FDA permits CPAPs to deal with shortfall of medical ventilators

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Finally FDA Permits CPAP Use to Deal With Deadly Shortfall Of Medical Ventilators; Simple Common Sense Move Could Save Hundreds of Thousands of Lives

WASHINGTON, D.C. (March 23, 2020) – With a predicted shortfall of hospital ventilators needed for COVID-19 patients with breathing problems at about 700,000, and some hospitals and governmental bodies already with death guidelines determining who will be left to die when hospitals run out of medical ventilators as the crisis expands, the Food and Drug Administration [FDA] has just recommended and authorized the use of CPAP and similar devices to help cover the acute shortage and save lives.

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FDA Suggests Alternatives To Meet Shortfall Of Medical Ventilators

In guidance dated Sunday, March 22nd, the FDA said that "Examples of alternative uses of respiratory devices used to address shortages [of ventilators] might include the following, which the FDA believes MAY HELP INCREASE AVAILABILITY:  Continuous Positive Airway Pressure (CPAP), auto-CPAP, and bilevel positive airway pressure (BiPAP or BPAP) machines typically used for treatment of sleep apnea (either in the home or facility setting) may be used to support patients with respiratory insufficiency provided appropriate monitoring (as available) and patient condition." [emphasis added]

Although there are far fewer of them, the same FDA guidance document also recommended and authorized the use during the ventilator shortage of continuous ventilators labeled for home use, emergency transport ventilators [such as those used in ambulances], anesthesia gas machines capable of providing controlled ventilation or assisted ventilation, and Noninvasive Ventilation (NIV) Patient Interfaces capable of prescribed breath, says Professor John Banzhaf, an MIT-educated inventor with several U.S. patents, who has been actively encouraging and publicizing this outside-the-box technique for meeting the ventilator shortage.

U.S. hospitals have only an estimated 162,000 medical ventilators, and there might be an additional 15,00 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 otherwise unable to breathe for themselves, the outlook was very grim, with hospitals and perhaps individual physicians having to decide who should get the few scarce ventilators, and who must be allowed to die because hospitals had no more ventilators for those suffering from respiratory insufficiency.

Using CPAPs To Provide Breathing Assistance

Banzhaf pointed out that, in contrast to medical ventilators (with only about 160K now in hospitals), there are literally millions of CPAP and similar devices already in use, or in warehouses waiting to be used - to reduce snoring and 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 scarce and expensive ventilators.

In addition to those, many current users might be paid a nominal sum to do without their CPAP machines for a few months in situations where it would not create a serious health risk for them, and especially in cases where they may have an older models left over from past use, or don't regularly use their existing CPAP machine because it is uncomfortable, intrusive, inconvenient, not truly necessary, etc.   Many CPAP owners have already agreed to do so, says Banzhaf.

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.

Hospitals Might Be Willing To Purchace Enough CPAPs

Moreover, at an average cost of only about $850 (and far less if purchased in bulk), hospitals would likely be much more willing and able to purchase enough CPAPs to help meet the growing surge in demand than medical ventilators ($25,00-$50,000 each plus costs of having trained personnel to operate and maintain them), especially since they would be able to sell or rent the CPAPs thereafter to patients with sleep apnea and/or excessive snoring after the current crisis and the demand for so many medical ventilators finally declines.

Indeed, as the Washington Post recently reported: "More Lifesaving Ventilators Are Available. Hospitals Can't Afford Them *** Health industry experts cite cost and uncertainty as disincentives to stocking up, leaving a potential life-and-death gap in treatment options."

Prof Banzhaf, who is already well known for saving millions of lives by requiring hundreds of millions of dollars worth of free radio and TV time for antismoking messages, and for eventually driving cigarette commercials off the air, says he is delighted that a concept he helped promote and publicize has now been accepted, promoted and - most importantly - authorized by the governmental agency which regulates the use of many medical devices, including CPAPs and similar machines.

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