A Bonafide TB Problem

by Vince Vacketta, DPM

A new communicable disease has slowly made its way into the world of orthopedics. The disease, first reported in 2021, involves the presence of Mycobacterium tuberculosis (TB) contamination in live cell bone grafts. There has now been a recent development regarding a second outbreak and a product recall on July 13, 2023.

You can’t find what you aren’t looking for

According to the FDA regulations, no evidence of negligence has been found in donor testing. Currently the FDA requires testing for communicable diseases, such as hepatitis, HIV, and syphilis for human tissue derived bone products, but this does not include TB. Given the recent outbreaks, there is a need for further consideration in TB screening in the testing standards, but the process will not be easy. Infectious disease specialist Dr. James Sunstrum, explains that a DNA “quick test” is simply not sufficient for thorough TB screening. Instead, a specimen culture requiring six to eight weeks of additional incubation is necessary to appropriately screen for this slow-growing bacteria.

Changes in orthopedics

The recent outbreaks have led several companies to electively withdraw live-cell bone graft products from their product lines until this issue is resolved. They are now focusing on improving donor screening, and specimen testing, to reduce the risk of further outbreaks. While efforts show potential for the safe return of these beneficial products, many infectious disease experts advocate for their complete removal from the market.

Vincent Vacketta is a fellowship-trained foot and ankle surgeon at the Midwest Orthopaedic Center in Peoria, Illinois. He specializes in elective surgical reconstruction, sports medicine, and trauma.