09/30 2015

FDA’s UDI Regulations – Friend or Foe?

At the IDN Summit last week, we held a focus group with supply chain and value analysis experts at leading hospitals from around the country about the impact of the FDA’s Unique Device Identification (UDI) regulation.  We talked about how this regulation, which was initially seen by many as a nuisance that was going to principally affect manufacturers, is already improving the quality of patient care and outcomes, particularly where it is being implemented using RFID technology at hospitals.  Terrie Reed of the FDA as well as Pam Kennedy, Director of Clinical Contracting at Beth Israel Deaconess Medical Center (BIDMC), participated remotely as guest facilitators.  Pam, whose organization is partnering with VUEMED and dozens of manufacturers to achieve UDI compliance, shared her experiences and gave many examples of how UDI implementation through RFID is enabling manufacturers as well as BIDMC to avoid waste, track recalled and expiring devices instantly, and achieve just-in-time par levels due to better predictive analysis.  Participants discussed how manufacturers typically have very poor data and control over the items they have under consignment, problems which will disappear once they use UDI-compliant RFID tags on their devices.  Inventory management will be automated and guesswork will be removed through real-time, accurate information.  Participants also talked about the inability of manufacturers to trace their devices; thus, when one gets returned to them for whatever reason, the manufacturers would rather dispose of the item than restock it somewhere else and run the risk associated with a product whose history and chain of custody information are unknown.  The ability to track the exact location and movements of medical devices with near 100% accuracy due to advanced UHF RFID technology is already helping the healthcare industry save money, avoid waste, and improve clinical outcomes.  For more information about VueTrack-UDI, our new global standards-based RFID solution for enabling manufacturers and hospitals to become UDI compliant, click here.