Legislation has been introduced in the U.S. House that would require all bone graft material to be tested for active and latent tuberculosis. It would also expedite the process for developing a screening test, according to a Dec. 13 report from The Detroit News.
The bill, sponsored by two Democratic and one Republican lawmakers, comes following the deaths of two patients who developed tuberculosis linked to tainted bone grafts.
The bill would establish with the FDA that a test for TB in bone graft materials needs to be fast-tracked, according to the report.
Aziyo Biologics, which manufactured the material, voluntarily recalled its viable bone matrix products July 13. Infections stemmed from a single lot that initially tested negative for Mycobacterium tuberculosis before it was released.
At least 36 patients were treated with the products before the recall. Shipments from the contaminated lot were sent to 13 facilities in seven states — Michigan, California, Louisiana, New York, Oregon, Texas and Virginia — between Feb. 27 and June 20.
All of the unused units have since been pulled from hospitals and dental offices.