National Consensus on Contraindications for Corneal Donation for Transplantation in Switzerland.

PURPOSE: To establish a national consensus on contraindications for corneal donation for transplantation in Switzerland. METHODS: Swisstransplant (SWT), the Swiss national foundation coordinating tissue and organ donations, convened a working group consisting of six national corneal surgeons and eye bankers and donation experts to create a contraindication list for corneal donation. The group reviewed available national and international guidelines and recommendations, while adhering to Swiss law and transplant regulations. In cases of opposing opinions, the group held follow-up meetings until a consensus was reached. A consensus was defined as agreement among all parties present. RESULTS: From March 2021 to November 2021, the study group held six meetings and created a standardized minimal contraindication list for corneal donation in Switzerland. Thanks to this list, SWT has created a mandatory working and documentation file for donor coordinators to use when evaluating multiorgan donors for corneal harvesting. The authors agreed that while the national consensus list provides standardized minimal contraindication criteria, local eye banks may choose to introduce additional, more rigorous criteria. CONCLUSION: Given that corneal transplantation is the most commonly performed transplantation, establishing a consensus on contraindications is crucial for recipient safety. The creation of a consensus on contraindications for corneal donation in Switzerland is an essential contribution to fulfil the legal requirements concerning quality assurance and provides sufficient high-quality donor tissue within the country. Therefore, periodic review and revision of the consensus is considered critical.

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

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.

Análise crítica das diferentes fontes de dados sobre transplante de córnea no Brasil / Critical analysis of the different data sources on corneal transplantation in Brazil

Resumo As doenças da córnea são responsáveis por cerca de 4 a 5% da cegueira reversível no mundo. O transplante de córnea é o tecido mais transplantado em todo o mundo e o único tratamento amplamente aceito para promover a transparência corneana e restaurar a visão. O monitoramento incorporou-se ao campo da Saúde Pública, com o objetivo de acompanhar sistematicamente a atuação das equipes e os dados de produção, por meio da criação de normas, inspeções de avaliação periódicas e acompanhamento dos indicadores de qualidade. As análises críticas dos resultados objetivam apontar falhas e riscos envolvidos no processo, e empreender ações capazes de modificar os achados negativos, a fim de aprimorar a qualidade dos serviços prestados à população. No Brasil, existem diferentes fontes de dados sobre transplantes de córnea e bancos de tecidos oculares. Nesta revisão, foi avaliada a precisão dos dados e a confiabilidade das informações divulgadas pelo Sistema Nacional de Transplantes, pela Associação Brasileira de Transplante de Órgãos e pela Agência Nacional de Vigilância Sanitária sobre a situação do transplante de córnea no Brasil, a fim de nortear governos, gestores em saúde pública e pesquisadores.

Abstract Corneal diseases account for about 4 to 5% of reversible blindness in the world. Corneal transplantation is the most transplanted tissue in the world and the only widely accepted treatment to promote corneal transparency and restore vision. Monitoring was incorporated into the field of Public Health, with the objective of systematically monitoring teams' performance and production data, through the creation of norms, periodic evaluation inspections and monitoring of quality indicators. The critical analyzes of the results aim to point out flaws and risks involved in the process, and to undertake actions capable of modifying the negative findings, in order to improve the quality of the services provided to the population. In Brazil, there are different sources of data on corneal transplants and ocular tissue banks. In this review, the accuracy of the data and the reliability of the information disclosed by the National Transplant System by the Brazilian Organ Transplant Association and the National Sanitary Surveillance Agency on the situation of corneal transplantation in Brazil were evaluated in order to guide governments, public health managers and researchers.

Doação e fila de transplante de córnea no Estado do Rio de Janeiro / Donation and waiting list for corneal transplantation in the State of Rio de Janeiro

O presente trabalho objetiva descrever o processo de doação, captação, fila de espera e transplante de órgãos e tecidos como uma das políticas de saúde no Brasil e no Estado do Rio de Janeiro, com ênfase nos procedimentos relativos aos transplantes de córnea. A baixa notificação de possíveis doadores e a alta taxa de negativa familiar na doação associado ao insuficiente número de córneas disponibilizadas por Banco de Olhos são os principais fatores que limitam o aumento do número dos transplantes de córnea no Brasil. A criação do Banco de Olhos do Rio de Janeiro, associado a politicas que estimulam o aumento da notificação e captação de córneas visa diminuir a fila de espera para transplante de córnea no Estado.

