Atlanta – The OPTN/UNOS Board of Directors, at its meeting June 1 and 2, approved policies to facilitate the transplant community’s participation in the federal HIV Organ Policy Equity Act (also known as the HOPE Act), which calls for study of the feasibility, effectiveness and safety of allowing transplantable organs from HIV-positive donors to be used for HIV-positive candidates. The policies approved by the Board allow the recovery of organs from HIV-positive donors and include patient safety measures intended to assure their use only for candidates known to be HIV-positive.
“This is a crucial step in the process of making the HOPE Act a reality,” said OPTN/UNOS President Carl Berg, M.D. “The new requirements build upon recent changes in federal law and regulation and provide a pathway for the clinical use of organs from HIV-positive donors. We expect this to increase the number of transplants, not only for HIV-positive candidates but for HIV-negative recipients who will have greater access to organs from HIV-negative donors.”
The National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health, is leading the development of research criteria for transplant programs that plan to use HIV-positive organs for HIV-positive recipients. Clinical studies may begin as early as 2016.
In other action, the Board approved more detailed standards for vascularized composite allografts (VCAs), such as face and hand transplantation. The updated requirements follow a set of criteria initially adopted in June 2014. They address a number of areas, including:
- membership requirements for VCA programs, including training and experience criteria for VCA surgeons and physicians
- allocation of VCA from deceased donors
- authorization of VCA donation from deceased donors
The Board also approved a guidance document addressing VCA donation from living donors. Its recommendations are not enforceable in the same way as OPTN policies but are intended as a resource while the transplant community develops consensus for additional policy development.
The Board approved, for the first time, training and experience criteria for surgeons and physicians at intestinal organ transplant programs. The Board also approved a white paper outlining ethical principles to be considered in organ allocation, as well as a resource document to help transplant professionals assess procedures to mark the laterality (right vs. left) of donor kidneys.
United Network for Organ Sharing (UNOS) serves as the Organ Procurement and Transplantation Network (OPTN) by contract with the U.S. Department of Health and Human Services, Health Resources and Services Administration, Division of Transplantation. The OPTN brings together medical professionals, transplant recipients and donor families to develop national organ transplantation policy.