On June 2, 2020, SAC shared that Health Canada had recently issued an interim order for the importation and sale of clear masks in Canada from the US company Clearmask LLC. This order is a temporary measure during the COVID-19 pandemic and SAC continues to advocate for and support a Canadian-made solution.
SAC recently contacted with Health Canada’s Medical Devices Directorate to seek clarification on the level of protection provided by facemasks from Clearmask LLC. This was due to the following disclaimer about this mask on the manufacturer’s website:
“DUE TO THE COVID-19 PANDEMIC, THE CLEARMASK™ IS CURRENTLY AVAILABLE FOR USE IN HOSPITALS AND BY HEALTHCARE PROVIDERS WITHOUT OBJECTION FROM THE FDA. THE CLEARMASK™ IS A FACE MASK THAT MAY BE USED WHEN FDA-CLEARED MASKS ARE UNAVAILABLE. PER THE FDA, USE OF THESE MASKS IN A SURGICAL SETTING, OR WHERE SIGNIFICANT EXPOSURE TO LIQUID BODILY OR OTHER HAZARDOUS FLUIDS MAY BE EXPECTED, IS NOT RECOMMENDED.”
Since the Canadian government released recommendations that address the particular challenges faced by Canadians with disabilities during this pandemic, including individuals with hearing loss, SAC has learned that ‘the Medical Devices Directorate at Health Canada did review evidence in support of the Clearmask. It is a unique device intended to serve a distinct purpose. It does not fit into the more common categories of respirators or surgical masks. Regulators (US and Canada) have defined it as a face mask, because it cannot be tested against the standards for a surgical mask. Similarly, it is not a face shield as it does not cover your eyes. It is a barrier to liquids but does not provide complete protection because of its lack of eye protection. It does not offer the filtration protection of a surgical mask due the need to allow lip reading. It is intended to assist with communication in a non-infectious environment. It provides droplet protection, if combined with goggles for example.’
SAC continues to follow up with Health Canada regarding any updates to their recommendations.