The U.S. organ transplant system has approved the first national policy for a controversial procedure used to remove organs from hospital patients. The guidelines are designed to protect potential donors. But critics say they do little to improve safety and fail to address deeply troubling ethical concerns.
The procedure is called normothermic regional perfusion, known as NRP. It can be used after a family has decided to withdraw care because there's no hope of meaningful recovery for the person. To perform NRP, doctors attach an external pump to a donor minutes after their circulation has ended and they've been declared dead. The pump restores blood flow to their hearts, lungs, kidneys, liver and other organs to keep them from deteriorating.
"The hope with NRP is that it increases the supply of organs and it increases the quality of the organs," says Dr. Raymond Lynch, the director of transplantation at the Health Resources & Services Administration, the federal agency that oversees the organ transplant system.
NRP could help solve the chronic organ shortage, Lynch says. More than 109,000 Americans are waiting for an organ transplant, according to HRSA. About 12 die every day because of a chronic organ shortage.
Critics, however, say NRP is unethical because it violates the Dead Donor Rule, which is the most important rule protecting potential donors. The rule says transplant surgeons can only take organs from patients after they are dead because of brain death or circulatory death. But because NRP restarts circulation, critics say the procedure reverses the very condition upon which the person has just been declared dead.
"In order to be dead by circulatory criteria it means we're not going to attempt to reestablish circulation. But that's exactly what they do in NRP," says Dr. Lainie Friedman Ross, a University of Rochester bioethicist. "So, yes, I have a real problem with NRP. I think it violates the dead donor rule. It's taking organs from people who are no longer dead."
The other aspect of NRP that troubles critics is what surgeons do to try to make sure the donor is also brain dead, after circulation has been restarted by a mechanical pump. They clamp off blood vessels that supply the head. But alarm bells started going off for organ retrieval teams when blood appeared to get restored – or "reperfused" – to the brain during some NRP cases.
"We have seen signs of life in NRP when the brain has been reperfused," says Dr. Claire Morgan, a transplant surgeon who serves on the transplant network's Patient Affairs Committee and was the first to report such cases to HRSA. "It's extremely disturbing."
Those cases prompted HRSA to instruct the Organ Procurement & Transplantation Network (OPTN), which runs the organ system, to investigate and develop a response. On Nov. 6, the OPTN board of directors approved the first phase of the first uniform national guidelines for how to perform NRP.
The new guidelines, which will go into effect Dec. 6, call for surgeons to do more than just clamp the blood vessels to the brain. They should also cut holes in them, according to the new policy.
"Clamping the blood vessels should stop blood flowing to the brain," says Lynch. "Cutting or venting above the level of the clamping is a second safeguard to make sure that if the clamping is insufficient that it immediately drains out of the head and is not supplying warm oxygenated blood to the brain."
The new policy also includes other protections, including recommending against giving donors drugs that would paralyze them and mask any movements.
But critics say the new safeguards are insufficient. Most surgeons already both clamp and vent blood vessels to the brain, for example, they say.
"I honestly don't believe they have created a policy that creates much or any more protection than these donors already had," says Morgan, who also disagrees with the decision to implement the first phase of the new guidelines on an emergency basis before the public had a chance to weigh in.
Critics also say the new policy doesn't begin to address the bigger concerns that NRP donors are not technically dead when surgeons remove their organs. They worry the adoption of the policy could speed the use of NRP before the troubling questions have been fully aired.
"I really think the policy is the cart before the horse," says Dr. Matthew DeCamp, a University of Colorado bioethicist. "The fundamental issues around NRP still remain unresolved."
Lynch, however, argues the new guidelines will protect donors and that NRP is ethical.
"This is an important first step to make sure NRP care is available but that the safety of the family's loved one is always at the forefront," Lynch says. "This is life-saving care that will extend the supply and improve the quality of organs that patients can get in transplant. And if it is done properly, it is safe."
