Congress Calls for Bone Graft Standards Following Tuberculosis Outbreaks
Looks like there will be some regulatory movement following an outbreak of TB from a viable bone matrix product; here’s what you need to know
What
Some Congressional leaders want stricter standards for bone grafts after a tainted product was linked to a severe tuberculosis (TB) outbreak. This summer, Elutia – formerly known as Aziyo Biologics – issued a voluntary recall for its ViBone allograft product after discovering the product was tainted with TB (which was covered as Breaking News in CORRelations when it happened). As of August 2023, the CDC reported 36 cases and two deaths related to the tainted product. This is not the first outbreak caused by Elutia’s bone graft products — in 2021, as many as 100 orthopaedic and dental patients received Aziyo's infected products, and eight died. Despite Elutia and other biologics companies taking precautions following this 2021 incident, a recent letter from Congressional leaders say this is not enough, and the FDA should create criteria to prevent infected products from being distributed in the future.
