London, 12 January 2023 – GS1 standards and the Scan4Safety initiative are set to play a significant role in the government’s response to the Independent Medicines and Medical Devices Safety Review (IMMDSR).
The government’s recent update report has outlined a commitment to creating “a public-facing unique device identification (UDI) database for UK devices based on the Global Unique Device Identification Database.” The Medicines and Healthcare products Regulatory Agency (MHRA) centralised medical device registry will fulfil this role, with GS1 authorised as an issuing entity for the unique identification and standardised capture of medical device data.
The response follows a 2018 inquiry, to investigate patient safety incidents surrounding three medical interventions: Primodos, Sodium Valproate and surgical mesh, that was commissioned by former Secretary of State for Health and Social Care, The Rt. Hon. Jeremy Hunt.
The inquiry chaired by Baroness Julia Cumberlege culminated in 2020 with the publication of the IMMDSR. The review outlined several recommendations for achieving two core objectives:
- Improving the quality of, and access to, medicine and medical device product information.
- Enhancing patient safety by improving the traceability of devices on the UK market.
GS1 standards support both objectives by increasing data accuracy and improving traceability through the unique identification of every person, product and place. They are system and device agnostic, allowing data to be shared seamlessly between solutions and registries supporting necessary data capture requirements.
The Government IMMDSR response states, “There are already 600,000 to 700,000 patients a year being recorded with device details in these exemplar registries. This provides a springboard for us to extend the scope of registries as a proven, sustainable approach for collecting data, which is critical given the variable digital maturity and data collection resource across providers.”
Medical device data would need to be captured at the point of care and attributed to the right patient. This would allow potential device defects to be identified early, preventing risks to patient safety. To help NHS trusts capture this information in real time, the report also highlights how, “NHSE will be exploring ways of making electronic registry data submission easier and accelerating the adoption of barcode scanning through the Scan4Safety programme and automation technologies”.
Glen Hodgson, head of healthcare, GS1 UK said, “GS1 standards have the capacity to transform how medical devices are identified, traced and monitored on a national scale. More than 90 per cent of medical device manufacturers are already using Global Trade Item Numbers (GTINs) as the primary identifier. In the United States for example the FDA GUDID has authorised GS1 as an issuing entity for UDI as part of several other international medical device regulations. Alignment will help to futureproof UK legislation and support manufacturers with global compliance.
“With programmes such as Scan4Safety based on the same data standards, procedural information can be captured in the same format and readily shared to any appropriate registry. Used together, these measures have the potential to drive end-to-end traceability of devices to make post-market surveillance more efficient, and most importantly, improve patient safety.”
About Scan4Safety
As part of the Scan4Safety programme six sites were selected by the Department of Health and Social Care to demonstrate the benefits of GS1 and Peppol standards. These were Derby Teaching Hospitals NHS Foundation Trust (now University Hospitals of Derby and Burton NHS Foundation Trust), The Leeds Teaching Hospitals NHS Trust, North Tees and Hartlepool NHS Foundation Trust, Plymouth Hospitals NHS Trust, Royal Cornwall Hospitals NHS Trust and Salisbury NHS Foundation Trust.
Following the success of the programme in England, Scan4Safety has since been adopted by many other NHS trusts in England. National Scan4Safety programmes have now been established in Scotland and Wales with Northern Ireland looking to implement point-of-care scanning via its transformational Encompass programme. Similar initiatives have also been developed in other countries including Norway, Japan and Ireland among others.
For more information visit: healthcare.gs1uk.org/scan4safety
About GS1 UK
Whether online, in store or in a hospital, the common language of GS1 global standards is helping our community of more than 58,000 organisations across the UK to uniquely identify, describe and track anything, creating greater trust in data for everyone.
From product barcodes to patient wristbands, GS1 standards have been transforming the way we work and live for nearly 50 years.
GS1 UK is one of 116 neutral and independent GS1 organisations operating worldwide.