FDA guidance restricts use of KN95 respirators, May 11

Oregon announcement by state health and safety officials follows federal restriction – SALEM, Ore.– Following a federal decision to restrict the use of KN95-style respirators for medical use in the United States, Oregon health and safety officials advise medical professionals to stop using KN95 respirators, in accordance with the Food and Drug Administration (FDA) guidance. Under an Emergency Use Authorization, the FDA previously allowed the use of KN95s for U.S. health care workers in the fight against the COVID-19 pandemic. On Thursday, the FDA revoked that authorization for more than 65 of the 80 authorized manufacturers, citing poor quality. The FDA guidance can be found here. The Oregon Health Authority (OHA) and Oregon’s Occupational Safety and Health Administration (OSHA) want to inform Oregonians this guidance applies only to the use of KN95 respirators. The FDA announcement does not impact other personal protective equipment, including N95 masks, which are safe to use.  The state who received KN95 respirators from the state stockpile and warned them that these are not for use as respirators. State officials also contacted counties, Tribes, and other recipient partners about the new restriction. KN95s can continue to be used as face coverings (similarly to the use of cloth, paper and disposable face coverings), but KN95s should not be used as respirators for health care professionals.  “In health care settings, personnel are sometimes required to use respirators for protection,” said Michael Wood, administrator for Oregon OSHA. “In such cases, medical personnel should only use KN95 respirators that are on the FDA’s approved list.”