Guidant to Blame for Response to Device Failures

Michael Johnson

Contributor

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Guidant's own expert panel, that was assembled last summer to assess the handling of heart device flaws, stated that the company failed to fully realize the affect on patient safety when publicizing product failures.

When a panel of doctors and experts investigated the method of handling the disclosures of flaws in heart devices to doctors, they discovered that Guidant used a statistical projection from an engineer rather assessments from doctors about the medical consequences of the failures. This relates back to May of last year when it was discovered that Guidant had failed to tell doctors about a flaw in one of it's defibrillators for three years after it was discovered. That notification was the beginning of a swell of recalls that has included well over 10,000 devices.

The rational for the non-disclosure was that in telling doctors about the flaws may result in unnecessary replacement surgeries causing more damage than good. This argument was flatly rejected by the panel. The panel called for immediate notification when a device poses significant health risks to a patient of any kind.

"The Independent Panel believes that under no circumstances should a potential or manifest risk of a preventable death be superseded by statistical analyses that indicate that performance remains with general guidelines," the panel concluded.

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