In order to get a new implantable heart device on the market, manufacturers must undergo an extremely rigorous approval process conducted by the US Food and Drug Administration; this helps ensure that the pacemaker or defibrillator implanted in a person’s heart doesn’t misfire or stop working altogether.
But most devices now approved to be implanted in patients have gone through a much speedier “supplement” review because they’re considered to be upgraded versions of older devices with just minor modifications, according to a new study conducted by Brigham and Women’s Hospital researchers.
The research, published Tuesday in the Journal of the American Medical Association, found that the FDA approved 77 applications for new cardiac implantable electronic devices and 5,829 supplements for updated devices from 1979 to 2012, which means 50 updated devices were approved for every new one.
What troubled the researchers most, however, was that 37 percent of the approved supplements involved a change to the device’s design, and many were approved without any clinical data to show that the new design was safe and effective.
Two years ago, the FDA issued a recall for electrical leads used in certain Riata defibrillators because the leads’ insulation wore out too quickly, causing the device to malfunction. The recalled leads were approved via the speedier supplement review, said study author Dr. Aaron Kesselheim, an assistant professor of medicine at Brigham and Women’s.
“We didn’t look in our study at whether devices approved under a supplement review were more likely to be withdrawn from the market,” Kesselheim said. “But we wanted to educate patients and physicians to the fact that this approval exists and is commonly used in devices with design changes.”
While the faster review enables the latest upgrades in medical device technology to reach patients more quickly, Kesselheim said it could also increase the possibility of safety risks. He urged doctors implanting devices with supplement approval to ask the company manufacturer whether clinical data was collected before it was approved. Patients getting the latest pacemaker or defibrillator may want to inquire as well.