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Implantable Heart Devices

Man-made heart attacks

Bargain-basement heart-helpers?

We've been tinkering with the human heart for decades. From transplantation with pig and baboon hearts to artificial hearts to all sorts of other contraptions like pacemakers and defibrillators, we just can't seem to leave our most important organ alone.

With a few notable exceptions (pacemakers do help a lot of folks live better), much of this monkeying around has been for nothing. Dr. Moreau-type experiments with the hearts of various animals have all met with eventual failure or rejection of the organ, I'm almost certain. And despite the medical industry's high hopes, artificial hearts (like the Jarvik, AbioCor, and others) have experienced only temporary success, at best a bridge measure before heart transplantation.

But as unfortunate as it is that the implantable heart devices we've developed aren't up to snuff (yet), with the ultimate advent of such devices, we'll all then be at the mercy of quality-control bean counters and corporate liability actuaries. We won't have the best hearts money can buy, we'll have the absolute cheapest hearts they can cobble together to meet some not-yet-established arbitrary standard - with parts made in China, Sri-Lanka, or Bangladesh. That's the way of the world. Just look at the automobile, home electronics, or drug businesses and you'll see what I mean.

These kinds of corner-cutting decisions are already being made in what relatively limited technology we have. According to a New York Times report from last month, the maker of a popular implantable heart defibrillator continued to sell old inventory of the devices even after it had made an improvement to eliminate a design flaw in the machine's electrical system. That's right: They sold defibrillators they knew were flawed even after they'd come out with a more reliable, improved model in mid-2002. A certain number of people are walking around out there with these things in their chests right now, and all because the manufacturer didn't want to eat any obsolete inventory.

Naturally, the FDA has promised to review the data, the company, and the defibrillators themselves to determine if any further regulatory or punitive actions are warranted. And of course, the device's makers claim they sold the remaining models of the old design because they're still a "highly reliable life-saving product," according to the Times piece. They also claim that the most current data support the reliability of the machines.

But doesn't this sound a lot like what drug makers say when one of their medications is found to be hazardous? I, for one, don't like the idea that manufacturers of anything that we're putting in our bodies (either in our mouths or sewn into our chests), can be given to us once it's found to be flawed, hazardous, or anything less than as good as science can make it. But that's just me.

And speaking of snafus with heart-assisting machines…

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Checking up = Checking out?

I listed pacemakers above as one of medicine's relatively successful heart-helping experiments. But you still have to TURN THEM ON.

According to a recent Reuters report, a doctor in Finland was fined (not de-licensed?) after forgetting to restart one of his heart patient's pacemakers following a routine check-up. The man later died as a result, court sources said.

The doctor was convicted of involuntary manslaughter and breach of duty, before being fined the Euro equivalent of around $2700. Wow, isn't that getting off a little light? No mention was made in the article about whether or not the victim's family is suing in the Finnish equivalent of a civil court or not.

I know I spend a lot of time talking about limiting malpractice awards and all, but any doctor who's that negligent should get more than a slap-on-the-wrist fine. If word gets out about this, that "Doctor Death" I wrote about last month (Daily Dose, 6/24) - the one who has been linked to the deaths of 7% of his patients - might open up shop there soon.

He's still at large, you know…

Finnish-ing what the mainstream starts (or doesn't start),

 William Campbell Douglass II, MD

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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