Health Canada is inviting stakeholder feedback on a draft guideline that explains how hospitals can comply with recent changes in the regulation that make it mandatory for them to report medical device incidents (MDIs) and serious adverse drug reactions (ADRs) to the government within 30 calendar days.
Currently, only device and drug companies are required to report MDIs and/or serious ADRs, whereas reporting by health-care institutions and consumers is voluntary. In June, the Canadian government changed the Medical Device and Food and Drugs regulations, making it mandatory for hospitals to report these incidents because, it said, a potentially significant number of MDIs and serious ADRs go unreported.
The government believes the collection and assessment of this real-world information will help Health Canada better monitor the safety of therapeutic products once they are on the market.
The new draft guideline clarifies that if an MDI or serious ADR incident is documented within the hospital, then the hospital is required to report it to Health Canada regardless of whether the incident originated outside of a hospital setting or whether the patient was admitted to hospital or not.
Specifically, reporting is mandatory in relation to MDIs and serious ADRs that are "in a hospital’s control." This means that hospitals would be required to submit incidents documented by health-care professionals within their facilities, but would not be required to further investigate the event with the institution where the MDI/serious ADR originated. They are, however, encouraged to follow up the matter with the concerned other health-care institution, e.g., a nursing home, to obtain the required information to submit a more complete report.
Health Canada initially proposed that the mandatory reporting requirement should only apply to hospitals that provided acute-care services. (Also see "Canada Proposes 30-Day Limit For Hospitals To Report Safety Incidents With Devices" - Medtech Insight, 30 Jun, 2017.) It has since broadened the scope of the regulations to capture incidents from potentially important facilities, such as chronic-care and extended-care hospitals and mental-health facilities, where treatment of such reactions/incidents may occur.
Comments on the draft guideline will be accepted through Aug. 29.
From the editors of Scrip Regulatory Affairs
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