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January 04, 2024
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Second TB outbreak linked to a viable bone allograft product

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Key takeaways:

  • This second outbreak of tuberculosis associated with a contaminated viable bone allograft product resulted in five cases and two deaths.
  • The first outbreak — reported in 2021 — resulted in 113 cases.

A second tuberculosis outbreak linked to a viable bone allograft product contaminated with Mycobacterium tuberculosis resulted in five more cases and two deaths, according to the outbreak investigation.

“During July 7 to 11, 2023, CDC received reports of two patients in different states with a tuberculosis (TB) diagnosis following spinal surgical procedures that used bone allografts containing live cells from the same deceased donor,” Jonathan M. Wortham, MD, lead of the CDC’s Division of Tuberculosis Elimination Outbreak Investigations Team, and colleagues wrote. “An outbreak associated with a similar product manufactured by the same tissue establishment (ie, manufacturer) occurred in 2021.”

IDN0124Wortham_Graphic_01_WEB
Wortham JM, et al. MMWR Morbid Mortal Wkly Rep. 2023;doi:10.15585/mmwr.mm725253a1.

This previous outbreak resulted in 113 cases across 18 states.

Because of concerns of a second outbreak, the CDC and the FDA began investigating and determined that the graft was obtained from a different donor than the one implicated in the previous outbreak. They also determined that the product was distributed to 13 facilities in seven states, prompting the organizations to send notifications to all seven states on July 12.

Further results of the investigation showed that five of 36 surgical bone allograft recipients received laboratory-confirmed TB disease diagnoses and two patients died of TB as of December 20. Additionally, the team reported that whole-genome sequencing demonstrated close genetic relatedness between positive M. tuberculosis cultures from surgical recipients and unused product, although the bone product had tested negative by nucleic acid amplification testing before distribution.

“This second outbreak of bone allograft-related TB in recent years underscores the urgent need to implement improved donor screening and culture-based testing to prevent tissue-derived M. tuberculosis transmission,” the authors concluded.