Bulletin 21-6

Potential Mycobacterium tuberculosis Transmission Through Tissue Transplantation

June 10, 2021

On June 7, 2021, AATB was notified by an accredited institutional member, Aziyo Biologics, of a potential Mycobacterium tuberculosis transmission through tissue transplantation. Aziyo Biologics has voluntarily recalled a lot of the FiberCel® product recovered from a single donor associated with this potential transmission and is actively working with their distributor, CDC, and FDA to contact all impacted hospital institutions and affected patients.  

AATB has convened a workgroup consisting of the chairs of both the Physicians Council and the Standards Committee to proactively monitor this evolving situation and to evaluate any future recommendations to tissue donor screening standards. Active serious infection in a donor, including any caused by tuberculosis, is a deferral under our standards. Transmission of tuberculosis through tissue is very unusual, and has not been reported in the US for more than 40 years.

AATB and its members are committed to ensuring that safe and high-quality tissue products are available for patients in need. AATB recommends all donated tissue be recovered and processed at an AATB Accredited establishment by AATB Certified Tissue Bank Specialists (CTBS). All human donated tissue should be ethically recovered, processed, distributed and transplanted in compliance with AATB Standards. AATB and its members are dedicated to honoring the gift of donation while respecting the wishes of the donor family. 

 

If you have any questions, please contact Beverly Bliss, VP Accreditation and Standards, at blissb@aatb.org.