Maine CDC rejects Chinese-made masks for poor quality

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The Maine Center for Disease Control and Prevention rejected an order of 300,000 KN95 face masks after samples proved to be of insufficient quality.

The Chinese-made KN95 facemasks had been considered an alternative as N95 respirator masks that meet U.S. standards became more expensive and harder to obtain due to high demand in the coronavirus response. 

The Maine CDC placed an order for the Chinese mask on April 2, while it and other state agencies were pressuring the U.S. Food and Drug Administration to approve KN95 masks for import. The Food and Drug Administration authorized emergency use of masks made in several countries but did not add China to the list until April 3, with an added level of scrutiny to verify the authenticity of the KN95 masks.  

A KN95 mask from Shauguan Taijie
Protection Technology Co., one of the approved manufacturers of KN95s under the U.S. Food and Drug Administration’s emergency use authorization of April 3. The Maine CDC did not disclose the vendor or manufacturer of the KN95 masks it ordered.

The U.S. Centers for Disease Control issued guidance that in crisis situations when there are not enough N95 masks available, other masks that meet standards of other countries may be used as long as a good fit is achieved. However, it recommended that Chinese-made masks be used only as a last resort if masks from other countries with emergency use authorization were unavailable. 

At an April 6 press briefing, Maine CDC director Dr. Nirav Shah said his team felt comfortable ordering the masks because of the FDA authorization and because several other states were ordering KN95s. 

Since then, however, representatives of two of Maine’s major hospital networks said they would not use the Chinese masks due to poor fit. 

“We don’t use KN95s, and do not regard them as acceptable substitutes for N95s, as they will not pass fit testing,” MaineHealth spokesman John Porter said April 22.

Northern Light Health spokeswoman Suzanne Spruce previously said hospital staff was not happy with KN95s they had tried. 

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

Maine’s order of 300,000 masks from an undisclosed Maine vendor was expected to be delivered at the end of April, but on Saturday Maine CDC spokesman Robert Long said the agency had canceled the order. 

“We received a sample of the KN95s and determined that the quality was not sufficient to complete the transaction,” he said. “We are continuing to explore multiple sources for N95s and other forms of personal protective equipment.”

The Maine CDC reported on April 21 it had 194,000 N95 masks available. On April 22 it reported that it had distributed 71,002 N95 masks since March 8 to institutions throughout the state, and another 1,500 on April 23.

In order for those to effectively protect the wearer against COVID-19, they must be fit-tested – a process that involves a bitter or sweet solution being sprayed at the wearer and the mask adjusted until the wearer cannot detect the scent.   

Shah said 14 National Guard members would be training health care workers at hospitals and long-term care facilities across the state to conduct fit tests of N95 masks. 

“The goal here is to expand the number of folks who can utilize PPE across the state, especially in affected health-care facilities,” he said. 

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