A Turnkey Solution for Medical Device Manufacturers
Vue-Med enables companies to comply with the FDA's identification mandate and achieve internal and supply-chain benefits.
When the U.S. Food and Drug Administration (FDA) established its Unique Device Identification (UDI) System to improve patient safety, it did not specify whether device manufacturers should use bar codes or RFID technology to identify medical implants, surgical instruments and life-support/life-sustaining machines. The regulation specifies that each medical device must carry a unique identifier to facilitate recalls, improve reports about adverse events and thwart counterfeiting.
The system leverages human- and machine-readable UDI labeling for identifying medical devices, and requires device labelers to submit information about each device to the FDA's Global UDI Database. The data includes lot, serial number and expiration date.
Boston Scientific, Cook Medical, Gore, Medtronic, St. Jude Medical and other large device manufacturers have adopted VueTrack-UDI and are encoding UDI information onto RFID tags at their distribution facilities. They are leveraging the technology for inventory management and chain-of-custody tracking and tracing of products, says Lana Makhanik, VueMed's COO. "Other companies are opting to use bar codes, because to shift to RFID involves a significant retooling of manufacturing and labeling operations," she says. "In terms of executing this, it's going to take time."
Device manufacturers use a Zebra RFID printer (R110Xi4, ZD500R or ZT400) to encode UDI data onto RFID tags and print the required labels. VueTrack-UDI can work with any EPC Gen 2 passive ultrahigh-frequency RFID tag that has the extended user memory required for UDI on-tag data (512 bytes).
Manufacturers can view Web-based reports to track medical devices throughout the supply chain, from their facility to a hospital's procedure room. The UDI tag data allows users to locate expiring and recalled products immediately.
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