Ventilators are the machines that push and pull air through a tube connected to the lungs, allowing people with compromised pulmonary capacity to breathe. For people with severe infections from this coronavirus, which attacks respiratory cells, these machines can literally be the difference between life and death.
Nobody is quite sure how many of the devices are available in the U.S. because there’s no central system of accounting for them. And nobody knows how many will be required because that depends on the course of the pandemic and whether efforts to slow its spread are successful.
The consequences of a shortage would be dire. Doctors would have to make harrowing decisions about who gets the ventilators and who doesn’t, decisions that doctors in coronavirus-ravaged China, Iran and Italy say they are making already.
Public officials like New York Gov. Andrew Cuomo (D) have been warning about this possibility with increasing urgency and begging the federal government for help. “We are looking for ventilators desperately,” Cuomo said in a press conference on Tuesday.
The industry has shifted into overtime. ... There’s a limit, however, to how much capacity it can ramp up on its own.Mark Van Sumeren, managing director of Health Industry Advisor
President Donald Trump and his advisers say they are on the case. At their own daily briefing, hours after Cuomo’s, they said they were taking a complete inventory of available ventilators while also ordering more. A day earlier, Trump had told governors to obtain them on their own, as The New York Times reported. The president on Tuesday said he never intended to suggest that federal authorities wouldn’t also take action.
Whatever the Trump administration is or isn’t doing already, it’s clear that the availability of ventilators depends in part on what steps the federal government takes and when it takes them.
Over the past week, HuffPost talked to about a dozen engineers, current and former executives in the medical device industry, and critical care physicians about how to make the most of the country’s existing ventilator stock and how to increase the supply as quickly as possible. Several asked that HuffPost not use their names because they still work in the industry.
None felt comfortable making firm pronouncements about what was possible. They cited the many unknowns, from the availability of electronic components to the severity and timing of the pandemic itself.
But they all said the federal government could make a big difference by making advance purchases, rushing the regulatory process, financing or even providing transportation, and making sure ventilators get to the places that need them most. Factories are already speeding up, they said, but there’s a chance to do even more.
“The industry has shifted into overtime to produce much-needed medical supplies, devices and equipment, such as ventilators,” Mark Van Sumeren, a device industry veteran who is managing director of the firm Health Industry Advisor, told HuffPost. “There’s a limit, however, to how much capacity it can ramp up on its own. Government can be a key partner here.”
Assessing The Current Ventilator Supply Is Difficult
Precise, reliable counts of available ventilators do not exist yet. The estimate most people cite comes from a 2009 survey that said 62,000 units were scattered across hospitals and clinics around the country. The number today is probably at least a few thousand higher, if only because that figure is a decade old and the population has grown significantly since then.
So that sounds like a lot. But it’s not as if those machines are just sitting there waiting for somebody to use them. On a normal day, the majority of working ventilators are already in use for patients with everything from cancer to heart disease. Usage rises even more during flu season.
“The need for ventilation services during a severe pandemic could quickly overwhelm these day-to-day operational capabilities,” a February report from the Johns Hopkins University Center for Health Security warned.
Hospitals can free up ventilators by cutting back on certain elective surgeries, as they are already, and by switching patients to alternative forms of breathing assistance that would not be appropriate for COVID-19, the illness caused by the coronavirus. (Some breathing devices can disperse droplets from the patient’s airway, potentially spreading infection.)
And there are other ventilators, possibly quite a lot of them, that could be put to use. The federal government keeps an emergency stockpile and officials have indicated it’s about 10,000 units, although the precise number and location are classified because it is part of the government’s defense plans against bioterrorism and biological warfare.
On Tuesday, the Defense Department announced it was releasing 2,000 ventilators to the Department of Health and Human Services.
Older, technically obsolete ventilators are also stored in warehouses and other facilities around the country, perhaps as many as 100,000 of them, according to the Society of Critical Care Medicine (SCCM), which represents doctors, nurses and other health professionals who work with patients who need intensive care.
Nobody is confident of the number or the reliability of those old units, but they could make a big difference if the crisis gets severe.
“Many patients would do fine with older ventilators,” said Craig Coopersmith, former president of SCCM and current interim director for the Emory University Critical Care Center in Atlanta. “These would represent patients who are sick enough to require mechanical ventilation but do not have the most severe form of respiratory failure.”
