Oracle's Unique Device Identifier Solution: A 3-Step Approach to FDA Compliance
By Terri Hiskey-Oracle on Sep 16, 2013
By Todd Hein, Senior Director of Life Sciences, Oracle
In 2007, the Food and Drug Administration Amendments Act was signed to improve patient safety by improving the flow of information on medical devices. This legislation is anticipated to be enforced within the next 12-18 months and, at minimum, requires Class II and Class III medical devices distributed in the U.S. to carry a Unique Device Identification (UDI), a unique numeric or alphanumeric code with an identifier specific to each device or model as well as an identifier with current production information.
The FDA's vision for the UDI system is to provide global visibility and support the following improvements in the medical device processes:
- 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.
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
- Lead to the development of a medical device identification system that is recognized around the world.
In order to help medical device companies to streamline the process and achieve UDI compliance in the short timeline available, Oracle has announced the 3-Step UDI Solution that combines enhanced business processes with data capture to achieve UDI compliance at a low total cost of ownership. Keeping with the theme of simplicity, the comprehensive Oracle solution achieves UDI compliance in three simple steps:
- Source, cleanse and validate legacy UDI attributes for each shippable SKU
- Process and manage UDI, Global Trade Information Number (GTIN) and SKU hierarchies
- Extract and submit accurate data to the Global Unique Device Identification Database (GUDID) and Global Data Synchronization Networks (GDSNs)
To develop the 3-Step UDI solution, Oracle worked closely with the FDA to gain a better understanding of the requirements, and also worked directly with the several leading medical device companies to ensure specific business challenges were addressed. Through a partnership with Inspirage, an Oracle Platinum Partner; the resulting solution provides a "Rapid Start" template approach to ensure that the aggressive FDA deadlines can be met.
The value of deploying this solution is not just limited to meeting FDA compliance mandates. With the underlying technology in the Oracle UDI solution, medical device companies have a strong foundation to expand parallel business processes across the enterprise for compounding business benefit.
The 3-Step UDI Solution demonstrates Oracle's commitment to addressing the unique requirements of the medical device industry. Combining industry knowledge with a comprehensive product line and partner expertise, Oracle is well-positioned to create valuable solutions to assist all medical device companies.
To learn more about the Oracle 3-Step UDI Solution, click here.