Quality assurance in corneal transplants: Donor cornea assessment and oversight.

The cornea is the most frequently transplanted human tissue, and corneal transplantation represents the most successful allogeneic transplant worldwide. In order to obtain good surgical outcome and visual rehabilitation and to ensure the safety of the recipient, accurate screening of donors and donor tissues is necessary throughout the process. This mitigates the risks of transmission to the recipient, including infectious diseases and environmental contaminants, and ensures high optical and functional quality of the tissues. The process can be divided into 3 stages: (1) donor evaluation and selection before tissue harvest performed by the retrieval team, (2) tissue analysis during the storage phase conducted by the eye bank technicians after the retrieval, and, (3) tissue quality checks undertaken by the surgeons in the operating room before transplantation. Although process improvements over the years have greatly enhanced safety, quality, and outcome of the corneal transplants, a lack of standardization between centers during certain phases of the process still remains, and may impact on the quality and number of transplanted corneas. Here we detail the donor screening process for the retrieval teams, eye bank operators. and ophthalmic surgeons and examine the limitations associated with each of these stages.

Principais motivos de descarte de córneas para transplante na Paraíba: por que o anti-HBc merece atenção?* / Main reasons for discarding corneas for transplant in Paraíba: why does anti-HBc deserve attention?*

RESUMO Objetivo: Identificar o perfil dos doadores de tecidos oculares humanos na área de atuação do Banco de Olhos da Paraíba, destacando o impacto da sorologia positiva para hepatite B no descarte dos tecidos para transplante. Métodos: O estudo é transversal e utilizou dados do Banco de Olhos da Paraíba entre janeiro de 2013 e dezembro de 2022. Dados sobre procedência, idade, sexo, causa do óbito, tempo entre óbito e enucleação, resultados sorológicos e motivo de descarte das córneas dos doadores foram coletados. Resultados: O maior motivo de descarte foi por sorologia positiva (56,5%), sendo positivadas as sorologias positivas para hepatite B e HBsAg em 11,1% e 4,75% dos pacientes, respectivamente. Conclusão: A sorologia positiva para hepatite B como um critério de descarte absoluto é responsável por grande parcela de descartes, apesar da pouca informação sobre suas repercussões e representação de infectividade nos receptores do transplante.

ABSTRACT Objective: To identify the profile of human ocular tissue donors in the area covered by the Eye Bank of Paraíba (PB), highlighting the impact of positive serology for hepatitis B (anti-HBc) in the disposal of tissues for transplantation. Methods: This is a cross-sectional that uses data from the Eye Bank of Paraíba (PB) between January 2013 and December 2022. Data on origin, age, sex, cause of death, time between death and enucleation, serological results, and reason for discarded donor corneas were collected. Results: The main reason for discarding was due to positive serology (56.5%), with positive anti-HBc and HBsAg serology in 11.1% and 4.75% of patients, respectively. Conclusion: Anti-HBc positive serology as an absolute disposal criterion is responsible for great part of disposals, despite little information about its repercussions and representation of infectivity in transplant recipients.

Impact of the COVID-19 Pandemic on Keratoplasty and Corneal Eye Banking.

PURPOSE: The purpose of this study was to assess the impact of COVID-19 guidelines for corneal donor tissue screening and the utility of routine postmortem COVID-19 testing of donors intended for surgical use at a single eye bank. METHODS: A retrospective analysis of referrals to and eligible donors from an eye bank between March 1, 2020, and June 30, 2020, was performed, with the same time period in 2019 as a control. Referrals who were not procured because of Eye Bank Association of America COVID-19 guidelines and eye bank-specific restrictions were noted. The results of 1 month of routine postmortem testing performed by the eye bank were examined. Analysis of variance tests were performed to assess the change between donors from 2019 to 2020. RESULTS: There was a significant reduction in both the number of total referrals to the eye bank (P = 0.044) and donors eligible for surgical transplantation (P = 0.031). Eye Bank Association of America COVID-19 guidelines reduced the number of referrals over this period by 4% to 14%. Of the 266 surgically eligible donors who received postmortem COVID-19 testing in June by the eye bank, 13 resulted positive (4.9%). CONCLUSIONS: Despite a reduction in referrals and eligible corneal transplant donors at a single eye bank, there was a surplus of surgically suitable corneal tissue during the first wave of the COVID-19 pandemic. Eye banks should consider routine postmortem COVID-19 testing to identify asymptomatic infected donors although the risk of transmission of COVID-19 from infected donors is unknown.

SARS-CoV-2: Impact on, Risk Assessment and Countermeasures in German Eye Banks.

