WASHINGTON (AP) — When Mark Hess saw reports last month about a shortage of ventilators looming because of the COVID-19 pandemic, he went to a museum in Great Bend, Kansas, to check out its 1950s model of an iron lung, the mechanical respirator used to help polio victims breathe.
With ventilators scarce, he saw it as a low-tech alternative for oxygenating patients and he developed a prototype of an iron lung he would like to sell to rural Kansas hospitals that lack intensive care units. His Hays-based company, Hess Services, Inc., normally manufactures storage tanks and other equipment for the oil industry.
Hess has climbed inside the pressurized cylinder to test it on himself. But as a non-medical manufacturer, he’s having trouble getting authorization from the Food and Drug Administration.
“I’ve put in 15 hours a day for the last four days on this and I’m not getting any closer,” Hess told The Kansas City Star on a recent Thursday after two weeks of seeking emergency approval.
“It’s frustrating from our level … Yeah, they’ll let you do this in an emergency, but here’s your 10 tiers bureaucracy,” Hess said. “It’s the whole government on this ‘cover your ass’ mentality.”
Manufacturers in Kansas and Missouri say they’re ready to respond to the pandemic by converting their plants to meet the surging demand for protective face masks, hospital gowns, ventilators and other items.
But many are running into hurdles caused by federal bureaucracy, an unfamiliarity with the medical supply business or a lack a capital.
Dentec Safety Specialists, a company with a factory in Lenexa, already produces reusable protective masks for shipbuilding and other industries.
Under a previous owner, the factory made the disposable masks that hospitals and first responders now desperately need. But in 2008 a flood of low-cost medical supplies from China forced the company out of the market.
In January, Dentec began contacting the Department of Health and Human Services, the Federal Emergency Management Agency, the Centers for Disease Control and Prevention and Kansas congressional offices about securing a federal grant to resume producing the N95 masks.
“We started this process contacting the federal agencies back in late January because we could see what was going to take place back then,” said Mike Bolden, the company’s vice president of sales. “We knew the Chinese were going to cut us off… We could see that coming and indeed it did.”
Bolden said the company discovered that no such federal grant existed. It means that Dentec has the expertise, but no capital to adjust its operation to make the N95 masks that are in high demand.
“It’s just funding to be able to do what we need to do in order to tool up,” Bolden said.
Bolden said the company still receives emails from the congressional offices, but it can no longer get a response from the federal agencies.
Rep. Sharice Davids, D-Kansas, one of the lawmakers Dentec contacted, said President Donald Trump needs to more fully utilize the Defense Production Act, the Cold War-era law that enables the president to order private sector production of necessary goods.
Trump has used the act to compel General Motors to produce ventilators and to stop 3M from exporting protective masks overseas. But he’s resisted calls from Democrats to apply the law more aggressively.
Davids said Congress should take its own steps with the next coronavirus relief bill to provide more pathways for companies seeking to make COVID-19-related supplies.
“I definitely think there needs to be stronger systems in place to allow companies like Dentec to produce supplies,” Davids said.
“We’re seeing a lot of people and companies in our community stepping up and the thing we need to do is making sure they have the resources available to help.”
A proposal from Sen. Josh Hawley, R-Missouri, would expand liability protections for companies engaged in emergency medical production for the federal government. The legislation would also provide subsidies for U.S. firms making medical goods in an effort to reduce the country’s reliance on foreign imports.
“When the government asks producers to expedite the production of emergency equipment, they shouldn’t have to worry about trial lawyers and navigating red tape while they are rushing to put out fires,” said Hawley’s spokeswoman Kelli Ford. “They should simply be able to answer the call.”
Sen. Jerry Moran, R-Kansas, addressed the hurdles manufacturers face during a phone conference with University of Kansas Health System officials.
“Every day that goes by we’re working with manufacturers and others to get them to put gowns and gloves into the hands of people who need it,” Moran said.
Moran wrote a letter to the FDA earlier this month asking about steps it has taken to expedite its review process and whether it needs additional resources from Congress to speed up approval. The letter noted Kansas’ “dangerously low” supply of protective equipment.
In the phone call, Moran said he’s pushing for the FDA to eliminate bureaucracy without reducing standards on products made in the U.S. or imported.
