Coding and traceability in Iran

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

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.     

Tissue Banking in India: Gamma-Irradiated Allografts

In India, the procurement of tissues for transplantation is governed by the Transplantation of Human Organs Act, 1994. Although this law exists, it is primarily applied to organ transplantation and rules and regulations that are specific to tissue banking which have yet to be developed. The Tata Memorial Hospital (TMH) Tissue Bank was started in 1988 as part of an International Atomic Energy Agency (IAEA) programme to promote the use of ionising radiation for the sterilisation of biological tissues. It represents the Government of India within this project and was the first facility in the country to use radiation for the sterilisation of allografts. It is registered with the Health Services Maharashtra State and provides freeze-dried, gamma irradiated amnion, dura mater, skin and bone. The tissues are obtained either from cadavers or live donors. To date the TMH Tissue Bank has provided 6328 allografts which have found use as biological dressings and in various reconstructive procedures. The TMH Tissue Bank has helped initiate a Tissue Bank at the Defence Laboratory (DL), Jodhpur. At present these are the only two Banks in the country using radiation for the terminal sterilisation of preserved tissues. The availability of safe, clinically useful and cost effective grafts has stimulated innovative approaches to surgery. There is an increased demand for banked tissues and a heightened interest in the development of tissue banks. Inadequate infrastructure for donor referral programmes and the lack of support for tissue transplant co-ordinators however, continue to limit the availability of donor tissue.     

Setting up a Tissue Bank in India: The Tata Memorial Hospital Experience

In India, the procurement of tissues for transplantation is governed by the Transplantation of Human Organs Act, 1994. However, although this law exists, it is primarily applied to organ transplantation and rules and regulations that are specific to tissue banking have yet to be developed.The Tata Memorial Hospital (TMH) Tissue Bank was started in 1988 as part of an International Atomic Energy Agency (IAEA) programme to promote the use of ionising radiation for the sterilisation of biological tissues. It represents the Government of India within this project and was the first such facility in the country. It is registered with the Health Services Maharashtra State and provides lyophilised amnion, dura mater, skin and bone that have been terminally sterilised with exposure to 25 kGy of gamma radiation from a Cobalt 60 source. These are obtained either from cadavers or live donors.To date the TMH Tissue Bank has provided 6328 allografts for use as biological dressings or in various reconstructive procedures.The TMH Tissue Bank has helped initiate a Tissue Bank at the Defence Laboratory (DL), Jodhpur. At present these are the only two Banks in the country using radiation for terminal sterilisation of banked tissues.The availability of safe, clinically useful and cost effective grafts have resulted in changes in surgical treatment with a concomitant increase in demand for grafts and an interest in developing more tissue banks. The availability of donor tissue however, continues to be a major limitation.     

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.     

Irradiation as a Safety Procedure in Tissue Banking

The Central Tissue Bank in Warsaw was established in 1963 and since then ionising radiation has been routinely applied to sterilise tissue grafts. Connective tissue grafts such as bone, cartilage, tendons, sclera, pericardium, skin, acellular dermis and amnion irradiated with a dose of 35 kGy in a ⁶⁰Co source and/or with an electron beam 10 MeV accelerator are prepared in our Tissue Bank and two other multi-tissue banks operating in Poland. Over 250,000 radiation-sterilised tissue grafts have been prepared and used in hospitals throughout Poland and no infectious disease transmission or other adverse post-transplantation reactions have been reported up to today. It should be kept in mind however, that high doses of ionising radiation can evoke numerous chemical and physical changes that may affect the biological quality of tissue allografts. Therefore, interdisciplinary research has been undertaken at the Central Tissue Bank in Warsaw to establish the origin and stability of free radicals and other paramagnetic entities induced by irradiation in bone. The effects of various preservation procedures (e.g. lyophilisation, deep-freezing) and irradiation conditions (doses, temperature of irradiation) on the osteoinductive potential and mechanical properties of bone and on the degradation of collagen, a major constituent of all connective tissue grafts, have been also studied. The results of these studies indicate that radiation-induced changes can be diminished by modification of tissue preservation methods and that, to some extent, it is possible to reduce undesired radiation-induced damage to the tissue grafts.     

