On January 6, 2025, the FDA published 6 guidance documents for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Two of the new guidances, the Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by HCT/Ps (Sepsis guidance) and Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by HCT/Ps (Mtb guidance), were issued as final guidance for immediate implementation, without public comment.
EBAA submitted comments January 17th to these final guidances and sent a detailed letter to FDA, asking for an extension on the implementation of the TB and sepsis final guidances, on the grounds that they represent such significant changes to eye banks’ processes that they cannot reasonably be implemented by the February 3 deadline.
We held an Informational Session: The Recent FDA Guidances Analysis and Discussion on January 22, released Quick Analysis of HCT/P Guidances, and provided an FDA update during the Town Hall. We prepared an open letter to surgeons and surgery centers explaining the circumstances around the FDA’s actions and their implications for their practices.
EBAA also submitted comments for the membership to FDA’s draft guidances that address HCT/P donor eligibility and recommendations to reduce the risk of HIV, hepatitis B virus and hepatitis C virus transmission by HCT/Ps.
FDA announced a revised implementation date of May 4, 2025for the recently released Sepsis and Mtb guidances.
EBAA, AATB, and AOPO submitted a joint letter to FDA Commissioner Marty Makary, MD reiterating concerns about the final Sepsis and Mycobacterium tuberculosis (Mtb) guidance documents issued on January 6, 2025.
FDA withdrew its final guidances on tuberculosis and sepsis and reissued both as draft guidances with a public comment period on May 2, 2025. EBAA prepared crosswalk documents to highlight the updates in both the Mtb guidance and the sepsis guidance.
EBAA held an informative webinar entitled Legal Perspectives on Recent FDA Guidance to unpack the legal and operational implications of these guidances, how the regulations should be interpreted, and what to include in eye bank comments to FDA.
The Sepsis Working Group created a workflow tool designed to assist eye bank Medical Director Designees and Medical Directors in determining the need for a consultation with the primary treating physician when considering a sepsis diagnosis. It is intended as a guidance document, not a medical standard. The tool outlines steps for evaluating potential sepsis, including:
- Deferral if sepsis is confirmed with no alternative explanation.
- Further review and consultation if sepsis is suspected but not confirmed.
- Use of a treating physician or knowledgeable healthcare professional for additional medical history.
EBAA submitted comments to the FDA on behalf of the membership to the revised draft guidance documents on reducing the risk of transmission of disease agents associated with sepsis and Mycobacterium tuberculosis (Mtb) by HCT/Ps.
EBAA challenged FDA’s classification of sepsis as a relevant communicable disease agent or disease (RCDAD). Donor screening criteria for sepsis would best be aligned with the presence of a true systemic infection transmissible by tissues, not the physiologic response to an infection. The cornea, being an avascular tissue, significantly reduces and/or eliminates the risk of transmitting sepsis-associated microbial pathogens to a recipient. Our comments also outline several practical concerns associated with these recommendations.
EBAA agrees with the FDA in identifying Mycobacterium tuberculosis (Mtb) as an RCDAD. However, many of the signs, symptoms, and exposure risks identified in the draft are nonspecific and may result in overly broad donor deferrals. We are concerned that donors with a false-positive TST must be deferred, despite the absence of any symptoms, exposure history, or radiographic findings. We ask that FDA further define “frequently” with regard to travel to TB endemic countries. We question the need to screen donors for nonspecific risk factors and medical conditions in the absence of clinical or physical evidence or suspicion of LTBI or TB disease.
EBAA will continue our engagement with FDA to ensure a safe and sufficient supply of ocular tissue for sight-restoring procedures. In September, EBAA requested a Liaison Meeting with CBER to present our concerns and expand on our regulatory comments. We plan to share EBAA initiatives and priorities, such as our medical standard changes in rabies screening, work on the UDRAI Task Force, and results of the Diabetes Endothelial Keratoplasty Study (DEKS) study. Due to the government shutdown, this meeting has yet to be scheduled by the Office of Therapeutic Products (OTP). We are hopeful this will occur in early 2026.
EBAA Response to Transplant-Transmitted Rabies Case
CDC reported a potential rabies transmission in a kidney transplant recipient who showed acute neurologic decline and hydrophobia before passing. Rabies was confirmed via PCR in an archived sample of the donor’s kidney, confirming organ-derived transmission.
The Donor Risk Assessment Interview (DRAI) questionnaire reported that the donor had been scratched by a skunk six weeks prior, with no follow-up or quarantine.
Corneal tissue from the same donor was used in two DMEK procedures and one gamma-irradiated CTAK. The cornea recipients underwent precautionary graft removal, received PEP and remained asymptomatic. CDC detected rabies virus RNA consistent with a silver-haired bat rabies virus variant in one previously implanted corneal graft.
The Medical Review Subcommittee released an Informational Alert on Rabies Screening with proposed EBAA Medical Standard changes.
The MAB approved the proposed revision to D1.110: EBAA Contraindications to Transplant at their June meeting.
- donors with suspected rabies, as well as persons who were bitten or scratched within the past 12 months by an animal suspected to be infected with rabies, or whose condition is otherwise unknown, should be deferred
Accreditation Modernization
EBAA purchased the ARMATURE Fabric™ Accreditation Management Software (AMS) platform to modernize our accreditation program. This will transform our accreditation workflows into an online platform, streamlining the process for eye banks, AB inspectors, and staff. The anticipated go-live date is February, 2026, with plans for use during the Fall 2026 Accreditation cycle.
EBAA plans to hire a part-time Administrative Inspector to review all accreditation documents to ensure completion and accuracy and assist the on-site inspectors.
The ARMATURE platform was paid for through the generosity of the Gene and Clara Gleissner Memorial Trust.
