Coronavirus Crisis Will Openly Test Which Regulations Actually Matter

The most common reason for COVID-19 patient admission to the ICU is severe hypoxic respiratory failure requiring mechanical ventilation.

A recent AHA estimate for COVID-19 projected that 4.8 million patients would be hospitalized, 1.9 million of these would be admitted to the ICU, and 960,000 would require ventilatory support. This would be fifteen times beyond the normal level of ICU respiratory capacity. We might be able to surge four times normal levels but we will have to relax every rule and regulation to get to what can work.

How can we push up ventilators and trained staff to safely and effectively operate ventilators?

The addition of older hospital ventilators, SNS ventilators, and anesthesia machines increases the absolute number of ventilators to possibly above 200,000 units. The older units may not good enough for patients with severe acute respiratory failure.

A shortage of ICU physicians, advanced practice providers, respiratory therapists, and nurses trained in mechanical ventilation would limit the maximum number of ventilated
patients to approximately 135,000.

One ICU doctor could watch over 96 patients on ventilators. An ICU doctor could watch over four non-ICU doctors who would oversee eight respiratory therapists, four ICU nurses and 12 non-ICU nurses.

Rules could be further loosened to allow fourth-year medical students with crash-course training to assist.

Details on Using Old Equipment and Other Equipment

Supply of mechanical ventilators in U.S. acute care hospitals: Based on a 2009 survey of AHA hospitals, U.S. acute care hospitals are estimated to own approximately 62,000 full-featured mechanical ventilators. About 46% of these can be used to ventilate pediatric and neonatal patients. Additionally, some hospitals keep older models for emergency purposes. Older models, which are not full-featured but may provide basic functions, add an additional 98,738 ventilators to the U.S. supply. The older devices include 22,976 noninvasive ventilators, 32,668 automatic resuscitators, and 8,567 continuous positive airway pressure (CPAP) units.

The SNS has an estimated 8,900 ventilators for emergency deployment. These devices are not full-featured but offer basic ventilatory modes. Accessing the SNS requires hospital administrators to request that state health officials ask for access to this equipment. SNS can deliver ventilators within 24-36 hours of the federal decision to deploy
them. States may have their own ventilator stockpiles as well. Respiratory therapy departments also rent ventilators from local companies, further expanding the supply. Additionally, many modern anesthesia machines are capable of ventilating patients and can be used to increase hospitals’ surge capacity.

The U.S. Department of Health and Human Services (HHS) estimated in 2005 that 865,000 U.S. residents would be hospitalized during a moderate pandemic (as in the 1957 and 1968 influenza pandemics) and 9.9 million during a severe pandemic (as in the 1918 influenza pandemic).

SOURCES – Society of Critical Care Medicine
Written By Brian Wang,

30 thoughts on “Coronavirus Crisis Will Openly Test Which Regulations Actually Matter”

  1. So how come no one is talking about ECMO machines? In China, 3% of patients were on ECMO (machine that directly oxygenates blood outside of the body). It may be because the FDA only approved long-term ECMO machines in February. Does this explain why the death rate is so high in Italy, Spain and US?

  2. How’s many ventilators does the military have?
    are they accessible?
    if severely impacted coastal bound residents were loaded onto dock mounted NAval ships, could the military make a noticablE impact

  3. The article is about the US readiness and response, had it been more general I might have referred only to those countries based on English Common Law traditions. I’m not familiar enough with Continental Law (based on the Code Napoleon) and, of course, communist and other countries suffering under dictatorships have ‘Sovereign Immunity’ to such lawsuits.

  4. Some other interesting figures from the little dysfunctional socialistic land in the north. The inventory of intensive care units with respirators have declined significantly during the strategic blackout since the collapse of the USSR. We are down to about half the capacity per capita compared to Italy. The politicians have cleaned out most resources to use the tax money for their hobby projects.
    The leadership will soon learn that math is a bitch on which their ideologies have no effect.

    Respirators 1993
    Civilian: 1 300
    Military: 900
    Buffer: 2 100
    Total: 4 300

    Respirators 2018
    Civilian: 534
    Military: 40
    Buffer: 0
    Total: 574

  5. Some examples of where things can go wrong with low-end 3D printing:
    — Inappropriate or poorly washed plastics releasing toxic fumes, putting the patient’s already stressed respiratory system under further stress.
    — Similar, but releasing microscopic particulates. This can happen with metal and ceramic printing as well.
    — Porosity is too high, so it ends up catching pathogens from one patient, then transferring them to the next. These things would essentially be single-use. The discarded porous valves full of absorbed pathgens are hazardous medical waste.
    — Mechanical failures.

    As I wrote elsewhere, better than nothing, but not ideal. Of course, there are ways to mitigate some of those and other issues, so it depends on the design.

  6. As someone who has actually printed and used medical respirators (not on patients), I think I can actually comment here.
    A respirator is not just physical parts. We also need motors, power supplies, and some fairly complex electronic control circuitry including things like (very sensitive) pressure sensors. None of that is 3D printer ready in 2020.

