Standardization News

The world has seen many new words enter the lexicon since the COVID-19 pandemic began, with terms that may have baffled us a year ago becoming part of our everyday language. We’ve learned that a “neck gaiter” has nothing to do with a large reptile, that “face shields” are no longer just an accessory for a football player’s helmet. And we’ve seen breathable “sports masks” proliferate in gyms and on basketball courts around the world.

This new and varied pandemic language has also created a certain amount of confusion. As more employers and societal institutions require some form of personal protective equipment (PPE) to be worn while engaging in everyday activities, the need for clear definitions — and further standardization — has emerged.

The Need

Jeffrey Stull is president of International Personnel Protection Inc. and a member of the committee on personal protective clothing and equipment (F23). To him, the current confusion with regard to what constitutes a “mask” and what function it fulfills has created something of a “Wild West” in the PPE field, with hundreds of vendors currently selling products that claim to provide some type of “source control” to protect the wearer. However, comparatively few of these products meet the committee’s definition of a true barrier face covering, defined as: “A product worn on the face, specifically covering at least the wearer’s nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate matter.”

READ MORE: Standards for Medical Face Masks and Protective Clothing

Stull says, “Many of these products may actually have very little if no filter material. And so in reality, there really isn’t anything going on in terms of performance for this intended function. So these are the reasons that we have referred to this as the ‘Wild West,’ because it is anybody and everybody going out, thinking that they have a product that is viable, and not always being due-diligent about it.”

Adding to the urgency for standardization is the new U.S. presidential administration’s focus on mask wearing as a way to slow the spread of the COVID-19 virus. The “National Strategy for the COVID-19 Response and Pandemic Preparedness” report, issued in the first days of the new administration, summarizes several new executive orders aimed at increased masking.

“The ‘Executive Order Protecting the Federal Workforce and Requiring Mask-Wearing,’ directs compliance with CDC (U.S. Centers for Disease Control and Protection) guidance on masking and physical distancing in federal buildings and on federal lands by federal employees and contractors,” reads the report, while the “Executive Order Promoting COVID-19 Safety in Domestic and International Travel,” “directs applicable agencies take immediate action to require mask-wearing on many airplanes, trains, and certain other forms of public transportation.”

Clearly, as masking ramps up and becomes mandatory in more areas of daily life, the need for agreed-upon standards grows. Enter the newly published specification for barrier face coverings (F3502), developed by the subcommittee on respiratory (F23.65). Stull calls this a “true specification” that revolves to a large degree around the critical concept of source control. The standard aims to fill a gap that exists for barrier face coverings that are neither a respirator nor a surgical mask.

Jon Szalajda is an F23 member and deputy director of the National Personal Protective Technology Laboratory with NIOSH (the U.S. National Institute for Occupational Safety and Health), which is part of the CDC. He says that the committee defines source control as “The use of a barrier face covering over the wearer’s nose and mouth as intended to contain the wearer’s respiratory secretions, including droplets and aerosols, to help prevent the transmission from infected individuals who may or may not have symptoms of a specific respiratory disease.” 

The new standard fills a gap for face coverings that are neither medical masks nor respirators.

The wide variety of products currently on the market have varying levels of quality and protection for the wearer and do not always provide protection to a degree that satisfies this definition. 

“We wanted a specification for the very important reason that in order for someone to claim that a product is meeting a specific function — source control — and perhaps providing a degree of respiratory protection, there have to be uniform methods for how those products are evaluated,” says Stull. “They have to meet certain design criteria and performance criteria and be classified according to their performance and appropriately labeled.”

In addition to labeling, which would provide consumers with information on testing for breathability and particle filtration efficiency levels, F3502 also includes a set of user instructions describing proper sizing, fit, and cleaning protocol. Performance criteria include the existing test method for sub-micron particulate filtration efficiency found in 42 CFR Part 84 (Subpart K).

The Bigger Picture

For standard development organizations (SDOs), the issue of PPE is more complex than a single standard, as important as that standard may be. Accordingly, ASTM International has outlined a larger scale, organizational effort to develop and advance PPE standards in the white paper, “Global Collaboration to Advance Personal Protective Equipment (PPE) Safety, Quality, and Innovation.” 

The white paper summarizes the state of PPE standards development and proposes a multi-faceted Global Collaboration Forum. The forum aims to unify PPE standardization efforts by leveraging the collective capabilities of the PPE industry and bringing together SDOs to collaborate in an environment that would act as a shared workspace.

The paper includes some of the biggest challenges identified by industry experts following a September 2020 virtual PPE workshop, “Fast-Tracking Standards Development to Address PPE Shortages Due to the COVID-19 Pandemic.” Jointly sponsored by the committees on medical and surgical materials and devices (F04) and F23, the workshop provided a forum for engineers, scientists, and medical professionals worldwide to exchange ideas. At the top of the list of challenges identified was the lack of standardization in the field. “While robust standards and requirements exist for many types of PPE,” the document notes, “There are major gaps related to some high-demand equipment.”

According to Jeff Grove, ASTM International’s vice president of global policy, cooperation, and communications, the goal of the forum is to address this need and move the standards work forward. “Our goal is to bring together stakeholders and establish formal partnerships and memorandums of understanding that advance R&D and the manufacturing of PPE,” he says. “We want to drive innovation in PPE by accelerating the use and adoption of advanced technologiues and new materials to enhance the manufacturing process.

The white paper also sums up the most important areas with standards gaps identified during the workshop – areas that ASTM and other SDOs can pursue to support PPE quality and availability: 

• Protective clothing and face shields,
• Respirators and face masks,
• Reprocessing and reuse of PPE,
• Conformity assessment, and
• Modeling and additive manufacturing.

The Global Collaboration Platform is ambitious, but the reward would be standardization that makes the world safer. Grove says, “We are promoting PPE product integrity and greater public awareness by developing a communications strategy and outreach to the global network of manufacturers, suppliers, testing laboratories, academia, standards organizations, and approval bodies.”

FOR YOU: Manufacturing Safe Vaccines

Additional Efforts

In addition to the new barrier face covering standard and ASTM’s organizational push to mobilize the world of PPE standards with a collaborative forum, other efforts are underway, particularly in the subcommittee on biological (F23.40). The subcommittee is considering a revision to the specification for performance of materials used in medical face masks (F2100), and others may be on the way. “In many ways, these efforts are complementary to the development of the barrier face covering specification,” says Stull.

With medical face masks seeing ever-increasing use in daily life, F23.40 saw a need to update aspects of F2100. “This work item [WK73330] seeks to better address full product performance related to medical face mask aspects such as ear loop and tie attachment strength, given the large influx of new manufacturers to this product area,” says Stull. Further improvements to the standard will be considered in the future to “align test methods, clarify sampling requirements, and potentially establish conformity assessment.” 

It’s clear that ASTM’s technical committees have fully mobilized to meet the challenges of PPE standards development, as has ASTM International at the organizational level. It’s equally clear that as PPE continues to become a more essential part of everyday life, new and revised standards will be needed, as will broader organizational efforts to bring together stakeholders, such as ASTM’s Global Collaboration Forum. 

If member and stakeholder enthusiasm is any indication, the determination is certainly there to meet these needs. “This particular topic has attracted incredible attention,” says Stull. “Our overall committee participation has resoundingly grown in recent months.” ■