Canadian Medical Devices Sentinel Network
The Canadian Medical Devices Sentinel Network (CMDSNet) is a pro-active surveillance program that encourages the reporting of medical device problem reports from all types of institutions. CMDSNet detailed reports obtained help to better characterize how organizations use devices, how problems are perceived, and which aspects of the system contribute to a particular event, potentially mitigating risk at an earlier stage. This program relies on a group of dedicated and trained professionals from acute or community based Canadian healthcare organizations that represents over 300 individual facilities to report high quality data to the regulator about adverse events associated with medical devices.
Adverse event reporting for medical devices consists of a combination of spontaneous reports from various sources and mandatory reporting by hospitals and manufacturers and importers of medical devices. CMDSNet provides a complementary data source for post market evaluations. More comprehensive incident data and earlier regulatory interventions also help to provide Canadians with timely new safety information to make informed decisions concerning the appropriate use of medical devices.
The CMDSNet program has led to:
- Access to early safety warnings and detection of potentials risks;
- Further development of quality/risk management approaches to medical devices safety;
- Improvement of manufacturing processes, licensing requirements and overall post-market product safety;
- A direct communication link between participating organizations and Health Canada;
- A sense of community among CMDSNet users, serving as an information- sharing forum;
- Increased awareness amongst front line users about the benefits of reporting incidents and knowledge of safe medical device usage.
In December 2018, Health Canada published its Action Plan on Medical Devices committing to do more to improve the safety and effectiveness of medical devices and to optimize health outcomes for patients. The Medical Devices Action Plan positively highlighted the contributions of CMDSNet program. As per the Action Plan, CMDSNet will expand the network to include additional facilities outside the hospital setting with a focus on long-term care facilities and private clinics in order to strengthen monitoring and follow-up of devices once they reach the Canadian market.
Only CMDSNet participating institutions report voluntary incidents occurring with medical devices within their organizations directly to the Marketed Health Products Directorate of Health Canada. Other voluntary reporting from non-participating facilities, consumers and health professional are encouraged to report device-related incidents directly to Health Canada by completing a Health Product Complaint Form via the Regulatory Operations and Enforcement Branch.
For additional information, contact the Canadian Medical Devices Sentinel Network.
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