Highlights: International developments

The NJR continued to support global patient safety initiatives and collaborate internationally

Global patient safety - Unique Device Identifiers (UDI)

International developments have influenced the registry’s work this year. The United States (US) Food and Drugs Administration (FDA) decided that all medical devices distributed in the US must have a Unique Device Identifier by September 2014. This UDI will be a barcode and contain both device information and production information (lot/batch number and expiry date).

This decision has far-reaching, international consequences for suppliers and the way in which registries, including the NJR, record implant data as implant devices are sold and used globally.

For the UDI barcode in the US, three barcode formats will be permissible. It is expected that the GS1 barcode standard, one of three permitted by the FDA, will be included.  The NJR already supports the GS1 barcode standard and of the approximately seventy suppliers on the NJR database, there are currently two suppliers already using the GS1 standard. 

Impact on the NJR

In terms of our work, it means that the NJR will only be required to support one barcode format, rather than the current eighteen.  It will also mean that maintenance of the implant database should be easier and that units will be able to enter data more easily using barcode scanners. Still, this will only be achievable through a comprehensive review and planned changes within the registry’s component database.

EU and UK decisions on UDI

Following the US lead, Europe has draft legislation in place which is expected to be approved by the European Commission in 2015.  However, it is not expected that Europe will be able to fully implement a UDI database until at least 2020. 

In the UK, the Department of Health is also due to publish its eProcurement Strategy and it is widely anticipated that NHS England will expect all medical suppliers to the NHS to adopt the GS1 barcode standard. The main driver for this is efficiency, and hence cost savings, in the supply chain. 

In Europe and the UK, no date has been set by which time suppliers are to have adopted the new standards, although many will have to make the necessary changes in order to meet the FDA deadline of September this year. 

There will be an overlap period as existing stocks of implants are drawn down in hospitals but, in the longer term, the introduction of UDI will make data entry easier and improve data quality.

Increased international collaboration

Related to the introduction of UDI, but separate from it, is an international effort to agree the type and format of implant reference data held by registries, eg brand, composition, size.  The NJR is actively involved in this work which will enable registries around the world to more easily share intelligence about implants and undertake broader analyses. 

The NJR has already undertaken work with the Australian Registry to compare knee and joint prostheses recorded on respective databases and this work will continue in 2014.