Santa Barbara, Calif.—Oct. 10, 2014—QAD Inc., a provider of cloud enterprise resource planning (ERP) solutions and services for global manufacturers, announced that it developed a solution for medical device manufacturers to help meet the Unique Device Identifier (UDI) rules as required by the Food and Drug Administration (FDA).
The FDA issued a rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier, except where the rule provides for an exception or alternative placement. The labeler must also submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID). The first phase of the UDI requirements applies to class III devices and requires that they display the UDI label by September 24, 2014. The UDI labels include a device identifier, which consists of the labeler and specific model of the device, and a production identifier that includes lot or batch numbers, expiration date and other valuable information.
When fully implemented, the UDI system will:
- Allow more accurate reporting, reviewing and analyzing of adverse event reports.
- Reduce medical errors by enabling health care professionals to rapidly identify a device.
- Enhance analysis of devices on the market by providing a standard way to document device use in electronic health records, clinical information systems, claim data sources and registries.
- Provide a standardized identifier to 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.
“We are pleased to offer life science product manufacturers a solution for the FDA’s Unique Device Identifier requirements,” stated QAD Life Sciences Director of Marketing Bart Reitter. “Meeting the UDI rule is extremely important for the life science industry. Our customers are well prepared to meet this mandate with an effective, integrated solution.”