This paper aims to describe the process of organ and tissue donation, tissue harvesting, queue and transplants as a health policy in Brazil and in the State of Rio de Janeiro, with emphasis on procedures for corneal transplantation. The low reporting of possible donors associated with a high rate of negative family in donation, associated with the insufficient number of corneas provided by Eye Banks are the main factors limiting the increase in the number of corneal transplants in Brazil. The creation of the Rio de Janeiro Eye Bank associated with policies that encourage increased reporting and collection of corneas aims to reduce the waiting list for corneal transplantation in Rio de Janeiro State.

Creación, funcionamiento y control de bancos de córneas y esclerótica: acuerdo gubernativo No. 440-2013 / Creation, operation and control of corneal and scleral banks: government agreement No. 440-2013

El documento tiene algunos problemas de nitidez, que dificultan un tanto su lectura, pero solo al inicio. Las afecciones de córnea, son una de las 5 enfermedades que causan ceguera y que son prevenibles. Describe las normas y requisitos para su autorización y funcionamiento. Incluye varias definiciones de conceptos inherentes al tema del acuerdo. Además de describir la organización y estructura de los bancos de córneas, propone la conformación de un comité de trasplantes, describiendo los profesionales que deben conformarlo y sus específicas funciones. Describe también las funciones de los técnicos de cada establecimiento, público y/o privado. Enumera y describe las características físicas (infraestructura), así como el equipamiento y detalles complementarios que deberán ser cumplidas por cada establecimiento solicitante. Otro tanto hace con los detalles, tanto de donadores como de receptores.

[The 2009 performance report of the German cornea banks]. / Leistungsbericht der Deutschen Hornhautbanken 2009.

BACKGROUND: In Germany, human tissue for corneal and amniotic transplantation is supplied by 27 cornea banks. METHODS: The Section for Tissue Transplantation and Biotechnology of the German Ophthalmological Society records the cornea banks' activities by means of an annual questionnaire. RESULTS: In 2009, a total of 4,818 corneal grafts were processed by 21 responding cornea banks, and 57% were deemed suitable for transplantation. This ratio is slightly higher than the European average. In addition, German cornea banks released 1,257 amniotic grafts in 2009. DISCUSSION: German cornea banks are currently facing new regulatory issues due to updated legislation regarding tissue transplantation. Recent updates in European law have limited the cutoff time for postmortem blood sampling to 24 h, and this regulation may lead to a significant reduction in potential donors.

Practical implications of the law on tissues for cornea banks in Germany.

ISSUE: On August 1, 2007, the Law on the Quality and Safety of Human Tissues and Cells came into force. IMPLICATIONS: As a consequence of the new legislation on human tissue, legislative changes were effected upon the Law Regulating Transplantations, Medicine Law and Transfusion Law and the regulation of pharmacies as well as the operating regulations for wholesale pharmaceutical holdings. RESULTS AND CONCLUSION: The substantial increase in regulation caused by the Tissue Act far exceeds the requirements of the EC directive on tissues. As such, it has resulted in a huge increase in material (financial, human) and bureaucracy, with no significant gains in safety or quality in an area that had functioned well under the previous legislation.

[Corneal transplantation in Romania]. / Transplantul de cornee in Romania--actualitati, perspective.

The paper shows the activity of corneal transplantation in Romania. The author discuss about the aspects involved in this activity. The laws about donation, prelevation and surgery. Juridical aspects about activity of tissues banks. Human resources. Material resources. The author tries to find some solutions for improvement of this activity.

[Eye banks and available transplants]. / Biobank for øyesykdommer.

BACKGROUND: Eye banks have procured, processed and stored donor corneas for decades. In parallel, new techniques have emerged employing allogeneic transplantation of various cells and tissues from the eye banks. This progress is a consequence of increased knowledge of stem cells, cell kinetics and immunological aspects and improved techniques for cell culturing, tissue storage and microsurgery. MATERIAL AND METHODS: Review article on available transplants for treating eye diseases, based on experience with eye banking, clinical ophthalmological practice, own research and literature retrieved from PubMed, Medline and www.google.com. RESULTS AND INTERPRETATION: Treatment techniques for eye diseases, which require biological material for grafting, need efficient eye banks for continuous supply of donor material of high quality. New Norwegian legislation, based on implementation of EU Directive 2004/23/EC, demands authorization of all eye banks. The EU Directive sets high and rigorous standards for quality and safety for donation, procurement, testing, processing, storage and distribution of tissues and cells. Well-run eye banks are of great importance for modern treatment of patients suffering from eye diseases and for progress and research in ophthalmology.

Nineteen years of penetrating keratoplasty in the Hotel-Dieu Hospital in Paris.

