Apr 30, 2007 (CIDRAP News) A hypothetical but not unlikely scenario: Amid an influenza pandemic, a small hospital has three patients who need mechanical ventilation. One has terminal cancer, another has severe chronic lung disease, and a third has a severe case of flu. With only one ventilator available, which patient will get it?
When the next flu pandemic comes, it's a good bet that ventilators will run short and clinicians will face wrenching decisions like these. Expecting that such choices will be excruciating for already stressed healthcare workers, a group of experts assembled by the New York State Department of Health (NYSDOH) is offering guidelines for rationing scarce ventilators.
Last month the group released a 52-page draft plan that provides detailed guidance for determining who will receive ventilator treatment in the face of a pandemic-related shortage. The plan calls for allocating ventilators in acute care hospitals solely on the basis of patients' medical need and chance of survival, without regard for age, occupation, ability to pay, or other factors.
"This isn't perfect," Tia Powell, MD, co-chair of the task force that wrote the guidelines, said in an interview. "People will certainly feel this proposal can be made better, but it's important to have some plan in place, and not simply defer to the overworked frontline provider in a crisis, to make a decision that you didn't grapple with when you had a good night's sleep and a meal."
The task force, called the New York State Workgroup on Ventilator Allocation in an Influenza Pandemic, has invited public comments on the proposed guidelines and plans to revise them in coming months.
Once the guidelines are finished, the expectation is that New York hospitals could use them as an acceptable standard of care if ventilators ran short in a pandemic, said Guthrie S. Birkhead, MD, the other co-chair of the task force and director of the NYSDOH Center for Community Health. Given that status, the guidelines might offer hospitals some protection against legal liability for ventilator allocation, he said.
Severe shortages possible
Hospitals in New York State have about 6,100 ventilators, 85% of which are in use at any given time, according to the draft guidelines. In a moderate pandemic, the authors estimate, more than 7,000 flu patients will need ventilators, more than 2,171 of them at the same time. Given the 85% usage rate, the state shortfall would be 1,256 ventilators.
In a severe pandemic (with the same 35% attack rate as a moderate pandemic but involving more severe disease), 58,000 patients may need ventilation, including 17,844 during the peak weeks, the document says. The state would need an estimated 16,929 more ventilators.
The state is stockpiling ventilators and other medical supplies for a pandemic. "But even so, in looking at the pandemic scenarios, the need would exceed any conceivable stockpile that we could maintain," Birkhead said. And even if there were enough ventilators, there wouldn't be enough trained staff to operate them, the report says.
The concern about ventilators goes back at least to 2005, when hospital officials at a pandemic planning conference in New York City talked about possible shortages of ventilators and other resources, according to Birkhead. "The question came back to us, 'Are you going to do some thinking about what the altered standards of care [in a pandemic] would be?'" he said.
The issue was handed over to the New York State Task Force on Life and the Law, a bioethics commission appointed by the governor, said Powell. The 29-member work group that was set up to write the guidelines consists partly of task force member and partly of nonmembers, including some experts from outside New York.
The plan is based on a set of ethical principles, including (1) healthcare workers' fundamental duty to care for patients, (2) the duty to steward scarce resources wisely, (3) the duty to plan in advance how to allocate ventilators, (4) statewide application of the allocation guidelines, so that the same rules apply in different hospitals and communities, and (5) transparency in proposing and refining the guidelines.
The proposal depicts rationing as a last resort. Hospitals would need to limit the need for ventilators by canceling or postponing elective medical procedures and would be expected to acquire as many ventilators as possible from their own suppliers or networks and the state and federal stockpiles.
"We'd reach this point [of rationing ventilators] only after many steps, and hospitals wouldn't do it on their own or in isolation, but as part of a whole statewide response," said Birkhead.
When rationing becomes necessary, the rules will apply to all patients in acute care hospitals, not just flu patients, without regard for age, occupation, or role in the community. The measuring stick will be patients' survival chances.
Relying on clinical criteria
"When a ventilator becomes available and many potential patients are waiting, clinicians may choose the patient with pulmonary failure who has the best chance of survival with ventilatory support, based on objective clinical criteria," the proposal states.
The clinical criteria are adapted from a protocol developed for the Ontario Health Plan for an Influenza Pandemic (OHPIP) and released in April 2006. The protocol relies on a critical care triage tool called the Sequential Organ Failure Assessment score, based on measurements of blood platelets, bilirubin, hypotension, creatinine, and other variables.
The proposal includes a set of "exclusion criteria"conditions that signal a high risk of mortality and thus exclude the patient from getting a ventilator. Among them are cardiac arrest, matastatic cancer with a poor prognosis, severe burns over more than 40% of the body, and end-stage failure of major organs.
Unlike some other proposals for allocating ventilators, the New York group decided not to list either specific diseases, such as AIDS, or age as exclusion criteria. "We tried to focus more on functionalitywe just want to know how sick you are and what your probability of survival is," said Powell.
Patients who do get a ventilator will be reassessed after 48 hours and again after 120 hours to see if they still need and can benefit from the treatment, the proposal says. Patients who don't receive ventilation or are taken off a ventilator would receive palliative care.
