Study of the usability of a Dry Powder Inhaler among people aged 12 to 75 years with the aim of creating Instructions For Use

Identifier:  TFG:8140

Handle: https://hdl.handle.net/20.500.11797/TFG8140

Authors:  Espinosa Reyes, Borja

Abstract:
The project presents the development and evaluation of a comprehensive Instructions for Use (IFU) for a Dry Powder Inhaler (DPI), in compliance with ISO and FDA standards. The process began with user needs assessment and risk analysis to identify potential failure modes and create an initial IFU proposal. Usability testing with 50 participants demonstrated a significant improvement in tasks success in correct use from 66% without the IFU to 85% with it. Identified issues, such as improper device cleaning and use, prompted revisions to enhance the IFU’s clarity and effectiveness. This research underscores the critical role of user-centered design in ensuring safety and efficacy of medical device documentation.