PURPOSE: To identify changing trends in penetrating keratoplasties (PKs) performed at the Hotel-Dieu Hospital in Paris between January 1980 and December 1999 and to explain the reasons for the changes. METHODS: We retrospectively reviewed 3,736 of the 3,836 PKs performed between January 1, 1980, and December 31, 1999, and classified them into diagnostic categories. RESULTS: The most common indications for PK were keratoconus (28.8%), herpetic infections (10.9%), graft failures (9.9%), aphakic and pseudophakic corneal edema (9.9%), Fuchs' endothelial dystrophy (9.4%), and nonherpetic leucoma (7.7%). Other indications represented 23.4% of the cases. The incidence of aphakic and pseudophakic corneal edema progressively increased between 1980 and 1991, became the most frequent indication in 1991 (21.4%), and then progressively decreased. The annual number of PKs increased between 1980 and 1986, decreased between 1987 and 1997, and increased again after September 1997. The decrease was caused by both a shortage of corneal buttons, and, in 1987, the fear of transmitting diseases through corneal transplantation, particularly human immunodeficiency virus. Beginning in 1992, decreases were also associated with stringent governmental regulations of eye bank tissue. CONCLUSION: Changes in the incidence and management of corneal disorders were the primary factors leading to modifications of grafting until 1987. After 1987, corneal button shortage probably corresponded to the acquired immune deficiency syndrome epidemic. Governmental regulations of eye banking led to a severe corneal button shortage between 1992 and 1997. Despite an increase in the number of PKs performed after 1997, corneal buttons are still preferentially allocated to patients in whom there is a high probability of graft success.

The effect of state legislation on eye donation.

PURPOSE: Pennsylvania Act 102 implemented in March 1995 required all acute care hospitals in Pennsylvania to routinely refer all deaths to the Organ Procurement Organization for determination of suitability for organ/tissue donation. This study analyzed the effect of the law on eye donation. METHODS: Retrospective analysis of the total number of referrals and the actual number of eye donations from 62 hospitals in Pennsylvania to the Lions Eye Bank of Delaware Valley was performed for the years 1993 to 1998. Information gathered included donor's age, gender, race, cause of death, referring institution, and result of referral. RESULTS: From 1993 to 1998, the total numbers of referrals were 988, 1,647, 8,101, 21,123, 21,783, and 22,987, and the numbers of donors were 570, 574, 660, 644, 594, and 568, respectively. The increase in the number of donors after implementation of the law was not commensurate with the number of referrals. This was caused by a disproportionate increase in the number of referrals older than 70 years of age (from a mean of 33% to 52%), which exceeded the donor age limit of 69 years, and also to a lower family consent rate (from a mean of 48% to 24%). CONCLUSIONS: Well-designed state legislation with proper implementation greatly increased hospital referrals for eye donation. However, there was only a small increase in the number of eye donors because many of the referrals were beyond the acceptable upper age limit for eye donation. A small increase in the donor age limit would increase the number of eye donations without having to expand the potential donor pool. Education of the public may help to improve the family consent rate.

Eye banking: the business of restoring sight.

This continuing education article provides an overview of how an eye bank operates, offers general criteria about who can be a donor, and introduces the process by which eye donation takes place. In presenting this information, we hope to bring honor to the memory of all eye donors and thank them, their loved ones and families for this truly philanthropic gift.

Eye donation movement in India.

Late Dr RES Muthiah started the very first eye bank in India and the first corneal transplantation took place successfully by him in India in 1948. From then on a movement started for donation of eyes. The prime concept of Eye Bank Association of India (EBAI) is to motivate the people for eye donation. A vast propaganda throughout the country is going on for eye donation. The community should come forward shedding all inhibitions. EBAI has envisaged a master plan of action to regulate eye bank activities. Under this plan eye donation movement is catching up in the country.

[Plea for a graft]. / Plaidoyer pour un greffon.

With the promulgation of the "Bioethics" laws in 1994 in France, the Etablissement français des Greffes was endowed with the task of defining the principles controlling human tissue grafts in France. These laws require a precise control of all material and human input involved in each step of the grafting process. Organ removal from human cadavers by the ophthalmologist, graft preservation, validation of organ banks and recipient grafting by the surgeon are some of the many steps which must follow precise rules of good practices. All those who participate in these activities from organ removal to recipient grafting must comply with these rules to obtain the necessary administrative authorization. As the "Bioethics" laws will be re-evaluated in 1999, now is the time to propose possible alternatives aimed at increasing organ procurement and shortening patient waiting lists.