In response to the new coronavirus epidemic, FDA has allowed entities to import and use N95-style masks. However, recent tests performed by CDC's National Institute for Occupational Safety and Health (NIOSH) has found that a large portion of imported masks fall short of U.S. quality standards—potentially putting health workers at risk, Austen Hufford and Mark Maremont report for the Wall Street Journal.
Testing raises safety concerns
According to Hufford and Maremont, NIOSH recently conducted tests on 10 samples of 67 different types of N95-style masks imported into the United States. Hufford and Maremont note that U.S. quality standard call for N95 masks to filter out 95% of particles—a standard that's also cited for KN95 masks, which is a Chinese standard that's similar to N95.
However, NIOSH found that 60% of the types of masks tested allowed in more particles than typically is allowed under the U.S. quality standard. For example, one mask, which had unauthorized FDA logos on its packaging, filtered out just 35% of particles, while another masked marked as KN95 filtered out less than 15% of particles on one sample test, NIOSH found.
The majority of the masks NIOSH tested also used ear loops to secure the masks to the head—a design that's not approved by NIOSH, which favors headbands to ensure the masks fit tightly, Hufford and Maremont report. According to Hufford and Maremont, a tighter fit helps to keep out small air droplets that could contain the new coronavirus.
In another example, Hufford and Maremont report that officials from the Federal Emergency Management Agency (FEMA) recently detained a shipment of 500,000 ear-loop masks from the importer Indutex USA that arrived at John F. Kennedy International Airport in New York. FEMA said it seized the shipment to ensure the masks met quality standards, and that the products' packaging said they were N95 masks approved by NIOSH. The Institute tested two batches of masks that came in the same packaging as those found in the Indutex shipment, and found they filtered only between 83% and 91% of particles, had ear loops, and had not been approved by the agency.
George Gianforcaro, president of Indutex USA, said the masks weren't supposed to be medical grade, but they had been certified as meeting NIOSH standards by a testing firm in China. Gianforcaro said, if NIOSH's test results are confirmed, he'd like to return the masks to the factory from which they came.
Health officials in Colorado, Illinois, Massachusetts, and Missouri similarly have reported that a number of imported masks failed their quality tests.
Gregory Rutledge, a professor at the Massachusetts Institute of Technology, said his lab tested more than 40 masks claiming to meet China's KN95 standards from Massachusetts' state stockpile, and just a third of them performed similarly to certified N95 masks, while another 25% performed close to the same level as certified N95 masks.
"There are some good masks out there, but not all are as advertised," Rutledge said.
Are health care workers protected?
As U.S. supplies of personal protective equipment remain scarce, NIOSH's tests suggest that hospitals could be paying high prices for masks that don't meet the advertised quality standards, Hufford and Maremont report.
For example, Lawrence General Hospital in Massachusetts said it had distributed 400 of the 7,000 masks with ear loops that it received from China before seeing an alert from NIOSH that such masks are of comparatively lower quality.
According to Lynn Risacher, a nurse at Lawrence General, about 75% of 40 colleagues in her unit had worn the masks with ear loops at some point. "We weren't protected," she said.
In a statement, Lawrence General said it has improved its procedures to determine whether medical gear is properly certified.
According to staff at the hospital, the masks bore the logo for Shanghai Dasheng Health Products Manufacture—a company that's been approved by NIOSH to manufacture more than 30 types of N95 masks. However, officials were not able to determine whether the masks were actually made by Dasheng, and the company did not respond to the Journal's requests for comment, Hufford and Maremont write.
According to NIOSH, Dasheng has said any masks with ear loops that bear its logo and N95 logos are counterfeits (Hufford/Maremont, Wall Street Journal, 5/3).