Society backs proposed federal rule on adding hand, face transplant to organ registry
ASPS has given its full support to a proposed federal rule aimed at including vascularized composite allografts (VCA), such as faces and hands, in the national organ donation registry.
The Health Resources and Services Administration (HRSA) is considering categorizing face and hand transplants to fall under protocols that would offer the same rigorous oversight to the processes surrounding VCA procurement, including tracking, handling and data collection currently provided for kidney, liver, heart and other solid organ donations.
The proposed federal rule would bring oversight of VCA procurement and assignation under the umbrella of the HRSA-sanctioned Organ Procurement and Transplantation Network (OPTN), as well as the United Network for Organ Sharing (UNOS). The OPTN was established by Congress under the National Organ Transplant Act of 1984.
"It is exactly what we need," says ASPS member W.P. Andrew Lee, MD, who led five hand transplant procedures at the University of Pittsburgh Medical Center (UPMC) between 2009 and 2010 before he was named chair of the Department of Plastic and Reconstructive Surgery at Johns Hopkins University School of Medicine in Baltimore in 2010. "Many colleagues and I have worked very hard under the auspices of the American Society for Reconstructive Transplantation (ASRT) to get the Department of Health and Human Services (HHS) to propose such a policy."
Unlike organs, tissue and bone donation is regulated by the FDA, which left the classification of VCAs unclear.
"Those of us who perform this surgery firmly believe that when you transplant a hand or face, the considerations and logistics in relation to the donor families are very much alike those of the organ transplant - and quite different from the skin and bone donation because the latter are basically preserved to be put on a shelf and be used any time," says Dr. Lee, who also serves as president of the American Society for Surgery of the Hand. "A hand or a face, obviously, just like a heart, kidney or liver cannot be without a blood supply for more than a few hours. They need to be transplanted right away."
It is a very important step to get on the same level with any other transplanted organs," adds ASPS member Bohdan Pomahac, MD, who has led both face and hand transplant procedures as director of Plastic Surgery Transplantation at Brigham and Women's Hospital in Boston. "It will allow us to unify a database of recipients as well as donors."
ASPS lends its support
The Society sent its endorsement of the proposed rule to HRSA officials in January. In the correspondence, ASPS Board Vice President Health Policy & Advocacy Robert X. Murphy Jr., MD, acknowledged growing medical skills, interest from the public and demand for VCA, and outlined the rising involvement in the field by ASPS members; the need for standardization in certain non-medical VCA processes; and the utility of resource-sharing among organizations with medical and non-medical experience in VCA.
"ASPS commends the OPTN on its recognition of the powerful impact these transplants have to improve the quality of life for patients who've suffered severe and debilitating injuries," Dr. Murphy writes. "Reconstructive transplantation is a rising field in plastic surgery and allows restoration of the human body otherwise unobtainable by other means.
"ASPS believes the proposed regulation appropriately appreciates the similarity of the VCA process to other frequently transplanted organs," he adds. "Including VCA within the OPTN/UNOS oversight will promote public trust, increase donor procurement and facilitate broader application of VCA in the future."
Among the issues the HRSA has placed behind its effort is the recent growth in face and hand transplantation - some of which is a result of injuries sustained by U.S. military personnel abroad - and others that reflect factors faced in the "early days of organ transplantation," including:
- Equitable access for patients
- Uniform allocation policies
- Consistent application of "recovery" and logistics processes
- Patient safety monitoring and data collection
- Consistency in facilities/operating theaters
"Sen. John Boozman (R-Ark.) has been very supportive of this effort to provide these parts to our wounded warriors and to the population at large," says ASPS member and ASRT President L. Scott Levin, MD, chairman of the Department of Orthopaedic Surgery and professor of Surgery (Plastic Surgery) at the University of Pennsylvania. "We've been on Capitol Hill campaigning to have this transition from tissue to organ occur, and I'd say there is a very good chance with the support of HHS Secretary Katherine Sebelius that this will take place."
ASRT efforts on Capitol Hill resulted in a bipartisan letter to Sebelius signed by 17 members of Congress urging HHS to adopt the rule.
ASPS transplant leaders agree
ASPS members on the forefront of VCA note that the growing ability of reconstructive surgeons to innovate - and to help patients in need - is driving the advances that have provided the impetus behind the proposed rule.
Dr. Lee says further advances in immunosuppression are necessary, but progress is being made in the ongoing effort to help patients regain lost limbs.
"We know hand and face transplant can be done technically, but I'm convinced the immunologic aspect is the critical one that determines the future of this exciting field," he says.
Dr. Levin, who led the 30-person team team that performed a bilateral hand transplant in September (pictured above) – Penn's initial foray into VCA - says the combination of surgical innovation and collaboration prevalent in this emerging field will only lead to further advances.
"This is the next frontier in reconstructive surgery," he says.
Next steps
HHS is evaluating various issues to determine the most appropriate approach for VCA protocols. One remaining question involves the potential impact of the proposed rule on the public - organ donor registries, organ donor card signatures and the "general willingness of individuals to agree to be deceased organ donors."
ASPS member Joseph Losee, MD, who leads the UPMC facial transplantation program and is the principal investigator on its hand transplantation program, says that he expects the public to embrace the idea VCA donation.
"We used to think that the limitation in this field would be access to donors," Dr. Losee says. "We thought we'd have a list of people wanting to be hand transplant recipients and we would be waiting for families to donate. I'm fairly convinced at this time that's not the case. Our organ procurement specialist has never asked a family for a donation and had them say no - never."
"People may feel slightly different about face," notes Dr. Pomahac. "It is more personal to talk about a donation of hand or face or other extremities, but I think it's a matter of time before it will be more routine - just like hearts, which have traditionally held a different standing among all the organs."
HHS has indicated it will seek public comment on an expanded definition of VCA.
Comments to the proposed rule closed Feb. 14, with final regulations to follow.
However, no timetable has been set by the HHS for a determination on the proposal.
For general information on the VCA issue, go to hrsa.gov.
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