U.S. Adopts First National Rules For Controversial Organ Retrieval Method

The federal network that oversees organ transplants has adopted the first national rules for a controversial organ-retrieval technique, ordering surgeons to physically block blood from ever reaching a donor's brain when they restart circulation in the rest of the body.^[1]

On November 6, the board of the Organ Procurement and Transplantation Network (OPTN) approved the initial phase of uniform guidelines for a procedure called normothermic regional perfusion, or NRP, with the policy set to take effect December 6 across US transplant centers.^[1] The rules require transplant teams to both clamp and cut or vent vessels leading to the head before machines restore circulation to the heart and other organs, an effort federal officials say will help expand the donor pool while critics warn it pushes the boundary of when someone is truly dead.^[1]

The new safeguards were ordered after some transplant teams reported seeing apparent "signs of life" in donors whose circulation was restarted with NRP and whose brains may have been unintentionally reperfused, undercutting the irreversible loss of circulation that was used to declare death in the first place.^[1] In response, the Health Resources and Services Administration (HRSA), which oversees the OPTN, directed the network to craft nationwide standards to prevent any blood flow to the brain once surgeons begin using pumps and oxygenators to warm and revive organs for transplant.^[1]

NRP emerged as a way to recover higher quality hearts, livers and other organs from people who die after life support is withdrawn, a category known as donation after circulatory death, or DCD.^[1] Traditionally, once a patient's heart stopped and doctors waited several minutes to confirm there was no spontaneous return of circulation, organ procurement teams could recover organs but could not restart blood flow in the body because that would undermine the very basis of the death declaration.^[1] NRP tries to square that circle by isolating the brain and then restarting circulation only to the chest and abdomen, using external machines to keep organs functioning until they can be transplanted.

HRSA officials and transplant leaders see the approach as a key tool to reduce a chronic organ shortage, arguing that many more patients could receive life-saving transplants if DCD donors' organs can be better preserved.^[1] But some bioethicists say even with the new head-vessel rules, NRP may violate the "dead donor rule," a core principle that organs can be taken only from patients who are already dead and that organ retrieval must not cause death.^[1] They argue that if death is declared based on permanent loss of circulation, then deliberately restoring circulation, even to part of the body, raises questions about whether the patient still meets that standard.

NPR reports that ethicists are especially troubled by cases in which NRP was started and donors showed movements or other reactions once blood flow restarted, episodes that have shaken confidence that earlier hospital-level protocols were sufficient.^[1] Supporters of NRP counter that the new OPTN policy is designed precisely to prevent any blood from reaching the brain and to lock in the determination that brain function is permanently lost, while still allowing organs to be salvaged for transplant candidates who may die waiting.^[1]

The national rules mark a shift from a patchwork of local practices to a single federal standard, but they are only the first phase of OPTN's guidance, and the controversy is likely to continue as more hospitals adopt NRP and more data emerge on its risks and benefits.^[1] HRSA and transplant leaders now face the challenge of convincing both the medical community and the public that the technique respects the line between caring for dying patients and recovering organs, a line many ethicists say has never felt more fragile.^[1]

1. NPR