Policy on the import of fresh frozen bodies and body parts
Originally issued 10 June 2009, reviewed and revised in January 2014.
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 from the deceased 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 provides guidance for establishments that wish to import relevant material. This policy supplements our codes, 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 a common practice for some HTA-licensed establishments. Currently, the reason fresh frozen material is imported from countries, such as the USA, is that there is only a limited source within the UK. Fresh frozen material is primarily used for surgical training. The benefit of using this material is that it provides healthcare professionals with opportunities to practise lifelike surgical techniques and procedures without posing any risks to patients.
4. All bodies and body parts should be treated with respect and dignity. There are also potential health and safety risks associated with fresh frozen cadaveric material.
HTA-licensed establishment importing fresh frozen cadaveric material
5. HTA-licensed establishments that import and store human tissue for a scheduled purpose, such as for Education or training relating to human health, must comply with the HTA’s standards. Further, as laid out in the import/export code of practice, 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.
6. Importing establishments should ensure that donors who have tested positive for HIV disease, 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. Donor 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.
7. The HTA would expect a donor sheet to accompany any imported cadaveric material, confirming the low-risk status of the donor and including testing results.
8. All specimens should be procured, wrapped and shipped appropriately to prevent accidental exposure and should conform to the international standards for the transport of hazardous clinical material. Detailed requirements for the carriage of ‘Dangerous Goods' are set out in the Technical Instructions approved and published by the International Civil Aviation Organisation (ICAO).
9. 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 guidance documents from the Health and Safety Executive. The first document concerns the handling of cadaveric material and has the title ‘Controlling the risks of infection at work from human remains’. Although it was published primarily for those in the funeral profession, it provides useful guidance 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.
10. The second piece of HSE guidance that the HTA expects importing establishments to have regard to has the title ‘Safe working and the prevention of infection in the mortuary and post-mortem room’. Although it was published primarily for those working in a post-mortem room, it provides useful guidance on the handling, storage and examination of bodies and pathological specimens, including safe working practices, health surveillance and risk assessment.
11. Exporting establishments, which are based abroad and are not licensed by the HTA, should follow any good practice guidelines and / or statutory requirements in the exporting country. For example, exporting establishments in the USA 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.