HealthCanada released “Guidance Document for Mandatory Problem Reporting for Medical Devices” on October 3, 2011. Mandatory problem reporting is intended to “improve monitoring and reduce the recurrence of incidents related to medical devices.” A mandatory problem report is required for any incident involving a medical device when the incident “relates to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use (section 59(1)(a)); and has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so if it were to recur (section 59(1)(b)).” Note that the manufacturer and importer must both make a problem report.
The three basic reporting criteria for an incident (requiring a report to Health Canada) are:
- An incident occurred within the meaning of Section 59(1)
- The device contributed to the incident within the meaning of Section 59(1)(a)
- The incident led to an outcome covered by Section 59(1)(b):
- Death of a patient, user or other person
- Serious deterioration in health of a patient, user or other person (where serious deterioration in health means “a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage”)
The full guidance is at the link provided: 2011 HealthCanada Guidance Document for Mandatory Problem Reporting for Medical Devices.