VueTrack-UDI is VUEMED’s cutting-edge RFID solution for enabling manufacturers and hospitals to comply with the FDA’s recently adopted Unique Device Identification (UDI) regulations for medical devices.
The FDA has established a mandate for a human and machine readable UDI labeling system for identifying medical devices. Device labelers must also submit information about each device to the FDA’s Global UDI Database (GUDID).
VUEMED created VueTrack-UDI in order to help enable this effort. VueTrack-UDI is a Software-as-a-Service (SaaS), UDI-compliant, GS1 EPC Gen2 passive RFID solution that achieves the following:
- Registers and encodes the RFID tag memory to UDI standards;
- Prints the UDI human readable label as required per the UDI specification, with options to configure the label or leave the label blank;
- Validates that the RFID data matches the information printed on the manufacturer’s product package;
- Integrates the UDI data into the hospital’s information systems; and
- Enables submission of the UDI data to the FDA’s Global UDI Database.
UDI data such as manufacturer name, batch, serial number, and expiration date are embedded into the user memory data portion of the tag, thereby giving the medical device a standards-based identity that can be accessed and used throughout its lifecycle. Manufacturers and hospitals can now immediately engage this UDI data to provide meticulous tracking of medical devices from deep within the manufacturer’s supply chain all the way to the point of use with a patient. With the UDI data, devices can also be tracked to the hospital’s clinical, billing, and ERP systems, as well as electronic health records (EHR). VueTrack-UDI can be integrated into existing UDI data sources and labeling systems, or simply installed as a stand-alone solution.
The UDI data on the RFID tag enables users to find expiring and recalled products instantly: (a) Expired products can be seen immediately throughout the facility with their exact location, and also blocked from continuing their progression through the clinical operations’ business processes; and (b) Both manufacturers and hospitals can use VUEMED’s Cloud-based reporting application, or any EPC Gen2 handheld or fixed reader, to identify and locate recalled products instantly. Furthermore, integration with clinical documentation and EHR systems can now be standardized with unprecedented accuracy.
With VueTrack-UDI, VUEMED is providing a world-class, standards-based RFID solution that enables the entire healthcare supply chain to immediately generate value while ensuring compliance with the FDA’s UDI regulatory mandates.
VueTrack-UDI is seamlessly integrated with all other VUEMED applications and services.