Broad implications of device recalls

Imagine this scenario… You’ve been told you need an implantable defibrillator or pacemaker, you decide that the benefits outweigh the risks, and you have the device implanted. Hundreds of thousands of patients have made this exact decision. Then you’re told that there is a small chance of the device malfunctioning and you may need to have it replaced. However, the replacement itself can cause life-threatening complications.

According to the Wall Street Journal (A Hard Choice for Heart Patients)

Nearly 200,000 heart patients depend on the devices affected by this year’s announcements [of device recalls by Medtronic and Guidant]… A number of heart-rhythm specialists say their assessment suggests that device replacement may pose the greater danger than leaving it in, for many patients. They note that four people are known to have died from malfunctions of defibrillators from Indianapolis-based Guidant. The recent failures of Guidant devices are occurring at rates the company has estimated at between 1 in 400 and 1 in 20,000, depending on the model.]

Defective defibrillators and pacemakers cause lots of trouble. First, the device itself could malfunction. Second, people could face serious complications (possibly even death) having devices replaced. Third, candidate patients may avoid implanting these devices and possibly die from that. Fourth, people with these devices (and their relatives) worry significantly about something that has low probability of occurring.

Experts say that these devices are more likely to save your life than to malfunction. However, when I read the actual FDA message on one of the Guidant device recalls, it says:

The malfunction that is the subject of the recall causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail.

I ask myself how this can be prevented in the first place and how to deal with the problem now that it has been identified. I don’t have any easy answers for how this can be prevented. Clearly, there are no certainties with technology, and the device approval process is highly regulated already. However, I do think that the problem should be addressed by a physician providing comprehensive patient education fully describing the benefits/risks substantiated with evidence-based research and letting each patient make their own decision.

October 13, 2005

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