New rules govern controversial organ donation procedure

Federal health officials approved the first national policy for a controversial organ retrieval procedure.

The guidelines, effective Dec. 6, govern normothermic regional perfusion, or NRP. This technique keeps organs viable after a patient's heart has stopped.

Doctors declare a patient dead by circulatory criteria when circulation ends. Under NRP, surgeons attach an external pump to the donor minutes after death. The pump restores blood flow to the heart, lungs, kidneys, and liver to prevent tissue deterioration.

Dr. Raymond Lynch, director of transplantation at the Health Resources and Services Administration, stated that NRP aims to increase the number and quality of available organs. HRSA data show more than 109,000 Americans are currently waiting for transplants. Approximately 12 patients die daily due to the shortage.

Critics argue the procedure violates the Dead Donor Rule, a core ethical standard in transplantation. This rule dictates that surgeons may only retrieve organs from patients who are dead from brain death or circulatory death. Because NRP restarts circulation, opponents say it reverses the condition used to declare death.

Dr. Lainie Friedman Ross, a bioethicist at the University of Rochester, said NRP contradicts the definition of circulatory death. "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," Ross said. She added that the procedure takes organs from people who are no longer dead.

A specific concern involves the brain. Surgeons typically clamp blood vessels to the head to stop blood flow. However, some retrieval teams observed blood returning to the brain during NRP cases. Dr. Claire Morgan, a transplant surgeon on the transplant network's Patient Affairs Committee, was the first to report these incidents to HRSA. "We have seen signs of life in NRP when the brain has been reperfused," Morgan said. "It's extremely disturbing."

These reports prompted the Organ Procurement and Transplantation Network to investigate. The OPTN board approved the initial phase of the guidelines on Nov. 6. The new rules require surgeons to do more than clamp the vessels. They must also cut or vent holes in the vessels above the clamp level. Lynch explained that this creates a second safeguard. If the clamp is insufficient, warm oxygenated blood drains out of the head instead of supplying the brain.

The policy also recommends against using drugs that paralyze donors, as these can mask movements. Critics contend the new safeguards offer limited additional protection. Morgan noted that many surgeons already perform both clamping and venting. She also criticized the emergency implementation of the first phase before public input was gathered. "I honestly don't believe they have created a policy that creates much or any more protection than these donors already had," Morgan said.

Dr. Matthew DeCamp, a bioethicist at the University of Colorado, said the policy does not resolve the fundamental issue of whether NRP donors are technically dead during retrieval. He described the move as the cart before the horse. Lynch countered that the guidelines prioritize the safety of the family's loved one. "This is life-saving care that will extend the supply and improve the quality of organs that patients can get in transplant," Lynch said. "And if it is done properly, it is safe."