Unique Device Identification for medical devices

Since 2013, Smith+Nephew has embarked on a significant initiative to achieve compliance with the U.S. federal government’s Food and Drug Administration (FDA) rule requiring that most medical devices sold in the U.S. bear a Unique Device Identifier (UDI). Similar to a barcode on consumer products, the UDI is a series of numeric or alphanumeric characters created through a global coding standard which enable the unambiguous identification of a specific medical device. The UDI is required on the label and, in some cases, the actual device and is the responsibility of the labeler of that device to implement.

We will achieve compliance by the FDA deadlines on the first two requirements of this rule, which mandate that the UDI be included on the product label and that certain product attributes be submitted to the FDA’s Global Unique Device Identifier Database (GUDID), which serves as a public reference catalog for every device with an identifier.

Smith+Nephew is now focusing its efforts on another mandate for UDI compliance, Direct Part Marking, which requires the UDI to be permanently added to the device at the point of manufacture. This requirement applies only to those devices where the UDI is required on the device label, the device is intended to be used more than once and is reprocessed before each use. The intent is to enable traceability of these reusable devices after they are separated from their labeling or packaging.