Canada Proposes to Require Acute Care Hospitals to Report Serious Device Incidents

New Canadian regulations would require certain healthcare providers to report serious medical device incidents to Health Canada.

The proposed amendment to the country’s Food & Drugs Act would require full incident reports to Health Canada from any hospital that provides acute care products.

Acute care institutions are most likely to have the infrastructure needed to comply with the reporting requirements, and their volume of patient transfers also makes it likely that they are able to capture medical device incidents that originated elsewhere, according to a consultation paper released by the agency. The proposal requires those hospitals to report on all medical device incidents in their control, including those with the potential to cause harm if they recur.