Supply chain for personal protective equipment: Standing Committee on Government Operations and Estimates—June 9, 2020
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- We are working with established suppliers and distributors, as well as quality assurance experts, and we have strong processes in place to help ensure that the supplies we receive meet all necessary standards
- In addition, the Public Health Agency of Canada (PHAC) has robust testing measures in place, and they are in place for the very purpose of ensuring quality control of these essential products before they go out to provinces and territories
- We must make sure that the equipment that our frontline workers rely on is high quality, so they can stay safe, and keep us safe too
- We have encountered situations where supplies were found to be substandard, and we have acted quickly to address these issues, and to ensure that replacement supplies are rolled out where they were needed most
- These actions include suspending orders with certain manufacturers, and working closely with others to ensure that production issues are identified and corrected as soon as possible
If pressed on N95 respirators:
- our priority is making sure that we get safe, effective equipment and supplies into the hands of frontline healthcare workers as we face COVID-19, we are working with a range of suppliers and distributors, and we have strong processes in place to help ensure that the supplies we receive meet all necessary standards, in particular, PHAC conducts stringent testing of items such as respirators before they go out to provinces and territories
- there was one order where a significant portion of N95 respirators did not meet our standards for this respirators type, of the close to 11 million N95 respirators received and tested from this supplier, roughly 9.8 million have not met our contractual specifications
- further assessment of testing results is underway, but, in the meantime, we have suspended further shipments of N95 respirators from this supplier, we can confirm that none of these respirators that failed our standards were distributed by PHAC for medical use, however, assessment is ongoing for other uses, approximately 1.8 million respirators thus far have been redirected for use by other organizations
- Canada will continue to receive plane loads of personal protective equipment (PPE), as consistent deliveries are planned in the days and weeks ahead to meet both our short and long-term needs. The large majority of the products received have met PHAC standards for use
- while we continue to receive significant shipments of PPE from international manufacturers, we are also putting in place made-in-Canada solutions, we are receiving orders from domestic manufacturers for gowns, face shields and hand sanitizer among other products, this also includes a contract awarded to Medicom, based in Pointe-Claire, Quebec, for the production of 20 million N95 respirators and 24 million surgical masks per year for the next 10 years, starting this summer
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
- The Technical Assessment Committee, led by the PHAC, establishes the technical specifications for various types of COVID-19-related PPE, the technical specifications are established in consideration of, but not limited to, the following internationally recognized bodies
- World Health Organization Disease Commodity Package for COVID-19
- United States Centre for Disease Control and Prevention
- United States Food and Drug Administration
- The product specifications are published on PSPC Buy and Sell website
- PSPC and/or Innovation, Science and Economic Development Canada (ISED) identify legitimate vendors based on the technical specifications for COVID-19-related PPE
- Vendors with established and credible history of supplying standard PPE in Canada are referred to procurement immediately
- For new foreign and domestic suppliers, and vendors offering new products (that is, new design or manufactured with alternative fabrics or materials), PSPC and/or ISED requests specifications of the product the company is selling
- PSPC and ISED concurrently validate whether the supplier/vendor has the necessary regulatory authorizations, such as a medical device establishment licence (MDEL), as well as consulting with Global Affairs Canada (GAC) who is assisting in the due diligence review of suppliers/vendors sourcing from outside Canada
- When product specifications are received and pending positive results from the validation of regulatory authorizations, PSPC and/or ISED refers the new products to the Technical Assessment Committee for technical assessment
- PHAC triages the concurrent technical assessment of the new products to the Technical Assessment Committee, which is comprised of multi-disciplinary representatives from PHAC, Health Canada, ISED, and the National Research Council of Canada (NRC)
- Factors considered in the PPE technical assessments include
- clinical use: determined by the type of anticipated exposure, such as touch, splashes or sprays, or large volumes of blood or body fluids that might penetrate the PPE, and by the category of isolation precautions for the COVID-19 patient
- durability and ease of use: may include assessment of comfort, and resistance to tears and snags, visual inspection of a new product prototype or new materials may also be required to verify presence of defects in design and construction
- meeting safety and regulatory requirements: including a product review under the Medical Devices Regulations and a determination whether a Health Canada MDEL is in place or required
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