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CPSA’s updated Medical Device Reprocessing (MDR) standards take effect Jan. 1, 2022. Physicians and community medical clinic teams can review a summary of major changes to make sure they are in compliance with the updated standards in the new year.
“One thing I hear from medical clinics is how ‘familiar’ the updated standards appear to be,” says Jason MacDonald, Infection Prevention and Control (IPAC) Program Manager. “The standards continue to promote high expectations for cleaning, disinfecting and sterilizing reusable medical devices. Clinics have noticed clearer language and more specificity, which helps them meet our minimum standards.”
Some of the major changes taking effect Jan. 1 are:
- Additional standards have been added to clarify minimum steps to achieve medical device disinfection and sterilization.
- While clinics are currently required to develop and maintain policies, procedures and process logs, additional documentation will now be required effective Jan. 1, 2022. Clinic teams should review their existing MDR policies and procedures to determine what documentation might be missing.
- Clinics will be required to ensure in advance that all medical devices they trial or purchase have a medical device licence. Reprocessing equipment and medical devices that do not have valid Health Canada licensing must not be used in the medical clinic or on patients.
- Standards have been added for clinics that reprocess devices via thermal disinfection or pasteurization.
CPSA encourages physicians and medical clinic teams to review the summary of major changes to MDR standards to help them prepare. “If you work in a medical clinic, please make sure you’re taking the steps now to meet the updated MDR standards,” says MacDonald. “Proper reprocessing is essential to both patient and staff safety.”
Questions about the updated MDR standards? Contact the IPAC team.
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