Consumer Reports advises patients to do their homework before having medical devices implanted in their bodies. Companies that sell defibrillators, stents or other such products can get approval from the Food and Drug Administration without their undergoing rigorous testing, Consumer Reports warned in a new report.
The FDA collects information on medical device malfunctions that lead to death. Data highlighted by Consumer Reports show 686 deaths from 2009 to last year connected to automated external defibrillators, such as the ones found at airport or sports stadiums. The FDA recalled 41 devices last year. One device listed was a ventilator used to support breathing.
[Consumer Reports recommends that people look up individual medical devices on the FDA website, ask about alternative medical procedures and write down a serial number for the device.]
The problem, according to Consumer Reports, is that the companies exploit a loophole in the law that allows them to submit new products to the FDA for instant review as long as they classify them as an upgrade even if the product has changes that could affect safety. Companies now use the process 90 percent of the time, according to a report published by Rep. Ed Markey, D-Mass., who is an advocate for industry reform.
In response to the Consumer Reports investigation, the FDA said in a statement, "Medical device safety is critical to protecting the public health but there is a potential risk with any drug or medical device, from aspirin to heart valves. The FDA weighs the benefits and risks of every medical device we review."
Companies have long argued that the instant testing procedure is not only good for business but encourages innovation. When new devices get on the market sooner rather than later, they argue, companies have more money to upgrade existing products.
But Consumer Reports argues that such an approach allows untested devices to reach the market.
"The amount of devices that we have are going up dramatically and the complexity of the devices is also going up dramatically," said Dr. Robert Klitzman, a professor of clinical psychiatry and bio-ethicist at Columbia University in New York City.
Medical device studies are also inherently more complicated than traditional drug trials.
When a doctor implants an experimental device, the patients is required to go under the knife. Removing a faulty device is more complicated than throwing away a pill bottle.
"They can't just take it off if it's embedded in their body and there are risks of going in to remove it," Klitzman said.
The FDA has the power to regulate the medical device industry but the agency is required by law to give medical device companies a pass until serious problems begin to surface.
"The FDA does not have clear authority to reject a 510(k) device application even in cases where the company is claiming that their product is similar to one that has fundamental design flaws," said Markey, who is pushing for a bill to grant the FDA such authority.
The gridlock in Washington has made it difficult for lawmakers like Markey to muster enough votes to ensure its passage.
But some people have stepped forward in other ways. The Washington Post reported in January that FDA whistle-blowers leaked information to congressional staffers sometime in 2009 that warned of a potentially unsafe cancer screening device that was receiving government approval.
Those employees former employees have filed suit against the FDA, alleging that supervisors spied on their work computers and used that information to harass and fire them. The FDA has not commented.