In a matter of weeks, hundreds of manufacturers across Colorado have suspended normal production of things like snowboards, outdoor gear and clothing to make personal protective equipment for health care workers on the front lines of the coronavirus outbreak.
They’re making masks and face shields and parts for ventilators. But federal red tape and limited capacity to test and certify the new products for medical use in Colorado have left some manufacturers in limbo.
“It is not unusual for any of us to get 100 emails in an hour,” said Noel Ginsburg, chairman of the state’s manufacturing and sourcing task force. “We can’t test everything, so we will prioritize those things that are going to go into the health care system first.”
“There’s a lot of positives going on for sure,” he said, “but it’s a complex system, and we have to set honest expectations.”
Colorado is in desperate need of N95 medical-grade masks and other personal protective equipment, including gloves and medical gowns. Last week, Colorado received 2 million masks from China, and will be receiving 100,000 more from Taiwan this week. But gear is still in short supply –– so much so that some health care providers have asked for help figuring out how to 3D print their own face shields.
As of Sunday afternoon, there are nearly 5,000 people who have tested positive for the virus in Colorado, and at least 140 have died.
“We are facing a crisis-level shortage of these essential supplies to protect our health care workers and first responders,” Gov. Jared Polis wrote in a March 28 letter to Vice President Mike Pence, who is in charge of the U.S. coronavirus task force.
The federal government has been slow to deliver the equipment Colorado has requested from the Strategic National Stockpile. According to data from the Colorado Department of Public Health and Environment, the state has received only 11% of the 2 million requested N95 masks; 11% of the 880,000 face shields; 11.6% of the 4.5 million surgical masks; 14% of the 720,000 gowns; 11.7% of 4.3 million gloves; and none of the 10,000 requested ventilators.
The lack of supplies has led Colorado companies and manufacturers to step in to help fill the gap. But the state is still figuring out how to streamline the process for new producers trying to get their products certified and into the state’s hospitals.
“We have tested some Colorado manufacturers’ masks and prototypes. But we are currently only testing what the state has asked us to test,” said Ellen Fisher, assistant vice president of strategic initiatives at Colorado State University, where researchers are evaluating the effectiveness of the new products. “We only have a few people that are doing this and we’ve got limited capacity for testing. So we are using the task force as the gatekeeper.”
How Colorado is testing personal protective equipment
Ginsburg’s task force is working only with manufacturers that have connections to Colorado and those that can be vouched for. He is worried about receiving counterfeit products and increased prices. Testing priority is also given to companies that already have Food and Drug Administration approval and can quickly scale up production.
“The need is so real and everyone is working every channel that they can to find manufacturers or importers that can reliably provide that approved PPE for immediate use,” said Cara Welch, a spokeswoman for the Colorado Hospital Association. “But every hospital in every state is doing the same thing. So it’s just really straining the existing supply chain.”
Colorado State University is leading efforts to test all imported and locally manufactured personal protective equipment for the state to make sure they meet the standards set by the FDA and the Centers for Disease Control and Prevention.
Twenty units of every new local or international shipment of equipment the state receives must be tested to ensure they are safe for medical professionals. CSU is primarily testing N95 face masks and medical gowns. A similar lab at the University of Colorado Anschutz Medical Campus is testing face shields.
CSU can test only 60 to 70 masks per day. The university is in the process of getting more equipment that will double or triple the lab’s capacity. Last week, CSU received a loaned piece of equipment called an environmental chamber from the National Institute of Standards and Technology in Boulder that will help speed up testing. CSU is also working to create a network of institutions that could help provide testing support.
When CSU gets a shipment of masks, the devices get an abridged test to essentially give the product a thumbs-up or a thumbs-down. And only the thumbs-up products go through the full testing process.
The testing is slow. To be certified for medical use, the masks must meet standards set by the FDA, the National Institute for Occupational Safety and Health, and the Occupational Safety and Health Administration.
Part of the protocol is a 25-hour preconditioning period, Fisher said. “It’s really just having them sit in an environmental chamber at the same temperature and a particular relative humidity for a period of time before they’re tested.”
There are two main types of medical-grade face masks: the N95 respirator and the surgical mask. Both help block large-particle “droplets, splashes, sprays, or splatter” that could contain the novel coronavirus. But the N95 respirator is more tightly fitted and can filter out 95% of very small particles, including viruses and bacteria.
