Context-Rich Medical Device Reports

Abstract

Healthcare technology management (HTM) professionals and other clinicians can provide critical information to help the Food and Drug Administration (FDA) understand serious device issues from the hospital's perspective. By reporting context-rich adverse events to the FDA, HTM professionals help ensure that medical devices remain as safe and effective as possible throughout their use across the continuum of patient care. The medical device reports discussed in this case example were submitted to the FDA by HTM professionals and incorporated additional clinicians' observations. Key context in the medical device reports indicated the scope and relative degree of health hazard of a recurrent device malfunction and informed a class I recall classification for the device.