Spotting the Fakes: Protecting Your Workers From Counterfeit Respirators

Counterfeit Respirators

More than 9,000 health care workers across the U.S. have contracted COVID-19, with nearly 30 succumbing to the illness according to a recent report released from the U.S. Centers for Disease Control and Prevention (CDC). These numbers are reinforcing concerns of many health care officials that infection rates of workers at the front line of the crisis are growing, largely since many are left to treat patients without appropriate protective equipment.

And health care advocates in Europe are raising similar warnings. In a recent interview with BBC News, the International Council of Nurses (ICN) expressed concerns over the sharp increase in COVID-19 infections amongst nurses and other front-line health care workers. Infection rates for health care workers were reaching 10% in some countries, endangering their lives and increasing absenteeism that was placing additional strain on already overtaxed health care systems.  Unsurprisingly, the tenuous supply of personal protective equipment (PPE) was identified as one of the key factors contributing to this concerning trend in infections.

This urgent need for personal protective equipment, and particularly masks and respirators, has contributed to the emergence of a growing market of counterfeit equipment entering the supply chain. Hospitals and governments desperate to find essential equipment for front-line health care workers are running into issues with product entering workplaces that will not provide the protection required.

While many leading manufacturers have issued warnings of counterfeit products entering the supply chain, the rise in these goods is pushing the onus on employers to not only perform adequate vetting of new suppliers, but also to inspect equipment once received to ensure it is legitimate before dispensing it to the front line.

Fortunately, the CDC has provided guidance to employers to help them identify potentially fraudulent protective devices, ensuring that businesses are not spending their limited resources on phony products, but most importantly, that health care workers are receiving the proper protective gear they need to reduce their risk of infection during the COVID-19 pandemic.

We’ve summarized some key things to watch out for when receiving new respirators and face masks so you can determine what’s legitimate and easily spot the fakes. 

7 Signs Your Respirator May be Counterfeit 

1. Spelling errors

A dead giveaway that a respirator may be counterfeit is if markings on the product or its packaging contain spelling errors (i.e. showing “NISH” instead of “NIOSH”).

2. Unapproved supplier: no approval (TC) number

All suppliers wishing to provide respirators into the US marketplace must have their products approved by NIOSH.  When a respiratory product is approved by NIOSH, it receives a unique TC (approval) number.  Employers should always check that the desired brand of respirator is listed in the NIOSH List of Manufacturers before purchasing.

3. False or misused approval numbers

While each NIOSH-approved respirator will be issued a unique TC number, unscrupulous vendors will often print the approval numbers of other respirators on their product to trick uninformed consumers.  Again, if you have doubts, always check that the TC number display on the desired product is correct. Counterfeiters will often also create false approval numbers to make a product look legitimate.

4. Incorrect, false or missing labels and markings

NIOSH-approved respirators must display appropriate labels, markings and logos on the face of the product, in accordance with NIOSH guidelines. The absence of any of these markings is a sign that the respirator is suspect.  Similarly, false markings are a clear indication of a fake.

Source:  U.S. CDC. 2020.  Example of the Correct Exterior Markings on a NIOSH-Approved Filtering Facepiece Respirator

Source: U.S. CDC. 2020: Example of the Correct Exterior Markings on a NIOSH-Approved Filtering Facepiece Respirator.

5. Unapproved products like respiratory protection for children

Recently, some manufacturers have been marketing specialty respirators, such as those specifically designed for children.  Bear in mind that NIOSH does not certify respiratory protection for kids – a clear red flag.

6. Incorrect design

Watch out for respirators that are designed differently from what you are used to.  Most N95 respirators are designed with 2 elastic straps: one to fit around the back of the neck, and the other over the crown of the head. The respirator also has a malleable metal insert that can be molded over the bridge of the nose. These components are essential to create a tight seal to the face.  N95 respirators designed with ear hooks are an indication that something is likely wrong.  While surgical masks are often manufactured with ear hooks, N95s are not.

7. Questionable performance data

There have been examples of respirators being marketed with protective qualities that do not align with known performance limitations of the product.  For example, some “suspect” N95 respirators have been marketed to be “96% efficient”.  This is a clear indication that the counterfeiter has a very poor understanding of the product and how it works.  N95 respirators carry that designation since they are designed and laboratory-tested to filter at least 95% of very small (0.3 micron) respirable particles from the air stream inhaled through the mask.  A product that espouses to provide more protection should be scrutinized heavily.

RELATED: COVID-19 Health Screening Assessment Toolset 

It’s relevant to note, however, that OSHA has indicated recently that employers unable to secure NIOSH-approved respirators are able to use filtering facepiece respirators (FFRs), air-purifying elastomeric respirators and compatible filters certified under standards from the jurisdictions listed below:

  • Australia:  AS/NZS 1716:2012
  • Brazil:  ABNT/NBR 13694:1996; ABNT/NBR 13697:1996; and ABNT/NBR 13698:2011
  • People’s Republic of China:  GB 2626-2006; and GB 2626-2019
  • European Union:  EN 140-1999; EN 143-2000; and EN 149-2001
  • Japan:  JMHLW-2000
  • Republic of Korea:  KMOEL-2014-46; and KMOEL-2017-64
  • Mexico:  NOM-116-2009

Again, organizations intending to purchase any products from international sources should validate that those products are manufactured in accordance to their governing standards.

Respirator Fit Testing: If it Doesn’t Fit, You Must Restrict (Its Use)

A respirator is only truly effective at protecting the wearer from inhalation hazards when it is properly fitted.  While employers are working feverishly to ensure that suitable personal protective equipment (PPE) is available, they must remember that respirators need to be properly fit-tested to ensure a proper seal is established on the user’s face.  OSHA Standard 1910.134, Appendix A sets out the approved protocols that employers must follow when conducting a qualitative or quantitative respirator fit test for their employees.

With respirators in short supply, employers are advised to adopt qualitative fit testing protocols to enable them to extend the useful life of the respirator.  While quantitative fit testing requires a hole to be punched into the respirator, moving toward a non-destructive qualitative testing method is preferable, especially when inventories are low, and supplies may need be tightly controlled. 

But employers should be asking themselves whether their existing processes are adequate to help them manage the potential backlog of respirator fit testing that may be necessary when ordering a high volume of new products for the workplace.  Investing in a respirator fit testing solution can help streamline the fit testing process by integrating workflows, so that when a product change is made, the solution will automatically reschedule affected workers for testing, send out notifications by email or SMS text message to those workers so they don’t forget, and will reduce the time spent by staff to manually enter the testing results, not to mention reducing the risk of errors that manual data entry tasks can cause.  These solutions will optimize your fit testing program, ensuring workers are properly protected, so they can do their jobs with minimal risk to their health.

Looking ahead

While new data appears to show promising signs that social distancing may be slowing the rate of COVID-19 infections, we need to acknowledge that we still have a very long road ahead of us.  And ensuring your workforce has reliable access to good quality personal protective gear is just one step we must take to help reduce the risks of infection. 

Recommended COVID-19 Resources

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