One person has died and at least four have been sickened by tuberculosis in infected bone materials, an outbreak that has cast a spotlight on the shortcomings of testing for such tissue products.
It’s the second tuberculosis outbreak linked to the biomaterial device company, Aziyo Biologics. In 2021, Aziyo’s product killed eight people after orthopedic and dental surgeons unwittingly implanted infected bone grafts into patients. The latest outbreak led Aziyo to recall all materials made from the same donor in July. One person has died from TB, and the Centers for Disease Control and Prevention has since identified 36 exposures. The product was shipped to seven states: California, Louisiana, Michigan, New York, Oregon, Texas, and Virginia.
The crisis lays bare the inadequacy of current tuberculosis testing for tissue donations in the United States, as well as a gaping regulatory hole. There is no commercially available tuberculosis test for bone tissue, which is used in spinal or dental surgeries repairing damaged bone. Even if that test existed, neither the FDA nor the American Association of Tissue Banks require companies to test their donor materials for TB.
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