The FDA has mandated that all medical devices will soon have to have a unique device identification (UDI) label. A UDI is simply a unique numeric or alphanumeric code that both humans and machines can read. While a simple concept, the application of the UDI ruling will no doubt pose some serious marking challenges for makers of items such as implants and other surgical devices.
Why is the UDI program being implemented?
According to the FDA.gov, a UDI system offers a number of benefits that will be more fully realized as they are integrated into the health care delivery system:
- 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 postmarket 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 SCHMIDT help?
More and more devices will be involved as the UDI system is phased in over the next few years (see compliance dates). With one of the most complete ranges of marking equipment in the industry and a highly qualified staff of engineers, SCHMIDT is uniquely qualified to help our customers comply with the ruling as their products come under its jurisdiction.