Professor Glyn O. Phillip's legacy within the IAEA programme on radiation and tissue banking.

Professor Phillips began his involvement in the implementation of this important IAEA programme, insisting that there were advantages to be gained by using the ionizing radiation technique to sterilize human and animal tissues, based on the IAEA experience gained in the sterilization of medical products. The outcome of the implementation of the IAEA programme on radiation and tissue banking demonstrated that Professor Phillips was right in his opinion.

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.

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.

The necessity of strengthening the cooperation between tissue banks and organ transplant organizations at national, regional, and international levels.

The donation of tissues and organs increases significantly when tissue banks and organ transplant organizations work together in the procurement of organs and tissues at donor sources (hospitals, coroners system, organ procurement agencies, and funeral homes, among others). To achieve this important goal, national competent health authorities should considered the establishment of a mechanism that promote the widest possible cooperation between tissue banks and organ transplant organizations with hospitals, research medical institutions, universities, and other medical institutions and facilities. One of the issues that can facilitate this cooperation is the establishment of a coding and traceability system that could identify all tissues and organs used in transplant activities carried out in any country. The promotion of national, regional, and international cooperation between tissue banks and organ transplant organizations would enable the sharing of relevant information that could be important for medical practice and scientific studies carried out by many countries, particularly for those countries with a weak health care system.

A review of the International Atomic Energy Agency (IAEA) international standards for tissue banks.

The IAEA International Standards for Tissue Banks published in 2003 were based on the Standards then currently in use in the USA and the European Union, among others, and reflect the best practices associated with the operation of a tissue bank. They cover legal, ethical and regulatory controls as well as requirements and procedures from donor selection and tissue retrieval to processing and distribution of finished tissue for clinical use. The application of these standards allows tissue banks to operate with the current good tissue practice, thereby providing grafts of high quality that satisfy the national and international demand for safe and biologically useful grafts. The objective of this article is to review the IAEA Standards and recommend new topics that could improve the current version.

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.

A model of a code of ethics for tissue banks operating in developing countries.

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 tissues for transplantation. This model of a Code of Ethics has been prepared with the purpose of being used for the elaboration of a Code of Ethics for tissue banks operating in the Latin American and the Caribbean, Asia and the Pacific and the African regions in order to guide the day-to-day operation of these banks. The purpose of this model of Code of Ethics is to assist interested tissue banks in the preparation of their own Code of Ethics towards ensuring that the tissue bank staff support with their actions the mission and values associated with tissue banking.

The future role of the professional associations in the promotion of tissue banking activities in Asia and the Pacific and in the Latin America regions.

There are several important roles that the established professional associations [Asia-Pacific Association of Surgical Tissue Banking (APASTB) and Latin American Association of Tissue Banks (ALABAT)] could play for the promotion of tissue banking activities in Asia and the Pacific and in the Latin American regions in the future. The International Atomic Energy Agency (IAEA) and the World Health Organisation (WHO) could also play an important role in supporting the activities of both professional associations in the field of training, exchange of scientific information, the standardisation of national norms and regulations, the use of the IAEA documents, particularly the "Radiation Sterilisation of Tissue Allografts: Requirements for Validation and Routine Control. A Code of Practice", with the purpose to improve the quality of the activities carried out by the established tissue banks and the nuclear facilities in charge of the sterilisation of the processed tissues, and to increase tissue donations. The role of APASTB and ALABAT could be relevant and important for the improvement of the work of the established tissue banks in Asia and the Pacific and in the Latin American regions, and could increase the effectiveness and efficiency of their works, the improvement of management good practices and for increasing the awareness of the community on the importance of the activities carried out by the tissue banks, among others.

The use of the internet training course modality in the field of tissue banking: the International Atomic Energy Agency (IAEA)/National University of Singapore (NUS) experience.

The International Atomic Energy Agency (IAEA) promoted and supported an important training program for the training of tissue bank operators and medical doctors within its radiation and tissue banking program. The purpose of the program was to train an increase number of tissue bank operators and medical doctors in Asia and the Pacific, Latin America and Eastern Europe, that were working or were associated to a number of tissue banks established in these regions under the IAEA program during the 1980s, 1990s and 2000s. The National University of Singapore Tissue Bank was designated, in 1996, as the Regional Training Centre (RTC) for Asia and the Pacific region and later on, in 2002, as the International Training Centre (ITC) for the whole IAEA program. The National Atomic Energy Commission of Argentina and the Faculty of Medicine of the University of Buenos Aires were also designated, in 1999, as the Regional Training Centre for the Latin American region. The objective of the ITC was to train tissue banks operators and medical doctors from all over the world and the RTCs to train tissue bank operators and medical doctors mainly from the Asia and the Pacific and the Latin American regions. Since 1997, training of tissue bank operators and medical doctors were carried out using the modality of distance training courses. However, due to its limitation, this type of courses was transformed, in 2002, in an Internet training course modality, with the purpose to increase not only the number of participants but, at the same time to reduce, as much as possible, the costs associated with the organisation of these courses. Since November 1997, the number of training courses carried out in the RTCs established under the IAEA program was 14, eight of them under the Internet training course modality. The total number of students registered in these courses was 261 and the total number of students graduated was 166 for a rate of approval of 63.6%. The National University of Singapore and the Faculty of Medicine from the University of Buenos Aires are the academic institutions that provide the certificate/diploma to the graduated students.

