David Malombe Mutia, Michael Munywoki, Peter N. Muchiri, James Wakiru

The biggest challenge experienced by biomedical engineers during the management of medical equipment during its mid-life cycle includes the identification of failures and the evaluation of proper mitigation. Medical equipment failures are the leading cause of medical errors during therapeutic or diagnostic operations, significantly compromising patient safety. The related errors are the leading cause of death and injuries among hospitalized patients. However, healthcare facilities retain numerous pieces of medical equipment that exhibit divergent operational and maintenance characteristics such as failure frequency, downtime, the presence of redundant units, and failure detection, which inherently compound these challenges. There is a need to identify, evaluate, and prioritize critical medical equipment and their respective failure modes, incorporating patient safety as one of the criteria for ranking the failure modes to address the impact of failure and downtime on patient safety. This research presents findings from a study establishing a unique Health Impact Failure Mode and Effect Analysis (Hi-FMEA) approach, with patient safety as one of the important criteria for prioritizing failure modes. 

Keywords: Failure Mode and Effect Analysis (FMEA), Healthcare Failure Mode and Effect Analysis (HFMEA), Maintenance, Medical Equipment, Critical Medical Equipment.