UDI Medical Device Traceability Goes Global

Updated: Jun 29

A recent regulation push for UDI in the U.S., EU, Australia/New Zealand, and China will lead to greater deployment of surgical tracking (SIT) systems in hospitals.

The U.S. FDA is now several years into its unique device identifier (UDI) program for medical device tracking. As we approach the Sept. 24, 2018, deadline for class II device UDI marking, a number of other countries are rolling out their own similar programs.

The goal of these programs is to improve safety, increase efficiency, and provide unambiguous accountability when it comes to control and tracking of medical devices and surgical instruments. RFID has rapidly emerged as a viable solution for tracking reusable devices like surgical instruments across these initiatives.

European Union

The EU has matched the FDA regulations for its own UDI programs via the EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Medical Device Regulation 2017/746. Compliance deadlines for different classes of medical devices in the EU will be rolled out through 2027.


The UDI program in China is focused on proving the authenticity of medical devices and identifying which devices are in the hands of a patient or medical staff/facility at any given time. In March, the CFDA released a draft of the UDI regulation for public comment, which included definitions of the UDI carrier that could include linear or 2D barcodes, as well as RFID or Near Field Communication (NFC) tags.

Australia/New Zealand

Last year, the two countries released a new surgical asset tracking standard (AS/NZS 4187:2014) that mandated tighter regulations of reusable medical device reprocessing. Automation has been identified as the most efficient means of meeting the new standard. Hospitals will be moving from tray tracking instrument lifecycle tracking, with ever stage requiring this type of tracking by December 2021.

A recent report from Brick42 lays out the case for RFID in these applications quite well. By automating the identification, counting, and tracking of surgical instruments, hospitals can provide a high return on investment while also ensuring compliance with UDI rules in these regions.

You can see these benefits clearly in the hospitals where Xerafy has already deployed its own surgical instrument tracking solutions. Xerafy has years of experience implementing medical device tracking with its rugged RFID tags, providing the type of visibility required under these evolving UDI standards and requirements.