Cardio group releases defibrillator guidelines

The Heart Rhythm Society, a leading cardiologist's group, released a much-anticipated set of guidelines governing how the healthcare industry should handle medical device recalls. The group recommend methods of collecting safety data to catch potential safety problems. It also says manufacturers should engage outside experts to monitor the performance of their products. Among the specific changes is a call for better reporting on malfunctions and routine inspections in cases in which a ICD device is suspected to have played a role in a patient's death. The group also suggests that the FDA drop the use of the word "recall" when issuing advisories.

- read this New York Times article

PLUS: The concern about device safety was prompted, of course, by last year's device recalls at Guidant and Medtronic. The Minneapolis Heart Institute's Dr. Barry Maron who was closely involved, says the patient deaths last year were "a wake up call." Article

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