Overall, SCCM estimates, up to 200,000 ventilators could be available right now. The worry is that even that might not be enough to handle surges, which is why hospital administrators and public officials all over the country are trying to figure out if there are ways to get more.
Scaling Up Factories Is The Easy Part
The idea of American factories going on a wartime footing to churn out breathing machines the way they churned out tanks, planes and ships for World War II has a certain romance to it.
A version of that may be happening already. Ventilator production is a global enterprise, with companies operating across Europe and Asia. But several large producers, including General Electric, ResMed and Vyaire, are either based in the U.S. or have large assembly operations here.
Normally these factories run relatively close to capacity. Orders for new machines started increasing in December and January, according to industry sources, as soon as the coronavirus started spreading. Many are at or even above their normal production levels now, they said, with some running extra shifts.
Adding even more shifts wouldn’t be out of the question. In theory, factories could run 24 hours a day, seven days a week. They could give extra hours to current workers or hire new ones, depending on their circumstances, though new workers would require training.
That strategy does have its limits. Production of medical devices requires sterile rooms that need daily cleaning, forcing a pause in the process, and a third shift might involve less-experienced workers or workers who are tired from laboring through other shifts. In either case, they might be less productive.
“When you add a third shift to a factory running two, you can’t think it as adding 50% capacity,” an executive said.
Still, assembly plants could dial up their output quickly, industry sources said, if the government is willing to guarantee purchases. One way to do that would be through the Defense Production Act, which authorizes the federal government to make “loans, loan guarantees, purchases, and purchase commitments, to improve, expand, and maintain domestic production capabilities needed to support national defense and homeland security procurement requirements.”
Several members of Congress, led by Rep. Andy Levin (D-Mich.), sent the White House a letter on Monday urging Trump to do just that. Trump on Tuesday said the option was under consideration.
At some point, increasing capacity would require getting manufacturers to build new factories or signing contracts with different manufacturers. In either case, federal regulators who watch over the production process for quality assurance would have to “validate” the new facilities, meaning they would have to certify them as producing ventilators with almost no chance of error or failure.
They have to be the exact components. … You can’t just pick up different screws at Home Depot and call it good.An engineer at a medical device company that manufactures ventilators
The federal government could expedite those reviews. Certifying a new factory or manufacturing process can take up to 180 days, industry executives said. But there are ways to reduce that time, especially if it’s a company that already manufactures ventilators adding factories rather than new entrants trying to build them for the first time.
“I could build a facility and have a clean room up and running ― I can do that in 90 days or less,” one executive said. “It would normally be another 6 to 9 months after that before I could get [Food and Drug Administration] approval for that facility. If we could have the FDA to fast-track that approval, it’d obviously make a big difference.”
Gathering the materials that factories need to build ventilators is a bit more complicated since many of the essential parts come from other countries. Both cargo carriers and passenger airlines (which still carry cargo) have been reducing overseas flights.
But this is another place where the federal government could help, by chartering some of the planes that carriers have idled or having the military run airlifts, and using similar strategies to transport goods by sea when appropriate. The government can also speed up the customs process, to make sure parts get to factories as soon as they arrive in the U.S.
“Government clearly has a role in facilitating the physical transportation of the vital supplies to U.S. hospitals from across the globe,” said Van Sumeren, “by relaxing importation and customs delays and addressing the certain backlogs we should expect at our nation’s ports.”
Sourcing Components May Be The Biggest Problem
But in order to transport component parts, there have to be component parts to transport. And there may not be, at least in the quantities that ventilator producers need right away. The sources HuffPost consulted all thought this would ultimately be the biggest factor limiting production.
“The biggest challenge on the pure supply chain side is just getting more parts so that you can build these ventilators,” one executive said. “They’re complex devices. They easily will have bills of material [that is, lists of components] with hundreds and hundreds of parts.”
These parts include everything from plastic casings to circuit boards, and they come from all over the world. But the majority are single-source: They come from one company and are custom designed for particular ventilator producers.
“They have to be the exact components. … You can’t just pick up different screws at Home Depot and call it good,” one engineer said. “They have to be tested and validated.”
Making matters worse, electronic components in particular frequently come from China, which has been reeling from the initial COVID-19 outbreak.
