REGULATORY UPDATE: AABB Releases Toolkit to Support Implementation of FDA’s Mtb and Sepsis HCT/P Guidances
January 29, 2025
AABB developed the toolkit to assist members in implementing the recommendations described in two Food and Drug Administration guidances issued this month:
As described in the documents, FDA issued these guidances “without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (see 21 CFR 10.115(g)(2)).”
FDA’s decision reflects an urgent public health need to reduce the risk of transmission of Mtb by HCT/Ps and for updated recommendations in making a donor eligibility determination to reduce the risk of transmission of infections due to sepsis by HCT/Ps. The agency identified a public health safety concern during the
investigation of reports of Mycobacterium tuberculosis (Mtb) infections in recipients of allograft bone products.
“These multi-state outbreaks indicate that there is a risk of transmission of Mtb infection by HCT/Ps, and Mtb is a disease agent that can cause sepsis,” FDA said.
The toolkit is intended to supplement understanding of the new recommendations and offer questions and flowcharts that facilities may consider when developing protocols to meet the HCT/P donor eligibility recommendations of the final guidance documents.
Additionally, AABB has created a
stand-alone document that includes only the additional questions and flowcharts.
