Someone Needs A Mental Defibrillator

The Food and Drug Administration is considering not using the word “recall” to warn patients and doctors about defective pacemakers and defibrillators at the request of a physicians’ group struggling to deal with a loss of public confidence in the safety of implantable heart devices.

FDA officials say they are conducting focus groups to see whether the currently used “recall” term is causing undue alarm when used to refer to heart devices the agency has decided might be faulty.

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The Heart Rhythm Society released guidelines today, asking the FDA to use “safety advisory” or “safety alert” when referring to device problems.

If your pacemaker or defibrillator is defective, does it really matter what “term” they use? Honestly. People should know what’s happening with the devices in their chests. If the FDA finds a brand of devices faulty, wouldn’t it be prudent to to just say so?

Why would the Heart Rythm Society want the FDA warnings to have that “warm fuzzy” feeling? The cold hard truth usually works best, especially when you are dealing with peoples’ health. You can’t recall the truth.

In fact, dead still means dead, no matter how warm and fuzzy you felt when you read the latest “safety advisory” and didn’t think it was a serious issue that applied to you.