The importance of establishing an international network of tissue banks and regional tissue processing centers

During the past four decades, many tissue banks have been established across the world with the aim of supplying sterilized tissues for clinical use and research purposes. Between 1972 and 2005, the International Atomic Energy Agency supported the establishment of more than sixty of these tissue banks in Latin America and the Caribbean, Asia and the Pacific, Africa and Eastern Europe; promoted the use of the ionizing radiation technique for the sterilization of the processed tissues; and encouraged cooperation between the established tissue banks during the implementation of its program on radiation and tissue banking at national, regional and international levels. Taking into account that several of the established tissue banks have gained a rich experience in the procurement, processing, sterilization, storage, and medical use of sterilized tissues, it is time now to strengthen further international and regional cooperation among interested tissue banks located in different countries. The purpose of this cooperation is to share the experience gained by these banks in the procurement, processing, sterilization, storage, and used of different types of tissues in certain medical treatments and research activities. This could be done through the establishment of a network of tissue banks and a limited number of regional tissue processing centers in different regions of the world.     

Development of a transplantation transmission sentinel network to improve safety and traceability of organ and tissues

The US lags behind other developed countries in creating a system to monitor disease transmission and other complications from human allograft use, despite a pressing need. The risks of transmission are amplified in transplantation, since at least 8 organs and more than 100 tissues can be recovered from a single common organ and tissue donor. Moreover, since many allografts collected in the US are distributed internationally, tissue safety is a global concern. In June 2005, participants of a US government-sponsored workshop concluded that a communication network for the tracking and reporting of disease transmissions for tissues and organs was critically needed. The United Network for Organ Sharing (UNOS) entered into a cooperative agreement with the Centers for Disease Control and Prevention (CDC) in 2006 to develop a system prototype. Over the following 3 years, the Transplantation Transmission Sentinel Network (TTSN) was developed and piloted with the participation of organ procurement organizations, tissue banks and transplant centers. The prototype centered around three elements of data entry: (1) donation, (2) tissue implantation, and (3) adverse event. The pilot proved that a system can be built and operated successfully, but also suggested that users may be hesitant to report adverse events. CDC has requested further input on scope and cost to build a transplant surveillance infrastructure for a fully functional national system. For tissues however, in contrast to organs, tracking from recovery to implantation will be necessary before a system is operable, requiring common identifiers and nomenclature. Until a US sentinel network is operational, future transmission events that are preventable may result nationally and globally due to its absence.     

A future vision of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking for Asia and the Pacific and Latin American regions

In order to solve some of the problems that are affecting tissue banking activities in the world, a new program/project proposal could be prepared by the IAEA and interested Member States in order to implement it in 2009. The main objective of the new program/project proposal could be the following: To consolidate tissue banks activities in a selected group of IAEA Member States by increasing the quality of the tissue processing and sterilization methods used. The specific objective to be reached by the new program/project proposal could be the following: To reach international standards in all activities carried out by a selected group of tissue banks, as well as the establishment of a limited regional tissue processing centres in specific regions. The following are the conditions to be met by the interested tissue banks, in order to participate in the new program/project proposal: To process different types of tissues for medical treatment using the ionizing radiation technique for tissue sterilization; To apply at least one of the current version of the IAEA Code of Practice, the IAEA Standards and the IAEA Public Awareness Strategies and to have the support of national health authorities for the use of the remaining IAEA documents in the near future; To have in force agreements with public and private hospitals for the use of the sterilized tissues processed by the bank for medical treatment; To have in place a donor referral system, or has the approval by the national health authorities to adopt such system in the near future; To receive the support from the national health authority to participate in the implementation of the new program/project proposal.     

The importance of ethic in the field of human tissue banking

A tissue bank is accountable before the community in fulfilling the expectations of tissue donors, their families and recipients. The expected output from the altruistic donation is that safe and high quality human tissue grafts will be provided for the medical treatment of patients. Thus, undertakings of tissue banks have to be not only authorised and audited by national competent health care authorities, but also comply with a strong ethical code, a code of practices and ethical principles. Ethical practice in the field of tissue banking requires the setting of principles, the identification of possible deviations and the establishment of mechanisms that will detect and hinder abuses that may occur during the procurement, processing and distribution of human tissues for transplantation. The opinions and suggestions manifested by the authors in this paper may not be necessarily a reflection of those within the institutions or community they are linked to.     

