Tags
Boston Scientific, FDA, Food & Drug Administration, Hip Replacement, Medical device, NEW YORK, New York City, UNited States
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier
WEBWIRE – Thursday, July 05, 2012
(New York, NY, July 6, 2012) The Rottenstein Law Group, which represents clients with claims stemming from injuries allegedly caused by surgical mesh products and hip replacement recalls , has learned that the U.S. Food and Drug Administration (FDA) has proposed a rule that would require most medical devices distributed in the United States to carry a unique device identifier, or UDI.
The FDA has proposed implementing an identification system that would assign to each medical device a unique code that will be the “key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information such as its expiration date and batch or lot number,” according to a July 3, 2012 press release .
The FDA expects the UDI system to, among other things, “allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly” and “provide a standardized identifier that will allow manufacturers, distributors and health care facilities to more effectively manage medical device recalls.”
Rochelle Rottenstein is the devoted advocate of claimants allegedly injured by recalled medical devices – including Boston Scientific’s Protegen Sling surgical mesh product, which was recalled in 1999, according to a May 4, 2009 New York Times article, and the DePuy ASR Hip Resurfacing System, which DePuy voluntarily recalled in August 2010, according to the manufacturer’s own Web site. This experience has made Rottenstein aware of the importance of keeping track of adverse event reports filed in connection with injuries sustained from medical devices. Accordingly, Rottenstein has long been a proponent of the FDA’s adoption of a UDI system, which she believes can go a long way toward minimizing the injuries caused by potentially dangerous medical devices.
Just last week, Rottenstein told a reporter from Medical Device and Device Industry (MD+DI), that, to better protect consumers, the FDA should act immediately to “require the use of unique device identifiers that would enable the FDA to better track medical device malfunctions.”
Anyone seeking more information about hip replacement recalls can visit http://www.depuyhipreplacementlawsuit.com . Information on surgical mesh lawsuits are also available at http://www.vaginalmeshlawsuit.com . These sites have vital information about the dangers of these medical devices along with easy-to-use social media features that allow for easy sharing on sites like Facebook and Twitter. Visitors are also encouraged to link to their own Web sites and blogs in order to spread the word about defective medical products and dangerous drugs.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit its Web site at http://www.rotlaw.com , or call (888) 9-ROT-LAW. Attorney advertising. Prior results do not guarantee a similar outcome.
Related articles
- Rottenstein Law Group Encouraged by FDA’s Proposed Rule Establishing a Unique Device Identification System (prweb.com)
- FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments (earlsview.com)
- FDA releases proposed UDI rule; reaction generally positive (earlsview.com)
- Medical Device ” The Senate Passes Unparalleled Medical Device User Fee Act (earlsview.com)
- Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today (earlsview.com)
- Rottenstein Law Group Applauds FDA Device Chief’s Recommendation To Close Dangerous Loophole In Agency’s Medical-Device Approval Process (prweb.com)
- Rottenstein Law Group Principal’s Opinion on FDA-Related Legislation Featured In Major Medical Device Publication (prweb.com)
- The Senate Passes Unparalleled Medical Device User Fee Act (depuyrecall.wordpress.com)
- Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit (earlsview.com)
- FDA Proposes IDs To Track Medical Device Safety (huffingtonpost.com)
Pingback: Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions « Earl's View
Pingback: FDA to help medical device sales with expanded pre-market feedback program « Earl's View
Pingback: Medical Device ID Proposal Unveiled – GovInfoSecurity « Earl's View
Pingback: Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register « Earl's View
Pingback: Is the US Medical Device Industry Heading the Way of the Dinosaur? « Earl's View
Pingback: Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform « Earl's View
Pingback: Dems urge FDA to boost medtech recall database | MassDevice.com « Earl's View
Pingback: » Medical device units recalled in Q2 represent eight-quarter high | MedCity News « Earl's View