03626nas a2200361   4500008003900000245009900039210006900138260000800207300000600215490000700221520269900228100001702927700002502944700001902969700001602988700001903004700000503023700001803028700002303046700000503069700000503074700001603079700000503095700001603100700002003116700001403136700000503150700001303155700001603168700001603184700001503200856004903215       2022                          d00aNationwide tuberculosis outbreak in the USA linked to a bone graft product: an outbreak report0 aNationwide tuberculosis outbreak in the USA linked to a bone gra  cNov  a70 v223 aBackground: Mycobacterium tuberculosis transmission through solid organ transplantation has been well described, but transmission through transplanted tissues is rare. We investigated 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 Food 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 (rt PCR) assays and culture. M tuberculosis isolates from unused product and recipients were compared using phylogenetic 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 median 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 tuberculosis isolates from unused product and recipients were more than 99·99% genetically identical.
Interpretation: Donor-derived transmission of M tuberculosis via bone allograft resulted in substantial morbidity and mortality. All prospective tissue and organ donors should be routinely assessed for tuberculosis risk factors and clinical findings. When these are present, laboratory testing for M tuberculosis should be strongly considered.1 aSchwartz, NG1 aHernandez-Romieu, AC1 aAnnambhotla, P1 aFilardo, TD1 aAlthomsons, SP1 a1 aWilson, Wyatt1 aDeutsch-Feldman, M1 a1 a1 aThacker, TC1 a1 aBenowitz, I1 aGlowicz, Burton1 aCowan, LS1 a1 aLoBue, P1 aStewart, RJ1 aWortham, JM1 aHaddad, MB  uhttps://www.notifylibrary.org/reference/5040