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No Fault Found Reporting and its Relation to Human Factors Related Design Faults of Medical Devices

This research used human factors methods to investigate the relationship between no fault found (NFF) incident frequency and device usability. NFF reporting occurs when a medical device sent for repair is found to be operating normally. NFF incidents are one of the most recurrent failure modes, and therefore have considerable impact on cost, dependability and safety. An analysis of medical equipment maintenance data was conducted and six devices with a high NFF reporting frequency were identified. Semi-structured interviews and heuristics evaluations revealed that usability issues likely caused many of the NFF incidents. Other factors suspected to contribute to increased NFF reporting include accessory issues, intermittent faults and environmental issues. Finally, in order to validate the results, usability testing was conducted on three of the devices. 23 usability-related design flaws were identified. Therefore devices containing latent usability-related design flaws can be identified through analysis of medical equipment maintenance data.

Identiferoai:union.ndltd.org:LACETR/oai:collectionscanada.gc.ca:OTU.1807/33427
Date22 November 2012
CreatorsFlewwelling, Christopher John
ContributorsCafazzo, Joseph
Source SetsLibrary and Archives Canada ETDs Repository / Centre d'archives des thèses électroniques de Bibliothèque et Archives Canada
Languageen_ca
Detected LanguageEnglish
TypeThesis

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