Improving the safety of disposable auto-injection devices: a systematic review of use errors

Abstract

Abstract Auto-injection devices must be easy and intuitive to use, especially in emergency situations. However, there are many reports of safety-related issues affecting auto-injectors and pen injectors, due to usability deficits. To minimize this type of problem, the identification of potential use errors is an important and critical task in usability engineering. The aim of this systematic, qualitative literature review was to identify and catalog use errors related to disposable auto-injection devices. The key terms “auto-injector”, “usability”, and “safety/errors” were used to search in the PubMed and Scopus databases for articles from peer-reviewed journals and conference proceedings published in English or French between 2000 and 2017. Use errors, close calls, and operational difficulties were identified, extracted and hierarchically classified. The analysis showed that of the 1415 initially identified publications, 38 met all the eligibility criteria. A qualitative analysis identified 232 instances of use errors and close calls, which were classified into 10 main categories and then 39 subcategories. The present results could be used to guide the design, evaluation and risk analyses of disposable auto-injection devices. Our approach is in line with the European Union’s latest regulations on improving the safety of medical devices - especially those concerning transparency and traceability.

Keywords

• Auto-injector
• Close call
• Human factors engineering
• Operational difficulty
• Pen injector
• Risk analysis