April 13, 2011
Thank you for the privilege of testifying at this important hearing. I am president of the National Research Center for Women & Families, a think tank dedicated to improving the health of adults and children. I am also testifying on behalf of our Cancer Prevention and Treatment Fund.
I was trained in epidemiology at Yale Med School, was a faculty member at Vassar and Yale, and a researcher at Harvard. I am a fellow at the University of Pennsylvania Center for Bioethics. My FDA expertise began as a committee staffer in Congress.
Today I will talk about our recently published study in the prestigious Archives of Internal Medicine.
We studied the recalls from 2005 to 2009 that FDA designated as the highest risk to patients because they can kill or permanently harm them. We found that most of those devices were not approved through the PMA process. They were cleared through the 510(k) process or exempt from review because they were thought to be such low risk.
GAO explained that FDA is ignoring the law when they clear high-risk devices through the 510(k) process.
I will explain how that harms patients.
There are 3 essential safeguards missing from the 510(k) process – that are in PMAs:
1. There are no clinical trials—testing on human patients.
2. Pre-market inspections are not required to make sure the device is made correctly
3. Post-market clinical trials or epidemiological studies are not required as a condition of approval.
Defenders of the status quo have said that what’s important is that less than 1% of device applications are later subject to a high-risk recall.
That might make sense from a business point of view, but not from the public health or policy points of view.
Americans are dying and being harmed because their devices were not tested in patients or inspected prior to sale.
As a scientist and logical person, I believe that if a device can kill you, it is not low-risk or moderate-risk. I’m not talking about lightning striking out of the blue. I’m talking about an implant that deteriorates inside the human body. Or a diagnostic test that is inaccurate. Those predictable life-threatening problems could be reduced.
We don’t celebrate every time we eat a meal that doesn’t poison us. We expect all our food to be safe, meal after meal, day after day. That’s why Congress improved food safety even though most foods were already safe. That will save lives. Improving how medical devices are tested will also save lives.
Devices are common. Those of us who wear contact lenses or hearing aids, or have a replacement hip or knee, or had LASIK or Botox, or use test strips for diabetes rely on medical devices every day.
More than 430 million devices were subject to high-risk recalls in just the first 6 months of 2010—more than one device for every man, woman, and child in the U.S.
It doesn’t make sense that standards for even the most innocuous drug-for constipation, for example—are more rigorous than for life-saving medical devices.
Mr. Hall’s analysis would not meet the standards of a peer-reviewed medical journal or even of the research methods course I’ve taught. I won’t go into details, which are in my written statement, but feel free to ask me about the flaws in his analysis.
There were almost 8,000 moderate risk recalls in the last 5 years – such as Katie’s hip. If you add those to 113 high-risk recalls, and divide by Mr. Hall’s estimated 20,000 submissions, devices would not have a 99% safety record—it would be 60%. If we use GAO’s lower number of recalls—almost 3,500—the safety record is still only about 82%. Moderate-risk recalled devices can result in death during surgery, and add billions to Medicare costs. That’s why we should include those recalls when we evaluate the safety record of the medical device approval and clearance processes.
We don’t know how many people die every year from unsafe medical devices. Hospitals are required to report deaths that might have resulted from medical devices, but doctors are not required to report them.
Even so, there were almost 5,000 reported deaths from medical devices in 2009, and hundreds of thousands of serious complications. These are the tip of the iceberg, because most doctors don’t report these adverse reactions to the FDA, even though medical facilities are required to do so.
In conclusion, lives could be saved and patients would spend less time in the hospital if FDA implemented the law as required. Billions of Medicare dollars could be saved.
The 510(k) process may be acceptable for devices that are truly low or moderate risk, but not for implanted devices or those that diagnose or treat potentially deadly diseases.