Failure Analysis of Medical Devices

Bearing in mind the three-legged stool approach of device design/manufacturing, patient factors, and surgical technique, this article aims to inform the failure analyst of the metallurgical and materials engineering aspects of a medical device failure investigation. It focuses on the device "fa...

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Bibliographic Details
Published inJournal of failure analysis and prevention Vol. 22; no. 1; pp. 154 - 180
Main Authors Bowers, Matthew, Ganot, Gabriel, Malito, Louis, Kondori, Babak, Ezechukwu, Anyanwu, Svedlund, Felicia, James, Brad
Format Journal Article
LanguageEnglish
Published Materials Park Springer Nature B.V 01.02.2022
Subjects
Corrosive wear
Design factors
Failure analysis
Failure investigations
Failure modes
Materials engineering
Medical equipment
Metallurgical analysis
Orthopedics
Surgical instruments
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Summary:Bearing in mind the three-legged stool approach of device design/manufacturing, patient factors, and surgical technique, this article aims to inform the failure analyst of the metallurgical and materials engineering aspects of a medical device failure investigation. It focuses on the device "failures" that include fracture, wear, and corrosion. The article first discusses failure modes of long-term orthopedic and cardiovascular implants. The article then focuses on short-term implants, typically bone screws and plates. Lastly, failure modes of surgical tools are discussed. The conclusion of this article presents several case studies illustrating the various failure modes discussed throughout.
ISSN:1547-7029
1864-1245
DOI:10.1007/s11668-021-01332-2