A defective medical device could lead to serious health issues. Complications caused by a defective device could lead to costly medical bills, lost wages, emotional distress, and decreased quality of life. Read on to learn more about medical device recalls. How the Food and Drug Administration handles defective device claims, and what you should do if you’ve been hurt.
Medical device recalls
The FDA lists all recalled medical devices on its website. They include devices as common as catheters and as sophisticated as 3D brain imaging software to assist surgeons in guiding their instruments.
In the case of the brain imaging software, it was on the market from 2011 to 2018. But was only recalled in January 2019. It was a Class 1 recall, the most dangerous type, which could lead to death or serious injury. The brain software was used for at least eight years before being recalled. Numerous patients could be harmed or even killed due to the faulty device. Which inaccurately depicted the exact location of a surgeon’s tool. That may lead to accidental damage to brain tissue.
The FDA’s 510(k) process
You might wonder how medical devices are often defective or don’t achieve their intended purpose. This is partly because of the FDA’s 510(k) process. According to the FDA, “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective. Additionally, one that is substantially equivalent to a legally marketed device that is not subject to PMA (Premarket Approval).” This means that new medical devices can be approved expedited if the manufacturer can prove that it is similar enough to a previous one that was already approved.
According to CNBC, the FDA approved 3,173 devices through this system, 82% of which were cleared. The FDA claims they have plans to overhaul the system so that devices older than ten years cannot be used as predicates. Those are the legal devices used to demonstrate that the new one is substantially equivalent to it.
What to do if a medical device injures you
If a defective medical device has injured you, please get in touch with the experienced product defects attorneys at Hach & Rose, LLP. Call us at (212) 779-0057 to schedule a free, no-obligation consultation to discuss how we can help you.