INTRODUCTION: Since the beginning of the COVID-19 pandemic there has been some debate regarding the risk of transmission through tissue transplantation and tissue banking processes. AIM OF THE STUDY: To analyze the changes that SARS-CoV-2 has caused regarding the harvesting of corneal donor tissue and eye bank activities in Germany. METHODS: A questionnaire was provided to 26 eye banks in Germany, consisting of questions about adaptations made in the screening of potential donors and the harvesting of corneal tissue following the pandemic spread of SARS-CoV-2. RESULTS: Eighteen eye banks actively reduced recruitment of donors and two banks ceased all activity. Additional diagnostic screening was performed in eight banks, using conjunctival swabs and/or nasopharyngeal swabs. In six eye banks, additional protective measures, such as FFP2 masks and/or facial shields, were implemented. Overall, a mean reduction in the number of obtained donor tissues of 17% was observed. DISCUSSION: Conjunctival and/or nasopharyngeal swabs of donors have been implemented by a minority. Reasons for not performing additional tests may be moderate sensitivity and lack of validation for postmortem use of RT-PCR testing. Also, the hazard of SARS-CoV-2 entering the corneal donor pool with subsequent transmission might be perceived as theoretical. Face shields provide a sufficient barrier against splash and splatter contamination but may be insufficient against aerosols. Additional face masks would provide support against aerosols, but it remains debatable if corneal harvesting can be considered an aerosol-producing procedure. In the future we expect to see changes in current guidelines because of a surge in scientific activities to improve our understanding of the risks involved with cornea donation in the COVID-19 pandemic, and because current practice may reduce the availability of donor corneas due to new exclusion criteria while the demand remains unchanged.

Webpalestra COVID-19 (Coronavírus): Bancos de Olhos e Transplantes de Córnea: impactos da pandemia COVID-19 no Brasil

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Eye banking in the coronavirus disease 2019 era.

PURPOSE OF REVIEW: Coronavirus disease 2019, caused by novel coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is highly infectious; however, the different routes of transmission are not well understood. Transmission through tissue transplantation is possible and must be considered. This review will evaluate the current literature regarding routes of transmission, the likelihood of transmission through ocular tissue transplantation, and the guidelines in place to mitigate this risk. RECENT FINDINGS: Although respiratory droplets have been the primary route of SARS-CoV-2 transmission, there is evidence that transmission through blood donation and organ or tissue transplantation is possible. This includes corneal transplantation, as SARS-CoV-2 has been detected in conjunctival swabs of infected patients, and the ocular surface may play an important role in viral entry. Several tissue transplantation organizations have guidelines in place regarding the screening of donors and tissue procurement procedures, including clinical and/or PCR screening of donors. The Eye Bank Association of America (EBAA) is currently not recommending asymptomatic PCR screening. However, their antiseptic protocols may play an important role in viral inactivation. SUMMARY: Based on the current literature and guidelines, the risk of SARS-CoV-2 transmission through corneal transplantation is likely low. However, tissue screening guidelines need to be re-evaluated regularly as knowledge regarding the SARS-CoV-2 virus evolves.

All India Ophthalmological Society - Eye Bank Association of India consensus statement on guidelines for cornea and eyebanking during COVID-19 era.

The COVID-19 pandemic has brought with it the huge burden of mortality and morbidity across the world and the added effects of the mandatory lockdown measures to try and control the spread. A number of aspects of healthcare including eye donation and eye collection require adequate safety precautions in place to keep both the involved healthcare workers and patients safe. This paper highlights the consensus-based guidelines by an expert panel on how to restart eye banking and eye collection services and carry out emergency corneal surgeries during this COVID-19 time. These guidelines will be applicable to all eye banks across the country and should help ophthalmologists and eye banking staff to restart eye banking while safeguarding themselves and their patients.

Ethics in Eye Banking: Understanding Professional Attitudes Toward Industry Changes.

PURPOSE: To describe the ethical attitudes of corneal surgeons and eye bank leadership toward for-profit entities in corneal donation, processing, and distribution. METHODS: Fifty postfellowship corneal surgeons practicing in the United States and 25 eye bank leaders (eg, eye bank directors, CEOs, or presidents) for the Eye Bank Association of America-accredited eye banks completed a 22-question interview, focusing on corneal donation industry changes, including the entry of for-profit institutions. RESULTS: Most participants in both study groups agreed that they have concerns with the entry of for-profit businesses into eye banking (62% corneal surgeons, 68% eye bank leadership), although physicians partnered with a for-profit corneal processor were significantly more likely to have no concerns with the entry of for-profits into eye banking than corneal surgeons partnered with a nonprofit processor (P = 0.04). The most frequently identified concerns with the entry of for-profit businesses into corneal banking were the hypothetical loss of donor trust (56% corneal surgeons, 64% eye bank leadership, P = 0.04) and the potential exploitation of donor generosity (72% corneal surgeons, 60% eye bank leadership). Qualitative theme analysis suggests that both study groups may view increased research/innovation as a potential benefit (64% corneal surgeons, 66% eye bank leadership) of for-profits in eye banking. CONCLUSIONS: Key stakeholders in eye banking do hold relevant ethical beliefs toward recent industry changes, and these attitudes should be considered in the future creation of the ethical corneal donation policy. Further research is needed to assess the attitudes of potential donors and donor families.

