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.

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Medical device problems

A medical device problem is related to:

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:

Report a medical device problem

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