The U.S. Food and Drug Administration (FDA) has proposed a universal product identification system that will aid in recalls and help consumers and healthcare professionals identify defective products, reports Drugwatch.com.
Under the proposal, all medical devices in the U.S. would be labeled with a unique device identifier (UDI), a universal system that would allow products to be tracked and identified, making it easier for the FDA to find defective products. The system would aid both consumers and medical professionals during recalls, and healthcare professionals would be able to quickly identify defective medical products and remove them from their patients.
The FDA is also looking to build a streamline and efficient online database that the public can utilize to discover information and recall announcements about their products.
Defective medical devices have caused serious and lasting injuries to patients across the U.S., most recently in the form of defective knee and hip replacements, as well as transvaginal mesh, which had life-changing implications yet were approved by the FDA.
The proposed UDIs would have a description of the device, a picture, and a tracking bar code, along with a batch and serial number to help find the manufacturer and its place of origin.
UDI labels will be placed on product packaging and on implantable devices like knee replacements so that they can be indentified. Reusable products that are continually sanitized will also carry the UDIs, as well as electronic devices.
The FDA’s proposal is still waiting approval, but once it passes, the new labels will be introduced in the next few years. Those products that sustain human life or have a high risk of injuring patients will require the UDIs within the first year of the law going into effect, with lower risk devices requiring UDIs later.
Parrish Law Firm, PLLC works with Virginia clients who have suffered because of a defective product, and we will work with you to garner the compensation that you deserve. Our Virginia product liability lawyers have years of experience, and will fight for your consumer rights as though they were our own. Contact us today for a free case consultation, or call us at 703-906-4229.