Applying HFMEA for the prevention of human error during instrument sterilization procedures: A case study on a medical center in central Taiwan

ABSTRACT This study aimed to demonstrate two main points: (1) not only employees from medical equipment supply rooms, but also others who use germ-free equipment, need to be educated; and (2) employee training on the comprehensive concept of asepsis is effective. A medical center in Central Taiwan was investigated for a case study, and 100 samples were stratified and randomly selected from the clinical units exhibiting three top defective rates. Healthcare failure mode and effect analysis (HFMEA) was adopted to evaluate the entire process of equipment sterilization. Hazard analysis and a decision tree were used to identify potential failure modes and factors that should be improved. This study indicates that the causes for failure are mostly human errors, including a lack of knowledge regarding precaution and professional knowledge, busyness, carelessness, cost saving, and unsuitable packages. The second part of our results showed that comprehensive knowledge of the equipment sterilization procedure is required; this can reduce the defect rate from 49% to 3.7%. The results showed that HFMEA could be applied for reducing risk factors in potential failure modes, thereby not only enhancing patient safety but also improving the effectiveness of the management of medical instruments and supplies.