Medical Device Recalls for Electronic Components

Abstract

Through the advancement of technology, an ever-increasing number of medical devices contain electronic components and sensors. As a result of these technological advances, smaller devices need more memory, sensors, processing power, and increased energy requirements. Ultimately, the performance of many medical devices is directly dependent on the functionality of these interconnected electronic components. In this article, medical device recalls are examined for malfunctions of electronic systems and components with respect to what system or component specifically did not perform as intended. From this examination, recalls related to electronic medical device systems and components are identified and grouped into common themes. By alerting the Food and Drug Administration to medical device failures, clinical engineering staff can help make manufacturers aware of issues that can be used to make future design changes or mitigations that can ultimately improve the performance and reliability of electronic medical devices.