Donor characteristics and risk factors for methicillin-resistant Staphylococcus aureus contamination in storage medium for corneal transplantation: A 10-year retrospective study.

PURPOSE: This study investigated the donor characteristics of methicillin-resistant Staphylococcus aureus (MRSA) contamination in storage medium before transfer of corneas to preservation medium for corneal transplantation, in order to identify donor characteristic risk factors for MRSA contamination. METHODS: This retrospective, cross-sectional study was performed using Juntendo Eye Bank records for all corneal transplantation procedures. Storage medium (EP-II® ) cultures for right eyes were included for the period between July 2008 and December 2017. The following donor characteristics were collected: age, sex, cause of death, history of cataract surgery, death-to-enucleation interval, death-to-preservation interval, and endothelial cell density (ECD). Donor characteristics were compared between MRSA and non-MRSA contamination groups. Odds ratios (ORs) for donor-related risk factors for MRSA contamination were determined using logistic regression. RESULTS: In total, 370 storage medium samples were examined; 222 were positive for bacterial cultures (60.0%) and 36 were MRSA-positive (9.7%). Donor age was significantly higher in the MRSA contamination group than in the non-MRSA contamination group (86.1 ± 9.5 years vs 75.9 ± 15.9 years, P < 0.001). Univariate logistic regression analysis showed that MRSA contamination risk factors were older age (OR = 1.07; 95% confidence interval [95% CI]: 1.03-1.11) and decreased ECD (OR = 0.9993; 95% CI: 0.9986-0.9992). The fully adjusted OR for every year of age as a risk factor for MRSA contamination was 1.07 (95% CI: 1.03-1.11). CONCLUSIONS: Aging was a risk factor for MRSA contamination in storage medium. Careful pre-banking assessment of elderly donor corneas is needed to prevent intractable postoperative MRSA infection.

Endothelial assessment of donated tectonic corneas: a viable option for posterior lamellar transplantation.

PURPOSE: Donated corneas are classified as tectonic if there are defects within any layers of the cornea which would prevent a satisfactory visual outcome after transplantation. This study aimed to evaluate whether some tectonic corneas have sufficient endothelial characteristics to allow their use in posterior lamellar keratoplasty, and explored their reclassification for use in this sight-improving procedure. METHODS: A retrospective review of all corneal tissues preserved by the Sorocaba Eye Bank from January to April of 2014 was performed. All donated corneas classified as tectonic were included. Endothelial tissue was defined as healthy and viable for posterior lamellar keratoplasty if endothelial cell density was ≥2000 cells/mm2. Additional parameters analyzed included Descemet folds and stretch marks, loss of endothelial cells, corneal endothelial polymegathism/ pleomorphism, pseudo-guttata, and reflectivity. RESULTS: During the study period, 2,847 corneas were preserved, of which 423 (14.85%) were classified as tectonic. Of these, 87 (20.56%) were reported as having endothelial viability and were included in the posterior lamellar keratoplasty group. Average corneal endothelial cell density of this group was 2,471 SD ± 256 cells/mm2 (range 2012-2967 cells/mm2). CONCLUSION: A significant number of corneas classified as tectonic showed endothelial viability and were included in the posterior lamellar keratoplasty group (20.56%). Despite stromal and/or epithelial alterations, these corneas could have been potentially distributed for posterior lamellar transplantation to improve vision, thus reducing the corneal transplantation waiting period. This study highlights how corneal tissue reclassification could increase the potential amount of corneal tissue available for optical transplantation.

