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

  |   April 8, 2020

OSHA recently provided some much-needed compliance relief for healthcare providers (HCPs).

On April 3, 2020, OSHA released two enforcement guidance memorandums to Regional Administrators and State Plan Designees regarding the emergency use of respirators that are not NIOSH-certified and respirators for which the use-by date has expired. This supplements earlier guidance that was the subject of the previous post on this topic.

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In general, OSHA has harmonized its compliance and enforcement activities with the recent directives provided by the FDA and guidance published by the CDC on the use of certain respirators during the COVID-19 crisis. This makes compliance with OSHA’s respiratory protection standard much easier for HCPs. They no longer need to navigate the conflicting requirements between OSHA, FDA and CDC while working to deliver patient care in a very challenging environment.

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OSHA Guidance on Re-Used and Expired Respirators

The first memorandum addresses the shortage of N95 respirators and permits:

  1. the extended use and reuse of respirators, and
  2. the use of respirators that are “expired”, meaning they are beyond their manufacturer’s recommended shelf life

This guidance, which applies to all industries including healthcare, includes some important stipulations the must be followed; including:

  1. Face seal checks (for example, positive and negative pressure checks) are performed every time the respirator is used.
  2. Wearers are properly fitted to the respirator; however, if a wearer has been fit tested to the same respirator previously, an annual fit test is not required, provided the provisions in OSHA’s March 14th compliance memorandum are followed.
  3. Respirators are checked for integrity and inspected to insure that all the components are in proper working order (for example, straps are not torn or frayed, nose bridge clip is in place and functional, no tears, rips or soiling of the face piece, etc.).
  4. Wearers of re-used respirators are provided training on how to wear and remove the respirator to prevent self-contamination.
  5. Expired respirators are not to be used for high risk procedures (such as bronchoscopy, intubation, etc.) if at all possible.

When using expired N95s, employers must:

  1. Make workers aware that they are expired.
  2. Insure that the expired respirators are segregated from the stock of unexpired respirators.
  3. Only allow NIOSH-certified respirators to be used.
  4. Seek guidance from the manufacturer on the use of expired respirators if they were issued from their own stockpile, and not the national stockpile.

 

OSHA Guidance on the Use of Respirators Not Certified by NIOSH

The second memorandum issued by OSHA on April 3rd supplied further guidance on the use of respirators not certified by NIOSH. OSHA recognizes, “that FFRs, air-purifying elastomeric respirators, and compatible filters certified under the following standards of other countries or jurisdictions will provide greater protection than surgical masks (that is facemasks, other than surgical N95s), homemade masks, or improvised mouth and nose covers, such as bandanas and scarves…”

In the memorandum, OSHA provides a list of acceptable standards from other countries, which mirrors the list provided by the FDA in their EUAs (see earlier blog post on this topic). If an employer allows its employees to use respirators that are not certified by NIOSH, they must, “make a good-faith effort to provide and ensure workers use the most appropriate respiratory protection available for the hazards against which workers need to be protected.”

OSHA Respirator Selection Hierarchy

OSHA stipulates a respirator selection hierarchy in its memorandum. Respirators should be selected and worn in the following order, from most desirable to least desirable:

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OSHA strongly cautions against the use of homemade masks or improvised mouth and nose covers and they should only serve as a last resort (such as when no respirators or facemasks are available and a patient requires immediate care).

The selection of the respirator should reflect the hazard presented by the activity. OSHA’s risk hierarchy is a useful framework for complying with the stipulations that allow for the use of respirators that are not NIOSH-certified or respirators that may be expired.

EH&E offers qualified, experienced professionals to perform the fit testing and training required to use these respirators including selecting an appropriate model, disinfection procedures and maintenance. Contact us today for help.

Notation

  1. https://www2a.cdc.gov/drds/cel/cel_form_code.asp