The coronavirus pandemic triggered a sudden and intense need for masks, which led Americans to make masks at home with t-shirts and bandanas. Hundreds of new, untested products flooded the market with almost no supervision or regulation, making consumer masks the Wild West of personal protective equipment.
This is set to change.
ASTM International, an international technical standards organization, and the National Personal Protective Technology Laboratory, are working on standards to “establish design, performance (testing), labeling, user instructions, reporting and classification, and compliance assessment requirements for coverages barrier face. “
In other words, they hope to help Americans know which masks really work.
The guidance project includes single-use, reusable masks and describes specific requirements for evaluating the performance of reusable masks.
They will be reviewed on Wednesday by ASTM International and its Respiratory Risk Subcommittee, which includes representatives from academia, industry stakeholders, government agencies and independent participants. The review process is ongoing and these guidelines are subject to additional revisions and changes.
The proposed standards are intended to create “a level playing field for demonstrating product claims and to avoid general confusion regarding the effectiveness of barrier coverage”, according to an outline of the standards provided to CNN by ASTM International.
Some experts have called for mask guidance and regulation since the beginning of the pandemic, and ASTM guidelines can be a crucial first step. CNN spoke to experts who did not see the confidential draft in its entirety.
Assessing size and fit
Dr. Donald Milton, professor of environmental health at the University of Maryland who studies how viruses are transmitted, believes that these standards will fill an important regulatory gap. “You have all these fake masks coming. They are not very good, claiming to be N95 and are not. So having some benchmarks is a step in the right direction, ”he told CNN.
“This is desperately necessary because people have no guidance at the moment,” Linsey Marr, a professor of civil and environmental engineering at Virginia Tech with experience in aerial virus transmission, air quality and nanotechnology, told CNN.
If standards are adopted, each mask will come with a set of user instructions that describe the appropriate size, fit and cleaning protocol. The standards strictly prohibit the use of vents, valves or any other means that allow people to blow or breathe unfiltered air.
The draft guidelines would also require manufacturers to test their facial coatings at accredited laboratories to certify performance, register their products and use the labeling system outlined to use ASTM label designations.
Perhaps the most important change that ASTM is proposing is a labeling system. Consumers in stores could assess the quality of the masks on store shelves from the packaging label. If a mask bears the ASTM label, it can assure the customer that the product meets the test and quality requirements.
The labeling requirements of the written ASTM standard would indicate the results of two test criteria: breathability and filtration efficiency. Normally, when a mask has higher filtration, it results in more resistance and can make breathing difficult.
According to ASTM’s preliminary guidelines, a lower performance, level one designation would require the product to filter 20% of the particles – something that would make the mask easy to breathe, but would provide less protection. A level two certification would designate high-performance filtration of at least 50% of the particles, but would provide less breathability.
“The use of ‘levels’ defines a classification system designed to assist in understanding possible compensations for higher levels of filtration efficiency with resistance to airflow (breathing),” said Jonathan Szalajda, deputy director of the National Laboratory for Personal Protection Technology, to CNN in a statement.
Exchange of comfort for protection
Milton believes that information about breathability would be an important consideration for consumers with chronic lung or heart disease and other conditions that may require easier respirability in a mask.
“It gives people information to make decisions about what they want and what level of protection they feel they need,” Milton told CNN.
ASTM’s main test – whether a mask can filter particles measuring 0.3 microns. Why that size? It is difficult to stop, and if a mask can handle a particle of this size, it can stop the droplets most likely to carry viruses and bacteria.
Marr understands why the 20% and 50% protection benchmarks may seem low to the public, but believes that the actual performance against the virus can exceed 50%.
“This criterion is for a given particle of size that is actually the most difficult size to filter,” she told CNN. “It is very likely that the virus is mainly in particles larger than the critical size, the size of the test.”
But while experts are increasingly concerned about the increasing spread of more transmissible variants of the coronavirus, some believe that the draft guidelines for the mask need to require a higher level of protection to slow the spread and protect people.
“The first iteration may not be where you would like it to be, but it is a step in the right direction to have some levels of quality here,” Milton told CNN. “I would like to see a level three at the top end.”
“If you had asked me that in November of last year, I would have said it was okay,” Marr told CNN. “But now with the most transferable variants. I’m more concerned. I think it’s a higher level of certification … I would like to see another level of performance like 80%.”
Several European countries have already demanded that people use masks with a minimum filtration efficiency of 80-90% against 0.3 micron particles. Germany, Austria and France forced the public to use high filter masks in public transport, shopping or public areas.
While she hopes to add a higher level of protection to these guidelines, Marr believes that if passed, the standards will have an impact because consumers want and need guidance.
“I think that if these standards are eliminated, there will be a demand for the highest level of protection for which ASTM is willing to have a level,” she told CNN. “Manufacturers, I think, are going to step up and provide that.”
Currently, only medical-grade masks and respirators should meet the standards. This includes N95 masks, which are regulated by the Food and Drug Administration, National Institute of Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) for adjustment, filtering efficiency, flammability and other qualities.
There are exceptions to this proposed standard that reflect the current CDC guidelines, with warnings against the use of a mask by children under 2 years old and those with breathing problems or inability to remove the masks. This guideline does not approve masks for any use in a healthcare environment and is not intended for surgical masks and respirators previously evaluated.
President Biden’s administration emphasized the importance of wearing a mask since his first day in office, when he challenged Americans to wear a mask for 100 days to reduce the spread of the coronavirus. Efforts to improve the quality of the mask are also being made in Congress. In a letter published on Monday, several Democratic lawmakers urged President Biden to increase the supply and availability of higher quality masks and to encourage public education about which masks are most effective.
“While many Americans understand that wearing a mask can help prevent transmission of the disease, many do not realize that a high-quality mask can make the user much less likely to contract the disease, even if exposed to an infectious person,” Senators Bernie Sanders of Vermont and Brian Schatz of Hawaii, along with California representatives Adam Schiff and Ro Khanna wrote.
They urged President Biden to “consider invoking the Defense Production Act to increase the supply of superior quality masks, including N95 or other medical grade masks”.
Lawmakers also ask President Biden to instruct the US Centers for Disease Control and Prevention and the FDA to “provide the public with clear, actionable and specific information on how to discern which masks are most effective and where to obtain them. on how to use the existing options. “