GS1 Standards for UDI Rule
UDI Rule establishes a unique device identification system for medical devices (“the UDI Rule”). Under the rule, the healthcare community and the public will be able to identify a device through a Unique Device Identifier (UDI) that will appear on the label and package of a device in both plain-text format and a format that can be read by automatic identification data capture (AIDC) technology (e.g., a barcode). A device will also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. In addition, device labelers will submit device information to an FDA database called the Global Unique Device Identification Database (GUDID). The GUDID will provide critical information about medical devices, and the UDI will provide the key for accessing device information from the GUDID.
A UDI is a unique numeric or alphanumeric identification code assigned to medical devices by the labeler (e.g., manufacturer) of the device. A UDI includes two segments: a “device identifier” and a “production identifier”:
- Device Identifier (DI): a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device
- Production Identifier (PI): a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
- (i) lot or batch number;
- (ii) serial number;
- (iii) expiration date;
- (iv) date of manufacture; and
- (v) for an HCT/P regulated as a device, the distinct identification code2 According to the UDI Rule, a device identifier is always present in a UDI.
However, a production identifier is only required if it otherwise appears on the device label. Therefore, UDIs can be comprised of either DI only, or DI+PI. Because most implants include at least one piece of production information on the label, most implant UDIs would include a production identifier.
The UDI Rule requires medical devices to be labelled with a UDI issued under a system operated by an FDA-accredited “issuing agency.” GS1 is one of three FDA-accredited Issuing Agencies for UDI,3 and GS1 Standards are being used to implement UDI by a majority of device manufacturers. When GS1 Standards are used to implement UDI:
- The device identifier is represented by the GS1 Global Trade Item Number® (GTIN®).
- The production identifiers are represented by GS1 Application Identifiers (AIs).
- The presentation of UDI on device labels is accomplished using GS1 Barcodes.
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