Project 416987

Medical devices (i.e. pacemakers, joints, breast implants, birth control devices) are needed to extend and improve life. In Canada, the makers/distributors of new devices apply to Health Canada for a license to sell them. Health Canada makes that decision based on research provided by device makers/distributors showing that the new device is safe and effective. However, if research does not test devices on patients with different characteristics (i.e. women and men), they may not work properly in all patients, possibly leading to serious problems. The overall aim of this research is to partner with Health Canada to explore if they can improve the way they make and communicate decisions about licensing of devices by more openly considering whether device safety and effectiveness were tested for sex (women/men) or gender-related factors (i.e. age, education level, ethnic background, region of Canada, urban-/rural-dwelling). The objectives are to: (1) Visit web sites and speak with representatives of device licensing agencies in other countries (i.e. Australia, England, United States) to explore if they make/communicate licensing decisions based on whether devices are proven to be safe/effective for patients who differ by sex/gender-related factors; (2) Explore Health Canada decision-making processes to date by examining the content of licensing applications they received from makers/distributors, licensing decision documents, and instructions prepared for makers/distributors, patients or clinicians for a range of devices; and (3) Based on the results, prepare recommendations for Health Canada on information they should request of makers/distributors, and employ when they make, document and communicate decisions to makers/distributors, patients and clinicians. By adopting the recommendations, Health Canada can strengthen decision-making processes, leading to licensing of thoroughly tested devices, which are more likely to be safe and effective for all Canadians.