The Food and Drug Administration (FDA) released its guidance for manufacturers of medical devices for reporting injuries and deaths, as well as other problems associated with medical devices. The goal is to help detect and correct problems quickly as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Dr. Jeffrey Shuren, head of the FDA’s device division, said many high-profile device safety issues discovered at inspections of 17 hospitals – that should have been reported but were not – are in direct violation of the agency’s reporting requirements. Because of this discovery, the FDA believes such under-reporting is a nationwide problem.
The update to the guidance states that the “FDA believes that manufacturers have a responsibility to inform all employees, including marketing, sales, engineering, manufacturing, regulatory, legal, installation, and service personnel, to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports.”
At Terrell • Hogan, helping families recover from injury due to defective products, is what we do every day, but we know that it’s best to try to find ways to prevent injury and loss before they happen. So, until there’s a solution to this worrisome problem, Terrell • Hogan will continue to repeat information about recalls of defective and dangerous products to help keep you informed and safe.
If you or a loved one has suffered an injury due to a defective medical device, you may be entitled to compensation. Contact Terrell • Hogan at (904) 722-2228 for a complimentary consultation.
The new guidelines are in direct response to inspections at hospitals following high-profile safety issues on medical devices.
FDA Faults Hospitals For Failing To Report Safety Problems With Medical Devices