FDA to Issue UDI and SNI Guidelines

The FDA will soon issue guidelines for marking medical devices with a Unique Device Identification (UDI) and for identifying pharmaceuticals with a Serial Number Identification (SNI).

The FDA’s goal has been to improve traceability of medical devices and pharmaceuticals, but delays have left many manufacturers and distributors of these products confused as to how they must proceed. Now, though, there are final draft recommendations available for review.

UDI

The UDI system identifies and tracks medical devices to a particular patient in order to determine the efficacy of a treatment or a device, and also tracks non-disposable medical equipment to determine when upgrades or service is needed. Such a system would also enable faster and more efficient recalls. The FDA wanted a standardized system that was unambiguous, unique, and harmonized globally.

The UDI is made of of two identifiers: a unique device identifier and a unique production identifier. The GS1 GTIN-14 provides the unique device identifier (the manufacturer’s ID and product ID). The production identifier can include a serial number, lot or batch number, a manufacturing or expiration date, or any combination of these numbers.

The UDI is then encoded in any standard bar code symbology determined by HIBCC or GS1 industry standards, then entered and stored in a UDI database. To see the final draft recommendations of global harmonization of UDIs developed by the Global Harmonization Task Force, go here.

SNI

Some states in the US already have drug pedigree laws. In fact, California is mandating that 50% of drugs must be serialized by January 2015 and the remaining by January 2016. Right now, pharmaceuticals are identified with a non-serialized National Drug Code, or NDC, managed by the FDA. The NDC is usually incorporated in a GS1 GTIN.

The SNI system defines an SNI as a 10-digit NDC plus up to 20 digits of serialization. The SNI data will be stored in a database for tracking and retrieval of lot and expiration data of the drug. The guidelines for SNI do not specify a particular technology, so linear, 2D barcodes, or RFID can be used. The final guidelines for serialization was issued in March 2011. For more on these guidelines, go here.

Many issues need to be addressed and developed, but UDI and SNI are here to stay. The FDA is hosting a UDI conference on November 30 to December 1 2011 in Cambridge, MA. See UID Conference 2011 for more information and registration details.

Are you dealing with UDI or SNI issues? We’d be interested in your thoughts.