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CDC - Second Nationwide Tuberculosis Outbreak Caused by Bone Allografts Containing Live Cells — United States, 2023

Mary Wilson

Well-known member
January 5, 2024

http://dx.doi.org/10.15585/mmwr.mm725253a1

Wortham JM, Haddad MB, Stewart RJ, et al.

Summary

What is already known about this topic?
Tuberculosis (TB) outbreaks associated with tissue transplantation are rare; one outbreak involving 113 patients occurred after surgical implantation of contaminated bone allografts in 2021.

What is added by this report?
Noting similarities to the 2021 outbreak, clinicians diagnosed and promptly reported two TB cases among bone allograft recipients. These case reports initiated an investigation that confirmed a bone allograft–related outbreak affecting 36 recipients. Removal of the product from further distribution prevented implantation of the implicated allografts in up to 53 additional persons.

What are the implications for public health practice?
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 Mycobacterium tuberculosis transmission.


Abstract

During July 7–11, 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. An outbreak associated with a similar product manufactured by the same tissue establishment (i.e., manufacturer) occurred in 2021. Because of concern that these cases represented a second outbreak, CDC and the Food and Drug Administration 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. Notifications to all seven states occurred on July 12. As of December 20, 2023, five of 36 surgical bone allograft recipients received laboratory-confirmed TB disease diagnoses; two patients died of TB. Whole-genome sequencing demonstrated close genetic relatedness between positive Mycobacterium tuberculosis cultures from surgical recipients and unused product. Although the bone product had tested negative by nucleic acid amplification testing before distribution, M. tuberculosis culture of unused product was not performed until after the outbreak was recognized. The public health response prevented up to 53 additional surgical procedures using allografts from that donor; additional measures to protect patients from tissue-transmitted M. tuberculosis are urgently needed.

https://www.cdc.gov/mmwr/volumes/72/wr/mm725253a1.htm?s_cid=mm725253a1_w#suggestedcitation
 
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