The Safety Gap: Device Dangers

By Karen Abernathy - bio | email

From defibrillators to pacemakers, some experts say too many mistakes are making it to market.

There are close to 24,000 companies across the globe manufacturing medical devices -- devices that help people live longer, healthier lives. New advances are made every day that lead to even more lifesaving technology. But while there's no doubt countless numbers of lives have been helped with these devices, a group of scientists in charge of inspecting these products say a stamp of approval by the FDA doesn't always mean it's safe.

Pam Alexson was surfing the web when an alert popped up about a device she was counting on.

"I was so afraid. I was absolutely beside myself."

The alert was a recall of the defibrillator she depends on to keep her heart beating.

"It said this young boy, 21-years-old from California, had died."

She scheduled surgery to have hers replaced. She still worries about the FDA approval process.

"We're dealing with human beings. We're not dealing with animals."

Dr. Ned Feder is an Investigator with the Project on Government Oversight in Washington, D.C.

"The top officials in the devices center decided sometime within the last two or three years that they were going to stop doing inspections."

A group of nine FDA scientists sent a series of letters to federal lawmakers. They accuse FDA leaders of intimidation and discouraging others from raising safety concerns about devices going to market. They wrote the review process has been "corrupted and distorted by current FDA managers, thereby placing the American public at risk."

Feder said, "They see these devices going on the market that aren't adequately tested, and their supervisors are saying to them, 'No, we should not take action.'"

Tim Wells knows the FDA inspection process inside and out.

"I had a 24-year career with the FDA. I started as a field investigator. They've always been short of resources the whole 24 years I was there. We were always behind, but trying to keep up."

Steve Grossman, President of  the Alliance for a Stronger FDA in Silver Spring, Maryland said,  "The reality is the agency is going to need large increases for a number of years to catch up with the work that they need to do."

FDA supporters argue scarce resources make it impossible for the agency to keep up with the exploding foreign device market. Of the nearly 700 manufacturing plants in china, the FDA inspected only 13 in 2007.

"It's not like we're buying t-shirts made in China. What can happen? You throw it away, big deal. But we're talking about life-sustaining products here," Wells said.

Pam is depending on one of those life-sustaining products to keep her heart beating.

"There are no do-overs. You go into fatal arrhythmia. If you don't have the device, you're gonna die."

In a recent follow-up letter, FDA scientists pleaded with President Obama to revisit the approval process of medical devices. An FDA-wide email in March promised the that the new FDA commissioner will revitalize the agency and work hard to support scientific integrity.

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