A Unique Device Identifier (UDI) For High-Risk Devices

Perry Larkin | July 17th, 2012

The FDA has formulated a plan to follow-up on medical devices after they’ve been released to the market. This will assign a unique device identifier (UDI) to high risk medical devices. These UDIs will be applied first to the highest-risk devices with over-the-counter and low-risk devices—bedpans for example—not requiring 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.

The FDA cites the following benefits to the new system:

  • Improved preparation for medical emergencies
  • Easier identification of counterfeit devices
  • More effective management of device recalls
  • Reduced medical errors
  • More accurate reporting and analyzing of adverse event reports

The FDA response to allegations of being slow to act

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 hired Zimmer hip lawyers and filed a lawsuit seeking compensation for hip problems like metal poisoning and premature loosening. Often these issues require surgery for revision of Zimmer hip.

Critics, including plaintiffs suing Zimmer, have blamed the FDA for being slow to act concerning post-marketing reports of problems. The agency responded in a July 3, 2012 press release announcing the proposal for a new system to track “metal-on-metal” devices like the Zimmer Durom Cup.

The purpose and benefits of a UDI database

The UDI is meant to improve upon the FDA’s ability to follow-up on medical devices after they’ve been released on the market and to create prompter recalls—such as a possible recall of the Zimmer hip implant—when necessary.

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. The UDI is similar to a product barcode. The information associated with the product will be contained in a publicly available UDI database.

With the new database, doctors could identify if a medical device may be inappropriate for certain patients. Plaintiffs involved in lawsuits for a failed device 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.