FDA Proposes New Medical Device Identification System

The FDA has recently proposed a new method of identifying and tracking medical devices. Under this system, most medical devices would be inscribed with a “unique device identifier”, or UDI. This code would contain product information including manufacturer, expiration and other device specifics. High risk medical devices are the first priority to receive UDI codes, whereas some less risky devices or over-the-counter devices may be exempt from the ruling. This information could be held in a database that is available to the public, greatly improving the transparency and accessibility of medical device implants.

The FDA is optimistic that continued post-market surveillance will help the medical community identify, isolate, and inform consumers about problematic devices. This proposal will be open to public comments for the next 120 days, and has already garnered much support for its potential to increase the safety of medical device implants.

This system will help manufacturers and hospitals to discern the problems of a given product faster and implement more efficient recalls. It is also suggested that UDI codes will make it easier to prevent counterfeit products from entering the market. This could greatly improve patient safety by limiting the amount of defective devices available and making it easier for consumers to learn when their safety may be at risk. FDA Commissioner Margaret A. Hamburg, M.D. is quoted in the Star Tribune: “The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.”

Overall, this proposal may hold great promise to increase consumer safety and medical accountability. Medical device disasters like metal hip implants and transvaginal mesh could have been mitigated by a system that made recognizing and recalling dangerous products more effective. Consumers deserve accurate and timely information regarding their well-being and the well-being of any device implants they may have received.


At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

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