Nationwide Tuberculosis Outbreak in the USA Linked to a Bone Graft Product: an Outbreak Report.

Background Mycobacterium tuberculosis transmission through solid organ transplantation has been well described, but transmission through transplanted tissues is rare. We inves ted a tuberculosis outbreak in the USA linked to a bone graft product containing live cells derived from a single deceased donor. Methods In this outbreak report, we describe the management and severity of the outbreak and identify opportunities to improve tissue transplant safety in the USA. During early June, 2021, the US Centers for Disease Control and Prevention (CDC) worked with state and local health departments and health-care facilities to locate and sequester unused units from the recalled lot and notify, evaluate, and treat all identified product recipients. Investigators from CDC and the US F. and Drug Administration (FDA) reviewed donor screening and tissue processing. Unused product units from the recalled and other donor lots were tested for the presence of M tuberculosis using real-time PCR (it PCR) assays and culture. M tuberculosis isolates from unused product and recipients were compared using phylo - etic analysis. Findings The tissue donor (a man aged 80 years) had unrecognised risk factors, symptoms, and signs consistent with tuberculosis. Bone was procured from the deceased donor and processed into 154 units of bone allograft product containing live cells, which were distributed to 37 hospitals and ambulatory surgical centres in 20 US states between March 1 and April 2, 2021. From March 3 to June 1, 2021, 136 (88%) units were implanted into 113 recipients aged 24-87 years in 18 states (some individuals received multiple units). The remaining 18 units (12%) were located and sequestered. 87 (77%) of 113 identified product recipients had microbiological or imaging evidence of tuberculosis disease. Eight product recipients died 8-99 days after product implantation (three deaths were attributed to tuberculosis after recognition of the outbreak). All 105 living recipients started treatment for tuberculosis disease at a m n of 69 days (IQR 56-81) after product implantation. M tuberculosis was detected in all eight sequestered unused units tested from the recalled donor lot, but not in lots from other donors. M tuber sis isolates from unused product and recipients were more than 99 - 99% genetically identical. Interpretation Donor-derived transmission of M tuberculosis via bone alio p resulted in substantial morbidity and mo ty. All prospective tissue and organ donors should be routinely assessed for tuberculosis risk factors and clinical findi. When these are present, laboratory testing for M tuber sis should be strongly considered. US government copyright Published by Elsevier Ltd.