Regulatory aspects of tissue donation,banking and transplantation in India

Amendments to India’s Transplantation of Human Organs Act, 1994, have established the legality of tissue donation and transplantation from deceased donors and the conditions under which they are permitted. The amended Act, now known as The Transplantation of Human Organs and Tissues Act, 1994, seeks to prevent the commercialization of tissue donation and to guarantee the safety of indigenous allografts. Registration of tissue banks, compliance with national standards and the appointment of transplant co-ordinators in hospitals registered under the Act are now mandatory. A national registry and Regional and State networks for donation and transplantation of tissues have been introduced. Despite the amendments a few anomalies of the principal Act persist as some of the differences between tissue and organ donation and transplantation have been overlooked. These include the possibility of skin donation in locations other than hospitals; the donation of medical and surgical tissue residues which does not pose any risk to the living donor; the non-requirement for compatibility between donor and recipient; the delayed time factor between tissue donation and transplantation which makes identification of a recipient at the time of donation impossible; and the easy availability of alternatives to tissues which make waiting lists redundant for many tissues. Rules for the implementation of the amended Act were framed in 2014 but like the Act must be adopted by the State health assemblies to become universally applicable in the country.     

Tissue allograft coding and traceability in USM Tissue Bank,Malaysia

In Malaysia, tissue banking activities began in Universiti Sains Malaysia (USM) Tissue Bank in early 1990s. Since then a few other bone banks have been set up in other government hospitals and institutions. However, these banks are not governed by the national authority. In addition there is no requirement set by the national regulatory authority on coding and traceability for donated human tissues for transplantation. Hence, USM Tissue Bank has taken the initiatives to adopt a system that enables the traceability of tissues between the donor, the processed tissue and the recipient based on other international standards for tissue banks. The traceability trail has been effective and the bank is certified compliance to the international standard ISO 9001:2008.     

Coding and traceability for cells,tissues and organs for transplantation

Modern transplantation of cells, tissues and organs has been practiced within the last century achieving both life saving and enhancing results. Associated risks have been recognized including infectious disease transmission, malignancy, immune mediated disease and graft failure. This has resulted in establishment of government regulation, professional standard setting and establishment of vigilance and surveillance systems for early detection and prevention and to improve patient safety. The increased transportation of grafts across national boundaries has made traceability difficult and sometimes impossible. Experience during the first Gulf War with miss-identification of blood units coming from multiple countries without standardized coding and labeling has led international organizations to develop standardized nomenclature and coding for blood. Following this example, cell therapy and tissue transplant practitioners have also moved to standardization of coding systems. Establishment of an international coding system has progressed rapidly and implementation for blood has demonstrated multiple advantages. WHO has held two global consultations on human cells and tissues for transplantation, which recognized the global circulation of cells and tissues and growing commercialization and the need for means of coding to identify tissues and cells used in transplantation, are essential for full traceability. There is currently a wide diversity in the identification and coding of tissue and cell products. For tissues, with a few exceptions, product terminology has not been standardized even at the national level. Progress has been made in blood and cell therapies with a slow and steady trend towards implementation of the international code ISBT 128. Across all fields, there are now 3,700 licensed facilities in 66 countries. Efforts are necessary to encourage the introduction of a standardized international coding system for donation identification numbers, such as ISBT 128, for all donated biologic products.     

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Argentina

Tissue banking activities in Argentina started in 1993. The regulatory and controlling national authority on organ, tissue and cells for transplantation activity is the National Unique Coordinating Central Institute for Ablation and Implant (INCUCAI). Three tissue banks were established under the IAEA program and nine other banks participated actively in the implementation of this program. As result of the implementation of the IAEA program in Argentina and the work done by the established tissue banks, more and more hospitals are now using, in a routine manner, radiation sterilised tissues processed by these banks. During the period 1992–2005, more than 21 016 tissues were produced and irradiated in the tissue banks participating in the IAEA program. Within the framework of the training component of the IAEA program, Argentina has been selected to host the Regional Training Centre for Latin American. In this centre, tissue bank operators and medical personal from Latin American countries were trained. Since 1999, Argentina has organised four regular regional training courses and two virtual regional training courses. More than twenty (20) tissue bank operators and medical personnel from Argentina were trained under the IAEA program in the six courses organised in the country. In general, ninety (96) tissue bank operators and medical personnel from eight Latin-American countries were trained in the Buenos Aires regional training centre. From Argentina 16 students graduated in these courses.     