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

In 1971, first bone bank was established at the Department of Orthopaedic Surgery in Catholic University of Korea. The first clinical case was reported at the Journal of Korean Orthopaedic Association in 1973. Subsequently, more than 60 surgical bone banks were established in the university and teaching hospitals throughout country. In 1990, the Korea Biomaterial Research Institute (KBRI) organised the IAEA/RCA training course on tissue banking. In this course students from 17 countries participated. In 1994 the first collaboration for cadaver tissue recovery was performed. It is important to single out that the various religious groups in Korea have favourable attitudes towards tissue donation, which contributes to the success of the tissue banking programs in the country. The demands of allograft were getting increased in the Korean medical and dental society. Currently, 62 hospital based bone banks, 5 processing tissue banks, 1 regional tissue bank and more than 30 tissue distributors are working in Korea. Based on the U.S.A. usage of more than 1,000,000 grafts per year, 100,000-200,000 grafts will be needed in Korea. Those findings indicate a greatly increased need for training of tissue bank operators. The Korean society will need at least 20-30 tissue bank operators for training in every year. The National Training Centre (NTC) for tissue bank operators and medical personal using the IAEA Curriculum in the Korean languages was established in 2003. From 2004 to 2006, NTC have been trained 40 tissue bank operators. They have produced at least 10,000 tissues per year. These figures indicate a cost saving of US$ 10 million. Within 5 years, NTC will train 100 tissue bank operators. These individuals and their respective banks will provide an increasing number of high quality grafts to the communities they serve at a cost far less than if they were acquired from abroad.

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

Tissue banking started in Mexico in 1948-1949, when two bone banks were established, one at the Infantile Hospital of Mexico and other at the Central Military Hospital. Mexico has benefited for the implementation of the IAEA program since through it has been able to settle down and to consolidate the Tissue Bank at the Instituto Nacional de Investigaciones Nucleares ININ (National Institute for Nuclear Research). This is the only bank in Latin America that has a Quality Management System in force, certified under ISO 9001:2000 since August 1, 2003. The first tissue processed was amnion. The main products of the BTR are amnion and pig skin. Both are biological tissues which their main use is as a wound dressing in patients with burns, scars, diabetic ulcers, epidermolysis bullosa, damaged ocular surface, etc. The General Health Law, published in 1984 and reformed in June 19, 2007, describes the procedure for the disposal of organs, tissues and human cadavers in its fourteenth title and in the Regulation for Sanitary Control. During the period 2001-2005, the ININ Tissue Bank produced 292 sterilised tissues (amnion, 86,668 cm(2), and frozen pig skin, 164,220 cm(2), at an estimated cost of 1,012,668 Mexican pesos. Until 2006, one hundred eighty five (185) patients have been treated with the use of sterilised tissues produced by the ININ Tissue Bank. The radiation source used for sterilisation of tissues is an industrial Cobalt-60 irradiator model JS-6500 AECL, which belongs to ININ. This equipment is located in other building, close to the BTR, in the Centro Nuclear de México "Dr. Nabor Carrillo Flores" (Nuclear Center of Mexico). Until 2006, six hospitals use in a routine way the sterilised tissues produced by the ININ Tissue Bank, for the treatment of burns originated by diverse agents like flame, electricity, liquids in boil, chemical reagents, as well as for the reconstruction of the ocular surface. Two of these hospitals treat patients of very low economic incomes, mainly needy individuals, who cannot afford to pay this type of treatments in other hospitals due to their high cost. The results obtained up to now are highly promising.

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.

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

The first multi-tissue bank was founded at Havana in 1958. At that time, freeze-drying was used at the bank as a method of preserving, as well as Cobalt 60 irradiation to sterilise bone tissue, heart valves and others. The impact of the IAEA program in tissue banking activities in Cuba can be summarised as follows: (a) Increase in the production of sterilised tissues using ionising radiation (bone, pig skin and amnion) for medical treatment in the tissue bank of the Hospital Frank Pais; (b) increase of the quality of the productions of bone tissues, pig skin and amnion; (c) reduction in the import of tissues by increasing the local production of tissues; (d) sustainability in the number of donors through the implementation of a public and professional awareness campaign; (e) training of six persons in the Regional Training Centre of Buenos Aires; (f) qualification of one person in the administration of a tissue bank and in the implementation of a Quality System. The amount of tissues produced and sterilised using the ionising radiation techniques in the established banks was 25,510 units. The amount of patients treated with sterilised tissues produced by the established banks was 2,448.

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 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.

