Frequently asked questions regarding the revised CSA Z314-18

HEALTH CANADA NOTICE:

Classification and Licensing of High-Level Disinfectants and Sterilants as Medical Devices  

In collaboration with Infection Prevention and Control Canada (IPAC), CAMDR has issued a comment on the Health Canada Notice: Classification and Licensing of High-Level Disinfectants and Sterilants as Medical Devices (March 16, 2018).


Notice: Classification and Licensing of High-Level Disinfectants and Sterilants as Medical Devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-classification-licensing-high-level-disinfectants-sterilants.html

CAN/CSA-Z314-18 – Canadian medical device reprocessing is now published and available on the CSA Store!  http://shop.csa.ca/en/canada/sterilization/cancsa-z314-18/invt/27043922018

For information only: The FDA (US) has announced the release of the voluntary standardized protocols for duodenoscope sample collection and culture and a date for a webinar to go over the new protocol. This is a US protocol that provides guidance. Please click on the link to view.  https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm598194.htm