FDA overhauls approval process as medical devices come under fire
Posted November 27, 2018 5:24 p.m. EST
(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."
But there are limits to this "passive reporting" system, she said. "A lot of the time, there's under-reporting, and we don't necessarily get a real-time look at what's happening. So we're trying to switch to this active system that we call NEST."
NEST relies on real-world evidence, including anonymized information from insurance claims, patient registries, and electronic health records, Kotz said. Combing through this data, the FDA would be able to see, in real time, which devices might be causing problems.
Another important component of NEST is the Unique Device Identification system, in which devices are marked with a specific code and if a particular device, model or batch of medical devices malfunction or become contaminated, the FDA can pull it from the market.
NEST, if funded by Congress, will help the FDA in its efforts to monitor the general medical device industry, yet device therapies unique to women's health require additional surveillance systems, Gottlieb and Shuren said. They noted that "the President's budget for fiscal year 2019 includes a request for an additional $46 million" to support NEST.
Women's health in the spotlight
Therapies unique to women, including treatments for uterine fibroids, pelvic floor disorder, female sterilization and long-acting reversible contraception, will become the focus of the FDA, Gottlieb and Shuren said. To evaluate real-world data on the safety and performance of medical products, the FDA will strengthen its Coordinated Registry Networks and, separately, its National Breast Implant Registry.
"We've heard from patients who are concerned that their implants may be linked to other health conditions, like chronic fatigue, cognitive issues and muscle pain," Gottlieb and Shuren said.
Another FDA concern is the "growing number" of manufacturers marketing "vaginal rejuvenation" devices to treat conditions and symptoms related to menopause, urinary incontinence or sexual function.
Finally, the FDA will convene an advisory committee in February to discuss the safety and effectiveness of surgical mesh for transvaginal pelvic organ prolapse repair. The meeting will provide an opportunity for the agency to hear from the public about their experiences.
Kotz said the FDA is committed to modernizing its 510(k) approval process, the regulatory pathway undertaken by manufacturers submitting new devices to the agency.
"We're planning to finalize this guidance early next year and will rename this new approach the 'Safety and Performance-Based Pathway' to reflect its focus on advancing improved safety and performance of new products," Kotz said.
The FDA's overhaul of its approval process may be too late for many patients, according to the International Consortium of Investigative Journalists.
"If a drug goes wrong, patients can stop taking it. Many implanted devices are installed adjacent to vital organs or pressed against sensitive nerves, meaning removal may carry risks of serious injury or death," the consortium notes. "Nearly 500,000 reports over the last decade describe explant surgeries in connection with a medical device."
Cortez said the FDA's modernization program "looks like the agency is trying to turn 510(k) reviews into a more rigorous process. Although we've seen hints of this coming for a few years, the new programs are important."