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

The Asia and the Pacific region was within the IAEA program on radiation and tissue banking, the most active region. Most of the tissue banks in the Asia and the Pacific region were developed during the late 1980s and 1990s. The initial number of tissue banks established or supported by the IAEA program in the framework of the RCA Agreement for Asia and the Pacific region was 18. At the end of 2006, the number of tissue banks participating, in one way or another in the IAEA program was 59. Since the beginning of the implementation of the IAEA program in Asia and the Pacific region 63,537 amnion and 44,282 bone allografts were produced and 57,683 amnion and 36,388 bone allografts were used. The main impact of the IAEA program in the region was the following: the establishment or consolidation of at least 59 tissue banks in 15 countries in the region (the IAEA supported directly 16 of these banks); the improvement on the quality and safety of tissues procured and produced in the region reaching international standards; the implementation of eight national projects, two regional projects and two interregional projects; the elaboration of International Standards, a Code of Practice and a Public Awareness Strategies and, the application of quality control and quality assurances programs in all participating tissue banks.

The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Asia and the Pacific and the Latin American regions.

The technical assistance program of the International Atomic Energy Agency (IAEA) for its member states in the framework of the implementation of its program on radiation and tissue banking focuses on ensuring the availability of quality radiation-sterilised tissue grafts. The IAEA also helps its member states to develop quality control capabilities in order to ensure the safe use of the processed tissues in certain medical treatments. The majority of developing countries does not have such capacity, and must import expensive sterilised tissues from developed countries. The IAEA's core contribution to its program on radiation and tissue banking in Asia and the Pacific and the Latin American regions is a technology for sterilisation by gamma radiation and a training program for tissue bank operators and medical personnel. The Agency develops capabilities for radiation sterilisation of tissue grafts, both for reducing the pre-processing bacterial load, and as a terminal sterilisation process. Sterilising tissue grafts offers a clear advantage in terms of safety. Moreover, compared to alternative sterilisation methods, radiation sterilisation is considered particularly safe in relation to environmental concerns, and the deposition of harmful residuals in the tissue, which occurs for example in the use of chemical such as ethylene oxide gas. Radiation sterilisation, thus, has become the method of choice for an increasing number of tissue banks. Radiation sterilisation of tissue grafts is a critical component in the chain connecting donors to recipients of high quality tissue grafts. Due to this fact, the IAEA has evolved as the only organisation in the UN System with expertise related to tissue banking.

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

Until 2000, efforts into organising tissue banks in Brazil had not progressed far beyond small "in house" tissue storage repositories, usually annexed to Orthopaedic Surgery Services. Despite the professional entrepreneurship of those working as part time tissue bankers in such operations, best practices in tissue banking were not always followed due to the lack of regulatory standards, specialised training, adequate facilities and dedicated personnel. The Skin Bank of the Plastic Surgery Department of the Hospital das Clinicas of Sao Paulo, the single skin bank in Brazil, was not an exception. Since 1956, restricted and unpredictable amounts of skin allografts were stored under refrigeration for short periods under very limited quality controls. As in most "tissue banks" at that time in Brazil, medical and nursing staff worked on a volunteer and informal basis undergoing no specific training. IAEA supported the implementation of the tissue banking program in Brazil through the regional project RLA/7/009 "Quality system for the production of irradiated sterilised grafts" (1998-2000) and through two interregional projects INT/6/049 "Interregional Centre of Excellence in Tissue Banking", during the period 2002-2004 and INT/6/052 "Improving the Quality of Production and Uses of Radiation Sterilised Tissue Grafts", during the period 2002-2004. In 2001-2002, the first two years of operation of the HC-Tissue Bank, 53 skin transplants were carried out instead of the previous 4-5 a year. During this period, 75 individuals donated skin tissue, generating approximately 90,000 cm(2) of skin graft. The IAEA program were of great benefit to Brazilian tissue banking which has evolved from scattered make shift small operations to a well-established, high quality tissue banking scenario.

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.

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

In 1986, the National Nuclear Energy Agency (Batan) in Jakarta started the research and development for the setting up of a tissue bank (Batan Research Tissue Bank/BRTB) by preserving fresh amnion or fetal membranes by lyophilisation and then sterilising by gamma irradiation. During the period of 1990 and 2000, three more tissue banks were set up, i.e., Biomaterial Centre in Surabaya, Jamil Tissue Bank in Padang, and Sitanala Tissue Bank in Tangerang. In 1994, BRTB produced bone allografts. The banks established under the IAEA program concentrated its work on the production of amnion, bone and soft tissues allografts, as well as bone xenografts. These tissues (allografts and xenografts) were sterilised using gamma irradiation (about 90%) and the rest were sterilized by ETO and those products have been used in the treatment of patients at more than 50 hospitals in Indonesia. In 2004, those tissue banks produced 8,500 grafts and 5,000 of them were amnion grafts for eye treatment and wound dressing. All of those grafts were used for patients as well as for research. In 2006, the production increased to 9,000 grafts. Although the capacity of those banks can produce more grafts, we are facing problems on getting raw materials from suitable donors. To fulfill the demand of bone grafts we also produced bone xenografts. The impact of the IAEA program in tissue banking activities in Indonesia can be summarised as follows: to support the national program on importing substitutes for medical devices. The price of imported tissues are between US$ 50 and US$ 6,000 per graft. Local tissue bank can produce tissues with the same quality with the price for about 10-30% of the imported tissues.