Toward safer health care: a review strategy of FDA medical device adverse event database to identify and categorize health information technology related events.
Approach to Improving Safety
Improved health information technology (IT) event databases are necessary to better understand safety events associated with health IT, but such databases are lacking. This study describes the use of the Food and Drug Administration Manufacturer and User Facility Device Experience database as a source to identify adverse events related to health IT. Frequently identified contributing factors to such events included hardware and software problems as well as user interface design issues.