Unfortunately, we can’t always count on manufacturers to take their products off the market or even notify consumers when they find a problem that could be dangerous. That’s why the federal government sometimes has to step in.
One would think that when it comes to defective medical devices, federal regulators would be especially vigilant. A recent article in the journal Health Affairs tells a very different story.
“Failing to meet the needs of public health”
Doctors who looked at the Food and Drug Administration’s (FDA) medical device recall system found that it’s “failing to meet the needs of public health amidst increasing consequential recall frequency and severity.” The process is overseen by the Government Accountability Office (GAO).
The doctors found that these failures have led to more adverse event reports and eventually to more Class I recalls which are reserved for the greatest level of urgency. If a recall has risen to the level of Class I, “there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
Key recommendations
The doctors made a number of recommendations to the GAO for improving the medical device recall system so that defective and dangerous products have less chance of being used. These include:
- Giving the FDA more authority to “identify safety concerns before device authorization.”
- Improving collaboration between the FDA and manufacturers in recalling products
- Minimizing “political pressure” on the FDA
If you or a loved one has suffered harm from a defective or otherwise dangerous medical device, it’s crucial to find out what your options are for seeking justice and compensation. Getting experienced legal guidance is a good way to start.