The Food and Drug Administration (FDA) of the United States has devised a unique device identification system to properly identify medical devices during their distribution and usage. Most devices' labels will include a unique device identifier (UDI) in both human and machine-readable formats when fully implemented. Device labelers must additionally provide specific device information to the FDA's Global Unique Device Identification Database (GUDID). The public can use AccessGUDID to look for and download FDA information.
The UDI system, which was implemented in 2013, provides a variety of benefits that will be realized more completely with the acceptance and integration of UDIs into the healthcare delivery system. According to the FDA, UDI deployment will improve patient safety, modernize device post-market surveillance, and make medical device innovation easier.
The FDA UDI rule applies to a device labeler. A labeler is anyone who applies a label to a device or modifies a device's label with the aim that the device would be commercially disseminated without any later replacement or modification of the label. The addition of the name and contact information of a person who distributes the device without making any other changes to the label is not considered a modification for establishing whether a person is a labeler.
The labeler is typically the device maker, but it can also be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.
A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following:
The device labeler must provide the UDI in two forms on labels and packages:
The keyword in the phrase "Unique Device Identifier" is unique. Rather than selecting a single industry numbering agency to manage the label identifiers and adhere to a single numbering model, the FDA certified 3 existing agencies. All three already had sects of companies abiding by their standards and identifiers, so this provided a comprehensive solution for companies.
The accredited issuing agencies are: GS1, HIBBC (Health Industry Business Communication Council), and ICCBBA.
Courtesy of www.usa.philips.com