Medical device and IVD manufacturers have been using barcodes to track samples and manage inventory for decades. However, only recently has the technology been widely embraced by regulatory authorities to improve traceability of devices throughout the entire device life cycle and distribution chain. The benefits of Unique Device Identifiers (UDI) extend far beyond traceability. UDI can help –
- Distinguish between device versions, sizes, and other characteristics
- Track devices from specific production facilities
- Make it easier for patients and users to report serious incidents
- Simplify recall management
- Improve efficiency by standardizing information in Electronic Health Records (EHR) systems, clinical information systems, and registries
- Reduce medical errors
- Make it harder to conceal counterfeit devices
UDI is required (or proposed) in several countries/regions including Argentina, Australia, Brazil, Canada, China, Europe, India, Japan, Saudi Arabia, Singapore, South Korea, Taiwan, Turkey, United Kingdom, and United States.
On the surface, a medical device UDI looks like any other bar code, but the data it contains falls into two distinct buckets.
|Device Identifier (DI) – US
|Production Identifier (PI) – US
Identifies the specific version or model of the device and the labeler of that device. This information is static and only changes when:
- A new model or version of the device is introduced on the market
- Change in device reprocessing requirements
- The device is remanufactured
- The device is relabeled
|When placed on the device, includes the lot, batch/serial number and date of manufacturing (or expiration), and software version, if applicable. This information is dynamic.