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Doctors Call for Sweeping Change in Heart-Device Safety Monitoring

The Heart Rhythm Society, which represents cardiac surgeons who implant heart devices, called for a broad overhaul of how the safety of such devices is monitored, according to the New York Times. Its report, released yesterday, recommends that outside experts be used to help determine when safety alerts should be issued, that more performance data be collected, and that notification of doctors and patients be standardized.

These suggestions, it said, could remove financial considerations from deliberations about when to communicate safety issues and commence recalls.  We certainly don't need another Guidant fiasco, and having more voices heard on these matters can only be a positive. But it's completely unrealistic to expect financial issues to hold no sway. Particularly naive is the statement that "single adverse events that could cause death or serious injuries in patients merit notification" if the problem is likely to recur. It would likely be very difficult to make generalizations based on one event, and it would be even more difficult for the mainstream media to report it with the proper perspective. Media-induced hysteria based on incomplete information would have serious financial consequences for the firm, and that is not something that can be removed from consideration. 

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