The Safety Gap: Dangerous Devices

WASHINGTON, D.C. (Ivanhoe Newswire) -- 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 -- many that help people live longer, healthier lives. But a group of scientists in charge of inspecting these life-saving products say a stamp of approval by the FDA doesn't mean it's safe.

Pam Alexson was surfing the Web when an alert popped up.

"I was so afraid," Alexson told Ivanhoe. "I was absolutely beside myself."

It 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," Alexson said. "He had a defibrillator, and that was the number and that was the type."

She scheduled surgery to have hers replaced.

"I said to myself, 'What if it's another bad device? What if it's another one that's not going to work right?'" Alexson said. "It could happen again."

Alexson's problems aren't over. The electrical cable that connects to her heart is the focus of another investigation. It has been linked to at least 13 deaths and 2,200 injuries.

"We're dealing with human beings," Alexson said. We're not dealing with animals. We're not dealing with inanimate objects. We're dealing with human beings."

She is furious life and death mistakes are slipping through the cracks … and she's not alone.

"The top officials in the devices center decided sometime within the last two or three years that they were going to stop doing inspections," Ned Feder, M.D., an investigator for Project on Government Oversight in Washingon, D.C., told Ivanhoe.

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."

"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," Dr. Feder said.

Dr. Feder says the letter proves fear is fueling the approval of some medical devices.

"They see the details of these devices, and they know very directly what the consequences are when these devices fail," Dr. Feder said.

In April, another letter from FDA scientists to the administration went out. They write about a breast cancer detection device approved despite FDA experts' recommendations against it, a knee implant device approved without proper screening and an anti-scarring device approved even though a similar device was pulled from the market for safety concerns.

"They've got to get on the market as fast as possible, and while it's on the market, they have to put the hard sell as much as possible," Peter Lurie, M.D., Deputy Director of Public Citizen's Health Research Group, told Ivanhoe. "If it turns out it's for some use the product doesn't even work, well, that doesn't make any difference. A dollar is a dollar."

The Government Accountability Office reported the FDA approved 228 medical devices without full complete evaluation of their safety and effectiveness from 2003 to 2007. The report found most devices are given quick approvals with minimal testing because manufacturers claim the products operate just like older devices that are already cleared.

"I had a 24-year career with the FDA," former FDA inspector Tim Wells told Ivanhoe. "I started as a field investigator."

Wells knows the FDA inspection process inside and out.

"They've always been short of resources the whole 24 years I was there," Wells said. "We were always behind but trying to keep up."

What makes it different now? Over the past 12 years, nearly 60 new laws have hit the books that need the FDA's oversight -- and funding hasn't kept up with the demand.

"I think public health is way too important to be cutting back resources," Wells 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," Steve Grossman, President of the Alliance for a Stronger FDA in Silver Spring, Md., told Ivanhoe.

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," Wells said. "You throw it away, big deal, but we're talking about life-sustaining products here."

Alexon depends on one of those products to keep her heart beating.

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

She doesn't care about funding problems or foreign inspections.

"It's about valuing human life," Alexson said. "We're all valuable."

She just wants to be assured her heart is in good hands.

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

More Information

If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Melissa Medalie at mmedalie@ivanhoe.com.

FOR MORE INFORMATION, PLEASE CONTACT:

Project on Government Oversight
(202) 347-1122
http://www.pogo.org