Ventilators, commonplace medical devices used to help critically ill patients breathe, were hardly a prime topic of international interest prior to this year. They’ve existed in much more primitive forms since the early 20th century and in their modern form since the 1980s. Yet these staple machines found in hospital ICUs and operating theaters have become a scarce commodity due to the lack of centralized coordination among world leaders in handling the COVID-19 pandemic.
“If this had been viewed as a global crisis and all the countries worked collaboratively to come up with quick ventilator design prototypes and manufacturing capacities, and unleashed the resources in a wartime effort, then we could have enough ventilators for the U.S. and most countries in the world,” said Nick Vyas, executive director and cofounder of University of Southern California Marshall Center for Global Supply Chain Management. “COVID-19 is not a political issue, but the lack of response is a political issue.”
How Do Ventilators Work?
Ventilators do the mechanical work otherwise performed by a person’s diaphragm and lungs of inhaling oxygen-rich air into the body and removing excess carbon dioxide-laden air during exhalation. In addition to complications from infection, ICU patients who require ventilators often have damage to part of the nervous system that controls breathing, or have weak thoracic muscles from illness or sedation.
Mechanical ventilators provide this support by way of an endotracheal tube inserted into a person’s windpipe (an invasive process called intubation) that is connected to the machine. The ventilator delivers air from a reservoir by means of a compression system and a flow valve that adjusts air pressure to the specific needs of a patient. The air pressure is then released, allowing for passive exhalation. A microprocessor controls the ventilator and enables digital monitoring of pulmonary function as well as provides options to adjust details such as oxygen concentration and humidity in the air. A much simpler version of the ventilator is the bag valve mask, which is often used by EMTs or for patients with mild breathing conditions. This device features a face mask attached to a self-inflating bladder that can be manually pumped to deliver air to a patient. Some companies are currently working on bag valve mask designs that pump air automatically.
Mechanical ventilators are advanced machines that can cost up to $50,000 and are generally made by companies that specialize in designing and producing these medical devices under strict regulatory controls. According to a report from the Johns Hopkins Center for Health Security, there are approximately 62,000 full-featured mechanical ventilators in U.S. hospitals and an additional 98,000 ventilators that provide basic functionality. A report by the Society of Critical Care Medicine estimated that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Strategic National Stockpile and other sources have 12,700 basic ventilators for emergency use.
A Spike in Demand
The COVID-19 pandemic abruptly spiked the demand for ventilators beginning in December 2019 in Wuhan, China, and demand is expected to continue in many countries for the for eseeable future. The respiratory illness caused by the SARS-CoV-2 virus can lead to a viral pneumonia in severe cases in which the lungs fill with moisture and cannot function normally, thus requiring a ventilator as life support. Data from Italy shows that between 10 and 25 percent of patients hospitalized due to COVID-19 will require ventilation, while the CDC estimates that 2.4 million to 21 million Americans could require hospitalization due to the pandemic. Based on these numbers, an article in the New England Journal of Medicine suggests that the number of patients in the U.S. who will require a ventilator could be between 1.4 and 31 patients per available ventilator.
Because emerging data is showing an uncharacteristically high death rate for COVID-19 patients who require ventilators, the rate of ventilator use for this disease could decrease somewhat. Overall death rates for patients on ventilators is somewhere around 40 or 50 percent; however, in New York City, COVID-19 patients on ventilators have been dying at a rate of over 80 percent. The reason for this high mortality has yet to be determined, but the ventilation process itself is risky as it requires sedation and the forceful application of air into the lungs. COVID-19 patients also remain on ventilators longer than other patients who require the machines. Specialized health care workers are needed to run ventilators, and the machines have to be cleaned very frequently in order to be used safely—both aspects of their usage that may be difficult to adhere to during this crisis. Harvard University in connection with the virtual educational platform edX just launched an online course for health care providers to help them learn about mechanical ventilation for COVID-19 patients.
“Because of the lack of capacity, there is evidence that we’re not putting people who need ventilators on them early enough,” Vyas commented. “If we did not have the constraints of ventilators, PPE and testing, we could have handled the crisis differently.” Vyas said that a consortium of supply chain and health care professionals is currently working to extend COVID-19 data modeling into the supply chain in order to get ventilators to the hospitals that need them ahead of time. Part of the current supply problem is that there are ventilators in some states and cities that don’t need them, while there’s a shortage in other places that do.
Analytics company GlobalData calculated that the U.S. is short 75,000 ventilators to keep pace with the pandemic, while France, Germany, Italy, Spain and the UK are collectively short by 74,000 machines. GlobalData found that the total global shortfall of ventilators is about 880,000. Also worrisome is that supplies of sedative drugs needed for patients on ventilators are also drying up.
“Ventilator shortages are a crucial reality as the COVID-19 outbreak continues to worsen globally,” commented Tina Deng, a medical devices analyst at GlobalData. “All ventilator manufacturers have full order books and hold little in stock—receiving orders not only from regular customers such as hospitals, but also directly from governments.”
Despite some doctors rethinking the criteria for which COVID-19 patients should be placed on ventilators, many patients will need this form of life support or they will be unable to breath. Because of the shortage, hospitals have taken drastic measures, such as makeshift conversions of the machines employing extra tubing so that two or more patients can share one ventilator. The American Society of Anesthesiologists released a statement advising against the sharing of ventilators, saying it “could lead to poor outcomes and high mortality rates for all patients cohorted.”
All Hands on Deck
These grim realities call for closing the gap between ventilator supply and demand, and major ventilator manufacturers have ramped up production of the machines. Philips, Drager and Hamilton Medical all announced they will dramatically increase their ventilator production by 50 percent or more, while Medtronic increased production of its PD980 ventilator and shared design specs of its PB560 ventilator so that other companies could build them. Getinge is targeting a 160 percent production increase, up from its original promise of a 60 percent increase. Vyaire made a $84 million deal with the U.S. to make 8,000 ventilators, and Smiths Group contracted with the UK to provide 10,000.
Automakers have also shifted gears to produce ventilators. GE Healthcare is collaborating with Ford with the goal of producing 50,000 of a more simplified ventilator design by July. Tesla is also switching to production of Medtronic-designed ventilators at its New York facility, while Xerox is producing a machine called the Go2Vent, which is a resuscitation device costing only $120 that can be used in the interim by hospitals experiencing ventilator shortages. Other companies have stepped up work on mass-producing low-cost designs that can be used as substitutes for mechanical ventilators, and while these efforts may help fill the gap, unregulated machines can also pose risks for patients.
“These devices will help bridge the current crisis, but it’s not a holistic solution; it’s more like a Band-Aid on a bullet hole,” said Vyas. “This is a golden opportunity for governments across the world to coordinate and work together.
“The U.S. and Europe have such an intelligent supply chain model, and we have been able to manufacture, source and deliver at such a fast scale and most efficient way to the global community,” Vyas added. “We have those capabilities, and so it’s unfortunate that in this public health crisis that we have completely missed the boat on not tapping into the global supply chain and collective intelligence, and instead tried to rely on this ad hoc approach that’s caused unnecessary pain and suffering in our society.”