Two Tuberculosis Deaths Linked to Bone Matrix Material

The Centers for Disease Control and Prevention informed health care providers about two fatal cases of tuberculosis disease linked to a single product lot of viable bone matrix material from Aziyo Biologics, Inc., distributed earlier in 2023. This follows Aziyo’s voluntary recall of the affected viable bone matrix products on July 13.

According to the CDC notice, the material was derived from human tissue and mainly used in surgical and dental procedures. A total of 36 individuals underwent procedures using products from the affected lot. The CDC has contacted all patients, facilities, and states associated with this product. All unused units from the affected lot have been sequestered. Additionally, the CDC issued recommendations for individuals potentially exposed to Mycobacterium tuberculosis (MTB), the bacteria causing tuberculosis. These guidelines are designed to help both patients and health care professionals navigate potential exposure.

AABB supports response efforts by the American Association of Tissue Banks (AATB) to swiftly address the MTB risks in Bulletin 23-6 issued Aug. 7. The AATB bulletin serves to update and clarify the AATB's understanding of the risk of MTB transmission from tissue donors and outlines donor eligibility recommendations for donors of both standard tissues and those containing viable cells.

AABB’s Cellular Therapy Standards Protect Patient Safety

AABB Standards for blood and cellular therapy have long required safety measures to effectively and rapidly address transmission risk via product tracking requirements. To support patient safety, AABB strongly encourages facilities that procure, process, store and/or distribute cellular therapy products to review the current standards in the 11th edition of AABB’s Standards for Cellular Therapy Services, outlining the most up-to-date practices for AABB-accredited cellular therapy facilities.

AABB standards encompass both overarching quality benchmarks and specific technical criteria. They integrate a comprehensive array of policies, processes and procedures pertaining to technical and quality systems. The goal is to comprehensively address all facets of cellular therapy, including critical material qualification, utilization, operational controls, product manipulation, aseptic methods, testing, and product identification and traceability.

AABB's CT Standards require that member facilities must establish, maintain and follow policies, processes and procedures related to product identification and traceability. These are designed to guarantee the seamless tracking of the chain of identity and chain of custody for each cellular therapy product and any associated samples. This tracking extends from the product’s initial cellular starting material or source, through processing, testing, and characterization, to final disposition. These guiding principles play a crucial role in mitigating risks within the realm of cellular therapy.

Organizations interested in adopting the Standards for Cellular Therapy Services can access a complimentary two-week trial of the electronic version of the 11th edition in the Standards Portal. Individuals with questions regarding the CT Standards should contact AABB’s Standards Department at standards@aabb.org.