So far, the industry executives said, the supply chain from China doesn’t seem to be slowing down. But they worry that it’s only a matter of time. Existing inventories may have allowed the flow of parts from China to continue even while many workers were in isolation and quarantine. At some point, those inventories will be depleted.
In theory, manufacturers could get their parts from elsewhere, including within the U.S. But anytime a manufacturer wants to switch suppliers, it has to get approval from regulators, who have to make sure the new parts ― like the old ones ― will have reliably high quality with minimal failure rates.
Another problem with finding new parts suppliers, or even extracting more production from existing ones, is that the entire world is looking to buy more ventilators right now. The companies that know how to make the parts are already running at or over capacity.
Finding People To Run Ventilators Is An Issue
In a normal medical setting, ventilators require attention from several health care professionals. A physician makes the decision to use a ventilator and “intubate” a patient ― meaning, to put a tube down the patient’s throat so that the ventilator can deliver air. Then respiratory therapists have to monitor the machine to make sure the patient is getting the oxygen they need.
As with every other health care worker involved with coronavirus treatment, the worry is that the respiratory therapists will be exposed to COVID-19, forcing them into isolation or quarantine, which could mean there won’t be enough respiratory therapists to handle the machines.
That’s a scary proposition, although perhaps not as cataclysmic as it sounds. Anesthesiologists and nurse anesthetists can operate ventilators. Typically they are too busy with other work to monitor ventilators, but delays in elective procedures would give them extra time.
In theory, other medical professionals could also step in with extra training. At Tuesday’s press conference, Cuomo talked about calling up retired health workers, which could include retired respiratory care experts.
Yet another option would be the employees of the ventilator manufacturers ― in particular, their training and repair staff typically include respiratory therapists who worked previously in clinical settings. If interested, and given incentive, they could move to the front lines.
“These are people who go out and either train hospital personnel to use the products, or they repair them,” an executive said. “Well, guess what, they know how to run the machines too.”
Innovating At The Factory ― And Bedside ― May Be Necessary
So in the end, how many more ventilators could the industry produce ― and how quickly? Forbes quoted one manufacturing executive who said that normal worldwide output is 40,000 to 50,000 units a year. That executive said that his company, one of the smaller ones, could increase its production five-fold within 90 to 120 days.
The sources HuffPost consulted were skeptical that the industry as a whole could replicate that figure. They speculated that quickly increasing capacity by 20% or 30% was possible, and maybe with an all-hands-on-deck approach 50% or even 100% within a few months. “But if you’re talking like five times the number we have now, I mean that’s just a huge undertaking that would take time,” said Larry Smith, a retired medical device executive who is now director of graduate business programs at Rider University.
Another executive still in the industry recalled the story of World War II factories ramping up production of “Liberty ships” and compressing the build time to just a few weeks and eventually a few days. But the executive also gave a warning: It took about two years to develop that capacity.
“It’s the quintessential American story, but they weren’t pumping them out that quickly in 1941,” the executive said. “There was a ramp-up period for that as well.”
Desperate circumstances sometimes lead to unexpected innovations. A few days ago, U.K. Prime Minister Boris Johnson pleaded with British manufacturers to start building ventilators. Companies like Rolls Royce are reportedly going over blueprints to see what they can do. Maybe they will discover they can retool and mass-produce more quickly than they realized.
The same could happen here, whether it’s existing manufacturers finding ways to increase production, new entrants getting into the business, or the U.S. turning to producers abroad. “You might be able to cut through the red tape and do something to get new manufacturers approved that are already making ventilators, but they weren’t selling in the USA,” Smith said.
And then there is always the possibility of creativity, sometimes very close to the patient’s bedside. A widely publicized example comes from Italy, where a hospital ran out of valves to connect patients with breathing machines and a local business with a 3D printer figured out a way to manufacture them. It probably saved dozens of lives.
The solution was far from ideal. Medical devices are intricate machines on which people’s lives depend. Every step of the production process has to be precise. In normal times, one device failure would be too many. But these are not normal times.
The surest solution to the ventilator shortage is to slow the spread of the pandemic, to “flatten the curve” of the infected population, so that the shortages never happen. But the surge of patients is likely to test the U.S. health care system’s capacity even under the best of circumstances, which is why the federal government should be acting now to increase that capacity as much as possible.
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