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Comment Sought on Proposed Rule Regarding Vascularized Composite Allografts

Comment Sought on Proposed Rule Regarding Vascularized Composite Allografts

The U.S. Department of Health and Human Services (DHHS) has issued a proposed rule to include vascularized composite allografts (VCA) within the definition of organs under the authority of the Organ Procurement and Transplantation Network (OPTN).  The proposed rule would also include VCA within the definition of human organs covered by section 301 of the National Organ Transplant Act.  DHHS is accepting public comment on this proposed rule through February 14, 2012.

The most common forms of VCA performed to date are hand and facial transplants, although other types of procedures may qualify under the proposed definition.  VCA surgery commonly involves transplantation of a set of anatomical structures including skin, bone, blood vessels, nerves, muscles and/or ligaments and tendons.  As with organ transplant recipients, VCA recipients require immunosuppressant drugs to reduce the risk of immune rejection of the graft.

Proposed inclusion of VCA within the OPTN’s authority under federal regulation (the OPTN Final Rule) would allow the OPTN to develop policies for equitable allocation of grafts, national data collection and reporting of procedures and outcomes, and standards for transplant centers to qualify to operate VCA transplant programs.

Proposed inclusion of VCA under the definition of human organs in the National Organ Transplant Act would add VCA to the existing list of organs prohibited for purchase or sale for the purpose of human transplantation.

For more detail about the proposed rule and how to submit a comment, please visit the Federal Register notice.

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