This spring, amid a panic over a shortage of ventilators to treat the anticipated surge in coronavirus cases, the Pentagon announced the purchase of $84 million worth of breathing machines from four companies. One of the ventilators, the SAVe II+, made by a small Plano, Tex.-based company called AutoMedx, stood out from the rest.
To start, the deal was for an upgraded version of the SAVe II that hadn’t even been designed yet, according to the company’s chairman. In addition, the existing $6,000 SAVe II machine, developed with military backing as a lightweight ventilator to keep wounded soldiers alive while being transported from the battlefield, had specifications far below the other three ventilators the Pentagon purchased. In a research study conducted for the Pentagon years earlier, the SAVe II had been declared unfit for use in a respiratory pandemic.
Defense Department medical workers who had been told to use the existing SAVe II device on covid-19 patients quickly came to the conclusion that it was ill-suited for the coronavirus pandemic, and began to voice their consternation to each other in emails that were shared with The Washington Post. One of the workers, who had been instructed to use the device if there were a surge of coronavirus patients, described it as “awful and under-powered.” Another raised concerns that using an ill-suited ventilator would “kill [covid-19 patients] just as fast as no ventilator at all.”
It’s unclear why AutoMedx, which had emerged from bankruptcy about six months earlier, received the no-bid emergency contract worth nearly $70 million for ventilators that, by every measure, were not suitable for covid-19 patients. AutoMedx eventually provided 11,200 ventilators at an average cost per ventilator of $6,274. Those ventilators are now in the country’s strategic reserve.
But who precisely authorized the contract remains unknown.
In mid-March, while hospitals were struggling to find ventilators to treat a surge of patients and U.S. cities were issuing stay-at-home orders, the White House began increasing spending in a scramble to prepare. Experts were predicting a widespread shortage of ventilators because covid-19, the disease caused by the coronavirus, can cause patients’ lungs to fill with liquid, making ventilators necessary to save lives. The Defense Department’s coronavirus spending plan included $312 million in Defense Production Act spending to increase the national stockpile of masks, ventilators, test kits and other supplies.
As part of those preparations, the Department of Health and Human Services published a list of 18 specifications that the devices must meet. Representatives from HHS and the Defense Department wouldn’t say where those specifications came from, but the document appeared to be an exact copy of specifications that had been listed on the AutoMedx website for five years, down to the format and order.
James Evans, CEO of AutoMedx, said the specifications were modeled after a 2008 article in the academic journal Respiratory Care. But Richard Branson, the lead author of that article, told The Washington Post that the specifications bore no similarity to the contents of the article he authored.
The Respiratory Care article contains a chart with a list of minimum ventilator specifications for treating illnesses like coronavirus. Branson rejected the idea that the AutoMedx specs could be based on that article. “If you look at it, it’s not the same. It doesn’t look anything like that,” Branson said.
In any case, the Respiratory Care article doesn’t explain why the government’s document and the specs listed on the AutoMedx website were nearly identical. "They didn’t even bother to change the orientation of it. If they were trying to be tricky, they could have at least started from the bottom and went down,” he said.
AutoMedx was not unknown to the U.S. government. Adrian Urias, an AutoMedx co-founder and current shareholder, advised the Trump administration’s coronavirus task force on ventilator purchases. AutoMedx’s current chief medical officer, Geoffrey Ling, was in charge of developing the company’s first ventilator, called the SAVe, while he served in the U.S. military.
AutoMedx is a private company, but it was founded with support and funding from the Pentagon’s research arm, the Defense Advanced Research Projects Agency, or DARPA. Ling’s boss at DARPA was Adm. Brett Giroir, a physician who now serves as assistant secretary of health and human services and is in charge of coronavirus testing for the Trump administration.
Urias did not respond to requests for comment. Stephanie M. Bialek, a spokeswoman for the Strategic National Stockpile, which is part of HHS, said Urias had no involvement in the AutoMedx contract. Giroir, through a spokesman, denied involvement in the AutoMedx contract.
In an interview, Ling said AutoMedx did not receive special treatment, to his knowledge, and said the company’s ventilator is a useful device for pandemic response. Air Force Lt. Col. Mike Andrews, a spokesman for the Office of the Secretary of Defense, said the agency’s goal in purchasing AutoMedx devices was “to source as many ventilators as possible in the immediate future.”
“AutoMedx’s ventilators are developed to provide lifesaving mechanical ventilation when there is a lack of full-featured ventilators or a shortage of the highly trained staff necessary to operate them,” Evans said in a statement. He said the company spent 2½ months improving the motor and software of the device to better meet the demands of coronavirus patients.
