Natural health products (NHPs) are attractive due to the public’s perception that they are natural and safe but there is wide variety of risks associated with these products. Post-market surveillance is the key to control hazards produced from NHPs. A set of activities are involved in post-market surveillance designed to assure the safety, efficacy and quality of products after being launched into the market. Although post-market surveillance is an efficient tool to preserve the safety of users from adverse reactions of NHPs but there are various challenges associated with performing post-market surveillance specifically for NHPs. This research project is focused on defining a framework for performing post-market surveillance for NHPs and on identifying best practices in its application. An international comparative analysis was undertaken to formulate best practices by reviewing existing frameworks for post-market surveillance of NHPs in Australia, Germany, New Zealand, United Kingdom and United States. Evidence-based best practices are compared with the Canadian post-market surveillance framework to identify key gaps in the Canadian system. Recommendations are provided for bridging each gap, and making the Canadian NHPs surveillance system, strong according to the international standards of best practices.

Natural health products (NHPs) are attractive due to the public’s perception that they are natural and safe but there is wide variety of risks associated with these products. Post-market surveillance is the key to control hazards produced from NHPs. A set of activities are involved in post-market surveillance designed to assure the safety, efficacy and quality of products after being launched into the market. Although post-market surveillance is an efficient tool to preserve the safety of users from adverse reactions of NHPs but there are various challenges associated with performing post-market surveillance specifically for NHPs. This research project is focused on defining a framework for performing post-market surveillance for NHPs and on identifying best practices in its application. An international comparative analysis was undertaken to formulate best practices by reviewing existing frameworks for post-market surveillance of NHPs in Australia, Germany, New Zealand, United Kingdom and United States. Evidence-based best practices are compared with the Canadian post-market surveillance framework to identify key gaps in the Canadian system. Recommendations are provided for bridging each gap, and making the Canadian NHPs surveillance system, strong according to the international standards of best practices.

Medical devices are used to diagnose, treat, or prevent a disease or abnormal physical condition without any chemical action in the body. They can also result in unintended incidents and other errors. This thesis was divided into three chapters: i) a systematic review on the recognition, reporting and resolution of incidents related to medical devices and other health technologies; ii) telephone interviews with physicians and registered nurses (RNs) to solicit information on the resolution, reporting and resolution of medical device-related incidents based on their professional experience; and iii) a case study to review the continuous quality improvement (CQI) data retrieved from the wireless smart infusion pump system at The Ottawa Hospital (TOH) and to propose a CQI data analysis process. The systematic review included 30 studies on factors that influence the recognition, reporting and resolution of incidents in hospitals and interventions to improve patient safety. Central themes that emerged for incident reporting were personal attitudes, awareness and perception of incident reporting systems, organizational culture, and feedback to healthcare professionals. In our telephone interviews, physicians and RNs attributed incident recognition to devices not operating based on the manufacturer’s instructions, and to the hospital staff’s knowledge of and professional experience with the use of the medical device, and clinical manifestations of patients. Suggestions to improve medical device safety surveillance centered on education and training to ensure that the staff is able to use the medical device properly and know what would be considered an error, and how to report these errors. The results of the systematic review and interviews helped to inform the design of a medical device surveillance framework in a hospital setting. Our case study assessed the Dose Error Reduction Software compliance and frequency of soft and hard limit alerts with wireless smart infusion pump systems over a one year period. A CQI data analysis process to monitor the performance of wireless smart infusion pumps is proposed. The findings of this doctoral thesis can contribute to the development of a medical device surveillance system that would help to improve health care delivery and patient safety in a health care institution.