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The U.S. organ transplant system is making a controversial change to a long-standing rule that was designed to protect potential donors. The revision aims to boost donations and reduce errors. But critics worry that the move may endanger patient care.
Under the change, the Organ Procurement and Transplantation Network, which runs the transplant system, will relax a strict firewall between the doctors and nurses trying to save patients in the hospital and the transplantation team standing by to procure patients' organs.
Previously, no one from that team was even supposed to talk to family members until after they had made the heart-wrenching decision to let a loved one go. The rule was intended to prevent pressure that could change the care patients receive. It was also in place to dispel any doubts that doctors aren't doing everything they can to save patients.
But the board of directors for the transplant system voted Aug. 20 to modify that rule as part of a new set of guidelines governing donation following circulatory death. That occurs after life-sustaining care has been withdrawn and now accounts for about half of organ donations.
The new rules, which go into effect Nov. 18, "allow discussions for organ donation to take place once end of life discussions are taking place with the potential deceased donor's agent," according to the new policy.
Why is the firewall previously barring these conversations coming down?
"I think the best way to think about it is that insisting on a bright line without focusing on what's happening on either side of that line is a false sense of security," Dr. Raymond Lynch, the director of transplantation at the Health Resources & Services Administration, the federal agency that oversees the organ network, told NPR in an interview.
The new rules aim to prevent disturbing mistakes that have occurred in the past. Those errors have included patients being wheeled into operating rooms to remove their organs when they were still alive.
"That specific line in the policy is part of a suite of improvements to the coordination and communication between the organ procurement organizations and the healthcare team that is caring for these patients in hospitals and the families of the patients themselves. And that really is a marked improvement over the policy that was in place before," Lynch says.
A balance of safety and speed
In addition to allowing donation teams to approach families sooner, the new policies include making it easier to pause organ retrieval if anyone becomes concerned that something is amiss and standardizing other patient protections, including testing for determining death.
"Documentation, clear coordination, deference to the primary healthcare team and consequences — that's what keeps patients safe," says Lynch.
The change in policy is also designed to make sure the organ retrieval team isn't brought in too late to conduct the tests and preparation necessary for families to honor their loved one's desire to be a donor.
When that happens, "the family loses out on that memory" of helping their loved one donate their organs, "the patient loses out on the choice that they made, and the people on the waiting list lose out on the chance to receive a lifesaving organ," Lynch says.
More than 109,000 Americans are waiting for an organ transplant, according to the Health Resources & Services Administration. About 12 die every day because of a chronic organ shortage.
Does the change cross an ethical line?
Critics, however, say the change is dangerous. It could subtly pressure families and caregivers to discontinue care and create confusion about who's in the intensive care unit to try to save their loved one and who's there to obtain their organs, which could deepen distrust in the organ donation system.
"It's a very important bright line," says Dr. Lainie Ross, a bioethicist at the University of Rochester. "Our primary responsibility is that patient's well-being and care. And we need a bright line. That's where our focus is, and we're not even going to start thinking about whether those organs are usable until death is inevitable and imminent."
She adds: "When my family member is in that hospital bed, I want to know that we're all on Team Mom and not worried the reason the doctor's really suggesting the treatments aren't working is because they want your organs for someone else."
Ross says she's "horrified to think that families will feel pressured. They'll feel manipulated."
Others also see problems with the change.
"I don't disagree with the desire to have more transplantable organs. I think transplants provide great benefit to many, many people," says Dr. Claire Morgan, a transplant surgeon who serves on the transplant network's Patient Affairs Committee. "But people may be pressured to make that decision too quickly. I don't want to interfere with a family's grieving process, and I don't want to interfere with a family's ability to make a decision for their family member at a time when it's correct for them."
Some critics say the change is the latest worrisome development for organ donors.
"This is part of a number of things that are going on in organ donation that are blurring lines," says Lois Shepherd, a professor of law and bioethics at the University of Virginia who opposed the change as a member of the working group that developed the new guidelines. "A lot of safeguards for patients are weakening. And that's a concern to me."
But the change was endorsed by the Association of Organ Procurement Organizations (AOPO), a trade group.
"Families/agents who are considering [withdrawing life support] must be informed about donation and how the donor evaluation process may affect the timing of the [withdrawal of life support]," the group said in its public comments. "Many families have expressed frustration with learning about this timing impact after planning for other family members to be present at the time of [withdrawing life support]. Waiting until the family has made the decision is too late."
The AOPO declined to make someone available for an interview with NPR. But AOPO President Allison Erickson said in a written statement: "Donation depends on public trust, and it is our responsibility to respect and maintain it. Any time there is confusion or concern, [organ procurement organizations] clarify and improve the process. Donor families deserve to fully understand each stage of the end-of-life and donation processes, as well as that their loved ones are cared for by all involved."
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