Endothelial assessment of donated tectonic corneas: a viable option for posterior lamellar transplantation / Avaliação da viabilidade do uso de córneas tectônicas em transplantes lamelares posteriores a partir da análise da vitalidade das células endoteliais

ABSTRACT Purpose: Donated corneas are classified as tectonic if there are defects within any layers of the cornea which would prevent a satisfactory visual outcome after transplantation. This study aimed to evaluate whether some tectonic corneas have sufficient endothelial characteristics to allow their use in posterior lamellar keratoplasty, and explored their reclassification for use in this sight-improving procedure. Methods: A retrospective review of all corneal tissues preserved by the Sorocaba Eye Bank from January to April of 2014 was performed. All donated corneas classified as tectonic were included. Endothelial tissue was defined as healthy and viable for posterior lamellar keratoplasty if endothelial cell density was ≥2000 cells/mm2. Additional parameters analyzed included Descemet folds and stretch marks, loss of endothelial cells, corneal endothelial polymegathism/ pleomorphism, pseudo-guttata, and reflectivity. Results: During the study period, 2,847 corneas were preserved, of which 423 (14.85%) were classified as tectonic. Of these, 87 (20.56%) were reported as having endothelial viability and were included in the posterior lamellar keratoplasty group. Average corneal endothelial cell density of this group was 2,471 SD ± 256 cells/mm2 (range 2012-2967 cells/mm2). Conclusion: A significant number of corneas classified as tectonic showed endothelial viability and were included in the posterior lamellar keratoplasty group (20.56%). Despite stromal and/or epithelial alterations, these corneas could have been potentially distributed for posterior lamellar transplantation to improve vision, thus reducing the corneal transplantation waiting period. This study highlights how corneal tissue reclassification could increase the potential amount of corneal tissue available for optical transplantation.

RESUMO Objetivo: Avaliar a vitalidade endotelial das córneas classificadas como tectônicas e discutir a viabilidade de seu uso na ceratoplastia lamelar posterior. Métodos: Realizou-se uma revisão retrospectiva de todos os tecidos corneanos preservados pelo Banco de Olhos Sorocaba de janeiro a abril de 2014. Todas as córneas doadas classificadas como tectônicas foram incluídas e avaliadas com ênfase na vitalidade endotelial. Os parâmetros de avaliação da lâmpada de fenda de cada córnea e densidade de células endoteliais medidos por microscópio especular foram registrados: córneas que apresentavam vitalidade endotelial apesar de alterações no estroma e/ou no epitélio foram selecionadas e incluídas em um grupo denominado grupo lamelar posterior. O tecido endotelial foi definido como saudável e viável para a ceratoplastia lamelar posterior, se houvesse uma densidade de células endoteliais ≥2.000 células/mm2. Outros parâmetros também foram analisados, incluindo; estrias ou pregas na Descemet, perda de células endoteliais, polimegatismo e pleomorfismo endotelial, pseudo-guttata e reflexividade endotelial. Resultados: Durante o período do estudo, foram preservadas 2.847 córneas, das quais 423 (14,85%) foram classificadas como tectônicas. Dessas, 87 (20,56%) apresentaram vitalidade endotelial e foram incluídos no grupo lamelar posterior. A densidade média das células endoteliais da córnea deste grupo era de 2.471 SD ± 256 células/mm2, variando de 2.012 a 2.967 células/mm2. Conclusão: Um número significativo de córneas classificadas como tectônicas apresentaram vitalidade endotelial e foram incluídas no grupo lamelar posterior (20,56%). Apesar de alterações estromais e/ou epiteliais, estas córneas poderiam ter sido potencialmente distribuídas para transplantes lamelares posteriores com finalidade ótica, otimizando a disponibilidade de tecidos, com impacto positivo na saúde pública.

Eye bank procedures: donor selection criteria.

Eye banks use sterile procedures to manipulate the eye, antiseptic measures for ocular surface decontamination, and rigorous criteria for donor selection to minimize the possibility of disease transmission due to corneal grafting. Donor selection focuses on analysis of medical records and specific post-mortem serological tests. To guide and standardize procedures, eye bank associations and government agencies provide lists of absolute and relative contraindications for use of the tissue based on donor health history. These lists are guardians of the Hippocratic principle "primum non nocere." However, each transplantation carries risk of transmission of potentially harmful agents to the recipient. The aim of the procedures is not to eliminate risk, but limit it to a reasonable level. The balance between safety and corneal availability needs to be maintained by exercising prudence without disproportionate rigor.

Quality indicators for eye bank.