Dana Hawkinson, medical director for Infection Prevention and Control for the KU Health System, stressed that as companies begin producing new protective equipment and coronavirus tests to fill national shortages, it’s important to verify their efficacy and safety.
“This is going on in all aspects of health care whether it’s PPE or testing,” he said.
The Department of Health and Human Services, which oversees the FDA, did not respond for a request for comment. Moran’s spokesman told The Star that the agency had acknowledged the letter and had offered to set up a phone call soon between the senator and FDA Commissioner Stephen Hahn.
Hahn said at a recent White House briefing that the agency has approved two companies to build machines to sterilize N95 masks. The U.S. government will purchase 60 machines, each capable of sterilizing 80,000 masks per day.
Hahn also said that the FDA has issued a guidance to manufacturers to allow them to make hospital gowns with “no further regulatory red tape” so the gowns can go into circulation immediately.
At least one area firm found a way to navigate around the government red tape.
The Trabon Group, a Kansas City company that primarily prints menus for restaurants, has been able to enter the protective equipment market without facing FDA’s regulatory hurdles.
After laying off or furloughing the bulk of its workforce in March because of the pandemic’s impact on the restaurant industry, the company began using its printing equipment to produce face shields.
It started by connecting with local hospitals for which it had previously made brochures. The firm was able to bring back 72 furloughed workers and is now producing 8,000 face shields a day for hospitals in Missouri, Kansas, Iowa and Texas.
“Hospitals that we’ve been working with have not asked for FDA approval … That does not seem to be an issue at the moment because of the dire need,” said Tony Trabon, the company’s vice president.
“We had nurses reaching out that they were performing C-sections without face shields … We’re not hearing any barriers at all. Everything we’re hearing is, ‘How soon can you get it to us?’”
The company has been in weekly contact with Missouri Democratic Rep. Emanuel Cleaver’s office, but it has had little luck connecting with the rest of the state’s congressional delegation. Trabon said the company was hoping that lawmakers would be able to steer it toward areas with the highest need.
“Reaching out directly to hospitals has proven way more effective than reaching out to politicians,” Trabon said.
Other companies in the region are developing new products intended to help fill the gap of protective equipment.
American Dish Service, a company which manufactures warewashing equipment based in Edwardsville, Kansas, has built a prototype of a 60 x 36 inch machine that cleans personal protective equipment with ultraviolet light based on a technique developed by the University of Nebraska Medical Center.
“We can definitely develop it on a larger scale,” said Sonya Gossard, the company’s director of sales.
Gossard said American Dish Service could produce between six to eight of the machines a day to sell to police and fire departments grappling with the national shortage of protective masks.
Gossard got the idea after watching a television report about the Johnson County Sheriff’s Office repurposing its crime lab’s ultraviolet lights to clean equipment.
Two designers, Dan Eber and Spencer Fritz, developed the prototype. A team from the crime lab has conducted a test of the efficacy of American Dish Service’s prototype and the company will determine its next steps based on the results.
But even if the test is successful, it may not start producing machines. Gossard said legal counsel has advised the company to proceed slowly.
“We’re certainly not going to risk our company with lawsuits, so we’re being very cautious,” she said. “We’re at a little bit of a standstill at the moment.”
Steve Matusek, the president of Aeromotive in Lenexa, wrote to state and federal officials last month asking how he could join the fight against the global coronavirus pandemic. He said his small manufacturing firm had the experience, expertise and equipment to help produce ventilators or other life-saving devices.
The 25-year-old company produces parts for performance automobiles, such as fuel pumps, filters and regulators. All IndyCar Series cars use Aeromotive products, as do less ambitious car enthusiasts. Matusek thinks his company’s two Lenexa plants could switch to producing needed supplies like ventilators to help fill what’s expected could be a national shortage.
“We’re just saying we’re here and we want to help,” he said. “We need information. We don’t know what to make. We don’t know what there’s a shortage of.”
Matusek couldn’t say how fast his plants could transition to ventilators, but he said it could be done in a “very expeditious manner.”
Ideally, Aeromotive could partner or subcontract with a firm that already designs and produces ventilators —rather than starting design and engineering from scratch. He said the company is willing to set aside its regular business over the short-term. And it would produce something like ventilators at cost, without any profit.
“We would be willing to share all that and say, ‘Listen, our people have to eat, we’re willing to help, we’re willing to invest,’” he said. “But we would open our books and try to do that as efficiently as possible.”