The Food and Drug Administration is expected to release new data this morning which shows that the number of problems with defibrillators rose sharply between 1992 and 2002. According to the FDA, pacemakers have shown an improvement over the same time frame, with the number of problems reported showing a decline. Between 1990 and 2002, the agency said 62 people died as a result of the failure either pacemakers or defibrillator failure.
Some observers are pointing at the fact that the report shows a sharp increase (50 percent) in errors in the last five years of the study, a jump some cardiologists attribute to the trend towards minaturization in the field. Others are likely to bring up the fact that the analysis stopped in 2002, excluding serious recalls which affected both Guidant and Medtronic.
- see this story from the New York Times
PLUS: The debate over the safety of ICD devices comes to a head today in Washington, as leading cardiologists meet to discuss the problem. Story
AND: Could opening the US market to Chinese device makers help improve quality? That's what China's Health Ministry is arguing. Story