Organ Transplants: Policy Statement From CDC On Use Of Potentially-HIV Positive Donors

Legal Eagle Eye Newsletter for the Nursing Profession

December 1996

   Quick Summary: The CDC has expressed concern that its 1994 guidelines for prevention of HIV transmission through transplantation of organs are being interpreted, in the interest of the highest level of safety, in a manner which is compromising the already limited supply of organs available for transplant.

   The CDC’s most recent announcement attempts to encourage the use of organs from donors, assuming they test HIV-negative, who had behavioral characteristics suggesting the possibility of HIV exposure.

   Organ recipients should be tested three months post-transplant for HIV.   FEDERAL REGISTER, November 1, 1996, Pages 56548 - 56549.

   The Centers for Disease Control and Prevention on November 1, 1996 announced a statement of policy intended to clarify its position on HIV virus screening practices for selection of human organ donors.

   The CDC has stated its purpose is to clarify its recommendations concerning the use of organs from potential donors who test HIV-antibody negative, but who had behavioral risk factors for HIV infection.

   According to the CDC, prevention of HIV transmission from transplantation of human organs is based primarily on two considerations:

    (a) Careful screening of potential donors for behaviors that place them at high risk of acquiring HIV infection; and

    (b) HIV-antibody testing of blood samples obtained from the potential donor.

   According to the 1994 guidelines, potential organ donors who have been tested HIV-antibody negative but have one or more behavioral exclusionary criteria may be accepted as donors, but only if the risk to the recipient of not performing the transplant is deemed to be greater than the risk of HIV transmission and disease (e.g., emergent, life-threatening illness requiring transplantation then no other organs/tissues are available and no other lifesaving therapies exist). In such a case, according to the 1994 guidelines, the transplant can go ahead, assuming informed consent regarding the possibility of HIV transmission has been obtained from the recipient.

   The CDC’s November 1, 1996 announcement, according to the CDC, is based on a recognition of the life-extending and -enhancing properties of organ transplantation, and on the dire shortage of available organs for transplant. Therefore, when a potential organ donor tests HIV-antibody negative but has behavioral risk factors for HIV infection, the decision to accept an organ for transplantation should be made after consideration of the relevant risk factors for the individual recipient and with recognition of the very low incidence of HIV transmission in such situations.

   The CDC recognizes the need for transplant centers, not organ procurement organizations, to deal with matters of patient consent in this setting.

   In accepting an organ for transplantation, transplant teams should assess immediately the medical and social information available from the organ procurement organization regarding the potential donor.

   In the context of the current organ shortage, transplant teams are encouraged to accept and transplant organs from medically appropriate donors who test HIV-antibody negative but have behavioral risk criteria for HIV infection after the transplant teams have discussed the risks and benefits with potential recipients and/or their families.

   As recommended in the 1994 guidelines, organ transplant recipients should be tested for HIV infection three months after their organ transplants.

   According to the CDC, the provisions of this notice apply only to the screening of human organ donors. This notice is not intended to apply to the screening of human tissue, blood or other donors.  FEDERAL REGISTER, November 1, 1996, Pages 56548 - 56549.