Health Canada announced that, as part of its Interim Order (IO) authorization process, manufacturers of filtering facepiece respirators (FFRs) must certify their products for use in Canada through an accredited certification program within six months of receiving their authorization. This includes manufacturers that have already been granted an IO authorization. Certification needs to be done through an accredited certification program, such as CSA Group’s new medical PPE certification program.
The ongoing COVID-19 pandemic has resulted in shortages of medical Personal Protective Equipment (PPE) for frontline workers in hospitals and healthcare facilities. To provide a rapid response to market demands, even manufacturers with no history of producing medical PPE products are stepping up to address the need for more PPE equipment like FFRs.
“The rapid introduction of these new products and the diverse and, in some cases, atypical sources of their manufacture, expose a number challenges in the PPE supply chain, including testing and certification,” explained Dana Parmenter, Commercial VP, Industrial at CSA Group. “A certification mark gives purchasing departments and buyers a quick and easy way to identify that a product has been tested and certified to help meet the requirements necessary for the performance of that product.”
In accordance with Health Canada regulations, all medical respirators used in Canada must meet the minimum performance testing requirements. To complete the certification process, manufacturers will need to provide product samples (regular production units and not prototypes) for testing, including:
- Biocompatibility
- Particulate filtration
- Mechanical head strap strength
- Airflow resistance
- Fit
Accredited by the Standards Council of Canada (SCC), CSA Group’s new certification program includes a special-purpose laboratory dedicated to the testing and certification of medical PPE, including medical FFRs, to the specified particulate filter efficiency (PFE) level, as required by Health Canada’s IO. FFR manufacturers certified through the program will undergo initial and ongoing quality and conformity assessments that ensure that the FFRs continue to meet quality and testing requirements post-certification, including:
- Initial facility inspections
- Unannounced quarterly factory inspections
- Production line and conformity testing
- Periodic surveillance of marketed products
CSA Group is one of few labs in Canada authorized to both test and certify medical-grade PPE, including FFRs, surgical masks, and surgical gowns. “Our team has years of experience in a wide range of testing services and we’re looking forward to our state-of-the-art lab serving manufacturers to demonstrate they meet regulations and allow every aspect of their PPE product to be properly tested,” said Inga Hipsz, CSA Group Regional Vice President of Americas Operations.