In an effort to protect primary treating physicians from the heavy burden of deciding whether their own patients will get or keep a ventilator, the guidelines assign the rationing decisions to the supervising clinician in charge of intensive care patients. This approach follows recommendations on emergency mass critical care published by a group of experts in 2005.
The aim is to put decisions in the hands of physicians who have the most experience in critical care while allowing the primary physicians "to care for their individual patients without facing a conflict of interest," in the words of the proposal.
Birkhead said it's impossible to know whether those charged with the tough decisions will follow the guidelines when the crisis comes.
"To have any protocol that says you're going to take people off a ventilator is difficult to contemplate," he said. "So the question whether healthcare workers will accept this is hard to answer ahead of time. But I think people will rise to a crisis."
No preference for healthcare workers
Some issues were more controversial than others as the guidelines were hammered out. One was "whether there would be priority access for healthcare workers and other first responders," said Powell. "The group has proposed that there not be prioritized access for healthcare workers. Once you're a critically ill patient, it doesn't matter what you do for a living."
The panel found several reasons not to prioritize healthcare workers. For one, "health care workers sick enough to require ventilators are unlikely to regain health and return to service during the pandemic," the proposal says.
Powell adds that the group of people who would risk exposure and do crucial work in a pandemic is large and hard to define, ranging from doctors and nurses to workers who clean the intensive care unit and emergency medical technicians, who in rural areas are often part-time volunteers.
"If you use up all those people you might run out of ventilators before you got to anyone else in the community, including children," she said. "That's unappealing," particularly in light of some evidence that children and adolescents may be particularly at risk for death from avian flu.
Powell said another controversial issue was how to deal with patients in chronic care facilities, including those who are chronic ventilator users. "We proposed that people in chronic care facilities be offered a different standard," she said. "To be in a chronic care facility, by definition, you're stable, you're not acutely ill. . . . We thought it was important to offer a haven for some of our most vulnerable chronically ill patients."
If the same clinical criteria were applied to people in chronic and acute care facilities, the proposal says, "the result might be the sudden and fatal extubation of stable, long-term ventilator-dependent patients in chronic care facilities." This might allow more people to survive, but it would "make victims of the disabled."
How to handle patients on kidney dialysis also generated some debate, according to Birkhead and Powell. The panel decided to include renal failure as an exclusion criterion, on the ground that "renal failure will increase the probability of mortality in those who also now require a ventilator," said Powell. "In addition, the need for dialysis creates an additional demand for nursing support, which is also a scarce resource."
But some panel members disagreed, pointing out "that the bridge therapy of dialysis puts end stage renal failure into a different and more hopeful category than liver or lung failure," she added.
A question on which the committee disagreed was what sort of process should be used to review the allocation decisions. A review process is needed to ensure consistency and justice in application of the criteria, but the participants "disagreed about whether a real-time or retrospective form of review would better serve the goal of providing a just and workable triage system," the report says.
The Ontario pandemic plan calls for a system in which triage decisions can be appealed, but that approach might cause unworkable delays and trigger "explosive debate during a time of scarce manpower and other resources," the New York document states. An alternative, it says, is to conduct a daily retrospective review of all triage decisions, which would help ensure correct and consistent use of the guidelines but would not allow intervention in individual decisions.
An effective liability shield?
Acknowledging that ventilator rationing would be likely to trigger lawsuits, the proposal says that guidelines issued by the NYSDOH "would provide strong evidence for an acceptable standard of care during the dire circumstances of a pandemic." However, it adds, there is no guarantee that a court would accept this view. Only legislation would provide certain protection.
The state health department has authority to issue regulations concerning standards of care during a pandemic, but turning the guidelines into regulations would create complications. For one, state law bars the health department from regulating physician practice, the document says. Another is the likelihood of causing unforeseen harmful consequences, given that the guidelines will not have been tested in practice.
"If you put something in a regulation or law, you really have to specify all the details, and in doing that you really lose some of your flexibility," said Powell. "You wouldn't be able to change a regulation as rapidly as you could something that would come out in the context of recommendations."
The NYSDOH has publicized the proposal via many avenues, starting by posting it on the department's Web site. The plan has been sent to state emergency preparedness coordinators, the Association of State and Territorial Health Officials, certain medical societies, advocacy groups for people with disabilities, hospital associations, the National Kidney Foundation, and state and county health officials in New York. The department also ran a satellite video conference with hospitals around the state and briefed hospital officials in New York City.
"We're very explicitly putting this out for public comment. We want to be sure people have ample opportunity for input," Birkhead said. The panel is asking for comments by the end of May.
Powell said a number of other states are considering the problem of ventilator allocation, but she was not aware of any other state that has published recommendations.
So far the response to the proposal has been positive, but some have asked for various clarifications, according to Powell. "Many facilities observe, quite correctly, that the document doesn't take you all the way to the level of detail of how you would operationalize it in your particular facility," she said. "So there's more work to be done.
"Happily the feedback overall is positive. We're getting a lot of comments, so we're trying to incorporate those and make it better."
Access to the Ontario Health Plan for a Pandemic