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 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 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.     

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.     

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

The National University Hospital (NUH) Tissue Bank was established in October 1988. The National University of Singapore (NUS) was officially appointed by IAEA to be the IAEA/NUS Regional Training Centre (RTC) for RCA Member States for training of tissue bank operators on September 18, 1996. In the first five years since its establishment the National University Hospital Tissue Bank concentrated its work on the sterile procurement and production of deep frozen femoral heads and were used in patients for bone reconstruction. The cost of producing these tissues were about SGD$ 250 per femoral head although cost fees were initially charged at SGD$ 50 per femoral head. The most important activity carried out by Singapore within the IAEA was training. Between November 1997 and April 2007, a total of nine courses were conducted by RTC with a total of 180 tissue bank operators registered, 133 from Asia and the Pacific region (13 countries, including 2 from Iran), 14 from Africa (Zambia, Libya, Egypt, Algeria, and South Africa), 6 from Latin America (Brazil, Chile, Cuba, Peru, and Uruguay), 9 from Europe (Greece, Slovakia, Poland, and Ukraine), and 2 from Australia. The last batch (ninth batch) involved 20 students registered in April 2007 and will be due to sit for the terminal examination in April 2008.     

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 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.     

Training tissue bank operators: the International Atomic Energy Agency (IAEA)/National University of Singapore (NUS) 10 years of experience

National University of Singapore (NUS) was appointed by IAEA to become IAEA/NUS Regional Training Centre (RTC) for Asia and the Pacific region in September 1996. The Government of Singapore (represented by the Ministry of Environment) with the National Science and Technology Board as the funding agency awarded a grant of S$225,500 to build a new purpose-built tissue bank to be the Regional Training Centre. National University Hospital provided a space of 2,000 square feet for this purpose. The first Diploma Course was launched on 3 November 1997 with 17 candidates with the first NUS Diploma Examination being held in October 1998. Between November 1997 and April 2007, a total of nine courses were conducted by RTC with a total of 180 tissue bank operators, 133 from Asia and the Pacific region (13 countries including 2 from Iran), 14 from Africa (Algeria, Egypt, Libya, Egypt, South Africa and Zambia), 6 from Latin America (Brazil, Chile, Cuba, Peru and Uruguay), 9 from Europe (Greece, Slovakia, Poland, Ukraine) and 2 from Australia. The last batch (ninth batch) involved twenty students registered in April 2007 and will be due to sit for the terminal examination only in April 2008.     

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 cm² 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 Chile

The Tissue Banking Project in Chile started as an idea in 1996. Before 1996 in Chile there were only a few small bone banks working with their own standards of quality. The first tissue bank (LPTR) was established in 1998, with the technical and financial support of the IAEA. Since 2001, the laboratory began to produce tissues for clinical use, starting with the processing of 6 amniotic membranes, 2 femoral heads and 19 batches of pig skin. In 2002, the laboratory began the processing of human skin. Five students from Chile have graduated from training courses carried out in Singapore and in Buenos Aires under the IAEA training program since 1998. The amount of tissues produced and sterilized using ionizing radiation by the LPTR in the last years was 320,000 cm² of human skin, 553,600 cm² of pig skin, 5,400 cm² of amniotic membrane, 49 femoral heads, 3 large bones and 300 g of bovine bone. The patients treated with sterilized tissues produced by the LPTR were 200 deep burns treated with human skin and pig skin, 40 bone transplants from femoral heads, 77 ophthalmologic patients treated with amniotic membrane and 150 bovine bone transplants for dental treatments.     

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.     

Diploma Training for Technologists in Tissue Banking

There is a great demand for a formal training programme for tissue bank technologists not only for the Asia Pacific Region but also for technologists in other regions including Latin America and Africa. To meet this need, National University Hospital (NUH) Tissue Bank was established as the International Atomic Energy Agency (IAEA)/National University of Singapore (NUS) Regional Training Centre for training tissue bank operators in the Asia Pacific Region (Regional co-operative Agreement, RCA) in November 1997. The training centre conducts a one-year distance learning Diploma in Tissue Banking offered by the NUS. The syllabus for the Diploma Course included the multi-media IAEA curriculum on tissue banking. The first Diploma Course has been successfully completed in October 1998. Twelve students convocated, 4 with Distinction, 5 with Credit and 3 with Pass. Sixteen candidates from the Asia Pacific Region registered for the Second Diploma Course in April 1999. This second batch will be due to sit for their Diploma Examination in April 2000. With the increasing popularity of this Diploma Course, the third batch of students which will be registered in April 2000, will include technologists not only from Asia Pacific Region but also from other regions including Africa.     

