Friday, September 14, 2012

Metal Hip Systems Should Be Priority At Upcoming FDA Conference On Unique Medical Device Identifiers


Metal hip systems ought to be top priority at FDA’s UDI Conference on September 18 and 19, 2012, Bernstein Liebhard LLP reports.

New York, NY (PRWEB) September 10, 2012
Metal hip systems as well as other high-risk medical devices, such as transvaginal mesh implants, should be the focus of an upcoming conference aimed at providing insight into the U.S. Food and Drug Administration’s (“FDA”) Proposed Regulation to implement unique device identifiers (“UDI”), Bernstein Liebhard LLP reports.* On September 18 and 19, 2012, the FDA will host a conference for medical device manufacturers, health care distributors, group purchasing organizations, hospitals and health care providers, and health care industry professionals who want to understand the newly-released UDI Proposed Regulation, which will “establish a single device identification system that is consistent, unambiguous, standardized, and globally harmonized. All manufacturers of medical devices will be required to comply with the new UDI methodology.”
“Given the known complications associated with certain medical devices such as metal hip systems and transvaginal mesh implants and their dangers to patients, we are heartened to hear of the FDA’s new plan to better track and monitor potentially dangerous devices in the future,” said Bernstein Liebhard LLP.
Purpose Of FDA’s Unique Identification System
As explained more fully in a July 3, 2012 FDA press release on the UDI Proposed Regulation, “A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify problems more quickly, better target recalls and improve patient safety.”** According to an article published in Bloomberg Businessweek discussing the FDA’s Proposed Regulation, UDIs will help regulators trace:
  • product flaws;

  • failures; and

  • incompatibility.
The codes will be stored in a public database, which will:
  • enable patients to be quickly informed of flaws and dangers; and

  • allow companies and hospitals to pull defective devices from the market quickly.***

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