Bill would require TB testing for bone graft material after Michigan woman's death

Washington ― New legislation introduced in the U.S. House this week would mandate that bone graft material be tested and screened for active and latent tuberculosis and expedite the process for developing such a test.

The bill ― sponsored by U.S. Reps. John Moolenaar, R-Caledonia; Debbie Dingell, D-Ann Arbor; and Lou Correa, D-California ― follows the death of Shandra Eisenga, 57, of Osceola County in August from tuberculosis linked to tainted bone graft material that also killed one other patient nationally, according to the CDC.

“No family should have to endure the pain Shandra and her family have experienced,” said Moolenaar, whose staffer, Tarin Brunink, was Eisenga's sister.

"The bill would actually establish with the FDA that there needs to be a fast-track process to develop a test for TB because currently there isn't a good test for these bone graft materials used with different surgeries."

Eisenga of Marion died Aug. 10 after being treated for a post-surgical TB infection in an intensive care unit at the University of Michigan in Ann Arbor.

She had contracted the TB from a contaminated bone graft product that was placed into her back during an elective spinal procedure she underwent in April, according to Dr. Robert Dickson, who consulted on her case as program physician for the Washtenaw County Tuberculosis Clinic. 

The contaminated bone tissue product from the same deceased donor was used in 36 patients who underwent surgical or dental procedures in hospitals and dental offices earlier this year.

More:TB death in Michigan linked to contaminated bone graft material

Aziyo Biologics initiated a voluntary recall on July 13 of its "viable bone matrix products," which are made from human tissue and used primarily in orthopedic and spinal procedures. The same company was involved in the outbreak of TB in 2021 in which eight people died and at least 87 developed a TB infection.

The CDC said shipments from the contaminated lot this year were sent to 13 facilities in seven states — Michigan, California, Louisiana, New York, Oregon, Texas and Virginia  — between Feb. 27 and June 20. A CDC spokeswoman said all patients, facilities and states where this lot was used have been contacted, and all unused units of this product lot have been removed from inventory in hospitals and dental offices.

Aziyo Biologics said in a statement at the time that samples from this specific lot of donor tissue prior to release had tested negative for mycobacterium tuberculosis — the bacterium that causes TB — by an independent laboratory using a nucleic acid test.

The new legislation directs the Secretary of Health and Human Services to expedite the development and review of the TB tests for bone graft material by designating them as "breakthrough" devices that get priority treatment by regulators.

It also would mandate that officials update federal health regulations to require the testing of donated bone graft material for both "active and latent" tuberculosis, and directs the FDA working with the CDC to update current guidance for "good tissue practice."

Dingell said she'd push for passage of the legislation as a member of the House Energy and Commerce Committee, which has jurisdiction over the issue.

"This is a preventable tragedy, and we must do more to protect patients," Dingell said. "This legislation will take meaningful steps to strengthen regulations and enhance TB testing and screening to prevent infection from" human cells, tissues, and cellular and tissue-based products.

mburke@detroitnews.com