FDA Creates New Identification System to Combat Defective Medical Devices

 Posted on November 22, 2013 in Defective Medical Devices

The Food and Drug Administration recently announced a new regulatory requirement for medical devices. All devices must now have a unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices. The development and safe operation of medical technology is literally of life and death importance, and manufacturers must uphold high standards in both quality and safety. The FDA UDI system will allow manufacturers to identify their products with a unique number.

The Unique Device Identification system will have a 14-digit number, which must be displayed conspicuously on device labeling and packaging. Further, attributes of each device associated with a particular UDI number must be submitted and stored in the FDA' Global Unique Device Identifier Database.

These regulations have a major impact on safety because they remove the necessity of renumbering old medical devices in the field. It also reduces the chances that a consumer of the product is using a counterfeit because the identity of all of the products will be known in the FDA's database. Finally, it enhances communication between manufacturers, hospitals, doctors and distributors. With improved communication, malfunctions or negative events caused by devices can be reported from end-users to manufacturers. Communication, of course, will more effectively flow the other way as well, and product recalls from manufacturers to patients can occur on a timelier basis.

Congress originally passed a law mandating the FDA to create regulations for a UDI system when it recommenced the FDA's medical device user fee program in 2007. Although, as that law failed to provide a deadline for action, the agency was able to consecutively delay the program without being forced into action. In 2012, Congress passed a law that set a deadline for implementation of the UDI regulations. Although more prompt action by the FDA would have probably prevented numerous deaths and injuries related to unsafe medical devices, and while the full benefits of the new rule will not be seen for several more years as implementation of the system will take time to mature, the new regulation is a welcome development.

If you are a patient who has been hurt by a defective medical device, you need an Illinois personal injury attorney. Medical devices regularly malfunction, and despite efforts from the FDA and other organizations to improve standards, you may still be at risk. We have over 50 years of experience litigating cases on defective medical devices, so get in touch with us today if you have any questions or concerns.