June 29, 2015 Industry news
Andy Crosbie spoke at our healthcare conference about the importance of safety from a patient’s perspective around unique device identification.
Andy Crosbie is Head of Biosciences and Implants at Medicines & Healthcare products Regulatory Agency (MHRA).
Patient Safety: What the NHS eProcurement Strategy says
GS1 [barcoding standards] is not just about procurement, it’s also about patient safety.”
Andy Crosbie
- The eProcurement strategy drives patient safety benefits
- Barcodes based on the GS1 standards can be read at any point in the healthcare supply chain so that a product subject to a safety alert can be quickly located and recalled
- Healthcare providers must be able to electronically track and trace individual medicines and medical devices to a specific patient
Patient Safety: Unique Device Identification
Using a Unique Device Identification (UDI) system based on international guidance will significantly enhance the post-market safety of medical devices by:
- Improving incident reporting
- Better targeting of recalls
- Better monitoring by competent authorities (MHRA)
- Reducing medical errors
- Fighting against counterfeit devices
- Improving purchase-policy and stock-management by hospitals
The global nature of GS1 standards means that [once implemented] suppliers to the NHS are naturally prepared for new regulations in the healthcare sector.
New regulations: a single source of truth
Putting product information into a central ‘data pool’ system allows a single point of entry for publishing a medical device’s product master data. It means manufacturers, suppliers and healthcare providers can automatically exchange information between each other seamlessly.
This is vital for the sharing of information with implant registries, regulators and for product safety recalls – giving complete track and traceability across the entire healthcare supply chain.
TrueSource is the name of GS1 UK’s data pool. It enables suppliers to meet all requirements for UDI regulations in the US – and upcoming regulations in Europe and Japan.
Uniquely identifying patients
Each patient is given a unique identifier that’s attached to their wristband, using a GS1 barcode.
When combining the unique identification of patients with the unique identification of products, it means that every procedure, product and implant used on every patient can be attributed directly to that them and recorded on their electronic record.
We then know which products have been used on which patients – complete end-to-end traceability all the way from a manufacturer to a patient.