Regulatory Focus™ > News Articles > US HRSA Proposes Regulating Face, Hand Transplants

US HRSA Proposes Regulating Face, Hand Transplants

Posted 06 January 2012 | By Alexander Gaffney, RAC 

The US Health Resources Services Administration (HRSA) wants to regulate face, hand, and other body part transplants much like it does for other organ transplants, according to the Washington Post.

HRSA's proposal would also institute:

  • waiting lists run by the United Network for Organ Sharing (UNOS);
  • donor matching systems;
  • organ distribution systems; and
  • systems to test for diseases and infections.

HRSA officials noted that they were seeking to issue the regulations due to the procedures becoming more mainstream and varied.  Transplants that would be regulated by the proposal include face, hand, feet, ankle, finger, windpipe, voice box, abdominal wall, uteri, and penile transplants.

"When you think about the human body, there is really nothing that could not be replaced by transplantation. Almost nothing," said Dr. Bohdan Pomahac, a surgeon at Brigham and Women's Hospital in Boston.

The Washington Post notes that the regulations would not change how the US Food and Drug Administration (FDA) regulates heart valves, bone or tissue transplants.  The regulation would only cover the transplantation of complex tissues such as those that combine blood vessels, muscle, and bone.

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