VUEMED, ZEBRA PARTNER ON SOLUTION FOR COMPLIANCE WITH FDA UDI REGULATIONS
time: 2015-05-11 16:21
VUEMED has announced that it is partnering with Zebra Technologies to release VueTrack-UDI, an RFID solution for enabling manufacturers and hospitals to comply with unique device identification (UDI) regulations from the U.S. Food and Drug Administration (FDA).
The FDA has established a program that leverages human- and machine-readable UDI labeling for identifying medical devices through their distribution and use (see Managing Medical Devices). Device labelers must submit information about each device to the FDA'sGlobal UDI Database. Current FDA regulations require that Class III medical devices have UDI labels. Class III medical devices are highly regulated "high-risk" devices—such as life-support or life-sustaining machines like pacemakers and heart valves—that are approved by the FDA for use in humans, and are also defined as those which pose a potentially unreasonable risk of illness or injury.
VueTrack-UDI is a software-as-a-service (SaaS), UDI-compliant, GS1 EPC Gen 2 passive RFID solution that uses Zebra scanners and printers to encode the RFID tag memory to UDI standards, validate the process, print the required labels, and register the UDI data with the FDA. According to VUEMED, VueTrack-UDI can be integrated into existing UDI data sources, or simply be installed as a standalone solution. VueTrack-UDI can work with any tag or or label meeting the specified RFID standards and the extended user memory required for UDI on-tag data (512 bytes). The reference spec for these tags and labels includes an Impinj 4QT chip, with a Smartrac 3D Frog inlay and special peel-off adhesive per FDA packaging requirements, according to Joe Dugan, president of the company's VueTrack-RF division.
With VueTrack-UDI, Dugan reports, manufacturers and hospitals can immediately engage the UDI data to provide tracking of medical devices from the manufacturer through to patient point-of-use, as well as clinical systems, billing and electronic health records (EHR). The UDI data on the RFID tag enables users to find expiring and recalled products instantly, and can be integrated with clinical documentation and EHR systems. Dugan says that major medical device manufacturers and a very large Northeastern hospital are using VueTrack-UDI to track Class III, Class II and Class I devices.