Analysis of Safety-Critical Computer Failures in Medical Devices

Abstract

Malfunctioning medical devices are one of the leading causes of serious injury and death in the US. Between 2006 and 2011, 5,294 recalls and approximately 1.2 million adverse events were reported to the US Food and Drug Administration (FDA). Almost 23 percent of these recalls were due to computer-related failures, of which approximately 94 percent presented medium to high risk of severe health consequences (such as serious injury or death) to patients. This article investigates the causes of failures in computer-based medical devices and their impact on patients by analyzing human-written descriptions of recalls and adverse event reports obtained from public FDA databases. The authors characterize computer-related failures by deriving fault classes, failure modes, recovery actions, and number of devices affected by the recalls. This analysis is used as a basis for identifying safety issues in life-critical medical devices and providing insights on the future challenges in the design of safety-critical medical devices.