Mask maker on approved list in FDA probe

Photo provided by Department of Military Affairs and Public Safety From left, Capitol Police Director Kevin Foreman, State Fire Marshal Ken Tyree, Capitol Police Deputy Director Jack Chambers, and DMAPS Deputy Secretary Tom Kirk help organize thousands of N95 masks for statewide distribution.

CHARLESTON — The U.S. Food and Drug Administration continued to give the green light to a Chinese maker of respiratory masks for use by first-responders for coronavirus protection — the same company that sent the State of West Virginia 50,000 of the wrong kind of masks.

The FDA issued guidance last week that certain N95 masks manufactured by certain Chinese companies may not provide the same level of protection as a standard N95 mask. The FDA prohibited 65 Chinese manufacturers from selling respiratory masks for medical use.

In a letter to health care providers, the FDA said these masks are not up to standards set by the National Institute for Occupational Safety and Health (NIOSH) or the National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC).

“Respirators… that did not meet their labeled performance standard… are no longer eligible and are no longer authorized to be marketed or distributed in the United States as respirators,” the letter stated. “The information is specific to respirators that are designed to achieve a very close facial fit and to filter airborne particles.”

The FDA issued guidance on April 3 allowing for the use of non-NIOSH-approved imported N95 masks as long as the products were authentic products for use by medical professionals and first-responders “to prevent wearer exposure to pathogenic biological airborne particulates during (mask) shortages resulting from the COVID-19 outbreak.”

In a follow-up email for additional information, the FDA said they became aware that some of these imported masks did not meet standards for blocking out more than 95 percent of particulates, water droplets, and aerosols even though these same companies submitted their own reports stating that the masks met standards. The new guidance released Thursday removed companies with independent test reports from a list of approved manufacturers.

The FDA removed 65 companies from a list of authorized respirators. There are now 14 Chinese manufacturers of N95 masks on the updated list of authorized respirators, including Shanghai Dasheng Health Products Manufacture Co., the manufacturer of 200,000 N95 masks that the West Virginia Department of Military Affairs and Public Safety and the Department of Health and Human Resources ordered on March 19 from Ballard Safety, a Martinsburg-based company.

Both departments purchased 100,000 NIOSH-approved N95 masks per department according to invoices made available by DMAPS on Monday. But out of the 200,000 N95 masks purchased, 50,000 masks were a variant called a KN95 mask. While NIOSH-approved N95 masks include head bands to keep the mask firmly sealed around the face, the KN95 masks use ear loops to secure the mask to the face. These masks do not provide as tight a seal and are not approved by NIOSH.

The state received the masks and started distributing them on March 23. Of the 100,000 masks ordered by DMAPS, 50,000 were sent to DHHR on top of the 100,000 masks they already ordered. Of the 50,000 remaining masks, 40,000 were distributed to city and county law enforcement, paid and volunteer firefighters, and county emergency management agencies. Another 9,000 were distributed to the state’s regional jails and correctional facilities, with 1,600 being sent to two hospitals.

According to an April 16 memo to first-responders from Jeff Sandy, cabinet secretary for DMAPS, the state didn’t become aware that some of the masks were the non-NIOSH-approved KN95 masks until April 10 when an unidentified fire chief notified the Division of Homeland Security and Emergency Management about his concerns about the masks and whether they were counterfeit.

“We notified the emergency managers association that this had come up and in fact, we had supplied them with what the fire chief had sent us,” Sandy said, speaking Thursday during the state’s daily coronavirus briefing at the State Capitol Building. “The state emergency managers should have known on or about April 10th.”

Sandy confirmed that the masks were not checked to make sure the state purchased the correct masks. At the time, Sandy said the priority was getting masks into the hands of front-line first-responders who might have contact with COVID-19 patients.

“The masks are in sealed plastic for sanitary purposes and they come in packs of 20 and we shipped them out to all the counties per what the emergency managers wanted,” Sandy said. “Then, the demand was for more and on or around April 1 another 20,000 went out to the state emergency managers.”

After the issue was brought to the attention of DMAPS, Sandy conducted an investigation between April 10 and April 16 to make sure the state didn’t receive counterfeit masks. After the authenticity of the masks were confirmed, Sandy sent out the April 16 memo detailing his investigation.

Maj. Gen. James Hoyer, adjutant general of the West Virginia National Guard, said earlier this week that the West Virginia Intelligence Fusion Center is now doing vetting of all manufacturers used to purchase N95 masks and other types of personal protective equipment. The National Guard is in charge managing the stock of PPE supplies. They are taking samples of various kinds of PPE in their stockpile for testing at West Virginia University’s Department of Occupational and Environmental Health Sciences.

“Through the fusion center, there is a vetting of the various companies that we utilize,” Hoyer said. “The national Guard team that manages the stock of supplied takes samples of each of the supplies that comes in…based on the establishment of that task force, we implemented those things based on the Governor’s direction.”

The combined cost of the two orders of 100,000 masks was $1.2 million, or $5.80 per mask. Other states have reported instances of price gouging for masks, as well as purchasing inferior — and sometimes counterfeit — masks.


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