Unlike other countries, the United States has no way to monitor medical devices after they are approved and used or implanted in patients. It is sort of the Wild West out there. When a medical device is defective and injures a patient, the patient, her doctor or lawyer have the option to make an adverse event report with the Food and Drug Administration (FDA) which may or may not ever be seen.
The FDA has a head-in-the sand approach to actually taking the data seriously and looking for any trends that the device is not working as marketed. Instead, the agency is hands-off and relies on the manufacturer’s integrity when it comes to about 90 percent of the medical devices used in this country.
With the perfect storm of a watchdog agency has few or no requirements for safety and efficacy, little follow up once the device is sold, and reliance on the questionable ethics of some of our global healthcare and device providers, it is no wonder that profit-driven medicine is putting products before patients and leaving behind thousands permanently injured by metal hips, annuloplasty rings, heart defibrillators and surgical mesh, among other devices.
There is a little good news. The FDA may be moving one step closer to actually keeping track of devices after they are sold.
The Office of Management and Budget (OMB) is now reviewing a proposed and final FDA rule that would establish a unique device identification system or UDI attached to each device. It’s been tried several times over the years unsuccessfully. Under the proposed plan, the agency could electronically track medical devices. The necessary information would be contained in the label and device packaging making it easier to spot defective devices that are harming patients and recall them much faster. Additionally, the UDI information would be directly marked on an implanted medical device just in case the packaging is lost over time.
All of the medical device information would be included in a publicly available database. In the event of an adverse event, such as the DePuy metal-on-metal hip that began to fail soon after it was introduced, failure trends could be identified earlier rather than later. That is what happened in Australia, which used its device registry to determine early revision or failure rates for the DePuy years ahead of the U.S. No doubt thousands of patients were saved from a hip implant gone bad.
The code would include the make, manufacturer and lot number and would be implemented over the next several years, depending on the device.
The rule was posted in the Federal Register a year ago. The review by the OMB is the final stage before becoming an official FDA rule. The UDI requirement would be added to the Federal Food, Drug, and Cosmetic Act.