Emergency Use of Uncertified Respirators: Can the FDA Allow Use of Uncertified Respirators to Protect Workers?

and   |   March 30, 2020

Can the FDA allow uncertified respirators to be used to protect worker health and safety?

Check out the newest post on this issue: OSHA Releases Guidance in Alignment with FDA and CDC

On March 28, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to allow healthcare providers (HCPs) to re-use respirators disinfected according to an “authorized decontamination system“. This EUA also reinforces an earlier EUA, issued on March 24, 2020, that allows HCPs to use “approved” respirators that are not certified by the National Institute of Occupational Safety and Health (NIOSH), provided the users adhere to the recommendations of the Centers for Disease Control and Prevention (CDC). The FDA determined “imported disposable FFRs (filtering facepiece respirators) that are not NIOSH-approved are appropriate to protect the public health or safety” as other countries follow acceptance testing procedures for respirators that are similar to those used by NIOSH. A list of the “approved” testing procedures can be found in Table 1 of the March 28, 2020 EUA issued by the FDA.

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The March 28, 2020, EUA supplements an earlier EUA issued by the FDA that allows for HCPs to use other types of respirators, including reusable half-face elastomeric respirators typically used in industrial settings. This EUA also allows HCPs to use respirators that are beyond their expiration date and “permits NIOSH-approved FFRs to be distributed to healthcare workers and to others to mitigate further transmission of COVID-19” in response to the current shortage of N95 respirators. Again, the emphasis of these EUAs is to limit the spread of the virus that causes COVID-19 in order to protect public health.

Reusable Elastomeric Respirators: Proper Use by Healthcare Workers
 
In the United States, the Occupational Safety and Health Administration (OSHA) has the sole authority to regulate and govern worker health and safety in both private and federally run healthcare settings. FDA’s jurisdiction regarding the approval of respiratory protection is limited to patient safety and to matters of public health (for example, use of respirators to stop the spread of the SARS-CoV-2 virus). The FDA cannot specifically regulate worker health and safety in hospitals and healthcare facilities in the United States; that is OSHA’s responsibility. However, the FDA can require the use of respirators to stop the spread of disease in a pandemic or other national public health emergencies.

Update – Emergency Use of Uncertified Respirators: OSHA Releases Guidance in Alignment with FDA and CDC
 

OSHA Requires the Use of NIOSH-Certified Respirators

In response to the growing COVID-19 crisis, OSHA published a memorandum to its Regional Administrators and State Designees that temporarily relaxes some of the requirements of its respiratory protection standard. However, there are a number of provisions in that memo that must be followed, including the use of NIOSH-certified respirators by workers. The March 24th and 28th EUAs issued by the FDA and the memo prepared by OSHA are clearly in conflict with regard to the use of NIOSH-certified respirators. This conflict creates uncertainty for hospitals and healthcare employers. Do they purchase and use uncertified respirators and risk violating OSHA standards, or do they continue to source only NIOSH-certified respirators and risk running out of respiratory protection due to the ongoing shortage of PPE?

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Risk Assessment Provides a Solution to the Conflicting Requirements of Certified Respirators

The health, safety and welfare of HCPs is paramount. Hospitals and healthcare facilities must make decisions around the sourcing and use of respirators that protect HCPs. With this in mind, hospitals and healthcare companies should conduct a risk assessment to identify those personnel and/or activities that present the greatest risk of exposure to respiratory droplets, the principal mode by which the COVID-19 virus spreads to uninfected individuals. OSHA provides guidance on this matter in a recent publication (see page 18 of the publication). NIOSH-certified respirators should be reserved for those employees at highest risk. In fact, reusable, half-face elastomeric respirators with P100 filters may be desirable for HCPs that are at the highest risk of exposure given that those respirators afford a greater level of protection compared to N95s. Those workers that have a moderate or low risk of exposure may be provided with the FDA “approved” respirators that are not certified by NIOSH. This approach provides an appropriate balance between exposure risk and compliance while recognizing the very real implications for worker health faced by HCPs as they work to combat the COVID-19 crisis in the midst of a PPE shortage.

Reusable Elastomeric Respirators: Proper Use by Healthcare Workers
 
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