Faulty Medical Devices Part II: Reforms on the Horizon
In our previous blog, we examined a report from the United States Food and Drug Administration (FDA) which indicates faulty medical devices have played a role in 83,000 deaths and 1.7 million injuries worldwide in the last 10 years. In that piece, we also looked at promises from the FDA to revise and improve the approval process for surgical implants and other medical technology.
The Scope of the Problem
According to Fortune Magazine, the FDA is poised to overhaul the current system used to approve surgical implants and medical devices before they are released to the market. The existing system—with few clinical trials and limited centrally held evidence—has failed to detect problems in many medical devices in circulation and led to many patient injuries.
For reference, the International Consortium of Investigative Journalists (ICIJ) has published a searchable database of 70,000 device notices, alerts, and recalls so patients can view the safety records of particular devices.
The Current System
The existing approval system depends heavily on a new device’s similarity to older, existing technology. An overhaul of the process will place a stronger emphasis on clinical testing. With a new process in place, the FDA hopes to create “a more robust medical device safety net for patients through better data,” adding: “Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market.”
The Intended Overhaul
Almost 20% of medical devices in current use are based on technology that is over 10 years old. With a revised approval process, the FDA hopes to encourage device manufacturers to develop emerging products based on technologies 10 years old or less—and may publish a list of medical devices based on older technologies in the name of consumer safety. FDA authorities emphasize the need to incorporate new and better technology, hoping device makers can manufacture surgical implants and medical devices which are safer and more effective.
Graves McLain is Here to Help
If you or a loved one has been injured by a Dangerous Drug or Defective Medical Device, call Graves McLain right away at 918-359-6600 or fill out a free consultation form online. When you call one of our experienced Tulsa, Oklahoma Product Liability Attorneys, we will speak with you for FREE and determine the best course of action.
We review every detail of your situation at no cost to you—and fight hard to protect your rights. Trust our team, we are here to help. At Graves McLain, you will never pay an attorney’s fee up front—and you owe us nothing until we win your case. At Graves McLain, we don’t get paid until you do.
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