U.S. health officials are working urgently to contain an outbreak of tuberculosis that has been linked to contaminated bone graft material. This is the second outbreak of the rare disease in just two years. The contaminated bone repair product, supplied by Aziyo Biologics, has already claimed one life and infected at least four others.
In 2021, a similar outbreak occurred when the same type of bone repair product used in spinal surgery was found to be contaminated with the bacteria that causes tuberculosis. This resulted in the deaths of eight people. Aziyo Biologics was also involved in that outbreak.
The contaminated product was used in at least 36 patients who underwent surgical or dental procedures earlier this year. However, the outbreak only became public knowledge when Aziyo issued a voluntary recall on July 13. All patients are now being treated as if they have tuberculosis due to the high risk associated with implanted bone material.
Tuberculosis, caused by the bacterium Mycobacterium tuberculosis, typically affects the lungs but can also attack other parts of the body. It spreads through the air from person to person and can be fatal if left untreated.
The bone products involved in the current outbreak were derived from a single donor and were sent to 13 facilities in seven states between February and June. Aziyo has recalled a single lot of the bone repair product, ViBone Moldable, as well as its bone grafting solution, alloOss Plus, used for dental procedures.
Aziyo has suspended shipments of all bone repair products from all donors. The company is responsible for ensuring the product is free of contamination, but current U.S. regulations do not require organ or tissue donors to be assessed for tuberculosis or tuberculosis risk factors. While human tissue used for products like the bone repair material is tested for other communicable diseases, such as hepatitis and HIV, tuberculosis testing is not mandatory.
The American Association of Tissue Banks, which promotes the safety and use
