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Heart Device Makers Feeling Heat

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Several Medical Safety Groups have criticized the makers of heart devices, like defibrillators and pacemakers, for failing to alert doctors to life-threatening flaws in their products. The physicians believe the these companies don’t fully assess the patient consequences because engineers, rather than doctors, made the decisions. Finally, two of the companies have agreed to broaden their product safety oversight to include more physicians in the monitoring process, and to send notices directly to patients. These steps are vital and necessary to prevent a corporate culture of loyalty to economic goals over the honest assessment of product performance and patient safety.