Risks associated with sourcing N95 respirators or acceptable equivalents during a supply shortage

July 23, 2020

What is the potential risk?

The COVID-19 pandemic has created a global supply shortage for N95 respirators approved by the U.S. National Institute for Occupational Safety and Health (NIOSH). NIOSH is the certification body that approves all N95 filtering facepiece respirators to a specific performance and quality standard, and NIOSH-approved respirators meet a standard acceptable to WorkSafeBC.

Given the supply shortages, employers may need to source acceptable equivalents to the N95 respirator. However, employers need to exercise extreme caution when purchasing alternatives to NIOSH-approved respirators or respirators marketed as NIOSH-approved. There have been reports of respirators that have turned out to be counterfeit, of inferior quality, or will not pass fit tests. These reports include respirators imported from other jurisdictions — such as some KN95s, which are manufactured in China and are a common substitute for the N95 respirator.

Employers who unknowingly provide substandard respirators to workers are not protecting them as intended and may be inadvertently exposing them to harmful airborne contaminants.

Which workers may be at risk?

Workers of any industry experiencing a shortage of NIOSH-approved respirators may be potentially affected by products that do not meet a standard acceptable to WorkSafeBC.

How can I reduce the risk in my workplace?

As an employer, you need to know if there is the potential for the risk identified in this advisory to be present in your workplace. It’s your responsibility to ensure that your safety procedures and practices control the risk.

Section 8.33(2) of the Occupational Health and Safety (OHS) Regulation states that only respirators meeting the requirements of a standard acceptable to WorkSafeBC may be used for protection against airborne contaminants in the workplace. OHS guideline G8.33(2)-1, Approved respirators identifies NIOSH certification requirements for respirators as a standard acceptable to WorkSafeBC. The guideline also lists particulate respirators from other jurisdictions that WorkSafeBC considers acceptable in certain situations, such as a supply shortage.

You should take the following information into consideration when purchasing respirators.

Counterfeits and misrepresentation

NIOSH publishes a list of known counterfeit products claiming to be NIOSH-approved respirators. It also provides useful advice on what to look for in a potential counterfeit respirator:

  • No markings at all on the filtering facepiece respirator (i.e., no NIOSH markings)
  • No TC (approval) number on filtering facepiece respirator or headband
  • “NIOSH” spelled incorrectly
  • Presence of decorative fabric or add-ons
  • Claims of approval for children
  • Filtering facepiece respirator has ear loops or one headband instead of two headbands

Be cautious about buying products sold through third-party marketplaces or from merchants that use free email account services (e.g., Hotmail, Gmail) to conduct business. When purchasing from a website, be sure to check the source and ownership of the site to ensure it’s legitimate.

It’s also important to be wary of counterfeits of alternatives to NIOSH-approved respirators, such as the KN95 (manufactured in China) and the FFP2 and FFP3 (manufactured in Europe).

Filter efficiency issues

There have been reports that some alternative respirators manufactured in other jurisdictions are not achieving the required filter efficiency of at least 95 percent.

For instance, NIOSH evaluated the filter efficiencies of certain brands of KN95 respirators and results indicated that many did not meet the filtration requirements (some had a filter efficiency as low as 20-50 percent). See Recalls and safety alerts from Health Canada for a list of respirators that have been recalled for not meeting the minimum 95 percent filtration efficiency.

Fit test issues

There have been issues with fitting workers to some alternative N95 respirators even when the respirators meet the filtration efficiency criteria of 95 percent.

NIOSH evaluations of some N95 alternatives have indicated that products that rely on ear loops or are folded in the middle vertically (like some KN95 respirators) may pose some difficulties in achieving a proper fit. Workers that require a N95 respirator equivalent will need to pass a fit test on the alternative respirator.

Quality issues

Counterfeit respirators are often poorly constructed and may show signs of physical damage to the straps or filter material in the original packaging, such as delamination of the filter material. Ensure the respirator has been well made (e.g., strap attachments are secure, material is good quality) and is in good condition before using it. Any respirator that is damaged must not be used and should be discarded.

Where can I find more information?