Medical Devices and Infection

Recent Recalls

Open heart surgery has saved the lives of thousands of patients across America, as well as the world. Performing this task takes a highly skilled team of doctors well equipped with the right medical devices to assist them. All of these tools require FDA approval and specific cleaning procedures prior to their implementation during surgery. The Center of Disease Control and Prevention announced that a heater cooler unit that has been used in the majority of these surgeries since 2012, could have been contaminated when it was in the manufacturing process.


Heater Cooler Units for Open Heart Surgery

These units help the patient remain stable throughout the surgery and are a vital part of the process. While the risk is low, the result is either severe injury or possibly death. The infection that results from the contaminated device does not display symptoms for what can be several months to years, until it may show up. This may be particularly concerning for elderly patients who commonly have weakened immune systems and are more susceptible to virus and disease.


Who is Responsible?

In the event that a patient does in fact contract the infection, there may be a claim for products liability, under a manufacturing defect. There are three different kinds of products liability defects, including design defects, manufacturing defects and marketing defects. As pertaining this case, a manufacturing defect occurs when the product is being made, departing from its intended design and purpose. In these cases, the manufacturer is held strictly liable. Strict liability means that the injured party does not have to show a finding of fault, only that the injury occurred as a result of using the manufacturer’s defective product.


Wrongful Death

If death to your loved one does result from an infection from a medical device, such as the one discussed above, the survivors of the deceased may file a claim for wrongful death as well. Wrongful death claims on behalf of the deceased can claim compensation for lost income, wages, medical expenses incurred by the patient prior to death, as well as other miscellaneous damages relating to the death.

Establishing the link between the infection and death is critical to making these claims, there must be no other influencing factors that could have been said to have been more at fault for the death.

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