Thursday, April 27, 2006

Heart Rhythm Society: ICD Recall, er, Safety Alert Guidelines

The Heart Rhythm Society released their "Draft" recommendations regarding the Device (a.k.a., pacemaker and defibrillator) Performance Policies and Guideline recommendations after this year's device failure and reporting fiasco. One of these recommendations is to remove the word "recall" from the FDA's lexicon, and instead use the term "Advisory Alert" or "Safety Alert." You can see the full report here (pdf file, 787K). They did a great job. It has recommendations for the FDA, industry, physicians, and Congress, and the Center for Medicare and Medicaid Services (CMS).

One suggestion I'd make: Make a Class I Safety Alert the least concerning, while Class III Safety Alert would be the most concerning.... this would be in line with other schema in medicine (Class A vs Class D cancer, Class I vs Class IV heart failure)... Just a thought.

On a (much) less serious note, since "recall" was thought by the committee to be to troublesome to the public, a few other terms that could be used instead of "Safety Alert" were passed around in our lab today. They included: "glitch," "hiccup," "boo-boo," and the best: "faux pas."


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