Unique Device Identification, also known as UDI, is coming in 2010. All manufacturers of medical devices will be required to comply with the new UDI methodology. The Everest software solution for customer complaints and corrective action tracking includes several features to help medical device manufacturers track a UDI as it relates to all types of medical device problems or defects including: 

• customer complaints
• return authorizations
• product defects
• adverse event – MDR

The FDA UDI Rule will establish a single device identification system that is consistent, unambiguous, standardized, and globally harmonized.

At the device level, marking procedures may include bar code, radio frequency identification (RFID) and direct part marking (DPM). At the organization level, the new UDI methodology offers opportunities for improvement in traceability, recalls, electronic records, materials management, defect analysis and problem resolution.

For FDA regulated medical device manufacturers, the Everest software solution is highly configurable for customer complaints, non-conforming product and corrective action tracking. Here are a few key Everest software features related to UDI…

Product Fields
“Based on a specific UDI, what are the product details related to the customer or patient concern?”

Shipped and Defective Quantities along with Serial Number, Lot Number and user defined fields for any other product details, including the UDI.

Product List
“Based on a specific UDI, how many other problems have been reported for the same type of device or related products?”

Everest includes a master product list based on; Product Id, Description, Product Group and Manufacturing Location. The product list can be imported from a spreadsheet template or updated systematically from a source database with the software’s automatic import program (sold separately).

Defect Codes
“Based on a specific UDI, what types of defects or reasons were attributed to the problem?”For each UDI entered, track results from root cause analysis with up to three levels of defect codes based on configurable terminology to define each; Source, Type, Reason. Everest defect codes enable point-and-click selection of multiple reason codes as needed to identify manufacturing, supplier quality, material non-conformances or other sources.

 Reports & Charts
“What type and volume of concerns are associated with the device and how does that compare with related products, different products and the reason codes?”

Standard reports and charts by Product Id or Product Group, plus a chart drill down feature to explore highest frequencies with drill down details for defect source, type and reason codes.

UDI provides an opportunity to improve patient care, increase efficiency and reduce costs. For manufacturers, a configurable database for tracking the UDI will provide the visibility that is essential to maintain high quality standards and superior customer service. The UDI enables early detection of defective devices to ultimately enhance patient safety and reduce medical errors.

For more information about UDI…

Global GS1 Contact and Website
Ulrike Kreysa, Director Healthcare, GS1 Global Office
ulrike.kreysa@gs1.org
GS1 Healthcare website:
http://www.gs1.org/healthcare

FDA
The FDA is taking the lead in the United States for UDI and will shortly begin developing draft regulations to implement requirements. For additional information about the regulations, visit the FDA website
http://www.fda.gov/cdrh/ocd/udi

UDI Conference – October 20-21, 2009 – Orlando, FL
Hilton Bonnet Creek, Orlando, FL
http://www.udiconference.com