Will more organs save more lives? Cost‐effectiveness and the ethics of expanding organ procurement

The assumption that procuring more organs will save more lives has inspired increasingly forceful calls to increase organ procurement. This project, in contrast, directly questions the premise that more organ transplantation means more lives saved. Its argument begins with the fact that resources are limited and medical procedures have opportunity costs. Because many other lifesaving interventions are more cost‐effective than transplantation and compete with transplantation for a limited budget, spending on organ transplantation consumes resources that could have been used to save a greater number of other lives. This argument has not yet been advanced in debates over expanded procurement and could buttress existing concerns about expanded procurement. To support this argument, I review existing empirical data on the cost‐effectiveness of transplantation and compare them to data on interventions for other illnesses. These data should motivate utilitarians and others whose primary goal is maximizing population‐wide health benefits to doubt the merits of expanding organ procurement. I then consider two major objections: one makes the case that transplant candidates have a special claim to medical resources, and the other challenges the use of cost‐effectiveness to set priorities. I argue that there is no reason to conclude that transplant candidates’ medical interests should receive special priority, and that giving some consideration to cost‐effectiveness in priority setting requires neither sweeping changes to overall health priorities nor the adoption of any specific, controversial metric for assessing cost‐effectiveness. Before searching for more organs, we should first ensure the provision of cost‐effective care.     

Tissue establishment as a necessary institution within the country health care system: importance,requirements and structure

A tissue establishment is a unit or service, inside or outside of a public or private hospital, generally operated by public or non-profit-making bodies or in some countries by private profit-making institutions that procure, process, sterilise, store, and distribute sterilised human tissues to private or public hospitals to be used in certain medical treatments. Each tissue establishment should adopt the best possible structure, hired the necessary well-trained staff, according to the level of its activities, and should establish the necessary internal committees to ensure the highest quality of its operation. In addition, the tissue establishment should adopt a quality management system in order to reduce the risk and maximize the benefits of the transplantation process.     

Overview on radiation and tissue banking in Latin America

The International Atomic Energy Agency (IAEA) played an important role in the establishment of new tissue banks and the improvement of already existing ones in Latin America. The Agency strongly supported, through regional, interregional and national technical cooperation projects, providing equipment, expert missions and training for the production and application of human tissues for transplantation. From 1999 to 2005 five regional courses were given in Buenos Aires under the modality of 1-year distance learning training courses and 1-week face to face courses. The courses were organized by the IAEA, through the National Atomic Energy Commission (CNEA) and the Faculty of Medicine of Buenos Aires University as Post Graduate Specialization Course. In 2005 the Latin American countries joined with Spain and Portugal, and created the Ibero American Network Council of Donation and Transplant (Red Consejo Iberoamericano de Donación y Trasplantes—RCIDT). The objective of this network is to cooperate among twenty-one Ibero American countries in organizational and legislative aspects, training of professionals, and ethical and social issues related to the donation and transplantation of organs, tissues and cells. The members of this Network work actively to harmonize the regulations and the control of donation and transplantation of human organs, tissues and cells. At present, in Latin America, more than 220 facilities of tissues banks are operating and tissue allografts are being produced by single and multi-tissue banks. The efforts made by the governments and professionals from the region allow the tissue banks to operate under quality systems and introduce new technologies.     

重塑组织边界：深圳医务社会工作的经验与反思

医务社会工作是医院与社会工作机构跨越组织边界的合作。通过对深圳医务社会工作的个案分析,揭示了医院与社会工作机构之间存在制度边界、物理边界、认同边界,具体表现为业务流程与管理规范的隔离、服务空间与信息流通的壁垒、主体间的认同困境,阻碍了医务社会工作的开展。医院主动开放边界的举措与社会工作机构主动渗透的策略促进了组织合作,重塑了组织边界,但也存在一定的不足。     

The evolution and impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in the Latin American region

Since 1993, the IAEA supported the establishment or the consolidation of seven tissue banks in the region. As a direct or indirect consequence of the implementation of the IAEA program, more than 53 tissue banks are now operating in the participating countries. The fast development of tissue banks in the Latin America region under the ARCAL Agreement and with the financial and technical support of the IAEA program made it necessary to train new tissue bank operators and medical personnel. In general, 90 tissue bank operators and medical personnel were trained in the training centre of Buenos Aires. Another six tissue bank operators and medical personnel were trained in the International Training Centre of Singapore. The main impact of the IAEA program in the region was the following: the establishment or consolidation of fifty-three tissue banks in nine countries in the region; the implementation of five national projects, allocating $1,006,737 dollars for this purpose and of one regional project allocating $284,741 dollars for this purpose; the use of the IAEA Standards, the IAEA Code of Practice and the IAEA Public Awareness Strategies in several tissue banks in the region; the application of quality control and quality assurances manuals in all of the participating countries.     

