The FDA today temporarily loosened its enforcement on ventilators and some related devices to address manufacturing limitations and supply shortages during the coronavirus pandemic.
The agency issued a temporary guidance that also covers certain anesthesia machines, respirators, oxygen conservers and delivery devices for hospital or home use. The guidance describes a limited number of modifications to the indications, claims, function, hardware, software or materials of FDA-cleared devices for patients with respiratory failure or insufficiency. It will remain in effect until the end of the public health emergency.
Such changes could include a significant change or modification in design, material, chemical composition, energy source or manufacturing process. Examples may include changes to the ventilator motor to allow an alternate supplier or changes to ventilator tubing to allow for more flexible material sourcing.
“We believe this approach will help manufacturers that want to add production lines or manufacture at alternative sites which may have different manufacturing equipment to increase manufacturing capacity and supply and reduce supply-change interruptions and manufacturing bottlenecks,” the agency said.
The guidance would also allow hospitals to use ventilators that are FDA-cleared for home use and to treat respiratory insufficiency patients with certain devices cleared for sleep apnea, such as CPAP and BiPAP machines. Oxygen concentrators may now be used for primary supply when medically clinically appropriate, the agency said.
“The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services secretary Alex Azar in a news release. “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. Hospitals and other health care providers can repurpose machines they have now to serve as ventilators. 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.”
FDA commissioner Dr. Stephen Hahn said the agency believes 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,” Hahn said.
You can find the guidance here.
