Solutions to comply with the FDA’s UDI mandate

medex2Tracking medical devices using rugged RFID tags can help manufacturers improve supply chain management, while making it possible for hospitals to improve asset utilization, reduce labor costs, and improve efficiency. More important, this type of tracking can help manufacturers comply with U.S. Food & Drug Administration (FDA) Unique Device Identification (UDI) requirements that call for a unique identifier to be placed on an ever-increasing group of medical devices. Xerafy partner MedEx-Intel delivers hospitals and implant manufacturers an autoclave-ready RFID tag system for individual implants and instruments to establish a foundation of tracking compliance with the FDA’s UDI mandate.

While there is no shortage of RFID solutions available in the healthcare market, MedEx~Intel has developed a single-source MedEx~Intellitrax solution to implement data management at the micro and macro levels, and one that provides customers with current and future solutions that embrace the inorganic Internet of Things and the organic domain of medical device implants. Managed together, this approach forms a more comprehensive Internet of Everything.

In simple terms, the complete MedEx~Intellitrax solution resides on a Cloud-based server, and consists of three distinct systems that can function independently or as a complete solution: MedEx, Intellitrax, and GlobalTrack.

In the medical device industry, the key to MedEx’s ability to serve its clients with a one-stop solution is to provide services specifically designed for implant and instrument design and part marking, as well as offering regulatory services that allow companies to become FDA Global UDI Database (GUDID) compliant. The company also provides the macro-services of automated inventory control at the OEM fabrication/ship level, through inventory management and into the operating room environment, and then back through the automated billing and replenishment cycle.

One of the keys to successfully tracking medical devices through their life cycle with the MedEx solution is the use of the Xerafy family of autoclavable RFID tags, such as the Dash and Dot for implant and instrument solutions, and the Roswell, Pico Plus and Microx II for implant and instrument case solutions.

RFID tags affixed to medical equipment must be small enough to be attached reliably without interfering with the instrument’s use; must have a reasonable size-to-performance ratio so that it can be reliably tracked; and must be biocompatible and durable enough to withstand the autoclave and other sterilization processes. Xerafy’s rugged RFID tags already have a well-documented track record when it comes to surgical instrument and medical device tracking, having been implemented at a number of hospitals and universities around the globe.

medexMedEx comes in two configurations. The Desk Mounted System is best suited to static manufacturing or central processing installations. The Free-Scan configuration allows inventory input, output and reconciliation functions to be carried out by the user with a hand-held scanner, either within a facility or by a sales representative/case manager anywhere in the world.

The Intellitrax portion of MedEx~Intellitrax suite of services is based on the philosophy that understanding the location of every asset in the Use Cycle can give customers a competitive edge, whether that asset is a paper file in an archive vault, or a shipping container at sea or on a truck travelling through Europe. MedEx~Intellitrax — through the implementation of Persistent Inventory and Chaotic Warehousing techniques — can stream clients near-instant information upon which sound logistical and strategic judgments can be made.

To achieve this, the Intellitrax program leverages the capabilities of the Xerafy ruggedized chips (such as Metal Skin, Cargo Trak, Global Trak, etc.) for durable assets, and couples this information with its Global Track GPS tracking hardware and software to provide location, mileage, speed, idle time, fuel usage, and other data. Armed with this information, the client can maintain a logistical awareness of everything that pertains to the movement of their goods.

GlobalTrack is the part of the solution triad that allows the MedEx~Intellitrax system to not only deliver logistic intelligence at the local scale of a facility or division, but also allow this data to be tracked on a global scale with the integration of MedEx~Intellitrax into the GlobalTrack GPS network hosted on the company’s Nimbus Cloud servers.

This three-tiered approach provides an end-to-end tracking solution that provides real, actionable business intelligence to medical device manufacturers, while ensuring compliance with FDA UDI requirements.

For further information, you can contact our partner, MedEx-Intel via e-mail at louis@medexintel.com, or david@medexintel.com.

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