The US Food and Drug Administration (FDA) has taken action to increase the availability of ventilators, their associated accessories and other respiratory devices to support patients with respiratory failure or difficulty breathing during the Covid-19 pandemic.
Medical device makers can now make changes to existing products more easily, such as changes to their suppliers or materials to help address manufacturing limitations or supply shortages. Manufacturers in other sectors, such as the automobile industry, will also be more easily able to repurpose their production lines to help increase supply.
Hospitals and other healthcare providers will be able to repurpose existing machines to function as ventilators, such as repurposing ventilators normally used for transporting patients in an ambulance for long-term hospital use. The FDA has also suggested that other devices, such as those used for treating sleep apnea, should be considered.
US Department of Health and Human Services (HHS) secretary Alex Azar said: “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.”
In light of the pandemic situation, the FDA has also waived the premarket review process for modifications made to ventilator devices, such as adding remote monitoring capabilities via Bluetooth.
The policy also recommends that ventilators are used beyond their indicated shelf life, which should increase the available capacity.
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The agency has also encouraged both foreign and domestic manufacturers to talk to the FDA about pursuing emergency use authorisation (EUA) to distribute their ventilators in the US.
FDA commissioner Stephen Hahn said: “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight.
“We believe this action will immediately increase ventilator availability. We will continue to engage with both traditional medical device manufacturers and other manufacturers about ways we can facilitate a ramping up of production of these life-saving medical devices.”