A Conversation I Never Want to Have

Mr. Smith, welcome back to the real world!

Did you know that your heart stopped earlier today, but thanks to your friendly neighborhood paramedic and a handy-dandy AED, we got it going again?

Amazing, huh?

We've done an extensive evaluation of your medical condition, Mr. Smith, and we think you need to have and ICD implanted.

What's that? Oh, an "ICD" is short for a implantable cardioverter defibrillator. It's a little device we implant under your skin that is attached to special wires we place in your heart that monitors your heart rhythm, so that should this happen again, the device can automatically detect, charge, and shock your heart back to normal rhythm lickety split.

Sound good? Great!

Now, a few things I need to ask you: we have three main manufacturers that make these devices here in the US: Medtronic, Boston Scientific, and St. Jude Medical. If those don't sound good, you can alternatively have us special-order you a device from Germany called a Biotronik device. It might cost you a bit more and I'm not sure there will always be a rep available to help check the device, but hey, we want to keep you well informed about ALL possibilities. Any preference?

What's that you say, you're not sure? Well, here's some more information:

The safety record for each of these manufacturers has been pretty good, but once in a while there have been some problems with recalls of leads and batteries of these devices. When this happens, believe it or not these suckers can explode inside your chest with lots of great big shocks and maybe even kill you. I'm not kidding. Really. Now admittedly this happens infrequently, but hey, I just want you to know about this. We want you informed. There's even legal action pending against all of the manufacturers. Did you know this? Now the FDA has all kinds of requirements that they make these device companies jump through, but you know, they've been a bit short-staffed lately. But they're getting stricker now. I mean they check everything now - heck new products? Well, they're still checking out the old ones. Oh, and those overseas plants that make parts? Well the FDA has to keep checking those too.

How often are there problems? Well, I'm so glad you asked!

Here's the manufacturers' published safety statistics for Boston Scientific, Medtronic, St. Jude. Study this information carefully. I really don't want you making the wrong decision! What's that you say? You're not sure if you should have one? But the data are so CLEAR!

Oh well, that's your decision, Mr. Smith. Never mind that you saw God earlier today.

Hey, at least I feel good you're now COMPLETELY informed!

* * *
It's easy to criticize our current system of checks and balances for medical device safety, as William H. Maisel, MD, MPH does so well in the New England Journal of Medicine this week. And while he makes some good points about the need for consideration of better overview of pre-release testing of new devices to the market, can we really expect that patients can understand all of the implications of ICD type, safety information, and implications for their care just after they've suffered an episode of aborted sudden death?

With remarkable failure to acknowledge efforts by the FDA, Heart Rhythm Society, and manufacturers already underway to improve post-market performance evaluations, he writes:

According to its mission statement, the FDA is "responsible for protecting the public health" and for "helping the public get the accurate, science-based information they need." Unfortunately, the agency is failing to fulfill that mission. In 1998, the Advisory Commission on Consumer Protection and Quality in the Health Care Industry adopted a Patients' Bill of Rights whose primary tenet is that patients have "the right to receive accurate, easily understood information to assist them in making informed decisions." Regrettably, patients considering implantation of medical devices often fail to receive critical information on device safety.

Should patients be faced with all available safety information when they present as the fictional patient above does? And what about the product performance report references that are already published, updated quarterly, and available on the web? Should they be given the opportunity to scour these data before signing their surgical consents? Should the data be updated weekly? Will patients be able to understand these data and the nuances of the recalls underway? How much more "safety data" will patient's need to absorb to meet Dr. Maisel's expectations for full "disclosure?"

Certainly, we should always strive for improved patient safety. But to suggest that efforts are not underway to assure timely reporting of post-market performance analysis flies in the face of the many countless individuals who have devoted huge personal effort and resources to continually improve this endeavor.

Maybe, just maybe, we should empower the doctors to present the data to the patient, rather than impose more governmental regulation.

No. I forgot.

In the medicine of today, bureaucracy always wins.

-Wes