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Novation Submits Comments to FDA in support of Unique Device Identification Rule

Thu, 11/08/2012 - 10:10am
Bio-Medicine.Org

IRVING, Texas, Nov. 8, 2012 /PRNewswire/ -- On November 6, Novation submitted comments to the Food and Drug Administration regarding the implementation of a Unique Device Identification (UDI) system for medical devices.     

An active advocate of UDI implementation for years, Novation is the health care industry's leading supply chain contracting and expertise company for the members and affiliates of VHA Inc., UHC, Children's Hospital Association and Provista. 

Novation welcomes the release of the proposed rule and believes it will present a significant opportunity to improve the safety of medical devices and will have a significant, positive impact on the healthcare industry. The healthcare industry has always faced substantial challenges with medical device and device package identification because there has not been a globally unique number that can be used by all supply chain participants for accurate identification. 

"The use of a mandated unique device identifier, similar to the FDA's National Drug Code System, will help to substantially improve the accuracy of medical device identification and improve overall patient safety through the reduction of medical errors, efficient device recalls and enhanced device adverse event reporting," says Jill Witter, General Counsel, Ethics and Compliance Officer, and Senior Vice President at Novation. "All of these improvements will enable hospitals to focus on what they do best – providing quality patient care."    

Highlights of Novation's comments include:

  • Encouraging a shorter timeline – Given the clear and substantial benefits that will be found through the adoption of a unique identification system, Novation encourages the FDA to move forward with implementation as expediently as possible.
  • Narrowing exceptions to the Rule – Novation does not believe a blanket except
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