You may have seen bar codes popping up on all sorts of medical devices and supplies in the last several years, including 2D barcodes on the SteriTite® Universal Sealed Container System. Maybe you’ve heard about how these unique device identifiers will eventually help streamline complex work processes, eliminate human error, and record important device information. The concept has been discussed for decades and is now becoming reality—in the form of the US FDA UDI initiative for Class II devices, including sterilization containers.
The Purpose and Goals of UDI
When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form and will offer a range of benefits to:
- Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
Are You Ready? SteriTite Containers and UDI
Case Medical is excited for the future of full traceability! We’ve embraced the purpose of UDI by assigning each SteriTite container and case cart its own UDI with laser-etched 2D barcode to uniquely identify the individual container or cart. Use the UDI to track the history of the specific item and trace sets to the patient—for complete infection prevention transparency. CaseTrak360® instrument tracking system software can use UDI data to provide asset management functionality including real-time reprocessing status, location information, and other useful feature. Contact Case Medical now to ensure that all current and future regulatory requirements for traceability are met with your critical devices and surgical sets.