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Health Canada to make medical device adverse event reporting mandatory

27th June 2019

Health Canada released new guidelines that will make the reporting of medical device incidents by Canadian hospitals mandatory within 30 days once the regulations come into force. The action was taken to address medical device safety and regulation.

Under this new guideline, the hospitals must report about such incidents within 30days from the time, it was documented. All the details like hospital’s name and contact information; name or identifier of the medical device; date of the incident; device’s manufacturer; description of the incident; serial number of the device; medical condition of the patient who suffered the incident; and effect on the patient’s health must be reported.

Outpatients clinics will also follow the new regulations while private clinics and long-term care facilities are not subjected to the mandatory reporting. When the patient’s condition is the only cause of any incident, the hospital may opt out of reporting a medical device incident.

Incidents due to off-label use of medical devices should be reported. But device deficiencies cannot be reported as a medical device incident under this regulation.

Health Canada can take serious actions for non-compliance against the hospitals.

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