Manufacturers see restrictions lifted in an attempt to boost supplies during the COVID-19 crisis.
The U.S. Food and Drug Administration (FDA) made moves to increase the availability of ventilators and other respiratory devices to help patients with respiratory failure during the COVID-19 pandemic.
The FDA is taking three key steps at this time:
• The agency is exercising enforcement discretion for certain modifications to FDA-cleared devices. Normally, any modification to a ventilator device, such as adding wireless remote monitoring, triggers an FDA review, which can delay getting the devices to providers. The guidance also helps manufacturers increase their output by adding production lines or alternative sites. For example, this will allow automotive manufacturers to start making ventilator parts.
• Hospitals and healthcare professionals may use ventilators intended for other environments. For example, ventilators normally used for transporting patients in an ambulance could be moved into the hospital for long-term use. This also applies to devices for treating sleep apnea (CPAP devices). The new policy also allows healthcare facilities to use ventilators beyond their indicated shelf life, which should boost capacity.
• The FDA is encouraging manufacturers, foreign or domestic, to pursue emergency use authorization, which would allow them to distribute their ventilators in the United States. This includes U.S.-based manufacturers that were previously engaged in making medical devices, but which have capabilities to increase their supply.
“The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services (HHS) Secretary Alex Azar in a statement. “With this boost from the FDA, medical device makers can more easily make changes to existing products, such as changes to suppliers or materials, to help address current manufacturing limitations or supply shortages. Other manufacturers, such as auto makers, can more easily repurpose production lines to help increase supply. HHS and FDA’s message is clear: If you want to help expand production of ventilators to save American lives in this pandemic, we are going to work with you to sweep every possible barrier out of your way.”
This guidance is one of many actions the FDA has taken to increase the availability of medical devices, including diagnostic supplies and personal protective equipment (PPE).
The FDA has been working closely with PPE manufacturers to understand their supply capabilities during this pandemic. The agency is also aware of challenges throughout the supply chain that are presently impacting the availability of PPE products and is taking steps to mitigate shortages that health care facilities are already experiencing. For example, on March 2, the FDA granted an Emergency Use Authorization to allow NIOSH-approved respirators typically used in industrial settings to be used in health care settings.
On Friday, the agency also issued a Letter to Health Care Providers sharing conservation strategies for surgical gloves, recognizing the need for PPE, such as medical gloves, may outpace the supply available to health care organizations during the COVID-19 pandemic. Proposed conservation strategies include using nonsterile disposable patient examination gloves for routine patient care or using medical gloves beyond the manufacturer-designated shelf life in a setting where there is a lower risk of transmission.