Chapter 3: overview of the principles underpinning these guidelines
Updated 21 May 2024
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This publication is available at https://www.gov.uk/government/publications/guidance-on-the-microbiological-safety-of-human-organs-tissues-and-cells-used-in-transplantation/chapter-3-overview-of-the-principles-underpinning-these-guidelines
Transplantation has been one of the great success stories in healthcare. However, there have been reports of transmissions of viruses, bacteria, fungi, protozoa, nematodes and prions following transplantation of organs, tissues and cells. These infections may be difficult to manage in the setting of immunosuppression, which may increase morbidity and mortality.
The risk of infection due to transplantation can never be completely removed. This guidance sets out precautions that should help to keep the risk as low as is reasonably possible while at the same time facilitating the maximum clinical benefit from transplantation.
Transplants have many benefits, whether life-preserving (such as heart or hematopoietic stem and progenitor cell (HSPC) transplants), life-producing (such as in-vitro fertilisation (IVF)), or aimed at improving the quality of life (such as bone grafts). Consequently, the risk of infection from a particular donor may be an absolute contra-indication to accepting a bone donation but only a relative contra-indication for liver donation where the potential recipient might otherwise die from liver failure. For this reason, the criteria used to accept a tissue donor are stricter than those for organ donors.
In cases where unusual (for example, Trypanosoma cruzi, malaria, and so on) or extra risks (for example, donation from a person who injects drugs, commercial sex worker, and so on) of infection are identified with a particular donation, these should be discussed before transplantation with the person who would receive the organs, with the parent or legal guardian in the case of a child who lacks capacity to consent, and with the family or carers where appropriate. The discussion and the consent if given should be recorded in the patient’s clinical notes. Specific treatment or prophylaxis of the recipient and appropriate close contacts may be offered to mitigate risks.
In the situation where the potential recipient lacks capacity for decision making for whatever reason then transplantation may be undertaken in accordance with existing legal frameworks.
Infection may also result from transplant material becoming contaminated from organisms in the environment. Contamination may occur while the material is being collected, processed, packed, tested, stored, transported and/or transplanted. Standard procedures for all these activities should include a microbiological risk assessment as part of a quality assurance programme.
A continuing audit of the outcome of tissue and organ transplantation is an essential part of maintaining and improving safety. The reporting of adverse outcomes of such treatment is an important component of this strategy and is discussed in more detail in chapters 16 and 17.