FDA warns of hazardous materials in the operating room

On Behalf of | Feb 5, 2020 | Products Liability

As is the case anywhere else in the country, operating rooms in Ohio’s hospitals and surgery centers need to be as sterile as possible in order to help reduce the risk of serious infection to the patient. Anytime the internal structures of the body are exposed, the patient’s life is jeopardized not only from the procedure itself, but also from everything in the room. If the materials and tools used are not properly sterilized, they become hazardous materials and a source of infection for the patient.

Recently, it became known that PreSource procedural packs that contain surgical gowns manufactured by Cardinal Health, along with the company’s level 3 surgical gowns, could be a source of infection for patients. Surgical gowns come in different protection levels, and level 3 gowns provide moderate protection. Surgeons use them in a wide array of procedures, such as knee replacements and open heart surgery. The company has not yet issued an official recall, but does recommend surgeons not use them due to possible contamination. 

Cardinal Health and the Food and Drug Administration do not yet know the full extent of the problem, but it has already begun affecting patients. Some hospitals and surgical centers have already started cancelling nonelective procedures due to the danger. The FDA advises that it would be wise to work with another manufacturer to replace the gowns and packs from Cardinal Health.

While the company and the FDA work to rectify the situation and clean up the supply chain, these hazardous materials could continue to cause harm to some patients before the removal of all products from the market. Anyone here in Ohio who suffered an infection, which may or may not have turned into sepsis, may want to explore whether the source was a contaminated surgical gown or pack. It may be possible to pursue restitution through the filing of a products liability claim.


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