FDA overhauls approval process as medical devices come under fire

"The FDA regulates more than 190,000 different devices," Commissioner Dr. Scott Gottlieb notes.

(CNN)As the US Food and Drug Administration publicizes its plans to overhaul the process for manufacturers that want to market medical devices in the United States, a year-long investigation by a nonprofit newsroom is reporting more than 80,000 deaths potentially linked to medical implants since 2008.

Despite the timing, the FDA denies any connection between its communications and the report from the International Consortium of Investigative Journalists.
"We didn't even know about what the ICIJ was doing until early October," FDA spokeswoman Deborah Kotz said Tuesday. She added that the agency issued its Medical Device Safety Action Plan in April, laying out what it has done and what new steps it plans to take to enhance device safety.
    "These actions are things that we've been working on for quite a while," Kotz said.
    Still, the concurrent release of information from the government regulator and the investigative team highlights the many challenges and missteps related to patient safety.

    Thousands of devices

    "The FDA regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide," FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren, director of the agency's Center for Devices and Radiological Health, said in a statement last week announcing the agency's plans. "On average, we approve, clear or grant marketing authorization to approximately 12 new or modified devices every business day after carefully determining -- based on valid scientific evidence -- that the devices are safe and effective."
    Meanwhile, the journalism collaboration, which included more than 250 journalists based in 36 countries, examined more than 8 million device-related health records, including death and injury reports. Called the "Implant Files," the extensive analysis of pacemakers, insulin pumps, breast implants, spinal cord stimulators and other surgically embedded appliances and materials found nearly 83,000 deaths and more than 1.7 million injuries possibly linked to medical devices and reported in the United States alone since 2008.
    Over the past decade, manufacturers have also paid out at least $1.6 billion to settle charges of regulatory violations, including corruption and fraud, around the world, according to the consortium, which published its analysis Sunday.
    "Patients around the world have become unwitting test subjects for new medical technology," the consortium said. "Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants."
    Nathan Cortez, a professor and associate dean for research at Southern Methodist University Law School, explained that "the process for FDA to review medical devices was established by Congress in 1976." He noted that in the 42 years since, "a lot of new medical devices" have been introduced into the US market.
    "What the general public probably doesn't understand is that many medical devices allowed on the market haven't received much in-depth scrutiny from the FDA," Cortez, who was not involved in the consortium's work or the FDA's plans, wrote in an email. "Some have; but most haven't.
    "For well over a decade, the FDA has had to listen to critiques from the Institute of Medicine (now the National Academy of Medicine), as well as academics, members of Congress, and manufacturers," he wrote.
    What is the FDA, tasked only with protecting American patients, doing to improve its own performance?
    A big element of its plan is "trying to implement a more active surveillance system to learn more about medical device problems," Kotz said. This system is known as NEST, the National Evaluation System for health Technology.

    FDA wants an active not passive surveillance capability

    Frequently, the FDA learns about device risk through the existing passive reporting system, by which doctors, hospitals, manufacturers and patients can post problems to an agency database, according to Kotz. "We analyze those, and if we see a signal, we can take action: We can ask the company to do a recall; we can issue a change of labeling, a safety communication."