Joe Severino
CHARLESTON, W.Va. 鈥� West Virginia distributed 50,000 respirator masks to first responders, then left the devices in use after being advised they might be counterfeit.
After the Centers for Disease Control warned the state鈥檚 top public safety official about the problem and the manufacturer鈥檚 concern that its products were 鈥渂eing counterfeited,鈥� he issued a 10-page report to first-responders asserting the masks are 鈥渁uthentic.鈥�
鈥淭hese masks are genuine products from Shanghai Dasheng Health Products Manufacture Co. Ltd. (Dasheng) and not counterfeit,鈥� Jeff Sandy, secretary of the Department of Military Affairs and Public Safety, wrote in the April 16 memo.
The CDC advised Sandy that a model of the mask known as a DTC3X with ear loops was 鈥渂eing misrepresented as鈥� approved by the National Institute of Occupational Safety and Health. Questions about the masks prompted the CDC to issue a cautionary notice on its website. Masks with ear loops frequently lack the fit needed to provide sufficient protection against pathogens, according to the health agencies.
Asked about the issue Monday, Sandy鈥檚 office provided an email sent to him April 13 by the chief of the NIOSH personal protective technology testing and evaluation lab in Morgantown that reiterated the CDC鈥檚 concerns.
鈥淎ll NIOSH approvals manufactured by [Dasheng] have headbands, not ear loops,鈥� John R. Powers Jr. wrote. 鈥淭his is why NIOSH suspected this to be a counterfeit product. We have been in communication with [Dasheng] and they have informed us that their products are being counterfeited, and we are reaffirming that information on the Buyer Beware section of our Respirator Trusted-Source Information webpage.鈥�
Sandy stood by the masks in his April 16 memo and in a response Monday to the Charleston Gazette-Mail.
鈥淪ecretary Sandy conducted research and concluded that these masks were made by the stated manufacturer and at its facility in China,鈥� said public safety department spokesman Lawrence Messina wrote in an email Monday evening. 鈥淗e notes that he conducted this research with a background as a career federal agent who had handled multiple international investigations.鈥�
Messina said Sandy advised emergency officials during a morning call about the CDC鈥檚 warnings and said he agreed with them. Sandy also read from a ruling from the Food and Drug Administration stating the masks 鈥渁re appropriate to protect the public health or safety.鈥�
Some emergency officials and others in the first-responder community remained concerned despite Sandy鈥檚 assurances, via a Freedom of Information Act request.
An expert whose guidelines are linked on the state fire marshal鈥檚 website also told county emergency officials in an email that the ear-loop masks 鈥渁re definitely counterfeit masks and they should not be used for front line emergency operations.鈥�
West Virginia bought 100,000 respirators for $567,000, according to an invoice. Half the masks were DTC3X models with ear loops.
All masks approved by NIOSH and sold by Dasheng are made with headbands, which allow for a tighter fit and greater protection against COVID-19, the CDC lab wrote in an email.
鈥淓ar loops are an automatic disqualifier,鈥� said Christina Baxter, the CEO of Emergency Response Tips, a company that develops support tools and training solutions for emergency response, according to its website.
Baxter is chairwoman of the National Fire Protection Agency鈥檚 chemical protective clothing committee. The state fire marshal promotes information from the 124-year-old nonprofit on its website.
Urged by emergency officials to advise first-responders across the state about the concerns, Sandy 鈥� who was appointed by Gov. Jim Justice and reports to him 鈥� instead declared the masks were 鈥渘ot counterfeit.鈥�
Some emergency management officials across the state said they are worried firefighters, paramedics, police and others on the front lines of the coronavirus fight are unaware of the risk.
