Lifesaving devices need to work, and they need to undergo clinical trial scrutiny. And doctors and hospitals need to pay attention, and get upset and even angry when their patients get harmed by them. Yes, doctors want to provide their patients with the next best thing. And no one wants to tamp innovation; but safety should be a greater concern.
In a phone interview this week, I asked Nissen if it's all the FDA's fault, or whether physicians and hospitals should bear some responsibility for letting these products slip through the cracks.
"There's lots of blame to go around," he says. He and his co-authors put some of the blame on AdvaMed, the manufacturers' advocacy group, for successfully blocking recent efforts to strengthen FDA's purview over these devices. FDA wanted to require clinical trials in more 510(k) reviews, have more premarket inspections and postmarket studies. But "AdvaMed, the largest association representing medical device manufacturers, opposes these changes," Nissen and his co-authors wrote.
Nissen also blames physicians who design and test these devices, and then own a share of the stock, as well as the doctors who flock to use the latest new thing, knowing it didn't have to go through a clinical trial and may not yet be totally safe.