[Federal Register Volume 61, Number 213 (Friday, November 1, 1996)]
[Notices]
[Pages 56548-56549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Clarification of Human Immunodeficiency Virus Screening Practices
for Organ Donors
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services.
ACTION: Notice.
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SUMMARY: In 1994, the Centers for Disease Control and Prevention (CDC)
published revised guidelines for preventing transmission of human
immunodeficiency virus through transplantation of human tissue and
organs.\1\ The guidelines were developed to minimize the risk of HIV
transmission to transplant recipients while maintaining the
availability of suitable donor organs/tissue. In developing the
document, CDC sought assistance from public and private health
professionals, including expert consultants involved in organ/tissue
transplantation, to ensure that the diverse circumstances surrounding
transplants were considered. Reports from the organ procurement and
transplantation community have indicated that, in attempts to ensure
the highest level of safety, the guidelines have been interpreted in a
way which has further compromised the already limited supply of human
organs. The purpose of this notice is to clarify the recommendations
concerning the use of organs from potential donors who test HIV-
antibody negative but who have behavioral risk factors for HIV
infection. The provisions in this notice apply only to screening of
organ donors; they do not apply to screening of tissue, blood, or other
donors.
\1\ CDC. Guidelines for preventing transmission of human
immunodeficiency virus through transplantation of human tissue and
organs. MMWR 1994;43(No. RR-8).
FOR FURTHER INFORMATION CONTACT: Martha F. Rogers, M.D., Division of
HIV/AIDS Prevention, CDC, Mailstop E-45, 1600 Clifton Road, Atlanta, GA
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30333, telephone 404-639-6130.
SUPPLEMENTARY INFORMATION: The 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 donors who test HIV-
antibody negative but have one or more behavioral exclusionary criteria
may be accepted as donors 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
when no other organs/tissues are available and no other lifesaving
therapies exist). In such a case, informed consent regarding the
possibility of HIV transmission should be obtained from the
recipient.\1\
CDC recognizes the life-extending and -enhancing properties of
organ transplantation. 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. 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
[[Page 56549]]
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 transplant.
Dated: October 23, 1996.
Claire Broome,
Deputy Director, Centers for Disease Control and Prevention (CDC).
[FR Doc. 96-28064 Filed 10-31-96; 8:45 am]
BILLING CODE 4163-18-P
