Abstract:

In the United States, when medical devices are associated with adverse events that result in death or serious injury, or have malfunctions that could lead to death/serious injury, these events must be reported to the Food and Drug Administration's Center for Devices and Radiologic Health by device manufacturers and user facilities. However, the defects in the medical device evaluation process (e.g., failing to identify the failure mechanisms), can result in assessment risks and reoccurrences of adverse events. This paper presents an approach for medical device evaluation by using failure modes, mechanisms, and effects analysis to identify the root causes and failure mechanisms, which can improve the designs and reliability of medical devices. This method can also help medical device manufacturers to generate an internal evaluation reports for medical device evaluation, which can improve the reporting process to Food and Drug Administration.

Keywords: Medical device; adverse event; failure modes, mechanisms, and effects analysis.

Complete article available to CALCE Consortium Members.