Disposable Respirators: FDA Recommends Transition from Use of Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities

The FDA issued a Letter to Health Care Personnel and Facilities recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse.

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) currently available to facilitate this transition, the FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems.

The Letter to Health Care Personnel and Facilities includes important information about the supply of respirators and the use of authorized decontamination and bioburden reduction systems for respirator reuse, including:

• Details on the domestic supply of NIOSH-approved respirators
• Recommendations for health care personnel
• Actions that the FDA has taken to address respirator availability for health care personnel
• Updates on related information from other 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)