AATB Submits Comment Letter to FDA on Sepsis Classification in Donor Eligibility Guidance

AATB recently submitted a comment letter to the US Food and Drug Administration (FDA) regarding the agency’s 2007 donor eligibility guidance, which determined that sepsis is a relevant communicable disease agent or disease (RCDAD).

In this comment letter and the two previous comment letters we have included alongside it, AATB urges FDA to rescind this determination. AATB further explains that sepsis does not meet the agency’s criteria for RCDADs and that its classification as such has become increasingly problematic since 2007 for various reasons, including changes in medical documentation associated with electronic medical records, billing practices, and other factors. The letter also notes that sepsis is a poor surrogate for transmissible disease risk.

AATB recommends that FDA instead support a more comprehensive donor evaluation approach that considers donor characteristics and epidemiological exposures, the adequacy of medical records, tissue type and processing methods, and pre-donation assessments. AATB is currently developing guidelines to support this approach, which will help more effectively identify unsafe donors while preserving access to safe, life-enhancing tissue. 

You can read AATB’s full comments and find all related advocacy communications on the Government Advocacy Correspondences page of the AATB website.