Bone Matrix Tuberculosis Outbreak Leads to CDC Calls for Better Donor Screening

A tuberculosis outbreak was linked to Aziyo Biologics earlier this year, resulting in at least five infections and two deaths; which is the second such bone matrix tuberculosis outbreak linked to the company's products.

Federal health officials are calling for tighter infectious disease screening of organ, bodily tissue, and blood product donors, following two nationwide tuberculosis (TB) outbreaks linked to bone matrix products, which have resulted in several deaths among recipients.

Researchers at the U.S. Centers for Disease Control and Prevention (CDC) indicate the recent bone graft tuberculosis outbreaks may have been prevented if the donors’ medical histories had been screened before their tissues were used for transplant procedures, according to findings published last week in the latest issue of the Morbidity and Mortality Weekly Report (MMWR).

Bone matrix grafts use bone and tissue donated from living or deceased individuals, and transplant it to patients undergoing spinal and orthopedic surgeries to repair or rebuild damaged and diseased bone. The grafts contain live cells, which are kept frozen until they are ready to be used.

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According to the report, CDC investigators have linked two nationwide tuberculosis outbreaks to tainted bone tissue that was donated. While laboratory testing alone cannot prevent all infectious diseases in donated tissue products, officials indicate the donors from both outbreaks were not tested for TB before they died, and both exhibited evidence of sepsis and respiratory illness while terminally hospitalized.

The donors should have been ineligible for tissue donation since they showed signs of illness, but their tissues were still used for bone graft transplants, CDC researchers concluded.

Bone Matrix Tuberculosis Problems

Tuberculosis lung infections are caused by Mycobacterium tuberculosis bacteria, which normally spread through the air when an infected person coughs, sneezes, or talks. The infections are severe and require a long course of antibiotics to treat.

The contagious infections are of such concern that all cases must be reported to local or state health department tuberculosis programs.

The CDC indicates at least 36 patients who underwent spinal surgeries invoving ViBone Modable or alloOss bone grafts, produced by Aziyo Biologics, may have been exposed to infected donated bone. The products were distributed to 13 health care facilities across seven states, and led to an outbreak of at least five TB infections. At least two bone graft recipients died as a result, according to a September 2023 report.

Investigators found the donor of the infected bone showed signs of sepsis and respiratory illness before he died. A chest scan was performed before the donor’s death, showing signs of TB, as well as a lung nodule. The cause of death was listed as pneumonia and sepsis. The CDC report indicates the donor’s tissue was still used for donation, even though the illnesses should have made them ineligible.

A similar nationwide TB outbreak occurred in 2021, which originated from the same manufacturer. The report indicates at least 113 FiberCel bone matrix recipients were exposed to contaminated bone. At least 19 patients developed TB, which resulted in at least eight deaths.

In that investigation, officials indicated the donor also showed signs of sepsis and was not tested for TB prior to their death. TB testing was conducted, but it took 40 days for the positive TB results to be reported.

According to the CDC, results for TB testing can take up to 56 days.

CDC officials recommend that health care facilities conduct TB testing, thoroughly review donor medical records, and follow current donor rejection procedures, including those stipulated for donors with sepsis, before distributing donated tissue. They should also implement tissue-tracking protocols, such as those currently required for solid organ and blood product donations, and monitor transplant recipients, in order to promptly catch and treat any infectious diseases that may occur, the researchers concluded.

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