New guidelines are meant to protect organ donors during a procurement procedure that keeps blood flowing to the liver, kidneys, lungs and heart. But bioethicists are asking troubling questions.
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Olga Pankova/Getty Images
The U.S. organ transplant system has approved the first national policy regarding a controversial procedure used to harvest organs from hospitalized patients. The guidelines are designed to protect potential donors. But critics say they do little to improve security 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 is no hope of a meaningful recovery for the person. To perform PNR, doctors attach an external pump to a donor a few minutes after their circulation ends and they die. The pump restores blood flow to the heart, lungs, kidneys, liver and other organs to prevent damage.
“The hope of the NRP is that it increases the supply of organs and their quality,” says Dr. Raymond Lynch, director of transplantation at the Health Resources & Services Administration, the federal agency that oversees the organ transplant system.
PNR 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 people die every day due to a chronic organ shortage.
Critics, however, claim that the NRP is unethical because it violates the dead donor rule, which is the most important rule protecting potential donors. The rule states that transplant surgeons can only remove organs from patients after they die due to brain death or circulatory death. But because NRP restarts circulation, critics say the procedure reverses the very condition in which the person was just declared dead.
“To be dead by circulatory criteria, that means we’re not going to try to restore circulation. But that’s exactly what they do in the NRP,” says Dr. Lainie Friedman Ross, a bioethicist at the University of Rochester. “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 worries critics is what surgeons do to try to ensure that the donor is also brain dead, after circulation has been restarted by a mechanical pump. They block the blood vessels that supply blood to the head. But alarm bells began to ring for organ procurement teams when blood appeared to be restored – or “reperfused” – into the brain in some cases of NRP.
“We observed signs of life in the NRP when the brain was 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 worrying.”
These cases prompted HRSA to ask the Organ Procurement and Transplantation Network (OPTN), which manages the organ system, to investigate and develop a response. On November 6, the OPTN Board of Directors approved the first phase of the first uniform national guidelines on how to implement the NRP.
The new guidelines, which take effect Dec. 6, call on surgeons to do more than just clamp blood vessels in the brain. They would also have to drill holes in it, according to the new policy.
“Clamping the blood vessels should prevent blood from flowing to the brain,” says Lynch. “Cutting or venting above the level of the clamp is a second protective measure to ensure that if the clamp is insufficient, it immediately drains from the head and does not deliver warm, oxygenated blood to the brain.”
The new policy also includes other protections, including recommending against giving donors medications that could paralyze them and obscure movement.
But critics say the new safeguards are insufficient. Most surgeons already clamp and vent blood vessels to the brain, for example, they say.
“Honestly, I don’t believe they’ve created a policy that creates much or 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 does not address larger concerns that PNR donors are not technically dead when surgeons harvest their organs. They fear that adopting this policy will accelerate the use of the PNR before the troubling issues have been fully raised.
“I really think politics is the cart before the horse,” says Dr. Matthew DeCamp, a bioethicist at the University of Colorado. “Fundamental questions around the PNR still remain unanswered.”
Lynch, however, says the new guidelines will protect donors and that the PNR is ethical.
“This is an important first step in ensuring that NRP care is available but that the safety of the family’s loved one is always at the forefront,” Lynch said. “This is lifesaving care that will expand the supply and improve the quality of organs that patients can obtain in transplant. And if done correctly, it is safe.”
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