What is a Unique Device Identifier (UDI)?
The Unique Device Identifier (UDI) is an essential part of medical device manufacturing and labeling. The UDI is a standard code used to precisely identify a medical-specific piece of equipment. The FDA has adopted the UDI system as part of its regulatory process to help ensure the safety, efficacy, and effective use of medical devices.
Each UDI must meet certain criteria such as content structure and label format that includes all relevant information about the device. This important identifier allows for easier traceability in the case of recalls or malfunctions. Manufacturers are responsible for generating UDIs for their medical devices, which can be applied in both human-readable forms—such as barcodes or QR codes—and machine-readable forms like RFID chips. This helps to ensure that no device goes unidentified during any steps in its lifecycle—from production to distribution and eventual sale.
By requiring that each medical device carry its own UDI, the FDA hopes to increase patient safety and improve the efficiency of healthcare delivery by allowing for faster tracking and recall notifications if necessary. With this important identifier, patients have more peace of mind when using medical devices knowing that each one has been correctly identified from start to finish.
UDI codes are composed of two parts: the device identifier (DI) and the production identifier (PI). The DI is a permanent and unique label that is assigned to each device, while the PI is an optional variable code used to record information about a specific batch or lot of products.
The UDI must be included on the item’s label in both machine-readable and human-readable formats. This allows for easy scanning of individual medical devices as well as tracking them throughout their lifecycle—from manufacturing to the healthcare facility, patient use, repair and maintenance, storage, disposal, and even recycling.
In some cases, additional elements like expiration dates or usage instructions may also be encoded into the UDI system. Additionally, UDIs can also help with determining whether medical supplies have been manufactured to required standards such as sterility requirements.
UDIs are also essential for informing patients of specific devices that should not be used together as potential safety concerns can arise due to incompatible combinations such as MRI compatibility. By providing an effective tracking system based on UDIs, recall programs become much simpler and more streamlined when responding to any major health issues related to medical device use.