Last data update: Apr 29, 2024. (Total: 46658 publications since 2009)
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Query Trace: Thacker TC [original query] |
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Second nationwide tuberculosis outbreak caused by bone allografts containing live cells - United States, 2023
Wortham JM , Haddad MB , Stewart RJ , Annambhotla P , Basavaraju SV , Nabity SA , Griffin IS , McDonald E , Beshearse EM , Grossman MK , Schildknecht KR , Calvet HM , Keh CE , Percak JM , Coloma M , Shaw T , Davidson PJ , Smith SR , Dickson RP , Kaul DR , Gonzalez AR , Rai S , Rodriguez G , Morris S , Armitige LY , Stapleton J , Lacassagne M , Young LR , Ariail K , Behm H , Jordan HT , Spencer M , Nilsen DM , Denison BM , Burgos M , Leonard JM , Cortes E , Thacker TC , Lehman KA , Langer AJ , Cowan LS , Starks AM , LoBue PA . MMWR Morb Mortal Wkly Rep 2024 72 (5253) 1385-1389 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. |
Incomplete tissue product tracing during an investigation of a tissue-derived tuberculosis outbreak
Marshall KE , Free RJ , Filardo TD , Schwartz NG , Hernandez-Romieu AC , Thacker TC , Lehman KA , Annambhotla P , Dupree PB , Glowicz JB , Scarpita AM , Brubaker SA , Czaja CA , Basavaraju SV . Am J Transplant 2023 24 (1) 115-122 In the United States, there is currently no system to track donated human tissue products to individual recipients. This posed a challenge during an investigation of a nationwide tuberculosis outbreak that occurred when bone allograft contaminated with Mycobacterium tuberculosis (Lot A) was implanted into 113 patients in 18 U.S. states, including two patients at one healthcare facility in Colorado. A third patient at the same facility developed spinal tuberculosis with an isolate genetically identical to the Lot A outbreak strain. However, healthcare records indicated this patient had received bone allograft from a different donor (Lot B). We investigated the source of this newly identified infection, including the possibilities of Lot B donor infection, product switch or contamination during manufacturing, product switch at the healthcare facility, person-to-person transmission, and laboratory error. Findings included gaps in tissue traceability at the healthcare facility, creating the possibility for a product switch at the point-of-care despite detailed tissue-tracking policies. Nationally, 6 (3.9%) of 155 Lot B units could not be traced to final disposition. This investigation highlights the critical need to improve tissue-tracking systems to ensure unbroken traceability, facilitating investigations of recipient adverse events and enabling timely public health responses to prevent morbidity and mortality. |
Nationwide tuberculosis outbreak in the USA linked to a bone graft product: an outbreak report.
Schwartz NG , Hernandez-Romieu AC , Annambhotla P , Filardo TD , Althomsons SP , Free RJ , Li R , Wyatt Wilson W , Deutsch-Feldman M , Drees M , Hanlin E , White K , Lehman KA , Thacker TC , Brubaker SA , Clark B , Basavaraju SV , Benowitz I , Burton Glowicz J , Cowan LS , Starks AM , Bamrah Morris S , LoBue P , Stewart RJ , Wortham JM , Haddad MB . Lancet Infect Dis 2022 22 (11) 1617-1625 BACKGROUND: 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. FUNDING: None. |
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