Safe Use of Medical Devices – Health Canada Patient Guidance

Overview and Purpose

Health Canada’s Safe Medical Devices fact sheet provides essential information for patients and caregivers on using medical devices safely at home or in healthcare settings. It emphasizes that while medical devices are regulated for safety and effectiveness, patients play a key role in proper use and prompt reporting of problems to prevent harm. The guidance covers a wide range of devices, from simple bandages to complex implants and life-sustaining equipment. Safe Medical Devices – Fact Sheet - Canada.ca

Understanding Medical Devices

Medical devices include any instrument, apparatus, or machine used to diagnose, treat, mitigate, or prevent disease, injury, or disability. Examples include:

• Diagnostic tools (e.g., blood glucose monitors, thermometers).
• Therapeutic devices (e.g., hearing aids, insulin pumps).
• Surgical and implantable devices (e.g., pacemakers, hip replacements).
• Home-use items (e.g., wheelchairs, CPAP machines, contact lenses).

All devices sold in Canada must be licensed by Health Canada, with higher-risk devices undergoing more rigorous review.

Key Safety Principles

• Always read and follow the manufacturer’s instructions for use (IFU), including storage, cleaning, and maintenance.
• Use the device only for its intended purpose and as directed by your healthcare provider.
• Check for damage, expiry dates, or defects before use.
• No medical device is completely risk-free – even approved devices carry some level of risk.

Recognizing and Responding to Problems

Patients should watch for signs that a device may be causing issues:

• Unexpected pain, infection, or allergic reaction.
• Device malfunction, breakage, or failure to perform as expected.
• Worsening of the condition being treated.
• Unusual symptoms that may be linked to the device.

If a problem occurs:

• Stop using the device if safe to do so and seek medical attention.
• Keep the device and packaging for possible examination.
• Report the issue to Health Canada via the MedEffect Canada website or by calling 1-866-234-2345.

Reporting helps identify trends, triggers investigations, and can lead to recalls, label changes, or other safety actions.

Special Considerations

• For implanted devices: Carry your implant card and inform healthcare providers of the implant before procedures.
• For home-use devices: Ensure proper training from your healthcare provider; ask questions about cleaning, troubleshooting, and when to seek help.
• For children or vulnerable users: Extra supervision may be needed; caregivers should be fully informed.

Where to Find More Information

• Health Canada’s Medical Devices Active Licence Listing (MDALL) to verify licensing.
• Manufacturer’s website or customer support for specific instructions.
• Your healthcare provider for personalized advice.
• MedEffect Canada for reporting problems and reading safety alerts.

This patient-focused guidance promotes awareness, responsible use, and active participation in device safety, contributing to better health outcomes across Canada. Full details, reporting links, and additional resources are available on the Health Canada Safe Medical Devices fact sheet page. Safe Medical Devices – Fact Sheet - Canada.ca