U.S. manufacturers say they have enough high-filtration respirators like N95s in their warehouses for every American adult, and they are calling on the Centers for Disease Control and Prevention to revise guidance that discourages the general public from getting them.
“The U.S. has ample supply of masks and meltblown material to protect the entire workforce and public with high-filtration masks,” wrote a new coalition of 49 American manufacturers in a letter obtained by CQ Roll Call.
The letter, dated Monday, is addressed to President Joe Biden, COVID-19 Response Coordinator Jeff Zients, National Institutes of Health senior official Anthony Fauci and CDC Director Rochelle Walensky.
The group, which is calling itself the American Mask Manufacturers Association, says its members have an inventory of 233 million N95 respirators or equivalent masks in their warehouses and the capacity to manufacture 298 million per month.
If given a $75 million government investment, they estimate they could ramp up monthly production to supply enough surgical masks and respirators for every American each month.
Nearly a year after the shortage of N95 masks first made headlines, nurses continue to reuse soggy and soiled ones although up to 20 certified manufacturers have entered the market.
High-quality respirators — masks capable of filtering out many of the tiny aerosols that carry the coronavirus — remain out of reach for millions of Americans.
Lloyd Armbrust, who started making respirators at Armbrust American last year, signed onto the letter. He said the government should be in charge of smoothing out the dysfunctional market.
“We’re America. We put people on the moon. We won World War II. But we can’t make enough masks?” Armbrust said. “Nurses are still quitting a year later because they can’t get the protection they need. It’s insane.”
The letter comes at a time when the largest U.S. respirator manufacturer, Prestige Ameritech, has increased production by 1,300 percent over 2019. But the company sought permission from the Federal Emergency Management Agency to export 3 million to 4 million N95 respirators each month this winter because of paltry U.S. demand. Prestige Ameritech CEO Mike Bowen, a longtime advocate of increasing U.S. production of N95s, has not been able to find international buyers either.
“Our warehouse is filling up with respirators,” said Bowen, whose company did not sign the letter. “Hospitals are reusing them when they don’t need to.”
Domestic manufacturers jockey for attention
Though many members of Congress stressed the importance of shoring up U.S. protective equipment manufacturing last year, the supply chain remains dominated by a few large importers using goods from China.
Manufacturers say the U.S. is at a tricky inflection point. Supply of N95s has increased, but hospitals are reluctant to spend millions more on respirators, which once comprised a small proportion of their health equipment budgets. Some hospitals continue to ration them and reuse them with a risky process aimed at decontamination that the Food and Drug Administration temporarily authorized on an emergency basis.
CDC has said that N95s should be reserved for health care workers because relaxing the guidance could lead to a run on supply.
The U.S. companies argue that fear is no longer justified. The CDC did not respond to a request for comment.
Another U.S. manufacturer, DemeTech, has 30 million unsold N95s, according to recent press reports.
As many as 20 new certified respirator manufacturers have received approval from the National Institute for Occupational Safety and Health, an agency under the CDC, according to industry experts.
“That’s a lot,” said Dan Glucksman, a spokesman for the International Safety Equipment Association.
Glucksman estimates that before the pandemic, there were fewer than 10 new respirator manufacturers over the last 10 years.
The surge of new manufacturers have not been able to break into a market dominated by a few large corporations, in part because of reluctance to refit employees, questions about the quality of new products and because the masks can be made more cheaply overseas.
A search of the government database USASpending.gov shows that the five largest federal contracts for respirators were awarded to 3M Company at $173 million, Honeywell at $148 million, W.S. Darley & Co. at $81 million, O&M Halyard Inc. at. $62 million and Panthera Worldwide LLC at $55 million.
“3M has more lobbyists than I have employees,” said Armbrust.
“Some of the traditional pre-COVID manufacturers of respirators are still finding that all of the respirators they can make are claimed — whether it is by FEMA, the [Strategic National Stockpile], a state public health agency or existing distributors. So the supply is still kind of tight at least for those companies,” Glucksman said.
The AMMA’s call for a $75 million investment from the U.S. government comes after some smaller American-made mask manufacturers say they haven't gotten as much federal support as they hoped.
Kansas-based Dentec, which signed onto the AMMA letter, first began lobbying the federal government for investment funding and more guidance over a year ago. President Claudio Dente, who has been in the business for 40 years, began reaching out to federal officials on Feb. 3, 2020.
“There is no doubt, and it has been well documented, that the demand in the health care industry for masks can not be met by 3M alone,” the company wrote in a March 2020 email to federal officials shared with CQ Roll Call. “Are there any available funds to help us, not only contribute to the production of masks and other PPE items needed for this current crisis, but also to build a more sustainable domestic chain of supply to meet future demand independent of Asian sources?”
“Our great desire is to get into this fight,” the company wrote in another email to FEMA on March 23, 2020.
The company said it never received a reply.
Questions about new products
Meanwhile, hospitals are reluctant to take on new manufacturers because of the administrative costs of “fit testing,” the process of ensuring each employee’s respirator does not have leaks.
As a result, group purchasing organizations that buy supplies for thousands of hospitals have mostly stuck with the same manufacturers. They say they have redoubled efforts to sort out the legitimate suppliers in a “gray market” flooded with hucksters and pseudoscience.
“At the height of the pandemic, we went through thousands of offers, and many of them, I would say the majority of them, turned out to be gray market,” said David Hargraves, senior vice president of supply chain for Premier. “From a volume perspective, our health care providers continue to buy from the larger suppliers that were in the business prior to the pandemic.”
Glucksman said that many more manufacturers have been denied approval from NIOSH.
Some question whether unproven masks are worse than reused masks.
There have been efforts to create new standards for masks for the general public that effectively filter aerosols, but do not meet hospital standards.
In February, ASTM International released new standards for consumer-friendly face coverings. In January, the Biomedical Advanced Research and Development Authority announced a new initiative to support the development of new respirators.
Other experts worry a larger federal role in the market for N95s would rankle the group purchasing organizations that dominate the market and the hospitals they serve.
“If the government came in and tried to control distribution, a lot of organizations would cry foul,” said Anne Miller, executive director of Project N95, a national clearinghouse for personal protective equipment. “It’s the compromise we make in having a free market system.”