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

The IAEA was instrumental in developing the first Malaysian tissue bank at University Hospital of Universiti Sains Malaysia (HUSM), Kubang Kerian, Kelantan in early 1990s and it was officiated as National Tissue Bank in 1994. Up to date, 38 government and private hospitals have received a supply from the bank. Bone allografts in term of bone chips, morsalised bone and long bones are procured from Malaysian donors. Almost thirty students from Malaysia graduated in the training courses carried out in Singapore since 1998 at regional and interregional levels. Organ donation is more readily accepted by the public at the moments, perhaps due to the vast promotion and advertisement given by the local newspapers and other media, but gradually tissue donation is catching up as well.     

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 importance of the selection of the audiences and the organization of media events within public awareness strategies for tissue banks

The main purpose of the International Atomic Energy Agency (IAEA) Public Awareness Strategies for Tissue Banks is to provide guidance on organizing and running awareness campaigns, in order to consolidate tissue banking activities. Within the IAEA Public Awareness Strategies for Tissue Banks, there are two important topics, which need to be singled out due to their importance for a successful public and professional awareness campaign. These are the selection of the audiences and the organization of media events within a Communication Strategy. The experience in the field of tissue banking in several countries has shown that interaction between the public, the professional health care staff, the media and the tissue bank personnel is essential if the activities of the banks are to be successful. It must be emphasized however, that any public and professional awareness strategy will not be successful, unless it is considered as part of an integrated system that is adopted by the concerned Government.     

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

The banking of tissues such bone and skin began in India in the 1980s and 1990s. Although eye banking started in 1945 there was little progress in this field for the next five decades. As part of the IAEA/RCA program to use ionising radiation for the sterilisation of biological tissues in Asia and the Pacific Region, the Tata Memorial Hospital (TMH) in 1986 decided to set up a tissue bank in Mumbai funded by the Government of India. The TMH Tissue Bank became operational in January 1988, and stands as a pioneering effort in the country to provide safe, clinically useful and cost-effective human allografts for transplantation. It uses the IAEA International Standards on Tissue Banking. All the grafts are sterilised terminally by exposure to a dose of 25 kGy of gamma radiation, which has been validated as recommended by the IAEA Code of Practice for the Radiation Sterilisation of Tissues Allografts: Requirements for Validation and Routine Control. The TMH Tissue Bank is registered with the Maharashtra State Health Authorities, and in May 2004, it became India’s first Tissue Bank to receive ISO 9001:2000 certification of its Quality Management System. From 1989 to September 2007, the TMH Tissue Bank has supplied 11,369 allografts to 310 surgeons operating in 69 hospitals in Mumbai and 56 hospitals in other parts of India. These numbers have been limited by difficulties with the retrieval of tissues from deceased donors due to inadequate resources and tissue donation policies of hospitals. As the Government of India representative in the IAEA program, the TMH Tissue Bank has promoted and co-coordinated these activities in the country and the development of tissue banks using radiation sterilisation of tissue grafts. Towards this end it has been engaged in training personnel, drawing up project proposals, and supporting the establishment of a Tissue Retrieval Centre in Mumbai. Currently it networks with the Zonal Transplant Co-ordination Centre of the Government of Maharashtra, and the newly instituted National Deceased Donor Transplantation Network, which will work with the Government of India to set up rules and regulations for organ and tissue donation and transplantation.     

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 International Atomic Energy Agency (IAEA) Program on Radiation and Tissue Banking: a Successful Program for Developing Countries

Since its inception the IAEA program in radiation and tissue banking supported the establishment of twenty five tissue banks in different countries. Now more than 103 tissue banks are now operating in these countries. The production of sterilized tissues has grown in an exponential mode within the IAEA program. From 1988 until the end of 2000 the production of sterilized tissues was 224,706 grafts, with an estimated value of at least $51,768,553 million dollars at the mean current charge rate in non-commercial banks in Europe and USA. During the period 1997–2002 several countries from Asia and the Pacific region produced more than 155,000 grafts, with an estimated value of about $36.7 million dollars. Training was considered to be one of the most important tasks to be supported. A total of 192 students were registered in the training program and 146 students graduated with a University Diploma. For many developing countries an additional benefit is not having to import expensive sterilized tissues from developed countries, but the exposure of orthopedic and plastic surgeons working, to new methods of using allografts in specific surgical treatments.