Indiana Accident News

Study: Many Defective Medical Devices Not Properly Tested By FDA

Is the medical device your doctor is using on you defective? Has your medical implant or medical device been properly tested for safety and vetted by the Food & Drug Administration (FDA) before it was put on the market? According to a new study published by the Archives of Internal Medicine, the FDA does not do nearly enough to protect patients from dangerous or defective medical devices.

The heart of the problem, researchers found, is that there are two different processes for approval at the FDA: one rigorous process that thoroughly tests a medical device and one much less rigorous process that is used to quickly approve “low-risk” devices. When the less rigorous and less expensive process is used, the study found, the device is much more likely to be involved in a defective product recall and more likely to cause long-term damage to patients.

For example, of the 113 defective medical device recalls by the FDA in the last five years, 71 percent of the products had been approved through the easier, cheaper 510(k) process that does not involve thorough testing or inspections. In contrast less than 20 percent of recalls had been vetted by the premarket approval (PMA) process that involves clinical tests and a close examination of the factory.

Usually, the FDA chooses the 510(k) process for approved medical devices that have undergone small changes, such as products that are being made by different companies or products that are being made with different materials.

The bottom line? The FDA is putting dangerous products on the market by failing to properly test and scrutinize products – just because they believe that those products probably don’t poise a risk to the public. The result is hundreds of recalled medical products and dozens of injured patients.

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