Problems with medical devices may be severely under-reported.

The purposes of this study were to determine whether registered nurses are familiar with the Health Canada Medical Device Problem Report Form, and if so, how often they use it to report problems and concerns compared to how often they experience problems and concerns with medical devices. A survey was mailed to a random sample of 1,000 Ontario nurses to collect demographic information and to determine their familiarity with the aforementioned form, as well as the frequency with which they encounter problems/concerns with medical devices. Seventy-two and a half percent of the nurses reportedly have problems/concerns with medical devices at least yearly, yet 94.2% of them did not know that the Health Canada Medical Device Problem Report Form existed. Therefore, problems/concerns with medical devices encountered by registered nurses may be severely under-reported to Health Canada, contributing to an underestimate of the actual threat that devices pose to patient safety.