Making ED organ transplant feasible puts providers in "difficult ethical territory"
Pilot project generated ethical debates
At the start of leading an 18-month pilot project to explore organ donation for patients who died in the emergency department (ED) at University of Pittsburgh Medical Center, Clifton W. Callaway, MD, believed the team was "creating, in reality, what the general public already thought existed." "In reality," he explains, "there is no established mechanism for patients who die in the ED to donate organs." "I think, in large part, the public expected that if they were in a car crash and died suddenly, and despite our best efforts could not be resuscitated, that was exactly when they would donate organs," he says. "We always notified the organ procurement organizations when we had a death, but that was the end of the process."
This is because all resuscitation efforts stop when a patient is pronounced dead by the ED team, and nothing is done to maintain organs for possible transplant. "We all walk away and talk to the family, and the organs have no blood flow," says Callaway, a professor of emergency medicine at the University of Pittsburgh. "Without blood flow, the kidney begins to suffer, and after about 30 minutes, we would expect the recipient would not do well. So there is a group of organ donors who currently don't have the opportunity to donate when they die."
Team always on call
The majority of organ donations occur when it becomes clear that an intensive care unit (ICU) patient's injury is not survivable, and the process occurs on a "more gentle time scale" than in the ED, says Callaway. "It's quite challenging to front load this into an ED setting, when somebody goes from being healthy to an organ donor in 60 minutes time. Fortunately, that is a rare situation. So there is not a huge untapped pool of potential donations."
No one involved in the care of a patient who might become a donor was involved in the donation process, stresses Callaway. The only change in ED practice was to prioritize the call to the organ procurement organization. If the patient was an organ donor, a second physician, different from the emergency physician, then began a procedure to pump cold fluids to lower the temperature of the organs that might be donated, in order to "buy time" until a surgeon could be available to procure any organs that would be donated. "We had a pretty pure separation between emergency care and donation," he says. "We had no concerns expressed by the public that there was anything different about our care or practice, and we really had no concerns from the hospital staff," he says.
Donation was attempted for only five patients who died in the ED during the 18-month pilot, which began in 2010 and was funded by a $321,000 grant from the Department of Health and Human Services, and none of the organs were transplanted. "We had two kidneys that looked usable on the pump, but were not matched to a recipient. None of the families were concerned about the ethical aspects of the donation," Callaway says. "From an ethical standpoint, we were extremely conservative in how we approached it."
The infrastructure cost of keeping a separate team available 24 hours a day, seven days a week, for an event that could occur at any time is one reason the project didn't continue. "Logistically, it was very difficult. When a potential organ donor dies five times in 15 months, that meant we had a team available on call for something that happens once every two or three months," says Callaway. "That is a tremendous resource to have, and it was not something we could sustain after the demonstration project was complete."
Delays are obstacle
Since the ED team made sure nothing was initiated until the first phone call was made informing the organ procurement organization that a donor had been pronounced dead, this decreased the chances that organs would be usable. "With a delay up to an hour, the transplant surgeon would not be enthusiastic about using that organ in another patient," he says. "We found it was tremendously challenging to make the time cutoffs that we said would be our benchmarks of success."
Cutting those delays means getting into "difficult ethical territory," however, says Callaway. "It would be much easier if we called when the resuscitation is still ongoing, but we felt that would be potentially unethical. We would not want to initiate anything prior to somebody being pronounced dead," he says, noting that Spain has a longstanding practice of continuing chest compressions after someone is pronounced dead. The team considered this practice, but ultimately rejected the idea.
"We were uncomfortable with the ethics of that. If you are doing chest compressions, it means you are still trying to save the patient in front of you, not just trying to save some organs for another patient," says Callaway. "To stop [cardiopulmonary resuscitation] for a little while, and then start it again in order to keep organs usable was something we had never done. We felt uncomfortable about instituting that into our program."
Callaway is still in favor of donation in the ED setting, but says current efforts are focused on improvements in resuscitation. "If nothing else, I think we identified the barriers to doing this and some areas for public discussion over the next few years to see what we should do in the ED and what should be off limits," he says.