Corey Russ, co-founder and CEO of Combat Medical Systems, the sole distributor for AutoMedx, said he agreed that the ventilator’s capabilities lag behind more robust systems used in hospitals, but he described the ventilator as being used on patients before they become so sick that they need a better ventilator. “You don’t go to battle with just a rifle or a shotgun. You go with a variety of weapons,” he said.
“I will tell you right now if I had to choose between a SAVe II ventilator and a full-featured one, I would take the full-featured one right now. They are incredibly wonderful pieces of medical equipment,” Ling said in an interview. As for the SAVe II, “It’s better than nothing.”
Ling said the simplified features of the AutoMedx ventilator have another benefit: Doctors who aren’t trained on ventilators can use it more easily. “The less-trained provider working with a full-featured ventilator can actually hurt somebody,” he said.
The SAVe, short for Simplified Automatic Ventilator, was created with funding from DARPA, the same government agency that created the precursor for the Internet, GPS satellites and the computer mouse. It was designed to be relatively inexpensive, lightweight, work on batteries and be operated by people with little medical training. The SAVe was on display at the 2007 DARPATech conference in Anaheim, Calif., a glitzy affair that was well attended by national tech reporters. With the promise of helping wounded soldiers make it from the battlefield to the hospital, the AutoMedx device received write-ups in publications such as Popular Mechanics.
The company was founded by Bill Wiesmann, a retired Army colonel turned entrepreneur who currently serves as chairman of the company, and Urias, an engineer who received a master’s degree in engineering from Harvey Mudd College in 2000.
The SAVe ventilator received approval from the Food and Drug Administration a month after the DARPA event and went into mass production in early 2008, according to a news release issued at the time by the company’s distributor at the time.
Giroir, who was director of science for DARPA at the time and oversaw the development of the SAVe, was also pushing the device as a solution to global pandemics, according to one person involved with the device who spoke on the condition of anonymity because they were not authorized to speak publicly. Many victims of the severe acute respiratory syndrome (SARS) outbreak of 2003 died because they essentially lost the ability to breathe, a syndrome known as acute respiratory distress syndrome (ARDS). By placing virus victims on ventilators, doctors were able to save some patients via artificial breath. But ventilators are expensive and complicated to use, and Giroir thought the SAVe would be a less expensive “surge” ventilator to be used in the case of another pandemic, this person said.
In 2009, the H1N1 flu virus, which also caused ARDS, spread around an unprepared world. Partly in response to H1N1, DARPA funded a research study at the University of Washington aimed at determining whether SAVe ventilators would help patients with ARDS. The results, published in the academic journal Critical Care Medicine in 2011, came from making laboratory pigs very sick, after which they were placed on the SAVe ventilator.
The pigs on the SAVe quickly died, leading researchers to conclude that it wouldn’t be effective in a pandemic such as H1N1.
At the time, AutoMedx was also developing the SAVe II, a new ventilator that had not yet received FDA approval, so researchers at the University of Washington also studied that device. They concluded that the SAVe II, which received FDA clearance in 2014, was better than its predecessor but still inadequate for treating ARDS.
The SAVe II ventilators “were not developed, nor intended, to treat critically ill patients, such as those we are seeing with covid-19, who are often advanced in age and have severe respiratory infections, requiring higher air pressure concentrations to aid in oxygenation,” said DARPA chief of communications Jared Adams.
Evans, the AutoMedx CEO, said the purpose of the University of Washington study was not to test the efficacy of the company’s devices but to “test a ‘novel’ lung injury test protocol.” He said the technique used in the study is not typically used to evaluate ventilators. He said the SAVe II device “functioned as it was intended” in the study.
“I remember the study. We considered it pretty biased,” Russ of Combat Medical Systems said in an interview, referring to the results as “ambiguous.” He said the SAVe II was tested on coronavirus patients but did not provide details.
Treating the victims of a pandemic is different from treating soldiers on the battlefield, doctors say. First, most soldiers are young and fit, with healthy lungs. Second, their injuries are not necessarily to the lungs themselves. And third, they often need breathing support for only a short time before they arrive at a medical facility. Virus victims with ARDS often are older and have less resilient lungs. By the time they need help breathing, their lungs are ravaged and filled with fluid, requiring breathing support for days, weeks, even months. Keeping them alive is extremely complicated medicine.
