CPAP Machines Embraced For COVID-19 Patients
The U.S. Food and Drug Administration (FDA) took significant steps to increase the availability of ventilators and other respiratory devices, to support patients with respiratory failure or difficulty breathing.
“Hospitals and other healthcare providers can repurpose (breathing) machines they have to serve as ventilators.”
With a predicted shortfall of hospital ventilators needed to treat people diagnosed with COVID-19 disease with breathing problems, the FDA has authorized the use of Continuous Positive Airway Pressure (CPAP) and similar devices to help cover the forecasted shortage.
On March 22, 2020, FDA Commissioner Stephen Hahn, M.D. announced: “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.”
“The FDA’s message is clear: If you want to help expand the 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.”
“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.”
U.S. hospitals have only an estimated 162,000 ventilators, and there might be an additional 15,000 available from the federal Strategic National Stockpile, and perhaps another 2,000 at the Defense Department.
But since the estimates are that some 900,000 may be needed at a time of peak demand by COVID-19 patients unable to breathe for themselves, the outlook for hospitals and individual healthcare providers appears challenging.
In this new guidance, the FDA said that "Examples of alternative uses of respiratory devices used to address shortages might include CPAP, auto-CPAP, and bilevel positive airway pressure (BiPAP or BPAP) machines typically used for the treatment of sleep apnea.
These devices treat sleep apnea by helping to force air into the lungs of users - which may now be used to help hospitalized COVID-19 patients who need breathing assistance, but who may not necessarily require the full power and sophistication of ventilators.
“The FDA is doing everything we can to support patients, health care professionals, hospitals, medical product manufacturers and the public during this pandemic,” concluded Dr. Hahn.
George Washington University Law professor John Banzhaf, an MIT-trained engineer, and inventor pointed out in an email on March 22nd, that, in contrast to medical ventilators there are literally millions of CPAP and similar devices already in use, or in warehouses waiting to be used.
Also, because they are much simpler to produce, and are currently made by many different companies, it is also much easier to increase CPAP production capacity to meet this extraordinary temporary demand; something not at all true for hospital ventilator machines, says Banzhaf.
Moreover, at an average cost of only about $850, hospitals would likely be much more willing and able to purchase enough CPAPs to help meet the growing surge in demand than ventilators and having trained personnel to operate and maintain them, says Banzhaf.
As the Washington Post recently reported: ‘More Lifesaving Ventilators Are Available. Hospitals Can't Afford Them’, industry experts cite cost and uncertainty as disincentives related to these treatment options."
This new FDA policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.
Precision Vaccinations publishes coronavirus device, medication, treatment and vaccine development news.
- FDA: Coronavirus (COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators
- FDA: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the COVID19 Public Health Emergency
- More lifesaving ventilators are available. Hospitals can’t afford them
- Can Sleep Apnea Machines Treat COVID-19 Patients?