FDA tries to put untested heart device on the market
Once again, the FDA is up to its old tricks. But this time, I’m not the only one calling them out. The federal agency is about to put its stamp of approval on a new electrical component for implantable heart devices – before adequate testing has been done and before they know of the potential risks.
Don’t be too surprised… after all, the amount of testing needed to prove the safety (or harm) of this device would cost precious time and money. And no one seems eager to expend either if they can get around it.
Dr. Robert G. Hauser, a cardiologist from the prestigious Minneapolis Heart Institute, says the makers of this new defibrillator wiring technology should conduct clinical trials to ensure that the wires won’t short circuit – a problem that would be deadly. After all, if the defibrillator can’t fire, it can’t deliver the electrical jolt needed to put an abnormal heartbeat back on track.
The FDA contends that the new wiring is merely a modification of an existing design, and not a new technology that requires human testing. This doesn’t wash with me: the key word here is “new.” If it’s a new modification, it hasn’t been proven. So it therefore requires SOME form of clinical trial.
This wiring should be held to the same standard the FDA claims it holds all pharmaceutical and medical manufacturing companies. It’s hardly an unreasonable request.
In typical FDA fashion, agency officials say they will require the companies to “carefully monitor the new units performance in people once the devices go on sale.” A heck of a lot of good that’s going to do. If the devices suddenly start to fail at that point, it’s going to cost many patients their lives…
“Let’s test it first, before we put it into tens of thousands of people,” Dr. Hauser said, noting that it will be incredibly difficult to address any design problems once the devices are implanted in patients nationwide.
Dr. Hauser is right on the money. The technology for implantable heart devices just isn’t up to snuff just yet, and truth be told, these devices are just as fallible and prone to failure as a hair dryer or electric razor.
It’s worth noting that Dr. Hauser has been correct about his suspicions regarding flawed heart devices in the past. It was Hauser who raised concerns about another Medtronic electrical defibrillator lead called Fidelis. The Fidelis leads were ultimately recalled for failing at a catastrophically high rate, and many of the 235,000 patients who’d been implanted with the leads had to undergo procedures to have them replaced.
Unfortunately, it seems the FDA has no interest in keeping history from repeating itself.
