The government agency of the Food and Drug Administration (FDA) is meant to protect the public. They review a wide variety of products, from food products to medical devices, or even makeup, to make sure they are safe for public use.
If that is the case, many people might wonder why so many defective devices make it on to the market? That is a valid question to ask. However, new reports might lead to many more—and many different—questions about how the FDA works to protect the public.
Past issues with the FDA in product recalls coming to light
Kaiser Health News recently reported about an issue with a defective medical device back in the early 2000s. The Sprint Fidelis was a heart device meant to give an electric shock that would regulate a heart’s rhythm. The product was recalled in 2007 because of two dangers, including:
- Issuing random electric shocks
- Failing to jolt when the patient needed it
These kinds of malfunctions are dangerous, but unfortunately common.
However, the article reports that the FDA has an alternative reporting program outside of the public eye. And that alternative program held more than 50,000 reports of malfunctions and serious incidents involving the Sprint Fidelis device.
Hidden reports and exemptions for negligent manufacturers?
According to the Kaiser Health News article, the FDA purposefully took measures to hide this important information. They did this by giving the manufacturer, Medtronic, an exemption to file reports out of the public eye.
The Sprint Fidelis device has been linked to serious injuries, heart failure and even fatalities. And while the fatal incident reports are public, many other relevant reports are not.
There are also apparently many more incidents of defective devices besides the Sprint Fidelis reports in this program that the public does not know.
Concerning loopholes in the FDA’s processes
The existence of an alternative reporting program is clearly a loophole in the recall process. However, many also voice their concerns over the FDA’s approval process as well. The 501(k) process requires new products to pass a clearance test. But many medical experts worry that the testing process is not extensive enough to prove a product’s safety.
The FDA states that its mission is to protect public health. Yet, there seems to be a significant inconsistency with that mission. If the FDA continues to give manufacturers an exemption for products proven to be harmful, then they could risk losing the trust of the public they claim to protect.