Arts and Humanities Commons^™

Ethical Issues Associated With The Introduction Of New Surgical Devices, Or Just Because We Can, Doesn’T Mean We Should, Sue Ross, Magali Robert, Marie-Andrée Harvey, Scott Farrell, Jane Schulz, David Wilkie, Danny Lovatsis, Annette Epp, Bill Easton, Barry Mcmillan, Joyce Schachter, Chander Gupta, Charles Weijer

Charles Weijer

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate …