Tissue safety

Since early February 2020, in addition to our standard safety precautions and medical screening criteria, Eversight has adhered to comprehensive coronavirus disease 2019 (COVID-19) screening guidelines from the U.S. Food and Drug Administration (FDA) and Eye Bank Association of America (EBAA). We apply symptomatic and behavioral guidelines from these regulatory bodies in our protocols for screening potential eye tissue donors for known and suspected COVID-19, in addition to any COVID-19 testing conducted by the referring hospital. Only tissue from donors who are cleared accordingly may be used for transplantation.

Standard infection prevention

Eversight continually assesses the latest scientific research and eye banking practices to ensure our techniques best mitigate any and all infection risk, not just the risk of COVID-19 (SARS-CoV-2). We researched, developed and implemented an improved infection prevention protocol in October 2019, further mitigating the risk of tissue contamination at the time of procurement with a proven double 5.0% povidone-iodine (PVP-I) antiseptic soak.

PVP-I is a proven antiseptic that inactivates wide-spectrum microorganisms, including viruses, and its safety profile up to 10% concentration is well established.6 Studies demonstrate virucidal activity of PVP-I against other viruses that are similar to SARS-CoV-2, such as MERS-CoV and SARS-CoV.3, 7-9 Eversight's stringent donor preparation protocol remains in effect for all tissue procurement and we are investigating its efficacy in inactivating the SARS-CoV-2 virus.

Post-mortem SARS-CoV-2 testing discontinued July 2021

Regulatory bodies require that eye banks follow rigorous standard safety precautions and medical screening criteria that effectively ensure tissue safety. These requirements do not include testing for SARS-CoV-2. However, out of an abundance of caution, Eversight began testing potential surgical tissue donors for SARS-CoV-2 in June 2020 to provide additional peace of mind for patients and surgeons. In the 12 months that followed, researchers at Eversight and other institutions investigated the transmission of SARS-CoV-2 and its presence in the eye. The data available as of June 2021 shows:

  • SARS-CoV-2 does not replicate in human corneal explants.1
  • Povidone-iodine has virucidal effects against SARS-CoV and SARS-CoV-2.2,3
  • Across all blood, tissue, organ and eye donations, there has been only one reported transmission of COVID-19. In this case, an organ donor had a negative PCR test for COVID-19 and the recipient subsequently contracted COVID-19 after lung transplantation.4
  • There have been nine cases reported to the EBAA where COVID-19 was discovered in the medical history of the donor after corneal transplantation took place. To date, the recipients have not developed COVID-19.5

These findings indicate that post-mortem testing of donors for SARS-CoV-2 does not provide greater safety to cornea transplant recipients. As such, Eversight discontinued donor testing for SARS-CoV-2 in July 2021, while maintaining strict screening criteria in accordance with EBAA guidelines. As announced when testing was first implemented, it was a temporary measure until we had a better understanding of the true risk of transmission. We are proud to continually assess the science surrounding SARS-CoV-2 and have adjusted our testing protocol accordingly as our knowledge of the disease has evolved.

1 Miner, J.J., Platt, D.J., Ghaznavi, C.M., et al. s.l. HSV-1 and Zika virus but not SARS-CoV-2 replicate in the human cornea and are restricted by corneal type III interferon. s.l. : Cell Reports, Vol. 33. 10.1016/j.celrep.2020.108339 
2 Anderson, D.E., Sivalingam, V., Kang, A.E.Z., et al. Povidone-iodine demonstrates rapid in vitro virucidal activity against SARS-CoV-2, the virus causing COVID-19 disease. 669-675, s.l. : Infect Dis Ther, 2020, Vol. 9. 10.1007/s40121-020-00316-3 
3 Kariwa, H., N. Fujii, and I. Takashima, Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology, 2006. 212 Suppl 1: p. 119-23. doi: 10.1159/000089211 
4 Kaul D.R., et al. Donor to recipient transmission of SARS-CoV-2 by lung transplantation despite negative donor upper respiratory tract testing. Am J Transplant, 2021. doi: 10.1111/ajt.16532
5 EBAA Annual Meeting, June 2021
6 Kanagalingam, J., et al., Practical use of povidone-iodine antiseptic in the maintenance of oral health and in the prevention and treatment of common oropharyngeal infections. Int J Clin Pract, 2015. 69(11): p. 1247-56. doi: 10.1111/ijcp.12707 
7 Eggers, M., et al., In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther, 2018. 7(2): p. 249-259. doi: 10.1007/s40121-018-0200-7 
8 Eggers, M., M. Eickmann, and J. Zorn, Rapid and Effective Virucidal Activity of Povidone-Iodine Products Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Modified Vaccinia Virus Ankara (MVA). Infect Dis Ther, 2015. 4(4): p. 491-501. doi: 10.1007/s40121-015-0091-9 
9 Kampf, G., et al., Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. J Hosp Infect, 2020. 104(3): p. 246-251. doi: 10.1016/j.jhin.2020.01.022

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