Informed Consent: Hospital Had Duty to Obtain Informed Consent before Using Sales Demonstration Ventilator

April 1, 2013 | Healthcare Risk, Quality, & Safety Guidance

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​A Utah appellate court found that a hospital had a duty to obtain informed consent from the parent of a critically injured boy who was placed on a vendor's demonstration ventilator, which malfunctioned and allegedly led to the child's death.

The boy, who suffered lung and brain injuries from a serious car accident, was a patient in the facility's pediatric intensive care unit. A computed tomography scan of the boy's brain was needed to assess his condition, and a high-powered ventilator was required to transport the boy to and from the radiology department, located on another floor. The only ventilator meeting this criterion in the hospital was a sales demo ventilator that was being considered for the organization's life-flight transport unit. The physician treating the boy was part of the committee evaluating the ventilator and was charged with creating the informed consent document for patients who agreed to test the ventilator. She also created the testing and use protocols; the committee had decided only to use the demo ventilator on patients who were moderately...

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