Unique Device Identifiers (UDI)
Following the US Food and Drugs Administration’s (FDA) decision to require device manufacturers and suppliers to use a Unique Device Identifier (UDI) by September 2014, the NJR has undertaken a project with all suppliers and manufacturers selling implants in the UK to obtain all the UDIs for their products. The UDI includes details about the supplier, the product, and manufacturing information (lot/batch number and expiry date). Not only will this improve data quality, it will improve patient safety.
As the UDI is provided as a barcode using one of two formats, this will make component data entry easier to support. The NJR currently supports many barcode formats and it is extremely difficult to maintain the database to support new products. However, by having only two barcode formats to support, hospitals will be able to scan all components using a barcode reader, making data entry easier and more accurate.
All suppliers have been contacted and asked to supply details of the product codes that they will be using, assuming that they are not already using one of the two standards.
Last year, we reported that the NJR was involved in an international effort to standardise the reference data held about components by various international registries. This work has continued to the stage where agreement has been reached and a package of work is scheduled for 2015/16 to change the NJR’s component database. This will not have any impact on users but will enable the NJR to undertake more detailed analyses and monitoring of implant performance. The additional data will enable the NJR, and other registries, to more easily identify outlier performance and to share intelligence.
Once the component database changes have been made, suppliers will be required to amend the data for existing implants, using a new application for entering and editing component details. The work required to amend the data for existing products is likely to take some time. Existing reporting services will continue to use the existing database until such time as all the data in the new database is complete.
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NJR 12th Annual Report 2015
Online appendices - NJR 12th Annual Report 2015
Prostheses used in hip, knee, ankle, elbow and shoulder replacement procedures
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