General Information about the IAEA Program

The IAEA Radiation and Tissue Banking Programme

1- The main reason for the establishment of this Programme by the IAEA

Developing countries have to import sterilised tissue allografts at great cost for use in transplant surgery (in orthopaedic reconstruction, treatment for cancer, trauma and high velocity impact damage), the treatment of burns, leprosy and intractable skin wounds and pressure sore ulcers in their own patients. A femur to save a limb at US $10,000 or 30 grams of bone chips at US $ 3,000 to fill a hole in a bone cavity caused by a tumour is out of the question for all except the very rich countries. With the improvement of the health sector in the developing countries in the last 30 years, more and more patients were treated using sterilized tissues imported from developed countries at a very high price, increasing significantly the cost of this treatment in the developing world. Many developing countries are not in a position to cover this increase cost for the treatment of patients and have asked the IAEA for assistance to produce their own tissues, based on the IAEA experience in the radiation technology, which was successfully developed to sterilize disposable medical products. This experience was considered by many developing countries as an important method to be used for the sterilization of their own tissues at a lower cost.

2- From small beginnings

The IAEA Programme began in the Asia Pacific with a single tissue bank in Myanmar in 1983. IAEA subsequently supported the development of another 17 tissue banks in the region. These catalysed the growth of tissue banking and there are now 66 tissue banks in the region associated with the Programme. The story is the same in Latin America where initiative came later, when a single bank was set up by IAEA in Argentina in 1993. There are now 37 tissue banks in seven countries of the region. An additional two countries from the Europe region joined the IAEA Programme in 2002. Africa too have gained from the IAEA Programme, and after a starting a tissue bank in Zambia, another seven countries have joined. However, the scale of the participation of the Africa region is still very limited.

3- Health and cost benefits

Since the inception of the IAEA Programme, the audited total graft production is 222,580, valued at US $51,768,553 (at mean European and USA Tissue Bank prices). The total expenditure by IAEA over the same period was US $6,313,335, which includes a training cost of US $2,036,034. Based on the regional importation costs, the countries would have had to pay at least 10 times more, some US$ 500 million for these grafts coming from outside. Without any doubt can be said that the IAEA Programme has produced a saving of more than US$ 450 millions for the developing countries participating in the Programme in the last 20 years.

The main benefit, however, is undoubtedly the improvement in health care in the individual countries. Allografts are available to these countries for the first time, which in many cases have not only save lives but also improved significantly the quality of lives of many patients. Skin and amnion offer immediate cover for burns, wounds or leprosy and paraplegic lesions, and promote healing, prevent fluid and energy loss and the introduction of infections. Bone allografts can restore limbs, prevent amputations, repair of fractures and treat spinal defects. Other grafts such dura mater, xenografts, pericardium, tendon, ligaments, and fascia are essential in reconstructive surgery. Now all are available to the developing countries participating in the IAEA Programme.

Another major advantage of the IAEA Programme is the exposure of surgeons in these countries to the newer methods of using allografts and creating a cultural change in their approach to surgical treatment in their country. In Western countries the use of such grafts is now routine, and more than 1 million are used worldwide. The perceived need in a developing country is not always apparent, but as the technology is introduced, the health benefits become clear. When this occurs, the graft supply is far from being sufficient. The IAEA Programme has inspired this revolution in many countries and the growth henceforth will be exponential.

4- The instruments which have been used

4.1- Training

Expert advice for training in all aspects of construction and operation of tissue banks was essential in the building up stage. The main international associations, particular the American and European Associations of Tissue Banking provide expertise in the design of tissue banks, methods of procurement, processing and packaging of tissues. But self-help was vital also. There was no training curriculum in this subject, anywhere in the world, which could be used. Initiated in the Asia and Pacific Region, with the support of international experts, the Singapore Government and the National University of Singapore, the first comprehensive IAEA/NUS Curriculum in Radiation and Tissue Banking was produced. It is now available also in Spanish and Korean. A programme of distance learning was introduced, first based in Singapore (in English) and later in Buenos Aires (in Spanish) to cover the Asia and Pacific and Latin American regions, when the successful candidates could graduate with a University Diploma - the first of its kind in the world. A total of 52 tissue bank operators, managers and medical doctors have graduated in Singapore and 18 from the University of Buenos Aires. To complement this specialised activity, expert missions, training courses, workshops and fellowships provided training for more than another 220 tissue bank personnel.

4.2- Developing a Public Acceptance Strategy

The willingness to donate bodies after death to provide the tissues often depends on the culture, religion and certainly on the extent of public education. A "Public Awareness Strategy for Tissue Banks" has been produced by the IAEA to support workshops and national programmes to be organized during 2003-2004 in the framework of the IAEA Programme.

4.3- Setting Standards and Quality

To ensure the uniform quality of operation of the tissue banks in the IAEA Programme and eventually to allow the future distribution of radiation-sterilised grafts from country to country, experts from all the regions, supported by international experts, have produced "International Standards for Tissue Banking". Additionally, guidelines have been drawn up which will assist Member States to ensure compliance to these Standards.

