Analysis of Safety-Critical Computer Failures in Medical Devices

Alemzadeh, Homa; Iyer, Ravishankar K.; Kalbarczyk, Zbigniew; Raman, Jai

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https://hdl.handle.net/2142/90436 Copy

Description

Title

Analysis of Safety-Critical Computer Failures in Medical Devices

Author(s)

• Alemzadeh, Homa
• Iyer, Ravishankar K.
• Kalbarczyk, Zbigniew
• Raman, Jai

Issue Date

2013-03

Keyword(s)

• Medical devices
• Failure analysis
• Safety
• FDA recalls
• FDA adverse events

Abstract

Incidents due to malfunctioning medical devices are a major cause of serious injury and death in the United States. During 2006–2011, 5,294 recalls and around 1.2 million adverse events were reported to the U.S. Food and Drug Administration (FDA). Almost 23% of these recalls were due to computer-related failures, of which around 94% presented medium-to-high risk of severe health consequences (such as serious injury or death) to patients. This paper 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. We 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.

Publisher

Coordinated Science Laboratory, University of Illinois at Urbana-Champaign

Series/Report Name or Number

Coordinated Science Laboratory Report no. UILU-ENG-13-2203, CRHC-13-03

Type of Resource

text

Language

en

Permalink

http://hdl.handle.net/2142/90436

Sponsor(s)/Grant Number(s)

• Princeton/MARCO / 2009-DT-2049
• Stanford/DTRA / 27451040-49741-A

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