Before assigning UDIs to products, there are a number of questions a manufacturer needs to answer about their products.
“What is the base unit of my product?”
“What are the packaging configurations?”
“What products are currently in distribution?”
In addition to these questions, one that I have been asked recently has to do with PACKAGING LEVELS and assigning of DEVICE IDENTIFIERS (DI).
A DI is the mandatory, fixed data of the UDI and the part that is submitted to the GUDID. The GUDID Data Elements Table http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396592.xls includes five (5) different DIs:
Primary DI: the main number for looking up a device in the GUDID and meets the requirements to uniquely identify a device through distribution and use
Unit of Use DI: an identifier assigned to an individual medical device (unit) when a UDI is not labeled on the individual device at the unit of use, such as tongue depressors in a box of 100; Its purpose is to associate the use of a device to/on a patient and links the single unit to the “base package.”
Direct Mark DI: the identifier that is marked directly on a device that is subject to direct marking and is different than the Primary DI.
Secondary DI: when DIs from multiple issuing agencies are used, the secondary DI is the alternate lookup for the device in the GUDID.
Package DI: the identifier for each package configuration containing multiple units of the base package; This does NOT include shipping or logistics containers.
“Package Level” is used to define the selling unit of the device (i.e. box of 6, case of 10). A helpful way to determine “package level” is to consider how the inventory is managed. When scanning the label, you want to know what the item is and the quantity of that item in the labeled package. Additionally, a unique UDI is applied to all levels of packaging, down to the lowest level or unit of use.
The “Base Package” is in its purest form one device in a package with a label that contains the Primary DI. If the base package has more than one unit, as in the case of the tongue depressors, the Primary DI is located on the “Primary Packaging” but is accompanied by the “unit of use DI,” thereby linking the single unit to the “base package.”
Since there can be one or multiple packaging configurations for a device, it is important to identify and determine these levels before assigning UDIs, as they must all be connected in the GUDID. It is also important to remember that changes to the packaging level are a DI trigger and require a new DI record. However, do not confuse packaging level with packaging material. If packaging material such as a protective plastic bag over a device inside a box or bubble wrap inside a package is used or changed, but the quantity of the “base package” remains the same, there is no change in packaging level.