“We’re not certifying anything that doesn’t meet the 95% particulate removal,” Fisher said. “And that’s because we don’t want to put out masks saying that they provide protection when we know that they don’t.”
Masks that fall short can still be used by the general public as face coverings to help slow the spread of the virus. Polis on Friday asked Coloradans to wear face coverings any time they leave their homes.
“We will prioritize those that are going to go into the health care system first,” Ginsburg said. “For the rest of the products that are considered face coverings, we encourage them to be handed out to neighbors or sent out to whoever needs them outside of the traditional health care sector.”
Ginsburg said he understands the frustrations of people who are reaching out to the state and not getting an immediate response.
“We set up a process in a matter of days to service tens of millions of units needed around the state,” he said. “It’s not because of lack of effort or lack of capability, it’s the sheer volume of what we’re trying to deal with.”
Ginsburg said he wishes that the state had more federal support.
“I have not gotten any guidance federally in terms of what they have and what they would allocate to Colorado,” Ginsburg said on Thursday. “We’re not working as a country, we’re working as 50 individual states because we have no choice.”
Manufacturers are being hampered by testing backlog and federal regulations
The nonprofit Manufacturer’s Edge –– which is part of the U.S. Department of Commerce’s Manufacturing Extension Partnership –– is collaborating with the state’s task force to connect Colorado’s 6,500 manufacturers with hospitals that need personal protective equipment.
On March 30, the organization’s spokeswoman received a call from a medical provider seeking advice on how to 3D print her own personal protective gear.
“What she was talking about was high-level manufacturing,” Jessica Cowden said. “These poor doctors are on the frontlines risking their lives trying to save people, and they’re so desperate for materials that they’re trying to start manufacturing their own.”
Cowden said it’s been inspiring to see just how quickly manufacturers have been able to turn over their manufacturing lines to an entirely different type of product. Her organization is helping them get FDA approval and move products into the jammed testing pipeline.
“The governor’s task force is pretty overwhelmed at this point and there’s a bit of a logjam there,” Cowden said. “And so people have really tried to spring into action and assist them by supplementing their efforts.”
Cowden said that once the state gets a large shipment of gear, the smaller producers get bumped to the bottom of the state’s testing queue. Some manufacturers, understanding the long wait, are moving forward without FDA approval and providing a disclaimer on their product saying they lack the official certificate, Cowden said.
Johnnie Apparel, a company that typically makes wholesale clothing for companies such as Nike and Adidas, mobilized one of its factories in China to start mass producing surgical face masks. The owner, Scott Katskee, who is based in Denver, said he contacted Colorado’s task force to gauge interest in his product but he never heard back.
“Right now, I’m going through weeks of federal red tape to get licensed to import this stuff and I still haven’t gotten a call back from the state,” Katskee said. “I’ve been through all the hoops and hurdles with the FDA to get approved.”
Meanwhile, Katskee estimates he can produce 400,000 masks a day, and in a few days, that will reach 1 million units per day. He said state officials have called some of his customers in Colorado to see how many masks they can make. “And they say they can maybe make a few hundred a day. Meanwhile, I could airlift 1 million of them by next Thursday,” he said.
Katskee, who has worked for 28 years in Asia, said getting masks to health care workers is a top priority. But to truly slow the spread of the virus, he said, everyone else should be wearing a mask, as people in Asia often do. “We are culturally behind in this.”
People in Asia have “been through SARS and they’ve been through MERS,” he said. “They’ve been through the bird flu and the swine flu … not to mention the fact that they have to wear masks because of airborne particulates and pollution.”
Katskee said FDA regulations are slowing down the United State’s efforts to get more personal protective equipment into hospitals. He said he has had samples of his masks stuck in customs in Memphis, Tennessee, for 15 days. And a small shipment of 24,000 masks is stalled in Chinese customs.
At the beginning of China’s coronavirus outbreak, officials created what they call an “import green channel” and allowed medical supplies to pass straight through. Katskee said the U.S. should do the same.
“I understand why the FDA and the CDC have regulations. They want to make sure that we’re getting good quality products,” Katskee said. “But at this point, when the president is telling people to make a mask out of a handkerchief, I think we need to change some regulations and get things done faster.”