About medical device problems

A medical device is any instrument or component used to treat, diagnose or prevent a human disease or abnormal physical condition. In this context, medical devices used on animals are not included.

On this page

• Medical device problems
• Medical device incidents
• Types of medical devices
• Why it is important to report a medical device problem

Medical device problems

A medical device problem is related to:

• inadequate labelling or instructions for use
• a failure of the device or a deterioration in its effectiveness
• an actual or potential deficiency that may affect product performance or safety
• a serious deterioration in the patient's health (possibly related to a medical device)
• death, or has the potential to lead to death if the device is used again

Medical device incidents

An incident refers to medical device problems that take place in a hospital.

As of December 16, 2019, hospitals are required to report medical device incidents.

Types of medical devices

All medical devices pose some level of risk based on their use in diagnosis or treatment, or due to malfunction. In Canada, medical devices are grouped into 4 classes based on the expected level of risk to a person's health and safety. Devices are classified according to their level of risk, with Class I offering the lowest risk and Class IV offering the highest risk.

Medical devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and pacemakers. They also include in vitro diagnostic devices, such as cancer screening tests, blood glucose monitors and pregnancy test kits.

Why it is important to report a medical device problem

Reporting a medical device problem helps Health Canada:

• identify potential safety issues
• identify previously unrecognized rare or serious medical device problems
• add to international data on the benefits, risks or effectiveness of medical devices
• undertake regulatory actions, such as removing a product from the Canadian market
• communicate changes in product safety information to industry, hospitals, health care providers and consumers

Report a medical device problem

Related links

• Medical devices
• MedEffect Canada
• About adverse reactions
• Medical devices action plan
• Medical device incidents database
• Canadian Medical Devices Sentinel Network
• Mandatory reporting requirements for hospitals
• A Patient Guide for Reporting Side Effects from Health Products
• Adverse reaction reporting and health product safety information - guide for health professionals