The U.S. Food and Drug Administration needs to update donor ineligibility criteria for human tissue transplants, according to a letter four Michigan members of Congress just sent to the federal agency. The letter was signed by Senators Gary Peters and Debbie Stabenow, along with Representatives John Moolenaar and Debbie Dingell.
In it, the Congresspeople note that 36 people across the country received bone graft implants contaminated with tuberculosis. Officials say one Michigan woman who received a transplant died from that infection earlier this month.
“In July 2023, a physician with Michigan Medicine contacted us regarding a TB infection transmitted from a ViBone Allograft to his patient. This patient experienced severe health complications after being one of 36 patients who received infected bone matrix materials that were implanted in patients across the country,” Peters, Stabenow, Moolenaar and Dingell wrote. “Regrettably, on August 10, 2023, the patient passed away due to the TB infection. No patient should suffer such devastating health outcomes from a transplant product.”
The letter urges the FDA to adopt new guidance from the American Association of Tissue Banks, which would update donor ineligibility criteria to include TB exposure, infection, travel history and age.
“We urge the FDA to consider these recommendations and promptly issue guidance or regulations based on sound science to protect patients and increase accountability for human tissue transplant products,” the members of Congress wrote.
According to the letter, this is the second TB contamination incident to occur at Azyio Biologics, a company located in Silver Spring, MD. A similar outbreak occurred in 2021 where TB was transmitted via bone graft.
“We have long supported investments into medical research that have produced life changing therapies, products, and pharmaceuticals for patients across the country,” the lawmakers said.
“While Azyio took proactive testing precautions after the 2021 incident, these precautions were not sufficient to prevent an outbreak two years later.”
