FDA Issues Guidance and Recommendations for Ventilators Needed for COVID-19 Crisis

March 27, 2020

In response to the limited supply of ventilators during the Coronavirus (COVID-19) pandemic, the Food and Drug Administration (FDA) issued an immediately in effect guidance for ventilators and a letter for healthcare providers based on the issued guidance that outlines supply mitigation strategies to increase availability of respiratory devices for patients with respiratory failure or insufficiency.

“The FDA is doing everything we can to support patients, health care professionals, manufacturers of FDA-regulated products, and the public during this pandemic,” said FDA Commissioner Stephen Hahn, in an agency news release. “The FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with federal partners, international regulators, and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 outbreak.”

Immediately in Effect Guidance on Ventilators During COVID-19

The FDA guidance document, Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency was issued without prior public comment to increase the availability of ventilators and related respiratory devices and accessories for use during the COVID-19 pandemic. Through the guidance, the agency expressed its willingness to be flexible and to work with manufacturers of respiratory devices and accessories to find new ways to provide these life-saving products during the crisis.

Specifically, the guidance aims to address “urgent public health concerns” with new policies that address:

  • Modifications to FDA-cleared devices
  • Hardware, software, and material changes to FDA-cleared ventilators and anesthesia gas machines
  • The use of ventilator and anesthesia gas machine breathing circuit devices beyond their indicated shelf life and duration of use
  • Validation of changes made to hardware, software, materials, and duration of use; and
  • Labeling of modified devices.

The FDA guidance also encourages domestic and international manufacturers to contact the agency about seeking emergency use authorization for distributing ventilators in the U.S.

The guidance will remain in effect for the duration of the crisis as declared by the Department of Health and Human Services.

Ventilator Supply Mitigation Strategies for Healthcare Providers

In a letter to healthcare providers and facilities during the COVID-19 public health emergency, the FDA recommends, 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 considering 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.
  • Take appropriate precautions with environmental control (e.g., negative pressure) or additional filtration where feasible.
  • Contact the device manufacturer or review the manufacturer website for guidance on updated labeling.
  • Conserve the use of accessories used with ventilators.
  • Please note if using ventilators from other regulatory jurisdictions.

The FDA said it 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 urges anyone aware of actual or potential shortage issues to email the agency at deviceshortages@fda.hhs.gov.