Accidents involving medical devices are relatively rare in healthcare, as compared with other adverse events such as drug safety and falls. However, it is estimated that over a million cases of medical device accidents occur annually in the US. Further, according to the Medical Device Safety Monitoring Center of the Food and Drug Administration in Korea, the number of accidents involving medical devices is on the rise. 

  It is difficult to identify and classify the issues and challenges related to medical devices because a wide range of technologies are associated with medical devices, and because, typically, a medical device is operated, maintained, and used by different persons. This provides sufficient support for the need to concentrate efforts on improving safety management in this area. In other words, more attention should be invested on patient safety associated with medical devices, as well as on the potential harm that medical technology poses. Additionally, more robust safety measures, including benchmarking of the pharmaceutical safety information monitoring system, need to be implemented. Therefore, it is critical to identify the safety issues related to medical devices, to accordingly plan improvement measures. 

  Despite the importance of managing safety issues, clear identification of the issues related to medical devices is difficult. Indeed, collecting expert opinions on the matter offers a good starting point. In fact, safety issues vary because the range of devices includes something as small as a needle, as well as enormous examination equipment. Therefore, it is important to establish rational safety standards with the help of experts who handle such devices on a daily basis.