NIOSH Studying Condition of Stockpiled Respirators, Surgical Gowns

Federal, state, city, and medical partners of NIOSH are awaiting its findings about the stockpiled PPE. Researchers are in the second year of a three-year project.

PHILADELPHIA -- Millions of respirators and surgical gowns are in storage around the country, stockpiled for use during infectious disease epidemics such as avian flu or Ebola. But after years in storage, will those items still protect the wearers as they should? A NIOSH team is trying to answer this question through a three-year study at stockpiles around the country, with sample items from them sent back to a NIOSH lab in Morgantown, W.Va., for testing. Lee A. Greenawald, Ph.D., a physical scientist and project officer with the agency's National Personal Protective Technology Laboratory, provided a snapshot of the project, now in its second year, on May 23 during the AIHce EXP conference here.

The United States learned from the 2009 H1N1 pandemic that shortages in the PPE supply chain can occur, she said, so stockpiles were created to be ready for such widespread disease outbreaks. Now, some very large stockpiles exist -- one contains 40 million air-purifying respirators, she said -- and the organizations maintaining them want to know what the shelf life is for these products and how to reduce the economic burden of storing them. NIOSH was asked to assess shelf life, storage practices at the existing stockpiles, and cost reduction strategies.

Partners in the project include Johns Hopkins, the University of Pittsburgh Medical Center, the Mayo Clinic, FDA, the Veterans Administration, OSHA, the HHS Assistant Secretary for Preparedness and Response (ASPR), the city of Chicago, and several states. Eight existing stockpiles in six HHS regions, all on the East or West Coasts, have agreed to collaborate for the study. The study is examining lots of 68 respirators or 64 gowns, some of which have been in storage for less than five, 5-10, or more than 10 years.

Greenawald said 4,995 APRs, many of which exceed their manufacturer's recommended shelf life, will be tested, and 1,216 level 3 and level 4 gowns will be; no shelf life is designated for the gowns, she explained. Site visits assessed the storage conditions at these sites, and testing of respirators is assessing visual damage, inhalation and exhalation resistance, particulate filter efficiency, and other qualities. Testing of the gowns will begin in July 2018; they will be assessed for visual damage, water resistance, bloodborne pathogens penetration, and packaging integrity, she said.

The site visits found a range of conditions for the stored PPE at stockpile sites, with boxes of respirators shrink-wrapped and fully protected at one but not well wrapped at another, for example, and pallets of boxes exposed to sunlight from large skylights at one, photos in her presentation showed.

Data are still coming in, Greenawald said, but the testing done so far on air-purifying respirators found relatively few failures in particulate filter efficiency -- 2 failures in a lot of 320 respirators, 1 failure in a lot of 240, and 34 failures in a third lot of 480 -- and no failures for inhalation/exhalation resistance.

When the work is complete, NIOSH will publish a stockpile best practices document, "PPE case" reports, and new shelf life guidelines for stockpile application, she said, adding, "Our partners are so interested in this study and are waiting for our results."

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