NDLI: Analysis of Safety-Critical Computer Failures in Medical Devices

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Table of Contents

Cybersecurity Education in Universities

Masthead

Security, Privacy, Policy, and Dependability Roundup

Silver Bullet Talks with Gary Warzala

Safety-Critical Systems: The Next Generation

Analysis of Safety-Critical Computer Failures in Medical Devices

Rock Stars of Big Data House Advertisement

Verifying Cyber-Physical Interactions in Safety-Critical Systems

Fault Injection for Software Certification

Mitigating XML Injection 0-Day Attacks through Strategy-Based Detection Systems

Making Sense from Snowden: What's Significant in the NSA Surveillance Revelations

The End of National Security Reporting?

Computer Security Competitions: Expanding Educational Outcomes

Gone in 15 Seconds: The Limits of Privacy Transparency and Control

Keeping Secrets on Low-Cost Chips

Pain Management for Entrepreneurs: Working with Venture Capital

Securing Control Systems from the Inside: A Case for Mediating Physical Behaviors

Big Data, Big Brother, Big Money

Using Whitelisting to Combat Malware Attacks at Fannie Mae

Bio-hacking: Tapping Life's Code to Deal with Unpredictable Risk

On Abandonment

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Analysis of Safety-Critical Computer Failures in Medical Devices

Content Provider	IEEE Xplore Digital Library
Author	Alemzadeh, H. Iyer, R.K. Kalbarczyk, Z. Raman, J.
Copyright Year	2003
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.
Sponsorship	IEEE Computer Society
Starting Page	14
Ending Page	26
Page Count	13
File Size	1247024
File Format	PDF
ISSN	15407993
Volume Number	11
Issue Number	4
Language	English
Publisher	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Publisher Date	2013-07-01
Publisher Place	U.S.A.
Access Restriction	One Nation One Subscription (ONOS)
Rights Holder	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Subject Keyword	Medical devices Analytical models Safety Security Biomedical equipment Accidents Injuries Computers Failure analysis Government agencies Food and Drug Administration medical devices failure analysis safety FDA recalls FDA adverse events MAUDE database FDA
Content Type	Text
Resource Type	Article
Subject	Law Computer Networks and Communications Electrical and Electronic Engineering

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database

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Evaluating Single Point Failures for Safety & Reliability

Analysis of Safety-Critical Computer Failures in Medical Devices

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Security and Interoperable-Medical-Device Systems, Part 2: Failures, Consequences, and Classification

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