Since the COVID-19 crisis began, NPPTL has been actively working to address the resulting needs and challenges to ensure that workers in healthcare, and other critical industries, have access to appropriate PPE.
The Coronavirus 2019 (COVID-19) pandemic has presented our nation and the world with remarkable challenges. While we work to respond and learn more about the virus, the pandemic has also thrust personal protective equipment (PPE) to the forefront, demonstrating the critical importance of PPE in keeping essential workers safe on the job.
Ensuring that PPE provides appropriate protection for workers is the purview of the National Personal Protective Technology Laboratory (NPPTL), part of the National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention. NPPTL prevents work-related injury, illness, and death by advancing the state of knowledge and application of personal protective technologies, the foundation for advancements in PPE.
NPPTL supports the more than 20 million U.S. workers who rely on PPE (such as respirators, clothing, gowns, gloves, eye protection and other types of protective gear) to keep them safe from on-the-job hazards. The laboratory is responsible for establishing the criteria and testing requirements for approving respiratory protective equipment for occupational use, including filtering facepiece respirators (FFRs) such as the widely used N95. FFRs are a key part of the PPE ensemble in many workplaces, particularly within healthcare settings.
Since the COVID-19 crisis began, NPPTL has been actively working to address the resulting needs and challenges to ensure that workers in healthcare, and other critical industries, have access to appropriate PPE. Specifically, NPPTL staff have been working to understand how best to support manufacturers to ramp up production and increase the number of respirators available to the workers who need them.
NPPTL Director Dr. Maryann D’Alessandro outlined the three main areas in the respirator approval activities that her team has been focused on during the COVID-19 outbreak:
- Supporting existing NIOSH respirator approval holders to increase their ongoing production;
- Quickly evaluating new domestic respirator applications for approval, prioritizing applications related to healthcare settings; and
- Providing up-to-date respirator and other PPE guidance.
In April 2020 alone, NIOSH more than tripled the number of respirator approval decisions, from 30 to more than 100 decisions. NPPTL staff scientists, engineers, and technicians worked longer shifts, seven days a week, to help increase the availability of respirators for the workers who need them.
“We appreciate the collaboration with ISEA and their member companies throughout the pandemic as we work together to develop creative solutions in our respirator approval processes to meet the COVID-19 response needs. It is a testament to government and industry working together to meet the needs of American workers and the general public,” said Dr. D’Alessandro.
While NPPTL recognized increasing access to respirators was crucial, it also had to balance the equally important requirement that all respirators meet rigorous standards for quality and protect the wearer. Consequently, NPPTL’s pandemic response work has not been limited to respirator approvals. As the COVID-19 response has evolved, the need for respirators has continued to outpace supply. CDC and NIOSH issued guidance to recommend the use of respirators conforming to international standards. Consistent with the CDC and NIOSH guidance, the FDA issued Emergency Use Authorizations (EUA) to significantly expand the inventory of respirators available for use in healthcare settings. This included several international EUAs permitting use of certain respirators from seven foreign countries approved under the standards in those countries.
Since NIOSH was given the responsibility to lead the respirator approval program in 1972, it has approved about 9,000 respirator designs. At any given time, there are typically more than 100 different manufacturers producing NIOSH-approved respirators with approximately 120 manufacturing sites located in 20 countries. NPPTL builds upon NIOSH’s extensive history in the field of respiratory protection, as well as the lessons learned during this unprecedented situation brought on by COVID-19, to look to the future.
NPPTL will concentrate on three areas as they focus on the future:
- Upgrades to test equipment,
- Improvements to the conformity assessment processes, and
- Broader implementation of the PPE Conformity Assessment framework.
Upgrades to testing equipment are needed to keep pace with state-of-the-art testing capabilities, including the implementation of robotics to serve as realistic human evaluation tools to support the approval process and alleviate the need for human subject testing. NIOSH also envisions increased involvement of third-party test laboratories. However, even with the use of third-party laboratories, NIOSH’s Respirator Approval Program must upgrade its facilities and equipment in order to serve as leader of the conformity assessment process, as well as to allow for standard test procedure development and to continue some level of in-house testing to maintain testing competency to review/audit labs where NIOSH’s standard test procedures are within their scope of accreditation.
Finally, NPPTL will work on the broader implementation of the PPE Conformity Assessment Framework. The National Framework for Personal Protective Equipment Conformity Assessment – Infrastructure provides a Framework to contribute to the development, structure, and conformity assessment of personal protective equipment used in American workplaces to ensure that when PPE is needed by the American workforce, workers can have confidence in the equipment they are relying on to keep them safe on the job