Our dependence on medical devices keeps 24,000 companies afloat across the globe, but who's keeping watch over their life-sustaining products?
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Melissa: Pam Alexson was surfing the web when an alert popped up. Pam Alexson: I was so afraid. I was just absolutely beside my self. Melissa: A recall of the defibrillator she depends on to keep her heart beating. Pam Alexson: It said that this young boy, 21 years old in California had died. Melissa: She scheduled surgery to have hers replaced. Pam Alexson: We’re dealing with human beings. We’re not dealing with animals. Ned Feder: The top officials in the devices center decided sometime within the last two or three years that they were going to stop doing inspections. Melissa: A group of nine FDA scientists sent a series of letters to federal lawmakers. They accused 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. They’re by placing the American public at risk. Ned Feder: They see these devices going on the market that are not adequately tested. Their supervisors are saying to them, “No. We should not take action.” Tim Wells: I had a 24-year career with FDA. I started as a field investigator. Melissa: Tim Wells knows the FDA inspection process inside and out. Tim Wells: They’ve always been short of resources the whole 24 years I was there. Steve Grossman: The reality is that the agency is going to need large increases for a number of years to catch up with the work that they need to. Melissa: 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. Tim Wells: It’s like we’re buying T shirts made in China. What can happen? You throw it away. Big deal. But we’re talking about maybe life sustaining products here. Melissa: Pam depends on one of those products to keep her heart beating. Pam Alexson: There are no do overs. If you go into fatal arrhythmia and you don’t have the device, you’re going to die. Melissa: She just wants to be assured her heart is in good hands. I’m Melissa Medalie reporting.