The Department of Health and Human Services (HHS) announced yesterday that it has developed “crisis standards of care strategies” to optimize ventilator use in the face of unprecedented demand on hospital and ICU resources during the COVID-19 pandemic.
Specifically, HHS partnered with FEMA, the U.S. Surgeon General, and the National Academies of Science, Engineering and Medicine, as well as healthcare systems, academic institutions, professional medical societies, and to develop the strategies.
In an open letter penned by the Surgeon General, states, government entities, and health care providers are urged to aggressively implement the following four measures:
- Rigorous adherence to all social distancing measures, including limitations on gatherings and travel. This is the best way to reduce infections and thus demand for ventilators.
- Following guidelines to optimize the use of mechanical ventilators, which are further outlined below and addressed in Appendix A of the letter.
- Judicious, data driven requests and usage of the Strategic National Stockpile (SNS) of ventilators and equipment. To be able to allocate ventilators where they are most needed, all states must be data-driven in their requests based on the actual capacity for mechanical ventilation, including anesthesia machine conversions.
- Increasing the capacity of the SNS through federal procurement. The SNS will receive at least an additional 20,000 mechanical ventilators by mid-May 2020.
In addition, the letter states that a possible crisis standard-of-care strategy is using one ventilator for two patients; however, the Surgeon General cautions that “Co-venting should only be considered as an absolute last resort and for a limited amount of time,” and should be “judged against the alternatives of long term ‘hand bagging’ or death.”
- Guidelines to Optimize the Use of Mechanical Ventilators – Appendix A, beginning on p. 4 of the letter outlines the eight-point guidance on optimizing ventilators:
- Cancel elective surgeries and other elective procedures that could result in the use of mechanical ventilators.
- Transfer ventilators, supplies, and personnel from ambulatory surgery centers and other facilities not being utilized for COVID-19 patients.
- Transfer ventilators, supplies, and personnel from areas of the state not experiencing COVID-19 outbreaks, or transfer COVID-19 patients to those areas when feasible.
- Anesthesia ventilation machines capable of providing controlled ventilation or assisted ventilation may be used outside of the traditional use for anesthetic indication. The ASA and FDA provide specific guidance on how to convert anesthesia machines for use on COVID-19 patients in respiratory failure.
- Transport ventilators may be used for prolonged ventilation in certain patients.
- Continuous ventilators labeled for home use may be used in a medical facility setting depending on the features of the ventilator and provided there is appropriate monitoring (as available) of the patient’s condition.
- Noninvasive Ventilation (NIV) Patient Interfaces capable of prescribed breath may be used for patients requiring such ventilator support, including NIV Patient Interfaces labeled for sleep apnea. Channeling exhalation through a filter is recommended to prevent aerosolization.
- Continuous Positive Airway Pressure (CPAP), auto-CPAP, and bilevel positive airway pressure (BiPAP or BPAP) machines typically used for treatment of sleep apnea (either in the home or facility setting) may be used to support patients with respiratory insufficiency. BiPAP may be used for invasive ventilation.
- If all other alternatives are exhausted, care providers could consider ventilation of two patients on a single ventilator for short-term use, although there are significant limitations to this strategy. Alternatively, manual bag-valve-mask ventilation done by ancillary providers can be considered as a bridging option to mechanical ventilation.
- Placing Multiple Patients on a Single Mechanical Ventilator – Appendix B, beginning on p. 6 of the letter contains a Consensus Statement on the concept of placing multiple patients on a single mechanical ventilator, issued 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.
- Technical Documents – Appendix C, beginning on p. 9 contains technical documents in which the “Washington DC COVID-19 Co-Ventilation Task Force” outlines a method for implementation of co-ventilation. The documents contain numbers illustrations, photos, and parameters regarding necessary supplies and discussions of limitations and challenges. Appendix D, on p. 26, contains a protocol for ventilator sharing developed by Columbia University and the New York-Presbyterian Hospital.
- Training and Resources – Also addressed in Appendix C, on p. 24, the Surgeon General points to a video tutorial on YouTube and notes that FEMA hopes to soon standup: (1) an FAQ document; (2) a 24-hour hotline for implementation guidance; and (3) a database for tracking clinical experience.
- CDC Statement – As included in the open letter, the Centers for Disease Control and Prevention (CDC) has stated the following: “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 health care 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 –Similarly, the Food and Drug Administration (FDA) states: “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.”
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