Coronavirus crisis: Maine CDC shows confidence in Chinese masks

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The Maine Centers for Disease Control and Prevention has purchased 300,000 Chinese-made face masks from an undisclosed supplier as domestic masks become harder to obtain.

As of Monday, the Maine CDC reported it had approximately 48,000 N95 masks made to U.S. standards, 45,000 surgical masks and 13,000 face shields.  

“We continue to seek additional sources of (personal protective equipment), some from the private market, some from the domestically manufactured market here in Maine,” CDC Director Dr. Nirav Shah said April 12. “Sadly we’ve also been informed by the federal government that the strategic national stockpile is tapped out. But we ourselves in Maine are taking matters into our own hands and seeking additional PPE.”

Sari Greene wears an N95 mask made by 3M while she volunteers April 5 at the South Portland Food Cupboard. (Courtesy Sari Green)

Shah said April 3 that the CDC had placed an order the day before for KN95 masks, a type manufactured in China that has been proposed as an alternative to N95s for use during the COVID-19 crisis. 

But the U.S. Food and Drug Administration has been slow to approve them, particularly due to concerns about difficulty in verifying their authenticity. An emergency use authorization was issued on April 3. 

National Institute for Occupational Safety and Health guidance documents state that masks produced under the standards authorized in certain countries are expected to provide the protection indicated, given that a proper fit is achieved. They are considered “suitable alternatives to provide protection during the COVID-19 response when supplies are short.”

However, NIOSH recommends the masks made in China should be used only in crisis situations.

“Non-NIOSH-approved products developed by manufacturers who are not NIOSH approval holders, including only products approved by and received from China, should only be used in crisis situations when no other NIOSH-approved N95 respirator … is available;”  the guidance reads. “They should not be used during aerosol-generating medical procedures unless the alternative is a loose-fitting surgical mask or improvised device.”

And at least one Maine hospital executive has expressed concerns about the masks.

Suzanne Spruce, a spokeswoman for Northern Light Health, said April 14 that Northern Light has purchased some KN95 masks but has not been happy with them.

“We don’t really like the way they fit,” she said, “so we have been trying to get more N95s.”

Shah said April 6 the Maine CDC team felt comfortable with purchasing KN95 masks based on the new FDA emergency use authorization, and because NIOSH indicated that KN95 masks can be used in health-care settings interchangeably with N95 masks, he said. 

A KN95 mask from Juntech (Jiaxing) Healthcare Materials Co., one of the approved manufacturers of KN95s under the U.S. Food and Drug Administration’s emergency use authorization of April 3.

“It was on the basis of those guidance documents from the federal government, as well as the fact that a number of other states are importing such masks that we felt comfortable moving forward,” Shah said. 

Other sources support their use, even U.S. N95 mask manufacturer 3M. A technical bulletin published in January by 3M states “it is reasonable to consider China KN95 …  as ‘equivalent’ to US NIOSH N95 … respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. viruses).”

In addition, On March 28, the Journal of the American Medical Association recommended purchasing PPE from international suppliers, specifically proposing China as a primary market given its manufacturing capacity and experience with COVID-19. 

The FDA states in its April 3 emergency use authorization that “based on the totality of scientific evidence available” certain masks that are manufactured in China and are not NIOSH-approved “are appropriate to protect the public health or safety.” 

The emergency use authorization also specifies that the masks manufactured in China would be subject to additional validation and review by FDA to confirm authenticity. An attachment to the authorization lists approved Chinese manufacturers of KN95 masks.  

Shah said the CDC purchased the KN95 masks from a Maine supply company, “with whom the state has done business for quite some time.” 

The Maine CDC did not disclose the company it purchased the masks from or the cost it paid per mask, but Shah said at the briefing that the price agreed was not out of line with what the agency had paid previously, or what other states have been paying.

Maine CDC spokesman Robert Long said April 14 that the supplier, manufacturer and price per mask will be disclosed when the transaction is complete. 

As early as Feb. 7, the World Health Organization reported that the cost of face masks on the market had increased 20-fold. “There are now depleted stockpiles and backlogs of four to six months,”  WHO Director-General Tedros Adhanom Ghebreyesus said at a Geneva press conference. “Global stocks of masks and respirators are now insufficient to meet the needs of WHO and our partners.” 

While there are many approved manufacturers of N95 masks, those made by 3M have become the gold standard during the coronavirus crisis and prices have skyrocketed. 

Mike Roman, CEO of 3M, wrote a letter to Attorney General William Barr stating that the company has not increased the prices it charges for N95 respirators and “will not increase its current pricing for respirators being used to help address the pandemic.” 

But the demand is driving the price higher outside of 3M’s control, as players are amassing stockpiles of the commodity to sell for a profit. The masks that could have been bought for under $1 apiece before the pandemic are reportedly being sold now at $6 each or more. 

The Service Employees International Union-United Healthcare Workers West reported March 26 that after launching a search the week before, it had located 39 million N95 masks made by 3M at a supplier selling them for $5 a mask. 

Meanwhile, 3M put out a statement warning of price gouging, counterfeit activity and people fraudulently representing themselves as being affiliated with 3M. 

“In many cases, these scammers will try and secure funds in advance and then disappear once the money is received. 3M will not tolerate any such activity by 3M authorized channel partners and we will aggressively pursue third-parties that seek to take advantage of this crisis,” the statement said. 

Shah said the Maine CDC is alert to these types of scams in sourcing PPE. 

“We actually have an entire team in place right now that is vetting those potential suppliers to make sure those stocks remain healthy,” he said.