COVID-19 and Ventilator Allocation: What is Legal and Ethical?
Eliza Yadav, B.A. candidate at the Institute for the Study of International Development at McGill University
COVID-19 has rapidly spread to 210 countries and over 2 million people worldwide since its first confirmed outbreak in Wuhan, China in December 2019. One of the largest issues currently concerning policymakers and medical workers is ventilator allocation. During the first wave of the virus, ventilators were running out in New York City, the epicenter of the COVID-19 outbreak in the United States. The New York State Ventilator Allocation Guidelines (the Guidelines) are a set of “instructions” with neonatal, pediatric, and adult elimination criteria that make it easier for medical professionals to decide who gets a ventilator and who does not during a crisis. Today, lawmakers and municipal leaders are considering real-world application of these Guidelines for effective resource allocation during the second wave of COVID-19 and future pandemics.
Ventilators serve a life-saving function for individuals who cannot breathe on their own by taking over the work of breathing through mechanical ventilation [1]. Without them, thousands in critical care may die preventable deaths during the second wave of the ongoing pandemic. In this critical climate, I wonder, what is the ethical and logical reasoning behind ventilator allocation, and how should this reasoning concretely materialize to save lives during the COVID-19 pandemic?
The Guidelines achieve their primary goal through prioritization of ventilator therapy to patients for whom it would be most lifesaving. In adults, the guidelines involve three steps: (1) application of exclusion criteria, (2) assessment of mortality risk, and (3) periodic clinical assessments [2]. In the first step, patients who have a medical condition that will result in immediate or near-immediate mortality, despite medical therapy, are excluded from receiving a ventilator. In the second step, patients who have a moderate risk of mortality and for whom ventilator therapy would be most-likely lifesaving are prioritized. Risk of mortality is measured through the Sequential Organ Failure Assessment (SOFA), a score which tracks a patient’s organ function by providing a quantitative score of the patient’s lung, heart, kidney, liver, brain, and blood-clotting functionalities. Finally, the third step involves periodic clinical assessments at the 48 and 120 hour-marks during which a patient is in medical care. A SOFA is performed at each mark to determine whether the patient should stay on ventilation or be removed so that another patient may receive the therapy.
Legal and ethical implications of the Guidelines include who creates policy, who makes the decisions on allocation, and what legal form such protocol should take. One of the major justifications behind the Guidelines is a duty to steward resources. However, this reasoning is not in line with the fundamentals of bioethics, a widely used ethical framework to guide medicine and related research. Perhaps the intuition behind inclusion of this component was to instill non-maleficence, the principle of “doing no harm” [3]. However, choosing who gets to live or die through allocation of lifesaving therapy is arguably an extension of “pulling the plug,” a direct contradiction to the aforementioned principle.
Further, the third step of the Guidelines specifically asks hospitals to remove ventilators from patients who perform poorly on SOFAs at 48 and 120-hour intervals. Removing a ventilator from an individual to simply allocate it to another during a pandemic in which thousands are suffering a similar plight can be mentally taxing on both the patient’s family and the patient’s medical team. What is the determinate proof that another patient will do better with ventilation therapy when h/she only has a marginally better clinical outcome? The heart of the issue is that these Guidelines are undeniably subjective: while the SOFA is impartial, it is performed by human beings who have flaws.
As well, SOFA is only performed at two intervals. The duration and frequency of these intervals is inadequate in relation to COVID-19. The Guidelines state that the 48 and 120-hour intervals were specifically chosen because they reflect the “duration of beneficial treatment for acute respiratory distress” [4]. Doctors at various universities such as Hofstra and Johns Hopkins have found that patients in acute care due to contraction of the Coronavirus take much more time to recover from the illness and therefore require extended intervals [5].
The reality of the Guidelines is that they recommend concrete policy with lethal outcomes in a crisis that could never have been planned for. They may be just what the world needs to fight COVID-19 but will first have to be thoroughly edited and ethically re-assessed before being implemented in New York City and beyond. Still, these Guidelines do not exist in isolation: they have to be complemented with precautionary public health measures such as social distancing and closure of non-essential facilities. Of course, as non-essential facilities reopen and people gather once again, correct compliance of social distancing is an increasing cause for concern. It seems that the world did not win against COVID-19 in the first and deadly wave, and the virus has returned again for a second and even more deadly rematch. For aversion of morbidity and mortality, it is absolutely essential that policymakers and governmental leaders learn from this current crisis for better management of medical crises in the future.
References
[1] American Thoracic Society. (2020). “Mechanical Ventilation, ATS Patient Education Series.” American Journal of Respiratory and Critical Care Vol. 196, P3-4. Retrieved from https://www.thoracic.org/patients/patient-resources/resources/mechanical-ventilation.pdf
[2] Zucker, Howard; Adler, Karl; Bleich, Rabbi; et al. (2015). “Ventilator Allocation Guidelines.” New York State Task Force on Life and the Law, New York State Department of Health. Retrieved from https://www.health.ny.gov/regulations/task_force/reports_publications/docs/ventilator_guidelines.pdf
[3] Beauchamp, T; Childress, J. (2013). “Principles of Biomedical Ethics, 7th edition.” Oxford University Press.
[4] New York State. (2020). “Frequently Asked Questions: New York State Task Force on Life and the Law and the New York State Department of Health’s Ventilator Allocation Guidelines.” New York State. Retrieved from https://www.health.ny.gov/regulations/task_force/reports_publications/docs/ventilator_guidelines_faqs.pdf
[5] Hamilton, John. (2020). “Ventilators Are No Panacea For Critically COVID-19 Patients.” NPR. Retrieved from https://www.npr.org/sections/health-shots/2020/04/02/826105278/ventilators-are-no-panacea-for-critically-ill-covid-19-patients
About the Author
Eliza Yadav is a final-year B.A. candidate at the Institute for the Study of International Development at McGill University. She has minors in Global Health and Entrepreneurship. Her research interests include health policy and governance in lower-middle income countries, and she is constantly seeking ways to intersect her passions in global health and the law. Currently, she serves as a Research Intern at the Institute for Health and Social Policy under Dr. Matthew Hunt. Their research study focuses on the moral and ethical dilemmas of healthcare providers and research investigators with patients either enrolled in or excluded from COVID clinical trials. Stay tuned for her future blog post on this study and more.