Dive Brief:

• Health Canada unveiled Wednesday new regulations that will require Canadian hospitals to report medical device incidents within 30 days once they come into force Dec. 16.
• The latest action by Canada builds on its Action Plan on Medical Devices, unveiled last year following in-depth reporting by the International Consortium of Investigative Journalists that called into question oversight of the device industry.
• In the U.S., hospitals are required to report suspected medical device-related deaths to FDA and the manufacturer. Serious injuries are required to be reported to the manufacturer, but FDA is directly notified by hospitals in cases when the hospital does not know the manufacturer. Malfunctions are not required to be reported by hospitals, but can be voluntarily disclosed, according to the FDA.                    

Dive Insight:

The move is the latest in a series of actions part of Canada's plan to address medical device safety and regulation, a priority of Minister of Health Ginette Petitpas Taylor.

Under the new regulations, from the time a medical device incident is first documented, the facility must report within 30 days: the name of the hospital and contact information for that hospital; the name or identifier of the medical device; the date the incident occurred, the manufacturer of the device; a description of the incident; the lot number or serial number of the device; the medical condition of the patient who experienced the incident; and the effect on the patient's health.

Outpatient clinics not physically located within a Canadian hospital will be subject to the new requirements, according to a guidance document. But private clinics and long-term care facilities are not subject to the mandatory reporting requirements.

"The rationale for limiting the scope of health care institutions to hospitals is that this is where the treatment of serious ADRs and MDIs is most likely to occur," the Canadian guidance document states.

Hospitals can elect to not submit a medical device incident report in cases when it can determine a patient's condition was the cause of an incident.

"To justify not submitting a report in this case, the hospital should have documented information available to conclude that the device performed as intended and did not cause, or contribute to, death or a serious deterioration in health," Health Canada's guidance document states.

Medical device incidents due to off-label use of medical devices, such as using a device indicated for adults in children, are also required to be reported under the new regulations. Device deficiencies identified by a user prior to patient use are not required to be reported because Canada does not consider such a case to be a medical device incident.

If a hospital has persistent non-compliance, Health Canada's Regulatory Operations and Enforcement Branch can take compliance and enforcement measures on a risk-based basis. If a situation is not resolved Health Canada may seek an injunction to compel hospitals to comply.