Supply chain for personal protective equipment: Standing Committee on Government Operations and Estimates—June 9, 2020

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Key messages

If pressed on N95 respirators:

Quality assurance

Our main priority is making sure we get safe, effective equipment and supplies into the hands of front-line healthcare workers. Given the high level of complexity in the global supply chain due to extremely high demand, new suppliers entering the market, and multiple countries competing for the same items, ensuring quality of the product Public Services and Procurement Canada (PSPC) is purchasing is extremely important.

Quality assurance is happening at multiple points. First, manufacturers are required to certify that they are meeting specific standards and requirements. Second, new controls introduced by the Chinese government require additional oversight before products are cleared for export. And third, PSPC is working closely with the Public Health Agency of Canada and Health Canada on all purchases, to ensure they meet standards and requirements. Once products are delivered, the Public Health Agency of Canada unpacks and inspects items before they are distributed for use.

We have had challenges with respect to quality of goods for both N95 respirators and with test swabs. In both cases we took immediate action including suspending orders with certain manufacturers, and working closely with others to ensure that production issues are identified and corrected as soon as possible. PSPC, PHAC, and Health Canada are taking strong measures to ensure that defective product will not be distributed to frontline workers.

With regard to the N95 respirators that arrived with strap and air filtration issues, we took immediate action to suspend all orders from certain manufacturers, and are working to address quality issues through the supply chain.

On April 9, 2020 PSPC received 380,000 swabs that were not sterile. The company recalled the swabs from circulation and offered to pay any disposal costs. The company is replacing the non-sterile swabs at no additional charge to Canada. In the interim, given the ongoing need for swabs, Canada is sterilizing the non-sterile swabs at a cost of approximately $160,000.

Testing of material in Canada: Public Health Agency of Canada

PHAC is the lead with respect to testing material in Canada, and specific questions on this matter should be directed to PHAC officials.

Background on testing of respirators

Health Canada has contacted companies that may be importing or distributing certain respirators, including KN95 respirators that may not meet expected performance standards in Canada to request that they stop sale and relabel the products as face masks instead of respirators.

This follows the recent US Food and Drug Administration (FDA) communication regarding concerns that certain filtering face piece respirators from China may not provide consistent and adequate respiratory protection based on testing conducted by the National Institute for Occupational Safety and Health (NIOSH)— National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC).

Health Canada has asked importers and distributors that may have imported respirators that do not meet performance standards to notify their customers and relabel products to indicate that while these masks may not meet the standards required for frontline healthcare workers, they could be used as face masks in settings where a 95% filtration is not needed. The products are not being removed from the market.

This action does not implicate KN95 respirators purchased by the Government of Canada and tested by PHAC. Before allocating any personal protective equipment to the provinces or territories for frontline healthcare workers, PHAC conducts a quality verification. For KN95 respirators, this includes a visual inspection to check for defects in design and construction, and testing to confirm that they meet filtering specifications. KN95 respirators distributed to provinces and territories by PHAC meet the Government of Canada’s technical specifications for healthcare settings for COVID-19 response.

Health Canada is following up with companies that may have imported and distributed respirators that were tested by the CDC NPPTL and did not meet performance standards.

Health Canada will ensure that any companies that have distributed impacted products take appropriate action to stop selling any impacted products, notify customers and relabel existing stock as face masks instead of respirators. Should additional safety concerns be identified, Health Canada will take appropriate action and inform Canadians, as necessary.

Testing and quality assurance process

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