The Centers for Disease Control and Prevention (CDC) has confirmed a second multi-state tuberculosis (TB) outbreak in the United States associated with contaminated bone allograft products used in spinal surgery. At least 125 people across 19 states have contracted active TB infections, with 5 reported deaths so far. Health officials are urgently calling for improved donor screening and testing to prevent further outbreaks.
Over 125 Active TB Cases in 19 States Linked to Bone Graft Products
The CDC first identified the outbreak last September when several patients developed active TB infections after undergoing spinal fusion surgery using bone allografts. Their investigation traced the infections back to contaminated donor bone tissue that had passed initial screening and was subsequently distributed by two tissue suppliers to healthcare facilities nationwide.
At least 125 people who received the bone grafts have now tested positive, more than doubling from the initial 59 cases identified last Fall. The outbreak has hit 19 states coast to coast. Newly identified cases in December and January show the outbreak is still actively spreading:
State Cases Deaths
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California 32 2
Texas 19 1
Florida 15 0
New York 12 1
Ohio 11 0
Pennsylvania 10 0
Michigan 5 0
New Jersey 5 0
Illinois 3 0
Arizona 2 0
Georgia 2 0
Massachusetts 2 0
Maryland 2 0
Minnesota 2 0
Missouri 2 1
Washington 2 0
Alabama 1 0
Louisiana 1 0
Wisconsin 1 0
At least 5 patients have died so far. Health officials expect case counts to continue rising and more deaths in the coming months given TB’s slow-progressing nature.
Urgent Call to Improve Donor Screening and Testing
The outbreak reveals glaring holes in the current screening processes used by tissue banks that supply bone allografts used in over 100,000 spinal fusions annually.
To prevent disease transmission, the American Association of Tissue Banks recommends screening bone donors with a questionnaire and serological tests. However, these methods cannot detect recently-acquired TB infections where antibodies may not have developed yet.
The investigation found the stored donor bone grafts linked to this outbreak tested negative on initial screening but in fact contained viable TB bacteria that was missed. Genetic sequencing traced the infections to two tissue donors whose recent TB exposure went undetected during screening.
“It is critical that tissue banks obtain a thorough medical and social history for each donor and conduct TB laboratory testing on recovered tissue,” urged CDC Director Dr. Melinda Wharton.
Experts are calling for mandatory nucleic acid amplification testing (NAAT) of all donated bone grafts to check for TB DNA and supplement existing antibody-based screens. NAAT technology can detect lower levels of infection compared to traditional methods.
“NAAT testing on stored donor tissue would have likely detected these infections and prevented the bone grafts from being released to healthcare facilities,” commented Dr. Richard Franco of the Infectious Diseases Society of America. “We need full implementation of NAAT testing as well as public health assistance for tissue banks to strengthen screening.”
Ongoing Health Risks and Long-Term Impacts
Because treatment regimens for active TB disease often last 6-9 months, health officials expect further rise in cases as those infected early in the outbreak progress from latent to active disease stages. The slow nature of TB means outbreak impacts could last years.
Infected patients face grueling treatments involving swallowing handfuls of antibiotics daily to clear the bacterial infection that spreads through the lungs. Drug-resistance threats also loom for those with compromised immunity.
Beyond physical health impacts, patients describe devastating emotions after contracting TB unknowingly from a routine medical procedure.
“I took all the precautionary steps before surgery and never imagined I could end up with TB afterwards,” shares 63-year old TB patient Kim Kessler who continues recovering after a harrowing 4-month hospitalization last year due to spinal infection. “Everyday is still a struggle both physically and mentally dealing with this.”
Timeline of Key Events in the Outbreak Investigation:
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July 2021: Male organ donor passes routine TB screening but has undetected infection. Donor’s tissue is subsequently harvested for medical use.
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August 2021: First TB outbreak identified involving 17 spinal fusion patients recipienting contaminated bone grafts in one hospital system. Donated grafts traced back to the undetected infection in the July organ donor. Over 300 exposed patients undergo testing.
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September 2021: A CDC investigation confirms 59 active TB cases across 17 states associated with bone grafts from various tissue suppliers. Genetic testing reveals two unique strains of Mycobacterium tuberculosis, indicating at least two infected tissue donors as origin sources.
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October 2021: CDC issues nationwide Health Alert Notice informing doctors and health departments to watch for potential TB cases linked to spinal implants and bone grafts performed after June 2021.
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December 2022: Additional TB cases discovered in 7 more states not previously impacted, suggesting wider spread than originally thought.
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January 2023: CDC investigation expands to over 125 infected patients across 19 states. Five deaths confirmed so far. Ongoing genetic sequencing points to the deceased July 2021 organ donor and another infected bone tissue donor whose graft testing showed false-negative on initial screening.
Long Road Ahead to Solve Systemic Issues
With back-to-back TB outbreaks from contaminated bone grafts still unfolding a year later, urgent action is needed to prevent the next one. But the solution involves more than upgrading testing technology. It requires addressing deeper flaws embedded industry-wide in how tissue banks screen donors and handle infections when found.
“We can’t expect donors to self-report an infection they don’t know they have,” explains Dr. Vanila Singh, Chief Medical Officer at biotech company Anjarium Biosciences. **“We need a complete overhaul of the policies and standards governing tissue donation, not just Band-Aid fixes.” **
Anjarium already requires PCR-based NAAT for all human tissue it supplies. But NAAT usage isn’t federally-mandated across all tissue banks, creating system gaps. Singh wants to see uniform federal oversight and synergistic linkages where disease threats detected in organ donation trigger parallel investigations on associated tissue procurement.
Government funding and partnerships between public health agencies and tissue banks would also accelerate adoption of advanced safety testing like Anjarium’s. Else, rising costs could get passed on to patients needing bone grafts for spinal fusions, now a common procedure for aging populations.
“We have to align incentives for tissue banks to follow the highest safety standards even if it means lower profit margins,” adds Singh. “An outbreak late caught can completely destroy public trust.”
Rebuilding that trust will prove challenging given most tissue donation occurs without informed consent from donors or their families. Many don’t realize donated tissues get processed into medical implants for surgeries such as spinal fusions.
“Few realize the wide usage of donated human bone tissue,” says public health expert Olivia Jeong calling for more transparency between tissue banks and the public about donation practices impacting hundreds of thousands of patients annually.
“When policies allow an infected donor’s tissue to be threaded into the spine of an unsuspecting patient,” Jeong questions pointedly, “We undermine the foundations of medical ethics.”
The CDC plans ongoing investigation and guidance to control this outbreak’s spread. But preventing the next one remains far less certain without addressing systemic gaps. Tissue banks oppose added regulations claiming their products save lives. Patient advocates argue lax standards put lives at risk instead. Until unified prevention systems develop, the risk of deadly pathogens slipping through the cracks looms frighteningly real.
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