An analytical approach to identifying potential use-related issues concerning a medical device under development

Abstract

Identifying potential use-related issues at the onset of the design process of a medical device can reduce use errors, enhance safety and improve usability of the product. Regulatory bodies such as the US Food and Drug Administration (FDA) suggest manufacturers should investigate use-related problems that have occurred in the past with devices that are similar to the one under development. Publically available device incident databases, such as the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, are a good source of information. However, haphazard searches of these databases can be confounding and unproductive. This paper presents a systematic approach to conducting the database searches, analysing the data and reporting the findings in a meaningful way. The approach outlined in this paper is an extract of the methodology that has been effectively implemented in a number of medical products that are already on the market, in submission or under development.

Keywords:

• Medical device
• human factors
• use error
• safety
• effectiveness

Acknowledgements

The authors would like to thank Cambridge Consultants for its support in writing this paper.

Disclosure statement

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.