US health officials are investigating a rare #tuberculosis outbreak among >100 patients who may have been infected after having spinal surgery or fracture repairs this spring with a bone product contaminated with Mycobacterium tuberculosis. The manufacturer of the bone repair product has recalled 154 containers of the material — a malleable bone putty that includes human cells and is used in a variety of orthopedic procedures. The products were shipped to 37 facilities in 20 states between March 3 and April 2, according to the Centers for Disease Control and Prevention.
The product, made by Aziyo Biologics Inc., a regenerative medicine company, came from a single donor, or cadaver, the company said. Of the total, 136 were implanted into 113 patients, according to CDC officials. Eight patients died after their procedures, but the cause of death is still being determined, CDC spokeswoman Martha Sharan said Thursday. It’s unlikely that tuberculosis was the cause because of the slow-growing nature of the disease, officials said.
Aziyo said in a statement it is “continuing to collaborate with FDA and the CDC on an investigation into the matter and at the appropriate time, we will provide more information.”
In the meantime, public health officials are recommending that the remaining patients who received these bone repair products be treated for tuberculosis even if they are not showing symptoms. Health-care providers are contacting 105 patients who used this product and all but four are being treated for the disease, the CDC said in a statement Thursday.
States were able to sequester 18 of the affected products to prevent additional surgeries, the CDC said. The agency is investigating the outbreak with state health departments, the Food and Drug Administration and the companies that manufactured and distributed the product.
Tuberculosis is caused by a bacterium, Mycobacterium tuberculosis. It usually affects the lungs, but can attack any part of the body, including the kidney, spine and brain. Not everyone infected becomes sick, but if not treated properly, the disease can be fatal. Typical treatment for TB that is not drug-resistant is a six-month course of antibiotics.
Aziyo, which processes the bone product, is responsible for ensuring it is free of contamination. But testing for the bacteria that causes tuberculosis is not currently conducted because that infection is so rare in bone grafts, said Beverly Bliss, vice president of accreditation and standards for the American Association of Tissue Banks. The last known case of this kind occurred in 1953, according to the CDC.
Typically, laboratories hired by processing companies test for HIV, hepatitis C and other infections that are more commonly spread by implantation of human tissue, Bliss said.
In addition, the organizations that collect bone and human tissue assess donors and interview family to determine the risk of infection and prevent pathogens from entering the system, she said.
Recovered tissue is typically frozen in 48 hours, Bliss said. The product, called FiberCel, is shipped frozen, according to a description of the product.
A spokesman for Medtronic, the exclusive distributor of FiberCel, said it has quality controls in place but does not test the material. The company has suspended distribution until the investigation is complete, said spokesman Ben Petok.
Aziyo said it issued a voluntary recall June 2 for a single lot of FiberCel. The company said it received a complaint from an unidentified hospital that reported post-surgical infections in seven of 23 patients who received FiberCel from one lot of the product, according to the FDA’s urgent recall notification. Four patients tested positive for tuberculosis, the FDA said.
Aziyo said its voluntary recall was issued to hospitals that received product from the specific lot after the company learned of post-surgical infections in patients treated with FiberCel, “including some patients that tested positive for tuberculosis.”
Genetic sequencing from some of the patients show the bacteria came from the same source, CDC officials said.
Indiana and Delaware have reported the most cases.
Indiana state health officials said they are working with local health departments and providers to investigate 30 individuals in 19 counties who received the bone repair product.
“All affected individuals have been notified, and appropriate public health actions have been taken,” Indiana Department of Health spokeswoman Megan Wade-Taxter said in a statement. “There is no risk to the public.”
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