  7. Based on reports of an italian hospital using 3D printed valves for ventilators, there’s now a semi-global grass roots effort to

    • assemble a cadre of 3D printer owners who can help on demand with parts and general equipment printing and put them in touch with local hospitals
    • try to acquire STL files for said ventilator parts (some makers of existing ventilators are actively resisting, despite themselves being unable to supply said parts to the hospitals currently)(this is leading to some 3D scanning+trial and error in replicating designs without manufacturer help, with some success for simple valve designs)
    • support efforts at low resource emergency ventilator designs of an open source hardware design, preferably suitable for 3D printing when appropriate

  8. Chinese published reports show their ECMO usage was 100% fatal. It clearly doesn’t have the effectivness desired for coronavirus patients.

  9. The only regulations that really matter to me are health and safety regulations, past that if someone can make an argument for a regulation on functionality, I’ll consider it.

  10. Don’t assume the regulatory environment of the US is the same as elsewhere. It is not and in many cases is far from it.

  11. Patents are indeed an issue. On the other side, medical certification is another. Those 3D printed valves are better than not having enough valves, but who knows how closely they fit the various requirements of a proper ICU valve. Those requirements are there for a reason, and making a proper valve is a lot more involved than just copying its geometric structure.

    This is an example of the quality vs quantity trade-off that I wrote about in my top-level comment.

  12. Home oxygen concentrators and pulse oximeters should also be increased in production. Oxygen therapy may be sufficient to keep some of the infected from having respiratory failure in the first place. Keeping the infected supported with oxygen may allow for better triage of the ventilator supply to those that cannot oxygenate sufficiently with supplemental oxygen.

  13. You will need to pass some legislation to override copyright laws – From the Verge:

    A medical device manufacturer has threatened to sue a group of volunteers in Italy that 3D printed a valve used for life-saving coronavirus treatments. The valve typically costs about $11,000 from the medical device manufacturer, but the volunteers were able to print replicas for about $1 (via Techdirt).

    …when the pair asked the manufacturer of the valves for blueprints they could use to print replicas, the company declined and threatened to sue for patent infringement, according to Business Insider Italia. Fracassi and Ramaioli moved ahead anyway by measuring the valves and 3D printing three different versions of them…

    …So far, the valves they made have worked on 10 patients as of March 14th.

  14. One ventilator can serve multiple people with attachments. As for additional staff we can train nurses and nurse aides in a few hours to preform the minimum care needed. Its better than no one. And yes, a lot of people will die because of the inadequate equipment and staff but its too late now. You will just do what you can.

  15. Recent orders:

    Italy 5000 units.
    Germany 10,000 units.

    Those numbers represent more than the normal global yearly production numbers for respirators.

  16. And then what? When you return the partitioned herd with zero antibodies to the greater herd, the problem starts again.

  17. ECMO can lead to liver failure, not saying it isn’t an option just that it has consequences.

  18. There are some things you can print, and some things you can’t. Not every printer is certified for or even capable of medical grade products. And 3D printers are difficult to operate, especially the professional and industrial ones. “just send each hospitals a 3D printer and tell them to print” is not realistic. But a service bureau with suitable equipment could print some useful parts.

  19. Personally… I think it’s easier to move everybody over the age of 60 to a camp in Arizona for 6 months…. and just let the covid 19 go wild… It cost less money to the economy…

  20. I think what we need is 3D printable respirator design… Then you just send each hospitals a 3D printer and tell them to print as many as they need… I always wondered if you could do that at an auto parts store… so many things they sell are just cheap plastic parts that you could easily print on demand…

  21. Right you are. After all, better to save many lives than to cover rare corner cases when you actually need the doctors expertise just to run the machine.

  22. Because after the pan(dem)ic is over, the lawyers will eat the hospital alive if they don’t have a facade of reasonable and prudent training of qualified personnel. Tort reform to give healthcare providers better coverage under ‘Good Samaritan’ provisions while responding to a pandemic would be useful.

  23. ECMO is a very invasive technique. You only use that if even a ventilator with oxygen doesn’t work.
    You certainly don’t substitute it for the ventilators if the patients don’t need it.

  24. There is a difference between emergency regulations and routine care regulations. Under emergency, the goal is to maximize quantity at some cost of quality. Under routine care it’s the reverse: maximize quality of care at the expense of quantity of patients (since there aren’t as many).

    It’s actually a spectrum of quality vs quantity trade-off, where theoretically one can dial in the maximum quality that can still match the required quantity. So there should be several levels in the regulations, matching different points on that trade-off spectrum.

  25. In Sweden we have one manufacturer of respirator machines (Getinge). Their yearly production is about 10000 units. Italy is buying all they can and I read they had a tender out for 5000 units. Getinge could only bid for 500 so the production capacity is maxed out.

  26. ECMO is a risky procedure : double flow central catheters, strong anti coagulation, possibly blood transfusion to replace cells damaged by the pumps…. Think open heart surgery….

  27. Come-on Brian .. there is ECMO (Extracorporeal Membrane Oxygenation) .. i.e. direct oxynation of blood — these devices should be much better against ARDS (acute respiratory distress syndrome) — its bypassing the lung as long as they are weak — if this still requires ventilators — I don’t know .. but hopefully some MD will eductate us about that soon ..

  28. Why not give a crash course to any Joe schmoe? You put the tubes in, flip the the switch. You replace the fluids. If the machine starts to beep you call a doctor. That’s it.

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