The U.S. Food and Drug Administration (FDA) recently published a proposed new rule in the Federal Register that would create an identification system for medical devices distributed within the U.S. The Food and Drug Administration Amendments Act of 2007 directed the FDA to develop rules implementing a Unique Device Identification (UDI) system. The new rule, if approved, would require manufacturers of most medical devices to include UDIs on the devices and their packaging. The system would improve patient safety, the FDA says, by making manufacturing and production information relating to specific devices more readily available to doctors, and allowing manufacturers and the government to identify patterns and trends that indicate the need for a product recall.
Each medical device would have its own UDI, which the FDA describes as a “numeric or alphanumeric code” consisting of two parts. A “device identifier” would describe the specific device and the device model. A “production identifier” would describe the device’s manufacturing history, including its serial number, batch or lot number, and any applicable expiration date. A database, currently still in development by the FDA, would include standard codes used in UDI’s. Much of the database would be accessible to the public. According to the FDA, UDIs will consist solely of product information, and will not include any identifying information about any person using a particular device.