Should Metal Hip Implants Carry Unique Medical Device Identifiers?
Did you receive a DePuy ASR hip replacement, yet only recently found out that it has been recalled? Although tens of thousands of people worldwide were affected by the 2010 DePuy ASR hip recall, because the United States doesn’t have an organized method to track and notify every recipient that the devices were defective, many individuals were left in the dark. Thankfully, the U.S. Food and Drug Administration (“FDA”) is taking action to make sure history doesn’t repeat itself. An upcoming conference hosted by the FDA and scheduled for September 18-19, 2012 will finally discuss proposed regulation to implement unique device identifiers (“UDI”) for medical devices.
The new UDI Proposed Regulation will “establish a single device identification system that is consistent, unambiguous, standardized, and globally harmonized.” All medical device manufacturers will be required to comply. According to a July 2012 FDA press release, “A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify problems more quickly, better target recalls and improve patient safety.”
Given the problems associated with dangerous medical devices in the U.S. such as transvaginal mesh implants or the recalled ASR hip implants, we are encouraged to hear that the FDA is making strides to improve monitoring of potentially dangerous devices.
Other countries have official registries that have helped with such recalls in the past. For example, the National Joint Registry of England and Wales was set up to collect information and monitor joint replacement surgery and implants. Data from this registry led to the DePuy ASR hip recall in August 2010. After data revealed that one in eight of these hip replacement implants failed within five years of surgery, DePuy Orthopedics reacted by issuing the voluntary worldwide recall.
According to Bloomberg Businessweek, the FDA’s Proposed Regulation will help regulators trace product flaws, failures and incompatibility. The codes will be stored in a public database, which will let patients be quickly informed of device flaws and dangers, and allow companies and hospitals to pull defective devices from the market promptly.
We are heartened by the FDA’s plan to implement a UDI system for medical devices in the U.S. Our lawyers are currently representing clients in lawsuits against manufacturers of defective medical devices such as the recalled ASR hip systems and metal hip implants manufactured by other companies, as well as transvaginal mesh implants. If you experienced complications from a faulty medical device, contact a lawyer today. You may be entitled to compensation for your injuries, medical expenses, lost wages and pain and suffering. Call today for a free case evaluation: (877) 779-1414.