FDA Proposes New System To Monitor Defects In Medical Devices And Implants

When a New Orleans resident needs a hip or knee replacement, they should have some assurance that the medical device being implanted will not result in further injury, such as what we are seeing with the recent Exactech Knee Recall. These devices are supposed to be rigorously tested for safety and proper functioning before being used. Unfortunately, over the last several years thousands of personal injury lawsuits have been filed for defective and unsafe medical implants that failed to perform as required.

As a result, the U.S. Food and Drug Administration is proposing changes to the manner in which implants and other medical devices are monitored following their release into the marketplace. However, there have been cases in which a victim of a faulty medical device has filed a defective product lawsuit.

In a recently released report entitled “Strengthening our National System for Medical Device Postmarket Surveillance,” the FDA proposes several changes to the current system of monitoring medical devices being released into the marketplace. These proposals include establishing a unique device identification system, developing national and international device registries for certain medical devices, and modernizing the manner in which problems with medical devices and implants are reported and analyzed.

While these changes are viewed as being part of a long-term plan, the FDA has already begun working on a method for implementing a unique identification system. Under this system, medical devices and implants would carry a unique code linked to the model, along with a production identifier associated with manufacturing information. The identification code would not be linked to any personal information regarding the patient.

This system would facilitate the reporting of medical problems associated with specific devices and make it possible to track who has received them should they be recalled. The FDA has recommended that this system be phased in for the highest-risk devices. Medical devices deemed to be low-risk and over-the-counter devices would be exempt.

If you have undergone a hip replacement or knee replacement and believe the medical implant is faulty or defective, we can answer your legal questions. Please call us at (504) 527-8767.