Objective: Medical technology designed for Western settings frequently does not function adequately or as intended when placed in an austere clinical environment because of issues such as the instability of the electrical grid, environmental conditions, access to replacement parts, level of provider training and general absence of biomedical engineering support. The purpose of this study was to demonstrate the feasibility of applying failure mode and effects analysis as part of an implementation strategy for medical devices in austere medical settings.
Design: Observational case-study. SETTING/PARTICIPANTS/INTERVENTION: We conducted failure mode and effects analysis sessions with 16 biomedical engineering technicians at two tertiary-care hospitals in Freetown, Sierra Leone. The sessions focused on maintenance and repair processes for the Universal Anaesthesia Machine. Participating biomedical engineers detailed local maintenance and repair processes and failure modes, including resource availability, communication challenges, use errors and physical access to the machine.
Main outcome measure(s): Qualitative descriptive themes in barriers perceived and solutions generated by biomedical engineers.
Results: Solutions generated involved redesigned work processes to increase the efficiency of identifying machine malfunctions, clinician engagement strategies, a formal plan for acquiring spare parts and plans for improving access to the machine. Follow-up interviews indicated solutions generated were implemented and perceived to be effective.
Conclusions: This study demonstrates the feasibility of using the failure mode and effects analysis approach to improve implementation of technology in austere medical environments.
© The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.