February 08, 2017 Industry news
GS1 UK launch new recommendations for using Unique Device Identifiers & GS1 standards within Field Safety Corrective Actions
Unique Device Identifiers (UDIs) are becoming increasingly vital in the healthcare sector with upcoming European regulation mandating that UDIs to be placed on the labelling of all medical devices and in-vitro diagnostic medical devices. This runs alongside the growing use of GS1 standards in Acute Trusts in England following the publication of the Department of Health’s eProcurement strategy in 2014.
These recommendations, produced by the GS1 UK Healthcare User Group, highlight how UDIs can be used in the process of Field Safety Corrective Actions (FSCAs) for both medical and in-vitro diagnostic medical devices and the benefits this brings, including:
- improved targeting of Field Safety Notices (FSNs)
- enhanced monitoring by competent authorities (such as the MHRA)
- reduced medical errors through improved traceability
Essentially, it means manufacturers can use GS1 UDIs in their FSNs and then share them electronically in a standardised spreadsheet. This gives an easy and standardised way for distributing this data, and simplifies the administration of FSCAs for healthcare providers. This not only contributes to a safer FSCA process but also eliminates the problem of having multiple formats of data for different customers.
These recommendations give healthcare providers everything they need to implement more automated and secure GS1-based FSCA processes, in line with the Department of Health eProcurement strategy.”
Jackie Pomroy, Head of Supply Chain at NHS South of England Procurement Services
“Developed in collaboration between industry, healthcare providers, the MHRA and with the help of GS1, this guideline, aimed to standardise FSCA information, simplify process and gain alignment across industry and healthcare providers, will benefit all parties in the administration of FSNs.” – Darren Stenlake, Director of Customer Service at Sysmex UK Ltd.
This builds on the adoption of GS1 standards by the Medicines and Healthcare products Regulatory Agency (MHRA), who first used Unique Device Identifiers in healthcare recalls in 2015. John Wilkinson, MHRA’s Director of Devices says:
“Using GS1 standards to identify every patient, product and place, enables increased patient safety, regulatory compliance and operational efficiency.
“When recalls take place GS1 Unique Device Identifiers mean hospitals can now easily identify all of the affected products that they hold, preventing their use.”
Join our one of our webinars to find out more about using UDIs to improve your recalls and Field Safety notices.