FDA Proposes Unique Device Identifier to Track Medical Implants
In the wake of safety concerns associated with medical device implants, including some reports of Zimmer NexGen knee failure, a new FDA proposal aims to assist heath practitioners by requiring all new medical devices to contain unique device identifiers (UDI). Such UDIs would consist of numeric or alphanumeric codes, and would help expedite information updates about the devices, including reports of complications that could potentially lead to a recall.
FDA regulation would help track devices
The proposed FDA regulation could have major implications in helping disseminate device information quickly and effectively. If effectuated, the regulation would help the FDA by allowing more accurate reporting and analysis of adverse event reports in order to identify problem devices. The new system would hypothetically reduce errors by helping practitioners locate device information, and offer consistency in entering device information in health databases, in establishing a standardized identifier for all recalls, and improving the overall global distribution chain in an effort to avoid device counterfeiting.
A bill like this could be especially effective in the event of a device recall. Despite complaints from a growing number of plaintiffs of NexGen complications requiring premature Zimmer knee revision surgery, neither the FDA nor the manufacturer has implemented a Zimmer NexGen knee recall.
Zimmer NexGen knee failure: Overview
In general, knee replacement devices typically are meant to last at least 15 years. However, some people who have been implanted with Zimmer NexGen CR-Flex knee devices have complained of failure within just a few years. Complications reported by plaintiffs include device dislocation, failure of the device to bond with natural bone, pain and immobility, and metallosis, or metal poisoning caused by the shedding of cobalt and chromium particles from the device.
Many plaintiffs claim that these side effects were so problematic that Zimmer knee revision surgery was required to completely remove and replace their implants.
The FDA is currently seeking feedback on its proposal of the UDI system from the medical community and the public at large. After a four-month information gathering period, the health agency will make a final decision on whether or not to commit to the plan.