Canadian Medical Devices Sentinel Network Pilot Project

The Canadian Medical Devices Sentinel Network (CMDSNet) pilot project relies on a group of dedicated and trained representatives from 10 acute or community based healthcare facilities within Canada to report high quality data to the regulator about adverse events associated with medical devices. Current adverse event reporting for medical devices relies on a system of spontaneous reports from various sources and mandatory reporting by manufacturers and importers of medical devices. CMDSNet will provide a complementary data source for post market evaluators. Having access to more information will enable them to identify emerging safety trends in the area of medical devices and improve the safe use of medical devices. More comprehensive incident data and earlier regulatory interventions will also help to provide Canadians with timely new safety information to make informed decisions concerning the appropriate use of medical devices.

Only CMDSNet participating institutions report incidents occurring with any medical device within their organizations directly to the Marketed Pharmaceutical and Medical Devices Bureau of Health Canada. The detailed reports obtained will help to better characterize how organizations use devices, how problems are perceived and reported and which aspects of the system contribute to a particular event, potentially mitigating risk at an earlier stage.

Expected project outcomes include:

• Further development of quality/risk management approaches to medical devices safety;
• Improvement of manufacturing processes, licensing requirements and post-market monitoring;
• Increased awareness by front line users about the benefits of reporting incidents and knowledge of safe medical device usage;
• Establishment of a communication link between organizations and Health Canada;
• Access to early warnings;
• Development of a sense of community among CMDSNet users, serving as an information sharing forum.

For additional information, contact the Canadian Medical Devices Sentinel Network.

Related Resources

• Adverse Reaction Reporting for Specific Products