CPAP Devices Can Be Used as Ventilators During Coronavirus Outbreak, FDA Guidance Says

Published in Member Communities on March 24, 2020

On March 22, it was announced that new temporary guidance from the FDA allows hospitals to re-purpose existing products such as CPAP devices as ventilators in an effort to meet major shortages in the United States during the coronavirus outbreak.

The guidance allows hospitals and manufacturers to make certain modifications to existing devices, or to production lines, to create more respiratory devices.

Ventilators normally used in other environments, such as ambulances, could be used for long-term care, the guidance says. It covers devices that aren't traditionally used for long-term care.

The guidance also would allow non-medical device companies, such as auto manufacturers, to start making ventilator parts.

The agency plans to use "enforcement discretion" for modifications to FDA-cleared devices. Traditionally manufacturers' modifications to ventilators would trigger an additional pre-market review, which could delay deployment.

The guidance means "America can make more ventilators during this crisis,” Health and Human Services Secretary Alex Azar said in a release.

The guidance also aims to create "maximum regulatory flexibility" while "still providing crucial FDA oversight," FDA Commissioner Stephen Hahn said in a release.

FDA is also encouraging manufacturers, including foreign ones, to contact the agency about emergency authorizations to distribute ventilators in the United States.

Original Updates:

 

From Our Experts

Online Registration Closes June 6 for Heartland 2022 thumbnail Online Registration Closes June 6 for Heartland 2022 Online registration for VGM's 21st anniversary Heartland Conference will close June 6. Guests will still be able to register on-site for the in-person educational event June 13-15 in Waterloo, Iowa. Online Registration Closes June 6 for Heartland 2022 thumbnail Online Registration Closes June 6 for Heartland 2022 Online registration for VGM's 21st anniversary Heartland Conference will close June 6. Guests will still be able to register on-site for the in-person educational event June 13-15 in Waterloo, Iowa. Distinguishing Your O&P Practice thumbnail Distinguishing Your O&P Practice Healthcare is increasingly moving to outcomes-based care models. Tomorrow's clinicians should prepare for refined and repeatable articulation of their impact on patient outcomes with referral sources, patients, and payers. Worker's Comp Prosthetic Bill In Iowa Passes House and Senate thumbnail Worker's Comp Prosthetic Bill In Iowa Passes House and Senate Today the Iowa legislature passed a bill allowing for prosthetic devices for a person injured on the job as long as it is medically necessary. Why the Right to Repair is NOT the Right Thing to Do to Address Delays in Wheelchair Repairs thumbnail Why the Right to Repair is NOT the Right Thing to Do to Address Delays in Wheelchair Repairs Right to Repair legislation has popped up in several states and is a topic that impacts all U.S. Rehab members. If passed, it could have devastating consequences to patients attempting to repair their own medical equipment. Heartland Session Sneak Peek: Inventory Management, Procurement, & Cash Flow thumbnail Heartland Session Sneak Peek: Inventory Management, Procurement, & Cash Flow Many members lament the challenge of staying cash flow positive while maintaining an inventory that allows them to serve their patients in a timely manner. Join Gerry at Heartland for a discussion on all things inventory management, procurement, and cashflow. Heartland Sneak Peek: Power Standing Mobility: From Research to Application thumbnail Heartland Sneak Peek: Power Standing Mobility: From Research to Application Providing power standing wheelchairs can be a complicated and overwhelming experience for even the best ATP or clinician. How do you get everything right and ensure that your client/patient gets the best outcome and the best equipment possible? The Importance of the Limb Loss and Preservation Registry thumbnail The Importance of the Limb Loss and Preservation Registry In this episode of Industry Matters, OPGA president, Todd Eagen, talks with Dr. Kenton Kauffman of the Mayo Clinic about the Limb Loss and Preservation Registry.