS with multiple systems including theatre management and inventory systems.
- UDI data capture in build/design
- Blood tracking – ensure right blood is given to right patient. Initial blood sample taken for analysis to allow for blood cross matching. If in stock the location of where blood is stored made available for collection from blood storage unit. Point of Care (PoC) checks ensure that correct blood is transfused.
- Mortuary documentation check. Body card completed on ward and patient information on wrist band are crossed checked. Pathology reports generated. Barcoding ensures all patient and documentation correct when leaving hospital.
- Longer term aim to share information from product systems with manufacturers for PMS purposes but initially focussed on the patients.
Application of Scan4 Safety in NHS Scotland
- Scan4Safety initiatives started in 2020.
- Drivers for the program:
- Regulatory compliance – PoC scanning
- Stock management
- Strategic planning
- Patient safety – track and recall medical devices
- Program focused on following areas:
- Acute care settings
- High risk implantable devices (class Ilb and III)
- 4 specialties
- Orthopaedics
- Ophthalmology
- Cardiology
- Interventional radiology
- Inventory management system (IMS), preceded adoption of GS1 standards and PoC scanning which started in 2023 and will continue to be rolled out across all health boards by 2026.
- Benefits of IMS
- Staff time saves
- Max stock levels reduction
- Excess stock reduction
- Stock expiry and wastage
Application Scan4Safety in NHS Wales
- Scan4Safety initiatives started in 2019
- Drivers for the program
- Right patient
- Right product
- Right place
- Right process
- Introducing data standards i.e. GS1 allows information to be linked between people (patients and staff), place, product and procedure.
- Single logistics operation allows visibility of stock across all boards in NHS Wales. Inventory management system (IMS) first introduced with GTINs being loaded onto system.
- Initiate known as ‘Minimal viable product’ covers
- inventory management
- materials management (enough of item)
- inventory management (know what you have and where it is), helps with recalls
- product patient linkage to implants
- patient product data linked to theatre and patient records
- Majority of boards have inventory management system live, with linkage to patient and theatres systems also being rolled out
GS1 history and future projects
- Use of 2D data matrix barcodes started in early 2000’s to address supply chain and regulatory challenges.
- One product, one barcode (2D data matrix). Multiple information (IFU, packaging material information, videos, summary of product characteristics, product verification) could be captured into single barcode avoiding issue with having multiple barcodes on packaging.
- Specific scanners needed to ‘read’ particular information.
- How standards can help support a more sustainable supply chain
- Exchange product impact data
- Inventory management and forecasting
- Green procurement
- Efficient reverse logistics (returns management, refurbishment, recycling and disposal)
- Important for visibility in a product’s entire lifecycle.
Advena can assist in conducting UDI gap analyses, reviewing draft UDI labelling and help you incorporate into your technical documentation.
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.
