FDA Proposes New System to Track Medical Devices
Over the past several years, thousands of patients have allegedly suffered from complications related to medical devices such as the Zimmer Durom Cup. Some have filed a lawsuit seeking compensation for Zimmer hip problems like premature loosening and metal poisoning, which often require revision surgery.
Critics, including Zimmer hip implant lawsuit plaintiffs, have blamed the FDA for being slow to act concerning post-marketing reports of problems. In a July 3, 2012 press release, the agency responded by announcing their proposal for a new system that would improve tracking of “metal-on-metal” devices like the Zimmer Durom Cup.
Will new system lead to Zimmer hip implant recall?
To improve their ability to follow-up on medical devices after they’ve been released on the market, and to create prompter recalls when necessary, the FDA proposed a plan to create a new system that would assign a unique identification number to each high-risk medical device. In 2007, Congress voted to support the agency’s plan, and just passed a new law that set a deadline for late this year for final enactment of the system.
When implemented, the system will assign a unique device identifier (UDI)—similar to a product barcode—to each device, such as the Zimmer Durom Cup. The information associated with the product will then be contained in a publicly available UDI database.
FDA cites benefits of new system
Those who are seeking compensation for Zimmer hip problems will likely support the implementation of the FDA’s new system. The agency stated in their press release that the benefits will include:
- More accurate reporting and analyzing of adverse event reports
- Reduced medical errors
- More effective management of device recalls
- Easier identification of counterfeit devices
- Improved preparation for medical emergencies
With the new database, doctors could identify if a medical device may be inappropriate for certain patients. Plaintiffs involved in a Zimmer hip implant lawsuit, for example, typically claim the company failed to adequately warn of complications. With the database in place, doctors could more quickly find out if a device were the subject of a number of adverse event reports.
High-risk devices to be labeled first
According to the FDA, the plan would be implemented in stages, with UDIs applied first to the highest-risk devices. Over-the-counter and low-risk devices like bedpans, for instance, would not require the code. The estimated cost to the industry will be $65 million or more, but for those at risk of health problems from medical devices, the cost may prove to be well worth it.