4.4- Code of Practice for the Radiation Sterilisation of Tissues Allografts

No international body has undertaken this important function, which is within the IAEA's technical competence. The Code, prepared by a group of international experts from all regions, is now available, and the indications are that the international community will adopt the Code, when approved by the IAEA, due to the increase importance that many countries, including countries from the developed world like the USA, are now given to the sterilization of tissues using radiation. This subject will be in the agenda of the Tissue Banking Community for the following months and the IAEA has an unique role to play in assistance this Community in the understanding of the implications of using radiation for the sterilization of tissues.

5- Support from the Global Tissue Banking Community

As the IAEA Programme has grown in size and importance, it is necessary to ensure that the future activities be extended with full technical and professional competence. A number of important initiatives have been undertaken to achieve this objective.

5.1- A Technical Advisory Committee

The Presidents of all the major International Tissue Bank Professional Associations now serve on this Committee and the first meeting was held to coincide with the World Tissue Banking Congress, held in Boston, USA in August 2002, which included the American Association of Tissue Banks, the European Association of Tissue Banks, the Asia Pacific Association of Surgical Tissue Banking and the newly formed Latin America Association of Tissue Banks, the Directors of the International Training Centre in Singapore, and the Regional Centre in Buenos Aires, as well as WHO and IAEA representatives. The Committee will scrutinize and provide technical advice and guidance to the IAEA Programme. Important recommendations for the IAEA Programme were adopted in the first meeting of the Committee.

5.2-Collaboration with Musculo-skeletal Transplant Foundation (MTF) in the USA and other interested partners

MTF is the largest tissue bank organisation in the world. A Memorandum of Understanding (MOU) between IAEA and MTF was signed in May 2002. Their acceptance of the IAEA Programme of tissue production and training is testimony to the mutual acceptance of common standards. This recognition can now lead to a joint programme of professional and public education, which will be of mutual benefit. In particular, the training of surgeons in the use of tissue transplants will be led by MTF, in co-operation with the IAEA. MTF in collaboration with the IAEA will support expert missions to a selected and limited number of tissue banks in the participating countries to raise the quality of their activities to international standards.

The tissue banks in Barcelona and Galicia in Spain have shown interest in supporting the IAEA Programme and a joint training programme for Transplant Coordinators will be discuss in the following days as well as a MoU to promote this cooperation will be in the Agenda of the discussions with Spanish representatives. Private tissue banks in the USA and in the Netherlands has requested information and documents prepared under the IAEA Programme

6-Looking to the future

IAEA in 1995 was the first into distance learning in tissue banking, which at the time was highly innovative. Now is the time to move on to achieve a truly global training programme using the Internet. The partnership with the National University of Singapore has been enshrined in a MOU with IAEA signed in July 2002. It will serve as the International Centre for Internet delivery of training using the high quality IAEA/NUS Curriculum. This centre will feed also Regional and National Centres using other languages.

The University of Buenos Aires will play a comparable role to the University of Singapore to cover the Latin America Region. It is expected that a MoU between the University of Buenos Aires and the IAEA could be signed before the end of 2002 on this subject. There will be also National Training Centre in the Republic of Korea, since it Government have already translated the IAEA/NUS Curriculum and all other documentation into the Korean language. Other national centres could soon be developed.

Negotiations to establish a Homepage for the IAEA Radiation and Tissue Banking Programme, managed from Korea, have been concluded, and will be operational on 1 January 2003. The Homepage will include all past and present activities in tissue banking in the participant countries from Africa, Asia, Europe and Latin America, facilitating the exchange of information and the promotion of a fruitful cooperation among the Tissue Banking Community. The IAEA will contribute to the establishment of this Homepage and Korea will undertake all the operational costs for the next 10 years.

Negotiations to set up an Advanced Training Course for Tissue Bank Operators, Managers and Medical Doctors in Thailand are making progress and it is expected that a revised programme will be submitted by Thailand for the consideration by the Agency before 31 December 2002. This course wills strength further the IAEA Training Programme for Tissue Bank Operators.

The needs Member States will be evaluated through a market survey, which is now planned to be carried out in 2003. With the demand for radiation sterilised tissues increasing exponentially, the possibility of establishing regional processing centres to ensure quality and concentration of resources is under consideration.

7- Organisation

Within IAEA structures have been set up to ensure direction, targeting and coherence for the future Programme. The main components of this structure is the following:

7.1-Inter-regional Programme

Building on the foundation provided, first by national programmes, then a regional structure, based on AFRA, ARCAL and RCA Programmes, it is more appropriate now to join together all regions under an Interregional Programme. This can prove effective since common global provision is available through the Internet using a common Curriculum, utilising the same Standards, Public Awareness Strategies, and Code of Practice and promoting an inter-related programme in all of the participating countries.

7.2-Steering Committee

Within IAEA all involved with aspects of the IAEA Programme, Project Managers, Technical Officers and other IAEA staff will serve on the Steering Committee, which will ensure that all decisions are transparent and implementable.

7.3- Technical Advisory Committee

This will ensure independent technical advice and guidance, ensuring a high level of expertise in areas where IAEA is not expert.

With all the resources, systems and international partners in place, the IAEA Programme is set to take another quantum leap in the next two years and the IAEA is the only international organization that can take the responsibility of leading this Programme in this crucial stage.