IS THE ADOPTION OF MORE EFFICIENT STRATEGIES OF ORGAN PROCUREMENT THE ANSWER TO PERSISTENT ORGAN SHORTAGE IN TRANSPLANTATION?

[I]s persistent organ shortage the major obstacle to the performance of more procedures as often popularly portrayed? Does the answer therefore lie in the adoption of more efficient strategies of organ procurement? While the measures taken to improve the efficiency of organ procurement may be inspired by the laudable motive of saving lives, they may ultimately prove to be myopic if the larger ethical issues raised by organ transplant programs for the allocation of national and organ resources are not given their due consideration. For any society that desires to include organ transplantation in its health delivery system, it must consider the social and ethical issues that transplant programs raise for the macroallocation of available national resources and the manner by which organ resources are procured, and distributed. The failure to resolve these issues in an ethically acceptable manner at any of these levels would render any transplant program ethically indefensible. This essay therefore argues that before a society decides on its policy of organ procurement it ought to make prior assessments of: a) its social priorities; b) the policies for ensuring fair access to organ resources; and c) the extent to which it is willing to support transplants.     

Skin allograft procurement and transplantation in Mashhad,Iran: Are burn patients’ needs being met?

Only a single donor’s tissue may save or improve lives of one hundred patients. Unfortunately, low governmental and media support of tissue procurement and transplantation programs is a worldwide problem. Loss of an effective tissue procurement program in many countries like Iran, may lead to loss of many thousands valuable tissues each year. To evaluate the rate of skin donation in Mashhad in comparison to other organs and tissues, we extracted the data related to tissue and organ procurement in Mashhad from 2001. Then we evaluated the annual skin allograft needs in the Burn Department of Imam Reza Hospital as the only referral burn center in the northeast of Iran. Brain dead potential donation rate per million populations of Mashhad in the years 2007–2014 was about 33. The mean refusal rate was 51%. Of patients who have consent for donation, more than 86% have consent for skin donation. Skin allograft procured from 119 (35.5%) candidates. Average of skin retrieval per cadaveric was 1525 cm² with a gradual increase from 1400 cm² in the first year to 1800 cm² in the last year. The recipient to donor ratio was 1.14. It is estimated that about 1 cm² of skin allograft is needed for any cm² burnt body surface area. Considering more than 700 acute burn hospitalization in our burn unit, the patients need for skin allograft would be more than 3.5 million cm², annually. The annual amount of skin procurement in Mashhad has been currently about 20,000 cm². It shows that our patients demand is higher than supply. Skin procurement and transplantation is a simple procedure which can be as lifesaving as organ procurement and transplantation. But there isn’t any national organization to regulate tissue procurement, banking and transplantation. Governmental support of skin procurement and transplantation programs especially nonprofit programs may improve skin procurement rate and save more lives of severely burnt patients.     

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Peru

The tissue bank “Rosa Guerzoni Chambergo” (RGCTB) located at the Child’s Health Institute was inaugurated in 1996, with the financial and technical support of the IAEA program on radiation and tissue banking. Since 1998, the biological bandage of fresh and lyophilised pigskin, amnion and bone tissue is processed routinely in this bank. In all cases, the tissue is sterilised with the use of Cobalt-60 radiation, process carried out at the Laboratories of Irradiation of the Peruvian Institute of Nuclear Energy (IPEN). The tissue bank in the Child’s Health Institute helped to save lives in an accident occurred in Lima, when a New Year’s fireworks celebration ran out of control in January 2002. Nearly 300 people died in the tragic blaze and hundreds more were seriously burned and injured. Eight Lima hospitals and clinics suddenly were faced with saving the lives of severely burned men, women and children. Fortunately, authorities were ready to respond to the emergency. More than 1,600 dressings were sterilised and supplied to Lima surgeons. The efforts helped save the lives of patients who otherwise might not have survived the Lima fire. Between 1998 and September 2007, 35,012 tissue grafts were produced and irradiated. Radiation sterilised tissues are used by 20 national medical institutions as well as 17 private health institutions. The tissue bank established in Peru with the support of the IAEA is now producing the following tissues: pigskin dressings, fresh and freeze-dried; bone allografts, chips, wedges and powdered, and amnion dressings air-dried. It is also now leading the elaboration of national standards, assignment being entrusted by ONDT (Organización Nacional de Donación y Transplantes; National Organisation on Donation and Transplant). This among other will permit the accreditation of the tissue bank. In this task is also participating IPEN.     

