On March 30, 2020, a letter to hospitals from U.S. Surgeon General Jerome Adams and U.S. Department of Health and Human Services Assistant Secretary for Health Adm. Brett Giroir released Guidelines to Optimize the Use of Mechanical Ventilators permitting the use of a single mechanical ventilator for two patients. However, this “strategy should only be considered as an absolute last resort, judged against the alternatives of long term ‘hand batting’ or death.” The decision to share a single ventilator for two patients “must be made on an individual institution, care-provider, and patient level.” The letter contained multiple appendices:
- Guidelines to Optimize the Use of Mechanical Ventilators
- Consensus Statement on the Concept of Placing Multiple Patients on a Single Mechanical Ventilator, provided by The Society of Critical Care Medicine; American Association for Respiratory Care; American Society of Anesthesiologists, Anesthesia Patient Safety Foundation; American Association of Critical-Care Nurses; and American College of Chest Physicians.
- Co-ventilating Patients During a Critical Ventilator Shortage Technical Documents
- Ventilator Sharing Protocol: Dual-Patient Ventilation with a Single Mechanical Ventilator for Use During Critical Ventilator Shortage, by Columbia University Vagelos College of Physicians & Surgeons and New York-Presbyterian Hospital.
The letter also contained comments from the U.S. Centers for Disease Control and U.S. Food and Drug Administration regarding the technical documents attached to the letter:
CDC Statement: The infection control implications of co-venting are not firmly established, since it would not meet general established standards for infection control for ventilated patients. However, with the criteria specified and if done with currently established infection control interventions to reduce healthcare associated infections, including ventilator associated infections, any additional risk is likely to be small and would likely be appropriate in a crisis standard of care.
FDA Statement: FDA does not object to the creation and use of the T-connector that meets specifications described in the instructions provided to us for use in placing more than one patient on mechanical ventilation when the number of patients who need invasive mechanical ventilation exceeds the supply of available ventilators and the usual medical standards of care has been changed to crisis care in the interest of preserving life. The FDA’s no objection applies during the duration of the declared COVID–19 emergency.
HHS also announced the Strategic National Stockpile would receive “at least an additional 20,000 mechanical ventilators by mid-May.”
Norton Rose Fulbright attorneys will continue to follow on a daily basis COVID-19-related developments pertinent to health care providers and publish regular updates in the Health Law Pulse.