Here’s another similarity between medical devices and cars: both can have recalls. This weekend, tens of thousands of patients with Guidant defibrillators (such as the Ventak Prism 2 DR) were informed that their devices could short-circuit. From the New York Times:
Several people with Guidant units said that when they heard about the troubled implants they reached into their wallets and pulled out a card that identifies the make and model of the device they carry inside. For those who found a match, the feeling was quick and sinking.
“My first reaction was a little bit of panic,” Mr. Parsons said.
The surgery to replace a defibrillator, which is the size of a pager and is implanted under the skin of the upper chest near the shoulder, takes an hour, and many people go home immediately afterwards. Full recovery takes about 7 to 10 days. But like any surgical procedure, the surgery carries a risk of infection.
For many, the risk of surgery and infection outweighs the potential for catastrophic failure. But it’s an unpleasant choice to have to make. And this Guidant situation is unusual because the company knew about the defect but didn’t disclose it — thousands of faulty devices were knowingly sold and implanted.
More at Guidant… and the FDA…
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