Medical device error.
This article discusses principal concepts for the analysis, classification, and reporting of problems involving medical device technology. We define a medical device in regulatory terminology and define and discuss concepts and terminology used to distinguish the causes and sources of medical device problems. Database classification systems for medical device failure tracking are presented, as are sources of information on medical device failures. The importance of near-accident reporting is discussed to alert users that reported medical device errors are typically limited to those that have caused an injury or death. This can represent only a fraction of the true number of device problems. This article concludes with a summary of the most frequently reported medical device failures by technology type, clinical application, and clinical setting.
Goodman
Gerald R
GR
Texas Woman's University, Houston 77030, USA. ggoodman@twu.edu
D016208:Databases, Factual; D019544:Equipment Failure Analysis / Q000379:methods* / Q000592:standards; D006801:Humans; D007255:Information Services; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D012308:Risk Management / Q000379:methods* / Q000458:organization & administration; D009626:Terminology as Topic; D014481:United States