(Released 10 December 2015) To protect health care workers and other patient caregivers in an influenza pandemic or other public health emergency, the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR) will support development of a high-speed manufacturing line to produce N95 respirators. This type of equipment is used in health care settings to prevent the transmission of microorganisms through airborne particles.
Development of the high-speed manufacturing line will take place under a 14-month, $1.6 million contract between ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and Halyard Health, formerly Kimberly-Clark Health Care, of Alpharetta, Georgia. The contract can be extended for two years and $5 million.
“Pandemic preparedness in the United States is imperative to protecting health and saving lives, and respirator manufacturing capacity remains a critical gap in that preparedness,” BARDA Director Robin Robinson, Ph.D., said. “Innovations in manufacturing like this high-speed line can help bridge that gap and by applying innovative approaches to manufacturing day-to-day, we improve readiness.”
U.S. manufacturing companies currently can produce up to about 150,000 respirators per day on a single machine. However, an analysis by the Institute of Medicine conducted in 2006 estimated that during a pandemic, at least 90 million filtering face-piece respirators, such as N95 respirators, would be needed in a 42-day period to treat influenza patients safely in U.S. health care settings.
Through the new BARDA-supported project, Halyard Health will research and test manufacturing processes, core manufacturing components, and design a new manufacturing line capable of functioning at high speeds to allow for greater surge capacity and rapid availability during a pandemic. If successful, the technology could be available to replace outdated and slow machines with high-speed machines that can produce between one and two million N95 respirators in one day.
The company will research ways to improve speed and to increase the number of products that can be manufactured in a given amount of time. High-throughput manufacturing techniques used to produce other consumer health products, such as tissue paper and cling wrap, will be applied to manufacturing respirators in North America.
Dr. Robinson noted that by adopting innovations such as high-speed manufacturing capability and similar innovations, domestic manufacturers could increase the global competitiveness of public health products manufactured in North America.
BARDA is seeking additional proposals for advanced development of new drugs and products to diagnose, prevent, treat, and protect health against influenza viruses with pandemic potential. Proposals are accepted through the Broad Agency Announcement BAA-16-100-SOL-00002, available on fbo.gov.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
To learn more about ASPR and BARDA, as well as preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, phe.gov and the HHS emergency medical countermeasures website, medicalcountermeasures.gov. Information about pandemic influenza is available at flu.gov.