Notice for Hospitals: Mandatory Reporting Requirement during the COVID-19 Pandemic
COVID-19 is a rapidly evolving global issue. The Government of Canada will do everything necessary to protect the health, safety, and wellbeing of Canadians, and is working around the clock to limit the spread of this pandemic. Our top priority remains the safety and security of all Canadians. Health Canada has been working closely with the Public Health Agency of Canada, which is leading the public health response and pandemic planning, as well as with provincial, territorial and international partners to respond to this evolving situation.
Health Canada appreciates the critical role health professionals in Canada play in identifying, reporting and managing potential cases of COVID-19 and recognizes the pressures a surge in people requiring medical care can cause on facilities.
In light of the current situation, Health Canada is clarifying expectations regarding the requirement for hospitals to report medical device incidents (MDIs) and serious adverse drug reactions (ADRs) during the COVID-19 pandemic.
Hospitals represent an important source of reports related to health products used in the management or treatment of COVID-19, among others, that can help inform public health decisions as this pandemic evolves. During the COVID-19 pandemic, the Department will continue to use the existing Canada Vigilance as well as medical device incident databases to monitor and analyze adverse events to health products. Subsets of these databases are available online for adverse reactions and medical device incidents.
During the COVID-19 pandemic, reporting expectations and timelines will not change for some high priority products or those that may be used in a pandemic. These include antivirals, vaccines, medicines for outbreak symptom management, medical devices related to the diagnosis and management of patients with COVID-19, blood and blood components, cells, tissues and organs (CTOs) and drug identification number-assigned (DIN) manufactured blood products. Furthermore, reports with death as an outcome should also be treated as priority.
If a patient has been identified as having COVID-19, this should be indicated in section B field 9 of the Medical Device Problem Report Form for Health Care Professionals or section B field 6 of the Serious Adverse Drug Reaction Reporting Form for Hospitals. These reports should be identified as priority and submitted in timeframes in accordance with the Food and Drug Regulations and Medical Device Regulations.
For all other reports, regulatory reporting of MDIs and serious ADRs should be maintained to the maximum extent possible. However, due to pandemic-related employee and personnel shortages, Health Canada accepts if the submission of MDI and serious ADR reports to Health Canada does not occur within the timeframes stipulated under the Food and Drug Regulations and Medical Devices Regulations, provided that any delayed submissions are sent as soon as feasible. Hospitals should maintain records to identify what has been delayed.
Please do not hesitate to contact the Canada Vigilance Program if you require further information.
Canada Vigilance Program
Marketed Health Products Directorate
Telephone: 1 (866) 234-2345
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