PURPOSE: The aim of this study is to identify quality indicators of the eye bank and validate their effectivity. METHODS: Adverse reaction rate, discard rate, protocol deviation rate, and compliance rate were defined as Quality Indicators of the eye bank. These were identified based on definition of quality that captures two dimensions - "result quality" and "process quality." The indicators were measured and tracked as part of quality assurance (QA) program of the eye bank. Regular audits were performed to validate alignment of standard operating procedures (SOP) with regulatory and surgeon acceptance standards and alignment of activities performed in the eye bank with the SOP. Prospective study of the indicators was performed by comparing their observed values over the period 2011-2016. RESULTS: Adverse reaction rate decreased more than 8-fold (from 0.61% to 0.07%), discard rate decreased and stabilized at 30%, protocol deviation rate decreased from 1.05% to 0.08%, and compliance rate reported by annual quality audits improved from 59% to 96% at the same time. In effect, adverse reaction rate, discard rate, and protocol deviation rate were leading indicators, and compliance rate was the trailing indicator. CONCLUSION: These indicators fulfill an important gap in available literature on QA in eye banking. There are two ways in which these findings can be meaningful. First, eye banks which are new to quality measurement can adopt these indicators. Second, eye banks which are already deeply engaged in quality improvement can test these indicators in their eye bank, thereby incorporating them widely and improving them over time.

Eye bank procedures: donor selection criteria / Procedimentos em banco de olhos: critério de seleção do doador

ABSTRACT Eye banks use sterile procedures to manipulate the eye, antiseptic measures for ocular surface decontamination, and rigorous criteria for donor selection to minimize the possibility of disease transmission due to corneal grafting. Donor selection focuses on analysis of medical records and specific post-mortem serological tests. To guide and standardize procedures, eye bank associations and government agencies provide lists of absolute and relative contraindications for use of the tissue based on donor health history. These lists are guardians of the Hippocratic principle "primum non nocere." However, each transplantation carries risk of transmission of potentially harmful agents to the recipient. The aim of the procedures is not to eliminate risk, but limit it to a reasonable level. The balance between safety and corneal availability needs to be maintained by exercising prudence without disproportionate rigor.

RESUMO Os bancos de olhos utilizam procedimentos estéreis na manipulação dos olhos, medidas antissépticas para a descontaminação da superfície ocular e critério rigoroso de seleção do doador. Essa seleção é feita por meio do prontuário médico e de testes sorológicos específicos post mortem. Para orientá-la e uniformizá-la, as associações de bancos de olhos e órgãos governamentais fornecem listas de contraindicações absolutas e relativas de uso do tecido, baseadas nas condições prévias de saúde do doador. Essas listas são as guardiãs do princípio de Hipócrates "primum non nocere" e, como tal, são conservadoras. Entretanto, cada transplante traz o risco de transmissão de agentes potencialmente nocivos ao receptor. O objetivo não é eliminar esse risco, mas limitá-lo a um nível razoável. Existe um equilíbrio entre a segurança e a disponibilidade de córneas. A sabedoria está em manter esse equilíbrio, exercendo a prudência sem rigor exagerado.

Technician Consistency in Specular Microscopy Measurements: A "Real-World" Retrospective Analysis of a United States Eye Bank.

PURPOSE: To quantify consistency of endothelial cell density (ECD) measurements among technicians in a single US eye bank operating under typical operating conditions. METHODS: In this retrospective analysis of 51 microscopy technicians using a semiautomated counting method on 35,067 eyes from July 2007 to May 2015, technician- and date-related marginal ECD effects were calculated using linear regression models. ECD variance was correlated with the number of specular microscopy technicians. RESULTS: Technician mean ECDs ranged from 2386 ± 431 to 3005 ± 560 cells/mm. Nine technicians had statistically and clinically significant marginal effects. Annual mean ECDs adjusted for changes in technicians ranged from 2422 ± 433 to 2644 ± 430 cells/mm. The period of 2007 to 2009 had statistically and clinically significant marginal effects. There was a nonstatistically significant association between the number of technicians and ECD standard deviation. CONCLUSIONS: There was significant ECD variability associated with specular microscopy technicians and with the date of measurement. We recommend that eye banks collect data related to laboratory factors that have been shown to influence ECD variability.

Ethical Issues in Transnational Eye Banking.

PURPOSE: To review ethical issues that may arise in the setting of transnational eye banking activities, such as when exporting or importing corneal tissue for transplantation. METHODS: A principle-based normative analysis of potential common dilemmas in transnational eye banking activities was performed. RESULTS: Transnational activities in eye banking, like those in other fields involving procurement and use of medical products of human origin, may present a number of ethical issues for policy makers and professionals. Key ethical concerns include the potential impact of export or import activities on self-sufficiency of corneal tissue supply within exporting and importing countries; potential disclosure requirements when obtaining consent or authorization for ocular tissue donation when donations may be exported; and difficulties inherent in assuring equity in the allocation of tissues available for export and in establishing and respecting standards of safety and quality across different jurisdictions. CONCLUSIONS: Further analysis of specific ethical issues in eye banking is necessary to inform development of guidelines and other governance tools that will assist policy makers and professionals to support ethical practice.