Requirements for Using Medical Devices

CPSA is responsible for overseeing Medical Device Reprocessing (MDR) in Alberta medical clinics that perform procedures using reusable medical devices. We also outline requirements for single-use medical devices.

Assessing the use of medical devices in Alberta clinics

When Albertans visit a medical clinic, they expect high-quality care in a safe space. CPSA helps medical clinics create these safe spaces for their teams and their patients through our requirements for using medical devices, which set out minimum expectations for medical device reprocessing (MDR) measures like cleaning, disinfecting and sterilizing reusable medical devices.

We also outline requirements and recommendations for single-use medical devices.

Read on to learn about CPSA’s requirements for using medical devices safely, see templates and resources for medical clinics, and find out what kind of MDR training clinic staff should have.

Additional guidance for clinics

These useful resources can help your clinic meet best practices on some elements not covered in our requirements. We recommend reviewing and sharing them with your clinic team regularly to stay up-to-date.

Qualifying sterilizers

This guidance describes the steps for installation and operational qualification of table-top sterilizers.

Cleaning reusable ear cleaning equipment

This resource shares valuable information about reprocessing tools used to clean ears. Consider this resource before you purchase ear cleaning equipment for your clinic.

Disinfecting devices that only touch the surface of the eye

CPSA is currently conducting research to find a long-term solution for MDR in ophthalmology offices. In the meantime, we strongly recommend clinics follow these guidelines from the American Academy of Ophthalmology and the Joint Commission, which emphasize the high-level disinfection of any devices that touch the surface of the eye.

Templates and resources for your clinic

 

Templates

To help you comply with CPSA’s MDR requirements, we have prepared templates you can use within your clinic. Please download the following files to see examples of how you can manage your clinic’s records.

MDR assessment flowchart

This flowchart outlines all the steps of an MDR assessment, from identifying if a clinic needs to be assessed, to surveying the clinic to learn what type of procedures they do, to the assessment and any other action CPSA might take. The complex flowchart includes lots of steps and reflects our detailed process to make sure Albertans receive safe care in their medical clinic.

Online MDR training

Every medical clinic needs an infection prevention and control lead, and if medical device reprocessing takes place, clinic staff need MDR education and training. We recommend either of the two courses below. These courses are not run by CPSA.

Reprocessing in community health care settings

These best practices will help you prevent the spread of infection. If you are responsible for medical device reprocessing in a community clinic, this Public Health Ontario course is for you.

In 9 modules (2-4 hours total), you’ll learn:

  • general concepts in reprocessing
  • information and skills for safely reprocessing reusable medical equipment/devices
  • information related to the importance of following best practices and the consequences of inadequate reprocessing
  • best practices in reprocessing

MDR in community healthcare settings

This online course from the Canadian Standards Association includes a variety of lessons, a document library, sample procedures and self-assessment quizzes. Choose from four optional modules categorized by area of expertise.

You’ll learn:

  • basic IPAC principles and semi-critical and critical medical device reprocessing
  • hands-on skills to increase the effectiveness of your reprocessing procedures
  • theory of decontamination
  • basic concepts of patient safety

Other online courses

Physicians and medical clinic staff can also take a free 30-minute module to understand their occupational health & safety (OHS) obligations under provincial legislation. Help ensure a safe working environment for you, your medical clinic staff and patients. CFPC Mainpro participants may claim Mainpro-M2 credits for this activity, while participants of the Royal College MOC Program may use this course as a stimulus to develop a personal learning project.

Subscribe to the IPAC mailing list

Subscribe to this CPSA mailing list to get the latest IPAC and MDR news, including updates to requirements, guidelines, policies and new resources.

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Information for Albertans

All medical clinics in Alberta must meet strict infection prevention and control requirements. CPSA routinely assesses clinics for medical device reprocessing. If you see a CPSA certificate in your community medical clinic, it means they’ve been assessed under our MDR requirments.

If you have a question or concern about how your clinic meets our MDR or IPAC requirements, reach out to us using the contact form below.

Questions or feedback? We'd love to hear from you.

Phone: 780-969-5004
Toll-free: 1-800-561-3899 ext. 5004 (in Canada)
Fax: 780-424-5859

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