Can a new medical clinic begin reprocessing before a medical device reprocessing assessment is completed?

Yes. New clinics, including clinics that have relocated, may begin reprocessing reusable medical devices before an on-site medical device reprocessing assessment. Clinics must perform installation and operation qualification of their sterilizer prior to reprocessing devices to be used on patients.

Clinics are responsible for maintaining compliance with all reusable and single-use medical device requirements, including:

• Reprocessing procedures
• Documentation and record keeping
• Staff training and competency assessment

Self-assessment and competency tools are available at cpsa.ca/mdr.