Change in U.S. law will make millions more masks available to doctors and nurses, White House says

The law, signed Wednesday, will let U.S. manufacturers sell N95 masks made for industrial uses to hospitals without fear of liability

Jeanne Whalen 
March 20, 2020 at 1:26 p.m. PDT

Vice President Pence said Thursday that new legislation will allow tens of millions more protective masks to reach U.S. health-care workers each month, beginning immediately, but it was still unclear whether total production will be enough to meet demand.

New legislation signed Wednesday provides manufacturers of N95 face masks protection against lawsuits when selling certain masks to health-care workers, Pence said. That will free producers including 3M and Honeywell to sell tens of millions more masks per month to hospitals, Pence said, helping alleviate alarming shortages that have surfaced in recent weeks amid the coronavirus crisis.

“They are available now,” Pence said when asked when the extra masks would hit the market.

And Honeywell, of Charlotte, will soon boost N95 mask output in the United States by an additional 120 million masks per year, Pence said.

Moldex, a manufacturer based in Culver City, Calif., said late Thursday it can produce eight million N95 masks a month. The bulk of those have traditionally been used by industrial customers, but with the legal changes they can now equip health-care workers “during this critical period,” the company said.

Those figures are still well short of the 3.5 billion N95 respirator masks the United States could need in a serious pandemic, an estimate Robert Kadlec, an assistant secretary at the Department of Health and Human Services, gave at a Senate hearing this month.

Doctors and nurses in some parts of the country have been forced to reuse masks or even make their own amid shortages caused by soaring global demand and the shutdown of Chinese factories.

The shortages have caused outrage among medical professionals. “I just think this has been atrocious,” said Eric Topol, a cardiologist at Scripps Research in La Jolla, Calif. “On January 21, the first patient was diagnosed in the U.S. Now it’s two months later and we still don’t have these methods of protecting patients, doctors and care workers.”

There are several other manufacturers of N95 masks for the U.S. market. Prestige Ameritech of North Richland Hills, Tex., didn’t immediately respond to an inquiry about its production levels Thursday.

Owens & Minor spokesman Chuck Graves said the company wouldn’t disclose its total mask production. On March 11, Chief Executive Edward Pesicka said the company had “aggressively ramped up” production of protective gear over the previous month, including N95 masks and surgical gowns, at facilities in the United States, Mexico and Honduras, according to a transcript of his remarks at a conference.

Honeywell expects to sign a contract with HHS imminently to produce N95 masks for the agency at a Rhode Island factory, spokesman Eric Krantz said. That is the factory Pence said could produce an extra 120 million masks a year. Krantz declined to disclose Honeywell’s total annual output of the masks.

3M since January has been producing at full capacity at its U.S. facility, manufacturing 35 million N95 masks per month, Pence said.

Before the legislative change, 3M could sell only five million of those masks to health-care workers a month, he said, with the rest going to industrial customers, which use them to protect workers from harmful dust and debris.

Any type of N95 mask provides the same level of protection, but masks for medical and construction workers can sometimes vary in design and fit, said Charles Johnson, president of the International Safety Equipment Association, which represents companies making protective gear.

Under U.S. law, masks for health-care workers typically have to be manufactured on production lines certified by the Food and Drug Administration. Masks for construction workers and other industrial users are approved by the National Institute for Occupational Safety and Health, or NIOSH.

The new liability protection allows manufacturers and hospitals to provide some industrial N95 masks to medical workers without fear of being sued if the masks fail, said Johnson, who helped work on the legislation. The government now assumes liability, he said.

The liability protection applies to dozens of models of NIOSH-approved N95 masks, including disposable models, until October 2024, according to the legislation and a March 2 FDA letter. Johnson said his association is pushing for further legislation to cover more mask types that could be useful in the crisis, including reusable models.

3M didn’t respond to a request for comment Thursday. Pence visited the company in Minnesota on March 5, where he discussed mask production with Chairman and Chief Executive Michael Roman.

The industrial masks “will provide the protection we’re looking for in order to keep our health-care workers safe,” Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association, said in an interview Thursday.

In his remarks Thursday, Pence didn’t address how industrial customers will procure masks if supply is being diverted to the health-care sector.

UPDATE: This story was updated Friday to clarify Johnson’s remarks about the types of masks the liability protection covers. The change means Minnesota-based 3M will now be free to sell 420 million masks a year to the U.S. health-care sector, Pence said.


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