FDA MedWatch - Transition from Use of Non-NIOSH-Approved Respirators

Increased domestic supply of new NIOSH-approved respirators currently available facilitate this transition

MedWatch - The FDA Safety Information and Adverse Event Reporting Program Update: FDA Recommends Transition from Use of Non-NIOSH-Approved Respirators- Letter to Health Care Personnel and Facilities Today, the U.S. Food and Drug Administration (FDA) issued an updated Letter to Health Care Personnel and Facilities recommending that they transition away from crisis capacity conservation strategies, such as using non-NIOSH-approved disposable respirators, including imported respirators such as KN95s. This recommendation is in follow-up to the April 9, 2021, letter in which the FDA recommended a transition away from decontamination or bioburden-reduction systems for cleaning and disinfecting disposable respirators, which were being reused by health care personnel. Based on the increased domestic supply of new respirators approved by the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), the FDA believes health care personnel and facilities can transition away from using non-NIOSH-approved respirators and from utilizing decontamination and bioburden reduction systems. These crisis capacity conservation strategies have been used to address respirator shortages during the COVID-19 outbreak. The Letter to Health Care Personnel and Facilities includes important information about the supply of NIOSH-approved respirators, including: Information on the domestic supply of NIOSH-approved respirators Recommendations for health care personnel Actions the FDA has taken to address respirator availability for health care personnel Updates on related information from government partners such as CDC/NIOSH Instructions for reporting problems with a device to the FDA  Questions? If you have questions about respirators or decontamination systems, contact the Division of Industry and Consumer Education (DICE).

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