AMS fails to back up leaky claims of its KN95s being Health Canada approved

In early February, the AMS was widely lauded for purchasing 195,000 KN95 masks during the return to in-person classes. Despite numerous assurances by the AMS, an investigation by The Ubyssey has revealed concerns about the legitimacy of the claim that the masks are Health Canada approved.

Over the last few months, the AMS has repeatedly insisted that its KN95 masks are Health Canada approved, but the student society has been unable to provide documentation supporting this claim.

Health Canada publishes public databases listing all authorized masks and respirators. An exhaustive search by The Ubyssey was not able to locate authorization for the KN95 masks distributed by the student union.

The Ubyssey was not able to find the masks on Health Canada's list of authorized medical devices, expanded use or exceptional import and sale. They were also not found on Health Canada's KN95 recall list.

As part of the return to campus, the AMS advocated for UBC to provide KN95 or N95 masks to community members. Citing supply and quality concerns, the university instead purchased 1.2 million medical masks, which appear to meet the relevant standard set by ASTM International.

However, experts generally agree that even counterfeit KN95 masks are likely to provide better protection than surgical and cloth masks.

In February, Yi Cui, professor of materials engineering at Stanford University, told New York Magazine that counterfeit KN95s his lab tested had filtration efficiencies between 40 and 80 per cent, compared to 30 per cent for surgical masks and 10 per cent for cloth masks.

“The truth is … any mask that fits closely to the face is better than a mask that does [not],” added Dr. Steven Gordon, an infectious disease doctor at the Cleveland Clinic.

The AMS's KN95 masks are manufactured by Jiangsu Feituo Medical Instruments in China under the EZ Med X brand, a Pennsylvania-based medical supplier. EZ Med X told The Ubyssey it does not import directly into Canada and fulfilment of the AMS order was likely through one of its distributors. The AMS declined to name the distributor used.

Generally, respirators like the N95, KN95 and KF94 provide a higher level of protection from spreading COVID-19 than surgical and cloth masks. When worn properly, respirators are designed to filter at least 95 per cent of airborne particles.

Compared to other respirator standards, KN95 masks have been mired in quality control issues throughout the pandemic due to the absence of a formal regulator. Testing in the United States by the Centre for Disease Control (CDC) showed that approximately 60 per cent of KN95 masks did not meet the minimum filtration levels advertised. In response, Health Canada recalled hundreds of KN95 masks and strengthened its approval process to require independent lab reports and random spot testing.

Following the recall, Health Canada ordered manufacturers to relabel KN95s that do not meet the 95 per cent filtration requirement as non-medical masks. In contrast, masks that meet minimum standards can receive Health Canada authorization to be sold as medical respirators.

The AMS’s KN95 masks are labelled for non-medical use. Health Canada explicitly stated it has never approved any non-medical masks as medical devices.

Based on a physical inspection from three different batches, the KN95 masks distributed by the AMS do not appear to meet basic KN95 requirements such as listing the number and year of standard on the mask, which the CDC warns is a common indicator of counterfeit masks.

In a written statement, Eshana Bhangu, vice-president academic and university affairs and president-elect of the AMS, maintained the masks are “Health Canada certified and approved.”

“This effort is in addition to the advocacy my team and I have been doing to increase access to high quality masks and … lower the barriers to accessing rapid tests on campus,” Bhangu emphasized in her statement.

Despite claiming it had already examined Health Canada certification from the distributor, when The Ubyssey asked for this documentation, the AMS said the distributor was unresponsive in providing it.

Alternatively, masks can be approved if the manufacturer or distributor holds a medical device establishment licence from Health Canada. The Ubyssey was not able to locate a licence for the manufacturer and the AMS declined to share the name of its distributor.

This article has been updated to clarify that most experts agree even counterfeit KN95s are better than most other masks.