The US Navy Tissue Bank: 50 Years on the Cutting Edge

The US Navy Tissue Bank was established in 1949 by Dr. George Hyatt, an orthopaedic surgeon at the Naval Medical Center in Bethesda, Maryland. The Navy program was the first of its kind in the world and established many of the standards that are followed today. During the 1950s, the identification of appropriate donor criteria for tissue donation, the development of procurement and processing methods, the establishment of a graph registry and documentation and the clinical evaluation of a variety of tissues were pioneered at this facility. Cryopreservation, freeze-drying, irradiation sterilization of tissue, as well as immunological principles of tissue transplantation, were developed during the 50 years of research and development by Navy scientists. Organ preservation, cadaveric bone marrow recovery and immunosuppressive protocols were also developed at the Navy Tissue Bank. The Navy was also instrumental in the establishment of the National Marrow Donor Program and the American Association of Tissue Banks in the US.Although the Navy Tissue Bank has ceased activity after 50 years of excellence, it should be recognized as the first standard setter for the world community of tissue banks.     

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 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.     

European Association of Tissue Banks Standards for Cryopreserved Cardiovascular Tissue Banking

The Cardiovascular Tissue Banking Standards are designed as an addition to the General Standards of the European Association of Tissue Banks to provide a minimum acceptable level for the donation, processing, storage, testing, labelling and distribution of cardiac tissue throughout Europe. The aim is that all heart valve banks in Europe should work to these Standards so that heart valves can be exchanged between countries without having to check the individual protocols of the donor processing facility. The writing of the Standards has been performed by the Heart Valve Council of EATB with input from cardiac surgeons. It is proposed that once the Standards are accepted they will form the document on which EATB may accredit tissue banks in the future and may form the basis on which National Legislation for Tissue Banking is based.     

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.     

American Association of Tissue Banks: A Historical Reflection Upon Entering the 21st Century

The American Association of Tissue Banks (AATB) is a scientific, not-for-profit, peer-group organization founded in 1976 to facilitate the provision of transplantable tissues of uniform high quality in quantities sufficient to meet national needs. The Association was created well before there was governmental oversight of tissue banking. The organization consists of individuals involved in tissue banking, medical users, and scientists in the field. Current structure consists of a 13-member Board of Governors with specific subgroups including Musculoskeletal, Reproductive, Skin, Tissue Bank Councils and Council of Accredited Tissue Banks. A historical review shows the evolution from development of guidelines to publication of standards, and from an inspection conducted by peers to one conducted by an independent, trained professional inspector. Association growth and historical accomplishments are highlighted.     

Coding and traceability for cells,tissues and organs for transplantation

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

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.     

Progress of National Multi-tissue Bank in Uruguay in the International Atomic Energy Agency (IAEA) Tissue Banking Programme

The transplant law of 1971 based on informed consent, allows people to register their willingness to be a donor upon death. Since 1978 the governmental Institution, the National Bank of Organs and Tissues (BNOT), have been regulated the organ and tissue donation. Important progress was implemented in the BNOT and specially in the National Multi-tissue Bank (NMTB). Since 2001 with the participation in the IAEA Tissue Banking Programme, Quality System Management has been implemented in the NMTB. New bio-production for radiosterilized tissues for the first time and improved procedures were carried out. As a result an increased production of high-quality tissues was obtained and distributed for clinical use.     

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 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.     

Cadaveric Tissue Supply to the Commercial Sector For Research: Collaboration between NHS Pathology and NBS Tissue Services in the U.K., Extending the Options for Donors

The Peterborough Hospital Human Tissue Bank (PHHTB) and National Blood Service Tissue Services (London and South East Zone) (NBSTS) operate within the U.K. National Health Service (NHS) and have a system in place to retrieve cadaveric tissues for commercial sector research. The collaboration meets the aims of PHHTB and NBSTS and is legal, ethical and safe. This paper presents the results of the first 20 successful retrievals referred from NBSTS to PHHTB. Cadaveric retrieval of tissue for research extends the options for donors and their relatives. The research option is particularly welcomed in cases where clinical retrieval for tissue transplantation is contraindicated. We believe the system is applicable to other centres.     

The Future Role of the International Atomic Energy Authority (IAEA) in Tissue Banking

The International Atomic Energy Agency, an agency of the United Nations, has supported tissue banking programmes in 28 countries to further extend the use of ionising radiation for medical sterilisation applications. Up to 1998, some 115,000 tissue allografts have been produced and clinically used. A new thematic approach has now been introduced to set strict criteria to govern future developments. The emphasis will be on appropriate training and the introduction of Quality Systems in order to achieve international standards. Countries wishing to gain further support will be required to demonstrate the need and performance. To ensure a training mode appropriate to a global organisation, a multi-media training curriculum has been developed, which can be delivered by distance learning methods. Following its successful launch in the Asia Pacific region, the curriculum is now being translated into Spanish for use in Latin American countries. The Republic of Korea government too has provided resources for translation into their language and to initiate a national programme. In other countries national networks are being set up for improving public and professional awareness, training and tissue distribution. Collaboration with international organisations is another new area of development.