U.S. health officials are racing to control an outbreak of tuberculosis linked to contaminated bone graft material that has killed one person and infected at least four others — the second outbreak of the rare disease in two years.
, the bone products were derived from a single donor and sent to 13 facilities in seven states: California, Louisiana, Michigan, New York, Oregon, Texas and Virginia, between Feb. 27 and June 20, according to the CDC.a single lot of the bone repair product, ViBone Moldable, which is made from human tissue and used primarily in orthopedic and spinal procedures, according to a July 13 company statement.
. Its authors include CDC, FDA and other federal and state health officials who investigated that outbreak, the largest recorded tissue-derived tuberculosis outbreak, the report said.as well as in the donor, an 80-year-old man who traveled frequently to an unidentified country where the annual number of new TB cases is more than eight times higher than in the United States, the report said.
The company said samples from the specific lot of bone material that was related to the tuberculosis infections had tested negative for the bacteria by an independent laboratory using a nucleic acid test that is designed to specifically detect the organism. “Our investigation has involved additional testing on the donor lot in question through multiple independent labs and in each instance, [the bacteria] has not been detected in the donor samples,” the company said.
Bliss said extensive investigations by both the AATB and the FDA did not turn up anything wrong in Aziyo’s processing of the bone in 2021. She declined to comment on why a single company, of the many in the United States that process tissue, is involved in both tuberculosis outbreaks.The FDA said it is working with the CDC “to fully understand the impact of this recall,” said Carly Kempler, an FDA spokesperson.
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