New guidelines are supposed to protect organ donors in a retrieval procedure that keeps blood flowing through livers, kidneys, lungs and hearts. But bioethicists have troubling questions.

Olga Pankova/Getty Images

hide caption

toggle caption
i

Olga Pankova/Getty Images

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.”