The Unique Device Identifier (UDI) is comprised of 2 segments:
- UDI-DI (device identifier) – which identifies the make and model of the device
- PI (production identifier) – which includes lot, serial number and expiration date
At a minimum, your Item Master should include:
- UDI-Device Identifier (DI) for the unit of measure purchased
- UDI-Device Identifier (DI) for the unit of measure used for patient care
Including the UDI-DI for the unit of measure purchased will allow you to use it in your transaction sets (purchase order, receipt, etc.) and help streamline your supply chain processes. The UDI-DI related to the unit of measure used for patient care can be interfaced into your Electronic Health Record (EHR) and will enable barcode scanning at the point of care. Manufacturers are required to have one UDI-DI for each unit of measure. So, the UDI will be different for a case, box or an each. It is important that the correct UDI-DI be associated with each unit of measure. This information was submitted by Industry to the Global UDI Data Base (GUDID) and can be accessed at no cost via AccessGUDID.
UDI-PI is not normally stored in the item master. A few of the cloud based ERP systems have the capability of storing UDI-PI information but most do not have this capability. A concern of including it in the item master is the potential to significantly increase the size of the item master especially in cases where the UDI-PI contains serial numbers.
For more education about UDI regulations, consider the following education and resources:
- White paper: The Critical Link Between Cost, Quality, and Outcomes (CQO) and Unique Device Identification (UDI)
- Business case for the UDI Presentation
- Webcast: Unlocking the Benefits of UDI
- UDI Case Studies
Search for more education and resources relating to UDI implementation at ahrmm.org.