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Organ/part organ that cannot be transplanted into the intended recipient

When an organ is referred to in this paper we mean organ/part organ.

Updated: April 2014

Description

2. HTA policy on the steps transplant units should take to prepare living organ donors for the unlikely scenario arising whereby it is not possible to transplant their organ into the intended recipient. The purpose of this process is to ensure that living donor organs are not “wasted”.

Background

3. There are very rare circumstances in which a living donor organ cannot be transplanted into the intended recipient.

4. The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplant Regulations) 2006 (the Regulations) are silent on the options available.

5. Where a donor has not consented to donate the organ to an alternate recipient, or to research, the organ would have to be re-implanted or disposed of. This is because consent would not be in place for the re-direction to occur.

6. Whilst this situation is extremely rare (two known cases in the last ten years), there is a potential risk to the living organ donation programme, as viable organs could be wasted where the donor’s decision is not known in advance of the surgery.

7. Legal advice identified four potential options for living donors to consider.

8. The options available are as follows:

  • organ can be transplanted into an alternative recipient waiting for a transplant on the national waiting list;
  • organ can be re-implanted into the donor (this option is not appropriate for liver lobes. In addition, paired / pooled donors are advised that this may not always be possible if their organ is already being transported);
  • organ can be used for research; or
  • organ can be disposed of.

9. All transplant units should ensure that living donors are asked their wishes on the alternate use of the organ in advance of surgery.
 
10. Surgeons should be aware of the donor’s choice prior to surgery and must follow the donor’s wishes in the rare event that the organ cannot be transplanted into the intended recipient.

Decision making

11. Legal advice indicated that this function could be delegated as it is the primary intention of the donor in these cases to direct their organ.

12. The Authority has therefore delegated the function of statutory approval for this group of cases, where the primary intention is for the donation to be directed, to the Executive.

Purpose

13. Under Section 5 of the Human Tissue Act 2004, if a surgeon proceeds to redirect an organ to an alternative recipient without the consent of the donor, this may be a criminal activity. A person guilty of an offence under section 5 is liable to imprisonment for up to a year and/or a fine.
 
14. This was communicated to Transplant Surgeons in May 2011. In July 2011 the HTA implemented changes to the secure system that Independent Assessors use to submit reports to the HTA, to identify the donor’s wishes. 

Non-directed altruistic donors

15. In cases of non-directed altruistic donation, the donor is not aware of the identity of the intended recipient prior to surgery. Therefore this policy does not apply to non-directed altruistic donors.

Review

16. This policy will be reviewed annually.