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:6/23/2016)... DUBLIN , June 23, 2016 ... the "Pharmaceutical Excipients Market by Type (Organic Chemical ... Preservative), Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast ... The global pharmaceutical excipients ... 2021 at a CAGR of 6.1% in the forecast ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Medical Market Analysis 2016 - Forecast to 2022" report ... The report contains up to date financial data derived from ... of major trends with potential impact on the market during ... market segmentation which comprises of sub markets, regional and country ...
(Date:6/23/2016)... 2016 Bracket , a leading clinical trial ... clinical outcomes platform, Bracket eCOA (SM) 6.0, at the ... – 30, 2016 in Philadelphia , Pennsylvania.  ... Assessment product of its kind to fully integrate with RTSM, ... eCOA 6.0 is a flexible platform for electronic clinical outcomes ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop ... The fitness app plans to fix the two major problems leading the fitness industry today:, ... all type program , They don’t eliminate all the reasons people quit their ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may ... to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To ... for healthy coping following a traumatic event. , Trauma sufferers tend to feel a ...
Breaking Medicine News(10 mins):