ABSTRACT
This chapter presents various aspects of medical systems safety. It covers medical systems safety-related facts and figures; medical device hardware and software safety and medical device safety versus reliability; types of medical device safety and essential safety-associated requirements for medical devices; safety in medical device life cycle; software-related issues in cardiac rhythm management products safety; medical device accident causes classifications and legal aspects of medical device safety; medical system safety analysis methods; problems; and references.
The methods covered are operating hazard analysis, fault tree analysis, and human error analysis. The chapter contains ten problems at the end of the chapter to test the reader’s comprehension in the area. Finally, it is added that the sources of most of the material presented in the chapter are given in its reference section. They will be useful to readers if they desire to delve more deeply into a specific area of interest.