鈥淢ost people don鈥檛 notice, including first responders, ear loops on N95s,鈥� said West Virginia Fire Chief Association President Randy James. 鈥淲hatever PPE are given to [first responders], I want them to know the absolute limitations of that device ... I鈥檓 not the professional here ... I wouldn鈥檛 have known about ear loops or anything like that; somebody throws me a mask, I put it on.鈥�
James emailed State Fire Marshal Ken Tyree on April 21, raising concerns about the respirators and urging that first responders be advised of the devices鈥� potential limitations.
鈥淩andy, I鈥檒l see what permission I鈥檒l be given to proceed on this,鈥� Tyree responded.
James said he never heard from Tyree.
The state fire marshal reports to the Military Affairs and Public Safety secretary.
In the same week Sandy authored the report to first responders, Illinois and Missouri recalled thousands of counterfeit masks purchased from China.
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The state purchased its respirators March 23, according to an invoice provided by Sandy鈥檚 office. His report traces the purchases from seven companies; from Ballard Safety Equipment in Martinsburg to Dasheng.
On April 10, an unnamed West Virginia fire chief claimed the state Division of Homeland Security and Emergency Management had sent several counterfeit masks to various counties, according to Sandy鈥檚 report.
On April 13, Braxton County Office of Emergency Services Director John Hoffman sent photos of the respirators to the CDC鈥檚 testing lab, according to emails.
鈥淲e suspect that these masks are either bogus or not true N95鈥檚,鈥� Hoffman wrote to the CDC.
The state distributed more than 50,000 of those respirators to first responders 鈥� 40,000 went to 鈥渃ity and county law enforcement, all firefighters, and county emergency management agencies;鈥� 9,000 went to the West Virginia Division of Corrections and Rehabilitation and 1,600 to two unnamed hospitals.
The CDC lab said in an April 14 email to Hoffman that state Homeland Security officials reached out to the agency April 10 with the photos and questions about the masks. The lab provided Hoffman its response to the state, sent the day before, according to the emails.
The language matched that of Powers, the lab chief in Morgantown: 鈥淎ll NIOSH approvals manufactured by [Dasheng] have headbands, not ear loops. This is why NIOSH suspected this to be a counterfeit product.鈥�
Respirators with ear loops failed what鈥檚 known as the Occupational Safety and Health Administration鈥檚 Quantitative Fit Test, the CDC lab wrote. That test calculates a respirator鈥檚 effectiveness while a person is using it, according to the CDC.
鈥淭he highest fit factor achieved was 11. The OSHA requirement is 100,鈥� the CDC lab wrote.
When Hoffman emailed Sandy asking about these assertions and pointing out that Sandy had been sent them a day earlier, Sandy replied: 鈥淎re you going to share this communication?鈥�
Hoffman then called on Sandy to relay the CDC鈥檚 information to all 55 counties鈥� emergency operations directors in his daily call. Sandy responded by clarifying he鈥檇 received the CDC email.
After Hoffman again turned to the CDC, another agency official responded citing problems with the DTC3X masks with ear loops.
鈥淭he photos of the DTC3X respirators sent by Jeff Sandy had ear loops and are being misrepresented as NIOSH-approved,鈥� wrote Kim Gavel, deputy branch chief of the CDC/NIOSH National Personal Protective Technologies Lab in Pittsburgh.
Sandy asked whether KN95s, a less effective version of the N95, with ear loops would provide the same protection as NIOSH-approved masks, Gavel wrote. She said products claiming to be KN95s should filter 95% of particulates, like the N95s 鈥� but the limited samples of potentially counterfeit respirators the CDC received and tested did not meet that standard.
A former Department of Defense official, Baxter, the Emergency Response Tips CEO, also told Hoffman the respirators were bogus, according to the emails, which were dated the same day.
鈥淔irst, these are definitely counterfeit masks and they should not be used for emergency front line emergency operations, especially for anyone dealing directly with a COVID-19 patient,鈥� she wrote.
The respirators the state distributed are more comparable to surgical masks, Baxter wrote.
Justice鈥檚 office did not respond to requests for comment.
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漏2020 The Charleston Gazette (Charleston, W.Va.)