Certain respirators made in China and respirators with exhalation valves should not be decontaminated for re-use by healthcare workers, the FDA announced today.
The agency revised these respirators’ emergency use authorizations (EUAs) to reflect the changes. The particular respirators from China “may vary in their design and performance,” the FDA said, basing its decision on test results from the National Institute for Occupational Safety and Health (NIOSH).
The agency also revised the EUAs for certain decontamination systems so they are are no longer authorized to decontaminate non-NIOSH-approved respirators manufactured in China. These systems now may only decontaminate NIOSH-approved, non-cellulose respirators that do not have an exhalation valve as well as certain imported, non-NIOSH-approved respirators with exhalation valves.
Manufacturers with revised EUAs include Stryker, Duke, Advanced Sterilization Products, Sterilucent, Steris and Battelle. Steris’ revised EUA adds two more of the company’s systems to its original authorization. Battelle’s revised EUA also allows it to distribute decontaminated, compatible N95 respirators to a different healthcare facility than the one from which they were collected.
The U.S. Centers for Disease Control and Prevention recommends that decontaminated respirators should only be used when new, FDA-cleared N95 respirators, NIOSH-approved N95 respirators, or other FDA-authorized respirators are not available.
“During this unprecedented global pandemic, the FDA continues to provide flexibility and adapt to the evolving needs of Americans based on data and science. We are committed to carefully evaluating available information and will continue to take action when there is a need to do so to protect the public health,” said Dr. Anand Shah, FDA deputy commissioner for medical and scientific affairs. “While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected. As part of those efforts, we are announcing that we have revised and reissued a number of EUAs to amend which respirators are authorized to be decontaminated.”
Healthcare workers should not reuse a respirator that is incompatible with an authorized decontamination system, the agency advised.
This is the second major EUA change for non-NIOSH-approved respirators manufactured in China. On May 7, the FDA removed non-NIOSH-approved respirators made by 60 companies in China from its emergency use list for COVID-19 over concerns that they may be “sub-standard.”
The FDA issued its first respirator EUA list March 24, including masks made by companies in Europe, Australia, Brazil, Japan, Korea and Mexico. At the time, the agency declined to authorize respirators made in China for use by U.S. healthcare workers over concerns about fraudulent masks.
Pressure to ease the shortage of respirators led the agency to add Chinese-made masks to the list, even though they were not approved by NIOSH. The FDA issued the new, longer list April 7, and said on May 7 that it had been fielding questions and complaints about some of the respirators on that new list. After the April 7 authorization, NIOSH began working with the FDA to assess the filter efficiency for respirators certified by other countries’ authorities.