The U.S. organ transplant system has approved the first national policy for a controversial procedure used to remove organs from hospital patients. While the guidelines are designed to protect potential donors, critics argue they fail to improve safety and ignore deeply concerning ethical questions.
The Debate Over Normothermic Regional Perfusion
The procedure is known as normothermic regional perfusion, or NRP, and can be used after a family decides to withdraw care due to a lack of hope for meaningful recovery. To perform NRP, doctors attach an external pump to a donor minutes after circulation has ended and they have been declared dead, restoring blood flow to the heart, lungs, kidneys, liver, and other organs to prevent deterioration.
Dr. Raymond Lynch, the director of transplantation at the Health Resources & Services Administration (HRSA), explained that the hope with NRP is to increase both the supply and quality of organs. Lynch noted that NRP could help solve the chronic organ shortage, as more than 109,000 Americans are waiting for a transplant and about 12 die every day because of the shortage, according to HRSA.
However, critics argue that NRP is unethical because it violates the Dead Donor Rule, which dictates that surgeons can only take organs from patients after they are dead by brain death or circulatory death. Because NRP restarts circulation, critics contend that the procedure reverses the condition used to declare the person dead.
Dr. Lainie Friedman Ross, a bioethicist at the University of Rochester, stated that declaring someone dead by circulatory criteria means not attempting to reestablish circulation, which is precisely what NRP does. Ross added that she has a serious problem with the procedure, believing it takes organs from people who are no longer dead.
New Guidelines and Ongoing Concerns
Another aspect of NRP that troubles critics is what surgeons do to ensure the donor is also brain dead after circulation resumes. Surgeons clamp off blood vessels supplying the head, but alarm bells rang when blood appeared to reach the brain during some NRP cases.
Dr. Claire Morgan, a transplant surgeon serving on the transplant network’s Patient Affairs Committee, reported seeing signs of life when the brain was reperfused, calling it extremely disturbing. These cases prompted HRSA to instruct the Organ Procurement & Transportation Network (OPTN) to investigate and develop a response. On November 6, the OPTN board of directors approved the first phase of uniform national guidelines for performing NRP.
The new guidelines, set to go into effect on December 6, require surgeons to both clamp blood vessels to the brain and cut holes in them. Lynch explained that cutting or venting above the clamping serves as a second safeguard to ensure blood drains out of the head rather than supplying warm oxygenated blood to the brain.
The policy also recommends against giving donors paralyzing drugs that could mask movements. Nevertheless, critics maintain the safeguards are insufficient because most surgeons already clamp and vent blood vessels. Morgan expressed disbelief that the policy provides any additional protection, while also criticizing the decision to implement the guidelines on an emergency basis without public input.
Furthermore, critics argue the policy fails to address the fundamental concern that NRP donors are not technically dead when their organs are removed, fearing the policy will accelerate NRP use before ethical questions are resolved. Dr. Matthew DeCamp, a University of Colorado bioethicist, described the policy as putting the cart before the horse, emphasizing that fundamental issues surrounding NRP remain unresolved.
Lynch defended the guidelines, asserting that the new rules will protect donors and that NRP is ethical. Lynch stated that the policy is an important first step to ensure safe NRP care while keeping family safety at the forefront, describing it as life-saving care that will safely extend and improve the organ supply if performed properly.
