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Eric T. Chaffin
Eric T. Chaffin
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Will New FDA Medical Device Tracking System Improve Public Safety?

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In the wake of thousands of lawsuits against manufacturers of metal-on-metal hip and knee implants, the FDA has proposed a new identification system that may make it easier for the agency to track post-marketing performance, identify problems, and respond more quickly with recalls, when necessary.

Over the last decade, products like the DePuy ASR hip, the Zimmer Durom Cup, the Biomet M2A-Magnum, the Stryker Rejuvenate, and others have come under fire because of high rates of loosening and device failure. The FDA has been criticized for a) approving these allegedly defective devices in the first place, and b) failing to respond quickly enough to the post-marketing reports of complications.

Will this new tracking system help prevent future injuries such as those witnessed with these products?

FDA Proposes Unique Device Identification System

This tracking system has been a long time coming. Congress actually passed legislation in 2007 directing the FDA to develop a unique device identification (UDI) system for medical devices, but as is often the case, there have been delays.

Congress just passed a new law called the "FDA Safety and Innovation Act"—and the President is expected to sign it—setting a deadline for late this year for final enactment of the system. In response, the FDA issued a press release on July 3, 2012, proposing that most medical devices distributed in the U.S. carry a UDI.

Similar to the bar code found on most products sold in stores, the UDI would include a unique numeric or alphanumeric code that would identify the device, as well as a "production identifier" that would contain additional information such as the name of the manufacturer, the type of device, and the serial number, as well as the expiration date and batch or lot number, where applicable.

All this information would then be included in a publicly available UDI database, so that "users of a medical device can easily look up information about the device," the agency stated.

Expected Benefits of the New UDI System

According to the FDA, the new system has the potential to improve the quality of information contained in medical device adverse event reports, and will help the FDA identify those products that are causing problems in patients more quickly.

Additional benefits, according to the agency, include:

  • More accurate reporting of problems
  • Reduced medical errors
  • Enhanced analysis of devices
  • More effective management of device recalls
  • Improved global distribution chain, which may help address counterfeiting
  • Potential for further development as a global system

Open for Public Comment

The FDA has given medical manufacturing and health-care industries 120 days to comment on the new proposed rules, after which the agency will have six months to create and issue the final rules. Once completed, the new system will be phased in through various stages over the next seven years, with the highest-risk devices labeled first.

Consumers Union, the advocacy arm of Consumer Reports, issued a statement applauding the FDA for the proposal. Novation, a supply contracting company for Children's Hospital Association and other health organizations, called the new UDI system a "milestone for patient safety." Those who have filed a lawsuit against various manufacturers of hip and knee devices, such as those who have filed a Stryker hip lawsuit or a Biomet hip lawsuit are likely to applaud the new system, but for many it's too late to repair the damage that has been done.