The FDA’s Unique Device Identification (UDI) system for medical devices was designed to allow the easy identification of products sold in the United States, enabling traceability from manufacturing through distribution to patient use. UDI is relevant to any organization working in or supplying medical device products (class I, II and III) to the USA.
WHY IS IT IMPORTANT AND HOW DOES IT AFFECT YOUR LABELING SOFTWARE?
UDI offers a practical solution to display standard product information in a standard format. Products need to include a UDI in a human and machine-readable form including (but is not limited to) the following information:
- 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) which is publicly searchable.
UDI offers a range of benefits to the medical device 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.
HOW CAN PRISYM ID HELP?
The PRISYM 360 cloud labeling solution was purpose-designed with functionality and features that address the specific challenges encountered in medical device labeling, including compliance with UDI labeling requirements. Unlike many solutions, the content and label management platform can be rapidly deployed with extensive documentation to support compliance and validation efforts.