The International Atomic Energy Agency (IAEA) Programme in Radiation and Tissue Banking: Past, Present and Future

The International Atomic Energy Agency has developed a programme of tissue banking in more than 30 countries, based on the use of radiation for the sterilization of tissues. The value of the tissue grafts produced to the developing countries is not less than 62.6 million US dollars at the mean price of grafts in Europe and the U.S.A. To support this programme a training curriculum was developed which can now be delivered by internet in several languages, from the Universities of Singapore and Buenos Aires. Partnerships have been developed with major organizations which will extend this programme into 2005-2006.     

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 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 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.     

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 cm², and frozen pig skin, 164,220 cm², 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 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 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 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 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 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.