Policy on the import of fresh frozen bodies and body parts
HTA policy on the import of fresh frozen bodies and body parts.
Issued 10 June 2009
1. The import of relevant material is not a licensable activity under The Human Tissue Act 2004 (the Act); however, the storage of relevant material for the scheduled purpose of education and training relating to human health must take place on premises licensed by The HTA.
2. The HTA's code of practice on Import and export of human bodies, body parts and tissue (code 8) provides guidance for establishments that wish to import relevant material. This policy supplements the code, as it covers The HTA's requirements for establishments importing fresh, frozen cadaveric material.
3. The import of fresh frozen bodies and body parts for the scheduled purpose of education and training relating to human health, is emerging as a potentially common practice for some HTA-licensed establishments. Currently, the reason cadaveric material is imported from countries, such as the USA, is that there is no source within the UK that supplies cadaveric material which is frozen while fresh, as opposed to being embalmed. Fresh frozen material is primarily used for surgical training. The benefit of using this material is that it provides healthcare professionals with opportunities to rehearse lifelike surgical techniques before they are carried out on living people.
4. All bodies, body parts or tissue should be treated with respect and dignity. There are also health and safety risks associated with the import of fresh frozen cadaveric material.
5. The expectations of the HTA, in relation to the licensed establishments involved in the practice of importing human tissue, are set out in Appendix A of this policy.
6. Exporting establishments, although not licensed by The HTA, should still be following any good practice guidelines and / or statutory requirements in the exporting country. This is addressed in Appendix B of this policy.
HTA-licensed establishment importing fresh frozen cadaveric material
A1. HTA-licensed establishments that import and store human tissue for a scheduled purpose, such as Education or training relating to human health, must comply with the HTA standards on Consent, Governance and quality systems, Premises, facilities and equipment and Disposal. Further, as laid out in code of practice eight, imported material should be procured, used, handled, stored, transported and disposed of with due regard for the safety considerations and the dignity and respect accorded to human bodies, body parts and tissue. Importers should be able to assure themselves that the material has been sourced with appropriate consent. Documentation should be available, which demonstrates the rationale for the decision to import in terms of accessibility, quality, timeliness of supply, risk of infection, quality of service, cost effectiveness or scientific or research need.
A2. Importing establishments should ensure that donors who have tested positive for HIV/AIDS, hepatitis B, hepatitis C, tuberculosis, a transmissible spongiform encephalopathy such as Creutzfeldt-Jakob Disease and meningitis have been excluded from donation by the supplier in the source country. Serological testing should have been carried out by an accredited / licensed laboratory and all the donor information reviewed and signed off before any specimen is considered available for release.
A3. The HTA would expect a donor sheet to accompany any imported cadaveric material, depicting the medical and social history of the donor as well as the serological results.
A4. All specimens should be procured, wrapped and shipped in fashion which will prevent accidental exposure and should conform to the international standards for the transport of hazardous clinical material. Detailed requirements are set out for the carriage of ‘dangerous goods'; which is defined as, "any article or substance identified in the Technical Instructions (2007-2008), approved and published by the International Civil Aviation Organisation (ICAO)".
A5. As fresh frozen cadaveric material will not have been subject to any chemical preservation, such as embalming, the HTA also expects establishments to adhere to two existing guidance documents from the Health and Safety Executive (HSE). The first concerns the handling of cadaveric material and is called Infection at work: controlling the risks from human remains (2005). It was published primarily for those in the funeral profession, including embalmers, and those involved in exhumation; however, it offers advice on precautionary measures to be taken by anyone who has contact with human remains, and in particular deals with the risk of infection, including the sources, transmission and host of infection.
A6. The second piece of HSE guidance that the HTA expects importing establishments to adhere to is called Safe working and the prevention of infection in the mortuary and post mortem- room (Second edition) ISBN 0 7176 2293 2. It was published primarily for those working in a post-mortem room on a daily basis. However, it provides advice on the handling, storage and examination of bodies and pathological specimens, including safe working practices, health surveillance and risk assessment.
B1. Exporting establishments, although not licensed by the HTA, should still follow any good practice guidelines and / or statutory requirements in the exporting country.
B2. Exporting establishments which adhere to the guidelines set out in the National Organ Transplant Act (NOTA) and the Uniform Anatomical Gift Act (UAGA) will ensure that tissue is only provided to organisations that have entered into a binding agreement prohibiting the sharing and redistribution of material. They will also obtain extensive medical and social history information from the donor's next of kin.