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INDIANAPOLIS (AP) - Guidant Corp.'s series of recalls and warnings last year arose from its long-standing policy of relying on engineers, not doctors, to assess whether flaws in its heart devices posed a safety threat to patients, a review found.
In a report released Tuesday, a panel of cardiologists, ethicists and statisticians faulted Guidant for relying on engineers' assessments when deciding whether to publicize problems with its defibrillators and pacemakers.
"Under no circumstances should a potential or manifest risk of a preventable death be superseded by statistical analyses that indicate that performance remains within the general guidelines of estimated failure rates," the report stated.
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