Clearing the Air: FDA vs. NIOSH

Right now, respiratory protection is getting a lot of attention in the news, at workplaces and from discussion in the general public as respirator use becomes the new norm. With so much coverage and importance placed on respirators, it’s crucial that the correct information is available to those who need a respirator for whatever application or reason they are being used.

The National Institute of Occupational Safety and Health (NIOSH) are the governing body for respirator testing and certification. The Occupational Safety and Health Administration (OSHA) determine the level of respiratory protection that is required for work environments and the appropriate NIOSH certified respirator is then used in that application. NIOSH certifies respirators based on their ability to filter out particulates, gases, and pathogens etc. Each respirator’s protection capability is determined when it is put up for NIOSH approval and this is where they receive their assigned protection factor (APF). Low level respiratory protection, such as an N95 respirator has an APF of 10, and this APF can reach greater than 1000 with a loose-fitting respirator. The greater the APF, the greater the protection.

The U.S Food and Drug Administration (FDA) approves surgical masks that are to be used by healthcare professionals during surgical procedures. Because NIOSH approved respirators are also used by industrial workers, these are not tested by the FDA, as OSHA requires NIOSH certification. Powered air purifying respirators (PAPRs) have now been recommended by the Centers for Disease Control and Prevention (CDC) as appropriate respiratory protection against the spread of pathogens in a pandemic. Again, these respirators are approved through NIOSH and are cleared to be used in healthcare settings. FDA approval is not a requirement in healthcare, but a recommendation. This has caused confusion as to what can and cannot be used in healthcare settings and this is where the myths about respirator usage is starting to form.

The CDC have one primary objective and that is to protect the public’s health and safety through the control and prevention of disease, injury, and disability. It is their job to have factual information that is going to help protect people’s lives, and so they have issued a list of trusted respirators, which includes all respirators with NIOSH approval that can be used in healthcare settings.

In summary, PAPR certification comes from NIOSH, not the FDA, and these respirators are approved for use in healthcare settings.