Navigation Links
Novation Submits Comments to FDA in support of Unique Device Identification Rule
Date:11/8/2012

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
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmaceutical Innovation Spotlighted at ISPE Annual Meeting
2. Frost & Sullivan: Global Increase in Adoption of Real-Time Location Systems Depends on Technological Innovations
3. VisionCare Implantable Telescope Technology Presentations Featured at Upcoming American Academy of Ophthalmology and Ophthalmology Innovation Summit Meetings
4. Novation Champions Reusable Packaging for Sustainability in Healthcare
5. New Study Highlights Enabling Factors for Biopharmaceutical Innovation in Middle-Income Countries
6. Kaiser Permanente Joins Rock Health to Support Digital Innovation in Health Care
7. Medical Device Daily releases Med-Tech on a Mission: Strategies to Drive Innovation
8. Medical Virtual Reality Technology Nominated Twice in the 2012 Accenture Innovation Awards
9. EMD Serono Expands the Grant for Fertility Innovation (GFI) Program to Include U.S. Investigators
10. Johnson & Johnson Announces Plans to Establish Innovation Centers
11. Innovations in Drug Delivery - Broad-based Proprietary Technology Platforms to Address Delivery Efficiency and Improve Patient Compliance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... NEW YORK , April 28, 2016 /PRNewswire/ ... will notably complement the company,s valve repair and ... the move also places Abbott more firmly into ... one of the fastest growing device areas, with ... to its recent report,  Advanced Remote Patient ...
(Date:4/28/2016)... 28, 2016  The blood testing market in ... to Kalorama Information and The Freedonia Group in a ... acid testing.  The healthcare research firm said that ... blood collection stations and in improving testing at the ... report, Blood Testing Market in China ...
(Date:4/28/2016)... , April 28, 2016 Oramed ... a clinical-stage pharmaceutical company focused on the development of oral ... in the upcoming PIONEERS 2016 conference, presented by Joseph ... 2016 in New York . Nadav ... at the conference. Presentation Details:   ...
Breaking Medicine Technology:
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... On Tuesday, ... hospitals across the Southeast, celebrated the signature of Gov. Nathan Deal on SB 258, ... Geoff Duncan (R - Cumming), offers a 70% tax credit to individuals and corporations ...
(Date:4/29/2016)... ... ... Coast Dental Fort Stewart is celebrating its grand opening with an open ... Mall at 112 Vilseck Road in Fort Stewart. There will be refreshments, giveaways, and ... the opportunity to meet general dentists Thomas Richards, DDS, and Josh Faulk, DMD, and ...
(Date:4/29/2016)... ... April 29, 2016 , ... World Patent Marketing , ... exercise invention which aids in proper muscle development. , "The Gym & Exercise ... Director of World Patent Marketing. "Globalization has threatened the future growth of the ...
(Date:4/29/2016)... ... April 29, 2016 , ... Reltok Nasal Products proudly announces that ... head and neck/ear, nose and throat specialty, has added the KOTLER NASAL AIRWAY™ to ... AIRWAY™ is a newly patented safety device secured by nasal surgeons onto the ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... media enterprise focused entirely on patients with cancer, today announced that Lynne Malestic, ... as the 2016 CURE® Extraordinary Healer® for Oncology Nursing , which honors ...
Breaking Medicine News(10 mins):