A while back, we covered the efforts of AdvaMed (the medical device lobbying group) to get the FDA to stop using the term “recall,” in favor or something like “field corrective action.” You can read our little rant here. In the comments, we mentioned that there’s a bit of a conflict of interest when it’s the device manufacturers and not doctors claiming the term is a problem. Well, one of two things has happened…either it really was a problem all along and now we’ve finally got some coverage on doctors’ opinions, or maybe in response to our commentary AdvaMed has gone and rounded up some doctors to make a nice little press blurb…
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.
“It’s a terrible term,” said Dwight Reynolds, president of the Heart Rhythm Society, an association of doctors who implant the devices. “The anxiety created among patients and physicians by this term is the No. 1 cause for replacement of devices.” According to Reynolds, patients who learn they have a faulty device often assume they need to have it removed immediately, even though the surgical procedure to replace the device typically involves more risk than leaving it in.
At least this time the terminology is better:
The Heart Rhythm Society released guidelines today, asking the FDA to use “safety advisory” or “safety alert” when referring to device problems.
So, while there’s no numerical data to back things up (pesky requirement for medical decisions to be evidence-based), we actually do have doctors claiming “recall” is a problem for the hysteria it generates in patients. Guess it’s time to eat some words (see previous post’s comments).
More from the AP…