In 2015, AutoMedx’s fortunes faded. It had partnered with Zoll, another ventilator manufacturer, to build a new ventilator. But the deal fell apart, and Zoll canceled its contract and asked for a refund, alleging that AutoMedx had failed to meet deadlines. AutoMedx sued and lost. It filed for bankruptcy in October 2018, emerging a year later.
When the pandemic hit, Evans quickly began pitching the SAVe II. “We’re getting ready to build 50,000 of these in the next 12 months,” he told Breitbart News on March 15.
Urias left AutoMedx in 2016 to join Tunnell Government Services, a consulting firm. He was appointed to work full time for the Biomedical Advanced Research and Development Authority, a division of HHS, as a subject matter expert on medical devices. Elleen Kane, a spokeswoman for HHS, confirmed that Urias volunteered to join the White House task force to advise it on ventilator purchases.
Giroir left DARPA in 2008 to serve as vice chancellor for research for the Texas A&M University System, according to his HHS bio. He continued to serve on the Defense Department’s Threat Reduction Advisory Committee after leaving DARPA.
On March 21, HHS issued a “request for information,” which was the government equivalent of a classified ad, calling on ventilator companies to quickly mass-produce and sell the devices to the government, in anticipation of a surge of virus cases that was expected to overwhelm hospitals. The RFI included the 18 minimum capabilities seemingly lifted from the AutoMedx website.
HHS spokeswoman Mia Heck said Giroir “did not have any role in the development of this document,” referring to the information request and the specs, and said Giroir had not seen it until The Post asked him to comment on it. The document was produced by HHS, but the agency’s representatives could not say who created it.
Andrews said the Defense Department had “no knowledge” of any involvement by Giroir in the decision to purchase the ventilator. Giroir has had “no contact with the program, company or ventilator development” since 2008, Heck said.
Urias “does not make decisions about procurements,” Kane said in a statement. “His role is limited to providing technical information about ventilators to federal staff, which mitigates any potential conflicts of interest. During the covid-19 response, he has continued to answer questions about the technical aspects of ventilators including the SAVe II ventilator.”
Combat Medical Systems quickly responded within the two-day deadline and was awarded a contract, along with several other ventilator manufacturers, to provide devices for the pandemic response.
Just days after the contract was signed, on April 1, a medical worker for the military sent an email to a group of military doctors around the country expressing concerns about using the SAVe II on covid-19 patients. According to the email chain, the devices were being pushed as a solution to a ventilator shortage. Many of the doctors on the email chain quickly concluded that it was ill-suited for pandemic victims. There were 28 medical personnel on the email chain. Four responded with concerns about the SAVe II. One doctor floated the idea that the ventilator might be used while transporting sick patients to a more capable ventilator.
Soon after that email chain, HHS concluded that the SAVe II was inadequate to treat covid-19 patients. Representatives for HHS declined to say whether the email chain influenced the department’s thinking on the matter. But rather than back out of the contract, the department requested that Combat Medical Systems make a new ventilator with improved features, according to Katie McKeogh, a spokeswoman for the department.
Even the new ventilator, dubbed the SAVe II+, was subpar for covid-19 patients, according to emergency room doctors interviewed by The Post.
“The SAVe II+ has fewer features and more limitations than other portable ventilators already in the national stockpile, including those we used in New York to support patients during the surge in March-April,” said Jeremy Beitler, a pulmonary disease specialist at Columbia University Irving Medical Center in New York. “The lack of features limits the ability to adjust the ventilator to patient-specific needs,” he said.
“I wouldn’t call it a ‘covid’ vent,” said Robert Owens, a director at the medical intensive care at University of California, San Diego Health in La Jolla, CA.
Evans pointed to a September article in the medical journal CHEST that listed the average settings used on Covid-19 patients at Massachusetts General Hospital. “Based on this data the SAVe II+ can ventilate the average COVID patient," he wrote in an email. However, the same article concluded the SAVe II+ was not suitable for treating critically ill covid patients. Rather, it could be used to transport patients or in lieu of a “bag valve mask,” which doctors can use to manually ventilate patients by squeezing a bag of air into their lungs. One other ventilator in the stockpile was also given that designation by the article’s authors.
Michelle Madej, spokeswoman for the Defense Logistics Agency, said the agency originally ordered 2,500 SAVe II+ ventilators, but that it canceled 1,300 because they were no longer needed. But according to Bialek, the Strategic National Stockpile spokeswoman, HHS still ordered an additional 10,000 SAVe II+ ventilators. They have not been used on pandemic patients, she said, and are being stored in warehouses.
