Since the start of the COVID-19 outbreak, frontline healthcare providers (HCPs) have consistently been forced to deal with dwindling, limited or non-existent PPE, especially N95 filtering facepiece respirators. Indeed, 66 percent of HCPs report that N95 respirators are still in short supply, according to a Washington Post-Ipsos poll.
But behind the scenes, another narrative is taking place: counterfeit respirators are flooding the market, increasing the risk of SARS-CoV-2 acquisition and transmission.
The saga reads as if it were taken from the pages of a crime thriller. It began in March with the discovery of a shipment of fake N95 respirators, sitting at Los Angeles International Airport. Subsequently, the National Institute for Occupational Safety and Health (NIOSH) voiced its concerns, issuing an alert on imported N95-style respirators that are being falsely marketed and sold as NIOSH-approved. Shortly thereafter, the Food and Drug Administration issued a letter highlighting numerous products failing to meet NIOSH’s 95 percent minimum particulate filtration efficiency.
At last count, more than 65 companies have been caught up in the enforcement sweep, and the numbers are increasing, according to The Washington Post. Filtering facepiece respirators and other fraudulent COVID-19 products have also caught the eye of the U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) unit, prompting the launch of ‘Operation Stolen Promise.’
How to tell if your N95 respirator is real
A number of news outlets report that as of early March, counterfeit N95 respirators had been circulated to numerous hospitals and clinics across the country. Even more troubling is that some remain in use by unsuspecting providers. That is why it is essential to know how to distinguish the real from the fake.
According to the latest guidance from The National Personal Protective Technology Laboratory (NPPTL):
- The biggest ‘tell’ is the use of ear loops vs. headbands. NIOSH-approved respirators have headbands, which provide a tighter fit and greater protection against COVID-19 air particles.
- All NIOSH-approved respirators carry an approval label on the packaging and/or within user instructions. If you don’t have access to the original box, check for an abbreviated approval sign on the respirator itself. Administrators can also check the veracity of the label on the NIOSH Certified Equipment List or the NIOSH Trusted-Source page.
- Counterfeit respirators commonly have no facepiece markings (including NIOSH), and/or approval (i.e. TC) numbers on either the facepiece or headband.
- “NIOSH” is often misspelled on counterfeit equipment.
- NIOSH-approved products do not contain decorative fabrics or add-ons, such as sequins.
- NIOSH products are never approved for use by children.
As long as the COVID-19 outbreak continues, it is safe to assume that counterfeits will continue to flood the marketplace. The bottom line? Err on the side of caution and practice due diligence.
- Mask shortage for most health-care workers extended into May, Post-Ipsos poll shows. Washington Post.
- Counterfeit masks Reaching Frontline Health Workers in U.S. Frontline.
- NIOSH Respiratory Protective Device Information. Centers for Disease Control and Prevention.
- Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection – Letter to Health Care Providers. U.S. Food & Drug Administration.
- NPPTL Respirator Assessments to Support the COVID-19 Response. Centers for Disease Control and Prevention.
- ‘No offense, but is this a joke?’ Inside the underground market for face masks. Washington Post.
- Operation Stolen Promise. An initiative targeting COVID-19 fraud. U.S. Department of Homeland Security.
- Counterfeit Respirators / Misrepresentation of NIOSH-Approval. Centers for Disease Control and Prevention.
- Certified Equipment List Search. The National Personal Protective Technology Laboratory (NPPTL).
- Respirator Trusted-Source Information. Centers for Disease Control and Prevention.
- Additional Tips for Spotting Counterfeit Respirators. Centers for Disease Control and Prevention.
- Coronavirus (COVID-19) Update: FDA Issues Second Emergency Use Authorization to Decontaminate N95 Respirators. U.S. Food & Drug Administration.
- Institution of a Novel Process for N95 Respirator Disinfection with VaporizedHydrogen Peroxide in the setting of the COVID-19 Pandemic at a Large Academic Medical Center. Journal of the American College of Surgeons.
- Decontamination Cycle for Decontaminating Compatible N95 Respirators. U.S. Food & Drug Administration.