Human Reliability Improvement Strategies for Medical Device Development

Abstract

Medical devices are flourishing thanks to the advances in technology and science Meanwhile the injuries caused by misusing the medical equipment have gradually received attention How to ensure and improve the safety and reliability of medical devices become important Many medical equipment companies do not perform appropriate human reliability assessments during the products design process Owing to the lack of consideration to the factors such as user environment organization etc many human errors have occurred Therefore how to make organizations fully understand the user security through human reliability assessments is an urgent issue This study collects information of human factors from the literature and we organized them into a semi-structured interview outline Next we interviewed some industrial experts by content analysis method to extract important and appropriate criteria for human reliability assessment The criteria from the literature and interviews are then designed to be questionnaires and the Decision Making Trial and Evaluation Laboratory methods (DEMATEL) are used to construct (frequency) impact analysis (Frequency-Impact analysis FIA) and Network relationship map (NRM) analysis It will be used to find out the interrelationship between factors of human reliability assessment We can develop improved pathways for human reliability assessment through frequency-impact analysis and Network Relationship Map analysis (FIA-NRM) Based on the results of the improved pathways the improved strategies and process orders between the dimensions and factors were built The medical device company can adopt the human reliability assessment model of this research to the initial product design and development process in order to reduce the risk of use from the equipment and improve the product’s usability

Date of Award	2019
Original language	English
Supervisor	Peng-Ting Chen (Supervisor)