4.4 Article

Association of Federal Regulations in the United States and Canada With Potential Corneal Donation by Men Who Have Sex With Men

Journal

JAMA OPHTHALMOLOGY
Volume 138, Issue 11, Pages 1143-1149

Publisher

AMER MEDICAL ASSOC
DOI: 10.1001/jamaophthalmol.2020.3630

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Question Regarding federal policy in the United States that prohibits corneal donation by men who have had sex with another man (MSM) in the preceding 5 years (or 12 months in Canada), what is the association of these policies with the supply of donated corneas? Findings These policies were associated with the disqualification of an estimated 1558 to 3217 corneal donations by otherwise eligible MSM donors in the United States and Canada in 2018. Meaning With reliable modern HIV testing and with many countries experiencing severe corneal shortages, these federal policies may be decreasing the availability of vision-restoring surgery, suggesting these policies should be reevaluated in light of current scientific evidence. This survey study estimates the number of potential corneal donations associated with deferral policies in the United States and Canada for men who have had sex with another man. Importance Federal policy in the United States prohibits corneal donation by men who have had sex with another man (MSM) in the preceding 5 years, whereas Canada enforces a 12-month ban. The potential consequences of these policies on corneal donations should be evaluated. Objective To estimate the number of potential corneal donations associated with MSM deferral policies in the United States and Canada. Design, Setting, and Participants A nonvalidated telephone survey study was conducted of all 65 eye banks in the United States and Canada to investigate how many potential corneal donors were disqualified in 2018 because of federal MSM restrictions. Published demographic data were also used to arrive at a separate estimate. Survey data were gathered from May 2019 to February 2020. Main Outcomes and Measures Eye banks were asked if they keep records of referrals disqualified specifically because of the federal MSM restrictions and, if so, how many referrals they disqualified in 2018 owing to MSM status. Results Fifty-four of 65 eye banks (83%) responded to the survey, with 30 eye banks reporting they do not keep specific records of MSM deferrals. The remaining 24 eye banks reported disqualifying 360 referrals in 2018 because of MSM status, equating to 720 corneas. The 24 eye banks accounted for 46.2% of corneal donations in the United States and Canada in 2018, yielding an estimate of approximately 1558 corneas rejected that year because of MSM status. A separate estimate using published MSM demographic data indicates that up to 3217 potential corneal donations may have been disqualified in 2018 because of these federal policies. Conclusions and Relevance Findings suggest that between 1558 and 3217 corneal donations were disqualified in 2018 because of federal regulations prohibiting corneal donation by men who have had sex with another man in the preceding 5 years in the United States or 1 year in Canada. With modern virologic testing that is reliable within days of HIV exposure and given the global shortage of corneal tissue, these policies should be reevaluated using current scientific evidence to increase the availability of vision-restoring surgery worldwide.

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