In September 2013, the US Food and Drug Administration (FDA) ruled that medical devices distributed in the United States must carry a unique-device identifier, or UDI, which will help the FDA identify product problems quicker, target recalls more effectively, and improve patient safety. The system established by this rule requires the label and device package of each medical device to include a UDI in a plain-text version and in a form that uses automatic identification and data-capture technology. The labeler must also submit product information concerning devices to FDA’s Global Unique Device Identification Database. Companies that miss the submission deadline can be restricted from selling their products in the US market. The scope of this effort, combined with the short time line within which to comply, made UDI compliance a top priority for Sorin Group.
The company started a global initiative across different business units and manufacturing sites and departments, such as R&D, design, production, quality assurance, and regulatory affairs, which impacted all therapeutic areas. The scope was to first source and cleanse legacy UDI data globally, and then centralize and submit device information to the FDA. Sorin Group applied the same UDI concept internally to increase the efficiency, quality, and traceability of its medical devices.
The company chose Oracle’s three-step UDI solution, which is based upon Oracle’s Agile Product Collaboration—a comprehensive and cost-effective solution that combines enhanced business-process enablement with data capture to enable UDI compliance. Sorin Group deployed the Oracle UDI solution in less than four months, thus avoiding any business disruption associated with noncompliance. The company also gained a low total cost of ownership for the solution that is automating the capture, cleansing, and validation of all legacy attributes to ensure information is current and accurate, and that all UDI data is centralized in an FDA-compliant archive. Sorin Group was the first company in Europe and the second company in the world to become UDI compliant, ensuring continuous availability of its devices to the US marketplace to improve and save lives through innovative cardiac surgery and cardiac-rhythm-management solutions.
Cesare Varzi, Vice President, Corporate IT, Sorin Group, said: “With the Oracle/Inspirage unique-device identifier solution, we were certain that we would get a global, well-tested, and collaborative-enterprise solution to accelerate transfer and standardization of legacy unique-device identifier attributes, streamline cross-functional processes, and ensure compliance.”
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