Monitoring device safety in interventional cardiology.
A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques.
Author(s): Matheny, Michael E, Ohno-Machado, Lucila, Resnic, Frederic S
DOI: 10.1197/jamia.M1908