WHAT IS UDI?
The FDA’s Unique Device Identification (UDI) of medical devices aims to offer a practical solution to display standard product information in a standard format for a product’s distribution and use. This information needs to include a UDI in human and machine-readable form and includes (but is not limited to):
- the manufacturer of the device
- expiry dates
- the make and model of the device
- serial or lot number
- any special attributes that the device may possess.
As part of the directive, organizations must submit the product information in a computer-readable structured labeling format to GUDID (Global Unique Device Identification Database) - a publicly searchable database.
UDI is relevant to any organization working in or supplying medical device products (class I, II and III) to the USA.
UDI offers a range of benefits to industry, FDA, consumers, healthcare providers and healthcare systems by:
- Allowing more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reducing medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- Enhancing analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
- Providing a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- Providing a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
- Leading to the development of a medical device identification system that is recognized around the world.