基于区域协同医疗的检测技术需求分析与解决方案

在分析县级医院及基层医疗机构医疗服务能力基础上,为提出提升基层医疗机构检测水平的方法,探讨通过区域医疗信息化手段建立面向三级医疗机构的区域协同医疗共享平台及系列信息化系统,提升基层医疗机构检测水平,推动多级医疗协同服务模式的实现,提升区域协同医疗业务能力。     

Coding and traceability in Iran

Transplantation has a long history in Iran. Cornea was the first tissue transplantation in 1935. The Central Eye Bank of Iran was established in 1991 and the Iranian Tissue Bank (ITB) in 1994. Now, there are also some private cell and tissue banks in the country, that produce different tissue grafts such as homograft heart valves, musculoskeletal tissues, soft tissues, cartilages, pericardium, amniotic membrane and some cell based products. There is not a separate legislation for tissue transplantation but the legal framework for tissue donation is based on the “Deceased or Brain dead patient organ transplantation” act (passed on April 6, 2000). For tissue banking there is no regulatory oversight by the national health authority. To increase the level of safety and considering the importance of effective traceability, each tissue bank has its own policy and terminology for coding and documentation without any correlation to others. In some cases tissue banks have implemented ISO based standards (i.e., ISO 9001) as a basic quality management system.     

Opt‐in or opt‐out to increase organ donation in South Africa? Appraising proposed strategies using an empirical ethics analysis

Utilising empirical ethics analysis, we evaluate the merits of systems proposed to increase deceased organ donation in South Africa (SA). We conclude that SA should maintain its soft opt‐in policy, and enhance it with ‘required transplant referral’ in order to maximise donor numbers within an ethically and legally acceptable framework. In SA, as is the case worldwide, the demand for donor organs far exceeds the supply thereof. Currently utilising a soft opt‐in system, SA faces the challenge of how to increase donor numbers in a context which is imbued with inequalities in access to healthcare, multiplicitous personal beliefs and practices, distrust of organ transplant and varying levels of education and health literacy. We argue that a hard opt‐in, opt‐out or mandated consent system would be problematic, and we present empirical data from Gauteng Province illustrating barriers to ethically sound practice in soft consent systems. Ultimately, we argue that in spite of some limitations, a soft opt‐in system is most realistic for SA because its implementation does not require extensive public education campaigns at national level, and it does not threaten to further erode trust at a clinical level. However, to circumvent some of the clinical‐level barriers identified in our empirical study, we propose a contextually sensitive option for “enabling” soft opt‐in through “required transplant referral”. We argue that this system is legally defensible, enhances ethical practice and could also increase donor numbers as it has in many other countries.     

建立适合中国国情的高效双向转诊机制

建立适应我国国情的高效双向转诊机制,对于推进我国的医疗体制改革具有至关重要的作用。本文通过对中西方现行卫生制度的对比,结合我国有中国特色的社会主义国家的国情,对我国的卫生制度中存在的问题进行了深入剖析,探讨如何才能有效地实现高效的双向转诊。目前,我国医疗卫生事业的问题覆盖多个方面：主要表现在医疗资源,医院管理,在岗医护人员的个人职业素质,卫生部门的监管,医疗资源的大量浪费,医院分级不平衡另多数患者普遍选择三级医院就诊,而选择二级以下医院就诊的患者则较少。如何在符合我国国情的基础上改变我国的医疗卫生现状、满足人民群众不断提高的医疗服务需求是我国医疗改革亟待解决的问题。建立高效率的双向转诊制度势在必行。目前,在双向转诊中遇到的问题：1．传统理念导致的对各级医疗机构职能的理解上存在偏差,2．医疗机构自身定位不明确,3．双向转诊制度的各项相关配套政策不完善,4．双向转诊制度的社会认同度低。高效双向转诊机制建立以后,可以节省大量的医疗资源,减少了不必要的浪费,推进了医疗资源的合理配置,减少了因地区差异引起的治疗时机延误,高效的双向转诊制度会使医疗卫生资源配置进一步优化、还可以加强医疗机构之间的协作、降低医疗费用支出、促进社区卫生服务迅速发展等有重大的意义。