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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.

Featured Guidance: Procuring a Table-top Steam Sterilizer

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.

Requirements for using medical devices

Requirements for using medical devices

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Requirements for using medical devices

Requirements for using medical devices

Proper medical device reprocessing (MDR) is critical to both patient and clinic staff safety. CPSA’s requirements for using medical devices cover MDR measures like decontamination, packaging, disinfection, sterilization and other important elements for both general devices and flexible endoscopes. Safe handling of single-use medical devices is also covered.

Our requirements are aligned with Canadian and Albertan standards–we frequently review them to make sure we meet MDR best practices.

Review CPSA's requirements for using medical devices in clinics
Perform a self-assessment of your medical clinic's MDR measures
How to comply with requirements for medical devices

How to comply with requirements for medical devices

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How to comply with requirements for medical devices

How to comply with requirements for medical devices

CPSA’s new requirements for using medical devices came into effect on Jan. 1, 2022. Additional guidance is available to help physicians and medical clinic teams understand and comply with the requirements.

This guidance acts as a companion to CPSA’s requirements for using medical devices, and includes tips and guidance for achieving and maintaining compliance.

Review our guidance for complying with the new requirements
IPAC Committee

IPAC Committee

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IPAC Committee

IPAC Committee

CPSA works with a multi-disciplinary team of provincial infection prevention and control (IPAC) experts and practising physicians to develop our IPAC and medical device requirements. They direct and advise us on preventing the transmission of infectious disease in medical clinics.

Learn more & get involved

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.

Procuring a table-top steam sterilizer

This guidance assists physicians and medical clinic staff in understanding what should be considered prior to purchasing a table-top steam sterilizer.

Download our guidance on procuring a table-top steam sterilizer to learn more

Building and using process challenge devices (PCD)

This guidance assists physicians and medical clinic staff in understanding how to build and use process challenge devices containing biological indicators to confirm the effective operation of table-top sterilizers.

Download our guidance on process challenge devices to learn more

Offsite reprocessing of medical devices

This guidance assists physicians and medical clinic staff in understanding general obligations related to offsite medical device reprocessing.

Download our guidance on offsite reprocessing of medical devices to learn more

This self-assessment tool assists clinics and offsite locations in confirming that medical device reprocessing requirements are being met.

Download our self-assessment tool for offsite reprocessing of medical devices to learn more

Qualifying sterilizers

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

Download our guidance on qualifying sterilizers to learn more

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.

Download our guideline on cleaning reusable ear equipment to learn more

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 refer to the following documents from the Alberta Heath Services, 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.

Download the Alberta Health Services Best Practice Recommendation
Download the American Academy of Ophthalmology Guideline
Download the Joint Commission Guideline

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. You have the option of downloading an Excel or PDF version of each template.

  • Endoscope reprocessing tracking log — (Excel) (PDF)
  • Minimum effective concentration log template — (Excel) (PDF)
  • Sterilization log template — (Excel) (PDF)
  • Sterilizer maintenance log template — (Excel) (PDF)
  • MDR staff training log template — (Excel) (PDF)
  • MDR staff competency assessment template — (Excel) (PDF)

Resources

Here are additional resources to support MDR in your medical clinic.

Additional MDR resources

All Resources

Alberta Health's MDR Standards

Alberta Health Click to view files

Canadian Standards Association Medical Device Reprocessing standard for purchase

Click to view files

Public Health Ontario's Best Practices for Cleaning, Disinfection and Sterilization in all Healthcare Settings

Public Health Ontario Click to view files

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 the courses below. These courses are not run by CPSA.

Sterilization Assistant Course

This course from University of Alberta Faculty of Medicine and Dentistry is a hybrid format (online and in-person) and includes a 4-day practicum placement in clinic settings. It aims to prepare individuals for a career in medical device reprocessing and infection prevention and control.

On your completion, you will be able to:

  • Apply basic infection prevention and control principles and practices to everyday practice.
  • Safely and effectively transport, disassembly, clean, disinfection, assembly, function testing, package and sterilization of medical devices in a community setting (dentistry, non-accredited medical clinics).
  • Perform quality assurance testing measures to ensure medical devices are safe to use.
  • Understand the minimum required documentation of reprocessing activities.
  • Understand the requirements for routine and preventative maintenance of all automated reprocessing equipment including basic troubleshooting.
Take the University of Alberta's course

Medical Device Reprocessing Techniques 

The Medical Device Reprocessing Association of Ontario (MDRAO) Medical Device Reprocessing Techniques online course provides information to support those working in the field of reprocessing. The course is self-paced, does not include a practicum component and must be completed in a 4-month timeframe.

This course supports those looking for an in-depth understanding of the principles of decontamination, assembly and sterilization and provide participants with a basis for critical decision-making when unusual incidents occur. The course materials rely heavily on the latest Canadian Standards Association (CSA) standards and regulations that guide Canadian health care.

Take the MDRAO's course

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
Take Public Health Ontario's course

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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