Research in context
Evidence before this study
Our preliminary report published in September, 2021, showed high attack rates of spinal and disseminated tuberculosis in bone allograft recipients at a single hospital. To identify previous reports of tuberculosis transmission through transplanted tissues, we searched PubMed for articles published between database inception and Nov 1, 2021, using the search terms “tuberculosis” and “transplant”, “transplantation”, “graft”, or “allograft”. We also reviewed regulatory and guidance documents from the US Food and Drug Administration, Centers for Medicare and Medicaid Services, American Association of Tissue Banks, and the Organ Transplantation and Procurement Network. We found three previous case reports of tuberculosis transmission through transplanted tissues and no current US regulations, guidelines, or professional standards that adequately address tuberculosis screening for tissue donors.
Added value of this study
We provide a detailed description of the largest recorded tissue-derived tuberculosis outbreak, including multiple lines of evidence supporting donor-derived transmission; the incidence and severity of tuberculosis disease among all product recipients in the USA; and the rapid and effective response by public health authorities. We show that standard screening was unsuccessful at detecting infection in the donor and donated tissues, and we propose measures to improve safety of tissue and organ donation. Based on our investigation, the American Association of Tissue Banks issued new recommendations for preventing tissue-derived tuberculosis transmission.
Implications of all the available evidence
All prospective tissue and organ donors should be routinely assessed for risk factors and clinical findings of tuberculosis. When these are present, laboratory testing for Mycobacterium tuberculosis should be strongly considered.