The process by which informed consent is granted to donate an organ, how to allocate available transplantable organs to those on the waiting list, and ensuring that the possibility of organ donation does not adversely affect the care that a sick patient receives, are three ethical concerns with organ donation in any context, says Kevin G. Munjal, MD, associate medical director of prehospital care at Mount Sinai Medical Center in New York City. "These issues are amplified in the often high-pressure environment surrounding death in the emergency room," he says.
Since the advent of donation, there has been an ongoing effort to educate the public on the donation process, the dead donor rule, and how death is declared, says Alexandra K. Glazier, Esq., vice president and general counsel at New England Organ Bank in Waltham, MA, and chair of the Organ Procurement and Transplant Network/United Network for Organ Sharing Ethics Committee. "As long as the death declaration process is made clear and the dead donor rule is maintained, public fears on new donation practices can be allayed," says Glazier. "However, the possibility of public misperception of new donation techniques, especially within the ED environment, should not be underestimated." (See related story on misconceptions, below.)
Sources
- Clifton W. Callaway, MD, PhD, Professor, Executive Vice-Chair, Department of Emergency Medicine, University of Pittsburgh (PA). Phone: (412) 647-9047. E-mail: [email protected].
- Alexandra K. Glazier, Esq., Vice President and General Counsel, New England Organ Bank, Waltham, MA. Phone: (617) 558-6615. E-mail: [email protected].
- Kevin G. Munjal, MD, Associate Medical Director of Prehospital Care, Department of Emergency Medicine, Mount Sinai Medical Center, New York City. E-mail: [email protected].
- Raquel M. Schears, MD, Associate Professor of Emergency Medicine, Mayo Clinic, Rochester, MN. E-mail: [email protected].
Public might worry that care will be compromised Conflict of interest is issue It was bioethicists who first called for firewalls to be erected between doctors determining death of donors and surgeons waiting to transplant the donated organs to recipients, says Raquel M. Schears, MD, associate professor of emergency medicine at Mayo Clinic in Rochester, MN. "The conflict of interest haunted the experiences of those involved in the earliest days of transplantation. They were called to make the determination of death, with a transplant surgeon at their elbow urging hasty judgment to assure the best possible organ viability for chosen recipients," she says. The transplant pioneers relied on donation after cardiac death methods, which predated clinical brain death determination for organ donation purposes, says Schears. U.S. doctors and patients rapidly adopted brain death determination in the hospital as equivalent with human death and abandoned the practice of donation after cardiac death. It is very important that efforts to resuscitate a patient aren't compromised, and don't even appear to be compromised, by the prospect of the death of one patient benefitting another who is waiting for an organ donation, warns Kevin G. Munjal, MD, associate medical director of prehospital care at Mount Sinai Medical Center in New York City. One method of doing this, which was embraced in certain European models, was to maintain a separation of those responsible for caring for a patient and determining death and others responsible for assessing the patient and discussing the prospect of organ donation with the family, he says. The acceptability of presumed consent for procedures on the newly dead involved in donation after circulatory death procurement has not met with public endorsement, notes Schears. "Perhaps the strongest indication about worry regarding death and donation personally comes in comparing survey results about whether or not people support organ donation in general," she says. Roughly 80% reply in the affirmative, yet less than half of those respondents follow through on their assertions and become a designated donor using existing mechanisms such as organ donation registries, and fewer than 20% of Americans have an advance directive, including the small subset of people who agree to posthumously donate their bodies to medical science, notes Schears. "Within six months after Texas put the organ donation question as a 'no' checkbox on their driver's license forms, so many people elected the negative, they had to redo the question to avoid collapsing the state's donation election rate among those applying for license renewal," she adds. Munjal says that in his experience, the public has been "overwhelmingly positive" about developing a mechanism for patients who die from cardiac arrest to donate their organs if they wish to. "In all our community outreach, the most striking thing was that even amongst religious and other groups that were not willing to be organ donors themselves, most were surprised to learn that the overwhelming majority of people that sign up or express an interest in being organ donors will not have their kidneys, livers, and other solid organs donated simply because they did not die in a hospital or did not die via brain death," he says. |
At the start of leading an 18-month pilot project to explore organ donation for patients who died in the emergency department (ED) at University of Pittsburgh Medical Center, Clifton W. Callaway, MD, believed the team was "creating, in reality, what the general public already thought existed."
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