What does the term "Unique Device Identifier" (UDI) refer to?

The term "Unique Device Identifier" (UDI) refers to a system that improves the identification of medical devices through a unique code. The UDI system is critical in enhancing patient safety and enabling more effective monitoring and tracking of medical devices throughout their life cycles. It consists of a numeric or alphanumeric code that is unique to each medical device model, which is crucial for ensuring accurate identification during distribution, reporting of adverse events, and recalls.

The UDI code typically includes two parts: a device identifier that specifies the model, and a production identifier that may include information such as the lot or serial number. This comprehensive identification system allows for better management and oversight of medical devices, ultimately contributing to improved healthcare outcomes.