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


11/8/2012 12:39:10 PM

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 exception of Class I devices sold in a retail setting is appropriate, nor in the best interest of patients. Novation believes that including a globally recognized UDI would lay the foundation for stability in the supply chain and additional patient safety enhancements in the future.
  • Defining labeling requirements Novation believes requirements should be in line with the best practices of the retail world. All products that reasonably can include a bar code should include a bar code. In instances where labeling the device isn't practical or is subject to an exemption, every effort should still be made to include a UDI on the packaging and device wrapper.
  • Adopting a global date format Novation supports utilizing the ISO date standard for the UDI label so one label can be used globally for all product identification.

"Novation has been a leader in pushing for a unique device identifier standard, and we will continue to partner with the FDA and the hospital members we serve to maximize the benefits of a UDI system," continues Witter.

About Novation, Winner of the Ethics Inside® Certification

Founded in 1998, Novation is the leading health care supply chain expertise and contracting company for the more than 65,000 members of VHA Inc. and UHC, two national health care alliances, Children's Hospital Association, an alliance of the nation's leading pediatric facilities, and Provista, LLC. Novation provides alliance members with sourcing services, as well as information and data services. Based in Irving, Texas, Novation develops and manages competitive contracts with more than 600 suppliers. VHA, UHC, and Provista members used Novation contracts to purchase more than $40 billion in 2011. Novation recently earned the coveted Ethics Inside® Certification from Ethisphere Institute, a leading international think tank dedicated to the research and promotion of best practices in corporate ethics and compliance. Novation was also named on Ethisphere's World's Most Ethical Companies list, and is the only company in the health care industry to earn both distinctions. To learn more about Novation, please visit www.novationco.com and follow @NovationNews.

SOURCE Novation


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