Addressing the safe, effective, and reliable reprocessing of reusable medical devices in Canada
Medical devices are used in nearly every health care procedure. If not properly reprocessed through complex processes that include cleaning, disinfecting, and sterilization (when required), medical devices can pose an infection risk to patients and health care professionals.
Increasingly, medical device reprocessing (MDR) is occurring not just in acute care hospitals but in dental offices, physician offices, and other community health care settings. Wherever MDR occurs, patients and health care professionals expect reprocessed medical devices to be functionally and microbiologically safe.
CAN/CSA Z314-18, Canadian Medical Device Reprocessing
In Canada, the safety of medical devices begins with the manufacturer and is supported and maintained by a system of national and international standards (e.g., CAN/CSA Z314-18, CAN/CSA-ISO 13485:16, CSA ISO 14971:21, CAN/CSA 60601 series) and government regulations (e.g., Food and Drugs Act).
CAN/CSA-Z314-18, a National Standard of Canada, is a comprehensive document aimed at addressing the requirements for safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow and is the core document in the CSA MDR portfolio. The Standard offers several benefits to managers and staff of any health care setting where MDR is performed, including:
- the use of one comprehensive document that streamlines and replaces nine previous standards;
- powerful search functionality to help health care professionals access the clauses and sections they need most;
- simplified guidance for setting up an MDR quality management system, including key performance indicators, policies and procedures planning, resources and operations, and other topics;
- covering personnel training, occupational health and safety, infection prevention and control, decontamination, sterilization, packaging, etc.; and
- new sections on pre-sterilization “prep and pack” processes and equipment maintenance.
Adoption of supporting standards from ISO/TC 198 for sterilization of health care products
CSA Group has also adopted several ISO/TC 198 standards that provide manufacturers and health care providers with specific requirements for cleaning, disinfection, sterilization processes, and aseptic processing. These include key standards such as:
- CSA Z11138-7:21, Sterilization of health care products – Biological indicators – Part 7: Guidance for the selection, use and interpretation of results; and
- CAN/CSA-ISO 11140-1:16, Sterilization of health care products — Chemical indicators — Part 1: General requirements and are meant to be used in conjunction with CAN/CSA Z314-18.
Role of CSA Technical Committee on Medical Device Reprocessing
The CSA Technical Committee on Medical Device Reprocessing is comprised of experts representing perspectives of industry, government, frontline workers, managers, and others. The Technical Committee members reach consensus on requirements covered by CAN/CSA Z314 and contribute Canadian content to standards developed by ISO/TC 198.
Related training and standards
CAN/CSA Z314 serves as the foundation for CSA Group’s comprehensive MDR training programs. The Standard is also referenced in Canadian legislation, accreditation, and policies and used by multiple professional associations.
The related standards and training are listed below:
- Certified Medical Device Reprocessing Technician (CMDRT) Personnel Certification
- Medical Device Reprocessing – A Comprehensive Review – Online Training
- Medical Device Reprocessing in Community Health Care Settings, (Core) – Online Training
- Medical Device Reprocessing in Community Health Care Settings and Dental Devices – Online Training
- Medical Device Reprocessing in Community Health Care Settings plus Endoscopes– Online Training
- Medical Device Reprocessing in Community Health Care Settings plus Foot Care – Online Training
- CAN/CSA-C22.2 No. 60601 series on Medical electrical equipment
- CAN/CSA-Z11135:15 (R2020), Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
- CAN/CSA-ISO 11137-2:16 (R2021), Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
- CAN/CSA -ISO/TS 11137-4:21, Sterilization of health care products – Radiation – Part 4: Guidance on process control
- CAN/CSA-ISO 11138-1:17, Sterilization of health care products — Biological indicators — Part 1: General requirements
- CSA Z11138-7:21, Sterilization of health care products – Biological indicators – Part 7: Guidance for the selection, use and interpretation of results
- CAN/CSA-ISO 11140-1:16 (R2021), Sterilization of health care products — Chemical indicators — Part 1: General requirements
- CAN/CSA-ISO 11607-1:21, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
- CSA-ISO 11607-2:21, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
- CSA -ISO 11737-2:21, Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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