by Seshadri Ramkumar
On June 18, Gov. Gavin Newsom of California issued a statewide order that mandates face coverings in public places and areas where social distancing is not feasible. Although a brief description of face covers was provided in the mandate, performance specifics and standard requirements were not listed. In fact, no specifications or standards for these face covers have emerged since COVID-19, and California represents a typical scenario of the “new normal,” which emphasizes the need to rapidly modify and/or develop new standards and establish specifications for new products.
The need for new products
The COVID-19 pandemic has put a spotlight on multiple types of personal protective equipment (PPE), but with the current information, as well as emerging studies, the mode of transmission of the virus, remedies and countermeasures are not well understood. This means that the circumstances regarding new products and standards are dynamic.
PPE is critically needed because of the nature of the virus and its mode of transmission. Understanding this will enable the development of products that address specific needs. Among the modes of transmission, movement of the virus as moisture droplets seems to be the most widely accepted path. Another theory is that smaller virus particles of 0.3 microns or less can be airborne, which enables them to travel farther and persist in the atmosphere for longer.
The intensity of the transmission and the spread of the infection depends on the size of virus particles, the viral load and the mode of transmission. Particularly with the current COVID-19 situation, still more research is needed on the mode of transmission. These issues play an important part in understanding how to develop proper face masks, surgical gowns and other nonmedical countermeasures, which may require modification of the existing standards.
The need for standards
Requirements for defining specifications and standards rely on science, but also end-user expectations. Although filtration efficiency is the most important functional attribute of a face mask, based on feedback from end users like physicians, other aspects like breathability and comfort, fluid resistance and flame spread must be taken into account.
“Not only functional aspects are important,” says Dr. Manickavasagam Sundaram, Department of Medicine, Lakeridge Health, Oshawa, Ont., Canada. “Face masks’ use and acceptability depend on their comfort and fit. Therefore, while developing standards, the focus should be holistic and involve all components.”
Although there are established and globally accepted standards for filtering facepiece respirators (FFRs, commonly referred to as N95 masks), standards are yet to be developed for face covers and filter-enhanced covers known as FISORS. One-size-fits-all will not be much help, as these products are meant to cater to different scenarios. Although there is ongoing debate about the effectiveness of face covers in countering viral spread, masks are recognized as an important enhancement to social distancing.
New standards evolution
Standards normally evolve in order to deliver needed products that meet the quality requirements for a particular task. These are developed based on stringent user and safety expectations, as well as consensus among end users, product developers and standardization agencies. In the case of face masks, depending on the nature of the application—such as for medical or defense uses—specific requirements and standards may vary.
Different manufacturers evaluate the product against requirements in multiple laboratories to arrive at consistency so that universal standards and test methods can be developed. This process involves collaboration and cooperation among stakeholders.
As the need for and use of different types of face masks emerge, specifics concerning the materials, structure, performance and comfort attributes have to be determined. Arriving at specifics for face covers is more complicated, since so many diverse product developers and end users are involved.
“Standards are derived internationally after extensive scientific discussions and research,” says Dr. Prakash Vasudevan, director of the Coimbatore-based South India Textile Research Association. “It is important that they not only assure the user of the suitability of a product for the intended end use, but also facilitate creating an ecosystem that ensures its continuous availability.”
Standards for product development and testing evolve appropriately when they are based on peer-reviewed science, need and cooperation. Consider, for example, the recent changes made by the U.S. Occupational Safety and Health Administration (OSHA) to the Respiratory Protection Standard. In accordance with more than one scientific study, OSHA reduced the number of fit exercises that led to shorter test duration. Based on revisions, instrument makers are helping users adapt existing machines to conform to the new guidelines.
For example, modified ambient aerosol fit test methods have been updated in the TSI PortaCount tester to comply with the new standard. Cooperation among instrument makers and end users has reduced the compliance burden without comprising quality.
The necessity of standardization
Generally, a new standard or a modification to existing ones evolves based on the situation, need and new applications. We are witnessing this situation with the need for different types of face masks, such as face covers, FISORS and similar PPE. The need for a new standard must be justified, arising from new findings, societal response and urgency. Again, using face covers as an example, a recent study by a team of researchers led by Texas A&M has shown, based on data and projections, which face covers prevented more than 66,000 infections in a month’s time in New York City.
Professor Renyi Zhang of Texas A&M, co-author of the study, says the mandated use of face covers has helped with containing COVID-19 in China. While it is an established understanding that N95 masks offer the best possible protection against aerosol particles, the above study also emphasizes the importance of alternative face protection to counter the pandemic.
Professor Mario Molina, Nobel laureate and co-author of the study, is among those who have said that face masks help prevent the transmission of droplets and safeguard an uninfected person from inhaling the particles. This research underscores the importance of developing standards for face covers and FISORS quickly, based on scientific studies as well as on a consensus among stakeholders. This is need-based standardization, where speed of standardization and the determination of specifics both play important roles.
The importance of quality
Although COVID-19 has created a new normal, it does not mean quality requirements have to be compromised. Particularly in the case of health and environmental considerations, attention must be paid to the quality of the products.
Early in the COVID-19 pandemic, when N95 masks were in short supply, the end-user community looked seriously at different decontamination methods. But the idea of reusing masks and decontamination protocols needed buy-in by medical practitioners, government agencies and the public.
Even when there is a shortage of resources, there should be no compromise in quality and functionality. Quality control and management systems must be implemented at both manufacturing and end-user levels.
“First and foremost, basic requirements of PPE products are to maintain high quality standards to avoid any transmission of virus during usage. Unfortunately, it is observed in many cases that some of the new products are substandard,” says Dr. Anup Rakshit, executive director of the Mumbai-based Indian Technical Textile Association.
“Probably the manufacturers are not able to produce these products with consistent quality due to a lack of understanding of product standards, and appropriate quality management systems [QMS] are not in place in their manufacturing factories,” he adds. “It is therefore necessary that PPE coverall and mask manufacturers implement QMS systems as per ISO 13485/ISO 9001 and follow international guidelines to become a trusted supplier of medical textiles.”
A way forward
Developing standards is critical to meet the requirements of a particular application, safety needs and acceptability by the end-user community. As the need emerges, modifications to existing standards must be considered. In the present globalized economy, harmonized standards will be the way to go.
Seshadri Ramkumar, Ph.D., is a professor in the Nonwovens and Advanced Materials Laboratory, Texas Tech University.
SIDEBAR: Face mask fundamentals
According to the Centers for Disease Control (CDC), cloth face coverings should:
- • fit snugly against the side of the face
- • be secured with ties or ear loops
- • include multiple layers of fabric
- • allow for breathing without restriction
- • be able to be laundered and machine dried without damage or change to shape