Table of Contents
Screening Potential Cornea Donors with Signs Indicating Possible Sepsis
Bradley Gustave, MD, MBA, Robert Enzenauer, MD, MPH, Dean Vavra, MS, CEBT
sepsis, corneal transplant, eligibility, suitability, donor, recipient
CONTEXT: The Eye Bank Association of America Medical Standards provide guidance to participating eye banks on safe tissue donation. According to D1.110: Contraindications, tissue from donors with active septicemia is potentially health-threatening for recipients, can compromise the success of the operation, and should not be offered for penetrating keratoplasty. The Food and Drug Administration’s Guidance for Industry states that sepsis is often described by clinical evidence of infection and lists 10 signs to screen for in donors. However, this document notes that “these signs [should] be considered in light of other information obtained about the donor in making a donor eligibility determination.”
PURPOSE: (1) To assess whether an increasing number of Food and Drug Administration criteria for sepsis met by donor candidates correlates with a higher incidence of donor ineligibility and (2) whether any signs correlate with a higher incidence of sepsis and thus donor ineligibility.
METHODS: The medical records of 75 potential donors from the North Carolina Eye Bank with signs of possible sepsis were reviewed by an infectious disease consultant.
RESULTS: The only sign independently associated with active septicemia was positive blood culture (χ2=27.5; df=9; P<.001). Sixty-five percent of donors whose charts were reviewed were cleared as appropriate cornea donors who did not have active sepsis or bacteremia at the time of death.
CONCLUSIONS: When considering signs of sepsis, there is no clear cutoff at which an increased number of signs correlated with a higher likelihood of septicemia. These signs largely represent the physiologic response known as shock (all types), not just septic shock.
Eye Bank Association of America. Cornea Donation and Transplantation Statistics. www.restoresight.org/donation/statistics. Accessed May 15, 2011.
Aiken-O’Neill P. Eye Bank Association of America (EBAA) comments on the Food and Drug Administration’s published Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). 67 Federal Register 122; June 25, 2002. www.fda.gov/ohrms/dockets/dailys/02/Dec02/122402/80043a70.pdf. Released Dec. 23, 2002. Accessed July 14, 2012.
Eye Bank Association of America. Medical Standards. Washington, DC: EBAA; October 2011. www.restoresight.org/wp-content/uploads/2011/11/Medical-Standards-October-2011.pdf. Released October 2011.
U.S. Department of Health and Human Services. Title 21-Food and Drugs, Chapter 1-Food and Drug Administration, Subchapter L-Regulations Under Certain Other Acts Administered by the Food and Drug Administration, Part 1271-Human Cells, Tissues, and Cellular and Tissue Based Products-Subpart C-Donor Eligibility.
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1271.75. Updated April 1, 2011. Accessed July 14, 2012.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products. www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm073964.htm. Released August 2007. Accessed July 14, 2012.