The coronavirus pandemic caused a sudden intense need for masks that led Americans to make t-shirts from T-shirts and bandanas. Hundreds of new and untested products have flooded the market with almost no supervision or regulation, leaving consumers in the Wild West masked with personal protective equipment.
That will change.
ASTM International, an international organization for technical standards, and the National Personal Protective Technology Laboratory, are working on standards to meet minimum requirements for design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for the fix barrier of face coverings. “
In other words, they hope they can help Americans tell which masks actually work.
The draft guidelines contain both disposable and reusable masks and contain specific requirements for evaluating the performance of reusable masks.
They will be reviewed on Wednesday by ASTM International and its subcommittee on respiratory hazards, which include representatives of the academy, industry stakeholders, government agencies and independent participants. The review process is ongoing, and these guidelines are subject to further review and change.
The proposed standards are intended to create a level playing field for the demonstration of product claims and to avoid the general confusion associated with the effectiveness of face covering ‘, according to a draft of the standards provided by ASTM International to CNN.
Some experts have called for mask guidance and regulation from the beginning of the pandemic, and the ASTM guidelines could be an important first step. CNN spoke to experts who did not see the confidential concept in its entirety.
Size and fit assessment
Dr. Donald Milton, a professor of environmental health at the University of Maryland who studies how viruses are transmitted, believes these standards could fill a huge gap in regulations. “There are all these shutdown masks coming in. They are not very good, claiming to be N95 and not. So it’s a step in the right direction to have some criteria,” he told CNN.
“This is vital because people currently have no guidance,” Linsey Marr, a professor of civil and environmental engineering at Virginia Tech with expertise in transmitting viruses in the air, air quality and nanotechnology, told CNN.
If the standards are accepted, each mask will contain a set of user instructions that describe the correct size, fit and cleaning protocol. The standards prohibit the use of openings, valves or any function that allows people to blow out or breathe unfiltered air.
The draft guidelines also require manufacturers to test their face coverings in accredited laboratories to certify performance, register their products and use the outlined labeling system to use the ASTM labeling instructions.
Perhaps the most important change that ASTM proposes is a labeling system. Consumers in stores would be able to evaluate the quality of masks on store shelves based on the labeling on the packaging. If a mask has ASTM labeling, it can assure the customer that the product meets the testing and quality requirements.
The established ASTM standard requirements for labeling indicate the results of two testing criteria: respiration and filtration efficiency. Usually, if a mask has a higher filter, it has more resistance and may be more difficult to breathe.
According to the ASTM draft guidelines, the level 1 designation of lower performance would require the product to filter 20% particles – something that makes the mask easy to breathe through, but which offers less protection. A level two certification indicates high-performance filtration of at least 50% particles, but will provide less respiration.
“The use of the ‘levels’ defines a classification system intended to understand potential compromises for higher levels of filtration efficiency with airflow resistance (breathing resistance),” Jonathan Szalajda, deputy director at the National Personal Protective Technology Laboratory, told CNN in a statement.
Trade facility for protection
Milton believes information on respiration is an important consideration for consumers with chronic lung or heart disease and other conditions that require easier breathing 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 most important test – whether a mask can filter 0.3 micron particles. Why this size? It is difficult to stop, and if a mask can handle a particle the size of it, it can stop droplets that are likely to carry viruses and bacteria.
Marr understands why 20% and 50% protection standards for the public may seem low, but believes that the actual performance against the virus can exceed 50%.
“The criteria is for a particular size particle that is really the hardest size to filter out,” she told CNN. “It is very likely that the virus is mostly in particles larger than the critical size, the test size.”
But while experts are increasingly concerned about the growing spread of more transmissible coronavirus variants, some believe the draft guidelines should require a higher level of protection to slow the spread and protect humans.
“The first iteration may not be where you want to be, but it’s a step in the right direction to have some quality levels here,” Milton told CNN. “I would like to see a level three on the higher side.”
“If you had asked me in November last year, I would have said it’s fine,” Marr told CNN. “But now, with the more transferable variants. I’m more concerned. I think it’s a higher level of certification … I would like to see another 80% performance level.”
Several European countries have already required people to wear masks with a minimum filter efficiency of 80-90% against 0.3 micron particles. Germany, Austria and France have instructed the public to wear high filter masks on public transport, shopping or in public areas.
While hoping for the addition of a higher level of protection added to these guidelines, Marr believes the standards will have an impact if approved, as consumers want and need guidance.
“I think if these standards do not exist, there will be a demand for the highest level of protection for which ASTM is willing to have a level,” she told CNN. “I think the manufacturers will act and provide it.”
Currently, only medical-grade masks and respirators must meet the standards. These include the N95 masks, which are regulated by the U.S. Food and Drug Administration, the National Institute of Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) for fit, filtration efficiency, flammability and other properties.
There are exceptions to this proposed standard that reflect current CDC guidelines, with warnings against the use of masks by children under 2 and those with respiratory problems or inability to remove masks. This guideline does not endorse masks for use in a healthcare setting and is not intended for previously evaluated surgical masks and respirators.
President Biden’s government stressed the importance of wearing a mask from his first day in office, when he challenged Americans to wear a mask for 100 days to reduce the spread of the coronavirus. Efforts are also being made to improve the quality of the mask. In a letter published Monday, several Democratic lawmakers called on President Biden to increase the supply and availability of higher-quality masks and to encourage the public about which masks are best.
“While many Americans understand that wearing a mask can help prevent the transmission of the disease, many people do not realize that a high quality mask can make it much less likely that the wearer will contract the disease. “Even if exposed to a contagious person.” Senators Bernie Sanders of Vermont and Brian Schatz of Hawaii, with California representatives Adam Schiff and Ro Khanna, wrote.
They urged President Biden to “consider with the Defense Production Act to increase the supply of higher quality masks, including N95 or other medical quality masks.”
Lawmakers are also asking President Biden to instruct the US Centers for Disease Control and Prevention and the FDA to “provide the public with clear, practical and specific information on how to determine which masks are most effective and where they can how to use existing options. “