On March 22, 2020, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance outlining a policy intended to help increase availability of ventilators and their accessories as well as other respiratory devices during the COVID-19 pandemic.
The policy fosters the continued availability of certain safe and effective medical devices while being flexible regarding manufacturer modifications made to ventilators, anesthesia gas machines and other respiratory devices, and their accessories, in response to the COVID-19 public health emergency.
This Letter provides recommendations for healthcare providers and facilities, based on the recently issued guidance, regarding the use of devices with patients who develop respiratory compromise from COVID-19 or other respiratory disorders. The FDA's recommendations are intended to augment, not replace, specific controls and procedures developed by health care organizations and the Centers for Disease Control and Prevention (CDC).
The FDA recommends healthcare providers and facilities, wherever possible:
· Use FDA-cleared conventional/standard full-featured ventilators when available to support patients with respiratory failure.
· Under the policy, manufacturers may make certain modifications to FDA-cleared indications, claims, or functionality of these devices, without prior submission of a premarket notification where the modification will not create an undue risk in light of the public health emergency. In such circumstances, FDA recommends that the manufacturer provide clear instructions delineating FDA-cleared indications and claims from those that are not FDA-cleared, in addition to a general statement about changes that have not been cleared by FDA.
If the number of ventilators in your facility is running low, consider alternative devices capable of delivering breaths or pressure support to satisfy medically necessary treatment practices for patients requiring such ventilatory support. Healthcare providers should use their judgment based on the condition of the patient and the circumstances in the facility to choose the best option. Examples of alternative uses of respiratory devices used to address shortages might include the following, which the FDA believes may help increase availability:
· For any patient needing ventilatory support, 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.
· For stable patients, emergency transport ventilators may be used for prolonged ventilation in a medical facility setting.
· For any patient needing ventilatory support, anesthesia gas machines capable of providing controlled ventilation or assisted ventilation may be used outside of the traditional use for anesthetic indication. Because of significant differences between the anesthesia gas machine and traditional critical care ventilators, use or supervision by an anesthesia provider is recommended. Refer to the manufacturers' websites for specific instructions on safe use of anesthesia gas machines for this indication.
· Noninvasive Ventilation (NIV) Patient Interfaces capable of prescribed breath may be used for patients requiring such ventilatory support, including NIV Patient Interfaces labeled for sleep apnea.
· 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 provided appropriate monitoring (as available) and patient condition.
Take appropriate precautions with environmental control (for example, negative pressure) or additional filtration where feasible: Ventilating patients with communicable diseases using devices that are single limb or noninvasive without a filtered seal from atmosphere may contaminate the room air and increase risk of transmission. This risk may be exacerbated by high-flow nasal cannula systems or CPAP machines.
Contact the device manufacturer or review the manufacturer website for guidance on updated labeling: If using a ventilator, gas machine, or other device outside of its labeled indications, FDA recommends contacting the device manufacturer for information on the features and limitations of the device in an emergency use situation.
Contact the appropriate professional societies for up-to-date information: For recently issued useful information relevant to this issue. Examples include:
· Anesthesia Patient Safety Foundation (APSF): FAQ on Anesthesia Machine Use, Protection, and Decontamination During the COVID-19 Pandemic
· American Society of Anesthesiologists: COVID-19 Information for Health Care Professionals
Conserve the use of accessories used with ventilators:
· Given the potential for extensive use of ventilators and anesthesia gas machines in response to the COVID-19 pandemic, and to avoid depletion of breathing circuit supplies, healthcare facilities may consider extending the shelf life and duration of use of these products for treating individual patients, depending on the availability of resources.
· Consider extending the duration of use of passive humidifiers (heat-moisture exchangers) for up to one week depending on patient condition and available resources.
· Please note if using ventilators from other regulatory jurisdictions: Where possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators to treat patients who develop respiratory failure or respiratory insufficiency. However, FDA is taking steps to help make available ventilatory support devices that are not currently legally marketed in the U.S. to support the wider availability of devices for patients in need of ventilatory support in the United States for the duration of the public health emergency, as described in the Enforcement Policy for Ventilators guidance.
The FDA is collaborating with manufacturers of ventilators, ventilator accessories, and other respiratory devices to better understand the current supply chain issues related to the COVID-19 outbreak and to help mitigate any widespread shortages of these devices. The FDA is also working with the Strategic National Stockpile (SNS) to develop strategies for the use of ventilators and ventilator accessories in the SNS. For more information, refer to HHS's Assistant Secretary for Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA).
