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re: Someone Asked Why Aren’t CPAP Machines Being Used As Ventilators
Posted on 3/26/20 at 7:34 pm to greygoose
Posted on 3/26/20 at 7:34 pm to greygoose
Here's a portion of a letter I received from ResMed yesterday:
quote:
Dear valued ResMed customer,
Amidst the rapidly evolving global situation caused by the coronavirus disease (COVID-19), we have received a number of inquiries regarding the recently released Food and Drug Administration’s (FDA) ventilator guidance, and wanted to provide some clarity from our perspective.
Can CPAPs be used as ventilators?
CPAP devices are designed to provide only PAP (positive airway pressure) and would require significant mechanical and software rework to function as a ventilator.
FDA guidance on March 21-22, 2020 signals to manufacturers of respiratory equipment that modifications to devices capable of providing modes of ventilatory support that may be clinically applicable for COVID-19 patients can be considered if those modifications would not create undue risk for patients. To be clear, the FDA guidance does not signal that CPAPs can be used – as is – to treat the respiratory symptoms of COVID-19. The FDA still requires those potential modifications be made in a manner that is consistent with existing safety, quality, and manufacturing standards applicable to our devices.
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