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Friday, July 29, 2011

Report calls for overhaul in testing medical devices

When your surgeon uses a new tool to perform an operation, or when you get an artificial hip to replace your old, arthritic one, you’d like to know that device was safe, wouldn’t you?

Unfortunately, because of a loophole in the law, the Food and Drug Administration doesn’t test 90 percent of new devices in 2009, according to a story by Christine Mai-Duc of the Chicago Tribune. A report by the Institute of Medicine, an arm of the National Academy of Sciences, said the system needs to be overhauled.

According to Mai-Duc, “more than 90,000 artificial hips were recalled last summer after studies showed that about one in eight recipients needed to have them replaced. The hips, manufactured by a subsidiary of Johnson & Johnson, were found to release small metallic particles into patients’ bloodstreams over time.”

The problem is that the law that gave the FDA authority to test new medical devices, passed in 1976, grandfathered in many devices that already existed and allowed an expedited process for devices that are similar to those old devices.

Independent organizations such as the ECRI Institute outside Philadelphia test devices for safety and effectiveness, but they have no authority to stop an unsafe device from going to market; they can just warn the FDA.

Read the full story and read a summary of the report here.


Medical Devices and the Public's Health


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