New FDA Safety Plan Includes Identification Numbers To Monitor High-Risk Medical Devices
Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, reports that on July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced a new plan that will monitor high-risk medical devices.* These devices will have a unique tracking number to help the agency identify problems. According to Bloomberg Businessweek, the unique device identifier (“UDI”) will help regulators trace:
- product flaws;
- failures; and
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.
Identifier Numbers Will Help Track And Monitor Defective Devices
Jeffrey Shuren, director of the FDA’s medical-device center, told the Wall Street Journal that the identification number is “a major game-changer.” Dr. Shuren believes that the UDIs will be “‘the cornerstone’ of a safety system in which the FDA will work with insurers and hospital chains’ databases to come to grips early on with the seriousness of a malfunction.” The original idea for the identifier number came from a 2007 federal law. The long-delayed plan will be open to public input for the next four months, until final enactment late this year. According to Dr. Shuren, the identifier numbers will start to appear on high-risk devices by early 2014.
According to the WSJ, there were over 17,700 deaths reported to the FDA tied to medical devices over a five-year period. Given the known complications of certain medical devices such as metal hip systems and transvaginal mesh implants and their dangers to patients, Bernstein Liebhard LLP is heartened to hear of the FDA’s new plan to better track and monitor potentially dangerous devices in the future.
The lawyers at Bernstein Liebhard LLP are actively representing clients in lawsuits against the manufacturers of defective medical devices in both state and federal courts. Those who have experienced complications from devices such as metal hip systems or transvaginal mesh implants may be entitled to compensation for medical expenses, pain and suffering, lost wages and other injuries. Learn more about your legal rights by visiting our website, www.consumerinjurylawyers.com, or by watching this metal hip replacement or transvaginal mesh video.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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