As COVID-19 testing remains elusive in the U.S., much of the nation’s focus has started to shift to how to treat the presumed millions of patients who are already or soon to be infected with the novel coronavirus. Much has been made of “flattening the curve” to prevent a massive influx all at once of COVID-19 patients into hospitals and intensive care units (ICUs).

But even in moderate scenarios, millions of people in the U.S. will require treatment in ICUs that typically involves ventilation support. If 40% of the U.S. population is infected, that translates into almost 99 million people, of whom roughly 20.6 million likely would require hospitalization. Meanwhile, an anticipated 4.4 million would need care in the ICU. That’s according to a recent analysis in Health Affairs that presumes a best-case scenario of a 20% infection rate and a worst case of 60%.

There are not nearly enough ventilators, ICU beds or trained staff to support that level of patient need – a situation that soon could be similar to what has been playing out in Italy. There also has been some speculation that a lack of access to ventilation has boosted COVID-19 mortality rates in China and Italy.

Expanding capacity

When it comes to ventilators, major manufacturers have acknowledged the rapidly emerging U.S. and European need and pledged to ramp up their production. There also are increasing calls for other kinds of manufacturers, including automakers General Motors, Ford and Tesla, to retool shuttered factories to make ventilators.

China’s demand for ventilators has peaked for now, as fewer new patients have become infected since Jan. 25 as a result of preventive measures. The country recently had its first day with no new infections reported. The disease typically only takes a few weeks to run its course.

“We can say that we see a global increase in customer demand,” Getinge AB’s North America President Eric Honroth told BioWorld. “In 2019, Getinge produced more than 10,000 ventilators. On March 17, Getinge announced a temporary increase in its production of ventilators by 60% in 2020 compared [with] 2019 at our production facility in Solna, Sweden. The ramp up will, pending availability of supply parts from subcontractors, start immediately and be balanced in close collaboration with Getinge’s suppliers.”

There is an estimated installed base of 160,000 ventilators in U.S. hospitals, with another almost 13,000 available via the National Strategic Stockpile held by the federal government. There are also only about 32,000 ICU beds available in the U.S., with the potential to boost that to almost 60,000 by reducing those allotted to non-COVID-19 patients. More ICU beds could be added by transitioning inpatient operating rooms, ambulatory surgical sites and postanesthesia care units into flexible ICUs, Health Affairs notes.

Many ventilator makers, such as Medtronic plc, Royal Philips NV, Getinge and others are based in Europe. It’s not yet clear the extent to which the global supply chain will be affected as nations increasingly assume a wartime footing when it comes to resources.

Medtronic, GE go around-the-clock

Dublin-based Medtronic makes its high-performance ventilators in Galway, Ireland. It employs more than 250 employees in ventilator manufacturing there and plans to more than double that number. It already has added shifts and plans to bring that plant up to a full production schedule of 24 hours a day for seven days a week.

The company said that it already had increased production by more than 40% and aims to more than double its capacity to manufacture and supply ventilators.

“Medtronic recognizes the demand for ventilators in this environment has far outstripped supply,” said Bob White, executive vice president and president of the minimally invasive therapies group at Medtronic. “No single company will be able to fill the current demands of global health care systems. However, with all manufacturers increasing their production and through partnerships with governments, hospitals and global health organizations, Medtronic is committed to getting more ventilators into the market and to the right locations in the world to help doctors and patients dealing with COVID-19.”

Similarly, Chicago-based GE Healthcare said that it is moving its ventilator manufacturing to around-the-clock shifts. It’s also hiring additional manufacturing employees for those production lines, as well as shifting existing employees to them. It did not commit to a specific increase in ventilator production.

The situation and expectations around it have evolved rapidly. On a March 5 earnings call, Lübeck, Germany-based Drägerwerk AG & Co. KGaA said it was seeing increased ICU ventilator demand in China and across Asia, but it did not expect it to continue. The company seemed largely unprepared to comment on increased ICU ventilator demand in the U.S., despite a query on the subject from an analyst.

“There is not much room to increase the capacity for production. It's already, at this point in time, running at a much higher pace than it usually does,” said Dräger Chairman Stefan Dräger. “The bottleneck is in testing equipment that cannot be increased on a short notice. So, that would take almost half a year to one year to increase that capacity.”

Beyond standard ICU ventilators?

GE Healthcare makes both invasive and noninvasive ventilators. ICU ventilators are for high-acuity patients who require more care. However, the company also makes mid-acuity ventilators that may be flexed up for use in a high-acuity setting.

Various other types of medical-grade breathing equipment also are starting to be assessed – even at-home ventilators and CPAP/BiPAP equipment for sleep apnea – to determine their potential usefulness for COVID-19 patients in the absence of standard ICU ventilators. ICU-grade ventilators typically cost as much as $50,000, while other less intensive ventilators can cost as little as $5,000.

Amsterdam-based Philips, which makes invasive, noninvasive and mixed-mode ventilators for critical care respiratory disease patients, said it is increasing manufacturing efforts. Standard ICU ventilators require intubation, making them invasive. Noninvasive approaches rely simply on masks to enhance respiration.

“We recognize the increased demand, and we are in the process of increasing our production for these critical products and solutions,” a Philips spokesperson said. “We are actively engaging with the relevant stakeholders, including governments, health authorities (such as the [World Health Organization]) and health care providers to discuss their needs. At the same time, we are closely collaborating with our suppliers to get the supplies (materials, components, etc.) that are needed for our increased production.”

San Diego-based Resmed Inc. specializes in at-home or hospital-based noninvasive ventilators. The company said that it has seen higher-than-usual demand for ventilators already from China and South Korea.

“We’re working hard to meet the fast-changing global demand for ventilators,” said Jayme Rubenstein, Resmed public relations director. “Our primary focus is to maximize the availability of these devices for the patients [who] need them most. At present, we are working hard to meet demand, but our ability to do so is challenged by the rapidly increasing demand, globally and within certain markets. The situation is very fluid and changes day to day.”