After the two recent tuberculosis outbreaks, health officials have granted new guidelines regarding screening tissue donations for possible tuberculosis.
Tuberculosis Outbreaks in the US
A tuberculosis outbreak that affected dozens of individuals last year has been linked to bone grafts. This echoes a bigger outbreak back in 2021.
The two outbreaks stress the importance of enhanced screening of donated tissues for bacteria behind tuberculosis before they are utilized in medical procedures. Scientists noted this in the report "Second Nationwide Tuberculosis Outbreak Caused by Bone Allografts Containing Live Cells - United States, 2023."
In the 2021 outbreak, 113 individuals who went through spinal surgeries had been exposed to Mycobacterium tuberculosis through a product for bone repair. Elutia made the product known as FiberCel, a putty derived from human bone tissue that was donated and consists of live cells. The FiberCel batch contaminated with bacteria came from the tissue of one deceased donor.
As for the 2023 outbreak, it was strikingly similar to the 2021 one. It also involved a bone-repair product of Elutia. The contaminated product batch also came from one donor's tissues.
News of the outbreak reached the CDC when two health agencies in the state reported infections of tuberculosis among two patients who went through spinal surgeries. Both of them were exposed to the product for bone repair. Both of them also subsequently died due to tuberculosis.
Outbreaks Linked to Bone-Repair Products
The CDC and the Food and Drug Administration (FDA) investigated. The manufacturer also voluntarily recalled its viable bone matrix products, including the contaminated ones. At the request of the FDA and CDC, the firm also quarantined the contaminated batch of products that were yet to be distributed.
However, part of the contaminated batch had already reached five dental offices and eight hospitals across seven states. Federal officials then contacted these facilities and discovered that 36 individuals had undergone procedures wherein the bone-repair products had been used. This included the cases of the two previously reported individuals.
Laboratory tests showed that five of these 36 individuals had tuberculosis. More people also exhibited less-definitive infection signs. Regardless, it was recommended by the CDC that all patients who were exposed had to receive immediate treatment for tuberculosis. No other people died.
Leading to the outbreak of 2023, the company screened its products for bacteria with a test called nucleic acid amplification. This test specifically looks for the bacteria's genetic material. While the test suggested that the contaminated batch had no pathogen, this was not the case.
The report notes that while the test is crucially useful for TB diagnosis, it is less sensitive than slower culture-based tests when identifying the bacteria. The report notes that safety testing should cover slower tests in the future.
The donors linked to the two outbreaks had no documented tuberculosis cases. However, both of them had sepsis, which tuberculosis can cause. The latter also exhibited clinical symptoms that the infection may have triggered.
The report notes that people who exhibit sepsis should become ineligible for the donation of tissues. On top of this, the FDA has also recently released further guidance regarding screening the tissues of donors for bacteria.
While the likelihood of getting TB through a bone graft is extremely low, the gap must be closed as the tissue transplant industry keeps growing.
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