Not only is the coronavirus difficult to contain, but so is the pandemic spread of counterfeit N95 respirator masks.
‘Real’ N95 masks carry an assurance they offer a defined standard of protection for health-care professionals, and anyone else who uses them properly. In the case of a counterfeit, who knows?
Ontario announced February 26 that a number of N95 respirators sent to health-care providers were counterfeit, and is now investigating how these items ended up in provincial inventories. Ontario’s situation is just one example of a worldwide phenomenon.
Washington state recently has gone through a similar situation, with 40 hospitals possibly supplied with fake N95s.
From the start of the pandemic to the end of the year, U.S. Customs and Border Protection seized more than 14.6 million counterfeit face masks entering the United States.
A mid-February release from the U.S. Department of Homeland Security said it had seized more than 11 million counterfeit 3M N95 respirator masks over the past few weeks. Globally, 3M said more than 30 million counterfeit respirators have been seized.
In Ontario, the counterfeit products emulated 3M markings and packaging. The government did not disclose the quantity of counterfeit items, nor their source. 3M Canada president Penny Wise told reporters they assisted Ontario in confirming that the N95 respirators “purchased from distributors with no relationship to 3M are not authentic 3M products.”
If provincial purchasing authorities can be misled about product authenticity, how can consumers expect to avoid being swindled? Health Canada offers a great deal of information about COVID-19 medical masks and respirators, but useful information for consumers can be difficult to find.
A search of the listing of authorized medical devices using the term N95 generates about 25 responses, but not any products from 3M. A separate page elaborates that Health Canada accepts the U.S. National Institute for Occupational Safety and Health (NIOSH) certification as an appropriate quality standard for N95 respirators. Health Canada restricts the use of the term respirator to the N95 products and classifies those products as medical masks.
Similar facial coverings that meet China’s KN95 standard may be approved for medical use in Canada if “the manufacturer can provide the evidence demonstrating testing to the appropriate standards.” Elsewhere there is a list of about 180 KN95 products which were subject to recall notices.
These products were allowed to stay on the market. Health Canada’s requirement was to have them relabelled as “face masks,” not “respirators,” unless proof of meeting the N95 standard from an authenticated testing facility was provided.
To help with authenticity, the Health Canada notices suggest consumers look for the NIOSH symbol and direct consumers to that site. The NIOSH site offers some guidelines to determine whether N95 respirators may be counterfeit, including:
- a lack of markings, including NIOSH markings, or NIOSH spelled incorrectly
- no approval number on the face piece or headband
- the presence of decorative fabric or add ons such as sequins
- claims that devices are approved for children (NIOSH does not approve any type of respiratory protection for children)
- the use of earloops instead of headbands. Earloops are generally less effective at providing protection.
Health Canada says it works with a number of agencies including the Competition Bureau and Canada Border Services Agency to protect against the import of fraudulent goods.
Ottawa-focused news service Blacklock’s Reporter reported a three-week audit last March uncovered fraudulent medical products in 1,724 of 2,984 shipments examined, worth more than $1.4 million. CBSA reported intercepting more than 8,000 unauthorized face masks shipped from China, Guatemala, Mexico, the Philippines and Vietnam. But CBSA agents can only inspect a small share of the shipping containers that enter Canada each year.
A 2019 Consumers Council of Canada report researched consumer attitudes towards counterfeit and pirated goods. That report found the focus on trademark and copyright issues has proven problematic and distracted or even disenfranchised many consumers from supporting protective measures.
“The Canadian anti-counterfeiting movement appears to be disinterested in expanding its focus beyond combatting trademark and copyright infringement on behalf of its rights holder members, and embracing a more holistic anti-fraud approach that puts primary focus on the health, safety and economic well-being of its members’ customers and all consumers,” the report said.