Case Studies - Read & Test
Case of the Month: Child Dies when Trial Model Ventilator Fails
A one-year-old boy was admitted into the pediatric intensive care unit (PICU) at a children's hospital as a result of severe injuries he sustained in a car accident. During his treatment, his physician concluded that a CT-scan was necessary to determine if bleeding or a blood clot in his brain was causing his deteriorating condition. The CT-scanner was located on a different floor of the hospital, so a transport ventilator was used to facilitate the child's transfer. The ventilator was a sales model of the unit that the hospital was considering purchasing. The child was placed on the ventilator for approximately an hour before the transport and was transported only after it was determined that the ventilator would provide the support needed. While returning to the PICU after the CT-scan, the ventilator lost power. Resuscitation attempts failed, and the child died.
The hospital had developed a procedure to test and evaluate equipment it was considering for purchase, such as the ventilator. The process included identifying the type of appropriate test-patient and then obtaining consent from the patient's parent before the equipment was used. This ventilator was only supposed to be used on "moderately ill" patients for air transport. The child's father was told that there was "some risk involved" in transporting the child, but he was not told that the ventilator was a test model being used for the first time. Several people accompanied the patient as he was moved to observe the ventilator in action, including a representative from the ventilator manufacturer.
The father sued, alleging negligence and failure to obtain informed consent. The hospital argued that expert testimony was needed to explain what information should have been given. The father contended that the matter was so straightforward that he did not need to provide expert testimony to establish the hospital's failure to obtain informed consent to use the ventilator.
From your analysis of the case, assess whether the following statements are true or false:
Answer
-
A hospital or healthcare provider using a test model
of new equipment does not need to reveal that fact
to the patient, as long as the equipment still belongs
to the salesperson.
True or False -
Informed consent involving the use of test or experimental
equipment requires more extensive informed consent than
procedures or treatment using standard equipment.
True or False -
A jury may be able to understand the need for providing
more information regarding use of a test model or
experimental procedure without an expert witness to
explain the need.
True or False
For answers to the quiz above, and a short discussion of the case, click here.