The United States Centers for Disease Control and Prevention (CDC) said on Friday (Jan 5) that a tuberculosis (TB) outbreak in the country last year which affected dozens of people was linked to bone grafts, echoing a larger outbreak in 2021. In its Morbidity and Mortality Weekly Report (MMWR), the CDC said that 113 people, who underwent spinal surgeries in 2021, were exposed to Mycobacterium tuberculosis, the bacterium behind tuberculosis, via a bone-repair product – called FiberCel which is made by Elutia.
The FiberCel batch contaminated with Mycobacterium tuberculosis had come from a deceased donor’s tissues. Now the outbreak last year strongly resembled the one in 2021 as it involved a similar bone-repair product made by Elutia, and the contaminated batch came from one tissue donor.
The CDC said on Friday that from July 7-11 last year, it received reports of two patients in different states with a TB diagnosis following spinal surgical procedures that used bone allografts containing live cells from the same deceased donor.
“An outbreak associated with a similar product manufactured by the same tissue establishment (i.e., manufacturer) occurred in 2021,” the statement said.
The statement added that as these cases (in 2023) represented a second outbreak, the CDC and the Food and Drug Administration (FDA) worked with the tissue establishment to determine that this product was obtained from a donor different from the one implicated in the 2021 outbreak and learned that the bone allograft product was distributed to 13 health care facilities in seven states – California, Louisiana, Michigan, New York, Oregon, Texas, and Virginia.
The statement said that eight hospitals and five dental offices in these seven states received 50 bone allograft units from this product lot from February 27–June 20 last year. On July 12, a notification was sent to these states.
Upon contacting the health facilities, officials learned that including the two previously reported cases, 36 total patients had undergone procedures in which the product was used.
“As of December 20, 2023, five of the 36 recipients had received a diagnosis of laboratory-confirmed TB disease, including four that were culture-confirmed,” the statement said.
The CDC recommended that all exposed patients receive prompt tuberculosis treatment, and no additional people died.
(With inputs from agencies)
