Tuberculosis outbreak came from infected bone grafts, CDC says. It’s not the 1st time
A tuberculosis outbreak that spanned seven states in 2023 has been tied to bone graft products from an infected donor — again.
Two spinal surgery patients died from a tuberculosis infection, or TB, after a bone allograft product was used during their surgery, according to a Morbidity and Mortality Weekly Report published on Jan. 5 from the Centers for Disease Control and Prevention.
On July 7, a state health department reported a TB infection to the CDC after a patient was experiencing meningitis symptoms five weeks after a spinal fusion surgery, the report said.
The surgery used a bone allograft, a type of tissue graft that uses live tissue cells from a deceased donor to fill the gap in the bone left after surgery.
Health officials said the patient was “otherwise healthy” before the surgery, but when the patient started experiencing atypical symptoms post-operation, doctors took a sample of their cerebrospinal fluid, the plasma that cushions the brain and spinal cord.
Somehow, the patient had contracted tuberculosis.
Just four days later, on July 11, the health department of a different state reported a patient that was experiencing an infection at the site of their laminectomy surgery that just wouldn’t go away, according to the report.
Surgeons had used a similar bone allograft product during the laminectomy, a surgery that removes part or all of a vertebrae of the spine to relieve pressure, the CDC said.
Doctors tested the infected surgical site, and once again, the patient tested positive for tuberculosis.
It was happening again.
The first outbreak
Just two years earlier, in 2021, Aziyo Biologics issued an urgent recall of their product FiberCel, a malleable bone putty that is created using live tissue cells from a human donor, the Washington Post reported.
The recall included one batch of their product that was made from the same donor body, and then was shipped to 37 medical facilities across 20 states between March and April of that year, the outlet reported.
The FiberCel product was then implanted into 113 patients, the CDC said in the 2023 report, before some of them started to get sick.
From the implants, 87 patients tested positive for tuberculosis and eight patients died, Scripps News reported.
Aziyo is responsible for ensuring the safety of their products and making sure the donors are contaminated, but the bacteria that causes tuberculosis is not part of the required testing, Beverly Bliss, Vice President of Accreditation and Standard for the American Association of Tissue Banks// told The Washington Post in 2021.
Labs test for HIV, hepatitis C and other common tissue infections, Bliss told the outlet, but since a case of TB from tissue implantation hasn’t been seen since 1953, it’s not on the list.
This time, alarm bells sounded after the first patient.
“When reporting these cases to their respective public health authorities, the clinicians caring for these two patients independently noted similarities to the 2021 outbreak and asked that CDC investigate,” the agency said.
A quick response
Immediately after being notified of the first case, the CDC told the Food and Drug Administration to establish a quarantine on any of the bone allografts from the same batch that may not have been shipped to medical facilities, according to the report.
Of the lot, 53 units were stopped before they were shipped, but another 53 had already been distributed to eight hospitals and five dental offices across California, Louisiana, Michigan, New York, Oregon, Texas and Virginia, the agency said.
“By July 14 (1 week after receipt of the first case report by CDC), health departments had worked with affected hospitals and dental facilities to confirm that 36 patients had undergone procedures using at least one unit from the product lot under investigation,” the agency said.
By December, five of the 36 patients tested positive for tuberculosis by a lab, the CDC said, and ten others had symptoms of the disease.
The two patients first diagnosed with TB in July died from the disease, the CDC said.
“Prior to release, samples from this specific lot had tested negative for (the TB bacteria) by an independent laboratory using a nucleic acid test that is designed to specifically detect the … organism,” Aziyo Biologics said in a statement on July 13.
The tests were wrong.
A call for testing changes
Tuberculosis is caused by the bacteria Mycobacterium tuberculosis, which typically infects the lungs, but has been known to enter the body in other ways, including bone grafts, according to the CDC.
The bacteria can go through latent phases, meaning someone can have the bacteria inside their body without developing the disease.
In the case of the bone allograft outbreaks, the donors likely had latent TB and the donations were made without the knowledge that their bone tissue would be a carrier of the bacteria, the CDC said.
It is this latent stage of TB that can be particularly hard to test for — and possibly the reason the infections were missed.
“Although extremely useful for diagnosing TB disease, nucleic acid amplification tests are less sensitive than are the slower culture-based tests for identifying (the TB bacteria),” the CDC said in the report.
Slower testing – which can sometimes take up to eight weeks to yield a result, Live Science reported – are more effective at identifying latent infections and should be used for safety testing, the report said.
“Because tissue allografts containing live cells are stored frozen and have expiration dates months or even years after manufacture, ample time exists for both culture-based testing and additional scrutiny of donor medical records,” the CDC said.
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